Sittings · Document

Draft report (COM(2023)0192 – C9-0143/2023 – 2023/0132(COD)) 2023-11-21

Union code relating to medicinal products for human use, and repealing Directive 2001/83/EC and Directive 2009/35/EC

Committee on the Environment, Public Health and Food Safety

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AM_Com_LegReport

Amendment 1208

Marian-Jean Marinescu

Proposal for a directive

Article 83 – paragraph 3

Text proposed by the Commission

Amendment

3. Where the Agency adopts scientific guidelines for the application of this Article it shall consult the Commission and the authorities or bodies referred to in Article 162 of [revised Regulation (EC) No 726/2004].

3. Where the Agency adopts scientific guidelines for the application of this Article it shall consult the Commission and the authorities or bodies as well as the stakeholders referred to in Article 162 of [revised Regulation (EC) No 726/2004].

Or. en

Justification

This amendment fulfils the requirements for an inclusive dialogue with all the stakeholders

Amendment 1209

István Ujhelyi

Proposal for a directive

Article 83 – paragraph 3

Text proposed by the Commission

Amendment

Or. en

Amendment 1210

Joanna Kopcińska

Proposal for a directive

Article 84 – paragraph 1 – introductory part

Text proposed by the Commission

Amendment

1. A regulatory data protection period of four years shall be granted for a medicinal product with respect to a new therapeutic indication not previously authorised in the Union, provided that:

1. A regulatory data protection period of two years shall be granted for a medicinal product with respect to a new and previously unknown therapeutic indication not previously authorised in the Union, provided that:

Or. en

Justification

To avoid situation that reward will be given for off-labels

Amendment 1211

Margrete Auken

Proposal for a directive

Article 84 – paragraph 1 – introductory part

Text proposed by the Commission

Amendment

1. A regulatory data protection period of four years shall be granted for a medicinal product with respect to a new therapeutic indication not previously authorised in the Union, provided that:

1. A regulatory data protection period of two years shall be granted for a medicinal product with respect to a new therapeutic indication not previously authorised in the Union, provided that:

Or. en

Amendment 1212

Nicolás González Casares, Tiemo Wölken

Proposal for a directive

Article 84 – paragraph 1 – introductory part

Text proposed by the Commission

Amendment

1. A regulatory data protection period of four years shall be granted for a medicinal product with respect to a new therapeutic indication not previously authorised in the Union, provided that:

1. A regulatory data protection period of two and a half years shall be granted for a medicinal product with respect to a new therapeutic indication not previously authorised in the Union, provided that:

Or. en

Amendment 1213

Heléne Fritzon

Proposal for a directive

Article 84 – paragraph 1 – introductory part

Text proposed by the Commission

Amendment

1. A regulatory data protection period of four years shall be granted for a medicinal product with respect to a new therapeutic indication not previously authorised in the Union, provided that:

1. A regulatory data protection period of one year shall be granted for a medicinal product with respect to a new therapeutic indication not previously authorised in the Union, provided that:

Or. sv

Justification

The aim is to reduce repurposing in the form of 'salami slicing' (where major diseases are split into subsets in order to benefit from anti-competitive safeguards). It is also reasonable to limit the period of protection, given that repurposing has proven to be an effective way of reducing the time, cost, effort and risk involved in developing medicines, especially for medicines that are already established.

Amendment 1214

Tomislav Sokol

Proposal for a directive

Article 84 – paragraph 1 – introductory part

Text proposed by the Commission

Amendment

1. A regulatory data protection period of four years shall be granted for a medicinal product with respect to a new therapeutic indication not previously authorised in the Union, provided that:

1. A non-cumulative period of regulatory data protection of four years shall be granted for a medicinal product with respect to a a new therapeutic option, including new therapeutic indication, posology, pharmaceutical form, method or route of administration or any other way in which the medicinal product may be used, not previously authorised in the Union, provided that:

Or. en

Amendment 1215

Dolors Montserrat, Nathalie Colin-Oesterlé, Stelios Kympouropoulos

Proposal for a directive

Article 84 – paragraph 1 – introductory part

Text proposed by the Commission

Amendment

1. A regulatory data protection period of four years shall be granted for a medicinal product with respect to a new therapeutic indication not previously authorised in the Union, provided that:

1. A non-cumulative period of regulatory data protection of four years shall be granted for a medicinal product with respect to a new therapeutic option, including a new indication, posology, pharmaceutical form, method or route of administration or any other way in which the medicinal product may be used, not previously authorised in the Union, provided that:

Or. en

Amendment 1216

István Ujhelyi

Proposal for a directive

Article 84 – paragraph 1 – introductory part

Text proposed by the Commission

Amendment

1. A regulatory data protection period of four years shall be granted for a medicinal product with respect to a new therapeutic indication not previously authorised in the Union, provided that:

Or. en

Amendment 1217

Adam Jarubas, Ewa Kopacz, Elżbieta Katarzyna Łukacijewska

Proposal for a directive

Article 84 – paragraph 1 – introductory part

Text proposed by the Commission

Amendment

1. A regulatory data protection period of four years shall be granted for a medicinal product with respect to a new therapeutic indication not previously authorised in the Union, provided that:

Or. en

Amendment 1218

Massimiliano Salini, Francesca Peppucci

Proposal for a directive

Article 84 – paragraph 1 – introductory part

Text proposed by the Commission

Amendment

1. A regulatory data protection period of four years shall be granted for a medicinal product with respect to a new therapeutic indication not previously authorised in the Union, provided that:

1. A non-cumulative period of regulatory data protection of four years shall be granted for a medicinal product with respect to a new therapeutic option, including a new indication, posology, pharmaceutical form, method or route of administration or any other way in which the medical product may be used, not previously authorised in the Union, provided that:

Or. en

Amendment 1219

Cristian-Silviu Buşoi

Proposal for a directive

Article 84 – paragraph 1 – introductory part

Text proposed by the Commission

Amendment

1. A regulatory data protection period of four years shall be granted for a medicinal product with respect to a new therapeutic indication not previously authorised in the Union, provided that:

1. A non-cumulative period of regulatory data protection period of four years shall be granted for a medicinal product with respect to a new therapeutic option, incuding a new indication, posology, pharmaceutical form, method or route of administration or any other way in which the medicinal product may be used, not previously authorised in the Union, provided that:

Or. en

Amendment 1220

Marian-Jean Marinescu

Proposal for a directive

Article 84 – paragraph 1 – introductory part

Text proposed by the Commission

Amendment

1. A regulatory data protection period of four years shall be granted for a medicinal product with respect to a new therapeutic indication not previously authorised in the Union, provided that:

1. A non-cumulative period of regulatory data protection period of four years shall be granted for a medicinal product with respect to a new therapeutic indication not previously authorised in the Union, provided that:

Or. en

Justification

Improves access to medicines

Amendment 1221

Margrete Auken

Proposal for a directive

Article 84 – paragraph 1 – point a

Text proposed by the Commission

Amendment

(a) adequate non-clinical or clinical studies were carried out in relation to the therapeutic indication demonstrating that it is of significant clinical benefit, and

(a) adequate clinical studies with an active-comparator were carried out by the marketing authorisation holder in relation to the therapeutic indication demonstrating that it is of significant clinical benefit, and

Or. en

Amendment 1222

Adam Jarubas, Ewa Kopacz, Elżbieta Katarzyna Łukacijewska

Proposal for a directive

Article 84 – paragraph 1 – point a

Text proposed by the Commission

Amendment

(a) adequate non-clinical or clinical studies were carried out in relation to the therapeutic indication demonstrating that it is of significant clinical benefit, and

(a) adequate non-clinical or clinical evidence was provided in relation to the therapeutic option demonstrating that it is of significant benefit, and

Or. en

Amendment 1223

Cristian-Silviu Buşoi

Proposal for a directive

Article 84 – paragraph 1 – point a

Text proposed by the Commission

Amendment

(a) adequate non-clinical or clinical studies were carried out in relation to the therapeutic indication demonstrating that it is of significant clinical benefit, and

(a) adequate non-clinical or clinical evidence was provided in relation to the therapeutic option demonstrating that it is of significant benefit, and

Or. en

Amendment 1224

Massimiliano Salini, Francesca Peppucci

Proposal for a directive

Article 84 – paragraph 1 – point a

Text proposed by the Commission

Amendment

(a) adequate non-clinical or clinical studies were carried out in relation to the therapeutic indication demonstrating that it is of significant clinical benefit, and

(a) adequate non-clinical or clinical evidence was provided in relation to the therapeutic option demonstrating that it is of significant benefit, and

Or. en

Amendment 1225

Dolors Montserrat, Nathalie Colin-Oesterlé, Stelios Kympouropoulos

Proposal for a directive

Article 84 – paragraph 1 – point a

Text proposed by the Commission

Amendment

(a) adequate non-clinical or clinical studies were carried out in relation to the therapeutic indication demonstrating that it is of significant clinical benefit, and

(a) adequate non-clinical or clinical evidence was provided in relation to the therapeutic option demonstrating that it is of significant benefit, and

Or. en

Amendment 1226

Tomislav Sokol

Proposal for a directive

Article 84 – paragraph 1 – point a

Text proposed by the Commission

Amendment

(a) adequate non-clinical or clinical studies were carried out in relation to the therapeutic indication demonstrating that it is of significant clinical benefit, and

(a) adequate non-clinical or clinical evidence was provided in relation to the therapeutic option demonstrating that it is of significant benefit, and

Or. en

Amendment 1227

Nicolás González Casares, Tiemo Wölken

Proposal for a directive

Article 84 – paragraph 1 – point a

Text proposed by the Commission

Amendment

(a) adequate non-clinical or clinical studies were carried out in relation to the therapeutic indication demonstrating that it is of significant clinical benefit, and

(a) adequate non-clinical or clinical studies were carried out by the marketing authorisation applicant in relation to the therapeutic indication demonstrating that it is of significant clinical benefit, and

Or. en

Amendment 1228

István Ujhelyi

Proposal for a directive

Article 84 – paragraph 1 – point a

Text proposed by the Commission

Amendment

(a) adequate non-clinical or clinical studies were carried out in relation to the therapeutic indication demonstrating that it is of significant clinical benefit, and

(a) adequate non-clinical or clinical evidence was provided in relation to the therapeutic option demonstrating that it is of significant benefit, and

Or. en

Amendment 1229

Jessica Polfjärd

Proposal for a directive

Article 84 – paragraph 1 – point b

Text proposed by the Commission

Amendment

(b) the medicinal product is authorised in accordance with Articles 9 to 12 and has not previously benefitted from data protection, or 25 years have passed since the granting of the initial marketing authorisation of the medicinal product concerned.

(b) the medicinal product is authorised in accordance with Articles 9 to 12 and has not previously benefitted from data protection, or 16 years have passed since the granting of the initial marketing authorisation of the medicinal product concerned.

Or. en

Justification

Restricting incentives for drug repurposing to very old off-patent medicines (over 25 years) may limit the impact of such provision.

Amendment 1230

Adam Jarubas, Ewa Kopacz, Elżbieta Katarzyna Łukacijewska

Proposal for a directive

Article 84 – paragraph 1 – point b

Text proposed by the Commission

Amendment

(b) the medicinal product is authorised in accordance with Articles 9 to 12 and does not fall in the same global marketing authorization as a medicinal product that has previously benefitted from data protection or market exclusivity, or 25 years have passed since the granting of the initial marketing authorisation of the medicinal product concerned.

Or. en

Amendment 1231

István Ujhelyi

Proposal for a directive

Article 84 – paragraph 1 – point b

Text proposed by the Commission

Amendment

Or. en

Amendment 1232

Cristian-Silviu Buşoi

Proposal for a directive

Article 84 – paragraph 1 – point b

Text proposed by the Commission

Amendment

Or. en

Amendment 1233

Dolors Montserrat, Nathalie Colin-Oesterlé, Stelios Kympouropoulos

Proposal for a directive

Article 84 – paragraph 1 – point b

Text proposed by the Commission

Amendment

Or. en

Amendment 1234

Tomislav Sokol

Proposal for a directive

Article 84 – paragraph 1 – point b

Text proposed by the Commission

Amendment

Or. en

Amendment 1235

Massimiliano Salini, Francesca Peppucci

Proposal for a directive

Article 84 – paragraph 1 – point b

Text proposed by the Commission

Amendment

(b) the medicinal product is authorised in accordance with Articles 9 to 12 and does not fall in the same global marketing authorisation as a medical product that has previously benefitted from data protection or market exclusivity, or 25 years have passed since the granting of the initial marketing authorisation of the medicinal product concerned.

Or. en

Amendment 1236

Jessica Polfjärd

Proposal for a directive

Article 84 – paragraph 2

Text proposed by the Commission

Amendment

2. The data protection period referred to in paragraph 1 may only be granted once for any given medicinal product.

deleted

Or. en

Justification

Restricting incentives by only offering data protection periods once for any given medicinal product, may limit the impact of such provision.

Amendment 1237

Heléne Fritzon

Proposal for a directive

Article 84 – paragraph 2

Text proposed by the Commission

Amendment

2. The data protection period referred to in paragraph 1 may only be granted once for any given medicinal product.

2. The data protection period referred to in paragraph 1 may only be granted once for a given medicinal product and provided that an established medicinal product continues to be available to patients during treatment without direct or indirect unreasonable changes in price or conditions.

Or. sv

Justification

This amendment is being proposed in order to minimise the risk of undue price increases and market abuse where established medicinal products are repurposed, which is a common phenomenon. It sets the conditions for continued supply of the established medicinal product, taking into account the initial indication and the patients being treated, without imposing, directly or indirectly, unfair price or contractual changes in Member States.

Amendment 1238

Massimiliano Salini, Francesca Peppucci

Proposal for a directive

Article 84 – paragraph 3

Text proposed by the Commission

Amendment

3. During the data protection period referred to in paragraph 1, the marketing authorisation shall indicate that the medicinal product is an existing medicinal product authorised in the Union that has been authorised with an additional therapeutic indication.

3. During the data protection period referred to in paragraph 1, the medicinal product shall be appointed as a value added medicinal product.

Or. en

Amendment 1239

Tomislav Sokol

Proposal for a directive

Article 84 – paragraph 3

Text proposed by the Commission

Amendment

3. During the data protection period referred to in paragraph 1, the medicinal product shall be designated as a value added medicinal product.

Or. en

Amendment 1240

Cristian-Silviu Buşoi

Proposal for a directive

Article 84 – paragraph 3

Text proposed by the Commission

Amendment

3. During the data protection period referred to in paragraph 1, the medicinal product shall be designated as a value added medicinal product.

Or. en

Amendment 1241

Dolors Montserrat, Nathalie Colin-Oesterlé, Stelios Kympouropoulos

Proposal for a directive

Article 84 – paragraph 3

Text proposed by the Commission

Amendment

3. During the data protection period referred to in paragraph 1, the medicinal product should be designated as a value added medicinal product.

Or. en

Amendment 1242

Nicolás González Casares, Tiemo Wölken

Proposal for a directive

Article 84 a (new)

Text proposed by the Commission

Amendment

Article84a

Reporting of research and development costs from the marketing authorisation holder

1. Where the marketing authorisation holder benefits from data and market protection granted under this Directive it shall:

(a) Upon request, submit to the Commission and/or the competent authorities of the Member States responsible for pricing and reimbursement an electronic report with detailed information on their expenditure in research and development activities related to the medicinal product;

(b) make the report available within 30 days from the receipt of the request;

(c) publish a summary of the report on the same webpage where the information described in Article 57 will be published. The link should be communicated to the competent authority of the Member State granting the marketing authorisation or, where appropriate, to the Agency;

(d) ensure that the electronic report and lay summary are accurate and have been audited by an independent external auditor.

2. The Commission shall promote transparency and data sharing mechanisms regarding reimbursement prices of medicinal products by the Member States.

3. The Commission shall adopt delegated acts to lay down the methodology and format in which the information should be reported and published pursuant to paragraph 1.

Or. en

Amendment 1243

Alessandra Moretti

Proposal for a directive

Article 84 a (new)

Text proposed by the Commission

Amendment

Article84a

Reporting of research and development costs from the marketing authorisation holder

1. Where the marketing authorisation holder benefits from data and market protection granted under this Directive it shall:

(a) Upon request, submit to the Commission and the competent authorities of the Member States responsible for pricing and reimbursement a report with detailed information on their actual costs and expenditure in research and development activities related to the medicinal product;

(b) make the report available within 30 days from the receipt of the request;

(d) ensure that the electronic report and lay summary are accurate and have been audited by an independent external auditor.

2.The Commission shall adopt implementing in acts to lay down the methodology and format in which the information should be reported and published pursuant to paragraph 1.

Or. en

Amendment 1244

Kateřina Konečná

Proposal for a directive

Article 84 a (new)

Text proposed by the Commission

Amendment

Article84a

Reporting of research and development costs from the marketing authorisation holder

1. Where the marketing authorisation holder benefits from data and market protection granted under this Directive it shall:

(b) make the report available within 30 days from the receipt of the request;

(d) ensure that the electronic report and lay summary are accurate and have been audited by an independent external auditor.

2.The Commission shall adopt implementing in acts to lay down the methodology and format in which the information should be reported and published pursuant to paragraph 1.

Or. en

Amendment 1245

Cristian-Silviu Buşoi

Proposal for a directive

Article 85 – paragraph 1 – introductory part

Text proposed by the Commission

Amendment

Patent rights, or supplementary protection certificates under the [Regulation (EC) No 469/2009 - OP please replace reference by new instrument when adopted] shall not be regarded as infringed when a reference medicinal product is used for the purposes of:

Patent rights, or supplementary protection certificates under the [Regulation (EC) No 469/2009 - OP please replace reference by new instrument when adopted] shall not be regarded as infringed when studies, trials and other activities are conducted and the subsequent practical requirements associated with such activities, for the purpose of:

Or. en

Amendment 1246

Adam Jarubas, Ewa Kopacz, Elżbieta Katarzyna Łukacijewska

Proposal for a directive

Article 85 – paragraph 1 – introductory part

Text proposed by the Commission

Amendment

Patent rights, or supplementary protection certificates under the [Regulation (EC) No 469/2009 - OP please replace reference by new instrument when adopted] shall not be regarded as infringed when necessary studies, trials and other activities are conducted exclusively for the purpose of:

Or. en

Amendment 1247

Stelios Kympouropoulos

Proposal for a directive

Article 85 – paragraph 1 – introductory part

Text proposed by the Commission

Amendment

Patent rights, or supplementary protection certificates under the [Regulation (EC) No 469/2009 - OP please replace reference by new instrument when adopted] shall not be regarded as infringed when studies, trials and other activities are conducted for the purpose of:

Or. en

Amendment 1248

Tomislav Sokol

Proposal for a directive

Article 85 – paragraph 1 – introductory part

Text proposed by the Commission

Amendment

Patent rights, or supplementary protection certificates under the [Regulation (EC) No 469/2009 - OP please replace reference by new instrument when adopted] shall not be regarded as infringed when studies, trials and other activities are conducted for the purpose of:

Or. en

Amendment 1249

Kateřina Konečná

Proposal for a directive

Article 85 – paragraph 1 – introductory part

Text proposed by the Commission

Amendment

Patent rights, or supplementary protection certificates under the [Regulation (EC) No 469/2009 - OP please replace reference by new instrument when adopted] shall not be regarded as infringed when studies, trials and other activities are conducted for the purpose of:

Or. en

Amendment 1250

Marian-Jean Marinescu

Proposal for a directive

Article 85 – paragraph 1 – introductory part

Text proposed by the Commission

Amendment

Patent rights, or supplementary protection certificates under the [Regulation (EC) No 469/2009 - OP please replace reference by new instrument when adopted] shall not be regarded as infringed when studies, trials and other activities are conducted for the purpose of:

Or. en

Justification

It is important to refer to all the activities allowed, not just to MA application, otherwise any other activity done with the API would be an infringement, which is not the intention of the legislation.

Amendment 1251

Nicolás González Casares, Tiemo Wölken

Proposal for a directive

Article 85 – paragraph 1 – introductory part

Text proposed by the Commission

Amendment

Patent rights, or supplementary protection certificates under the [Regulation (EC) No 469/2009 - OP please replace reference by new instrument when adopted] shall not be regarded as infringed when:

Or. en

Amendment 1252

Margrete Auken

Proposal for a directive

Article 85 – paragraph 1 – introductory part

Text proposed by the Commission

Amendment

Patent rights, or supplementary protection certificates under the [Regulation (EC) No 469/2009 - OP please replace reference by new instrument when adopted] shall not be regarded as infringed when:

Or. en

Amendment 1253

Maria Angela Danzì

Proposal for a directive

Article 85 – paragraph 1 – introductory part

Text proposed by the Commission

Amendment

Patent rights, or supplementary protection certificates under the [Regulation (EC) No 469/2009 - OP please replace reference by new instrument when adopted] shall not be regarded as infringed when:

Or. en

Justification

All obstacles that prevent generic and biosimilar medicines from entering the market on the first day after the protection expires should be removed.

Amendment 1254

Alessandra Moretti

Proposal for a directive

Article 85 – paragraph 1 – introductory part

Text proposed by the Commission

Amendment

Patent rights, or supplementary protection certificates under the [Regulation (EC) No 469/2009 - OP please replace reference by new instrument when adopted] shall not be regarded as infringed when:

Or. en

Amendment 1255

Ondřej Knotek, Billy Kelleher

Proposal for a directive

Article 85 – paragraph 1 – introductory part

Text proposed by the Commission

Amendment

Patent rights, or supplementary protection certificates under the [Regulation (EC) No 469/2009 - OP please replace reference by new instrument when adopted] shall not be regarded as infringed when:

Or. en

Amendment 1256

Tomislav Sokol

Proposal for a directive

Article 85 – paragraph 1 – point a

Text proposed by the Commission

Amendment

(a) studies, trials and other activities conducted to generate data for an application, for:

deleted

(i) a marketing authorisation of generic, biosimilar, hybrid or bio-hybrid medicinal products and for subsequent variations;

(ii) health technology assessment as defined in Regulation (EU) 2021/2282;

(iii) pricing and reimbursement.

Or. en

Amendment 1257

Dolors Montserrat, Massimiliano Salini, Nathalie Colin-Oesterlé

Proposal for a directive

Article 85 – paragraph 1 – point a – introductory part

Text proposed by the Commission

Amendment

(a) studies, trials and other activities conducted to generate data for an application, for:

(a) studies, trials and other activities are conducted to generate data for the purpose of:

(i) obtaining a marketing authorisation of generic, biosimilar, hybrid or bio-hybrid medicinal products and for subsequent variations;

(ii) conducting a health technology assessment as defined in Regulation (EU) 2021/2282;

(iii) obtaining pricing and reimbursement approval;

(iv) complying with any other regulatory or administrative requirement in the Union or elsewhere;

and the subsequent practical requirements associated with such activities.

Or. en

Amendment 1258

Stelios Kympouropoulos

Proposal for a directive

Article 85 – paragraph 1 – point a – introductory part

Text proposed by the Commission

Amendment

(a) studies, trials and other activities conducted to generate data for an application, for:

(a) (i) obtaining for a marketing authorisation and subsequent variations;

(ii) conducting a health technology assessment as defined in Regulation (EU) 2021/2282;

(iii) obtaining for pricing and reimbursement approval;

(iv) enabling public and private procurement of medicinal products after expiry of the relevant patents or supplementary protection certificate;

(v) complying with any other regulatory or administrative requirement in the Union or elsewhere;

and the subsequent practical requirements associated with such activities.

Or. en

Amendment 1259

Kateřina Konečná

Proposal for a directive

Article 85 – paragraph 1 – point a – introductory part

Text proposed by the Commission

Amendment

(a) studies, trials and other activities conducted to generate data for an application, for:

(a) applying to a marketing authorisation of generic, biosimilar, hybrid or bio-hybrid medicinal products and for subsequent variation

facilitating health technology assessment as defined in Regulation (EU) 2021/2282;

filing for pricing and reimbursement;

participating in a tender to enable market entry of generic and biosimilar products as soon as the relevant patents or supplementary protection certificates expire.

Or. en

Amendment 1260

Cristian-Silviu Buşoi

Proposal for a directive

Article 85 – paragraph 1 – point a – introductory part

Text proposed by the Commission

Amendment

(a) studies, trials and other activities conducted to generate data for an application, for:

(a) deletion

Or. en

Amendment 1261

Nicolás González Casares, Tiemo Wölken

Proposal for a directive

Article 85 – paragraph 1 – point a – introductory part

Text proposed by the Commission

Amendment

(a) studies, trials and other activities conducted to generate data for an application, for:

(a) studies, trials and other activities are conducted for the purpose of:

Or. en

Amendment 1262

Adam Jarubas, Ewa Kopacz, Elżbieta Katarzyna Łukacijewska

Proposal for a directive

Article 85 – paragraph 1 – point a – introductory part

Text proposed by the Commission

Amendment

(a) studies, trials and other activities conducted to generate data for an application, for:

(a) obtaining a marketing authorisation and subsequent variations;

Or. en

Amendment 1263

Ondřej Knotek, Billy Kelleher

Proposal for a directive

Article 85 – paragraph 1 – point a – introductory part

Text proposed by the Commission

Amendment

(a) studies, trials and other activities conducted to generate data for an application, for:

(a) studies, trials and other activities are undertaken in order to:

Or. en

Amendment 1264

Margarita de la Pisa Carrión

Proposal for a directive

Article 85 – paragraph 1 – point a – introductory part

Text proposed by the Commission

Amendment

(a) studies, trials and other activities conducted to generate data for an application, for:

(a) studies and trials needed to generate data for an application, for:

Or. en

Amendment 1265

Maria Angela Danzì

Proposal for a directive

Article 85 – paragraph 1 – point a – introductory part

Text proposed by the Commission

Amendment

(a) studies, trials and other activities conducted to generate data for an application, for:

(a) studies, trials and other activities conducted for the purpose of :

Or. en

Justification

This amendment proposes clarifications needed for the Bolar exemption to be effectively implemented. There should be no doubt about the application for authorization and filing for pricing and reimbursement, as well as conducting health technology assessment. Applying for supply is also needed to effectively achieve a day-one launch.

Amendment 1266

Alessandra Moretti

Proposal for a directive

Article 85 – paragraph 1 – point a – introductory part

Text proposed by the Commission

Amendment

(a) studies, trials and other activities conducted to generate data for an application, for:

(a) studies, trials and other activities are conducted for the purpose of:

Or. en

Amendment 1267

Stelios Kympouropoulos

Proposal for a directive

Article 85 – paragraph 1 – point a – point i

Text proposed by the Commission

Amendment

(i) a marketing authorisation of generic, biosimilar, hybrid or bio-hybrid medicinal products and for subsequent variations;

deleted

Or. en

Amendment 1268

Adam Jarubas, Ewa Kopacz, Elżbieta Katarzyna Łukacijewska

Proposal for a directive

Article 85 – paragraph 1 – point a – point i

Text proposed by the Commission

Amendment

(i) a marketing authorisation of generic, biosimilar, hybrid or bio-hybrid medicinal products and for subsequent variations;

deleted

Or. en

Amendment 1269

Kateřina Konečná

Proposal for a directive

Article 85 – paragraph 1 – point a – point i

Text proposed by the Commission

Amendment

(i) a marketing authorisation of generic, biosimilar, hybrid or bio-hybrid medicinal products and for subsequent variations;

deleted

Or. en

Amendment 1270

Margarita de la Pisa Carrión

Proposal for a directive

Article 85 – paragraph 1 – point a – point i

Text proposed by the Commission

Amendment

(i) a marketing authorisation of generic, biosimilar, hybrid or bio-hybrid medicinal products and for subsequent variations;

(i) medical authorization for comercialization

Or. en

Amendment 1271

Tomislav Sokol

Proposal for a directive

Article 85 – paragraph 1 – point a – point i

Text proposed by the Commission

Amendment

(i) a marketing authorisation of generic, biosimilar, hybrid or bio-hybrid medicinal products and for subsequent variations;

(i) obtaining a marketing authorisation and subsequent variations;

Or. en

Amendment 1272

Cristian-Silviu Buşoi

Proposal for a directive

Article 85 – paragraph 1 – point a – point i

Text proposed by the Commission

Amendment

(i) a marketing authorisation of generic, biosimilar, hybrid or bio-hybrid medicinal products and for subsequent variations;

(i) obtaining a marketing authorisation and subsequent variations;

Or. en

Amendment 1273

Ondřej Knotek, Billy Kelleher

Proposal for a directive

Article 85 – paragraph 1 – point a – point i

Text proposed by the Commission

Amendment

(i) a marketing authorisation of generic, biosimilar, hybrid or bio-hybrid medicinal products and for subsequent variations;

(i) obtain a marketing authorisation and its subsequent variations;

Or. en

Amendment 1274

Nicolás González Casares, Tiemo Wölken

Proposal for a directive

Article 85 – paragraph 1 – point a – point i

Text proposed by the Commission

Amendment

(i) a marketing authorisation of generic, biosimilar, hybrid or bio-hybrid medicinal products and for subsequent variations;

(i) obtaining a marketing authorisation for productsand subsequent variations;

Or. en

Amendment 1275

Alessandra Moretti

Proposal for a directive

Article 85 – paragraph 1 – point a – point i

Text proposed by the Commission

Amendment

(i) a marketing authorisation of generic, biosimilar, hybrid or bio-hybrid medicinal products and for subsequent variations;

(i) applying to a marketing authorisation of generic, biosimilar, hybrid or bio-hybrid medicinal products and for subsequent variations;

Or. en

Amendment 1276

Maria Angela Danzì

Proposal for a directive

Article 85 – paragraph 1 – point a – point i

Text proposed by the Commission

Amendment

(i) a marketing authorisation of generic, biosimilar, hybrid or bio-hybrid medicinal products and for subsequent variations;

(i) applying for a marketing authorisation and subsequent variations;

Or. en

Justification

Amendment 1277

Marian-Jean Marinescu

Proposal for a directive

Article 85 – paragraph 1 – point a – point i

Text proposed by the Commission

Amendment

(i) a marketing authorisation of generic, biosimilar, hybrid or bio-hybrid medicinal products and for subsequent variations;

(i) obtaining a marketing authorisation of generic, biosimilar, hybrid or bio-hybrid medicinal products and for subsequent variations;

Or. en

Justification

Amendment 1278

Stelios Kympouropoulos

Proposal for a directive

Article 85 – paragraph 1 – point a – point ii

Text proposed by the Commission

Amendment

(ii) health technology assessment as defined in Regulation (EU) 2021/2282;

deleted

Or. en

Amendment 1279

Adam Jarubas, Ewa Kopacz, Elżbieta Katarzyna Łukacijewska

Proposal for a directive

Article 85 – paragraph 1 – point a – point ii

Text proposed by the Commission

Amendment

(ii) health technology assessment as defined in Regulation (EU) 2021/2282;

deleted

Or. en

Amendment 1280

Kateřina Konečná

Proposal for a directive

Article 85 – paragraph 1 – point a – point ii

Text proposed by the Commission

Amendment

(ii) health technology assessment as defined in Regulation (EU) 2021/2282;

deleted

Or. en

Amendment 1281

Ondřej Knotek, Billy Kelleher

Proposal for a directive

Article 85 – paragraph 1 – point a – point ii

Text proposed by the Commission

Amendment

(ii) health technology assessment as defined in Regulation (EU) 2021/2282;

(ii) undertake health technology assessment as defined in Regulation (EU) 2021/2282;

Or. en

Amendment 1282

Tomislav Sokol

Proposal for a directive

Article 85 – paragraph 1 – point a – point ii

Text proposed by the Commission

Amendment

(ii) health technology assessment as defined in Regulation (EU) 2021/2282;

(ii) conducting a health technology assessment as defined in Regulation (EU) 2021/2282;

Or. en

Amendment 1283

Alessandra Moretti

Proposal for a directive

Article 85 – paragraph 1 – point a – point ii

Text proposed by the Commission

Amendment

(ii) health technology assessment as defined in Regulation (EU) 2021/2282;

(ii) facilitating health technology assessment as defined in Regulation (EU) 2021/2282;

Or. en

Amendment 1284

Cristian-Silviu Buşoi

Proposal for a directive

Article 85 – paragraph 1 – point a – point ii

Text proposed by the Commission

Amendment

(ii) health technology assessment as defined in Regulation (EU) 2021/2282;

(ii) conducting a health technology assessment as defined in Regulation (EU) 2021/2282;

Or. en

Amendment 1285

Maria Angela Danzì

Proposal for a directive

Article 85 – paragraph 1 – point a – point ii

Text proposed by the Commission

Amendment

(ii) health technology assessment as defined in Regulation (EU) 2021/2282;

(ii) conducting health technology assessment as defined in Regulation (EU) 2021/2282;

Or. en

Amendment 1286

Marian-Jean Marinescu

Proposal for a directive

Article 85 – paragraph 1 – point a – point ii

Text proposed by the Commission

Amendment

(ii) health technology assessment as defined in Regulation (EU) 2021/2282;

(ii) conducting a health technology assessment as defined in Regulation (EU) 2021/2282;

Or. en

Justification

Amendment 1287

Nicolás González Casares, Tiemo Wölken

Proposal for a directive

Article 85 – paragraph 1 – point a – point ii

Text proposed by the Commission

Amendment

(ii) health technology assessment as defined in Regulation (EU) 2021/2282;

(ii) conducting a health technology assessment as defined in Regulation (EU) 2021/2282;

Or. en

Amendment 1288

Margarita de la Pisa Carrión

Proposal for a directive

Article 85 – paragraph 1 – point a – point iii

Text proposed by the Commission

Amendment

(iii) pricing and reimbursement.

deleted

Or. en

Amendment 1289

Adam Jarubas, Ewa Kopacz, Elżbieta Katarzyna Łukacijewska

Proposal for a directive

Article 85 – paragraph 1 – point a – point iii

Text proposed by the Commission

Amendment

(iii) pricing and reimbursement.

deleted

Or. en

Amendment 1290

Kateřina Konečná

Proposal for a directive

Article 85 – paragraph 1 – point a – point iii

Text proposed by the Commission

Amendment

(iii) pricing and reimbursement.

deleted

Or. en

Amendment 1291

Stelios Kympouropoulos

Proposal for a directive

Article 85 – paragraph 1 – point a – point iii

Text proposed by the Commission

Amendment

(iii) pricing and reimbursement.

deleted

Or. en

Amendment 1292

Tomislav Sokol

Proposal for a directive

Article 85 – paragraph 1 – point a – point iii

Text proposed by the Commission

Amendment

(iii) pricing and reimbursement.

(iii) obtaining pricing and reimbursement approval;

Or. en

Amendment 1293

Cristian-Silviu Buşoi

Proposal for a directive

Article 85 – paragraph 1 – point a – point iii

Text proposed by the Commission

Amendment

(iii) pricing and reimbursement.

(iii) obtaining pricing and reimbursement approval.

Or. en

Amendment 1294

Maria Angela Danzì

Proposal for a directive

Article 85 – paragraph 1 – point a – point iii

Text proposed by the Commission

Amendment

(iii) pricing and reimbursement.

(iii) obtaining pricing and reimbursement approval;

Or. en

Justification

It is essential to clarify that the exemption allows to obtain a pricing and reimbursement decision as well as to be able to conduct procurement procedures for supply after IP expiry. This is the only way to effectively allow day-one launch, which otherwise would be impossible.

Amendment 1295

Ondřej Knotek, Billy Kelleher

Proposal for a directive

Article 85 – paragraph 1 – point a – point iii

Text proposed by the Commission

Amendment

(iii) pricing and reimbursement.

(iii) obtain pricing and reimbursement listing;

Or. en

Amendment 1296

Alessandra Moretti

Proposal for a directive

Article 85 – paragraph 1 – point a – point iii

Text proposed by the Commission

Amendment

(iii) pricing and reimbursement.

(iii) filing for pricing and reimbursement.

Or. en

Amendment 1297

Marian-Jean Marinescu

Proposal for a directive

Article 85 – paragraph 1 – point a – point iii

Text proposed by the Commission

Amendment

(iii) pricing and reimbursement.

(iii) obtaining pricing and reimbursement approval;

Or. en

Justification

Amendment 1298

Nicolás González Casares, Tiemo Wölken

Proposal for a directive

Article 85 – paragraph 1 – point a – point iii

Text proposed by the Commission

Amendment

(iii) pricing and reimbursement.

(iii) obtaining pricing and reimbursement approval;

Or. en

Amendment 1299

Nicolás González Casares, Tiemo Wölken

Proposal for a directive

Article 85 – paragraph 1 – point a – point iii a (new)

Text proposed by the Commission

Amendment

(iii a) participating in public and private procurement tenders of medicinal products for which the fulfillment of the obligations laid out in the tender will commence after the expiry of the relevant patents or supplementary protection certificates;

Or. en

Amendment 1300

Alessandra Moretti

Proposal for a directive

Article 85 – paragraph 1 – point a – point iii a (new)

Text proposed by the Commission

Amendment

(iii a) participating in a tender to enable market entry of generic and biosimilar products as soon as the relevant patents or supplementary protection certificates expire.

Or. en

Amendment 1301

Maria Angela Danzì

Proposal for a directive

Article 85 – paragraph 1 – point a – point iii a (new)

Text proposed by the Commission

Amendment

(iii a) enabling public and private procurement of medicinal products after expiry of the relevant patents or supplementary protection certificate;

Or. en

Justification

Amendment 1302

Tomislav Sokol

Proposal for a directive

Article 85 – paragraph 1 – point a – point iii a (new)

Text proposed by the Commission

Amendment

(iii a) enabling public and private procurement of medicinal products after expiry of the relevant patents or supplementary protection certificate;

Or. en

Amendment 1303

Cristian-Silviu Buşoi

Proposal for a directive

Article 85 – paragraph 1 – point a – point iii a (new)

Text proposed by the Commission

Amendment

(iii a) enabling public and private procurement of medicinal products after expiry of the relevant patents or supplementary protection certificate;

Or. en

Amendment 1304

Marian-Jean Marinescu

Proposal for a directive

Article 85 – paragraph 1 – point a – point iii a (new)

Text proposed by the Commission

Amendment

(iii a) enabling public and private procurement of medicinal products after expiry of the relevant patents or supplementary protection certificate

Or. en

Justification

Amendment 1305

Ondřej Knotek, Billy Kelleher

Proposal for a directive

Article 85 – paragraph 1 – point a – point iii a (new)

Text proposed by the Commission

Amendment

(iii a) comply with all other regulatory or administrative requirement in the Union or in third countries;

Or. en

Amendment 1306

Margrete Auken

Proposal for a directive

Article 85 – paragraph 1 – point a – point iii a (new)

Text proposed by the Commission

Amendment

(iii a) Bolar examption for pre-production of products

Or. en

Amendment 1307

Nicolás González Casares, Tiemo Wölken

Proposal for a directive

Article 85 – paragraph 1 – point a – point iii b (new)

Text proposed by the Commission

Amendment

(iii b) complying with any other regulatory or administrative requirements necessary for the purpose of placing the medicinal product on the Union market or for export in third countries markets, after expiration of the patent or supplementary protection certificate.

Or. en

Amendment 1308

Maria Angela Danzì

Proposal for a directive

Article 85 – paragraph 1 – point a – point iii b (new)

Text proposed by the Commission

Amendment

(iii b) complying with any other regulatory or administrative requirement in the Union or elsewhere;

and the subsequent practical requirements associated with such activities.

Or. en

Justification

Any other minor but still necessary regulatory and administrative requirements for obtaining approvals (eg. validation of escalation processes) should also be included, or otherwise the whole purpose of the Bolar would be frustrated.

Amendment 1309

Marian-Jean Marinescu

Proposal for a directive

Article 85 – paragraph 1 – point a – point iii b (new)

Text proposed by the Commission

Amendment

(iii b) complying with any other regulatory or administrative requirement in the Union or elsewhere and the subsequent practical requirements associated with such activities.

Or. en

Justification

Amendment 1310

Ondřej Knotek, Billy Kelleher

Proposal for a directive

Article 85 – paragraph 1 – point a – point iii b (new)

Text proposed by the Commission

Amendment

(iii b) enable public and private procurement of medicinal products for the supply after expiry of the relevant patents or supplementary protection certificate;

Or. en

Amendment 1311

Tomislav Sokol

Proposal for a directive

Article 85 – paragraph 1 – point a – point iii b (new)

Text proposed by the Commission

Amendment

(iii b) complying with any other regulatory or administrative requirement in the Union or elsewhere;

Or. en

Amendment 1312

Cristian-Silviu Buşoi

Proposal for a directive

Article 85 – paragraph 1 – point a – point iii c (new)

Text proposed by the Commission

Amendment

(iii c) complying with any other regulatory or administrative requirement in the Union or elsewhere;

Or. en

Amendment 1313

Tomislav Sokol

Proposal for a directive

Article 85 – paragraph 1 – point a – point iii c (new)

Text proposed by the Commission

Amendment

(iii c) and the subsequent practical requirements associated with such activities.

Or. en

Amendment 1314

Ondřej Knotek, Billy Kelleher

Proposal for a directive

Article 85 – paragraph 1 – point a a (new)

Text proposed by the Commission

Amendment

(a a) the subsequent practical requirements linked to such activities.

Or. en

Amendment 1315

Cristian-Silviu Buşoi

Proposal for a directive

Article 85 – paragraph 1 – point b

Text proposed by the Commission

Amendment

(b) the activities conducted exclusively for the purposes set out in point (a), may cover the submission of the application for a marketing authorisation and the offer, manufacture, sale, supply, storage, import, use and purchase of patented medicinal products or processes, including by third party suppliers and service providers.

deleted

Or. en

Amendment 1316

Adam Jarubas, Ewa Kopacz, Elżbieta Katarzyna Łukacijewska

Proposal for a directive

Article 85 – paragraph 1 – point b

Text proposed by the Commission

Amendment

(b) conducting a health technology assessment as defined in Regulation (EU) 2021/2282;

Or. en

Amendment 1317

Dolors Montserrat, Nathalie Colin-Oesterlé, Massimiliano Salini

Proposal for a directive

Article 85 – paragraph 1 – point b

Text proposed by the Commission

Amendment

(b) the activities conducted exclusively for the purposes set out in point (a) include the submission of the application for a marketing authorisation and the offering, manufacture, sale, supply, storage, import, export, use and purchase of products or processes, including by third party suppliers and service providers.

This exception shall not cover the placing on the market in a Member State, while relevant patent rights or supplementary protection certificates are in force in that Member State, of the medicinal products purposes.

Or. en

Amendment 1318

Margrete Auken

Proposal for a directive

Article 85 – paragraph 1 – point b

Text proposed by the Commission

Amendment

(b) the activities conducted exclusively for the purposes set out in point (a), may cover the submission of relevant documents to competent authorities, including the application for a marketing authorisation and the offer, health technology assessment, manufacture, sale, supply, storage, import, export, use and purchase of patented medicinal products or processes, including by third party suppliers and service providers.

Or. en

Amendment 1319

Marian-Jean Marinescu

Proposal for a directive

Article 85 – paragraph 1 – point b

Text proposed by the Commission

Amendment

(b) The activities falling within the first subparagraph include the offering, manufacture, sale, supply, storage, import, export, use and purchase of products or processes, including by third party suppliers and service providers.

Or. en

Justification

Amendment 1320

Tomislav Sokol

Proposal for a directive

Article 85 – paragraph 1 – point b

Text proposed by the Commission

Amendment

Or. en

Amendment 1321

Maria Angela Danzì

Proposal for a directive

Article 85 – paragraph 1 – point b

Text proposed by the Commission

Amendment

Or. en

Amendment 1322

Ondřej Knotek, Billy Kelleher

Proposal for a directive

Article 85 – paragraph 1 – point b

Text proposed by the Commission

Amendment

(b) Those activities falling within the first subparagraph include the offering, manufacture, sale, supply, storage, import, export, use and purchase of products or processes, including by third party suppliers and service providers.

Or. en

Amendment 1323

Stelios Kympouropoulos

Proposal for a directive

Article 85 – paragraph 1 – point b

Text proposed by the Commission

Amendment

(b) the activities conducted for the purposes set out in point (a), include the offering, manufacture, sale, supply, storage, import, export, use and purchase of products or processes, including by third party suppliers and service providers.

Or. en

Amendment 1324

Nicolás González Casares, Tiemo Wölken

Proposal for a directive

Article 85 – paragraph 1 – point b

Text proposed by the Commission

Amendment

(b) the activities conducted exclusively for the purposes set out in point (a), shall cover the offering, manufacture, sale, supply, storage, import, export, use and purchase of products or processes, including by third party suppliers and service providers.

Or. en

Amendment 1325

Margarita de la Pisa Carrión

Proposal for a directive

Article 85 – paragraph 1 – point b

Text proposed by the Commission

Amendment

(b) the activities conducted exclusively for the purposes set out in point (a), may cover manufacture, sale, supply, storage, import, use and purchase of patented medicinal products or processes, including by third party suppliers and service providers.

Or. en

Amendment 1326

Alessandra Moretti

Proposal for a directive

Article 85 – paragraph 1 – point b

Text proposed by the Commission

Amendment

(b) the activities falling under the first subparagraph include the submission of the relevant files to the competent authorities or bodies for their assessment, the offer, manufacture, sale, supply, storage, import, export, use and purchase of products or processes, including by third party suppliers and service providers.

Or. en

Amendment 1327

Kateřina Konečná

Proposal for a directive

Article 85 – paragraph 1 – point b

Text proposed by the Commission

Amendment

Or. en

Amendment 1328

Adam Jarubas, Ewa Kopacz, Elżbieta Katarzyna Łukacijewska

Proposal for a directive

Article 85 – paragraph 1 – point b a (new)

Text proposed by the Commission

Amendment

(b a) obtaining pricing and reimbursement approval;

Or. en

Amendment 1329

Adam Jarubas, Ewa Kopacz, Elżbieta Katarzyna Łukacijewska

Proposal for a directive

Article 85 – paragraph 1 – point b b (new)

Text proposed by the Commission

Amendment

(b b) enabling public and private procurement of medicinal products after expiry of the relevant patents or supplementary protection certificate;

Or. en

Amendment 1330

Adam Jarubas, Ewa Kopacz, Elżbieta Katarzyna Łukacijewska

Proposal for a directive

Article 85 – paragraph 1 – point b c (new)

Text proposed by the Commission

Amendment

(b c) complying with any other regulatory or administrative requirement in the Union or elsewhere;

Or. en

Amendment 1331

Adam Jarubas, Ewa Kopacz, Elżbieta Katarzyna Łukacijewska

Proposal for a directive

Article 85 – paragraph 1 a (new)

Text proposed by the Commission

Amendment

The activities falling within the first subparagraph include the offering, manufacturing, selling, suppling, storing, importing, exporting, using and purchasing of products or processes, including by third party suppliers and service providers.

Or. en

Amendment 1332

Cristian-Silviu Buşoi

Proposal for a directive

Article 85 – paragraph 1 a (new)

Text proposed by the Commission

Amendment

The activities falling within the first subparagraph may include the offering, manufacture, sale, supply, storage, import, export, use and purchase of products or processes, including by third party suppliers and service providers.

Or. en

Amendment 1333

Ondřej Knotek, Billy Kelleher

Proposal for a directive

Article 85 – paragraph 2

Text proposed by the Commission

Amendment

This exception shall not cover the placing on the market of the medicinal products resulting from such activities.

This exception shall not cover the placing on the market in a Member State of the medicinal products manufactured for the purposes mentioned above, while the relevant patent rights or supplementary protection certificates are in force in that Member State.

Or. en

Amendment 1334

Tomislav Sokol

Proposal for a directive

Article 85 – paragraph 2

Text proposed by the Commission

Amendment

This exception shall not cover the placing on the market of the medicinal products resulting from such activities.

Or. en

Amendment 1335

Stelios Kympouropoulos

Proposal for a directive

Article 85 – paragraph 2

Text proposed by the Commission

Amendment

This exception shall not cover the placing on the market of the medicinal products resulting from such activities.

Or. en

Amendment 1336

Cristian-Silviu Buşoi

Proposal for a directive

Article 85 – paragraph 2

Text proposed by the Commission

Amendment

This exception shall not cover the placing on the market of the medicinal products resulting from such activities.

Or. en

Amendment 1337

Maria Angela Danzì

Proposal for a directive

Article 85 – paragraph 2

Text proposed by the Commission

Amendment

This exception shall not cover the placing on the market of the medicinal products resulting from such activities.

Or. en

Amendment 1338

Adam Jarubas, Ewa Kopacz, Elżbieta Katarzyna Łukacijewska

Proposal for a directive

Article 85 – paragraph 2

Text proposed by the Commission

Amendment

This exception shall not cover the placing on the market of the medicinal products resulting from such activities.

Or. en

Amendment 1339

Marian-Jean Marinescu

Proposal for a directive

Article 85 – paragraph 2

Text proposed by the Commission

Amendment

This exception shall not cover the placing on the market of the medicinal products resulting from such activities.

Or. en

Justification

Amendment 1340

Nicolás González Casares, Tiemo Wölken

Proposal for a directive

Article 85 – paragraph 2

Text proposed by the Commission

Amendment

This exception shall not cover the placing on the market of the medicinal products resulting from such activities.

This exception shall not cover the placing on the market of the medicinal products resulting from such activities before expiry of relevant patent or supplementary protection certificates.

Or. en

Amendment 1341

Maria Angela Danzì

Proposal for a directive

Article 85 a (new)

Text proposed by the Commission

Amendment

Article 85a

Ban of patent linkage

1. Applications, decision-making procedures and decisions to regulate marketing authorizations or the prices of medicinal products or to determine their inclusion within the scope of public health insurance systems or the public and private procurement of medicinal products shall be considered by Member States as regulatory or administrative procedures which, as such, are independent from the enforcement of intellectual property rights.

2. The protection of intellectual property rights shall not be a valid ground to refuse, suspend, delay, withdraw or revoke decisions relating to marketing authorisations, the price of a medicinal product or its inclusion within the public health insurance system, or the public and private procurement of medicinal products.

3. The applications, decision-making procedures and decisions referred to in paragraph 1 shall not be subject to conditions which expose applicants to a risk of infringement of the intellectual property rights.

4. Paragraphs 1, 2 and 3 shall apply without prejudice to the Union and national legislation relating to the protection of intellectual property.

Or. en

Justification

Patent linkage occurs when generic & biosimilars’ Marketing Authorisations/P&R decisions/tender bids are blocked due to existing patents covering the reference product. The EC considers it “unlawful” and anti-competitive in its Pharmaceutical Sector Inquiry Report of 2009, as it delays generic/biosimilar medicines systematically. The 2012 EC Proposal for Revised Transparency Directive included a prohibition of patent linkage. The European Parliament Resolutions on Access to Medicines in 2017 & on the Pharmaceutical Strategy in 2021 urged the Commission to end patent linkage to ensure immediate market entry for generic/biosimilar competitors. A June 2021 study of the European Parliament confirms the issue, and the European Parliament Report on the IP Action Plan urges to ban patent linkage and to address Bolar.Therefore, a new art. 85b and should include not only marketing authorisations but also P&R and tender bids. Like the Bolar provides an exemption from patent/SPC infringement also for P&R procedures and potentially tender bids, also the ban of patent linkage should cover P&R and tender bids, with the aim to only clarifies that since conducting MA/P&R/Tender procedures is not a patent infringement, MA/P&R/Tender procedures should not be affected by the status of patents/SPCs.

Amendment 1342

Adam Jarubas, Ewa Kopacz, Elżbieta Katarzyna Łukacijewska

Proposal for a directive

Article 85 a (new)

Text proposed by the Commission

Amendment

Article85a

4. Paragraphs 1, 2 and 3 shall apply without prejudice to the Union and national legislation relating to the protection of intellectual property.

Or. en

Amendment 1343

Marian-Jean Marinescu

Proposal for a directive

Article 85 a (new)

Text proposed by the Commission

Amendment

Article 85a

4. Paragraphs 1, 2 and 3 shall apply without prejudice to the Union and national legislation relating to the protection of intellectual property.

Or. en

Justification

A ban of patent linkage is foreseen in Recital 65. It should be reflected in the legal text in order to remove the possibility for reference product owners to misuse the patent system to systematically delay generic entry

Amendment 1344

Sirpa Pietikäinen

Proposal for a directive

Article 85 a (new)

Text proposed by the Commission

Amendment

Article 85a

4. Paragraphs 1, 2 and 3 shall apply without prejudice to the Union and national legislation relating to the protection of intellectual property.

Or. en

Amendment 1345

Ondřej Knotek, Billy Kelleher

Proposal for a directive

Article 85 a (new)

Text proposed by the Commission

Amendment

Article85a

3. The applications, decision-making procedures and decisions referred to in paragraph 1 shall not be subject to conditions exposing applicants to risks of infringement of the intellectual property rights.

4. Paragraphs 1, 2 and 3 shall apply without prejudice to the Union and national legislation relating to the protection of intellectual property.

Or. en

Amendment 1346

Dolors Montserrat, Massimiliano Salini, Nathalie Colin-Oesterlé, Tomislav Sokol

Proposal for a directive

Article 85 a (new)

Text proposed by the Commission

Amendment

Article85a

1. Applications, decision-making procedures and decisions to regulate marketing authorizations or the prices of generics, biosimilars, hibryds and biohibrids or to determine their inclusion within the scope of public health insurance system of medicinal products shall be considered by Member States as regulatory or administrative procedures which, as such, are independent from the enforcement of intellectual property rights.

2. The protection of intellectual property rights shall not be a valid ground to refuse, suspend, delay, withdraw or revoke decisions relating to marketing authorisations, the price of generics, biosimilars, hibryds and biohibrids or its inclusion within the public health insurance system.

Paragraphs 1, 2 and 3 shall apply without prejudice to the Union and national legislation relating to the protection of intellectual property.

Or. en

Amendment 1347

Stelios Kympouropoulos

Proposal for a directive

Article 85 a (new)

Text proposed by the Commission

Amendment

Article 85a

1. Applications, procedures, and decisions to regulate marketing authorisations, the prices of medicinal products, or to decide on their inclusion within the scope of public helath insurance or public and private precurement, shall be considered by the Member States as administrative or regulatory precedures independent from the enforcement of intellectual propoerty (IP) rights.

2. The protection of IP rights shall not be used unjustifiably as a reason to refuse, suspend, delay, withdraw, or revoke decisions on the regulatory or administatives procedures outlined in paragraph 1.

3. The applications, decisions, and procedures reffered to in paragraph 1 shall not be subject to conditions which expose applicants to a risk of infringement of the IP rights.

4. All paragraphs of this article shall apply without prejudice to the Union and national law relating to the protection of IP.

Or. en

Amendment 1348

Nicolás González Casares, Tiemo Wölken

Proposal for a directive

Article 85 a (new)

Text proposed by the Commission

Amendment

Article85a

Prohibition on patent linkage

1. Member States shall not, when conducting regulatory or administrative procedures in regards to activities carried out in accordance with Article 85, enforce intellectual property rights as a valid ground for refusal, suspension, delay, withdrawal or revocation of marketing authorisation, pricing and reimbursement decisions or tender bids in regards to public and private procurement of medicinal products.

2. If the market authorization holder ceases to commercialise a medicinal product in the Union, the Commission shall have a public purchase option for all related intellectual property rights.

Or. en

Amendment 1349

Margarita de la Pisa Carrión

Proposal for a directive

Article 86 – paragraph 1 – subparagraph 1

Text proposed by the Commission

Amendment

Where an application for marketing authorisation, includes the results of all studies conducted in compliance with an agreed paediatric investigation plan, the holder of the patent or supplementary protection certificate shall be entitled to a six-month extension of the period referred to in Article 13, paragraphs 1 and 2 of [Regulation (EC) No 469/2009 - OP please replace reference by new instrument when adopted]. Where the agreed paediatric investigation plan is conducted in relation to a disease that is different from the one for which the medicinal product is intended in the adult population, the holder of the patent or supplementary protection certificate shall be entitled to a 12-month extension of the period.

Or. en

Amendment 1350

Sunčana Glavak

Proposal for a directive

Article 86 – paragraph 1 – subparagraph 1

Text proposed by the Commission

Amendment

Where an application for marketing authorisation, includes the results of all studies conducted in compliance with an agreed paediatric investigation plan, or the supplementary evidence based on extrapolation and/or from the appropriately designed post-marketing long-term studies in pediatric patients receiving the drug, the holder of the patent or supplementary protection certificate shall be entitled to a six-month extension of the period referred to in Article 13, paragraphs 1 and 2 of [Regulation (EC) No 469/2009 - OP please replace reference by new instrument when adopted].

Or. en

Amendment 1351

Margarita de la Pisa Carrión

Proposal for a directive

Article 86 – paragraph 1 – subparagraph 1 a (new)

Text proposed by the Commission

Amendment

The periods of extension referred to in paragraph 1 shall not apply to orphan medicinal products which have elected for and benefited from the extension of market exclusivity provided in Article 72(3) of [revised Regulation 726/2004].

Or. en

Amendment 1352

Nicolás González Casares, Tiemo Wölken

Proposal for a directive

Article 86 a (new)

Text proposed by the Commission

Amendment

Article86a

Measuring pharmaceutical access within the EU

1.The Commission, in collaboration with Member States, shall develop objective and specific indicators to measure pharmaceutical access within the EU. The indicators related to pharmaceutical access should include but not be limited to availability, health system and patient affordability and accesibility of medicines.

(a) The Commission shall ensure that these indicators are evidence-based, measurable, and regularly reviewed to reflect the evolving healthcare landscape within the EU. Additionally, the Commission shall ensure that confidentiality of pricing and reimbursement data is overcome to avoid distorsion estimates.

(b) The Commission, in collaboration with Member States, shall produce a quinquennial report on the state of pharmaceutical access within the Union. This report shall comprehensively analyse the indicators defined in paragraph 1, evaluating their effectiveness in gauging access to medicines. The Commission shall also establish a public database for annual update of paramenters defined in the quinquennial report.

Or. en

Amendment 1353

Margrete Auken

Proposal for a directive

Article 87 – paragraph 1 – subparagraph 1 – introductory part

Text proposed by the Commission

Amendment

After the granting of a marketing authorisation, the competent authority of the Member State may impose an obligation on the marketing authorisation holder:

At the time of or after the granting of a marketing authorisation, the competent authority of the Member State may impose an obligation on the marketing authorisation holder:

Or. en

Amendment 1354

Sirpa Pietikäinen

Proposal for a directive

Article 87 – paragraph 1 – subparagraph 1 – point a

Text proposed by the Commission

Amendment

(a) to conduct a post-authorisation safety study if there are concerns about the risks of an authorised medicinal product. If the same concerns apply to more than one medicinal product, the competent authority of the Member State shall, following consultation with the Pharmacovigilance Risk Assessment Committee, encourage the marketing authorisation holders concerned to conduct a joint post-authorisation safety study;

(a) to conduct a post-authorisation safety study if there are concerns about the risks of an authorised medicinal product to public health or environment. If the same concerns apply to more than one medicinal product, the competent authority of the Member State shall, following consultation with the Pharmacovigilance Risk Assessment Committee, encourage the marketing authorisation holders concerned to conduct a joint post-authorisation safety study;

Or. en

Amendment 1355

Sunčana Glavak, Tomislav Sokol

Proposal for a directive

Article 87 – paragraph 1 – subparagraph 1 – point b a (new)

Text proposed by the Commission

Amendment

(b a) to conduct a post-authorisation safety and efficacy long-term study in children receiving the drug “of the label” because the paediatric investigation plan could not be accomplished due to failure to timely complete paediatric clinical studies.

Or. en

Amendment 1356

Margarita de la Pisa Carrión

Proposal for a directive

Article 87 – paragraph 1 – subparagraph 1 – point c – paragraph 1

Text proposed by the Commission

Amendment

to conduct a post-authorisation environmental risk assessment study, collection of monitoring data or information on use, if there are concerns about the risks to the environment or public health, including antimicrobial resistance, due to an authorised medicinal product, or related active substance.

to conduct a post-authorisation environmental risk assessment study, collection of monitoring data or information on use, if there are concerns about the risks to the environment and/or antibiotic resistance, due to an authorised medicinal product, or related active substance. Such measures may be imposed at both initial marketing authorisations and as response to a review where a risk to the environment has been identified.

Or. en

Amendment 1357

Fulvio Martusciello

Proposal for a directive

Article 87 – paragraph 1 – subparagraph 1 – point c – paragraph 1

Text proposed by the Commission

Amendment

to conduct a post-authorisation environmental risk assessment study, collection of monitoring data or information on use, if there are concerns about the risks to the environment and/or antibiotic resistance, due to an authorised medicinal product, or related active substance. Such measures may be imposed at both initial marketing authorisations and as response to a review where a risk to the environment has been identified.

Or. en

Amendment 1358

Nicola Procaccini

Proposal for a directive

Article 87 – paragraph 1 – subparagraph 1 – point c – paragraph 1

Text proposed by the Commission

Amendment

to conduct a post-authorisation environmental risk assessment study, collection of monitoring data or information on use, if there are concerns about the risks to the environment and/or antibiotic resistance, due to an authorised medicinal product, or related active substance. Such measures may be imposed at both initial marketing authorisations and as response to a review where a risk to the environment has been identified.

Or. en

Amendment 1359

Peter Liese, Tiemo Wölken

Proposal for a directive

Article 87 – paragraph 1 – subparagraph 1 – point c – paragraph 1

Text proposed by the Commission

Amendment

Or. en

Amendment 1360

Peter Liese, Tiemo Wölken

Proposal for a directive

Article 87 – paragraph 1 – subparagraph 1 – point c – paragraph 1 a (new)

Text proposed by the Commission

Amendment

Where the application concerns an antimicrobial medicinal product, the competent authority or the Member States shall require the marketing authorisation holder to conduct post-authorisation studies as outline in Article 87(1c) in order to ensure that the benefit-risk balance remains positive with a view to the possible development of antimicrobial resistance.

Or. en

Amendment 1361

Peter Liese, Tiemo Wölken

Proposal for a directive

Article 87 – paragraph 1 – subparagraph 1 – point c – paragraph 1 b (new)

Text proposed by the Commission

Amendment

Under the provisions of Article 87 (1d) Member States shall;

(a) collect relevant and comparable data on the volume of sales and on the use of antimicrobial medicinal products used, to enable in particular the direct or indirect evaluation of the use of such products with the aim to monitor the development of antimicrobial resistances;

(b) send collated data on the volume of sales and the use per types of antimicrobial medicinal products to the Agency. The Agency shall cooperate with Member States and with other Union agencies to analyse those data and shall publish an annual report. The Agency shall take into account those data when adopting any relevant guidelines and recommendations.

Or. en

Amendment 1362

Margrete Auken

Proposal for a directive

Article 87 – paragraph 1 – subparagraph 2

Text proposed by the Commission

Amendment

The imposition of such an obligation shall be duly justified, notified in writing, and shall include the objectives and timeframe for submission and conduct of the study.

The imposition of such an obligation shall be duly justified, notified in writing, and shall include the objectives and timeframe for submission and conduct of the study. Information on imposed post-authorisation studies shall be noted in the product’s European Public Assessment Report, package leaflet and a medicine repository of the competent authority

Or. en

Amendment 1363

Peter Liese

Proposal for a directive

Article 87 a (new)

Text proposed by the Commission

Amendment

Article 87a

Amendment and Integration of Antimicrobial Usage and Data Collection in Veterinary Medicine

The Commission shall if approrpiate propose an amendment of (EU) 2019/6 on veterinary medicinal products. The proposal shall, if possible, contain the following provisions in line with the provisions of this Directive:

1. A prescription for antibiotic products shall:

(a) be limited to the amount required for the treatment or therapy concerned;

(b) only be prescribed for a limited duration to cover the period of risk, in particular when used as metaphlylaxis or prophylaxis;

(d) not be influenced by any form of economic incentive provided directly or indirectly to persons who prescribe veterinary medicinal products, given the risks associated with antimicrobial resistance.

(i) Prior to the prescription of an antibiotic product, the person qualified to prescribe is required to examine the sensitivity of the bacterial pathogens causing the illness (antibiogram). The antibiogram shall be conducted:

(a) in the case of treatments with antibiotics; or

(b) when changing the antibiotic product during a course of treatment; or

(c) in the case of combined adminsitration of antibiotics for one indication, except for authorised ready-made products containing a combination of antibiotic active substances;

(ii )By derogation from point i of this article, an antibiogram is not required:

(a) if the collection of samples would involve a risk of additional impairment to the health status of the patient to be treated; or

(b) if there is no suitable method available for the determination of the sensitivity of the pathogen;

If, due to the derogations set out in (2c), point ii, an antibiogram cannot be performed, an appropriate rapid test must be conducted.

2. The amendment of (EU) 2019/6 of the European Parliament and of the Council shall also ensure the inclusion of priority antimicrobials in the list reserved for the treatment of certain infections in humans. The Commission shall incorporate priority antimicrobials into the designated list in alignment with the WHO recommendations on priority antimicrobials.

3. The amendment of (EU) 2019/6 of the European Parliament and of the Council shall utilize relevant and comparable data on the volume of sales and the use of antimicrobial medicinal products in animals, as collected in accordance with Article 57 of Regulation (EU) 2019/6. A system of benchmarks for the use of antimicrobial medicinal products shall be introduced, including the establishment of official controls for enterprises significantly exceeding these benchmarks.

Or. en

Amendment 1364

Peter Liese

Proposal for a directive

Article 87 b (new)

Text proposed by the Commission

Amendment

Article 87b

Integration of Antimicrobial Usage Data in Human Medicine

In accordance with Article 87 of this Directive, upon the completion of data collection and appropriate analysis, the Commission shall, if appropriate, propose the setting of benchmarks and the establishment of suitable reduction targets. These targets shall consider the specific circumstances of different medical specialties, focusing on the prudent use of antimicrobial medicinal products in human medicine.

Or. en

Amendment 1365

Margrete Auken

Proposal for a directive

Article 89 – paragraph 1

Text proposed by the Commission

Amendment

1. The marketing authorisation holder shall incorporate any safety or efficacy conditions referred to in Articles 44, 45 and 87 in the risk management system.

1. The marketing authorisation holder shall incorporate any safety or efficacy conditions referred to in Articles 44 and 87 in the risk management system.

Or. en

Amendment 1366

Margrete Auken

Proposal for a directive

Article 89 – paragraph 2

Text proposed by the Commission

Amendment

2. The Member States shall inform the Agency of the marketing authorisations that they have granted subject to conditions pursuant to Articles 44, 45 and of any obligations imposed in accordance with Article 87.

2. The Member States shall inform the Agency of the marketing authorisations that they have granted subject to conditions pursuant to Article 45 and of any obligations imposed in accordance with Article 87.

Or. en

Amendment 1367

Margarita de la Pisa Carrión

Proposal for a directive

Article 92 – paragraph 3

Text proposed by the Commission

Amendment

3. The procedures for examination of applications for variations shall be proportionate to the risk and impact involved. Those procedures shall range from procedures that allow implementation only after approval based on a complete scientific assessment to procedures that allow immediate implementation and subsequent notification by the marketing authorisation holder to the competent authority. Such procedures may also include updates by the marketing authorisation holder of their information held in a database.

Or. en

Justification

Recognition in the proposed legislation, through the expansion ofconditional authorization to new indications, that the benefit ofthe medicine's new indication for immediate availability topatients is greater than the risk inherent in the fact that additionaldata are still required, is acknowledged and welcome.Commensurate with the recognition of the importantimprovements new indications for treating, preventing ordiagnosing seriously debilitating or life-threatening diseases canprovide to patients, new indications addressing an unmet needs inthese areas should be eligible for an accelerated assessment.

Amendment 1368

Sunčana Glavak, Tomislav Sokol

Proposal for a directive

Article 96 – paragraph 1 – subparagraph 1

Text proposed by the Commission

Amendment

Member States shall operate a pharmacovigilance system for the fulfilment of their pharmacovigilance tasks and their participation in the Union pharmacovigilance activities.

Member States shall operate a pharmacovigilance system for the fulfilment of their pharmacovigilance tasks and their participation in the Union pharmacovigilance activities including the pharmacovigilance over the post-authorization safety and efficacy long-term studies in children using the drug off label, because of the failed marketing authorization for reasons such as failure to timely complete paediatric clinical studies.

Or. en

Amendment 1369

Marian-Jean Marinescu

Proposal for a directive

Article 97 – paragraph 1 – point e a (new)

Text proposed by the Commission

Amendment

(e a) Facilitate harm reduction from adverse events through developing and implementing corrective patient safety plans for safe medicinal product administration and handling which can include the deployment of digital medication safety systems in hospitals and ambulatory care settings.

Or. en

Justification

To close gaps in the current EU pharmacovigilance policy and legislation tackling the downstream determinants of harm to better protect the health of European citizens from medication hazards in healthcare settings is required

Amendment 1370

Nicolás González Casares, Tiemo Wölken

Proposal for a directive

Article 97 – paragraph 1 – point e a (new)

Text proposed by the Commission

Amendment

(e a) facilitate harm reduction from adverse events through developing and implementing corrective patient safety plans for safe medicinal product administration and handling which can include the deployment of digital medication safety systems in hospitals and ambulatory care settings.

Or. en

Amendment 1371

Margrete Auken

Proposal for a directive

Article 101 – paragraph 2

Text proposed by the Commission

Amendment

2. Paragraph 1 shall not preclude the competent authorities of the Member States from charging fees to marketing authorisation holders for performing pharmacovigilance activities on the condition that the independence in the performance of those pharmacovigilance activities is strictly guaranteed.

Or. en

Amendment 1372

Margrete Auken

Proposal for a directive

Article 102 – paragraph 1 – point b a (new)

Text proposed by the Commission

Amendment

(b a) where applicable, documentation related to received scientific advice;

Or. en

Amendment 1373

Margrete Auken

Proposal for a directive

Article 102 – paragraph 1 – point b b (new)

Text proposed by the Commission

Amendment

(b b) environmental risk assessment reports;

Or. en

Amendment 1374

Margrete Auken

Proposal for a directive

Article 102 – paragraph 1 – point b c (new)

Text proposed by the Commission

Amendment

(b c) conditions imposed on marketing authorisation holder pursuant to Article 44;

Or. en

Amendment 1375

Margrete Auken

Proposal for a directive

Article 102 – paragraph 1 – point d a (new)

Text proposed by the Commission

Amendment

(d a) periodic safety update reports;

Or. en

Amendment 1376

Margrete Auken

Proposal for a directive

Article 102 – paragraph 1 – point d b (new)

Text proposed by the Commission

Amendment

(d b) information related to antimicrobials referred to in Article 17 and the awareness card, where relevant;

Or. en

Amendment 1377

Margrete Auken

Proposal for a directive

Article 102 – paragraph 1 – point d c (new)

Text proposed by the Commission

Amendment

(d c) information on the shortage status of medicinal products as referred to in Article 121(1)(b) of [revised Regulation (EC) No 726/2004];

Or. en

Amendment 1378

Margrete Auken

Proposal for a directive

Article 102 – paragraph 1 – point d d (new)

Text proposed by the Commission

Amendment

(d d) dates of expiry of IP and regulatory data and market protection periods.

Or. en

Amendment 1379

Nicolás González Casares, Tiemo Wölken

Proposal for a directive

Article 104 – paragraph 2

Text proposed by the Commission

Amendment

2. The marketing authorisation holder shall ensure that information to the public is presented objectively and is not misleading.

2. The marketing authorisation holder shall ensure that information to the public is presented objectively and is not misleading, and it is presented in a clear and adjusted language.

Or. en

Amendment 1380

Maria Angela Danzì

Proposal for a directive

Article 105 – paragraph 2

Text proposed by the Commission

Amendment

2. Marketing authorisation holders shall not refuse to consider reports of suspected adverse reactions received electronically or by any other appropriate means from patients or healthcare professionals.

Or. en

Amendment 1381

Nicolás González Casares, Tiemo Wölken

Proposal for a directive

Article 105 – paragraph 2

Text proposed by the Commission

Amendment

Or. en

Amendment 1382

Kateřina Konečná

Proposal for a directive

Article 105 – paragraph 2

Text proposed by the Commission

Amendment

Or. en

Amendment 1383

Catherine Amalric, Frédérique Ries, Max Orville, Billy Kelleher, Susana Solís Pérez, Erik Poulsen, Ondřej Knotek

Proposal for a directive

Article 105 – paragraph 2

Text proposed by the Commission

Amendment

Or. en

Amendment 1384

Susana Solís Pérez, Catherine Amalric

Proposal for a directive

Article 105 – paragraph 2

Text proposed by the Commission

Amendment

Or. en

Amendment 1385

Kateřina Konečná

Proposal for a directive

Article 106 – paragraph 1 – subparagraph 1

Text proposed by the Commission

Amendment

Each Member State shall record all suspected adverse reactions that occur in its territory and that are brought to its attention from healthcare professionals and patients. This shall include all authorised medicinal products and medicinal products used in accordance with Article 3, paragraphs 1 or 2. Member States shall involve patients and healthcare professionals, as appropriate, in the follow-up of any reports they receive in order to comply with Article 97(1), points (c) and (e).

Or. en

Amendment 1386

Nicolás González Casares, Tiemo Wölken

Proposal for a directive

Article 106 – paragraph 1 – subparagraph 1

Text proposed by the Commission

Amendment

Or. en

Amendment 1387

Margrete Auken

Proposal for a directive

Article 106 – paragraph 1 – subparagraph 1 a (new)

Text proposed by the Commission

Amendment

Member States shall ensure that patients and healthcare professionals who report adverse reactions shall be able to opt in for an automated notifications shall there be any update on the safety profile of the product.

Or. en

Amendment 1388

István Ujhelyi

Proposal for a directive

Article 106 – paragraph 5

Text proposed by the Commission

Amendment

5. Member States shall ensure that reports of suspected adverse reactions arising from an error associated with the use of a medicinal product that are brought to their attention are made available to the Eudravigilance database and to any authorities, bodies, organisations or institutions, responsible for patient safety within that Member State concerned. They shall also ensure that the authorities responsible for medicinal products within that Member State are informed of any suspected adverse reactions brought to the attention of any other authority within that Member State. These reports shall be appropriately identified in the forms referred to in Article 102 of [revised Regulation (EC) No 726/2004].

5. Member States shall ensure that reports of suspected adverse reactions arising from an error, including those associated with the use, administration, and dispensation of a medicinal product, by professionals, that are brought to their attention are made available to the Eudravigilance database and to any authorities, bodies, organisations or institutions, responsible for patient safety within that Member State concerned. They shall also ensure that the authorities responsible for medicinal products within that Member State are informed of any suspected adverse reactions brought to the attention of any other authority within that Member State. These reports shall be appropriately identified in the forms referred to in Article 102 of [revised Regulation (EC) No 726/2004]

Or. en

Amendment 1389

Marian-Jean Marinescu

Proposal for a directive

Article 106 – paragraph 5

Text proposed by the Commission

Amendment

Or. en

Justification

The EMA’s (2015) ‘good practice guidance on recording, coding, reporting and assessment of medication errors[1]’ states that it is good practice that competent authorities in EU Member States are also aware of adverse reactions associated with medication errors.

Amendment 1390

Marian-Jean Marinescu

Proposal for a directive

Article 106 – paragraph 5 a (new)

Text proposed by the Commission

Amendment

5 a. Competent Authorities of the Member States, members of the Pharmacovigilance Risk Assessment Committee, the Committee for Medicinal Products for Human Use and the coordination group by means of a repository referred to in Article in 104 of [revised Regulation (EC) No726/2004) shall ensure that reports of adverse reactions arising from medication errors associated with the incorrect administration and dispensation of a medicinal product available in the Eudravigilance database are included in periodic safety update reports, and cooperate with healthcare professionals to define, if needed, corrective action to achieve high standards of medication safety in healthcare settings, such as the implementation of digital medication safety systems.

Or. en

Justification

Medication errors arise from mistakes in the everyday manual medicinal product administration and handling processes in healthcare settings rather than coming from HCPs not from the medicine itself. Therefore, for high-performing health systems, unintended medication errors should be recorded in the Eudravigilance database to support European policy-making to prevent and manage medication errors in healthcare settings.

Amendment 1391

Margrete Auken

Proposal for a directive

Article 107 – paragraph 3 a (new)

Text proposed by the Commission

Amendment

3 a. The Agency shall make publicly available the reports referred to in paragraph 1 points (a) and (b).

Or. en

Amendment 1392

Margrete Auken

Proposal for a directive

Article 107 – paragraph 4 – subparagraph 1 – point a

Text proposed by the Commission

Amendment

(a) where such obligation has been laid down as a condition in the marketing authorisation in accordance with Articles 44 or 45; or

(a) where such obligation has been laid down as a condition in the marketing authorisation in accordance with Article 44; or

Or. en

Amendment 1393

István Ujhelyi

Proposal for a directive

Article 107 – paragraph 4 a (new)

Text proposed by the Commission

Amendment

4 a. The Agency and Member States shall cooperate to achieve high standards of safety in public health delivery, including in the prescribing, administration and monitoring of medicinal products, by supporting the digital transition of health systems in cooperation with healthcare professionals and service providers.

Or. en

Amendment 1394

Stelios Kympouropoulos

Proposal for a directive

Article 108 – paragraph 6 a (new)

Text proposed by the Commission

Amendment

6 a. The Agency and the Member States shall work together to achieve high standards of safety in public health delivery, by supporting the digital transition of health systems together with healthcare professionals and service providers.

Or. en

Amendment 1395

Marian-Jean Marinescu

Proposal for a directive

Article 112 – paragraph 1 – point 1 (new)

Text proposed by the Commission

Amendment

(1) Upon receipt of a periodic assessment report that records adverse reactions arising from a medication error decide whether any corrective action is required to achieve high standards of medication safety in hospitals and ambulatory care settings.

Or. en

Justification

For high-performing health systems, unintended medication errors should be recorded in the Eudravigilance database to support European policy-making to prevent and manage medication errors in healthcare settings.

Amendment 1396

István Ujhelyi

Proposal for a directive

Article 112 – paragraph 2 a (new)

Text proposed by the Commission

Amendment

2 a. Upon receipt of a periodic assessment report that records adverse reactions arising from a medication error decide whether any corrective action is required to achieve high standards of medication safety in hospitals and ambulatory care settings.

Or. en

Amendment 1397

Catherine Amalric, Frédérique Ries, Max Orville, Billy Kelleher, Susana Solís Pérez

Proposal for a directive

Article 112 a (new)

Text proposed by the Commission

Amendment

Article112a

Medicines under additional monitoring

1. The Agency shall, in collaboration with the Member States, set up, maintain and make public a list of medicinal products that are subject to additional monitoring.

That list shall include the international non-proprietary names and active substances of:

(a) medicinal products authorised in the Union that contain a new active substance which was not contained in any medicinal product authorised in the Union;

(b) any biological medicinal product not covered by point (a) that was authorised after [date of implementation];

(c) medicinal products that are authorised pursuant to this Regulation, subject to the conditions referred to in point (f) of Article 12(4), point (a) of Article 20(1) or Articles 18, 19, 30 or 113;

(d) medicinal products that are authorised pursuant to [revised Directive 2001/83/EC], subject to the conditions referred to in points (b) and (c) of the first paragraph of Article 44, Article 45, or point (a) of the first subparagraph of Article 87(1) thereof.

At the request of the Commission, following consultation with the Pharmacovigilance Risk Assessment Committee, medicinal products that are authorised pursuant to this Regulation subject to the conditions referred to in points (d), (e) or (g) of Article 12(4), point (b) of Article 20 (1) or Article 46(2), may also be included in the list referred to in paragraph 1 of this Article.

At the request of a national competent authority, following consultation with the Pharmacovigilance Risk Assessment Committee, medicinal products that are authorised pursuant to [revised Directive 2001/83/EC] subject to the conditions referred to in points (a), (d) or (f) of the first paragraph of Article 44, point (b) of the first subparagraph of Article 87 or Article 100(2) thereof, may also be included in the list referred to in paragraph 1 of this Article.

2. The list referred to in paragraph 1 shall include an electronic link to the product information and to the summary of the risk management plan.

3. In the cases referred to in points (a) and (b) of paragraph 1 of this Article, the Agency shall remove a medicinal product from the list five years after the Union reference date referred to in Article 108(5) of [revised Directive 2001/83/EC].

In the cases referred to in points (c) and (d) of paragraph 1 of this Article, the Agency shall remove a medicinal product from the list once the conditions have been fulfilled.

4. For medicinal products included in the list referred to in paragraph 1, the summary of product characteristics and the package leaflet shall include the statement ‘This medicinal product is subject to additional monitoring’. The statement shall be preceded by an inverted black triangle, and shall be followed by a standardised explanatory sentence.

5. The Agency shall, in cooperation with the competent authorities, develop and conduct awareness campaigns on the promotion of information about medicines under additional monitoring. Those campaigns shall be intended to raise awareness amongst healthcare professionals, patients, consumers and the general public of the pharmacovigilance system and the additional monitoring of medicines.

Or. en

Amendment 1398

Margrete Auken

Proposal for a directive

Article 117 – paragraph 4

Text proposed by the Commission

Amendment

4. Payments to healthcare professionals for participating in non-interventional post-authorisation safety studies shall be restricted to the compensation for time and expenses incurred.

4. Payments to healthcare professionals for participating in non-interventional post-authorisation safety studies shall be transparent and restricted to the compensation for time and expenses incurred.

Or. en

Amendment 1399

Margrete Auken

Proposal for a directive

Article 120 – paragraph 1

Text proposed by the Commission

Amendment

1. Upon completion of the study, a final study report shall be submitted to the competent authority of the Member State or the Pharmacovigilance Risk Assessment Committee within 12 months of the end of data collection unless a written waiver has been granted by the competent authority of the Member State or the Pharmacovigilance Risk Assessment Committee, as appropriate.

Or. en

Amendment 1400

Joanna Kopcińska

Proposal for a directive

Article 123 – title

Text proposed by the Commission

Amendment

Guidance to facilitate the performance of pharmacovigilance activities

Or. en

Justification

We propose to consider whether these regulations should take the form of generally applicable law. It should be emphasized that the adoption of guidelines in this case will not guarantee the need to strictly comply with these regulations.

Amendment 1401

Margrete Auken

Proposal for a directive

Article 123 – paragraph 1 – introductory part

Text proposed by the Commission

Amendment

The Agency shall, in cooperation with competent authorities of the Member States and other interested parties, draw up:

The Agency shall, in cooperation with competent authorities of the Member States and other interested parties, in particularly those referred to in Article 162 of [reviesed Regulation (EC) No 726/2004], draw up:

Or. en

Amendment 1402

Margrete Auken

Proposal for a directive

Article 123 – paragraph 1 – point a a (new)

Text proposed by the Commission

Amendment

(a a) guidance for national competent authorities and marketing authorisation holders on the effective inclusion of patients, consumers and healthcare professionals in the data collection and communication of the risks of medicinal products within the pharmacovigilance systems referred to in Articles 96 and 99;

Or. en

Amendment 1403

Heléne Fritzon

Proposal for a directive

Article 123 – paragraph 1 – point b

Text proposed by the Commission

Amendment

(b) scientific guidance on post-authorisation efficacy studies.

(b) scientific guidance on post-authorisation efficacy studies in accordance with the consultation process laid down under Article 162 of revised Regulation (EU) No 726/2004.

Or. sv

Justification

Revision of EU medicinal products legislation creates scope to bring EMA's scientific advice for obtaining market authorisation further into line with the work and requirements of the EU HTAR Joint Scientific Consultation (JSC) subgroup.

Stepped-up collaboration between EMA, the JSC subgroup (and competent pricing and subsidy authorities such as TLV in Sweden) is strongly supported. This would be especially relevant, given the (accelerated) timelines for EMA authorisation and joint clinical assessments.

Amendment 1404

Nicolás González Casares, Tiemo Wölken

Proposal for a directive

Article 123 – paragraph 1 – point b

Text proposed by the Commission

Amendment

(b) scientific guidance on post-authorisation efficacy studies.

(b) scientific guidance on post-authorisation efficacy studies, following the consultation process established under Article 162 of the [revised Regulation (EU) 726/2004].

Or. en

Amendment 1405

Marian-Jean Marinescu

Proposal for a directive

Article 123 – paragraph 1 – point b a (new)

Text proposed by the Commission

Amendment

(b a) scientific guidance on post-authorisation treatment optimisation studies.

Or. en

Justification

A methodological guideline for treatment optimisation research is necessary and would have to be composed by the EMA

Amendment 1406

Alessandra Moretti

Proposal for a directive

Article 123 – paragraph 1 – point b a (new)

Text proposed by the Commission

Amendment

(b a) scientific guidance on post-authorisation treatment optimisation studies.

Or. en

Amendment 1407

Nicolás González Casares, Tiemo Wölken

Proposal for a directive

Chapter X – title

Text proposed by the Commission

Amendment

X Homeopathic medicinal products and traditional herbal medicinal products

X Traditional herbal medicinal products

Or. en

Amendment 1408

Nicolás González Casares, Tiemo Wölken

Proposal for a directive

Chapter X – Section 1

Text proposed by the Commission

Amendment

[...]

deleted

Or. en

Amendment 1409

Nicolás González Casares, Tiemo Wölken

Proposal for a directive

Article 125

Text proposed by the Commission

Amendment

Article 125

deleted

Registration or authorisation of homeopathic medicinal products

1. Member States shall ensure that homeopathic medicinal products manufactured and placed on the market in the Union are registered in accordance with Articles 126 and 127 or authorised in accordance with Article 133(1), except where such homeopathic medicinal products are covered by a registration or authorisation granted in accordance with national legislation on or before 31 December 1993. In case of registrations, Chapter III, Sections 3 and 4, and Article 38, paragraphs 1, 2 and 3 shall apply.

2. Member States shall establish a simplified registration procedure referred to in Article 126 for the homeopathic medicinal products.

Or. en

Amendment 1410

Nicolás González Casares, Tiemo Wölken

Proposal for a directive

Article 126

Text proposed by the Commission

Amendment

Article 126

deleted

Simplified registration procedure for homeopathic medicinal products

Homeopathic medicinal products that satisfy all of the following conditions may be subject to a simplified registration procedure:

(a) they are administered orally or externally;

(b) no specific therapeutic indication appears on the labelling of the medicinal product or in any information relating thereto;

For the purposes of point (c), the medicinal product may not contain either more than one part per 10000 of the mother tincture or more than 1/100th of the smallest dose used in allopathy with regard to active substances whose presence in an allopathic medicinal product results in the obligation to submit a doctor’s prescription.

The Commission is empowered to adopt delegated acts in accordance with Article 215 to amend the first subparagph, point (c), in order to take account of scientific progress.

At the time of registration, Member States shall determine the prescription status for the dispensing of the homeopathic medicinal product.

2. The criteria and rules of procedure provided for in Article 1(10), point (c), Article 30, Chapter III, Section 6, Articles 191, 195 and 204 shall apply by analogy to the simplified registration procedure for homeopathic medicinal products, with the exception of the proof of therapeutic efficacy.

Or. en

Amendment 1411

Nicolás González Casares, Tiemo Wölken

Proposal for a directive

Article 127

Text proposed by the Commission

Amendment

Article 127

deleted

Application requirements for simplified registration

An application a simplified registration may cover a series of homeopathic medicinal products derived from the same homeopathic stock or stocks. The following shall be included with the application in order to demonstrate, in particular, the pharmaceutical quality and the batch-to-batch homogeneity of the homeopathic medicinal products concerned:

(a) the scientific name or other name given in a pharmacopoeia of the homeopathic stock or stocks, together with a statement of the various routes of administration, pharmaceutical forms and degree of dilution to be registered;

(b) a dossier describing how the homeopathic stock or stocks are obtained and controlled, and justifying their homeopathic use, on the basis of an adequate bibliography;

(c) the manufacturing and control file for each pharmaceutical form and a description of the method of dilution and potentisation;

(d) the manufacturing authorisation for the homeopathic medicinal product concerned;

(e) the copies of any registrations or authorisations obtained for the same homeopathic medicinal product in other Member States;

(f) one or more mock-ups of the outer packaging and the immediate packaging of the homeopathic medicinal products to be registered;

(g) the data concerning the stability of the homeopathic medicinal product.

Or. en

Amendment 1412

Nicolás González Casares, Tiemo Wölken

Proposal for a directive

Article 128

Text proposed by the Commission

Amendment

Article 128

deleted

Application of decentralised and mutual recognition procedures to homeopathic medicinal products

1. Article 38, paragraphs 4 and 6, Articles 39 to 42 and 95 shall not apply to the homeopathic medicinal products referred to in Article 126.

2. Chapter III, Sections 3 to 5, shall not apply to the homeopathic medicinal products referred to in Article 133(2).

Or. en

Amendment 1413

Nicolás González Casares, Tiemo Wölken

Proposal for a directive

Article 129

Text proposed by the Commission

Amendment

Article 129

deleted

Labelling of homeopathic medicinal products

Homeopathic medicinal products, with the exception those referred to in Article 126(1), shall be labelled in accordance with the provisions of Chapter VI and shall be identified by a reference on their labels, in clear and legible form, to their homeopathic nature.

Or. en

Amendment 1414

Nicolás González Casares, Tiemo Wölken

Proposal for a directive

Article 130

Text proposed by the Commission

Amendment

Article 130

deleted

Specific requirements for labelling of certain homeopathic medicinal products

The labelling and, where appropriate, the package insert for homeopathic medicinal products referred to in Article 126(1) in addition to the clear mention of the words ‘homeopathic medicinal product’, shall bear the following, and no other, information:

(a) the scientific name of the stock or stocks followed by the degree of dilution, making use of the symbols of the pharmacopoeia used in accordance with Article 4(62);

(b) name and address of the registration holder and, where appropriate, of the manufacturer;

(d) pharmaceutical form;

(e) expiry date, in clear terms (month, year);

(f) contents of the sales presentation;

(g) special storage precautions, if any;

(h) a special warning if necessary for the medicinal product;

(i) manufacturer's batch number;

(j) registration number;

(k) ‘homeopathic medicinal product without approved therapeutic indications’;

(l) a warning advising the user to consult a doctor if the symptoms persist.

As regards the first subparagraph, point (a), if the homeopathic medicinal product is composed of two or more stocks, the scientific names of the stocks on the labelling may be supplemented by an invented name.

2. Notwithstanding paragraph 1, Member States may require the use of certain types of labelling in order to show:

(a) the price of the homeopathic medicinal product;

(b) the conditions for refunds by social security bodies.

Or. en

Amendment 1415

Nicolás González Casares, Tiemo Wölken

Proposal for a directive

Article 131

Text proposed by the Commission

Amendment

Article 131

deleted

Advertising of homeopathic medicinal products

1. Chapter XIII shall apply to homeopathic medicinal products.

By derogation from paragraph 1, Article 176(1) shall not apply to medicinal products referred to in Article 126(1).

However, only the information specified in Article 130(1) may be used in the advertising of such homeopathic medicinal products.

Or. en

Amendment 1416

Nicolás González Casares, Tiemo Wölken

Proposal for a directive

Article 132

Text proposed by the Commission

Amendment

Article 132

deleted

Exchange of information on homeopathic medicinal products

Member States shall communicate to each other all the information necessary to guarantee the quality and safety of homeopathic medicinal products manufactured and marketed within the Union, and in particular the information referred to in Articles 202 and 203.

Or. en

Amendment 1417

Nicolás González Casares, Tiemo Wölken

Proposal for a directive

Article 133

Text proposed by the Commission

Amendment

Article 133

deleted

Other requirements for homeopathic medicinal products

1. Homeopathic medicinal products other than those referred to in Article 126(1) shall be granted a marketing authorisation in accordance with Articles 6 and 9 to 14 and labelled in accordance with Chapter VI.

A Member State may introduce or retain in its territory specific rules for the non-clinical tests and clinical studies of homeopathic medicinal products other than those referred to in Article 126(1), in accordance with the principles and characteristics of homeopathy as practised in that Member State.

In this case, the Member State concerned shall notify the Commission of the specific rules in force.

3. Chapter IX shall apply to homeopathic medicinal products, with the exception of those referred to in Article 126(1). Chapter XI, Chapter XII, Section 1, and Chapter XIV shall apply to homeopathic medicinal products.

Or. en

Amendment 1418

Nicolás González Casares, Tiemo Wölken

Proposal for a directive

Article 134 – paragraph 1 – subparagraph 1 – point a

Text proposed by the Commission

Amendment

(a) they have therapeutic indications exclusively appropriate to traditional herbal medicinal products that, by virtue of their composition and purpose, are intended and designed for use without the supervision of a medical practitioner for diagnostic purposes or for prescription or monitoring of treatment;

(a) they have therapeutic indications exclusively appropriate to traditional herbal medicinal products that, by virtue of their composition and purpose, are intended and designed for use for diagnostic purposes or for prescription or monitoring of treatment;

Or. en

Amendment 1419

Nicolás González Casares, Tiemo Wölken

Proposal for a directive

Article 134 – paragraph 1 – subparagraph 1 – point a a (new)

Text proposed by the Commission

Amendment

(a a) they are composed of plants with a known natural therapeutic properties;

Or. en

Amendment 1420

Nicolás González Casares, Tiemo Wölken

Proposal for a directive

Article 134 – paragraph 1 – subparagraph 1 – point b

Text proposed by the Commission

Amendment

(b) they are exclusively for administration in accordance with a specified strength and posology;

(b) they are exclusively for administration in accordance with a specified strength and posology that do not present risks for human health;

Or. en

Amendment 1421

Nicolás González Casares, Tiemo Wölken

Proposal for a directive

Article 134 – paragraph 3

Text proposed by the Commission

Amendment

3. However, in cases where the competent authorities judge that a herbal medicinal product that fulfils the conditions laid down in paragraph 1 (‘traditional herbal medicinal product’) fulfils the criteria for a national marketing authorisation in accordance with Article 5 or for a simplified registration in accordance with Article 126, the provisions of this Section shall not apply.

Or. en

Amendment 1422

Nicolás González Casares, Tiemo Wölken

Proposal for a directive

Article 139 – paragraph 1

Text proposed by the Commission

Amendment

1. The Commission shall adopt implementing acts to establish a list of herbal substances, preparations and combinations thereof for use in traditional herbal medicinal products, taking into account the draft list prepared by the herbal medicinal products working group. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 214(2). The list shall contain, with regard to each herbal substance, the therapeutic indication, the specified strength and the posology, the route of administration and any other information necessary for the safe use of the herbal substance as a traditional herbal medicinal product.

1. The Commission shall adopt delegated acts to establish a list of herbal substances, preparations and combinations thereof for use in traditional herbal medicinal products, taking into account the draft list prepared by the herbal medicinal products working group. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 214(2). The list shall contain, with regard to each herbal substance, the therapeutic indication, the specified strength and the posology, the route of administration, the adverse effects, the confirmed and potential interactions with other medicinal products, foods or traditional herbal medicinal products, the contraindications and any other information necessary for the safe use of the herbal substance as a traditional herbal medicinal product.

Or. en

Amendment 1423

Nicolás González Casares, Tiemo Wölken

Proposal for a directive

Article 140 – paragraph 1

Text proposed by the Commission

Amendment

1. Article 1(5), points (a) and (b) and Article 1(10), point (c), Articles 6 to 8, 29, 30, 44, 46, 90, 155, Article 188, paragraphs 1 and 11, Articles 191, 195, 196, 198, 199(2), 202, 203 and 204 and Chapters IX and XI of this Directive as well as Commission Directive 2003/94/EC77 shall apply, mutadis mutandis, to traditional-use registrations granted under this Section.

1. Article 1(5), points (a) and (b) and Article 1(10), point (c), Articles 6 to 8, 29, 30, 44, 46, 90, 97, 155, Article 188, paragraphs 1 and 11, Articles 191, 195, 196, 198, 199(2), 202, 203 and 204 and Chapters IX and XI of this Directive as well as Commission Directive 2003/94/EC[1] shall apply, mutadis mutandis, to traditional-use registrations granted under this Section.

_________________

77 Commission Directive 2003/94/EC of 8 October 2003 laying down the principles and guidelines of good manufacturing practice in respect of medicinal products for human use and investigational medicinal products for human use (OJ L 262, 14.10.2003, p. 22).

Or. en

Amendment 1424

Nicolás González Casares, Tiemo Wölken

Proposal for a directive

Article 140 – paragraph 2 – subparagraph 1 – point a

Text proposed by the Commission

Amendment

(a) the product is a traditional herbal medicinal product for use in specified therapeutic indication(s) exclusively based upon long-standing use; and

(a) the product is a traditional herbal medicinal product for use in specified therapeutic indication(s) exclusively based upon long-standing use and with possible adverse effects;

Or. en

Amendment 1425

Nicolás González Casares, Tiemo Wölken

Proposal for a directive

Article 140 – paragraph 2 – subparagraph 1 – point b

Text proposed by the Commission

Amendment

(b) the user should consult a doctor or a qualified healthcare practitioner if the symptoms persist during the use of the traditional herbal medicinal product or if adverse effects not mentioned in the package leaflet occur.

Or. en

Amendment 1426

Nicolás González Casares, Tiemo Wölken

Proposal for a directive

Article 140 – paragraph 2 – subparagraph 1 – point b a (new)

Text proposed by the Commission

Amendment

(b a) herbal medicinal products may be contraindicated in some people and may produce pharmacological interactions with other medications, altering their safety and efficacy. Consult a doctor or a qualified healthcare practitioner.

Or. en

Amendment 1427

Nicolás González Casares, Tiemo Wölken

Proposal for a directive

Article 140 – paragraph 3

Text proposed by the Commission

Amendment

3. In addition to the requirements set out in Chapter XIII, any advertisement for a traditional herbal medicinal product registered under this Section shall contain the following statement: Traditional herbal medicinal product for use in specified therapeutic indication(s) exclusively based upon long-standing use, with possible adverse effects, contraindications and interactions with other medicines. For more information, consult a healthcare professional.

Or. en

Amendment 1428

Margrete Auken

Proposal for a directive

Article 141 – paragraph 2 a (new)

Text proposed by the Commission

Amendment

2 a. Invited experts shall provide their declaration of interest ahead of the meeting to the Agency.

Or. en

Amendment 1429

Margrete Auken

Proposal for a directive

Article 141 – paragraph 5

Text proposed by the Commission

Amendment

5. The herbal medicinal products working group shall draft its rules of procedure.

5. The herbal medicinal products working group shall draft its rules of procedure, including regarding provisions laid down in Article 208 and Article 147 of [revised Regulation (EC) No 726/2004].

Or. en

Amendment 1430

Margrete Auken

Proposal for a directive

Article 142 – paragraph 3 – point a

Text proposed by the Commission

Amendment

(a) preparation, dividing up, changes in packaging or presentation where these processes are carried out, solely for retail supply, by pharmacists in dispensing pharmacies or by persons legally authorised in the Member States to carry out such processes; or

(a) preparation, dividing up, changes in packaging or presentation where these processes are carried out, solely for retail and hospital supply, by pharmacists in dispensing pharmacies or by persons legally authorised in the Member States to carry out such processes; or

Or. en

Amendment 1431

Margrete Auken

Proposal for a directive

Article 143 – paragraph 1 – subparagraph 2 – point a a (new)

Text proposed by the Commission

Amendment

(a a) environmental impact assessment of the product’s manufacturing process;

Or. en

Amendment 1432

Margrete Auken

Proposal for a directive

Article 143 – paragraph 1 – subparagraph 2 – point b a (new)

Text proposed by the Commission

Amendment

(b a) proof that the product’s supply chain is diversified, identifying alternatives for each component;

Or. en

Amendment 1433

Nicolás González Casares, Tiemo Wölken

Proposal for a directive

Article 147 – paragraph 1 – subparagraph 1 – point j a (new)

Text proposed by the Commission

Amendment

(j a) comply with the risk mitigating measures in accordance with Article 22(4). In this regard, they shall comply and permit representatives of competent authorities of Member States to access their manufacturing premises, sites, and any outdoor facilities and effluents at any time. This obligation shall also apply where decentralised manufacturing or testing takes place.

Or. en

Amendment 1434

Margrete Auken

Proposal for a directive

Article 147 – paragraph 1 – subparagraph 1 – point j a (new)

Text proposed by the Commission

Amendment

(j a) comply with risk mitigation measures identified and considered in accordance with Article 22(4).

Or. en

Amendment 1435

Nicolás González Casares, Tiemo Wölken

Proposal for a directive

Article 148 – paragraph 8 – introductory part

Text proposed by the Commission

Amendment

8. The competent authority of the Member State supervising the decentralised site pursuant to paragraph 4 shall cooperate with the relevant authorities responsible for the supervision of the manufacturing or testing activities under other Union acts as regards the following:

8. In order to ensure the smooth functioning of the decentralised sites with activities relevant for other Union legal frameworks, the competent authority of the Member State supervising the decentralised site pursuant to paragraph 4 shall coordinate their activities and supervisory tasks with the relevant authorities responsible for the supervision of the manufacturing or testing activities under other Union acts as regards the following:

Or. en

Amendment 1436

Nicolás González Casares, Tiemo Wölken

Proposal for a directive

Article 148 – paragraph 8 a (new)

Text proposed by the Commission

Amendment

8 a. The competent authorities referred to paragraph 8 shall guarantee that the modalitities of coordination shall not adversely affect the preparation of SoHO therapies on a Member State level.

Or. en

Amendment 1437

Nicolás González Casares, Tiemo Wölken

Proposal for a directive

Article 148 – paragraph 9

Text proposed by the Commission

Amendment

9. Where relevant, competent authorities of the Member State supervising the central and decentralised sites may liaise with the competent authority of the Member State responsible for the supervision of the marketing authorisation.

9. Where relevant, competent authorities of the Member State supervising the central and decentralised sites shall liaise with the competent authority of the Member State responsible for the supervision of the marketing authorisation.

Or. en

Amendment 1438

Margrete Auken

Proposal for a directive

Article 159 – paragraph 1 – subparagraph 1

Text proposed by the Commission

Amendment

At the request of a third country, the Commission shall assess whether that country’s regulatory framework applicable to active substances exported to the Union and the respective control and enforcement activities ensure a level of protection of public health equivalent to that of the Union.

Or. en

Amendment 1439

Margrete Auken

Proposal for a directive

Article 159 – paragraph 2 – subparagraph 2 – point a

Text proposed by the Commission

Amendment

(a) the country’s rules for good manufacturing practice;

(a) the country’s rules for good manufacturing practice, including local environmental manufacturing standards, occupational health and labour rights standards;

Or. en

Amendment 1440

Nicolás González Casares, Tiemo Wölken

Proposal for a directive

Article 160 – paragraph 1 – introductory part

Text proposed by the Commission

Amendment

The Commission may adopt implementing acts in accordance with Article 214(2) to supplement this Directive by specifying:

The Commission shall adopt implementing acts in accordance with Article 214(2) to supplement this Directive by specifying:

Or. en

Amendment 1441

Margrete Auken

Proposal for a directive

Article 160 – paragraph 1 – introductory part

Text proposed by the Commission

Amendment

The Commission may adopt implementing acts in accordance with Article 214(2) to supplement this Directive by specifying:

The Commission may adopt delegated acts in accordance with Article 215 to supplement this Directive by specifying:

Or. en

Amendment 1442

Nicolás González Casares, Tiemo Wölken

Proposal for a directive

Article 160 – paragraph 1 – point b a (new)

Text proposed by the Commission

Amendment

(b a) the principles and measures on reducing the environmental impact of medicinal products and active substances in manufacturing and distribution

Or. en

Amendment 1443

Margrete Auken

Proposal for a directive

Article 160 – paragraph 1 – point b a (new)

Text proposed by the Commission

Amendment

(b a) measures to reduce the negative impact on the environment posed by the development, manufacturing, use and disposal of medicinal product.

Or. en

Amendment 1444

Nicolás González Casares, Tiemo Wölken

Proposal for a directive

Article 160 – paragraph 2

Text proposed by the Commission

Amendment

Where relevant, these principles shall be specified in coherence with any principles of good practices established under any other Union legal framework.

Where relevant, these principles shall be aligned with with any principles of good practices established under any other Union legal framework.

Or. en

Amendment 1445

Catherine Amalric

Proposal for a directive

Article 160 – paragraph 2 a (new)

Text proposed by the Commission

Amendment

2. The Commission is empowered to adopt delegated acts in order to supplement this Directive by establishing, within good manufacturing practices for medicinal products and active substances, principles, guidelines and detailed guidelines to ensure that water pollution , soil and air linked to their manufacture are reduced as much as possible, in accordance with the state of scientific knowledge. The obligations created by the delegated acts will first have been the subject of a feasibility study including at least an assessment of their impacts in terms of environmental risk management and security of supply for the European market.

Or. en

Amendment 1446

Margarita de la Pisa Carrión

Proposal for a directive

Article 166 – paragraph 1 – point c

Text proposed by the Commission

Amendment

(c) obtain, including by financial transactions, their supplies of medicinal products only from persons who are themselves in possession of a wholesale distribution authorisation in the Union or a manufacturing authorisation referred to in Article 163(3);

(c) obtain, including by financial transactions, (except in the case of financial transactions within the same corporate group their supplies of medicinal products only from persons who are themselves in possession of a wholesale distribution authorisation in the Union or a manufacturing authorisation referred to in Article 163(3);

Or. en

Amendment 1447

Margarita de la Pisa Carrión

Proposal for a directive

Article 166 – paragraph 1 – point d

Text proposed by the Commission

Amendment

(d) supply, including by financial transaction, medicinal products only to persons who are themselves wholesale distribution authorisation holders or who are authorised or entitled to supply medicinal products to the public;

(d) supply, including by financial transaction (except in the case of financial transactions within the same corporate group) , medicinal products only to persons who are themselves wholesale distribution authorisation holders or who are authorised or entitled to supply medicinal products to the public;

Or. en

Amendment 1448

Peter Liese

Proposal for a directive

Article 166 – paragraph 1 – point l

Text proposed by the Commission

Amendment

(l) continuously guarantee the appropriate and continued supply of an adequate range of medicinal products to meet the requirements of a specific geographical area, and deliver the supplies requested over the whole of the area in question, within a reasonable timeframe, which shall be defined in the national legislation;

(l) appoint full-line wholesalers, who shall, pursuant to Article 56 (3) continuously ensure the appropriate and continued supply of an adequate range of medicinal products to meet the requirements of a specific geographical area, and deliver the supplies requested over the whole of the area in question, within a reasonable timeframe, which shall be defined in the national legislation;

Or. en

Justification

This creates a mandate for full-line wholesale distributors to be supplied, establishing a structure that supports pharmaceutical full-line wholesalers in meeting their public service obligations.

Amendment 1449

Marian-Jean Marinescu

Proposal for a directive

Article 166 – paragraph 1 – point l

Text proposed by the Commission

Amendment

(l) continuously guarantee the appropriate and continued supply of an adequate range and the necessary quantity of medicinal products to meet the requirements of a specific geographical area, and deliver the supplies requested over the whole of the area in question, within a reasonable timeframe, which shall be defined in the national legislation;

Or. en

Justification

ensure access to medicines and prevent shortages of medicines

Amendment 1450

Marian-Jean Marinescu

Proposal for a directive

Article 166 – paragraph 1 – point m

Text proposed by the Commission

Amendment

(m) cooperate with marketing authorisation holders and competent authorities of the Member States on the security of supply.

(m) cooperate with marketing authorisation holders and competent authorities of the Member States on the security of supply, according to the principels of Public Service Obligations;

Or. en

Justification

ensure access to medicines and prevent shortages of medicines

Amendment 1451

Marian-Jean Marinescu

Proposal for a directive

Article 166 – paragraph 1 – point m a (new)

Text proposed by the Commission

Amendment

(m a) comply with the provisions of Public Service Obligations.

Or. en

Justification

ensure access to medicines and prevent shortages of medicines

Amendment 1452

Margarita de la Pisa Carrión

Proposal for a directive

Article 167 – paragraph 1

Text proposed by the Commission

Amendment

1. With regard to the supply of medicinal products to pharmacists and persons authorised or entitled to supply medicinal products to the public, Member States shall not impose upon the wholesale distribution authorisation holder that has been granted by another Member State any obligation, in particular public service obligations, more stringent than those they impose on persons whom they have themselves authorised to engage in equivalent activities.

Or. en

Amendment 1453

Margrete Auken

Proposal for a directive

Article 167 – paragraph 2

Text proposed by the Commission

Amendment

2. The wholesale distributors of a medicinal product placed on the market in a Member State shall ensure appropriate and continued supplies of that medicinal product to pharmacies and persons authorised to supply medicinal products so that the needs of patients in the Member State in question are covered.

Or. en

Amendment 1454

Dolors Montserrat, Nathalie Colin-Oesterlé, Tomislav Sokol

Proposal for a directive

Article 167 – paragraph 2

Text proposed by the Commission

Amendment

2. The wholesale distributors of a medicinal product placed on the market in a Member State shall, within the limits of their responsibilities, ensure appropriate and continued supplies of that medicinal product to pharmacies and persons authorised to supply medicinal products so that the needs of patients in the Member State in question are covered. Member States shall rely on the information contained in the repositories system referred to in Article 67, paragraph 2, second sub-paragraph, point (e) to ensure wholesale distributors comply with their supply obligations.

Or. en

Amendment 1455

Nicolás González Casares, Tiemo Wölken

Proposal for a directive

Article 167 – paragraph 2

Text proposed by the Commission

Amendment

Or. en

Amendment 1456

Marian-Jean Marinescu

Proposal for a directive

Article 167 – paragraph 2

Text proposed by the Commission

Amendment

2. The wholesale distributors of a medicinal product placed on the market in a Member State shall, within the limits of their contractual responsibilities, ensure appropriate and continued supplies of that medicinal product to pharmacies and persons authorised to supply medicinal products so that the needs of patients in the Member State in question are covered.

Or. en

Justification

ensure access to medicines and prevent shortages of medicines

Amendment 1457

Catherine Amalric, Frédérique Ries, Max Orville, Billy Kelleher, Susana Solís Pérez

Proposal for a directive

Article 167 – paragraph 3 a (new)

Text proposed by the Commission

Amendment

3 a. To ensure continued supply to patients, the wholesale distributors shall not be authorised to supply medicinal products in another Member State should this, in any way, prevent them from covering the needs of the patients in the Member States concerned.

Or. en

Amendment 1458

Nathalie Colin-Oesterlé

Proposal for a directive

Article 168 – paragraph 1 – introductory part

Text proposed by the Commission

Amendment

1. For all supplies of medicinal products to a person authorised or entitled to supply medicinal products to the public in the Member State concerned, the authorised wholesaler must enclose a document that makes it possible to ascertain the following:

1. For all supplies of medicinal products to a person authorised or entitled to supply medicinal products to the public in the Member State concerned, the authorised wholesaler must provide a document, which may be submitted in electronic format, that makes it possible to ascertain the following:

Or. fr

Amendment 1459

Stelios Kympouropoulos

Proposal for a directive

Article 172 – paragraph 1 – introductory part

Text proposed by the Commission

Amendment

1. Without prejudice to national legislation prohibiting the offer for sale at a distance of prescription medicinal products to the public by means of information society services, Member States shall ensure that medicinal products are offered for sale at a distance to the public by means of services as defined in Directive (EU) 2015/1535 of the European Parliament and of the Council78 laying down a procedure for the provision of information in the field of technical regulations and of rules on Information Society services under the following conditions:

1. Member States shall ensure that medicinal products are offered for sale at a distance after prescription to the public by means of services as defined in Directive (EU) 2015/1535 of the European Parliament and of the Council78 laying down a procedure for the provision of information in the field of technical regulations and of rules on Information Society services under the following conditions:

_________________

78 Directive (EU) 2015/1535 of the European Parliament and of the Council of 9 September 2015 laying down a procedure for the provision of information in the field of technical regulations and of rules on Information Society services (OJ L 241, 17.9.2015, p. 1).

Or. en

Amendment 1460

Nicolás González Casares, Tiemo Wölken

Proposal for a directive

Article 172 – paragraph 1 – point a

Text proposed by the Commission

Amendment

(a) the natural or legal person offering the medicinal products is authorised or entitled to supply medicinal products to the public, also at a distance, in accordance with national legislation of the Member State in which that person is established;

Or. en

Amendment 1461

Nicolás González Casares, Tiemo Wölken

Proposal for a directive

Chapter XII a (new)

Text proposed by the Commission

Amendment

XII a Chapter XII(a)

Health claims made on non-medicinal products

Article 174(a)

Non-medicinal products

1.Only products authorised though the procedures described on this Directive and in [revised Regulation 2023/0131(COD)] shall be considered as medicinal products.Products that can not prove pharmacological activity, efficacy, safety and quality or that have not been evaluated though the described procedures shall not be considered as medicinal products.

2.Products authorised for human use that are intended to be administered to the human body (i.e. oral, parenteral or topical administration) that are not considered medicinal products shall be regulated under other legislations of Member States and the Union, inter alia, legislations laying down the rules for food and cosmetics, where applicable.These shall include all the provisions related to safety and quality controls and to the limitation of health claims.

Article 174(b)

Consumer awareness and protection measures

1.Where a Member State has serious grounds for considering that a non-medicinal product´s health claims exceed the legal limits for which the product is authorised, including claims related to therapeutic activity and health benefits, that Member State may temporaly suspend the authorisation of the product.It shall inform the other Member States and the Commission and give reasons for the suspension.

2.Where the Commission has serious grounds for considering that a non medicinal product in a Member State makes health claims that exceed legal limits for which the product is authorised, including claims related to therapeutic and health benefits, they shall immediately notify the relevant authorities of the Member State in question that shall reply within 2 months and take the necessary corrective measures.

3.Member States shall actively monitor non substantiated health claims of non medicinal products, specially those posing high risk for individuals and public health (including the risk of pharmacological treatment abandonment) and apply corrective mesasures where necessary, in favor of individual and public health.

4.By one year after the entry into force of this Directive the Commission shall establish a list of non medicinal products in the Union that exceed legal limits for health claims for which the product is authorised.Member States shall, on the basis of the list created at Union level, apply corrective action in accordance with Union and national law.

5.By two years after the entry into force of this Directive, the Commission shall make publicly available the list of non medicinal products referred to in paragraph 3 and accompany information, conclusions and corrective actions taken at Union and Member State level to address non substantiated health claims.The Commission shall regularly update this list in consultation with Member States, who at national level are responsible for monitoring non substantiated health claims of non medicinal products.Where relevant, the Commission may also consult relevant stakeholders including health professionals, consumer organisations, and academics.

6.The Commission shall cooperate with Member States in order to establish national education programmes and awareness raising campaigns related to health literacy and the risks associated with non medicinal products making non substantiated health claims.

7.Member States shall at national level create dedicated channels for the reporting of non medicinal products claiming therapeutic and health benefits whereby national authorities shall investigate these claims, and where relevant apply corrective measures.These channels shall be easily available for health professionals, consumers and patient associations and citizens.In cases of corrective measures applied at national level, the authorities shall report to the Commission on the findings and measures applied.

8.The Commission shall adobt delegated acts with specific requirements for consumer awareness and protection measures related to therapeutic and health benefit claims of non-medicinal products.

Or. en

Amendment 1462

Nicolás González Casares, Tiemo Wölken

Proposal for a directive

Article 175 – paragraph 1 – subparagraph 2 – point e

Text proposed by the Commission

Amendment

(e) the provision of inducements to prescribe or supply medicinal products by the gift, offer or promise of any benefit or bonus, whether in money or in kind, except when their intrinsic value is minimal;

(e) the provision of inducements to prescribe or supply medicinal products by the gift, offer or promise of any benefit or bonus, whether in money or in kind,

Or. en

Amendment 1463

Margrete Auken

Proposal for a directive

Article 175 – paragraph 1 – subparagraph 2 – point e

Text proposed by the Commission

Amendment

(e) the provision of inducements to prescribe or supply medicinal products by the gift, offer or promise of any benefit or bonus, whether in money or in kind,

Or. en

Justification

Studies show that even a small gift may result in preferential prescriptions; in addition, it is difficult to say what is considered minimal (debatable)

Amendment 1464

Margarita de la Pisa Carrión

Proposal for a directive

Article 175 – paragraph 2 – point d a (new)

Text proposed by the Commission

Amendment

(d a) clear, impartial and independent information from an accredited health professional to the public about a medicinal product and its correct use, provided that it does not fall within the circumstances referred to in the preceding subparagraph and meets the conditions laid down in the legislation of each Member State.

Or. en

Amendment 1465

Dolors Montserrat

Proposal for a directive

Article 175 – paragraph 2 – point d a (new)

Text proposed by the Commission

Amendment

(da) clear, impartial and independent information imparted to the general public by an accredited healthcare professional on a medicinal product and its correct use, provided that it is not covered by the circumstances provided for in the previous paragraph and that it complies with the conditions laid down in each Member State's own legislation.

Or. es

Justification

en algunos Estados miembro se ha dado la circunstancia de que, a partir del concepto de publicidad de medicamentos establecido por la Directiva (y que se traslada prácticamente idéntico a esta propuesta) los profesionales sanitarios -que tienen un deber de trasladar información sanitaria a la población- han visto obstaculizada su función divulgativa al entenderse por las autoridades que, a partir de la definición de la directiva, esta información sanitaria, sin ánimo publicitario, puede considerarse publicidad sobre medicamentos a efectos legales.Esta situación implica que los profesionales sanitarios -que, por lo general, cuentan con obligaciones específicas que le imponen exigencias respecto a su independencia- tengan tantas, o incluso más dificultades que el resto de los operadores para emitir información imparcial y completamente independiente sobre el uso racional y seguro de los medicamentos.A la postre, este impedimento para que los profesionales sanitarios puedan emitir esta clase de información imparcial redunda en una falta de información o, en el peor de los casos, desinformación que desemboca en una confusión en la población, en una falta de rigor y en una limitación de la educación sanitaria de la ciudadanía. Estas acciones de divulgación por parte de los profesionales sanitarios ayudan a combatir la preocupante desinformación y bulos en salud que circulan libremente en Internet, como se demostró con las vacunas durante la pandemia de Covid-19.

Amendment 1466

Margrete Auken

Proposal for a directive

Article 176 – paragraph 3 – point a

Text proposed by the Commission

Amendment

(a) shall encourage the rational use of the medicinal product, by presenting it objectively and without exaggerating its properties;

(a) shall promote the rational use of the medicinal product, by presenting it objectively and without exaggerating its properties;

Or. en

Amendment 1467

Alessandra Moretti

Proposal for a directive

Article 176 – paragraph 3 – point b

Text proposed by the Commission

Amendment

(b) shall be accurate, verifiable and not be misleading.

(b) shall be accurate, verifiable, based on strict scientific evidence and data and not be misleading.

Or. en

Amendment 1468

Nicolás González Casares, Tiemo Wölken

Proposal for a directive

Article 176 – paragraph 3 – point b

Text proposed by the Commission

Amendment

(b) shall be accurate, verifiable and not be misleading.

(b) shall be accurate, verifiable, not be misleading or omit any key information without which could be mislead;

Or. en

Amendment 1469

Nicolás González Casares, Tiemo Wölken

Proposal for a directive

Article 176 – paragraph 3 – point b a (new)

Text proposed by the Commission

Amendment

(b a) shall not induce to an excesive or abusive use of the medicinal product.

Or. en

Amendment 1470

Nicolás González Casares, Tiemo Wölken

Proposal for a directive

Article 176 – paragraph 4

Text proposed by the Commission

Amendment

4. Any form of advertising that aims to highlight negatively another medicinal product shall be prohibited. Advertising that suggests that a medicinal product is safer or more effective than another medicinal product shall also be prohibited, unless demonstrated and supported by the summary of product characteristics.

Or. en

Amendment 1471

Alessandra Moretti

Proposal for a directive

Article 176 – paragraph 4

Text proposed by the Commission

Amendment

Or. en

Amendment 1472

Margrete Auken

Proposal for a directive

Article 176 – paragraph 4

Text proposed by the Commission

Amendment

Or. en

Justification

There can be different efficacies in the real world so it is easy to inflate this or provide partial truths

Amendment 1473

Kateřina Konečná

Proposal for a directive

Article 176 – paragraph 4

Text proposed by the Commission

Amendment

Or. en

Amendment 1474

Catherine Amalric, Frédérique Ries, Max Orville, Billy Kelleher, Susana Solís Pérez, Erik Poulsen

Proposal for a directive

Article 177 – paragraph 1 – subparagraph 1 (new)

Text proposed by the Commission

Amendment

Member States shall monitor the digital market services or products, websites, applications likely to broadcast advertising for prescription medicinal products for which advertising is prohibited according to article 177, paragraph 1.

Or. en

Amendment 1475

Margrete Auken

Proposal for a directive

Article 177 – paragraph 1 – point b a (new)

Text proposed by the Commission

Amendment

(b a) contain substances listed in Annex X of Directive 2000/60/EC, individual priority substances in Annex I to Directive 2008/105/EC or substances in Annex I of Directive 2006/118/EC;

Or. en

Amendment 1476

Sirpa Pietikäinen

Proposal for a directive

Article 177 – paragraph 1 – point b a (new)

Text proposed by the Commission

Amendment

(b a) contain substances listed as individual priority substances in Annex I to Directive 2008/105/EC [Environmental Quality Standards Directive].

Or. en

Amendment 1477

Nicolás González Casares, Tiemo Wölken

Proposal for a directive

Article 177 – paragraph 1 – point b a (new)

Text proposed by the Commission

Amendment

(b a) contain substances that are known to produce adictive behaviours;

Or. en

Amendment 1478

Alessandra Moretti

Proposal for a directive

Article 177 – paragraph 1 – point b a (new)

Text proposed by the Commission

Amendment

(b a) contains substances that might generate addiction.

Or. en

Amendment 1479

Margarita de la Pisa Carrión, Joanna Kopcińska

Proposal for a directive

Article 177 – paragraph 1 – point b a (new)

Text proposed by the Commission

Amendment

(b a) are antibiotics.

Or. en

Amendment 1480

Dolors Montserrat

Proposal for a directive

Article 177 – paragraph 1 – point b a (new)

Text proposed by the Commission

Amendment

(ba) are antibiotics;

Or. es

Amendment 1481

Margarita de la Pisa Carrión

Proposal for a directive

Article 177 – paragraph 1 – point b a (new)

Text proposed by the Commission

Amendment

(b a) are antibiotics

Or. en

Amendment 1482

Margrete Auken

Proposal for a directive

Article 177 – paragraph 1 – point b b (new)

Text proposed by the Commission

Amendment

(b b) contain hazardous substances during pregnancy;

Or. en

Amendment 1483

Nicolás González Casares, Tiemo Wölken

Proposal for a directive

Article 177 – paragraph 1 – point b b (new)

Text proposed by the Commission

Amendment

(b b) are an antimicrobial.

Or. en

Amendment 1484

Margrete Auken

Proposal for a directive

Article 177 – paragraph 1 – point b c (new)

Text proposed by the Commission

Amendment

(b c) contain substances affected by potential or actual shortage.

Or. en

Amendment 1485

Nicolás González Casares, Tiemo Wölken

Proposal for a directive

Article 177 – paragraph 2

Text proposed by the Commission

Amendment

2. Medicinal products may be advertised to the general public where, by virtue of their composition and purpose, they are intended and designed for use without the intervention of a medical practitioner for diagnostic purposes or for the prescription or monitoring of treatment, with the advice of the pharmacist, if necessary.

2. Medicinal products may be advertised to the general public where, by virtue of their composition and purpose, they are intended and designed for use without the obligatory intervention of a medical practitioner for diagnostic purposes or for the prescription or monitoring of treatment, with the advice of a medical practitioner or a pharmacist, if necessary.

Or. en

Amendment 1486

Margrete Auken

Proposal for a directive

Article 177 – paragraph 2

Text proposed by the Commission

Amendment

2. Medicinal products may be advertised to the general public where, by virtue of their composition and purpose, they are intended and designed for use without the intervention of a healthcare professional for diagnostic purposes or for the prescription or monitoring of treatment, with the advice of the pharmacist, if necessary.

Or. en

Justification

in some MS pharmacists have enhanced role, so this should be broader

Amendment 1487

Margarita de la Pisa Carrión

Proposal for a directive

Article 177 – paragraph 2

Text proposed by the Commission

Amendment

2. Medicinal products may be advertised to the general public where, by virtue of their composition and purpose, they are intended and designed for use without the intervention of a health professional for diagnostic purposes or for the prescription or monitoring of treatment, with the advice of the pharmacist.

Or. en

Amendment 1488

Joanna Kopcińska, Margarita de la Pisa Carrión

Proposal for a directive

Article 177 – paragraph 2

Text proposed by the Commission

Amendment

2. Medicinal products may be advertised to the general public where, by virtue of their composition and purpose, they are intended and designed for use without the intervention of a health professional for diagnostic purposes or for the prescription or monitoring of treatment, with the advice of the pharmacist.

Or. en

Amendment 1489

Dolors Montserrat

Proposal for a directive

Article 177 – paragraph 2

Text proposed by the Commission

Amendment

Or. es

Justification

El asesoramiento adecuado del paciente es muy importante, especialmente en el caso de los medicamentos sin receta, y forma parte de las actividades profesionales básicas de los farmacéuticos, tal como se estipula en la Directiva sobre cualificaciones profesionales (art. 45(2) g) “suministro de información y asesoramiento sobre medicamentos como tales, incluido el uso apropiado”. Por lo tanto, dicho asesoramiento se encuentra íntimamente relacionado con el acceso seguro del paciente al medicamento y, por ende, con el mantenimiento de la salud pública en los Estados miembros. La figura del farmacéutico, y las garantías que estos ofrecen respecto a la información que proporcionan al consumidor a través del asesoramiento constituye un elemento minimizador de los riesgos para la salud pública que implica el consumo excesivo y la utilización incorrecta de medicamentos.

Amendment 1490

Alessandra Moretti

Proposal for a directive

Article 177 – paragraph 2 a (new)

Text proposed by the Commission

Amendment

2 a. products for which there is no scientifically based proof of efficacy, such as homeopatic or traditional medicinal products, shall not be advertised as valid alternatives to science based therapies and medicinal products, and their advertisement shall clearly inform the public regardig the lack of scientific base for their effects and therapeutic efficacy;

Or. en

Amendment 1491

Alessandra Moretti

Proposal for a directive

Article 177 – paragraph 3

Text proposed by the Commission

Amendment

3. Member States shall be entitled to ban, on their territory, advertising to the general public of medicinal products the cost of which may be reimbursed.

3. Member States shall be entitled to ban, anytime on their territory, advertising to the general public of any medicinal products, particularly for public health reasons and to prevent overuse and misuse of such products;

Or. en

Amendment 1492

Kateřina Konečná

Proposal for a directive

Article 177 – paragraph 3

Text proposed by the Commission

Amendment

3. Member States shall be entitled to ban, on their territory, advertising to the general public of medicinal products the cost of which may be reimbursed.

3. Member States shall be entitled to ban, anytime on their territory, advertising to the general public of medicinal products other than those referred to in paragraph 1.

Or. en

Amendment 1493

Margrete Auken

Proposal for a directive

Article 177 – paragraph 3

Text proposed by the Commission

Amendment

3. Member States shall be entitled to ban, on their territory, advertising to the general public of medicinal products the cost of which may be reimbursed.

3. Member States shall be entitled to ban, on their territory, advertising to the general public of medicinal products other than those referred to in paragraph 1.

Or. en

Amendment 1494

Nicolás González Casares, Tiemo Wölken

Proposal for a directive

Article 177 – paragraph 3

Text proposed by the Commission

Amendment

3. Member States shall be entitled to ban, on their territory, advertising to the general public of medicinal products the cost of which may be reimbursed.

3. Member States shall be entitled to ban, anytime on their territory, advertising to the general public of medicinal products other than those referred to in paragraph 1.

Or. en

Amendment 1495

Nicolás González Casares, Tiemo Wölken

Proposal for a directive

Article 177 – paragraph 4

Text proposed by the Commission

Amendment

4. The prohibition contained in paragraph 1 shall not apply to vaccination campaigns carried out by the industry and approved by the competent authorities of the Member States.

4. The prohibition contained in paragraph 1 shall not apply to vaccination campaigns approved by the competent authorities of the Member States.

Or. en

Amendment 1496

Margarita de la Pisa Carrión

Proposal for a directive

Article 177 – paragraph 4

Text proposed by the Commission

Amendment

4. The prohibition contained in paragraph 1 shall not apply to vaccination campaigns carried out by the industry and approved by the competent authorities of the Member States.

4. The prohibition contained in paragraph 1 shall not apply to vaccination campaigns approved by the competent authorities of the Member States.

Or. en

Amendment 1497

Joanna Kopcińska, Margarita de la Pisa Carrión

Proposal for a directive

Article 177 – paragraph 4

Text proposed by the Commission

Amendment

4. The prohibition contained in paragraph 1 shall not apply to vaccination campaigns carried out by the industry and approved by the competent authorities of the Member States.

4. The prohibition contained in paragraph 1 shall not apply to vaccination campaigns approved by the competent authorities of the Member States.

Or. en

Amendment 1498

Margrete Auken

Proposal for a directive

Article 177 – paragraph 4

Text proposed by the Commission

Amendment

4. The prohibition contained in paragraph 1 shall not apply to vaccination campaigns carried out by the industry and approved by the competent authorities of the Member States.

4. The prohibition contained in paragraph 1 shall not apply to vaccination campaigns approved by the competent authorities of the Member States.

Or. en

Amendment 1499

Dolors Montserrat

Proposal for a directive

Article 177 – paragraph 4

Text proposed by the Commission

Amendment

4. The prohibition contained in paragraph 1 shall not apply to vaccination campaigns carried out by the industry and approved by the competent authorities of the Member States.

4. The prohibition contained in paragraph 1 shall not apply to vaccination campaigns approved by the competent authorities of the Member States.

Or. es

Amendment 1500

Alessandra Moretti

Proposal for a directive

Article 178 – paragraph 1 – point a a (new)

Text proposed by the Commission

Amendment

(a a) an explicit reminder of the potential risks associated to self medication together with the request to keep the family doctor informed about the use of any medicinal product;

Or. en

Amendment 1501

Margrete Auken

Proposal for a directive

Article 178 – paragraph 1 – point b – point i

Text proposed by the Commission

Amendment

(i) the name of the medicinal product, as well as the common name if the medicinal product contains only one active substance;

(i) the name of the medicinal product, international non-propriety name, as well as the common name;

Or. en

Amendment 1502

Margrete Auken

Proposal for a directive

Article 178 – paragraph 1 – point b – point ii

Text proposed by the Commission

Amendment

(ii) the information necessary for correct use of the medicinal product;

(ii) the information necessary for correct use and disposal of the medicinal product;

Or. en

Amendment 1503

Nicolás González Casares, Tiemo Wölken

Proposal for a directive

Article 178 – paragraph 1 – point b – point iii

Text proposed by the Commission

Amendment

(iii) an express, legible invitation to read carefully the instructions on the package leaflet or on the outer packaging, as the case may be.

(iii) an express, legible invitation to read carefully the instructions on the package leaflet or on the outer packaging, as the case may be, and to consult a medical practitioner or a pharmacist for extended information.

Or. en

Amendment 1504

Nicolás González Casares, Tiemo Wölken

Proposal for a directive

Article 178 – paragraph 1 a (new)

Text proposed by the Commission

Amendment

1 a. Any indirect advertising included, whether intentional or not, in any type of communication whose objective is not expressely and obviously advertising shall be prohibited. This includes any mention to specific medicinal products in i.e. social media, television programms or media platforms.

Or. en

Amendment 1505

Alessandra Moretti

Proposal for a directive

Article 178 – paragraph 2 a (new)

Text proposed by the Commission

Amendment

2 a. The European Commission shall adopt implementing acts with specific requirements in relation to the advertising of medicinal products through social media, and consumers’ exposure to such type of content in that platform.

Or. en

Amendment 1506

Nicolás González Casares, Tiemo Wölken

Proposal for a directive

Article 178 – paragraph 2 a (new)

Text proposed by the Commission

Amendment

Or. en

Amendment 1507

Kateřina Konečná

Proposal for a directive

Article 178 – paragraph 2 a (new)

Text proposed by the Commission

Amendment

2 a. The Commission shall adopt delegated acts with specific requirements in relation to the advertising of medicinal products through social media, and consumers’ exposure to such type of content in that platform.

Or. en

Amendment 1508

Nicolás González Casares, Tiemo Wölken

Proposal for a directive

Article 179 – paragraph 1 – point h

Text proposed by the Commission

Amendment

(h) suggests that the safety or efficacy of the medicinal product is due to the fact that it is natural;

(h) suggests that the safety or efficacy of the medicinal product is due to the fact that it is natural and/or not chemical;

Or. en

Amendment 1509

Margrete Auken

Proposal for a directive

Article 180 – paragraph 2 a (new)

Text proposed by the Commission

Amendment

2 a. The Commission shall adopt a delegated act, in accordance with Article 215, regarding restrictions and obligations related to advertising of medicinal products on social media, including on the involvement of celebrities and influencers in the promotion of medicinal products online.

Or. en

Amendment 1510

Nicolás González Casares, Tiemo Wölken

Proposal for a directive

Article 183 – paragraph 1

Text proposed by the Commission

Amendment

1. Where medicinal products are being promoted to persons qualified to prescribe or supply them, no gifts, pecuniary advantages or benefits in kind may be supplied, offered or promised to such persons unless they are inexpensive and relevant to the practice of medicine or pharmacy.

Or. en

Amendment 1511

Margrete Auken

Proposal for a directive

Article 183 – paragraph 1

Text proposed by the Commission

Amendment

Or. en

Amendment 1512

Nicolás González Casares, Tiemo Wölken

Proposal for a directive

Article 185 – paragraph 1 – point g

Text proposed by the Commission

Amendment

(g) no samples of medicinal products containing substances classified as psychotropic or narcotic within the meaning of international conventions may be supplied.

(g) no samples of medicinal products containing substances classified as psychotropic or narcotic within the meaning of international conventions, or those known to produce adictive behaviours, may be supplied.

Or. en

Amendment 1513

Dolors Montserrat

Proposal for a directive

Article 185 – paragraph 1 – point g

Text proposed by the Commission

Amendment

(g) no samples of medicinal products containing substances classified as psychotropic or narcotic within the meaning of international conventions may be supplied.

(g) no samples of medicinal products containing substances classified as antibiotic, psychotropic or narcotic within the meaning of international conventions may be supplied.

Or. es

Amendment 1514

Margarita de la Pisa Carrión

Proposal for a directive

Article 185 – paragraph 1 – point g

Text proposed by the Commission

Amendment

(g) no samples of medicinal products containing substances classified as psychotropic or narcotic within the meaning of international conventions may be supplied.

(g) no samples of medicinal products containing substances classified as antibiotic, psychotropic or narcotic within the meaning of international conventions may be supplied.

Or. en

Amendment 1515

Joanna Kopcińska, Margarita de la Pisa Carrión

Proposal for a directive

Article 185 – paragraph 1 – point g

Text proposed by the Commission

Amendment

(g) no samples of medicinal products containing substances classified as psychotropic or narcotic within the meaning of international conventions may be supplied.

(g) no samples of medicinal products containing substances classified as antibiotic, psychotropic or narcotic within the meaning of international conventions may be supplied

Or. en

Amendment 1516

Peter Liese

Proposal for a directive

Article 185 – paragraph 1 – point g – point i (new)

Text proposed by the Commission

Amendment

i) no samples of medicinal products classified as antimicrobial may be supplied.

Or. en

Amendment 1517

Margrete Auken

Proposal for a directive

Article 186 – paragraph 1

Text proposed by the Commission

Amendment

1. Member States shall ensure that there are adequate and effective methods to monitor the advertising of medicinal products. Such methods, which may be based on a system of prior vetting, shall in any event include legal provisions under which persons or organisations regarded under national law as having a legitimate interest in prohibiting any advertisement inconsistent with this Chapter, may take legal action against such advertisement, or bring such advertisement before the competent authority of the Member State either to decide on complaints or to initiate appropriate legal proceedings.

1. Member States shall ensure that there are adequate and effective methods to monitor the advertising of medicinal products. Such methods, which shall be based on a system of prior vetting especially when advertising is targeted at the general public, shall in any event include legal provisions under which persons or organisations regarded under national law as having a legitimate interest in prohibiting any advertisement inconsistent with this Chapter, may take legal action against such advertisement, or bring such advertisement before the competent authority of the Member State either to decide on complaints or to initiate appropriate legal proceedings.

Or. en

Amendment 1518

Nicolás González Casares, Tiemo Wölken

Proposal for a directive

Article 186 – paragraph 1

Text proposed by the Commission

Amendment

1. Member States shall ensure that there are adequate and effective methods to monitor the advertising of medicinal products. Such methods, which shall be based on a system of prior vetting, at least for advertisements to the general public, shall in any event include legal provisions under which persons or organisations regarded under national law as having a legitimate interest in prohibiting any advertisement inconsistent with this Chapter, may take legal action against such advertisement, or bring such advertisement before the competent authority of the Member State either to decide on complaints or to initiate appropriate legal proceedings.

Or. en

Amendment 1519

Kateřina Konečná

Proposal for a directive

Article 186 – paragraph 1

Text proposed by the Commission

Amendment

1. Member States shall ensure that there are adequate and effective methods to monitor the advertising of medicinal products. Such methods, which shall be based on a system of prior vetting at least for advertisements to the general public, shall in any event include legal provisions under which persons or organisations regarded under national law as having a legitimate interest in prohibiting any advertisement inconsistent with this Chapter, may take legal action against such advertisement, or bring such advertisement before the competent authority of the Member State either to decide on complaints or to initiate appropriate legal proceedings.

Or. en

Amendment 1520

Margrete Auken

Proposal for a directive

Article 186 – paragraph 4 a (new)

Text proposed by the Commission

Amendment

4 a. Member State shall set up and maintain a national transparency register of transfers of value regarding the advertising activities referred to in Articles 175, 177, 180, 182, 183, 184 and 185, targeting persons qualified to prescribe medicinal products. The Commission shall on its website publish a listing referring to all national registries.

Or. en

Justification

In 2019 Mental Health Europe published a useful report on this aspect, most important are pages 18-27 which show the specific national situations at the time: https://mhe-sme.org/wp-content/uploads/2019/01/MHE-SHEDDING-LIGHT-REPORT-Final.pdf

It is high time that there was an EU requirement to have such provisions implemented in all MS to prevent malpractice of healthcare professionals in this regard

Currently the French law is considered a European standard setter in this aspect, link here: https://www.legifrance.gouv.fr/loda/id/JORFTEXT000027434029

There is also Belgian register which is available in English: https://betransparent.be/en/

Amendment 1521

Margrete Auken

Proposal for a directive

Article 186 – paragraph 4 b (new)

Text proposed by the Commission

Amendment

4 b. The national registries referred to in paragraph 4a shall include at least the following information:

(a) the name of the marketing authorisation holder;

(b) the name of a person qualified to prescribe medicinal products;

(d) type of advertising activity, referred to in Article 175 paragraph 1 points (b) to (g) and Article 184;

(e) monetary value.

Or. en

Amendment 1522

Margrete Auken

Proposal for a directive

Article 186 – paragraph 4 c (new)

Text proposed by the Commission

Amendment

4 c. Marketing authorisation holders shall use the national transparency register referred to in paragraph 4a to submit information referred to in paragraph 4b in relation to each person qualified to prescribe medicinal products in respective Member State where such activity takes place.

Or. en

Amendment 1523

Margrete Auken

Proposal for a directive

Article 186 – paragraph 5

Text proposed by the Commission

Amendment

5. The paragraphs 1 to 4 shall not exclude the voluntary control of advertising of medicinal products by self-regulatory bodies and recourse to such bodies, if proceedings before such bodies are possible in addition to the judicial or administrative proceedings referred to in paragraph 1.

5. The paragraphs 1 to 4c shall not exclude the voluntary control of advertising of medicinal products by self-regulatory bodies.

Or. en

Amendment 1524

Margrete Auken

Proposal for a directive

Article 187 – paragraph 2 – point d a (new)

Text proposed by the Commission

Amendment

(d a) report activities in national registries, as laid down in Article 186 (4c).

Or. en

Amendment 1525

Nicolás González Casares, Tiemo Wölken

Proposal for a directive

Article 188 – paragraph 1 – subparagraph 1

Text proposed by the Commission

Amendment

The competent authority of the Member State concerned shall, in cooperation with the Agency and where relevant, other Member States, ensure compliance with the rules of this Directive, namely the principles of good manufacturing practice and good distribution practices referred to in Articles 160 and 161.

The competent authority of the Member State concerned, namely the supervisory authority, shall, in cooperation with the Agency and where relevant, other Member States, ensure compliance with the rules of this Directive, namely the principles of good manufacturing practice and good distribution practices referred to in Articles 160 and 161.

Or. en

Amendment 1526

Nicolás González Casares, Tiemo Wölken

Proposal for a directive

Article 188 – paragraph 3 – introductory part

Text proposed by the Commission

Amendment

3. The competent authority of the Member State shall ensure that the measures referred to in paragraph 1, second subparagraph, are carried out by the official representatives of the competent authority of the Member State:

3. The competent authority of the Member State, namely the supervisory authority, shall ensure that the measures referred to in paragraph 1, second subparagraph, are carried out by the official representatives of the competent authority of the Member State concerned:

Or. en

Amendment 1527

Nicolás González Casares, Tiemo Wölken

Proposal for a directive

Article 188 – paragraph 5 – introductory part

Text proposed by the Commission

Amendment

5. Where the competent authority of the Member State considers it necessary, in particular where there are grounds for suspecting non-compliance with the rules of this Directive, including with the principles of good manufacturing practice and good distribution practices, referred to in Articles 160 and 161, it may have its official representatives carry out the measures referred to in paragraph 1, second subparagraph at the premises or on the activities of:

5. Where the competent authority of the Member State, namely the supervisory authority, considers it necessary, in particular where there are grounds for suspecting non-compliance with the rules of this Directive, including with the principles of good manufacturing practice and good distribution practices, referred to in Articles 160 and 161, or based on a risk assesment, it may have its official representatives carry out the measures referred to in paragraph 1, second subparagraph at the premises or on the activities of:

Or. en

Amendment 1528

Nicolás González Casares, Tiemo Wölken

Proposal for a directive

Article 188 – paragraph 5 – point d

Text proposed by the Commission

Amendment

(d) distributors of medicinal products or active substances located in third countries;

(d) distributors of medicinal products or manufacturers or distributors of active substances located in third countries;

Or. en

Amendment 1529

Nicolás González Casares, Tiemo Wölken

Proposal for a directive

Article 188 – paragraph 7 – point a a (new)

Text proposed by the Commission

Amendment

(a a) Examine any documents and records to verify compliance with the particulars of this Directive , and obtain evidence, such as copies of documents, photographs or videos.

Or. en

Amendment 1530

Nicolás González Casares, Tiemo Wölken

Proposal for a directive

Article 189 – paragraph 1 – subparagraph 1

Text proposed by the Commission

Amendment

Upon request by one or more competent authorities, inspections referred to in Article 188, paragraphs 3 and 5, may be carried out by official representatives from more than one Member State, together with the inspectors of the Agency in accordance with Article 52(2), point (a) of [revised Regulation (EC) 726/2004] (‘the joint inspection’).

Upon request by one or more competent authorities of the Member States, inspections referred to in Article 188, paragraphs 3 and 5, may be carried out by official representatives from more than one Member State, together with the inspectors of the Agency, if specifically requested by the aforementioned competent authorities, in accordance with Article 52(2), point (a) of [revised Regulation (EC) 726/2004] (‘the joint inspection’).

Or. en

Amendment 1531

Nicolás González Casares, Tiemo Wölken

Proposal for a directive

Article 189 – paragraph 1 – subparagraph 2 – point a

Text proposed by the Commission

Amendment

(a) it is demonstrated, or there are reasonable ground for suspecting, that the activities carried out on the territory of the Member State receiving the request pose a risk to the safety and quality in the Member State of the competent authority requesting the joint inspection;

Or. en

Amendment 1532

Nicolás González Casares, Tiemo Wölken

Proposal for a directive

Article 189 – paragraph 1 – subparagraph 2 – point c

Text proposed by the Commission

Amendment

(c) the competent authority of the Member State receiving the request agrees that there are other reasonable grounds such as training of inspectors, sharing of good practice, for for conducting a joint inspection.

Or. en

Amendment 1533

Nicolás González Casares, Tiemo Wölken

Proposal for a directive

Article 189 – paragraph 2 – point b

Text proposed by the Commission

Amendment

(b) the roles of the participating inspectors during and following the inspection, including the designation of an authority leading the inspection;

(b) the roles of the participating inspectors during and following the inspection, including the designation of an authority leading the inspection, if the supervisory authority refuses to lead the inspection;

Or. en

Amendment 1534

Nicolás González Casares, Tiemo Wölken

Proposal for a directive

Article 192 – paragraph 1

Text proposed by the Commission

Amendment

For the purpose of implementing Article 191, Member States may require manufacturers of immunological products to submit to a competent authority of the Member States copies of all the control reports signed by the qualified person in accordance with Article 153.

For the purpose of implementing Article 191, Member States may require manufacturers of immunological products and of medicinal products derived from substances of human origin to submit to a competent authority of the Member States copies of all the control reports signed by the qualified person in accordance with Article 153.

Or. en

Amendment 1535

Nicolás González Casares, Tiemo Wölken

Proposal for a directive

Article 193 – paragraph 1 – subparagraph 1

Text proposed by the Commission

Amendment

to submit samples from each batch of the bulk or the medicinal product for examination by an Official Medicines Control Laboratory or a laboratory that a Member State has designated for that purpose before release on to the market unless the competent authority of another Member State has previously examined the batch in question and declared it to be in conformity with the approved specifications. In such a case the declaration of conformity issued by another Member States shall be directly recognised. Member States shall ensure that any such examination is completed within 30 days of the receipt of the samples.

to submit samples from each batch of the bulk and/or the medicinal product for examination by an Official Medicines Control Laboratory or a laboratory that a Member State has designated for that purpose before release on to the market unless the competent authority of another Member State has previously examined the batch in question and declared it to be in conformity with the approved specifications. In such a case the declaration of conformity issued by another Member States shall be recognised. Member States shall ensure that any such examination is completed within 60 days of the receipt of the samples and documentation of the controls carried out by the marketing authorisation holder in accordance with article 191.

Or. en

Amendment 1536

Joanna Kopcińska

Proposal for a directive

Article 193 – paragraph 1 – subparagraph 1

Text proposed by the Commission

Amendment

Or. en

Amendment 1537

Nicolás González Casares, Tiemo Wölken

Proposal for a directive

Article 193 – paragraph 2

Text proposed by the Commission

Amendment

2. Where, in the interests of public health, the laws of a Member State so provide, the competent authorities of the Member State may require the marketing authorisation holder for medicinal products derived from human blood or human plasma to submit samples from each batch of the bulk or the medicinal product for testing by an Official Medicines Control Laboratory or a laboratory that a Member State has designated for that purpose before being released into free circulation, unless the competent authorities of another Member State have previously examined the batch in question and declared it to be in conformity with the approved specifications. Member States shall ensure that any such examination is completed within 60 days of the receipt of the samples.

2. Where, in the interests of public health, the laws of a Member State so provide, the competent authorities of the Member State may require the marketing authorisation holder for medicinal products derived from human blood or human plasma to submit samples from each batch of the bulk and/or the medicinal product for testing by an Official Medicines Control Laboratory or a laboratory that a Member State has designated for that purpose before being releasedto the market, unless the competent authorities of another Member State have previously examined the batch in question and declared it to be in conformity with the approved specifications. In such a case the declaration of conformity issued by another Member State shall be recognised. Member States shall ensure that any such examination is completed within 60 calendar days of the receipt of the samples and documentation of the controls carried out by the marketing authorisation holder in accordance with article 191.

Or. en

Amendment 1538

Nicolás González Casares, Tiemo Wölken

Proposal for a directive

Article 194 – title

Text proposed by the Commission

Amendment

Processes for the preparation of medicinal products derived from human blood or human plasma

Processes for the preparation of medicinal products derived from substances of human origin

Or. en

Amendment 1539

Nicolás González Casares, Tiemo Wölken

Proposal for a directive

Article 194 – paragraph 1

Text proposed by the Commission

Amendment

1. Member States shall take all necessary measures to ensure that the manufacturing and purifying processes used in the preparation of medicinal products derived from human blood or human plasma are properly validated, attain batch-to-batch consistency and guarantee, insofar as the state of technology permits, the absence of specific viral contamination.

1. Member States shall take all necessary measures to ensure that the manufacturing and purifying processes used in the preparation of medicinal products derived from substances of human origin are properly validated, attain batch-to-batch consistency and guarantee, insofar as the state of technology permits, the absence of risks for the human health, including contaminations..

Or. en

Amendment 1540

Margrete Auken

Proposal for a directive

Article 194 – paragraph 1

Text proposed by the Commission

Amendment

1. Member States shall take all necessary measures to ensure that the manufacturing and purifying processes used in the preparation of medicinal products derived from human blood or human plasma are properly validated, attain batch-to-batch consistency and guarantee the absence of specific contamination that may pose a risk to patients.

Or. en

Amendment 1541

Nicolás González Casares, Tiemo Wölken

Proposal for a directive

Article 194 – paragraph 2

Text proposed by the Commission

Amendment

2. To this end manufacturers shall notify the competent authorities of the Member States of the method used to reduce or eliminate pathogenic viruses liable to be transmitted by medicinal products derived from human blood or human plasma. The competent authority of the Member State may submit samples of the bulk or the medicinal product for testing by a State laboratory or a laboratory designated for that purpose, either during the examination of the application pursuant to Article 29, or after a marketing authorisation has been granted.

2. To this end manufacturers shall notify the competent authorities of the Member States of the methods used to ensure the quality and safety of the substances of human origin, as described in Regulation (EU) No [SoHO Regulation]. The competent authority of the Member State may submit samples of the bulk and/or the medicinal product for testing by a State laboratory or a laboratory designated for that purpose, either during the examination of the application pursuant to Article 29, or after a marketing authorisation has been granted.

Or. en

Amendment 1542

Marian-Jean Marinescu

Proposal for a directive

Article 195 – paragraph 2

Text proposed by the Commission

Amendment

2. The competent authorities of the Member States or, in the case of centralised marketing authorisation, the Commission may suspend for 3 months or vary a marketing authorisation if a serious risk to the environment or public health has been identified and not sufficiently addressed by the marketing authorisation holder. If, after the 3 months suspension, the serious risk to the environment or public health has not been sufficiently addressed by the marketing authorisation holder, the competent authorities of the Member States or, in the case of centralised marketing authorisation, the Commission may revoke the marketing authorisation.

Or. en

Justification

Introducing the possibility to revoke a marketing authorisation based on environmental grounds would negatively impact patient’s access to medicines, therefore introducing a compliance period would be for the benefit of patients.

Amendment 1543

Susana Solís Pérez

Proposal for a directive

Article 195 – paragraph 2

Text proposed by the Commission

Amendment

2. The competent authorities of the Member States or, in the case of centralised marketing authorisation, the Commission may suspend or vary a marketing authorisation if a serious risk to the environment, including public health, has been identified and not sufficiently addressed by the marketing authorisation holder. Should the environmental risks, which also encompass public health dangers, surpass the therapeutic benefits for the intended patients and if these risks are not adequately reducible, the relevant Member State authorities or the Commission may revoke the marketing authorization of the holder.

Or. en

Amendment 1544

Andreas Glück

Proposal for a directive

Article 195 – paragraph 2

Text proposed by the Commission

Amendment

2. The competent authorities of the Member States or, in the case of centralised marketing authorisation, the Commission may suspend, revoke or vary a marketing authorisation if a serious risk to the environment or public health has been identified and not sufficiently addressed by the marketing authorisation holder. The responsible authority must clearly consider whether this suspension is proportionate to the loss for the affected patients and should first consider further steps to reduce the risk.

Or. en

Justification

The suspension of a medicine may be a devastating judgment for affected patients. Therefore, it should be carefully looked at whether the advantages outweigh the disadvantages.

Amendment 1545

Catherine Amalric, Frédérique Ries, Max Orville, Billy Kelleher, Susana Solís Pérez, Erik Poulsen, Andreas Glück, Ondřej Knotek

Proposal for a directive

Article 195 – paragraph 2

Text proposed by the Commission

Amendment

2. The competent authorities of the Member States or, in the case of centralised marketing authorisation, the Commission may suspend, revoke or vary a marketing authorisation if a serious risk to the environment or public health has been identified and not sufficiently addressed by the marketing authorisation holder, with the exception of medicinal products authorised before 30 october 2005 to avoid restricting patients' access to existing treatments.

Or. en

Amendment 1546

Joanna Kopcińska, Andrey Slabakov

Proposal for a directive

Article 195 – paragraph 2

Text proposed by the Commission

Amendment

2. The competent authorities of the Member States or, in the case of centralised marketing authorisation, the Commission may suspend, revoke or vary a marketing authorisation if a serious risk to the environment or public health has been identified and not sufficiently addressed by the marketing authorisation holder with clear prioritatization of public health over risk to environment.

Or. en

Amendment 1547

Margarita de la Pisa Carrión

Proposal for a directive

Article 195 – paragraph 2

Text proposed by the Commission

Amendment

2. The competent authorities of the Member States or, in the case of centralised marketing authorisation, the Commission may suspend, or vary a marketing authorisation if a serious risk to the environment or public health has been identified and not sufficiently addressed by the marketing authorisation holder via conditions laid out in Articles 44(h) or 87(c). .

Or. en

Amendment 1548

Massimiliano Salini, Francesca Peppucci

Proposal for a directive

Article 195 – paragraph 2

Text proposed by the Commission

Amendment

Or. en

Amendment 1549

Fulvio Martusciello

Proposal for a directive

Article 195 – paragraph 2

Text proposed by the Commission

Amendment

Or. en

Amendment 1550

Margrete Auken

Proposal for a directive

Article 195 – paragraph 2

Text proposed by the Commission

Amendment

2. The competent authorities of the Member States or, in the case of centralised marketing authorisation, the Commission shall suspend, revoke or vary a marketing authorisation if a serious risk to the environment or public health has been identified and not sufficiently addressed by the marketing authorisation holder.

Or. en

Amendment 1551

Susana Solís Pérez

Proposal for a directive

Article 195 – paragraph 2

Text proposed by the Commission

Amendment

Or. en

Amendment 1552

Stanislav Polčák

Proposal for a directive

Article 195 – paragraph 2

Text proposed by the Commission

Amendment

Or. cs

Amendment 1553

Margrete Auken

Proposal for a directive

Article 195 – paragraph 3

Text proposed by the Commission

Amendment

3. A marketing authorisation may also be suspended, revoked or varied where the particulars supporting the application as provided for in Articles 6, 9 to 14 or Annexes I to V are incorrect or have not been amended in accordance with Article 90, or where any conditions referred to in Articles 44, 45 and 87 have not been fulfilled or where the controls referred to in Article 191 have not been carried out.

3. A marketing authorisation may also be suspended, revoked or varied where the particulars supporting the application as provided for in Articles 6, 9 to 14 or Annexes I to V are incorrect or have not been amended in accordance with Article 90, or where any conditions referred to in Articles 44 and 87 have not been fulfilled or where the controls referred to in Article 191 have not been carried out.

Or. en

Amendment 1554

Annalisa Tardino

Proposal for a directive

Article 195 – paragraph 3

Text proposed by the Commission

Amendment

3. A marketing authorisation may also be suspended or varied where the particulars supporting the application as provided for in Articles 6, 9 to 14 or Annexes I to V are incorrect or have not been amended in accordance with Article 90, or where any conditions referred to in Articles 44, 45 and 87 have not been fulfilled or where the controls referred to in Article 191 have not been carried out.

Or. it

Amendment 1555

Catherine Amalric, Frédérique Ries, Max Orville, Billy Kelleher, Susana Solís Pérez, Erik Poulsen, Ondřej Knotek

Proposal for a directive

Article 196 – paragraph 1 – point f

Text proposed by the Commission

Amendment

(f) a serious risk to the environment or to public health via the environment has been identified and not sufficiently addressed by the marketing authorisation holder.

(f) a serious risk to the environment or to public health via the environment has been identified and not sufficiently addressed by the marketing authorisation holder, with the exception of medicinal products authorised before 30 october 2005 to avoid restricting patients’ access to existing treatments.

Or. en

Amendment 1556

Marian-Jean Marinescu

Proposal for a directive

Article 196 – paragraph 1 – point f

Text proposed by the Commission

Amendment

(f) a serious risk to the environment or to public health via the environment has been identified and not sufficiently addressed by the marketing authorisation holder.

(f) a serious risk to the environment or to public health via the environment has been identified and not sufficiently addressed by the marketing authorisation holder, within 3 months since the serious risk to the environment or to public health via the environment has been identified.

Or. en

Justification

Amendment 1557

Massimiliano Salini, Francesca Peppucci

Proposal for a directive

Article 196 – paragraph 1 – point f

Text proposed by the Commission

Amendment

(f) a serious risk to the environment or to public health via the environment has been identified and not sufficiently addressed by the marketing authorisation holder.

(f) a serious risk to the environment or to public health via the environment has been identified and not sufficiently addressed by the marketing authorisation holder via conditions specified in Articles 44(h) or 87(c).

Or. en

Amendment 1558

Fulvio Martusciello

Proposal for a directive

Article 196 – paragraph 1 – point f

Text proposed by the Commission

Amendment

(f) a serious risk to the environment or to public health via the environment has been identified and not sufficiently addressed by the marketing authorisation holder.

(f) a serious risk to the environment has been identified and not sufficiently addressed by the marketing authorisation holder via conditions laid out in Articles 44(h) or 87(c).

Or. en

Amendment 1559

Nicola Procaccini

Proposal for a directive

Article 196 – paragraph 1 – point f

Text proposed by the Commission

Amendment

(f) a serious risk to the environment or to public health via the environment has been identified and not sufficiently addressed by the marketing authorisation holder.

(f) a serious risk to the environment has been identified and not sufficiently addressed by the marketing authorisation holder via conditions laid out in Articles 44(h) or 87(c).

Or. en

Amendment 1560

Stanislav Polčák

Proposal for a directive

Article 196 – paragraph 1 – point f

Text proposed by the Commission

Amendment

(f) a serious risk to the environment or to public health via the environment has been identified and not sufficiently addressed by the marketing authorisation holder.

(Does not affect the English version.)

Or. cs

Amendment 1561

Sirpa Pietikäinen

Proposal for a directive

Article 197 – paragraph 3

Text proposed by the Commission

Amendment

3. If the medicinal product in question is suspected of presenting a serious risk to public health, the competent authority of the Member State in which that product was first identified shall, without undue delay, transmit a rapid alert notification to all Member States and all actors in the supply chain in that Member State. In the event of such medicinal products being deemed to have reached patients, urgent public announcements shall be issued within 24 hours in order to recall those medicinal products from the patients. Those announcements shall contain sufficient information on the suspected quality defect or falsification and the risks involved.

3. If the medicinal product in question is suspected of presenting a serious risk to public health or to environment, the competent authority of the Member State in which that product was first identified shall, without undue delay, transmit a rapid alert notification to all Member States and all actors in the supply chain in that Member State. In the event of such medicinal products being deemed to have reached patients, urgent public announcements shall be issued within 24 hours in order to recall those medicinal products from the patients. Those announcements shall contain sufficient information on the suspected quality defect or falsification and the risks involved.

Or. en

Amendment 1562

Margrete Auken

Proposal for a directive

Article 200 – paragraph 2

Text proposed by the Commission

Amendment

2. Member States shall ensure that adequate financial resources are available to provide the staff and other resources necessary for the competent authorities to carry out the activities required by this Directive and [revised Regulation (EC) No 726/2004].

2. Member States shall ensure that adequate financial resources are available to provide the staff and other resources, including appropriate digital infrastructure, necessary for the competent authorities to carry out the activities required by this Directive and [revised Regulation (EC) No 726/2004].

Or. en

Amendment 1563

Margrete Auken

Proposal for a directive

Article 200 – paragraph 3

Text proposed by the Commission

Amendment

3. The competent authorities of the Member States shall cooperate with each other and with the Agency and the Commission in the performance of their tasks under this Directive and [revised Regulation (EC) No 726/2004] to ensure proper application and due enforcement. The competent authorities of the Member States shall transmit to each other all necessary information.

Or. en

Amendment 1564

Nicolás González Casares, Tiemo Wölken

Proposal for a directive

Article 200 – paragraph 4 – subparagraph 1

Text proposed by the Commission

Amendment

The competent authority of the Member State may process personal health data from sources other than clinical studies to support their public health tasks and, in particular, the evaluation and monitoring to medicinal products, for the purpose of improving the robustness of the scientific assessment or verifying claims of the applicant or marketing authorisation holder.

The competent authority of the Member State may process personal health data from sources other than clinical studies including the Eudravigilance database, electronic health data obtained pursuant to the applicable rules of the European Health Data Space to support their public health tasks and, in particular, the evaluation and monitoring to medicinal products, for the purpose of improving the robustness of the scientific assessment or verifying claims of the applicant or marketing authorisation holder. The competent authorities must put in place sufficient, effective and specific technical and organisational measures to safeguard the fundamental rights and interests of data subjects in line with Regulation (EU) 2016/679 and Regulation (EU) 2018/1725, including but not limited to clear and targeted data retention and deletion policies, state-of-the-art anonymisation and pseudonymisation requirements and techniques, confidentiality and data security measures, and access control mechanisms.

Or. en

Amendment 1565

Catherine Amalric, Frédérique Ries, Max Orville, Billy Kelleher, Susana Solís Pérez, Erik Poulsen, Andreas Glück, Ondřej Knotek

Proposal for a directive

Article 200 – paragraph 4 – subparagraph 1

Text proposed by the Commission

Amendment

The competent authority of the Member State may process personal health data from sources other than clinical studies, including real world data, to support their public health tasks and, in particular, the evaluation and monitoring to medicinal products, for the purpose of improving the robustness of the scientific assessment or verifying claims of the applicant or marketing authorisation holder.

Or. en

Amendment 1566

István Ujhelyi

Proposal for a directive

Article 201 – paragraph 1

Text proposed by the Commission

Amendment

1. Member States, in applying this Directive, shall ensure that when questions arise with regard to the regulatory status of a medicinal product, in relation to their link to substances of human origin as referred to in Regulation (EU) No [SoHO Regulation], the competent authorities of the Member States shall consult the Agency and the relevant authorities established under that Regulation. The Agency shall coordinate the review and outcomes of the questions and will publish relevant details after deletion of any information of a commercially confidential nature.

Or. en

Amendment 1567

Susana Solís Pérez, Catherine Amalric

Proposal for a directive

Article 201 – paragraph 1

Text proposed by the Commission

Amendment

1. Member States, in applying this Directive, shall ensure that when questions arise with regard to the regulatory status of a medicinal product, in relation to their link to substances of human origin as referred to in Regulation (EU) No [SoHO Regulation], the competent authorities of the Member States shall consult the Agency and the relevant authorities established under that Regulation. The Agency shall oversee the examination and results of inquiries and disclose pertinent information, ensuring any commercially sensitive data is removed prior to publication.

Or. en

Amendment 1568

Margrete Auken

Proposal for a directive

Article 201 – paragraph 1 a (new)

Text proposed by the Commission

Amendment

1 a. Member States shall ensure a consultation process between national competent authorities for medicinal products and other relevant authorities or bodies for the exchange of information and pooling of expertise related to provisions laid down in this Directive, including, as appropriate, notified bodies under Regulation (EU) 2017/745 and Regulation (EU) 2017/746, bodies responsible for health technology assessment as referred to in Regulation (EU) 2021/2282 and national bodies responsible for pricing and reimbursement.

Or. en

Amendment 1569

Nicolás González Casares, Tiemo Wölken

Proposal for a directive

Article 201 – paragraph 2 a (new)

Text proposed by the Commission

Amendment

2 a. The Commission, in applying this Directive, in order to improve regulatory certainty and cross-sectoral cooperation it shall on an annual basis, or more frequently where deemed necessary, organise joint meetings between the Agency and the relevant advisory and regulatory bodies established under other Union legislation to assess emergeing trends and questions on the regulatory status of products and to find agreement on common regulatory status principles. The summaries and conclusions of these joint meetings shall be made publicly available, including the opinions and conclusions of each of the respective bodies.

Or. en

Amendment 1570

Kateřina Konečná

Proposal for a directive

Article 206 – paragraph 1 – subparagraph 1

Text proposed by the Commission

Amendment

Member States shall lay down the rules on penalties applicable to infringements of national provisions adopted pursuant to this Directive and shall take all measures necessary to ensure that they are implemented. The penalties must be effective, proportionate and dissuasive. Member States shall, without delay, notify the Commission of those rules and of those measures and shall notify without delay of any subsequent amendment affecting them.

Member States shall lay down the rules on penalties applicable to infringements of national provisions adopted pursuant to this Directive and shall take all measures necessary to ensure that they are implemented. The penalties must be effective, proportionate and dissuasive. Member States shall, without delay, and taking into consideration the provision in paragraph 4, notify the Commission of those rules and of those measures and shall notify without delay of any subsequent amendment affecting them.

Or. en

Amendment 1571

Nicolás González Casares, Tiemo Wölken

Proposal for a directive

Article 206 – paragraph 1 – subparagraph 1

Text proposed by the Commission

Amendment

Member States shall lay down the rules on penalties applicable to infringements of national provisions adopted pursuant to this Directive and shall take all measures necessary to ensure that they are implemented. The penalties must be effective, proportionate and dissuasive. Member States shall, without delay, and taking into consideration the provision in paragraph 4, notify the Commission of those rules and of those measures and shall notify without delay of any subsequent amendment affecting them.

Or. en

Amendment 1572

Margrete Auken

Proposal for a directive

Article 206 – paragraph 1 a (new)

Text proposed by the Commission

Amendment

1 a. When deciding on the amount of the penalty in each individual case, all relevant circumstances of the specific situation shall be taken into account and due regard shall be given to the following:

(a) the nature, gravity and duration of the infringement and of its consequences, taking into account the nature, scope as well as the number of persons affected and the level of damage suffered by them;

(b) whether penalties have been already applied by other competent authorities to the same infringing party;

(d) the intentional or negligent character of the infringement;

(e) any action taken by the infringing party to mitigate the damage of the infringement;

(f) the degree of responsibility of the infringing party taking into account technical and organisational measures implemented to prevent the infringement;

(g) the degree of cooperation with the competent authorities, in order to remedy the infringement and mitigate the possible adverse effects of the infringement;

(h) the manner in which the infringement became known to the competent authorities, in particular whether, and if so to what extent, the infringing party notified the infringement;

(i) the risk to public health presented by the falsification of medicinal products.

Or. en

Amendment 1573

Margrete Auken

Proposal for a directive

Article 206 – paragraph 1 b (new)

Text proposed by the Commission

Amendment

1 b. The non-compliance of an entity with any requirements or obligations under this Directive, including the supply of incorrect, incomplete or misleading information to national competent authorities, shall be subject to penalties of up to 20 000 000 EUR or, or in the case of an undertaking, up to 5% of its total worldwide annual turnover for the preceding financial year, whichever is higher. In case of ongoing non-compliance, the national competent authority may fine the entity with fines for each day of delay, which shall be transparent and proportionate. The amount of the fines shall be established by the competent authority pursuant to criteria laid down in paragraph 1a.

Or. en

Amendment 1574

Nicolás González Casares, Tiemo Wölken

Proposal for a directive

Article 206 – paragraph 2 – point d

Text proposed by the Commission

Amendment

(d) non-compliance with the provisions laid down in this Directive on pharmacovigilance;

(d) non-compliance with the provisions laid down in this Directive on pharmacovigilance, and the provisions laid down in paragraph 2 of Article 17 in relation to the stewardship plan for antimicrobials, and in Article 44 on national marketing authorisations subject to conditions;

Or. en

Amendment 1575

Margrete Auken

Proposal for a directive

Article 206 – paragraph 2 – point d a (new)

Text proposed by the Commission

Amendment

(d a) non-compliance with the provisions laid down in this Directive on obligations imposed by national competent authorities, including related to product’s efficacy, safety and environmental impact, including antimicrobial resistance;

Or. en

Amendment 1576

Margrete Auken

Proposal for a directive

Article 206 – paragraph 2 – point d b (new)

Text proposed by the Commission

Amendment

(d b) non-compliance with the provisions related to supply obligation;

Or. en

Amendment 1577

Margrete Auken

Proposal for a directive

Article 206 – paragraph 2 – point d c (new)

Text proposed by the Commission

Amendment

(d c) non-compliance with launches of products in Member States, as laid down in article 58a;

Or. en

Amendment 1578

Cyrus Engerer

Proposal for a directive

Article 206 – paragraph 2 – point e a (new)

Text proposed by the Commission

Amendment

(e a) non-compliance with the obligations laid down in this Directive in Chapter V.

Or. en

Amendment 1579

Margrete Auken

Proposal for a directive

Article 206 – paragraph 3

Text proposed by the Commission

Amendment

3. Where relevant, the penalties shall take into account the risk to public health presented by the falsification of medicinal products.

deleted

Or. en

Justification

Moved to paragraph 1a point i

Amendment 1580

Kateřina Konečná

Proposal for a directive

Article 206 – paragraph 3 a (new)

Text proposed by the Commission

Amendment

3 a. 4. The European Commission shall lay down criteria for establishing the penalties, taking into account paragraphs 1, 2 and 3, and the highest penalties laid down amongst Member States before the application of this Directive

Or. en

Amendment 1581

Nicolás González Casares, Tiemo Wölken

Proposal for a directive

Article 206 – paragraph 3 a (new)

Text proposed by the Commission

Amendment

3 a. The European Commission shall lay down criteria for establishing the penalties, taking into account paragraphs 1, 2 and 3, and the highest penalties laid down amongst Member States before the application of this Directive.

Or. en

Amendment 1582

Susana Solís Pérez, Catherine Amalric

Proposal for a directive

Article 207 – paragraph 1

Text proposed by the Commission

Amendment

Member States shall ensure that appropriate collection systems are in place for medicinal products that are unused or have expired.

Member States shall ensure that appropriate collection systems are in place for medicinal products that are unused or have expired and that the medicinal products gathered are managed appropriately, preventing any technically preventable environmental leakage.

Or. en

Amendment 1583

Dolors Montserrat, Nathalie Colin-Oesterlé, Stelios Kympouropoulos

Proposal for a directive

Article 207 – paragraph 1

Text proposed by the Commission

Amendment

Member States shall ensure that appropriate collection systems are in place for medicinal products that are unused or have expired.

Member States shall ensure that appropriate collection systems are in place for medicinal products that are unused or have expired and that the collected medicinal products are managed properly without any technically avoidable leakage to the environment.

Or. en

Amendment 1584

István Ujhelyi

Proposal for a directive

Article 207 – paragraph 1

Text proposed by the Commission

Amendment

Member States shall ensure that appropriate collection systems are in place for medicinal products that are unused or have expired.

Or. en

Amendment 1585

Nicolás González Casares, Tiemo Wölken

Proposal for a directive

Article 207 – paragraph 1

Text proposed by the Commission

Amendment

Member States shall ensure that appropriate collection systems are in place for medicinal products that are unused or have expired.

Member States shall ensure that appropriate collection systems are in place for medicinal products that are unused or have expired, and that the collected medicinal products are managed properly without any technically avoidable leakage to the environment.

Or. en

Amendment 1586

Margrete Auken

Proposal for a directive

Article 207 – paragraph 1

Text proposed by the Commission

Amendment

Member States shall ensure that appropriate collection systems are in place for medicinal products that are unused or have expired.

Member States shall ensure that appropriate collection and disposal systems are in place for medicinal products that are unused or have expired.

Or. en

Amendment 1587

Nicolás González Casares, Tiemo Wölken

Proposal for a directive

Article 207 – paragraph 1 – point 1 (new)

Text proposed by the Commission

Amendment

(1) By ... [18 months after the date of entry into force of this Directive], Member States shall draw up national plans including measures designed to:

(a) monitor the rates of correct and incorrect disposal of unused and expired medicinal products;

(b) inform the general public about the environmental risks associated with incorrect disposal of medicinal products, in particular those that contain substances referred to in Article 22(2);

(c) inform healthcare professionals about the environmental risks associated with incorrect disposal of unused or expired medicinal products, in particular those that contain substances referred to in Article 22(2);

(d) increase the rate of correct disposal of unused or expired medicinal products;and

(e) designate public and private actors responsible for the collection systems referred to in paragraph 1.

Or. en

Amendment 1588

Catherine Amalric, Frédérique Ries, Max Orville, Billy Kelleher, Susana Solís Pérez, Erik Poulsen

Proposal for a directive

Article 207 – paragraph 1 – subparagraph 1 (new)

Text proposed by the Commission

Amendment

Member States shall promote awareness-raising and educational campaigns for the general public on the environmental risks of pharmaceuticals and on how to improve disposal practices.

Or. en

Amendment 1589

Margrete Auken

Proposal for a directive

Article 208 – paragraph 1

Text proposed by the Commission

Amendment

1. In order to guarantee independence and transparency, the Member States shall ensure that members of staff of the competent authority responsible for granting authorisations, rapporteurs and experts concerned with the authorisation and surveillance of medicinal products have no financial or other interests in the pharmaceutical industry that could affect their impartiality. These persons shall make an annual declaration of their financial interests.

1. In order to guarantee independence and transparency, the Member States shall ensure that members of staff of the competent authority responsible for granting authorisations, rapporteurs and experts concerned with the authorisation and post-authorisation surveillance of medicinal products have no direct or indirect financial or other interests in the pharmaceutical industry that could affect their impartiality. These persons shall make an annual declaration of their financial interests which shall be made publicly available on the authority’s website.

Or. en

Amendment 1590

Catherine Amalric, Frédérique Ries, Max Orville, Billy Kelleher, Susana Solís Pérez, Dacian Cioloş

Proposal for a directive

Article 208 – paragraph 1

Text proposed by the Commission

Amendment

1. In order to guarantee independence and transparency, the Member States shall ensure that members of staff of the competent authority responsible for granting authorisations, rapporteurs and experts concerned with the authorisation and surveillance of medicinal products have no financial or other interests in the pharmaceutical industry that could affect their impartiality and their independance. These persons shall make an annual declaration of their financial interests and update them annually and whenever necessary.

Or. en

Amendment 1591

Kateřina Konečná

Proposal for a directive

Article 208 – paragraph 1

Text proposed by the Commission

Amendment

Or. en

Amendment 1592

Nicolás González Casares, Tiemo Wölken

Proposal for a directive

Article 208 – paragraph 1

Text proposed by the Commission

Amendment

Or. en

Amendment 1593

Margrete Auken

Proposal for a directive

Article 208 – paragraph 2

Text proposed by the Commission

Amendment

2. In addition, the Member States shall ensure that the competent authority makes publicly available its rules of procedure and those of its committees, agendas for its meetings and records of its meetings, accompanied by decisions taken, details of votes and explanations of votes, including minority opinions.

2. In addition, the Member States shall ensure that the competent authority makes publicly available its rules of procedure and those of its committees, including their working groups and expert groups, agendas for its meetings and records of its meetings, accompanied by decisions taken, details of votes and explanations of votes, including minority opinions.

Or. en

Amendment 1594

Catherine Amalric, Frédérique Ries, Max Orville, Billy Kelleher, Susana Solís Pérez, Dacian Cioloş

Proposal for a directive

Article 208 – paragraph 2 a (new)

Text proposed by the Commission

Amendment

2 a. 3. The multidisciplinarity of experts may constitute a guarantee of the independence and impartiality of their work.

Or. en

Amendment 1595

Joanna Kopcińska

Proposal for a directive

Article 214 – paragraph 3

Text proposed by the Commission

Amendment

3. Where the opinion of the Committee is to be obtained by written procedure and reference is made to this paragraph, that procedure shall be terminated without result only when, within the time limit for delivery of the opinion, the chair of the Committee so decides.

deleted

Or. en

Amendment 1596

Margrete Auken

Proposal for a directive

Article 214 – paragraph 4

Text proposed by the Commission

Amendment

4. The rules of procedure of the Standing Committee on Medicinal Products shall be made publicly available.

4. The rules of procedure, meeting agenda and minutes with detailed records including information on decisions taken, details and explanation of votes, including minority opinions shall be made publicly available. Names of members and other national experts participating in the Standing Committee on Medicinal Products shall be made publicly available on the Commission’s website.

Or. en

Amendment 1597

Margrete Auken

Proposal for a directive

Article 214 – paragraph 4 a (new)

Text proposed by the Commission

Amendment

4 a. Members and experts participating in the Committee shall act in an independent manner and shall have no direct or indirect financial or other interests in the pharmaceutical industry that could affect their impartiality. They shall submit their conflict of interest declaration to the Chair of the Committee ahead of each meeting.

Or. en

Amendment 1598

Catherine Amalric, Frédérique Ries, Max Orville, Billy Kelleher, Susana Solís Pérez, Erik Poulsen

Proposal for a directive

Article 216 – paragraph 1

Text proposed by the Commission

Amendment

By [OP please insert the date = 10 years following 18 months after the date of entering into force of this Directive], the Commission shall present a report to the European Parliament and the Council on the application of this Directive, including an assessment of the fulfilment of its objectives and the resources required to implement it.

Or. en

Amendment 1599

Margrete Auken

Proposal for a directive

Article 216 – paragraph 1

Text proposed by the Commission

Amendment

By [OP please insert the date = 7 years following 18 months after the date of entering into force of this Directive], the Commission shall present a report to the European Parliament and the Council on the application of this Directive, including an assessment of the fulfilment of its objectives and the resources required to implement it.

Or. en

Amendment 1600

Margrete Auken

Proposal for a directive

Article 217 – paragraph 2

Text proposed by the Commission

Amendment

2. Directive 2009/35/EC is repealed with effect from [OP please insert the date = 18 months after the date of entering into force of this Directive].

deleted

Or. en

Amendment 1601

István Ujhelyi

Proposal for a directive

Article 218 – paragraph 1

Text proposed by the Commission

Amendment

1. The procedures concerning the applications for marketing authorisations for medicinal products validated in accordance with Article 19 of Directive 2001/83/EC before [OP please insert the date = 18 months after the date of entering into force of this Directive] and that were pending on [OP please insert the date = the day before 18 months after the date of entering into force of this Directive] shall be completed in accordance with Article 29.

Or. en

Amendment 1602

Margrete Auken

Proposal for a directive

Article 218 – paragraph 6

Text proposed by the Commission

Amendment

6. By way of derogation from paragraph 3, the reporting obligations as referred to in Article 57, shall not apply with regards to medicinal products authorised in accordance with Directive 2001/83/EC before [OP please insert the date = 18 months after the date of entering into force of this Directive].

6. By way of derogation from paragraph 3, the reporting obligations as referred to in Article 57 and 57a, shall not apply with regards to medicinal products authorised in accordance with Directive 2001/83/EC before [OP please insert the date = 18 months after the date of entering into force of this Directive].

Or. en

Amendment 1603

Joanna Kopcińska

Proposal for a directive

Article 219 – paragraph 1

Text proposed by the Commission

Amendment

1. Member States shall bring into force the laws, regulations and administrative provisions to comply with this Directive by [18 months after the date of entering into force of this Directive]. They shall immediately communicate the text of those measures to the Commission.

1. Member States shall bring into force the laws, regulations and administrative provisions to comply with this Directive by [24 months after the date of entering into force of this Directive]. They shall immediately communicate the text of those measures to the Commission.

Or. en

Justification

Implementation of the above regulation into national law will require appropriate time. We propose extending the deadline for transposition of the directive to at least 24 months from the date of entry into force of the directive.

Amendment 1604

Kateřina Konečná

Proposal for a directive

Annex I – point 13 a (new)

Text proposed by the Commission

Amendment

(13 a) Patient experience data in accordance with article 22a (new).

Or. en

Justification

This amendment is linked to amendment on the inclusion of patient-relevant outcomes in the marketing authorisation dossier, in order to strengthen patient involvement throughout the life cycle of medicinal products and to fully integrate patient-relevant parameters into clinical development plans.

Amendment 1605

Maria Angela Danzì

Proposal for a directive

Annex I – point 21 – point a – introductory part

Text proposed by the Commission

Amendment

a) an antimicrobial stewardship plan which shall in particular outline:

a) an antimicrobial resistance mitigation plan which shall in particular outline:

Or. en

Justification

Activities to be taken solely by the pharmaceutical company should not be called antimicrobial stewardship, as this term is reserved for a broader and systemic actions to be taken by health systems and healthcare professionals

Amendment 1606

Margrete Auken

Proposal for a directive

Annex I – point 21 – point a – introductory part

Text proposed by the Commission

Amendment

a) an antimicrobial stewardship plan which shall in particular outline:

a) an antimicrobial stewardship and access plan which shall in particular outline:

Or. en

Justification

Alignment with the US programme. It would be clearer for developers to have the same set of requirements, if they develop under the US scheme and want to switch to the EU they can have the same conditions, moreover, the COM’s proposal suggests lower standards in the EU than in the US, which we find inadequate.

Amendment 1607

Margrete Auken

Proposal for a directive

Annex I – point 21 – point a – point i

Text proposed by the Commission

Amendment

(i) information about risk mitigation measures to limit antimicrobial resistance development related to the use, prescription and administration of the medicinal product;

(i) risk mitigation strategy outlining measures to limit antimicrobial resistance development related to the use, prescription and administration of the medicinal product;

Or. en

Amendment 1608

Margrete Auken

Proposal for a directive

Annex I – point 21 – point a – point ii

Text proposed by the Commission

Amendment

(ii) how the marketing authorisation holder intends to monitor and report to the competent authority the resistance to the antimicrobial medicinal product.

(ii) how the marketing authorisation holder intends to monitor and report to the competent authority the resistance to the antimicrobial medicinal product;

Or. en

Amendment 1609

Margrete Auken

Proposal for a directive

Annex I – point 21 – point a – point ii a (new)

Text proposed by the Commission

Amendment

(ii a) strategy to ensure access, including proposed production chain with sufficient capacity, supply systems, approach to product labelling, and the approach to overcome economic barriers to access;

Or. en

Amendment 1610

Margrete Auken

Proposal for a directive

Annex I – point 21 – point a – point ii b (new)

Text proposed by the Commission

Amendment

(ii b) obstacles and constraints to stewardship and access;

Or. en

Amendment 1611

Margrete Auken

Proposal for a directive

Annex I – point 21 – point a – point ii c (new)

Text proposed by the Commission

Amendment

(ii c) exploitation strategy for IP rights, including whether it is planned for the IP rights to be transferred to a third party for non-prioritised territories; exploitation strategy for IP rights, including whether it is planned for the IP rights to be transferred to a third party for non-prioritised territories;

Or. en

Amendment 1612

Margrete Auken

Proposal for a directive

Annex I – point 21 – point a – point ii d (new)

Text proposed by the Commission

Amendment

(ii d) strategy to ensure marketing approvals are received for key territories in a timely manner; and

Or. en

Amendment 1613

Margrete Auken

Proposal for a directive

Annex I – point 21 – point a – point ii e (new)

Text proposed by the Commission

Amendment

(ii e) strategy and methodology for monitoring effectiveness of stewardship and access, including proposed metrics to measure success.

Or. en

Amendment 1614

Margrete Auken

Proposal for a directive

Annex I – point 21 – point a a (new)

Text proposed by the Commission

Amendment

a a) The stewardship and access plan should be made publicly available by the EMA when market authorization has been granted.

Or. en

Amendment 1615

Kateřina Konečná

Proposal for a directive

Annex I – point 23 a (new)

Text proposed by the Commission

Amendment

(23 a) A summary of the applicant’s expected market launch plans in the EU.

Or. en

Justification

In addition to the market launch incentive, the Directive should require marketing authorisation applicants to indicate their market access plans in the application dossier, including indicative timelines. If marketing authorisation applicants do not wish to launch the product in all 27 Member States, this information will be crucial to determining where the medicine will be available to patients. Unequal access to medicines is a major cause of health inequalities.

Amendment 1616

Kateřina Konečná

Proposal for a directive

Annex II – Part I – point 5 – point 5.2 – point 5.2.5 – point 5.2.5.1 – paragraph 1 – introductory part

Text proposed by the Commission

Amendment

In general, clinical trials shall be done as ‘controlled clinical trials’ if possible, randomised and as appropriate versus placebo and versus an established medicinal product of proven therapeutic value; any other design shall be justified. The treatment of the control groups will vary from case to case and also will depend on ethical considerations and therapeutic area; thus it may, in some instances, be more pertinent to compare the efficacy of a new medicinal product with that of an established medicinal product of proven therapeutic value rather than with the effect of a placebo.

In general, clinical trials shall include patients who are representative of the population to be treated with the new medicinal product, use clinically meaningful endpoints, and be done as ‘controlled clinical trials’ randomised and versus the best proven intervention; placebo control may be used in addition if necessary and ethical.

The Agency shall adopt scientific guidelines on criteria for identifying the best proven intervention(s) taking into account the outcome of the consultation with the Commission, and with the stakeholders involved in the consultation mechanism referred to in Article 162 of [revised Regulation (EC) 726/2004].

Any study design other than that referred to in the first subparagraph shall be duly justified; the grounds for any exceptions and conditions shall be laid down in a guideline developed by the Agency following the same consultation process described in the second subparagraph. The scientific guidelines adopted by the Agency shall observe the principles of the Declaration of Helsinki.

Or. en

Amendment 1617

Maria Angela Danzì

Proposal for a directive

Annex II – Part I – point 5 – point 5.2 – point 5.2.5 – point 5.2.5.1 – paragraph 1 – introductory part

Text proposed by the Commission

Amendment

Clinical trials shall be done as ‘controlled clinical trials’ randomised and as appropriate versus placebo and versus an established medicinal product of proven therapeutic value; any other design shall be duly justified providing ethical and clinical reasons. The treatment of the control groups will vary from case to case and also will depend on ethical considerations and therapeutic area; thus it may, in some instances, be more pertinent to compare the efficacy of a new medicinal product with that of an established medicinal product of proven therapeutic value rather than with the effect of a placebo.

Or. en

Justification

The revised legislation should improve evidence requirements for the approval of new medicinal products. The acceleration of science and innovation can never compromise patient safety. EU regulatory framework shall therefore require submission of randomized clinical trials assuring quality, efficacy and safety, and any other design shall be duly justified.

Amendment 1618

Nathalie Colin-Oesterlé

Proposal for a directive

Annex III – point 2

Text proposed by the Commission

Amendment

2. The qualified person shall have acquired practical full-time experience over at least two years, in one or more undertakings that are authorised manufacturers, obtaining sufficient knowledge of manufacture, testing, supply chains, good manufacturing practice and pharmaceutical quality systems as well as regulatory processes and dossier content for ensuring the quality of medicinal products. The length of practical experience required may be reduced by one year where the university course was longer than five years, and by one and a half years where the university course was longer than six years.

Or. fr

Amendment 1619

Nathalie Colin-Oesterlé

Proposal for a directive

Annex III – point 4

Text proposed by the Commission

Amendment

4. The qualified person shall have acquired practical experience over at least two years, in one or more undertakings or not-for-profit entities that are authorised to manufacture medicinal products, in the activities of qualitative analysis of medicinal products, of quantitative analysis of active substances and of the testing and checking necessary to ensure the quality of medicinal products. The length of practical experience required may be reduced by one year where the university course was longer than five years, and by one and a half years where the university course was longer than six years.

Or. fr

Amendment 1620

Margrete Auken

Proposal for a directive

Annex IV – paragraph 1 – point a

Text proposed by the Commission

Amendment

(a) the name of the medicinal product, including in Braille, followed by its strength and pharmaceutical form, and, if appropriate, whether it is intended for babies, children or adults; where the medicinal product contains up to three active substances, the international non-proprietary name (INN) shall be included, or, if one does not exist, the common name;

(a) the name of the medicinal product, including in Braille, followed by its strength and pharmaceutical form, and, if appropriate, whether it is intended for babies, children or adults; the international non-proprietary name(s) (INN) shall be included, or, if one does not exist, the common name;

Or. en

Amendment 1621

Margrete Auken

Proposal for a directive

Annex IV – paragraph 1 – point g a (new)

Text proposed by the Commission

Amendment

(g a) for antimicrobials, a pictogram and a warning that improper use and disposal of the medicinal product contributes to antimicrobial resistance;

Or. en

Amendment 1622

Margrete Auken

Proposal for a directive

Annex IV – paragraph 1 – point j

Text proposed by the Commission

Amendment

(j) specific precautions relating to the disposal of unused medicinal products or waste derived from medicinal products, where appropriate, as well as reference to any appropriate collection system in place;

(j) specific precautions relating to the disposal of unused medicinal products or waste derived from medicinal products as well as reference to any appropriate collection system in place;

Or. en

Amendment 1623

Kateřina Konečná

Proposal for a directive

Annex IV – paragraph 1 – point j

Text proposed by the Commission

Amendment

(j) specific precautions relating to the disposal of unused medicinal products or waste derived from medicinal products, as well as reference to any appropriate collection system in place;

Or. en

Justification

The packaging of a medicinal product and/or the leaflet, should always contain information on the adequate disposal of unused medicines and a reference to collection system in place.

Amendment 1624

Margrete Auken

Proposal for a directive

Annex V – paragraph 1 – point 4 – point a a (new)

Text proposed by the Commission

Amendment

(a a) efficacy-related information and risk-benefit assessment, including information on remaining uncertainty about the medicine’s efficacy and safety profile;

Or. en

Amendment 1625

Margrete Auken

Proposal for a directive

Annex V – paragraph 1 – point 4 – point b

Text proposed by the Commission

Amendment

(b) posology and method of administration for adults and, where necessary for children,

(b) posology and method of administration for adults and, where necessary for children, and where relevant, a comprehensive and accurate illustrated description of the measuring and/or delivery device,

Or. en

Amendment 1626

Margrete Auken

Proposal for a directive

Annex V – paragraph 1 – point 6 – point f

Text proposed by the Commission

Amendment

(f) special precautions for disposal of a used medicinal product or waste materials derived from such medicinal product, if appropriate. In case of antimicrobial medicinal products in addition to the precautions a warning that inappropriate disposal of the medicinal product contributes to antimicrobial resistance.

(f) special precautions for disposal of a used medicinal product or waste materials derived from such medicinal product. In case of antimicrobial medicinal products in addition to the precautions a warning that inappropriate disposal of the medicinal product contributes to antimicrobial resistance;

Or. en

Amendment 1627

Margrete Auken

Proposal for a directive

Annex V – paragraph 1 – point 6 – point f a (new)

Text proposed by the Commission

Amendment

(f a) for products containing substances classified based on Annex I of Regulation (EC) No 1272/2008 as persistent, bioaccumulative and toxic (PBT), very persistent and very bioaccumulative (vPvB), persistent, mobile and toxic (PMT), very persistent and very mobile (vPvM) or are endocrine active agents, a warning that improper use and disposal of the medicinal product, inter alia through toilets, contributes to deteriorating the aquatic environment;

Or. en

Amendment 1628

Margrete Auken

Proposal for a directive

Annex V – paragraph 1 – point 6 – point f b (new)

Text proposed by the Commission

Amendment

(f b) summary of environmental impact assessment.

Or. en

Amendment 1629

Kateřina Konečná

Proposal for a directive

Annex VI – paragraph 1 – point 2

Text proposed by the Commission

Amendment

(2) the therapeutic indications;

(2) the therapeutic indications and efficacy-related information;

Or. en

Amendment 1630

Kateřina Konečná

Proposal for a directive

Annex VI – paragraph 1 – point 2 a (new)

Text proposed by the Commission

Amendment

(2 a) a key information section reflecting the results of consultations with target patients’ organisations to ensure that it is legible, clear and easy to use;

Or. en

Justification

The inclusion of a key information section in the package leaflet, drafted in collaboration with patients, would allow patients and healthcare professionals to quickly identify key safety messages with information on the benefits of the medicines. The elderly and people with low literacy skills are particularly disadvantaged, but in general, these problems affect all patients.

Amendment 1631

Margrete Auken

Proposal for a directive

Annex VI – paragraph 1 – point 2 a (new)

Text proposed by the Commission

Amendment

(2 a) efficacy-related information per therapeutic indication;

Or. en

Amendment 1632

Margrete Auken

Proposal for a directive

Annex VI – paragraph 1 – point 4 – point b

Text proposed by the Commission

Amendment

(b) the method and, if necessary, route of administration;

(b) the method and, if necessary, route of administration; where relevant, a comprehensive and accurate illustrated description of the measuring and/or delivery device, including all the different steps of medicine preparation and administration;

Or. en

Amendment 1633

Margrete Auken

Proposal for a directive

Annex VI – paragraph 1 – point 6 a (new)

Text proposed by the Commission

Amendment

(6 a) a list of pending post-authorisation studies and other obligations;

Or. en

Amendment 1634

Margrete Auken

Proposal for a directive

Annex VI – paragraph 1 – point 8 a (new)

Text proposed by the Commission

Amendment

(8 a) for products containing substances classified based on Annex I of Regulation (EC) No 1272/2008 as persistent, bioaccumulative and toxic (PBT), very persistent and very bioaccumulative (vPvB), persistent, mobile and toxic (PMT), very persistent and very mobile (vPvM) or are endocrine active agents, a warning that improper use and disposal of the medicinal product, inter alia through toilets, contributes to deteriorating the aquatic environment.

Or. en

Justification

Patients, healthcare professionals and pharmacists must be informed of the impact on the aquatic environment of products containing PBT, vPvB, PMT and vPvM substances, as well as endocrine disruptors, so they dispose properly of products and can make informed choices between alternative treatments.

Amendment 1635

Nathalie Colin-Oesterlé

Proposal for a directive

Annex VI – paragraph 1 – point 8 a (new)

Text proposed by the Commission

Amendment

(8a) Further to the measures provided for in Article 64(2a), for medicinal products included in the list referred to in Article 112a of [Regulation (EC) No 726/2004 as amended], the following additional statement shall be added: ‘This medicinal product is subject to additional monitoring.’ This statement shall be preceded by the symbol referred to in Article 112a of [Regulation (EC) No 726/2004 as amended] and followed by an appropriate standardised explanatory sentence.

Or. fr

Amendment 1636

Sirpa Pietikäinen

Proposal for a directive

Annex VI – paragraph 1 – point 8 a (new)

Text proposed by the Commission

Amendment

(8 a) for products containing substances listed in Article 22 paragraph 2 of this Directive, a warning that improper use and disposal of the medicinal product, inter alia through toilets, contributes to deteriorating the aquatic environment.

Or. en