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 813

Nicolás González Casares, Tiemo Wölken

Proposal for a directive

Article 57 – paragraph 1

Text proposed by the Commission

Amendment

1. The marketing authorisation holder shall declare to the public any direct financial support received from any public authority or publicly funded body, in relation to any activities for the research and development of the medicinal product covered by a national or a centralised marketing authorisation, irrespective of the legal entity that received that support.

1. The marketing authorisation holder shall declare to the public any direct and indirect financial support received from any foreign or european private entity, including philantropic entities, public authority or publicly funded body, including tax advantages and subsidies, in relation to any activities for the research and development of the medicinal product covered by a national or a centralised marketing authorisation, irrespective of the legal entity that received that support.

Or. en

Amendment 814

Alessandra Moretti

Proposal for a directive

Article 57 – paragraph 1

Text proposed by the Commission

Amendment

1. The marketing authorisation holder shall declare to the public any financial support received, including tax breaks or any form of taxation advantage, from any public authority or publicly funded body, as well as any charity, in relation to any activities for the research and development of the medicinal product covered by a national or a centralised marketing authorisation, irrespective of the legal entity that received that support.

Or. en

Amendment 815

Margrete Auken

Proposal for a directive

Article 57 – paragraph 1

Text proposed by the Commission

Amendment

1. The marketing authorisation holder shall declare to the public any direct and indirect financial support received from any public authority or publicly funded body, philanthropic or non-for profit organisation or fund in relation to any activities for the research and development of the medicinal product covered by a national or a centralised marketing authorisation, irrespective of the legal entity that received that support.

Or. en

Amendment 816

Maria Angela Danzì

Proposal for a directive

Article 57 – paragraph 1

Text proposed by the Commission

Amendment

1. The marketing authorisation holder shall declare to the public any direct or indirect financial support received, including tax breaks, from any public authority or publicly funded body, as well as any charity, in relation to any activities for the research and development of the medicinal product covered by a national or a centralised marketing authorisation, irrespective of the legal entity that received that support.

Or. en

Justification

It should be a requirement that the R&D costs of medicinal products that have benefited from public funding are transparent and include minimum information on the breakdown between private and public investment. This would empower national authorities by reducing information asymmetry in pricing negotiations, enable informed discussion on what constitutes a fair price for these medicines and allow public accountability for the use of public resources. It is important to know the ratio of the public and private investments, to know the scale of public support, which often is higher than claimed.Also, charities, such as cancer societies, often play an important role in development of new drugs by funding the research (e.g. Zolgensma). Not all charities are publicly funded bodies, therefore it should be clarified that financial support provided by them must also be reported.

Amendment 817

Cindy Franssen, Tom Vandenkendelaere

Proposal for a directive

Article 57 – paragraph 1

Text proposed by the Commission

Amendment

1. The marketing authorisation holder shall declare to the public any direct or indirect financial support received, including possible tax breaks, from any public authority, publicly funded body or charity, in relation to any activities for the research and development of the medicinal product covered by a national or a centralised marketing authorisation, irrespective of the legal entity that received that support.

Or. en

Amendment 818

Marian-Jean Marinescu

Proposal for a directive

Article 57 – paragraph 1

Text proposed by the Commission

Amendment

1. The marketing authorisation holder shall declare to the public any direct and indirect financial support and in-kind contribution received from any public authority or publicly funded body, in relation to any activities for the research and development of the medicinal product covered by a national or a centralised marketing authorisation, irrespective of the legal entity that received that support.

Or. en

Justification

Consolidated transparency of public funds

Amendment 819

Susana Solís Pérez

Proposal for a directive

Article 57 – paragraph 1

Text proposed by the Commission

Amendment

1. The marketing authorisation holder shall declare to the public any direct financial support received from any public authority or publicly funded body of the European Union, in relation to any activities for the research and development of the medicinal product covered by a national or a centralised marketing authorisation, irrespective of the legal entity that received that support.

Or. en

Amendment 820

István Ujhelyi

Proposal for a directive

Article 57 – paragraph 1

Text proposed by the Commission

Amendment

Or. en

Amendment 821

Kateřina Konečná

Proposal for a directive

Article 57 – paragraph 1

Text proposed by the Commission

Amendment

1. The marketing authorisation holder shall declare to the public any indirect and direct financial support received from any public authority or publicly funded body, in relation to any activities for the research and development of the medicinal product covered by a national or a centralised marketing authorisation, irrespective of the legal entity that received that support.

Or. en

Amendment 822

Margrete Auken

Proposal for a directive

Article 57 – paragraph 1 a (new)

Text proposed by the Commission

Amendment

1 a. The marketing authorisation holder shall declare all cases where the product was acquired at any stage of development from an entity not engaged in an economic activity (‘not-for-profit entity’) or a public-private research consortium.

Or. en

Amendment 823

Nicolás González Casares, Tiemo Wölken

Proposal for a directive

Article 57 – paragraph 1 a (new)

Text proposed by the Commission

Amendment

1 a. The marketing authorisation holder shall also report an estimate of the costs incurred for the research and development of the medicinal product covered by a national or a centralised marketing authorization.

Or. en

Amendment 824

Maria Angela Danzì

Proposal for a directive

Article 57 – paragraph 2 – point a – point i

Text proposed by the Commission

Amendment

(i) the amount of financial support received and the date thereof;

(i) the amount of direct and indirect financial support and tax breaks received and the date thereof;

Or. en

Justification

Besides the direct financial support provided by ‘public money’, an indirect one can be provided by tax deductions or exemptions - this also needs to be reported for full transparency of public financial support.

Amendment 825

Marian-Jean Marinescu

Proposal for a directive

Article 57 – paragraph 2 – point a – point i

Text proposed by the Commission

Amendment

(i) the amount of financial support received and the date thereof;

(i) the amount of financial support and description of in-kind contribution received and the date thereof;

Or. en

Justification

Consolidated transparency of public funds

Amendment 826

Cindy Franssen, Tom Vandenkendelaere

Proposal for a directive

Article 57 – paragraph 2 – point a – point i

Text proposed by the Commission

Amendment

(i) the amount of financial support received and the date thereof;

(i) the amount of financial support and tax breaks received and the date thereof;

Or. en

Amendment 827

Marian-Jean Marinescu

Proposal for a directive

Article 57 – paragraph 2 – point a – point i a (new)

Text proposed by the Commission

Amendment

(i a) the concrete activities financed from the financial support received and how was used the in-kind contribution.

Or. en

Justification

Consolidated transparency of public funds

Amendment 828

Margrete Auken

Proposal for a directive

Article 57 – paragraph 2 – point a – point ii

Text proposed by the Commission

Amendment

(ii) the public authority or publicly funded body that provided the financial support referred to in point (i);

(ii) the public authority, publicly funded body, philanthropic or non-for-profit organisation or fund that provided the financial support referred to in point (i);

Or. en

Amendment 829

Maria Angela Danzì

Proposal for a directive

Article 57 – paragraph 2 – point a – point ii

Text proposed by the Commission

Amendment

(ii) the public authority or publicly funded body that provided the financial support referred to in point (i);

(ii) the public authority or publicly funded body as well as the charity that provided the financial support referred to in point (i);

Or. en

Justification

Also, charities, such as cancer societies, often play an important role in development of new drugs by funding the research (e.g. Zolgensma). Not all charities are publicly funded bodies, therefore it should be clarified that financial support provided by them must also be reported.

Amendment 830

Cindy Franssen, Tom Vandenkendelaere

Proposal for a directive

Article 57 – paragraph 2 – point a – point ii

Text proposed by the Commission

Amendment

(ii) the public authority or publicly funded body that provided the financial support referred to in point (i);

(ii) the public authority, publicly funded body or charity that provided the financial support or tax break referred to in point (i);

Or. en

Amendment 831

Nicolás González Casares, Tiemo Wölken

Proposal for a directive

Article 57 – paragraph 2 – point a – point ii

Text proposed by the Commission

Amendment

(ii) the public authority or publicly funded body that provided the financial support referred to in point (i);

(ii) the entity that provided the financial support referred to in point (i);

Or. en

Amendment 832

Nicolás González Casares, Tiemo Wölken

Proposal for a directive

Article 57 – paragraph 2 – point a – point iii a (new)

Text proposed by the Commission

Amendment

(iii a) any independent legal entity from which it obtained a license in relation to, or acquired, the medicinal product in its previous phases of development, and at which stage of the research and development process. The marketing authorisation holder shall, as much as possible, include in the report information on any public or private funding received by the independent entity for its research activities in relation to the medicinal product.

Or. en

Amendment 833

Kateřina Konečná

Proposal for a directive

Article 57 – paragraph 2 – point a – point iii a (new)

Text proposed by the Commission

Amendment

(iii a) any independent legal entity from which it obtained a license in relation to, or acquired, the medicinal product in its previous phases of development, and at which stage of the research and development process. The marketing authorisation holder shall, as much as possible, include in the report information on any public funding received by the independent entity for its research activities in relation to the medicinal product.

Or. en

Justification

The early stages of drug development usually take place within public research centers. Pharmaceutical companies then build from the knowledge and molecules discovered through such public research. To have a more accurate picture of the public sector’s role in drug development, it is important to shed light on the role played directly by public universities and biomedical research centers in that process.

Amendment 834

Catherine Amalric, Frédérique Ries, Max Orville, Billy Kelleher

Proposal for a directive

Article 57 – paragraph 2 – point a – point iii a (new)

Text proposed by the Commission

Amendment

(iii a) the percentage of total research and development costs of the medicinal product covered by the support referred to in point (i);

Or. en

Amendment 835

Maria Angela Danzì

Proposal for a directive

Article 57 – paragraph 2 – point a – point iii a (new)

Text proposed by the Commission

Amendment

(iii a) the percentage of total research and development costs of the medicinal product covered by the support referred to in point (i);

Or. en

Justification

Amendment 836

Margrete Auken

Proposal for a directive

Article 57 – paragraph 2 – point a – point iii a (new)

Text proposed by the Commission

Amendment

(iii a) the percentage of total research and development costs covered by the financial support referred to in paragraph 1;

Or. en

Amendment 837

Alessandra Moretti

Proposal for a directive

Article 57 – paragraph 2 – point a – point iii a (new)

Text proposed by the Commission

Amendment

(iii a) the percentage of the total research and development costs of the particular product funded with public contributions;

Or. en

Amendment 838

Nicolás González Casares, Tiemo Wölken

Proposal for a directive

Article 57 – paragraph 2 – point a – point iii b (new)

Text proposed by the Commission

Amendment

(iii b) an estimate of the total costs incurred for the research and development of the medicinal product, which shall be disaggregated to each stage of drug research and development, including basic research, pre-clinical research, phase I, II, III of the clinical investigation of the medicinal product; as well as post-market studies.

Or. en

Amendment 839

Margrete Auken

Proposal for a directive

Article 57 – paragraph 2 – point a – point iii b (new)

Text proposed by the Commission

Amendment

(iii b) where applicable, information related to acquiring of product license from a not-for-profit-entity or a public-private consortium, including the amount of public funding invested prior to acquisition of the product, stage of development and name of the entity.

Or. en

Amendment 840

Alessandra Moretti

Proposal for a directive

Article 57 – paragraph 2 – point a – point iii b (new)

Text proposed by the Commission

Amendment

(iii b) the percentage of the total research and development costs of the particular product funded by philanthropic and not-for-profit contributions;

Or. en

Amendment 841

Alessandra Moretti

Proposal for a directive

Article 57 – paragraph 2 – point a – point iii c (new)

Text proposed by the Commission

Amendment

(iii c) the percentage of the total research and development cost of the particular product funded by private investments;

Or. en

Amendment 842

Alessandra Moretti

Proposal for a directive

Article 57 – paragraph 2 – point a – point iii d (new)

Text proposed by the Commission

Amendment

(iii d) key disaggregated costs for publicly-funded clinical trials;

Or. en

Amendment 843

Marian-Jean Marinescu

Proposal for a directive

Article 57 – paragraph 6

Text proposed by the Commission

Amendment

6. The Commission may adopt implementing acts to lay down the principles and format for the information to be reported pursuant to paragraph 2. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 214(2).

6. The Commission shall adopt implementing acts to lay down the principles and format for the information to be reported pursuant to paragraph 2, no later than 12 months after the date of entering into force of this Directive. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 214(2).

Or. en

Justification

This amendment fulfils the need for harmonized and clear content of the financial reports. Also, a clear deadline is need for predictability.

Amendment 844

Margrete Auken

Proposal for a directive

Article 57 a (new)

Text proposed by the Commission

Amendment

Article 57a

Responsibility to report on research and development costs

In addition to the information listed in Article 57, the marketing authorisation holder shall, when submitting an application for reimbursement in a Member State for a nationally or centrally authorised product, declare upon request from the national competent authority responsible for pricing and reimbursement a detailed externally-audited reporting on the company’s expenditure related to the research and development cost of the medicinal product.

Or. en

Amendment 845

Margrete Auken

Proposal for a directive

Article 58 – title

Text proposed by the Commission

Amendment

Traceability of substances used in the manufacture of medicinal products

Traceability of substances used in the manufacture of medicinal products and manufacturing in the environmental impact assessment

Or. en

Amendment 846

Margarita de la Pisa Carrión

Proposal for a directive

Article 58 – paragraph 1

Text proposed by the Commission

Amendment

1. The marketing authorisation holder shall, when necessary, ensure the traceability of an active substance, starting material, excipient or any other substance intended or expected to be present in a medicinal product at all stages of manufacturing and distribution.

Or. en

Amendment 847

Margarita de la Pisa Carrión, Joanna Kopcińska, Andrey Slabakov

Proposal for a directive

Article 58 – paragraph 1

Text proposed by the Commission

Amendment

Or. en

Amendment 848

Margrete Auken

Proposal for a directive

Article 58 – paragraph 1

Text proposed by the Commission

Amendment

1. The marketing authorisation holder shall ensure the traceability of an active substance, starting material, excipient or any other substance intended or expected to be present in a medicinal product at all stages of manufacturing and distribution.

Or. en

Amendment 849

Margrete Auken

Proposal for a directive

Article 58 – paragraph 1 a (new)

Text proposed by the Commission

Amendment

1 a. The marketing authorisation holder shall include the manufacturing process of the substances referred to in paragraph 1 as an integral part of the environmental impact assessment referred to in Article 22 and in line with requirements set in Annex II.

Or. en

Amendment 850

Nicolás González Casares, Tiemo Wölken

Proposal for a directive

Article 58 – paragraph 4

Text proposed by the Commission

Amendment

4. The marketing authorisation holder and its suppliers shall have in place systems and procedures to identify the other natural or legal persons to whom products referred to in paragraph 2 have been supplied. This information shall, upon request, be made available to the competent authorities.

4. The marketing authorisation holder´s suppliers shall have in place systems and procedures to identify the other natural or legal persons to whom products referred to in paragraph 2 have been supplied. This information shall, upon request, be made available to the competent authorities.

Or. en

Amendment 851

Pernille Weiss

Proposal for a directive

Article 58 a (new)

Text proposed by the Commission

Amendment

Article58a

Obligation to submit an application for pricing and reimbursement in all Member States

1. The marketing authorisation holder shall, upon request by a Member State in which the marketing authorisation is valid, submit in good faith and within the limits of its responsibilities an application for pricing and reimbursement for the medicinal product no later than two years from the date when the Member State made its request, or within four years from that date for any of the following entities:

(i) SMEs;

(ii) entities not engaged in an economic activity (‘not-for-profit entity’); and

(iii) undertakings that, by the time of granting the marketing authorisation, have received not more than seven centralised marketing authorisations for the undertaking concerned or, in the case of an undertaking belonging to a group, for the group of which it is part, since the establishment of the undertaking or the group, whichever is earliest.

For the purposes of this Directive and [revised Regulation (EC) No 726/2004], the Commission shall by ... [18 months after the date of entry into force of this Directive] adopt delegated acts in accordance with Article 215 to supplement this Directive by laying down the criteria to qualify as a micro, small and medium-sized enterprise, taking into account the specificities of enterprises of this sector within the Union.

The marketing authorisation holder shall notify that it fulfilled the obligations set out in the first subparagraph through the EU Access to Medicines Notification System provided for in Article 58b.

2. For the purposes of paragraph 1 of this Article, Member States shall make their request within two years of the granting of a marketing authorisation and notify this in the EU Access to Medicines Notification System provided for in Article 58b. Following the filing for pricing and reimbursement by the marketing authorisation holder, Directive 89/105/EEC shall apply. Where a Member State has not complied with the time limits laid down in Directive 89/105/EEC, the obligation on the marketing authorisation holder set out in this Article shall be considered to be fulfilled in that Member State.

Without prejudice to the deadline and procedure set out in paragraph 1, Member States shall in the case of vaccines have included this product in their national immunisation programme, or shall have initiated the process for this, before making their request.

3. By way of derogation from paragraph 1, the marketing authorisation holder for a designated orphan medicinal product or for an advanced therapy medicinal product may choose instead:

(a) to make a medicinal product available to patients and the prescribing doctors who requested it; or

(b) to submit an application for pricing and reimbursement in good faith and within the limits of its responsibility only in the Member States where the relevant patient population has been identified.

4. Following agreement between a Member State and a marketing authorisation holder, timelines that are different from those set out in paragraphs 1 and 2 may apply. A Member State may choose, after making a request in accordance with paragraph 1, to issue a product-specific waiver after which the obligation to submit an application shall be considered to be fulfilled in that Member State.

5. The Commission shall, after consultation with the Agency, adopt by means of implementing acts a list of products to be exempted from the obligations set out in this Article. The inclusion of a medicinal product in that list shall where relevant take into account circumstances related to regulatory and reimbursement procedures pertaining to particular products, or to the administration of a medicinal product in most Member States being impracticable. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 214(2).

6. Where a marketing authorisation is transferred to a different legal entity before the end of the period referred to in paragraph 1, the obligations shall be transferred to the new marketing authorisation holder.

7. The Commission shall by means of implementing acts establish a conciliation mechanism to facilitate discussions between applicants and Member States to resolve potential disputes related to the process for submission of applications for pricing and reimbursement and with respect to the timelines set out in Directive 89/105/EEC. In respect of national competences with regard to assessments on the added value of a medicinal product or subsequent decisions on pricing and reimbursement as well as on budgetary decisions and the allocation of financial resources in the area of protection and improvement of human health, the conciliation mechanism shall exclude opinions on these issues.

In the event of continued disagreement between an applicant and a Member State regarding the fulfilment of the obligations set out in this Article, the Commission shall be empowered to issue a legally binding Commission decision following an opinion of the Agency.

8. The provisions of this Article shall not prevent a marketing authorisation holder from submitting an application for pricing and reimbursement and placing a medicinal product on the market of a Member State without a Member State having made a request in accordance with paragraph 1.

9. The Commission shall assess barriers to timely access to medicinal products in each Member State as well as on an aggregated Union level and publish a report with the results of its assessment. The report shall be drawn up for the first time by [OP: Please insert date of the end of the second year after the date of entry into force of this Directive] and every four years thereafter.

Or. en

Justification

To replace amendment to Article 58a of the Draft Report.

Amendment 852

Massimiliano Salini, Francesca Peppucci

Proposal for a directive

Article 58 a (new)

Text proposed by the Commission

Amendment

Article58a

Obligation to submit an application for pricing and reimbursement in all Member States

1. Upon the Member State's request, the entity holding the marketing authorization must, in good faith, submit an application for pricing and reimbursement within two years from the date of the request. Alternatively, for for the following specific entities, this submission may be made within four years from the mentioned date:

(i) SMEs;

(ii) entities not engaged in an economic activity (‘not-for-profit entity’); and

(iii) activities that, at the time of marketing authorization approval, have garnered no more than seven centralized marketing authorizations for the specific undertaking. In the instance of an undertaking within a group, this limit applies to the entire group since its inception, or the establishment of the individual undertaking, whichever occurred first.

For the implementation of this Directive and the amended Regulation (EC) No 726/2004, the Commission is required to adopt delegated acts within 18 months from the date of application of this Directive. These acts, in accordance with Article 215, will serve to complement this Directive by establishing criteria for the classification of micro, small, and medium-sized enterprises. The Commission will consider the unique characteristics of businesses in this sector within the Union during this process. The holder of the marketing authorization shall use the EU Access to Medicines Notification System, as described in Article 58b, to notify others that it has complied with the requirements outlined in the first subparagraph.

2. In the context of paragraph 1 of this Article, Member States shall submit their request within two years from the date of granting a marketing authorization. In the case of vaccines, Member States shall have already incorporated the vaccine into the national immunization program before making a request as per this paragraph. Directive 89/105/EEC shall be applicable following the submission of pricing and reimbursement by the marketing authorization holder. If a Member State fails to adhere to the timelines outlined in Directive 89/105/EEC, the obligation imposed on the marketing authorization holder in this Article shall be deemed satisfied in that Member State.

3. By derogation to paragraph 1, the holder of the marketing authorization for a specified orphan medicinal product or an advanced therapy medicinal product shall have the flexibility to:

a) provide patients and prescribing doctors who have requested it with direct access to a medicinal product; or

b) apply for pricing and reimbursement, submit the application exclusively in the Member States where the pertinent patient population has been identified.

4. Following consensus between a Member State and a marketing authorization holder, timelines deviating from those outlined in paragraphs 1 and 2 may be applicable. After a request in compliance with paragraph 1, a Member State may decide to issue a product-specific waiver, relieving the obligation to submit an application.

5. Following consultation with the Agency, the Commission shall adopt, through implementing acts, a list of products to be excluded from the obligations outlined in this Article. The inclusion of a medicinal product in this list may depend on criteria such as the inability to administer the product in most Member States. These implementing acts shall be adopted in line with the examination procedure outlined in Article 214(2).

6. If a change in the legal entity receiving a marketing authorization occurs before the period mentioned in paragraph 1 expires, the responsibilities shall be transferred to the new holder of the marketing authorization. The Commission shall enact a conciliation mechanism through implementing acts to ease discussions between applicants and Member States for resolving potential disputes related to the submission of applications for pricing and reimbursement and Directive 89/105/EEC. If animosity persists between an applicant and a Member State regarding the fulfillment of obligations outlined in this Article, the Commission shall have the authority to issue a legally binding decision after receiving the Agency's opinion.

Or. en

Amendment 853

Margrete Auken

Proposal for a directive

Article 58 a (new)

Text proposed by the Commission

Amendment

Article58a

Obligation to launch products in Member States

1. The marketing authorisation holder shall, upon request by a Member State in which the marketing authorisation is valid, release and continuously supply into the supply chain the requested product in a sufficient quantity and in the presentations necessary to cover the needs of the patients in the Member State no later than nine months from the date when the Member State made its request, or within 18 months from that date for any of the following entities:

(i) SMEs;

(ii) entities not engaged in an economic activity (‘not-for-profit entity’); or

2. The obligation laid down in paragraph 1 shall not prevent the marketing authorisation holder from submitting a pricing and reimbursement application in a Member State before receiving the request.

3. Following agreement between a Member State and a marketing authorisation holder, timelines other than those set out in paragraph 1 may apply.

4. For products authorised under [revised Regulation 726/2004], the marketing authorisation holder shall notify the Agency about the result of placing on the market of the products, in order to fulfil obligations set out in Article 138(2) of [revised Regulation 726/2004].

5. Following the filing for pricing and reimbursement by the marketing authorisation holder, Directive 89/105/EEC shall apply.

Or. en

Justification

Some countries have a prerequirement to have the product already reimbursed in a MS. Since this is not linked to MA date but rather the request, we believe 9 & 18 months is a sufficient time frame

Amendment 854

Stelios Kympouropoulos

Proposal for a directive

Article 59 – paragraph 1

Text proposed by the Commission

Amendment

Where medicinal products are authorised for a paediatric indication following completion of an agreed paediatric investigation plan and those medicinal products have already been marketed with other therapeutic indications, the marketing authorisation holder shall, within two years of the date on which the paediatric indication is authorised, place the medicinal product on the market in the Union taking into account the paediatric indication in all Member States where the medicinal product is already placed on the market. A Member State and the marketing authorisation holder may, within 3 months of the date on which the paediatric indication is authorised, agree on an alternative arrangement rhat will make available the medicinal product in question to patients, including but not limited to, according the provisions set out in Directive 2011/24/EU and Regulation (EC) No 883/2004 or based on a request from a prescribing doctor.

Or. en

Amendment 855

Dolors Montserrat, Nathalie Colin-Oesterlé, Tomislav Sokol

Proposal for a directive

Article 59 – paragraph 1

Text proposed by the Commission

Amendment

Or. en

Amendment 856

Alessandra Moretti

Proposal for a directive

Article 63 – paragraph 1

Text proposed by the Commission

Amendment

1. A package leaflet shall be mandatory for medicinal products.

1. A paper package leaflet shall be mandatory for medicinal products to be complemented by an electronic version.

Or. en

Amendment 857

Margrete Auken

Proposal for a directive

Article 63 – paragraph 2

Text proposed by the Commission

Amendment

2. The package leaflet shall be written and designed in a clear and understandable way, enabling users to act appropriately, when necessary with the help of healthcare professionals.

2. The package leaflet shall be written and designed in a clear and understandable way and proofread by relevant patient representatives, enabling users to act appropriately, when necessary with the help of healthcare professionals.

Or. en

Amendment 858

Joanna Kopcińska

Proposal for a directive

Article 63 – paragraph 2

Text proposed by the Commission

Amendment

2. The package leaflet shall be written and designed in a clear and understandable way, enabling users to act appropriately, when necessary with the help of healthcare professionals.

2. The package leaflet shall be written and designed in a clear and understandable way, enabling users to act appropriately, preferably without the help of healthcare professionals.

Or. en

Justification

leaflets should be constructed in more understandable way - for self-care of patients

Amendment 859

Nathalie Colin-Oesterlé

Proposal for a directive

Article 63 – paragraph 2 a (new)

Text proposed by the Commission

Amendment

2a. Further to the measures provided for in paragraph 2, 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 860

Dolors Montserrat

Proposal for a directive

Article 63 – paragraph 2 a (new)

Text proposed by the Commission

Amendment

2a. In addition to the measures specified in paragraph 2, for medicinal products included in the list referred to in Article 112a of [revised Regulation (EC) 726/2004], the following additional statement shall be included: 'This medicinal product is subject to additional monitoring'. This statement shall be preceded by the symbol referred to in Article 112a and followed by a standardised explanatory sentence.

Or. es

Justification

La legislación modificada debe mantener el concepto de "seguimiento adicional", ya que puede ayudar a identificar mejor los posibles efectos secundarios de los medicamentos aprobados recientemente y a aplicar medidas de mitigación de riesgos. De la misma manera, los prospectos deben incluir un símbolo que sea fácil de identificar y vaya acompañado de una nota que explique el concepto de seguimiento adicional de una manera sencilla pero, al mismo tiempo, lo suficientemente completa.En las enmiendas propuestas al Reglamento, proponemos mantener el ámbito actual de los "medicamentos sometidos a un seguimiento adicional", ya que incluye las sustancias activas nuevas, los productos biológicos, los medicamentos aprobados mediante sistemas de acceso temprano y los medicamentos para los que existen obligaciones específicas de seguridad post comercialización.La eliminación del triángulo negro invertido suscita preocupación por las futuras repercusiones en el seguimiento y la notificación de los acontecimientos adversos relacionados con los medicamentos con autorización de comercialización condicional y sometidos a seguimiento adicional. Dado que la nueva legislación prevé compartimentos estancos reglamentarios y regímenes de aprobación acelerada, aumentará considerablemente el volumen de medicamentos comercializados sujetos a vigilancia adicional. El actual triángulo negro invertido se utiliza como señal para que los farmacéuticos comunitarios expliquen que el medicamento que está tomando un paciente está sometido a un seguimiento adicional, concienciando sobre la importancia de notificar las reacciones adversas a los medicamentos y el funcionamiento del sistema de farmacovigilancia.

Amendment 861

Alessandra Moretti

Proposal for a directive

Article 63 – paragraph 3

Text proposed by the Commission

Amendment

3. Member States shall ensure that the package leaflet is made available in paper format and complemented by the electronic version.

Or. en

Amendment 862

Kateřina Konečná

Proposal for a directive

Article 63 – paragraph 3

Text proposed by the Commission

Amendment

3. Member States may decide that the package leaflet shall be made available in paper format or electronically, complementary to the mandatory paper format.

Or. en

Justification

Medicines package leaflets contain safety information for patients and should remain accessible in all circumstances. Unlike digital leaflets, paper leaflets ensure that patients always have crucial information with them to prevent and recall adverse effects, for example in the event of serious allergic reactions to a drug or an unexpected cross-reaction. Furthermore, paper-based information ensures equity, especially for people who do not have access to the internet or digital technologies or whose digital literacy is limited.

Amendment 863

Margarita de la Pisa Carrión

Proposal for a directive

Article 63 – paragraph 3

Text proposed by the Commission

Amendment

3. Member States shall ensure that the prospectus is available in paper and electronic form. The marketing authorisation holder shall ensure that a package leaflet in paper form is included on the packaging of a medicinal product.

Or. en

Amendment 864

Margrete Auken

Proposal for a directive

Article 63 – paragraph 3

Text proposed by the Commission

Amendment

3. The package leaflet shall be made available in both electronic and paper format. The printed copy of the package leaflet shall be included in the product’s packaging. It shall be ensured that the information in digital format is easily accessible to all patients.

Or. en

Amendment 865

Maria Angela Danzì

Proposal for a directive

Article 63 – paragraph 3

Text proposed by the Commission

Amendment

3. The package leaflet shall be made available in paper format or electronically, a package leaflet in paper format shall be included in the packaging of a medicinal product. It should be ensured that the information in digital format is easily accessible to all patients.

Or. en

Justification

Ensuring that product information is accessible to all, and in particular to patients/consumers with diverse abilities, is essential, and therefore the electronic product information (ePI) should never replace the paper version included in medicine packets but remain complementary. If used, ePI must meet standards of objectivity, be transparent, independent, and free of any advertising or commercial interests. Same rule should apply to AMR awareness card.

Amendment 866

Nicolás González Casares, Tiemo Wölken

Proposal for a directive

Article 63 – paragraph 3

Text proposed by the Commission

Amendment

3. Member States shall ensure that the package leaflet is available in paper format and electronically. Member States may choose to use only electronic leaflets for a limited range of medicines dispensed to in-hospital patients where the provision of medical information will be ensured by health professionals.

Or. en

Amendment 867

Marian-Jean Marinescu

Proposal for a directive

Article 63 – paragraph 3

Text proposed by the Commission

Amendment

3. For a transitional period of 3 years, the package leaflet shall be made available in paper format and electronically and in all EU official languages. After the transitional period, the package leaflet shall only be made available electronically and the patient’s right to a printed copy of the package leaflet should be guaranteed upon request and free of charge.

Or. en

Justification

The electronic leaflet is a tool that supports the mitigation of shortage of medicines.

Amendment 868

Peter Liese, Tomislav Sokol, Stelios Kympouropoulos

Proposal for a directive

Article 63 – paragraph 3

Text proposed by the Commission

Amendment

3. Member States may decide that the package leaflet shall be made available in paper format or electronically, or both. In the absence of such specific rules in a Member State, a package leaflet in paper and electronical format shall be made available. If the package leaflet is only made available electronically, it should be ensured that the information in digital format is easily accessible to all patients.

Or. en

Amendment 869

Erik Poulsen, Asger Christensen, Morten Løkkegaard

Proposal for a directive

Article 63 – paragraph 3

Text proposed by the Commission

Amendment

3. Member States may decide that the package leaflet shall be made available electronically or both electronically and in paper format. Member States are encouraged to take this decision within two years following 18 months after the date of entering into force of this Directive. In the absence of such specific rules in a Member State, a package leaflet shall be made available electronically and be included in paper format in the packaging of a medicinal product. If the package leaflet is only made available electronically, the patient’s right to a printed copy of the package leaflet should be guaranteed upon request and free of charge and it should be ensured that the information in digital format is easily accessible to all patients.

Or. en

Amendment 870

Joanna Kopcińska, Andrey Slabakov

Proposal for a directive

Article 63 – paragraph 3

Text proposed by the Commission

Amendment

3. Member States may decide that the package leaflet shall be made available in paper format or electronically, or both. In the absence of such specific rules in a Member State, an electronic format should be mandatory. If the package leaflet is only made available electronically, the patient’s right to a printed copy of the package leaflet should be guaranteed upon request and free of charge and it should be ensured that the information in digital format is easily accessible to all patients.

Or. en

Amendment 871

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

Proposal for a directive

Article 63 – paragraph 3

Text proposed by the Commission

Amendment

3. After carefully considering all relevant factors, including but not limited to the level of digitalisation of the country and the status of digital literacy of its citizens, Member States may decide that the package leaflet shall be made available in paper format or electronically, or both. The electronic format should allow the reactive integration of new data on the drug including pharmacovigilance data. In the absence of such specific rules in a Member State, a package leaflet in paper format shall be included in the packaging of a medicinal product. If a Member State decides that the package leaflet shall be made available electronically, a paper package leaflet in addition to the electronic format may always be made available on a voluntary basis. If the package leaflet is only made available electronically, the patient’s right to a printed copy of the package leaflet should be guaranteed upon request and free of charge and it should be ensured that the information in digital format is easily accessible to all patients.

Or. en

Amendment 872

Fulvio Martusciello

Proposal for a directive

Article 63 – paragraph 3

Text proposed by the Commission

Amendment

3. Member States may decide that the package leaflet shall be made available in paper format or electronically, or both. In the absence of such specific rules in a Member State, a package leaflet in paper format shall be included in the packaging of a medicinal product. If a Member State decides that the package leaflet shall be only made available electronically, it shall not preclude the marketing authorisation holder from providing the package leaflet in paper format in addition to the electronic format on a voluntary basis. If the package leaflet is only made available electronically, the patient’s right to a printed copy of the package leaflet should be guaranteed upon request and free of charge and it should be ensured that the information in digital format is easily accessible to all patients.

Or. en

Amendment 873

Cristian-Silviu Buşoi

Proposal for a directive

Article 63 – paragraph 3

Text proposed by the Commission

Amendment

3. Member States may decide that the package leaflet shall be made available in paper format or electronically, or both. In the absence of such specific rules in a Member State, a package leaflet in paper format shall be included in the packaging of a medicinal product. If a Member State decides that the package leaflet shall be made available electronically, a package leaflet in paper format in addition to the electronic format may always be made available on a voluntary basis. If the package leaflet is only made available electronically, the patient’s right to a printed copy of the package leaflet should be guaranteed upon request and free of charge and it should be ensured that the information in digital format is easily accessible to all patients.

Or. en

Amendment 874

Dolors Montserrat, Nathalie Colin-Oesterlé

Proposal for a directive

Article 63 – paragraph 3

Text proposed by the Commission

Amendment

3. Member States may decide that the package leaflet shall be made available in paper format or electronically, or both. In the absence of such specific rules in a Member State, a package leaflet in paper format shall be included in the packaging of a medicinal product. If a Member State decides that the package leaflet shall be made available electronically, a package leaflet in paper format in addition to the electronic format may always be made available on a voluntary basis. If the package leaflet is only made available electronically, the patient’s right to a printed copy of the package leaflet should be guaranteed upon request and free of charge and it should be ensured that the information in digital format is easily accessible to all patients.

Or. en

Amendment 875

Massimiliano Salini, Francesca Peppucci

Proposal for a directive

Article 63 – paragraph 3

Text proposed by the Commission

Amendment

3. Member States may decide that the package leaflet shall be made available in paper format or electronically, or both. In the absence of such specific rules in a Member State, a package leaflet in paper format shall be included in the packaging of a medicinal product. If a Member State chooses to provide the package leaflet in an electronic format, there is always the option to voluntarily offer a paper version of the package leaflet in addition to the electronic one. If the package leaflet is only made available electronically, the patient’s right to a printed copy of the package leaflet should be guaranteed upon request and free of charge and it should be ensured that the information in digital format is easily accessible to all patients.

Or. en

Amendment 876

Annalisa Tardino

Proposal for a directive

Article 63 – paragraph 3

Text proposed by the Commission

Amendment

3. Member States may decide that the package leaflet shall be made available in paper format or electronically, or both. In the absence of such specific rules in a Member State, a package leaflet in paper format shall be included in the packaging of a medicinal product. If the package leaflet is only made available electronically, the patient’s right to a printed copy of the package leaflet should be guaranteed upon request and free of charge and it should be ensured that the information in digital format is clear, easy to understand and easily accessible to all patients. In this context too, it should be possible to include, on a voluntary basis, the package leaflet in printed form.

Or. it

Amendment 877

Nathalie Colin-Oesterlé

Proposal for a directive

Article 63 – paragraph 3

Text proposed by the Commission

Amendment

3. Member States may decide that the package leaflet shall be made available in paper format or electronically, or both. In the absence of such specific rules in a Member State, a package leaflet in paper format shall be included in the packaging of a medicinal product. Where a Member State decides that the package leaflet must be available electronically, a paper version may still be made available on a voluntary basis. If the package leaflet is only made available electronically, the patient’s right to a printed copy of the package leaflet should be guaranteed upon request and free of charge and it should be ensured that the information in digital format is easily accessible to all patients.

Or. fr

Amendment 878

Sirpa Pietikäinen

Proposal for a directive

Article 63 – paragraph 3

Text proposed by the Commission

Amendment

Or. en

Amendment 879

Andreas Glück

Proposal for a directive

Article 63 – paragraph 3

Text proposed by the Commission

Amendment

3. Member States may decide that the package leaflet shall be made available electronically, or electronically and in paper format. In the absence of such specific rules in a Member State, a package leaflet in paper format shall be included in the packaging of a medicinal product. If the package leaflet is only made available electronically, the patient’s right to a printed copy of the package leaflet should be guaranteed upon request and free of charge. It should be ensured that the information in digital format is easily accessible to all patients.

Or. en

Justification

Package leaflets should generally be digitized. This offers many advantages, for example adaption of content for products which are already in circulation or facilitated cross-border exchanges.

Amendment 880

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

Proposal for a directive

Article 63 – paragraph 3 – subparagraph 1 (new)

Text proposed by the Commission

Amendment

By way of derogation from paragraph 3, when the medicinal products is not delivered directly to the patients, such as in hospital environment, the package leaflet may be available only in electronic format.

Or. en

Amendment 881

Peter Liese, Tomislav Sokol, Stelios Kympouropoulos

Proposal for a directive

Article 63 – paragraph 3 a (new)

Text proposed by the Commission

Amendment

3 a. If the package leaflet is only made available electronically, the patient’s right to a printed copy of the package leaflet shall be guaranteed upon request and free of charge. Member States shall establish regulatory frameworks for compensation obligations on the marketing authorisation holder for expenses incurred in the provision of a printed copy of the package leaflet. Compensations shall directly benefit the provider of the printed copy of the package leaflet. If the package leaflet is only to be made available electronically, a package leaflet in paper format may still be provided on a voluntary basis by the marketing authorisation holder in addition to the electronic package leaflet.

Or. en

Amendment 882

Nathalie Colin-Oesterlé

Proposal for a directive

Article 63 – paragraph 3 a (new)

Text proposed by the Commission

Amendment

3a. By way of derogation from paragraph 3, where the product is not intended directly for the patient or where it is intended for the European reserve of medicines of health and strategic interest (MISSs), established by Article 134 of [Regulation (EC) No 726/2004 as amended], the package leaflet may be supplied in electronic format only.

Or. fr

Amendment 883

Kateřina Konečná

Proposal for a directive

Article 63 – paragraph 3 a (new)

Text proposed by the Commission

Amendment

3 a. By way of derogation from paragraph 3, where the medicinal product is not intended to be delivered directly to the patient (e.g. in hospital by the MD), the package leaflet may be made available electronically only.

Or. en

Amendment 884

Joanna Kopcińska, Andrey Slabakov

Proposal for a directive

Article 63 – paragraph 3 a (new)

Text proposed by the Commission

Amendment

3 a. By way of derogation from paragraph 3, where the medicinal product is not intended to be delivered directly to the patient, the package leaflet shall be made available electronically only.

Or. en

Amendment 885

Massimiliano Salini, Francesca Peppucci

Proposal for a directive

Article 63 – paragraph 3 a (new)

Text proposed by the Commission

Amendment

3 a. By way of derogation from paragraph 3, if the medicinal product is not meant to be directly administered to the patient, the package leaflet can be provided electronically exclusively.

Or. en

Amendment 886

Fulvio Martusciello

Proposal for a directive

Article 63 – paragraph 3 a (new)

Text proposed by the Commission

Amendment

3 a. By way of derogation from paragraph 3, where the medicinal product is not intended to be delivered directly to the patient, the package leaflet may be made available electronically only.

Or. en

Amendment 887

Cristian-Silviu Buşoi

Proposal for a directive

Article 63 – paragraph 3 a (new)

Text proposed by the Commission

Amendment

3 a. By way of derogation from paragraph 3, where the medicinal product is not intended to be delivered directly to the patient, the package leaflet may be made available electronically only.

Or. en

Amendment 888

Erik Poulsen, Asger Christensen, Morten Løkkegaard

Proposal for a directive

Article 63 – paragraph 3 a (new)

Text proposed by the Commission

Amendment

3 a. If a Member State has decided that the package leaflet is only to be made available electronically, patients shall be made aware of their right to a printed copy of the package leaflet.

Or. en

Amendment 889

Dolors Montserrat, Nathalie Colin-Oesterlé

Proposal for a directive

Article 63 – paragraph 3 a (new)

Text proposed by the Commission

Amendment

3 a. By derogation from paragraph 3, where the medicinal product is not intended to be delivered directly to the patient, the package leaflet may be made available electronically only.

Or. en

Amendment 890

Maria Angela Danzì

Proposal for a directive

Article 63 – paragraph 3 a (new)

Text proposed by the Commission

Amendment

3 a. A package lealeft shall include a key information section summarising benefit and harm data for each authorised indication.

Or. en

Justification

Amendment 891

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

Proposal for a directive

Article 63 – paragraph 3 a (new)

Text proposed by the Commission

Amendment

3 a. A package leaflet shall include key information summarising benefit and harma data for each authorised indication.

Or. en

Amendment 892

Peter Liese, Tomislav Sokol, Stelios Kympouropoulos

Proposal for a directive

Article 63 – paragraph 3 b (new)

Text proposed by the Commission

Amendment

3 b. Where the medicinal product is intended for dispensation and administration by a qualified healthcare professionals rather than for self-administration by the patient, the Commission is empowered to adopt delegated acts in accordance with Article 215 to amend paragraph 3 of this Article by making only the electronic version of the package leaflet mandatory in this specific context. In such a case, a printed copy of the package leaflet may still be provided upon request.

Or. en

Amendment 893

Margrete Auken

Proposal for a directive

Article 63 – paragraph 5

Text proposed by the Commission

Amendment

5. The Commission is empowered to adopt delegated acts in accordance with Article 215 to amend paragraph 3 by making mandatory the electronic version of the package leaflet. That delegated act shall also establish the patient’s right to a printed copy of the package leaflet upon request and free of charge. The delegation of powers shall apply as of [OP please insert the date = five years following 18 months after the date of entering into force of this Directive].

deleted

Or. en

Amendment 894

Maria Angela Danzì

Proposal for a directive

Article 63 – paragraph 5

Text proposed by the Commission

Amendment

deleted

Or. en

Justification

Amendment 895

Marian-Jean Marinescu

Proposal for a directive

Article 63 – paragraph 5

Text proposed by the Commission

Amendment

deleted

Or. en

Amendment 896

Joanna Kopcińska

Proposal for a directive

Article 63 – paragraph 5

Text proposed by the Commission

Amendment

deleted

Or. en

Justification

considering paragraph 3 - the obligation should not be introduced through delgated acts

Amendment 897

Margarita de la Pisa Carrión

Proposal for a directive

Article 63 – paragraph 5

Text proposed by the Commission

Amendment

deleted

Or. en

Amendment 898

Alessandra Moretti

Proposal for a directive

Article 63 – paragraph 5

Text proposed by the Commission

Amendment

deleted

Or. en

Amendment 899

Massimiliano Salini, Francesca Peppucci

Proposal for a directive

Article 63 – paragraph 5

Text proposed by the Commission

Amendment

5. The Commission is empowered to adopt delegated acts in accordance with Article 215 to amend paragraph 3 by making mandatory the electronic version of the package leaflet and removing the requirement to include a printed package leaflet within the packaging. That delegated act shall also establish the patient’s right to a printed copy of the package leaflet upon request and free of charge. The delegation of powers shall apply as of [OP please insert the date = one year following 18 months after the date of entering into force of this Directive].

Or. en

Amendment 900

Fulvio Martusciello

Proposal for a directive

Article 63 – paragraph 5

Text proposed by the Commission

Amendment

5. The Commission is empowered to adopt delegated acts in accordance with Article 215 to amend paragraph 3 by making mandatory the electronic version of the package leaflet and removing the obligation to include a package leaflet in paper format in the package. That delegated act shall also establish the patient’s right to a printed copy of the package leaflet upon request and free of charge. The delegation of powers shall apply as of [OP please insert the date = one years following 18 months after the date of entering into force of this Directive].

Or. en

Amendment 901

Cristian-Silviu Buşoi

Proposal for a directive

Article 63 – paragraph 5

Text proposed by the Commission

Amendment

5. The Commission is empowered to adopt delegated acts in accordance with Article 215 to amend paragraph 3 by making mandatory the electronic version of the package leaflet and removing the obligation to include a package leaflet in paper format in the package. That delegated act shall also establish the patient’s right to a printed copy of the package leaflet upon request and free of charge. The delegation of powers shall apply as of [OP please insert the date = one year following 18 months after the date of entering into force of this Directive].

Or. en

Amendment 902

Dolors Montserrat, Nathalie Colin-Oesterlé

Proposal for a directive

Article 63 – paragraph 5

Text proposed by the Commission

Amendment

5. The Commission is empowered to adopt delegated acts in accordance with Article 215 to amend paragraph 3 by making mandatory the electronic version of the package leaflet and removing the obligation to include a package leaflet in paper format in the package. That delegated act shall also establish the patient’s right to a printed copy of the package leaflet upon request and free of charge. The delegation of powers shall apply as of [OP please insert the date = one year following 18 months after the date of entering into force of this Directive].

Or. en

Amendment 903

Kateřina Konečná

Proposal for a directive

Article 63 – paragraph 5

Text proposed by the Commission

Amendment

5. The Commission is empowered to adopt delegated acts in accordance with Article 215 to amend paragraph 3 by making mandatory the electronic version of the package leaflet, in addition to the paper version. The delegation of powers shall apply as of [OP please insert the date = five years following 18 months after the date of entering into force of this Directive].

Or. en

Justification

The paper version should remain available alongside the electronic version. As such, the patient’s “right to a printed copy” does not need to be defined in the delegated act. Regardless of how the paper copy is provided, should member states decide to provide alternatives to the “traditional” leaflet printed by the manufacturer or in case of public health needs (e.g., to address shortages), the patient should receive the paper copy in a systematic way (i.e., not “upon request”) and free of charge.

Amendment 904

Nathalie Colin-Oesterlé

Proposal for a directive

Article 63 – paragraph 5

Text proposed by the Commission

Amendment

5. The Commission is empowered to adopt delegated acts in accordance with Article 215 to amend paragraph 3 by making mandatory the electronic version of the package leaflet and waiving the obligation to provide a package leaflet in paper format. That delegated act shall also establish the patient’s right to a printed copy of the package leaflet upon request and free of charge. The delegation of powers shall apply as of [OP please insert the date = one year following 18 months after the date of entering into force of this Directive].

Or. fr

Amendment 905

Erik Poulsen, Asger Christensen, Morten Løkkegaard

Proposal for a directive

Article 63 – paragraph 5

Text proposed by the Commission

Amendment

5. The Commission is empowered to adopt delegated acts in accordance with Article 215 to amend paragraph 3 by making mandatory the electronic version of the package leaflet and to remove the requirement for leaflets in paper formats. That delegated act shall also establish the patient’s right to a printed copy of the package leaflet upon request and free of charge. The delegation of powers shall apply as of [OP please insert the date = five years following 18 months after the date of entering into force of this Directive].

Or. en

Amendment 906

Nicolás González Casares, Tiemo Wölken

Proposal for a directive

Article 63 – paragraph 5

Text proposed by the Commission

Amendment

5. The Commission is empowered to adopt delegated acts in accordance with Article 215 to amend paragraph 3 in order to progressively reduce the use of the paper format of the leaflet. That delegated act shall also establish the patient’s right to a printed copy of the package leaflet upon request and free of charge. The delegation of powers shall apply as of [OP please insert the date = five years following 18 months after the date of entering into force of this Directive].

Or. en

Amendment 907

Cyrus Engerer

Proposal for a directive

Article 63 – paragraph 5

Text proposed by the Commission

Amendment

5. The Commission is empowered to adopt delegated acts in accordance with Article 215 to amend paragraph 3 by making mandatory the electronic version of the package leaflet. That delegated act shall also establish the patient’s right to a printed copy of the package leaflet upon request and free of charge. The delegation of powers shall apply as of [OP please insert the date = two years following 18 months after the date of entering into force of this Directive].

Or. en

Amendment 908

Alessandra Moretti

Proposal for a directive

Article 63 – paragraph 6

Text proposed by the Commission

Amendment

6. The Commission shall adopt implementing acts to establish common standards for the electronic version of the package leaflet, the summary of product characteristics and the labelling, taking into account available technologies. The Commission shall formally consult the European Data Protection Board and the Agency on this process.

Or. en

Amendment 909

Kateřina Konečná

Proposal for a directive

Article 63 – paragraph 6

Text proposed by the Commission

Amendment

Or. en

Amendment 910

Nicolás González Casares, Tiemo Wölken

Proposal for a directive

Article 63 – paragraph 6

Text proposed by the Commission

Amendment

6. The Commission shall adopt implementing acts in accordance with the examination procedure referred to in Article 214(2) to establish common standards for the electronic version of the package leaflet, the summary of product characteristics and the labelling, taking into account available technologies. Member States shall implement this article after the publication of the Commission implementing acts on the common standards for electronic versions of the package leaflet.

Or. en

Amendment 911

Margarita de la Pisa Carrión

Proposal for a directive

Article 63 – paragraph 6

Text proposed by the Commission

Amendment

6. The Commission shall adopt implementing acts in accordance with the examination procedure referred to in Article 214(2) to establish common standards for the electronic version of the package leaflet, the summary of product characteristics and the labelling, taking into account available technologies. The Commission shall consult the European Data Protection Supervisor and the Agency in this process.

Or. en

Amendment 912

Massimiliano Salini, Francesca Peppucci

Proposal for a directive

Article 63 – paragraph 6

Text proposed by the Commission

Amendment

6. The Commission shall adopt implementing acts in accordance with the examination procedure referred to in Article 214(2) to establish common standards for the electronic version of the package leaflet, the summary of product characteristics and the labelling, taking into account available technologies at the latest by [1 year after publication of this Directive].

Or. en

Amendment 913

Cristian-Silviu Buşoi

Proposal for a directive

Article 63 – paragraph 6

Text proposed by the Commission

Amendment

6. The Commission shall adopt implementing acts in accordance with the examination procedure referred to in Article 214(2) to establish common standards for the electronic version of the package leaflet, the summary of product characteristics and the labelling, taking into account available technologies at the latest by [1 year after publication of this Directive].

Or. en

Amendment 914

Dolors Montserrat, Nathalie Colin-Oesterlé

Proposal for a directive

Article 63 – paragraph 6

Text proposed by the Commission

Amendment

6. The Commission shall adopt implementing acts in accordance with the examination procedure referred to in Article 214(2) to establish common standards for the electronic version of the package leaflet, the summary of product characteristics and the labelling, taking into account available technologies at the latest by [1 year after publication of this Directive].

Or. en

Amendment 915

Marian-Jean Marinescu

Proposal for a directive

Article 63 – paragraph 6

Text proposed by the Commission

Amendment

6. The Commission shall adopt implementing acts in accordance with the examination procedure referred to in Article 214(2) to establish common standards for the electronic version of the package leaflet, the summary of product characteristics and the labelling, taking into account available technologies, no later than 12 months after the date of entering into force of this Directive.

Or. en

Justification

A deadline is necessary to ensure the adoption of this implementing act in a timely manner, which will be necessary to enable the introduction of electronic package leaflet.

Amendment 916

Fulvio Martusciello

Proposal for a directive

Article 63 – paragraph 6

Text proposed by the Commission

Amendment

6. The Commission shall adopt implementing acts in accordance with the examination procedure referred to in Article 214(2) to establish common standards for the electronic version of the package leaflet, the summary of product characteristics and the labelling, taking into account available technologies at the latest by [1 year after publication of this Directive].

Or. en

Amendment 917

Fulvio Martusciello

Proposal for a directive

Article 63 – paragraph 6 a (new)

Text proposed by the Commission

Amendment

6 a. After consultation with Member States and relevant stakeholders, the Agency shall implement a system providing public access to the electronic version of the package leaflet, the summary of product characteristics and the labelling on the database provided in Article 138 of [revised Regulation (EC) No 726/2004] The system shall be implemented by the Agency and used by all Member States at the latest by [30 months after publication].

Or. en

Amendment 918

Marian-Jean Marinescu

Proposal for a directive

Article 63 – paragraph 6 a (new)

Text proposed by the Commission

Amendment

6 a. The Agency shall make available a system to accommodate the electronic product information in the database provided in Article 138(1)(n) and 138(2) of the Revised Regulation (EC) No 726/2004 after consultation with Member States and the relevant stakeholders. The system shall be implemented by the Agency and used by all Member States at the latest by 24 months after the date of entering into force of this Directive.

Or. en

Justification

A system should be developed to ensure that electronic product information can be provided by marketing authorisation holders. A single system should be used throughout Europe, based on the existing work done by the regulatory authorities.

Amendment 919

Massimiliano Salini, Francesca Peppucci

Proposal for a directive

Article 63 – paragraph 6 a (new)

Text proposed by the Commission

Amendment

6 a. Following consultation with Member States and pertinent stakeholders, the Agency shall make a system available to accommodate the electronic product information in the database specified in Article 138(1)(n) and 138(2) of the [revised Regulation (EC) No 726/2004] . By [30 months after publication], at the latest, the Agency will have the system operational and all Member States will be using it.

Or. en

Amendment 920

Dolors Montserrat, Nathalie Colin-Oesterlé, Tomislav Sokol

Proposal for a directive

Article 63 – paragraph 6 a (new)

Text proposed by the Commission

Amendment

6 a. The Agency shall make available a system to accommodate the electronic product information in the database provided in Article 138(1)(n) and 138(2) of the [revised Regulation (EC) No 726/2004] after consultation with Member States and the relevant stakeholders. The system shall be implemented by the Agency and used by all Member States at the latest by [30 months after publication].

Or. en

Amendment 921

Cristian-Silviu Buşoi

Proposal for a directive

Article 63 – paragraph 6 a (new)

Text proposed by the Commission

Amendment

Or. en

Amendment 922

Margarita de la Pisa Carrión

Proposal for a directive

Article 63 – paragraph 7

Text proposed by the Commission

Amendment

7. When the prospectus is available electronically, the individual International Directorate’s right to privacy shall be guaranteed. Any technology providing access to information shall ensure the protection of personal data in accordance with Regulation (EU) 2016/679 and Directive 2002/58/EC and shall not allow the identification or monitoring of persons, nor shall it be used for commercial purposes, including advertising and marketing activities.

Or. en

Amendment 923

Dolors Montserrat

Proposal for a directive

Article 63 – paragraph 7

Text proposed by the Commission

Amendment

7. Where the package leaflet is made available electronically, the individual right to privacy shall be ensured. Any technology giving access to the information shall not allow the identification or tracking of individuals, guaranteeing the protection of personal data in accordance with Regulation (EU) 2016/679 and Directive 2002/58/EC, nor shall it be used for commercial purposes, including advertising and marketing activities.

Or. es

Amendment 924

Alessandra Moretti

Proposal for a directive

Article 63 – paragraph 7

Text proposed by the Commission

Amendment

7. Where the package leaflet is made available electronically, the individual right to privacy shall be ensured. Any technology giving access to the information shall ensure the protection of personal data in line with Regulation (EU) 2016/679 and Directive 2002/58/EC and shall not allow the identification, profiling or tracking of individuals, nor shall it be used for commercial purposes including advertising and marketing activities.

Or. en

Amendment 925

Kateřina Konečná

Proposal for a directive

Article 63 – paragraph 7

Text proposed by the Commission

Amendment

7. Where the package leaflet is made available electronically, the individual right to privacy shall be ensured. Any technology giving access to the information shall ensure the protection of personal data in line with Regulation (EU) 2016/679 and Directive 2002/58/EC and not allow the identification, profiling or tracking of individuals, nor shall it be used for commercial purposes including advertising and marketing activities.

Or. en

Amendment 926

Nicolás González Casares, Tiemo Wölken

Proposal for a directive

Article 63 – paragraph 7

Text proposed by the Commission

Amendment

7. Where the package leaflet is made available electronically, the individual right to privacy shall be ensured. Any technology giving access to the information shall ensure the protection of personal data in line with Regulation (EU) 2016/679 and Directive 2002/58/EC and not allow the identification, profiling or tracking of individuals, nor shall it be used for commercial purposes, including advertising and marketing activities.

Or. en

Amendment 927

Margrete Auken

Proposal for a directive

Article 63 – paragraph 7

Text proposed by the Commission

Amendment

7. Where the package leaflet is made available electronically, the individual right to privacy shall be ensured. Any technology giving access to the information shall ensure the protection of personal data pursuant to Regulation 2016/679 and not allow the identification, profiling or tracking of individuals, nor shall it be used for commercial purposes.

Or. en

Amendment 928

Maria Angela Danzì

Proposal for a directive

Article 63 – paragraph 7

Text proposed by the Commission

Amendment

7. Utilisation of the electronic package lealeft shall ensure the individual right to privacy. Any technology giving access to the information shall not allow the identification or tracking of individuals, nor shall it be used for commercial purposes.

Or. en

Justification

Amendment 929

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

Proposal for a directive

Article 63 – paragraph 7 – subparagraph 1 (new)

Text proposed by the Commission

Amendment

The progressive transition to the electronic version of the package leaflet shall be supported by pharmacists in their duties to compound, dispense and sell medicinal products that patients need, to provide advice on their proper use and possible adverse effects and, if needed, to design a personalised pharmaceutical plan, as prescription assistance software and dispensing assistance software evolve.

Or. en

Amendment 930

Margarita de la Pisa Carrión

Proposal for a directive

Article 63 – paragraph 7 a (new)

Text proposed by the Commission

Amendment

7 a. The competent authority of the Member State or, where appropriate, the Agency, shall supervise the technology providing access to the electronic version of the package leaflet, ensuring compliance with paragraph 7.The competent authority of the Member State shall decide on the means of storage and access to the electronic version of the prospectus which shall be available through the national web portals and the web portal of the European Agency for Medicinal product within the meaning of Article 102(1).

In addition to the measures specified in paragraph 2, for medicinal products included in the list referred to in Article 112 a of [revised Regulation (EC) No 726/2004], the following additional declaration shall be included: "This drug is subject to additional monitoring". This reference shall be preceded by the symbol referred to in Article 112 bis and followed by a standard explanatory phrase.

Or. en

Amendment 931

Dolors Montserrat

Proposal for a directive

Article 63 – paragraph 7 a (new)

Text proposed by the Commission

Amendment

7 a. The competent authority of the Member State, or the Agency where appropriate, shall have oversight of the technology giving access to the electronic version of the package leaflet, ensuring compliance with paragraph 7. The competent authority of the Member State shall determine the means of storage and access to the electronic version of the package leaflet which shall be available via national web-portals and via the European Medicines Agency's web-portal in line with Article 102(1).

Or. es

Amendment 932

Nathalie Colin-Oesterlé

Proposal for a directive

Article 63 – paragraph 7 a (new)

Text proposed by the Commission

Amendment

7a. After consulting the Member States and stakeholders, the Agency shall establish a single system to ensure that patients have access to the electronic package leaflets of their products. This system must be used in all Member States and available at the time of publication of the delegated acts referred to in paragraph 5.

Or. fr

Amendment 933

Margrete Auken

Proposal for a directive

Article 64 – paragraph 1 a (new)

Text proposed by the Commission

Amendment

1 a. The package leaflet shall include a summary of benefits and risk related to each authorised indication.

Or. en

Amendment 934

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

Proposal for a directive

Article 64 – paragraph 2 a (new)

Text proposed by the Commission

Amendment

2 a. In addition to the measures specified in paragraph 2, for medicinal products included in the list referred to in Article 112a of the [revised Regulation (EC) No 726/2004], the following additional statement shall be included ‘This medicinal product is subject to additional monitoring’. This statement shall be preceded by the symbol referred to in Article 112a and followed by a standardised explanatory sentence.

Or. en

Amendment 935

Nicolás González Casares, Tiemo Wölken

Proposal for a directive

Article 64 – paragraph 3 a (new)

Text proposed by the Commission

Amendment

3 a. In addition to the measures specified in paragraph 2, for medicinal products included in the list referred to in Article 112a of the [revised Regulation (EC) No 726/2004], the following additional statement shall be included ‘This medicinal product is subject to additional monitoring’. This statement shall be preceded by the symbol referred to in the aforementioned Article and followed by a standardised explanatory sentence that is appropriate, clearly legible, and easy to understand by users.

Or. en

Amendment 936

Catherine Amalric

Proposal for a directive

Article 65 – paragraph 2 – point b a (new)

Text proposed by the Commission

Amendment

(b a) define the minimum mandatory labeling information to be included on primary packaging for medications dispensed individually.

Or. en

Amendment 937

Cyrus Engerer

Proposal for a directive

Article 65 – paragraph 2 a (new)

Text proposed by the Commission

Amendment

2 a. Member States may decide that the labelling particulars, referred to in paragraph 1 and listed in Annex IV, shall be made available on the packaging and digitally. Where the labelling particulars are made available digitally, the individual right to privacy shall be ensured, and shall happen via the Member States’ or European marketing authorisation databases. Any technology giving access to the information shall not allow the identification or tracking of individuals, nor shall it be used for commercial purposes.

Or. en

Amendment 938

Catherine Amalric

Proposal for a directive

Article 66 – paragraph 1

Text proposed by the Commission

Amendment

1. The particulars laid down in Annex IV shall appear on immediate packagings other than those referred to in the paragraphs 2 and 3.

1. The particulars laid down in Annex IV shall appear on immediate packagings other than those referred to in the paragraphs 2 and 3 and shall allow, at the request of the national competent authorities, single dispensation, particularly in the event of a shortage or major public health issue.

Or. en

Amendment 939

István Ujhelyi

Proposal for a directive

Article 66 – paragraph 2 – introductory part

Text proposed by the Commission

Amendment

2. The following particulars at least shall appear on immediate packagings that take the form of blister packs and are placed in an outer packaging that complies with the requirements laid down in Articles 65 and 73.

(a) the name of the medicinal product;

(b) the strength of the medicinal product;

(d) the expiry date;

(e) the batch number.

Each single dose of the blister pack shall include the following labelling particulars:

(a) the name of the medicinal product;

(b) the strength of the medicinal product;

(i) the Global Trading Index Number (GTIN)

(ii) the expiry date;

(iii) the batch number.

Or. en

Amendment 940

István Ujhelyi

Proposal for a directive

Article 66 – paragraph 2 – point a

Text proposed by the Commission

Amendment

(a) the name of the medicinal product;

deleted

Or. en

Amendment 941

Margrete Auken

Proposal for a directive

Article 66 – paragraph 2 – point a a (new)

Text proposed by the Commission

Amendment

(a a) the international non proprietary name;

Or. en

Amendment 942

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

Proposal for a directive

Article 66 – paragraph 2 – point a a (new)

Text proposed by the Commission

Amendment

(a a) the strength of the medicinal product;

Or. en

Amendment 943

Margrete Auken

Proposal for a directive

Article 66 – paragraph 2 – point a b (new)

Text proposed by the Commission

Amendment

(a b) the strength of the medicinal product;

Or. en

Amendment 944

István Ujhelyi

Proposal for a directive

Article 66 – paragraph 2 – point b

Text proposed by the Commission

Amendment

(b) the name of the marketing authorisation holder placing the product on the market;

deleted

Or. en

Amendment 945

István Ujhelyi

Proposal for a directive

Article 66 – paragraph 2 – point c

Text proposed by the Commission

Amendment

deleted

Or. en

Amendment 946

István Ujhelyi

Proposal for a directive

Article 66 – paragraph 2 – point d

Text proposed by the Commission

Amendment

(d) the batch number.

deleted

Or. en

Amendment 947

Margrete Auken

Proposal for a directive

Article 66 – paragraph 2 a (new)

Text proposed by the Commission

Amendment

2 a. Each single dose of the blister pack shall include the following labelling particulars:

(a) the name of the medicinal product;

(b) the strength of the medicinal product;

(i) the Global Trading Index Number (GTIN)

(ii) the expiry date;

(iii) the batch number.

Or. en

Justification

manufacturers should be obliged to include single unit dose barcodes on each cell of the blister. Barcoding medicinal products to the single unit dose and bedside scanning of medications have for example proven to be an efficient way to diminish medication errors and adverse drug events. In Dutch hospitals alone the use of single unit dose barcoding would save 47 patient lives each year. While in Denmark, a 57% decrease in medication administration errors on a haematological ward was observed after the introduction of single unit dose barcoding. This measure resulted in a cost-effectiveness ratio of 2.01 euro per avoided administration error. Similar financial findings were reported by a study for Dutch hospitals which concluded that the country-wide usage of single unit does barcoding could lower healthcare spending by 21 million euro per year

Amendment 948

Margrete Auken

Proposal for a directive

Article 66 – paragraph 3 – point a

Text proposed by the Commission

Amendment

(a) the name of the medicinal product and, if necessary, the route of administration;

(a) the name of the medicinal product, the international non proprietary name, and, if necessary, the route of administration;

Or. en

Amendment 949

Margarita de la Pisa Carrión

Proposal for a directive

Article 66 – paragraph 3 – point a

Text proposed by the Commission

Amendment

(a) the name of the medicinal product and, if necessary, the route of administration;

(a) the name of the medical product and the international non-proprietary name (INN) either in the local language or in Latin;

Or. en

Amendment 950

Margarita de la Pisa Carrión

Proposal for a directive

Article 66 – paragraph 3 – point a a (new)

Text proposed by the Commission

Amendment

(a a) Pharmaceutical form

Or. en

Amendment 951

Margarita de la Pisa Carrión, Joanna Kopcińska

Proposal for a directive

Article 66 – paragraph 3 – point b

Text proposed by the Commission

Amendment

(b) the method of administration;

(b) the route of administration;

Or. en

Amendment 952

Margarita de la Pisa Carrión

Proposal for a directive

Article 66 – paragraph 3 – point b

Text proposed by the Commission

Amendment

(b) the method of administration;

(b) the route of administration;

Or. en

Amendment 953

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

Proposal for a directive

Article 66 a (new)

Text proposed by the Commission

Amendment

Article66a

Labelling of blister packs in case of unit dose dispensing

Wherever a Member State imposes dispensing of medicinal products by pharmacists, to fight against antibioresistance, or for any other reason, it shall ensure that the doses are packaged and labelled on unit dose pre-cut blisters. Each per-cut blister shall include the following labelling particulars:

(a) the name of the medicinal product;

(b) the strength of the medicinal product;

(i) the Global Trading Index Number (GTIN);

(ii) the expiry date;

(iii) the batch number.

Member States shall promote the use of unit dose pre-cut blisters in hospital environment and, progressively, in dispensing pharmacies, when necessary.

Or. en

Amendment 954

Margrete Auken

Proposal for a directive

Article 66 a (new)

Text proposed by the Commission

Amendment

Article 66a

Labelling of blister packs in case of unit dose dispensing

Where a Member State imposes unit dose dispensing of medicines by pharmacists, to fight against antimicrobial resistance, or for any other public health reason, it shall ensure that the doses are packaged and labelled on the unit dose pre-cut blisters.

Or. en

Amendment 955

Sirpa Pietikäinen

Proposal for a directive

Article 67 – paragraph 2 – subparagraph 3 – point e

Text proposed by the Commission

Amendment

(e) other potential risks to public health.

(e) other potential risks to public health or environment.

Or. en

Amendment 956

Pietro Fiocchi

Proposal for a directive

Article 67 – paragraph 6

Text proposed by the Commission

Amendment

6. Member States may, for the purposes of reimbursement, pharmacovigilance, pharmacoepidemiology or for data protection prolongation for market launch use the information contained in the repositories system referred to paragraph 2, second subparagraph, point (e).

6. Member States may, for the purposes of reimbursement, pharmacovigilance, pharmacoepidemiology, shortage monitoring or prevention, for implementation of Article 56(3), for compliance with enforcement of distributor public service obligations, making product information available electronically, or for data protection prolongation for market launch use the information contained in the repositories system referred to paragraph 2, second subparagraph, point (e).

Or. en

Amendment 957

Dolors Montserrat, Nathalie Colin-Oesterlé, Tomislav Sokol

Proposal for a directive

Article 67 – paragraph 6

Text proposed by the Commission

Amendment

Or. en

Amendment 958

Margarita de la Pisa Carrión

Proposal for a directive

Article 67 – paragraph 6

Text proposed by the Commission

Amendment

6. Member States may, for the purposes of reimbursement, pharmacovigilance and pharmaco-epidemiology, use the information contained in the repository system referred to in the second subparagraph of paragraph 2, point (e) .

Or. en

Amendment 959

Margrete Auken

Proposal for a directive

Article 67 – paragraph 6

Text proposed by the Commission

Amendment

6. Member States may, for the purposes of reimbursement, pharmacovigilance, pharmacoepidemiology or monitoring of medicine shortages use the information contained in the repositories system referred to paragraph 2, second subparagraph, point (e).

Or. en

Amendment 960

Margarita de la Pisa Carrión

Proposal for a directive

Article 67 – paragraph 7 a (new)

Text proposed by the Commission

Amendment

7 a. For the purpose of patient safety, Member States may decide that medicinal products imported or distributed in parallel shall be repackaged in new outer packaging.

Or. en

Amendment 961

Maria Angela Danzì

Proposal for a directive

Article 69 – paragraph 1

Text proposed by the Commission

Amendment

1. The marketing authorisation holder shall ensure availability of educational material to healthcare professionals, including through medical sales representatives as referred to in Article 175(1), point (c), regarding the appropriate use of diagnostic tools, testing or other diagnostic approaches related to antimicrobial-resistant pathogens, that may inform on the use of the antimicrobial.

1. In case of absence of appropriate guidelines, the marketing authorisation holder may ensure availability of informational material to healthcare professionals, regarding the appropriate use of diagnostic tools, testing or other diagnostic approaches related to antimicrobial-resistant pathogens, that may inform on the use of the antimicrobial.

The informational material referred to in the first subparagraph shall be compatible with the summary of product characteristics.

Materials referred to in the first subparagraph shall not constitute advertising referred to in Chapter XIII.

Or. en

Justification

The best source of information on the use of diagnostics tools are the official guidelines. Only in cases, where such guidelines do not exist, marketing authorisation holders may provide information to healthcare professionals. The medical sales representatives are not the right way to provide this information to healthcare professionals. It must be ensured that the information on appropriate use of the diagnostic tools is compatible with the summary of products characteristics and does not involve advertising .

Amendment 962

Nicolás González Casares, Tiemo Wölken

Proposal for a directive

Article 69 – paragraph 1

Text proposed by the Commission

Amendment

1. The marketing authorisation holder shall ensure availability of educational material to healthcare professionals, , regarding the appropriate use of diagnostic tools, testing or other diagnostic approaches related to antimicrobial-resistant pathogens, that may inform on the use of the antimicrobial. As referred to in paragraph 1 , point (b) of Article 17, the competent authority responsible for approving the antimicrobial shall review the content of the educational material and validate the final version.

Or. en

Amendment 963

Margrete Auken

Proposal for a directive

Article 69 – paragraph 1

Text proposed by the Commission

Amendment

1. In the absence of specific medical guidelines, the marketing authorisation holder shall ensure availability of informational material to healthcare professionals, regarding the appropriate use of diagnostic tools, testing or other diagnostic approaches related to antimicrobial-resistant pathogens, that may inform on the use of the antimicrobial. Any informational material must be compatible with the summary of product characteristics.

Or. en

Justification

Amendment 964

Kateřina Konečná

Proposal for a directive

Article 69 – paragraph 2 – subparagraph 1

Text proposed by the Commission

Amendment

The marketing authorisation holder shall include in the packaging of antimicrobials a document that contains specific information about the medicinal product concerned and that is made available to the patient in addition to the product leaflet (“awareness card”) with information on antimicrobial resistance and the appropriate use and disposal of antimicrobials.

Or. en

Justification

In the same way as the package leaflet, the awareness card should be available on paper for people who do not have access to the internet or who have a low level of digital literacy, to ensure equity.

Amendment 965

Margrete Auken

Proposal for a directive

Article 69 – paragraph 2 – subparagraph 2

Text proposed by the Commission

Amendment

Member States may decide that the awareness card shall be made available in paper format or electronically, or both. In the absence of such specific rules in a Member State, an awareness card in paper format shall be included in the packaging of an antimicrobial.

The awareness card shall be available both in electronic format and in a paper format and included in the packaging of an antimicrobial.

Or. en

Amendment 966

Joanna Kopcińska

Proposal for a directive

Article 69 – paragraph 2 – subparagraph 2

Text proposed by the Commission

Amendment

Or. en

Amendment 967

Maria Angela Danzì

Proposal for a directive

Article 69 – paragraph 2 – subparagraph 2

Text proposed by the Commission

Amendment

The awareness card shall be made available in paper format and electronically. In the absence of such specific rules in a Member State, an awareness card in paper format shall be included in the packaging of an antimicrobial.

Or. en

Justification

Ensuring that AMR awareness information is accessible to all, and in particular to patients/consumers with diverse abilities, is essential, and therefore the AMR awareness card with information on antimicrobial resistance and disposal shall be accessible in paper format as well. Same rule should apply to package leaflet.

Amendment 968

Nicolás González Casares, Tiemo Wölken

Proposal for a directive

Article 69 – paragraph 2 – subparagraph 2

Text proposed by the Commission

Amendment

Member States shall ensure that the awareness card is made available in both in paper format and electronically. In the absence of such specific rules in a Member State, an awareness card in paper format shall be included in the packaging of an antimicrobial.

Or. en

Amendment 969

Margrete Auken

Proposal for a directive

Article 69 – paragraph 3

Text proposed by the Commission

Amendment

3. The text of the awareness card shall be aligned with Annex VI.

3. The text of the awareness card shall reflect the results of consultations with target patient groups and professionals to ensure that it is legible, clear and easy to use and shall be aligned with Annex VI.

Or. en

Amendment 970

Nicolás González Casares, Tiemo Wölken

Proposal for a directive

Article 69 – paragraph 3

Text proposed by the Commission

Amendment

3. The text of the awareness card shall be aligned with Annex VI.

3. The text of the awareness card shall be standarded by the Agency and shall be aligned with Annex VI.

Or. en

Amendment 971

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

Proposal for a directive

Article 69 – paragraph 3 – subparagraph 1 (new)

Text proposed by the Commission

Amendment

Members States shall introduce appropriate disposal systems for antimicrobials in the community setting, and inform the general public on the correct disposal methods for antimicrobial.

Or. en

Amendment 972

István Ujhelyi

Proposal for a directive

Article 69 – paragraph 3 a (new)

Text proposed by the Commission

Amendment

3 a. The marketing authorisation holder may include in the packaging of a fixed-dose combination medicinal product a document that is made available to the patient in digital form or when applicable in paper form in addition to the product leaflet (“awareness card”) with information on the importance of compliance with treatment plans and the support available in their Member State with therapeutic adherence.Member States may decide that the awareness card shall be made available in paper format or electronically, or both.In the absence of such specific rules in a Member State, an awareness card in paper format shall be included in the packaging of a fixed-dose combination medicinal product.

The text of the awareness card shall be aligned with Annex VI.

Or. en

Amendment 973

Nathalie Colin-Oesterlé

Proposal for a directive

Article 69 a (new)

Text proposed by the Commission

Amendment

Article 69a

Raising awareness of treatment compliance

The marketing authorisation holder may include in the packaging of a fixed-dose combination medicinal product an additional document to the package leaflet made available to the patient in digital or paper format. This awareness-raising card shall contain information on the importance of respecting treatment plans and on the help available in their Member State with regard to treatment compliance. The Member States may decide whether the awareness-raising card should be made available in paper format or electronically, or both.

Or. fr

Amendment 974

Susana Solís Pérez

Proposal for a directive

Article 69 a (new)

Text proposed by the Commission

Amendment

Article69a

The marketing authorization holder may add to the fixed-dose combination medicinal product's packaging an "awareness card" in digital or paper form. This card shall inform patients about the importance therapeutic adherence and available support for adherence in their Member State. Unless a Member State specifies otherwise, the card shall be included in paper format. The content of the awareness card should comply with Annex VI.

Or. en

Amendment 975

Margrete Auken

Proposal for a directive

Article 71 – paragraph 1

Text proposed by the Commission

Amendment

The name of the medicinal product shall also be expressed in Braille format on the packaging. The marketing authorisation holder shall ensure that the package leaflet referred to in Article 63 is made available upon request from patients' organisations in formats appropriate for persons with disabilities, including blind and partially-sighted persons.

The name of the medicinal product shall also be expressed in Braille format on the outer and immediate packaging. The marketing authorisation holder shall ensure that the package leaflet referred to in Article 63 is made available in formats appropriate for persons with disabilities, including blind and partially-sighted persons.

Or. en

Amendment 976

Margrete Auken

Proposal for a directive

Article 73 – paragraph 1

Text proposed by the Commission

Amendment

The outer packaging and the package leaflet may include symbols or pictograms designed to clarify certain information set out in Articles 64(1) and 65 and other information compatible with the summary of product characteristics that is useful for the patient, to the exclusion of any element of a promotional nature.

The outer packaging, the immediate packaging and the package leaflet may include symbols or pictograms designed to clarify certain information set out in Articles 64(1), 65 and 69 and other information compatible with the summary of product characteristics that is useful for the patient, to the exclusion of any element of a promotional nature.

Or. en

Amendment 977

Margrete Auken

Proposal for a directive

Article 74 – paragraph 1

Text proposed by the Commission

Amendment

1. The particulars for labelling listed in Articles 64 and 65, shall appear in an official language or official languages of the Member State where the medicinal product is placed on the market, as specified, for the purposes of this Directive, by that Member State.

1. The particulars for labelling listed in Articles 64 and 65, shall appear in official languages of the Member State where the medicinal product is placed on the market, as specified, for the purposes of this Directive, by that Member State.

Or. en

Amendment 978

Margrete Auken

Proposal for a directive

Article 74 – paragraph 3

Text proposed by the Commission

Amendment

3. The package leaflet must be clearly legible in an official language or official languages of the Member State where the medicinal product is placed on the market, as specified, for the purposes of this Directive, by that Member State.

3. The package leaflet must be clearly legible in official languages of the Member State where the medicinal product is placed on the market, as specified, for the purposes of this Directive, by that Member State.

Or. en

Amendment 979

Nicolás González Casares, Tiemo Wölken

Proposal for a directive

Article 74 – paragraph 4

Text proposed by the Commission

Amendment

4. The competent authorities of the Member State may also grant a full or partial exemption to the obligation that the labelling and the package leaflet must be in an official language or official languages of the Member State where the medicinal product is placed on the market, as specified, for the purposes of this Directive, by that Member State. For the purpose of multi-language packages, Member States may allow the use on the labelling and package leaflet of an official language of the Union that is commonly understood in the Member States where the multi-language package is marketed.

4. Based on any of the grounds listed in Article 75, the competent authorities of the Member State may also grant a full or partial exemption to the obligation that the labelling and the package leaflet must be in an official language or official languages of the Member State where a medicinal product is placed on the market, as specified, for the purposes of this Directive, by that Member State. When a competent authority grants an exemption to the language requirements that apply to the paper package leaflet, the patients’ right to a printed copy of the document in the official language or official languages of the Member State shall be guaranteed upon request and free of charge.

For the purpose of multi-language packages, Member States may allow the use on the labelling and package leaflet of an official language of the Union that is commonly understood in the Member States where the multi-language package is marketed.

Or. en

Amendment 980

Margrete Auken

Proposal for a directive

Article 74 – paragraph 4

Text proposed by the Commission

Amendment

4. In cases referred to in Article 75, the competent authorities of the Member State may also grant a full or partial exemption to the obligation that the labelling and the package leaflet must be in an official languages of the Member State where the medicinal product is placed on the market, as specified, for the purposes of this Directive, by that Member State. In case of such exemption, Member States shall guarantee that patients can request a printed copy of the label and leaflet in their language free of charge from their physician or pharmacist. For the purpose of multi-language packages, Member States may allow the use on the labelling and package leaflet of an official language of the Union that is commonly understood in the Member States where the multi-language package is marketed.

Or. en

Amendment 981

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

Proposal for a directive

Article 74 – paragraph 4 – subparagraph 1 (new)

Text proposed by the Commission

Amendment

The offical language obligation as mentioned in paragraph 1 shall not apply when the medicinal product is not intended to be delivered to the patient for self-administration. In this case a single appropriate language may be used.

Or. en

Amendment 982

Nathalie Colin-Oesterlé

Proposal for a directive

Article 74 – paragraph 4 a (new)

Text proposed by the Commission

Amendment

4a. In the event of shortages, the competent authorities of the Member States may wholly or partially waive the obligation to draw up the labelling and package leaflet in the official language of the Member State in which the product is marketed if they consider that there is another official EU language that is widely understood in that territory. In such cases, they shall inform the Agency, justify their decision and indicate the period during which this regulatory flexibility is to apply.

Or. fr

Amendment 983

Cristian-Silviu Buşoi

Proposal for a directive

Article 74 – paragraph 4 a (new)

Text proposed by the Commission

Amendment

4 a. By derogation, when dully justified (eg. health emergencies), the official language obligation as mentioned in Article 74, paragraph 1 shall not apply when the product is not intended to be delivered to the patient for self-administration.

Or. en

Amendment 984

Dolors Montserrat, Nathalie Colin-Oesterlé

Proposal for a directive

Article 74 – paragraph 4 a (new)

Text proposed by the Commission

Amendment

4 a. The official language obligation as mentioned in Article 74, paragraph 1 shall not apply when the product is not intended to be delivered to the patient for self-administration. In this case a single appropriate language maybe be used.

Or. en

Amendment 985

Marian-Jean Marinescu

Proposal for a directive

Article 74 – paragraph 4 a (new)

Text proposed by the Commission

Amendment

Or. en

Justification

Removal of the requirement for a single language for products not intended to be delivered to the patient for self-administration, in addition to electronic product information, would improve the availability of medicines and facilitate the reallocation of products across Member States

Amendment 986

Margrete Auken

Proposal for a directive

Article 75 – paragraph 1 – introductory part

Text proposed by the Commission

Amendment

The competent authorities of the Member States may, subject to measures they consider necessary to safeguard public health, grant an exemption to the obligation that the particulars required in Articles 64 and 65 should appear on the labelling and in the package leaflet in the following cases:

The competent authorities of the Member States may, subject to measures they consider necessary to safeguard public health, grant an exemption to the obligation that the particulars required in Articles 64, 65 and 74 should appear on the labelling and in the package leaflet in the following cases:

Or. en

Amendment 987

Margrete Auken

Proposal for a directive

Article 75 – paragraph 1 – point c

Text proposed by the Commission

Amendment

(c) where there are space constraints due to the size of the packaging or of the package leaflet or in case of multilingual packages or package leaflets;

deleted

Or. en

Amendment 988

Margrete Auken

Proposal for a directive

Article 77 – paragraph 1 – point a a (new)

Text proposed by the Commission

Amendment

(a a) the wording on prudent use and safe disposal of antimicrobials;

Or. en

Amendment 989

Alessandra Moretti

Proposal for a directive

Article 80 – title

Text proposed by the Commission

Amendment

Regulatory data and market protection

Regulatory data, market protection and market exclusivity

Or. en

Amendment 990

Nicolás González Casares, Tiemo Wölken

Proposal for a directive

Article 80 – title

Text proposed by the Commission

Amendment

Regulatory data and market protection

Regulatory data, market protection and market exclusivity

Or. en

Amendment 991

Adam Jarubas, Ewa Kopacz, Elżbieta Katarzyna Łukacijewska

Proposal for a directive

Article 80 – paragraph 2

Text proposed by the Commission

Amendment

2. A medicinal product concerned by a subsequent marketing authorisation referred to in paragraph 1 shall not be placed on the market for a period of two years after the expiry of the relevant regulatory data protection periods referred to in Article 81.

2. A medicinal product concerned by a subsequent marketing authorisation referred to in paragraph 1 shall not be placed on the market for a market protection period of two years after the expiry of regulatory data protection period of the reference product (‘market protection period’).

Or. en

Amendment 992

Margrete Auken

Proposal for a directive

Article 80 – paragraph 2

Text proposed by the Commission

Amendment

2. A medicinal product concerned by a subsequent marketing authorisation referred to in paragraph 1 shall not be placed on the market for a period of two years after the expiry of the regulatory data protection periods referred to in Article 81.

Or. en

Amendment 993

Nicolás González Casares, Tiemo Wölken

Proposal for a directive

Article 80 – paragraph 2 a (new)

Text proposed by the Commission

Amendment

2 a. The period referred to in paragraph 2 shall be extended by an addittional period of one year, where the marketing authorization holder obtains, during the data protection period referred to in Article 81, an authorisation for an additional therapeutic indication for which the marketing authorisation holder has demonstrated, with supporting data, a significant clinical benefit in comparison with existing therapies. This extension may only be granted once.

Or. en

Amendment 994

Jessica Polfjärd

Proposal for a directive

Article 80 – paragraph 4

Text proposed by the Commission

Amendment

4. By way of derogation from the paragraphs 1 and 2, when a compulsory licence has been granted by a relevant authority in the Union to a party to address a public health emergency, the data and market protection shall be suspended with regard to that party insofar as the compulsory licence requires, and during the duration period of the compulsory licence.

deleted

Or. en

Justification

The criteria for a situation described as “emergency mode” or “crisis mode” that would activate the option for compulsory licensing are defined in such an ambiguous way as it currently is formulated, that the compulsory license could be subject to scenarios beyond public health emergency and threats. It is also not clear what the wording “suspension” would mean of data and market protection and its impacts on products marketed under a union compulsory license.

Amendment 995

Margarita de la Pisa Carrión

Proposal for a directive

Article 80 – paragraph 4

Text proposed by the Commission

Amendment

4. By way of derogation from the paragraphs 1 and 2, when a compulsory licence has been granted by the final decision of National Parliaments to a party to address a public health emergency, the data and market protection shall be suspended with regard to that party insofar as the compulsory license requires, for the indication relevant to the public health emergency, only for the duration period of the compulsory licence and, where relevant, only in the Member State(s) where the compulsorylicense is granted. The marketing authorization holder of the medicinal product for which the data and market protection are suspended shall be notified by the relevant competent authority before the date such suspension takes effect.

Or. en

Amendment 996

Nicola Procaccini

Proposal for a directive

Article 80 – paragraph 4

Text proposed by the Commission

Amendment

4. By way of derogation from the paragraphs 1 and 2, when a compulsory licence has been granted by the final decision of a relevant authority in the Union to a party to address a public health emergency, the data and market protection shall be suspended with regard to that party insofar as the compulsory licence requires, for the indication relevant to the public health emergency, only for the duration period of the compulsory licence and, where relevant, only in the Member State(s) where the compulsory licence is granted. The marketing authorisation holder of the medicinal product for which the data and market protection are suspended shall be notified by the relevant competent authority on or before the date on which such suspension takes effect.

Or. en

Amendment 997

Fulvio Martusciello

Proposal for a directive

Article 80 – paragraph 4

Text proposed by the Commission

Amendment

4. By way of derogation from the paragraphs 1 and 2, when a compulsory licence has been granted by the final decision of a relevant authority in the Union to a party to address a public health emergency, the data and market protection shall be suspended with regard to that party insofar as the compulsory licence requires, for the indication relevant to the public health emergency, only for the duration period of the compulsory licence and, where relevant, only in the Member State(s) where the compulsory license is granted. The marketing authorization holder of the medicinal product for which the data and market protection are suspended shall be notified by the relevant competent authority on or before the date such suspension takes effect.

Or. en

Amendment 998

Massimiliano Salini, Francesca Peppucci

Proposal for a directive

Article 80 – paragraph 4

Text proposed by the Commission

Amendment

4. By way of derogation from the paragraphs 1 and 2, when a compulsory licence has been granted by the ultimate decision of a relevant authority in the Union to a party to address a public health emergency, the data and market protection shall be suspended with regard to that party insofar as the compulsory license requires, for the indication pertaining to the public health emergency, solely during the compulsory license's period, and, if applicable, exclusively within the Member State where the compulsory license is authorized. The competent authority relevant to the suspension of data and market protection shall notify the marketing authorization holder of the medicinal product prior to the effective date of such suspension.

Or. en

Amendment 999

Nicolás González Casares, Tiemo Wölken

Proposal for a directive

Article 80 – paragraph 4

Text proposed by the Commission

Amendment

4. By way of derogation from the paragraphs 1 and 2, when a compulsory licence has been granted by a relevant authority in the Union to a party to safeguard public health, the data and market protection as well as the market exclusivity referred to in Article 71 of [revised Regulation (EC) No 726/2004], shall be suspended with regard to that party insofar as the compulsory licence requires, and during the duration period of the compulsory licence.

Relevant authorities in the Union shall also be able to reduce the duration of data protection, market protection, or market exclusivity for medicinal products that are not protected by a patent or a supplementary protection certificate, where necessary to safeguard public health.

Or. en

Amendment 1000

Alessandra Moretti

Proposal for a directive

Article 80 – paragraph 4

Text proposed by the Commission

Amendment

4. By way of derogation from the paragraphs 1 and 2, when a compulsory licence has been granted by a relevant authority in the Union to a party, the data and market protection, as well as the market exclusivity referred to in Article 71 of [revised Regulation (EC) No 726/2004], shall be suspended with regard to that party insofar as the compulsory licence requires, and during the duration period of the compulsory licence.

Or. en

Amendment 1001

Margrete Auken

Proposal for a directive

Article 80 – paragraph 4

Text proposed by the Commission

Amendment

4. By way of derogation from the paragraphs 1 and 2, when a compulsory licence has been granted by a relevant authority in the Union to a party, the data and market protection and market exclusivity shall be suspended with regard to that party insofar as the compulsory licence requires, and during the duration period of the compulsory licence.

Or. en

Justification

This is not the condition at the WTO, the CL legislative proposal shouldn't set the trend to add new general conditions on CL rules.

Amendment 1002

Margrete Auken

Proposal for a directive

Article 80 – paragraph 4 a (new)

Text proposed by the Commission

Amendment

4 a. National competent authorities may reduce the duration of data and market protection and market exclusivity for medicinal products that are not protected by a patent or a supplementary protection certificate, where necessary to safeguard public health.

Or. en

Justification

sometimes patents are already expired, but still other exclusivities are in place

Amendment 1003

Heléne Fritzon

Proposal for a directive

Article 80 – paragraph 5 – subparagraph 1 (new)

Text proposed by the Commission

Amendment

The relevant marketing authorisation holder for a medicinal product which has been granted data protection for a medicinal product shall be treated in the same way as an undertaking in a dominant position in the authorised areas of indication for that product for the entire data protection period. That requires a sound code of conduct in the European pharmaceutical market, in accordance with Article 102 of the Treaty on the Functioning of the European Union, as well as possible sanctions for infringements.

Or. sv

Justification

It should be noted that data and market protection that can be granted to a firm under Article 80 also implies restriction of competition in the area of indication for the medicinal product concerned. The scope for the Commission and Member State competition authorities to actively monitor anti-competitive conduct and abuse of market power should therefore be clarified in the legislation.

Amendment 1004

Massimiliano Salini, Francesca Peppucci

Proposal for a directive

Article 81 – paragraph 1

Text proposed by the Commission

Amendment

1. The regulatory data protection period shall be six years from the date when the marketing authorisation for that medicinal product was granted in accordance with Article 6(2). For marketing authorisations that belong to the same global marketing authorisation the period of data protection shall start from the date when the initial marketing authorisation was granted in the Union.

1. The regulatory data protection period shall be ten years from the date when the marketing authorisation for that medicinal product was granted in accordance with Article 6(2). For marketing authorisations that belong to the same global marketing authorisation the period of data protection shall start from the date when the initial marketing authorisation was granted in the Union.

Or. en

Amendment 1005

Margarita de la Pisa Carrión

Proposal for a directive

Article 81 – paragraph 1

Text proposed by the Commission

Amendment

1. The regulatory data protection period shall be eight years from the date when the marketing authorisation for that medicinal product was granted in accordance with Article 6(2). For marketing authorisations that belong to the same global marketing authorisation the period of data protection shall start from the date when the initial marketing authorisation was granted in the Union.

Or. en

Justification

A strong intellectual property framework is a pivotal element of a competitive innovation ecosystem. The proposals to reduce RDP from 8 to 6 years (together with uncertain and complex exclusivity modulations) will undermine investments in the development of transformational therapies and as a result adversely impact access/affordability objectives. RDP is an important ex ante consideration that underpins much R&D investment in Europe. It is the last to expire protection that is key for approximately one-third of innovative medicines. Weaker incentives may prevent a new product but also a new indication and/or formulation from being developed (or mean that it is developed outside Europe), thereby undermining the pipeline of off-patent medicines in the long term.

Amendment 1006

Annalisa Tardino, Maria Veronica Rossi, Rosanna Conte

Proposal for a directive

Article 81 – paragraph 1

Text proposed by the Commission

Amendment

1. The regulatory data protection period shall be nine years from the date when the marketing authorisation for that medicinal product was granted in accordance with Article 6(2). For marketing authorisations that belong to the same global marketing authorisation the period of data protection shall start from the date when the initial marketing authorisation was granted in the Union.

Or. it

Amendment 1007

Andreas Glück

Proposal for a directive

Article 81 – paragraph 1

Text proposed by the Commission

Amendment

Or. en

Justification

Tying incentive systems to market access is not the right approach and leads to uncertainty among producers. Supply of medical medicinal product in all Member States can also be achieved differently, for example by an obligation to submit an application for pricing and reimbursement in all Member States.

Amendment 1008

Margarita de la Pisa Carrión

Proposal for a directive

Article 81 – paragraph 1

Text proposed by the Commission

Amendment

Or. en

Amendment 1009

Erik Poulsen, Asger Christensen, Morten Løkkegaard

Proposal for a directive

Article 81 – paragraph 1

Text proposed by the Commission

Amendment

Or. en

Justification

While at the end of last century almost 50% of all innovative medicines was discovered in Europe. Today only 1 in 5 new treatments is researched and developed in Europe. To compete at global scale it is important that along with other measures that EU RDP protection is extended to at least 9 years to continue remain attractive for investments.

Amendment 1010

Jessica Polfjärd

Proposal for a directive

Article 81 – paragraph 1

Text proposed by the Commission

Amendment

Or. en

Justification

Regulatory Data Protection (RDP) is a central incentive to turn research findings into development of innovative therapies as well as to guarantee that those therapies enter the EU market and are available to patients in a timely manner. The proposed modulation of Regulatory Data Protection will hamper innovation and accessibility of this innovation to patients as well as risk making the EU less competitive at global level and less attractive to investments and increase the regulatory burden. Any deterioration in Regulatory Data Protection will disproportionately affect small and mid-sized companies often depending on external investments and may aggravating to conduct development due to decrease in resources. A deterioration of Regulatory Data Protection would eventually affect the will to invest that would lead to less treatment options available for patients and fewer therapies being developed in certain areas.

Amendment 1011

Christel Schaldemose

Proposal for a directive

Article 81 – paragraph 1

Text proposed by the Commission

Amendment

Or. en

Amendment 1012

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

Proposal for a directive

Article 81 – paragraph 1

Text proposed by the Commission

Amendment

Or. en

Amendment 1013

Ondřej Knotek

Proposal for a directive

Article 81 – paragraph 1

Text proposed by the Commission

Amendment

1. The regulatory data protection period shall be seven years from the date when the marketing authorisation for that medicinal product was granted in accordance with Article 6(2). For marketing authorisations that belong to the same global marketing authorisation the period of data protection shall start from the date when the initial marketing authorisation was granted in the Union.

Or. en

Amendment 1014

Adam Jarubas, Ewa Kopacz, Elżbieta Katarzyna Łukacijewska

Proposal for a directive

Article 81 – paragraph 1

Text proposed by the Commission

Amendment

Or. en

Amendment 1015

Nicolás González Casares, Tiemo Wölken

Proposal for a directive

Article 81 – paragraph 1

Text proposed by the Commission

Amendment

1. The regulatory data protection period shall be four years from the date when the marketing authorisation for that medicinal product was granted in accordance with Article 6(2). For marketing authorisations that belong to the same global marketing authorisation the period of data protection shall start from the date when the initial marketing authorisation was granted in the Union.

Or. en

Amendment 1016

Edina Tóth

Proposal for a directive

Article 81 – paragraph 2 – subparagraph 1 – introductory part

Text proposed by the Commission

Amendment

Subject to a scientific evaluation by the relevant competent authority, the data protection period referred to in paragraph 1 shall be prolonged by:

Subject to a scientific evaluation by the relevant competent authority, the data protection period referred to in paragraph 1 shall be prolonged by 24 months where

Or. en

Amendment 1017

Joanna Kopcińska

Proposal for a directive

Article 81 – paragraph 2 – subparagraph 1 – introductory part

Text proposed by the Commission

Amendment

Subject to a scientific evaluation by the relevant competent authority, the data protection period referred to in paragraph 1 shall be prolonged by:

Subject to a scientific evaluation by the relevant competent authority, the market protection period referred to in paragraph 1 shall be prolonged by:

Or. en

Amendment 1018

Annalisa Tardino, Maria Veronica Rossi, Rosanna Conte

Proposal for a directive

Article 81 – paragraph 2 – subparagraph 1 – point a

Text proposed by the Commission

Amendment

(a) 24 months, where the marketing authorisation holder demonstrates that the conditions referred to in Article 82(1) are fulfilled within two years, from the date when the marketing authorisation was granted or, within three years from that date for any of the following entities:

deleted

(i) SMEs within the meaning of Commission Recommendation 2003/361/EC;

(ii) entities not engaged in an economic activity (‘not-for-profit entity’); and

(iii) undertakings that, by the time of granting of a marketing authorisation, have received not more than five centralised marketing authorisations for the undertaking concerned or, in the case of an undertaking belonging to a group, for the group of which it is part, since the establishment of the undertaking or the group, whichever is earliest.

Or. it

Amendment 1019

Christel Schaldemose

Proposal for a directive

Article 81 – paragraph 2 – subparagraph 1 – point a

Text proposed by the Commission

Amendment

deleted

(i) SMEs within the meaning of Commission Recommendation 2003/361/EC;

(ii) entities not engaged in an economic activity (‘not-for-profit entity’); and

Or. en

Amendment 1020

Andreas Glück, Erik Poulsen, Asger Christensen, Morten Løkkegaard

Proposal for a directive

Article 81 – paragraph 2 – subparagraph 1 – point a

Text proposed by the Commission

Amendment

deleted

(i) SMEs within the meaning of Commission Recommendation 2003/361/EC;

(ii) entities not engaged in an economic activity (‘not-for-profit entity’); and

Or. en

Justification

Amendment 1021

Margrete Auken

Proposal for a directive

Article 81 – paragraph 2 – subparagraph 1 – point a

Text proposed by the Commission

Amendment

deleted

(i) SMEs within the meaning of Commission Recommendation 2003/361/EC;

(ii) entities not engaged in an economic activity (‘not-for-profit entity’); and

Or. en

Justification

6 years of regulatory data protection are guaranteed in trade agreements, therefore, we would be keen on aligning the base with that and keep 6 in paragraph 1

As for prolongation, we believe the upon request obligation to launch is a more appropriate way, please see our AMs to Article 58a

Amendment 1022

Adam Jarubas, Ewa Kopacz, Elżbieta Katarzyna Łukacijewska

Proposal for a directive

Article 81 – paragraph 2 – subparagraph 1 – point a

Text proposed by the Commission

Amendment

deleted

(i) SMEs within the meaning of Commission Recommendation 2003/361/EC;

(ii) entities not engaged in an economic activity (‘not-for-profit entity’); and

Or. en

Amendment 1023

Massimiliano Salini, Francesca Peppucci

Proposal for a directive

Article 81 – paragraph 2 – subparagraph 1 – point a

Text proposed by the Commission

Amendment

deleted

(i) SMEs within the meaning of Commission Recommendation 2003/361/EC;

(ii) entities not engaged in an economic activity (‘not-for-profit entity’); and

Or. en

Amendment 1024

Maria Angela Danzì

Proposal for a directive

Article 81 – paragraph 2 – subparagraph 1 – point a

Text proposed by the Commission

Amendment

deleted

(i) SMEs within the meaning of Commission Recommendation 2003/361/EC;

(ii) entities not engaged in an economic activity (‘not-for-profit entity’); and

Or. en

Amendment 1025

Margarita de la Pisa Carrión

Proposal for a directive

Article 81 – paragraph 2 – subparagraph 1 – point a

Text proposed by the Commission

Amendment

deleted

(i) SMEs within the meaning of Commission Recommendation 2003/361/EC;

(ii) entities not engaged in an economic activity (‘not-for-profit entity’); and

Or. en

Amendment 1026

Edina Tóth

Proposal for a directive

Article 81 – paragraph 2 – subparagraph 1 – point a – introductory part

Text proposed by the Commission

Amendment

(a) the marketing authorisation is granted in relation to a disease in respect of which there is no medicinal product authorised in the Union, or

Or. en

Amendment 1027

Erik Poulsen, Asger Christensen, Morten Løkkegaard

Proposal for a directive

Article 81 – paragraph 2 – subparagraph 1 – point a – introductory part

Text proposed by the Commission

Amendment

(a) 12 months, where the marketing authorisation holder demonstrates that the conditions referred to in Article 82(1) are fulfilled within two years, from the date a Member State request as referred to in Article 82(1) or, within four years from that date for any of the following entities:

Or. en

Amendment 1028

István Ujhelyi

Proposal for a directive

Article 81 – paragraph 2 – subparagraph 1 – point a – introductory part

Text proposed by the Commission

Amendment

(a) 24 months, where the marketing authorisation holder demonstrates that the conditions referred to in Article 82(1) are fulfilled within three years, from the date when the marketing authorisation was granted or, within four years from that date for any of the following entities:

Or. en

Amendment 1029

Catherine Amalric, Max Orville, Billy Kelleher

Proposal for a directive

Article 81 – paragraph 2 – subparagraph 1 – point a – introductory part

Text proposed by the Commission

Amendment

(a) 12 months, where the marketing authorisation holder demonstrates that the conditions referred to in Article 82(1) are fulfilled within two years, from the date when the marketing authorisation was granted or, within three years from that date for any of the following entities:

Or. en

Amendment 1030

Marian-Jean Marinescu

Proposal for a directive

Article 81 – paragraph 2 – subparagraph 1 – point a – introductory part

Text proposed by the Commission

Amendment

Or. en

Justification

Foreseeing 12 months instead of 24 in case of launch in all EU ensures that the current maximum length of protection (11 years) is not exceeded, in line with the stated objective of the legislation to ensure timely access not only to innovative products but also to generic and biosimilar products.

Amendment 1031

Joanna Kopcińska

Proposal for a directive

Article 81 – paragraph 2 – subparagraph 1 – point a – introductory part

Text proposed by the Commission

Amendment

Or. en

Amendment 1032

Jessica Polfjärd

Proposal for a directive

Article 81 – paragraph 2 – subparagraph 1 – point a – introductory part

Text proposed by the Commission

Amendment

(a) 24 months, where the marketing authorisation holder demonstrates that the conditions referred to in Article 82(1) are fulfilled within four years, from the date when the marketing authorisation was granted or, within five years from that date for any of the following entities:

Or. en

Justification

Amendment 1033

Annalisa Tardino, Maria Veronica Rossi, Rosanna Conte

Proposal for a directive

Article 81 – paragraph 2 – subparagraph 1 – point a – point i

Text proposed by the Commission

Amendment

(i) SMEs within the meaning of Commission Recommendation 2003/361/EC;

deleted

Or. it

Amendment 1034

Adam Jarubas, Ewa Kopacz, Elżbieta Katarzyna Łukacijewska

Proposal for a directive

Article 81 – paragraph 2 – subparagraph 1 – point a – point i

Text proposed by the Commission

Amendment

(i) SMEs within the meaning of Commission Recommendation 2003/361/EC;

deleted

Or. en

Amendment 1035

Edina Tóth

Proposal for a directive

Article 81 – paragraph 2 – subparagraph 1 – point a – point i

Text proposed by the Commission

Amendment

(i) SMEs within the meaning of Commission Recommendation 2003/361/EC;

deleted

Or. en

Amendment 1036

Annalisa Tardino, Maria Veronica Rossi, Rosanna Conte

Proposal for a directive

Article 81 – paragraph 2 – subparagraph 1 – point a – point ii

Text proposed by the Commission

Amendment

(ii) entities not engaged in an economic activity (‘not-for-profit entity’); and

deleted

Or. it

Amendment 1037

Edina Tóth

Proposal for a directive

Article 81 – paragraph 2 – subparagraph 1 – point a – point ii

Text proposed by the Commission

Amendment

(ii) entities not engaged in an economic activity (‘not-for-profit entity’); and

deleted

Or. en

Amendment 1038

Adam Jarubas, Ewa Kopacz, Elżbieta Katarzyna Łukacijewska

Proposal for a directive

Article 81 – paragraph 2 – subparagraph 1 – point a – point ii

Text proposed by the Commission

Amendment

(ii) entities not engaged in an economic activity (‘not-for-profit entity’); and

deleted

Or. en

Amendment 1039

Annalisa Tardino, Maria Veronica Rossi, Rosanna Conte

Proposal for a directive

Article 81 – paragraph 2 – subparagraph 1 – point a – point iii

Text proposed by the Commission

Amendment

deleted

Or. it

Amendment 1040

Adam Jarubas, Ewa Kopacz, Elżbieta Katarzyna Łukacijewska

Proposal for a directive

Article 81 – paragraph 2 – subparagraph 1 – point a – point iii

Text proposed by the Commission

Amendment

deleted

Or. en

Amendment 1041

Edina Tóth

Proposal for a directive

Article 81 – paragraph 2 – subparagraph 1 – point a – point iii

Text proposed by the Commission

Amendment

deleted

Or. en

Amendment 1042

Kateřina Konečná

Proposal for a directive

Article 81 – paragraph 2 – subparagraph 1 – point a – point iii

Text proposed by the Commission

Amendment

The holder of a conditional marketing authorisation shall respond to a Member State’s call for negotiation and conclusion of a risk-sharing or managed entry agreement when such institute is required for making placing the medicinal product on the Member State’s market.

Or. en

Amendment 1043

Jessica Polfjärd

Proposal for a directive

Article 81 – paragraph 2 – subparagraph 1 – point a – point iii

Text proposed by the Commission

Amendment

(iii) undertakings that, by the time of granting of a marketing authorisation, have received not more than ten centralised marketing authorisations for the undertaking concerned or, in the case of an undertaking belonging to a group, for the group of which it is part, since the establishment of the undertaking or the group, whichever is earliest.

Or. en

Justification

Amendment 1044

Nicolás González Casares, Tiemo Wölken

Proposal for a directive

Article 81 – paragraph 2 – subparagraph 1 – point a a (new)

Text proposed by the Commission

Amendment

(a a) 12 months, where the marketing authorisation holder demonstrates that the preclinical development of the medicinal product has been done within the Union as referred to in Article 82a;

Or. en

Amendment 1045

Heléne Fritzon

Proposal for a directive

Article 81 – paragraph 2 – subparagraph 1 – point b

Text proposed by the Commission

Amendment

(b) six months, where the marketing authorisation applicant demonstrates at the time of the initial marketing authorisation application that the medicinal product addresses an unmet medical need as referred to in Article 83;

deleted

Or. sv

Justification

The introduction of a tiered model creates uncertainty as to when protection periods actually expire and risks becoming a barrier to competition. The general rule should be that such anti-competitive safeguards should be used restrictively and in a more targeted fashion against medicines that address real treatment gaps, can demonstrate clinical added value for patients and contribute to scientific and technological progress (‘frog leaps’).

Amendment 1046

Edina Tóth

Proposal for a directive

Article 81 – paragraph 2 – subparagraph 1 – point b

Text proposed by the Commission

Amendment

deleted

Or. en

Amendment 1047

Joanna Kopcińska

Proposal for a directive

Article 81 – paragraph 2 – subparagraph 1 – point b

Text proposed by the Commission

Amendment

deleted

Or. en

Amendment 1048

Margarita de la Pisa Carrión

Proposal for a directive

Article 81 – paragraph 2 – subparagraph 1 – point b

Text proposed by the Commission

Amendment

(b) one year, where the marketing authorisation applicant demonstrates that the medicinal product addresses an unmet medical need as referred to in Article 83;

Or. en

Amendment 1049

Erik Poulsen, Catherine Amalric, Asger Christensen, Morten Løkkegaard

Proposal for a directive

Article 81 – paragraph 2 – subparagraph 1 – point b

Text proposed by the Commission

Amendment

(b) 12 months, where at the request of the marketing authorisation applicant the marketing authorisation applicant demonstrates that the medicinal product addresses an unmet medical need at least in one of its indications as referred to in Article 83;

Or. en

Amendment 1050

Massimiliano Salini, Francesca Peppucci

Proposal for a directive

Article 81 – paragraph 2 – subparagraph 1 – point b

Text proposed by the Commission

Amendment

(b) one year, where the marketing authorisation applicant demonstrates at the time of the initial marketing authorisation application or subsequent variation that the medicinal product addresses an unmet medical need as referred to in Article 83;

Or. en

Amendment 1051

Peter Liese

Proposal for a directive

Article 81 – paragraph 2 – subparagraph 1 – point b

Text proposed by the Commission

Amendment

(b) eighteen months, where the marketing authorisation applicant demonstrates at the time of the initial marketing authorisation application that the medicinal product addresses an unmet medical need as referred to in Article 83;

Or. en

Justification

The European Parliament has repeatedly called for the recognition and rewarding of pharmaceutical advancements addressing Unmet Medical Needs. We commend the initiative to extend the additional incentives for medicinal products that signify a genuine therapeutic breakthrough. By steering research and development towards these areas, we can ensure that our healthcare systems evolve to meet all patient needs, not just those that are commercially attractive.

Amendment 1052

Annalisa Tardino, Maria Veronica Rossi, Rosanna Conte

Proposal for a directive

Article 81 – paragraph 2 – subparagraph 1 – point b

Text proposed by the Commission

Amendment

(b) twelve months, where the marketing authorisation applicant demonstrates at the time of the initial marketing authorisation application that the medicinal product addresses an unmet medical need as referred to in Article 83;

Or. it

Amendment 1053

Adam Jarubas, Ewa Kopacz, Elżbieta Katarzyna Łukacijewska

Proposal for a directive

Article 81 – paragraph 2 – subparagraph 1 – point b

Text proposed by the Commission

Amendment

Or. en

Amendment 1054

Jessica Polfjärd

Proposal for a directive

Article 81 – paragraph 2 – subparagraph 1 – point b

Text proposed by the Commission

Amendment

(b) 24 months, where the marketing authorisation applicant demonstrates at the time of the initial marketing authorisation application that the medicinal product addresses an unmet medical need as referred to in Article 83;

Or. en

Justification

Amendment 1055

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

Proposal for a directive

Article 81 – paragraph 2 – subparagraph 1 – point b

Text proposed by the Commission

Amendment

(b) 12 months, where the marketing authorisation applicant demonstrates at the time of the initial marketing authorisation application that the medicinal product addresses an unmet medical need as referred to in Article 83;

Or. en

Amendment 1056

Heléne Fritzon

Proposal for a directive

Article 81 – paragraph 2 – subparagraph 1 – point c

Text proposed by the Commission

Amendment

deleted

Or. sv

Justification

Amendment 1057

Joanna Kopcińska

Proposal for a directive

Article 81 – paragraph 2 – subparagraph 1 – point c

Text proposed by the Commission

Amendment

deleted

Or. en

Amendment 1058

Adam Jarubas, Ewa Kopacz, Elżbieta Katarzyna Łukacijewska

Proposal for a directive

Article 81 – paragraph 2 – subparagraph 1 – point c

Text proposed by the Commission

Amendment

deleted

Or. en

Amendment 1059

Margrete Auken

Proposal for a directive

Article 81 – paragraph 2 – subparagraph 1 – point c

Text proposed by the Commission

Amendment

deleted

Or. en

Amendment 1060

Edina Tóth

Proposal for a directive

Article 81 – paragraph 2 – subparagraph 1 – point c

Text proposed by the Commission

Amendment

deleted

Or. en

Amendment 1061

Margarita de la Pisa Carrión

Proposal for a directive

Article 81 – paragraph 2 – subparagraph 1 – point c

Text proposed by the Commission

Amendment

(c) A period of twelve months, during which the applicant for marketing authorization shows, either at the point of the first application for marketing authorization or upon modification, that the pharmaceutical product fulfills a previously unaddressed healthcare necessity in at least one of its uses, as mentioned in Article 83.

Or. en

Justification

This incentive should be expanded and awarded based on post- approval submissions of comparative clinical trial data, as it is often not possible to deliver such data at the time of the initial marketing authorisation application. Without this, there is a risk that initial filings may be delayed until comparative trial data are available. We note there are circumstances where treatments have no standard of care with which to compare (e.g. UMN developments), where comparative studies are unethical (e.g. non-responsive/treatment-resistant patients), or not feasible (e.g. some rare / paediatric diseases), so that incentive would in practice not be available.

Amendment 1062

Stelios Kympouropoulos

Proposal for a directive

Article 81 – paragraph 2 – subparagraph 1 – point c

Text proposed by the Commission

Amendment

(c) six months, for medicinal products containing a new active substance, where the clinical trials supporting the initial marketing authorisation application use a relevant and evidence-based comparator in accordance with scientific advice provided by the Agency or an undertaking to generate real world evidence, including patient-reported outcomes gathered during regular clinical practice, in accordance with internationally recognised standards.

Or. en

Amendment 1063

Kateřina Konečná

Proposal for a directive

Article 81 – paragraph 2 – subparagraph 1 – point c

Text proposed by the Commission

Amendment

(c) six months, for medicinal products containing a new active substance, where the clinical trials supporting the initial marketing authorisation application use a relevant and evidence-based comparator in accordance with scientific advice provided by the Agency in consultation with health technology assessment authorities, set out in a delegated act in accordance with Article 215;

Or. en

Justification

The incentive for using comparative clinical trial data should encourage alignment with data requirements in health technology assessment (HTA) processes, helping national authorities to better assess the cost-effectiveness of new medicines and reduce access time in the patient journey. The evidence and data requirements are different between the marketing authorisation, the HTA bodies and the payers. The scientific evidence provided to obtain marketing authorisation is often considered insufficient by HTA agency assessors, which creates delays and inefficiencies.

Amendment 1064

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

Proposal for a directive

Article 81 – paragraph 2 – subparagraph 1 – point c

Text proposed by the Commission

Amendment

(c) 12 months, for medicinal products containing a new active substance, where the clinical trials supporting the initial marketing authorisation application use a relevant and evidence-based comparator in accordance with scientific advice provided by the Agency in consultation with health technology assessment authorities, set out in a delegated act in accord with article 215;

Or. en

Amendment 1065

Christel Schaldemose

Proposal for a directive

Article 81 – paragraph 2 – subparagraph 1 – point c

Text proposed by the Commission

Amendment

(c) Tvelve months, for medicinal products containing a new active substance, where the clinical trials supporting the initial marketing authorisation application use a relevant and evidence-based comparator in accordance with scientific advice provided by the Agency;

Or. en

Amendment 1066

Erik Poulsen, Catherine Amalric, Asger Christensen, Morten Løkkegaard

Proposal for a directive

Article 81 – paragraph 2 – subparagraph 1 – point c

Text proposed by the Commission

Amendment

Or. en

Amendment 1067

Heléne Fritzon

Proposal for a directive

Article 81 – paragraph 2 – subparagraph 1 – point d

Text proposed by the Commission

Amendment

(d) 12 months, where the marketing authorisation holder obtains, during the data protection period, an authorisation for an additional therapeutic indication for which the marketing authorisation holder has demonstrated, with supporting data, a significant clinical benefit in comparison with existing therapies.

deleted

Or. sv

Justification

Amendment 1068

Adam Jarubas, Ewa Kopacz, Elżbieta Katarzyna Łukacijewska

Proposal for a directive

Article 81 – paragraph 2 – subparagraph 1 – point d

Text proposed by the Commission

Amendment

deleted

Or. en

Amendment 1069

Nicolás González Casares, Tiemo Wölken

Proposal for a directive

Article 81 – paragraph 2 – subparagraph 1 – point d

Text proposed by the Commission

Amendment

deleted

Or. en

Amendment 1070

Joanna Kopcińska

Proposal for a directive

Article 81 – paragraph 2 – subparagraph 1 – point d

Text proposed by the Commission

Amendment

Or. en

Amendment 1071

Margrete Auken

Proposal for a directive

Article 81 – paragraph 2 – subparagraph 1 – point d

Text proposed by the Commission

Amendment

(d) six months, where the marketing authorisation holder obtains, during the data protection period, an authorisation for an additional therapeutic indication for which the marketing authorisation holder has demonstrated, with supporting data, a significant clinical benefit in comparison with existing therapies.

Or. en

Amendment 1072

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

Proposal for a directive

Article 81 – paragraph 2 – subparagraph 1 – point d a (new)

Text proposed by the Commission

Amendment

(d a) 12 months, where the marketing authorisation applicant has submitted a clinical trial application for a new medicinal product in all Member States, including decentralised clinical trials while safeguarding the rights and well-being of participants as well as the robustness and reliability of the data collected.

Or. en

Amendment 1073

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

Proposal for a directive

Article 81 – paragraph 2 – subparagraph 1 – point d b (new)

Text proposed by the Commission

Amendment

(d b) 12 months, for new medicinal products developed, produced, used and diposed in full respect of the scientific guidelines of the environmental risk assessment of medicinal products for human use.

Or. en

Amendment 1074

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

Proposal for a directive

Article 81 – paragraph 2 – subparagraph 1 – point d c (new)

Text proposed by the Commission

Amendment

(d c) 12 months, where the marketing authorisation applicant has committed to support the establishment of public-private partnerships, University Hospital Institutes, centres of excellence and bioclusters to accelerate research and development of a new medicinal product.

Or. en

Amendment 1075

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

Proposal for a directive

Article 81 – paragraph 2 – subparagraph 1 – point d d (new)

Text proposed by the Commission

Amendment

(d d) 12 months, for medicinal products containing critical active pharmaceutical ingredients produced in Europe.

Or. en

Amendment 1076

Massimiliano Salini, Francesca Peppucci

Proposal for a directive

Article 81 – paragraph 2 – subparagraph 2

Text proposed by the Commission

Amendment

In the case of a conditional marketing authorisation granted in accordance with Article 19 of [revised Regulation (EC) No 726/2004] the prolongation referred to in the first subparagraph, point (b), shall only apply if, within four years of the granting of the conditional marketing authorisation, the medicinal product has been granted a marketing authorisation in accordance with Article 19(7) of [revised Regulation (EC) No 726/2004.

In the case of a conditional marketing authorisation granted in accordance with Article 19 of [revised Regulation (EC) No 726/2004] the prolongation referred to in the first subparagraph, point (b), shall only apply if, throughout the period of regulatory data protection the medicinal product has been granted a marketing authorisation in accordance with Article 19(7) of [revised Regulation (EC) No 726/2004.

Or. en

Amendment 1077

Margrete Auken

Proposal for a directive

Article 81 – paragraph 2 – subparagraph 2

Text proposed by the Commission

Amendment

In the case of a conditional marketing authorisation granted in accordance with Article 19 of [revised Regulation (EC) No 726/2004] the prolongation referred to in the first subparagraph, point (b), shall only apply if, within three years of the granting of the conditional marketing authorisation, the medicinal product has been granted a marketing authorisation in accordance with Article 19(7) of [revised Regulation (EC) No 726/2004.

Or. en

Amendment 1078

Adam Jarubas, Ewa Kopacz, Elżbieta Katarzyna Łukacijewska

Proposal for a directive

Article 81 – paragraph 2 – subparagraph 3

Text proposed by the Commission

Amendment

The prolongation referred to in the first subparagraph, point (d), may only be granted once.

deleted

Or. en

Amendment 1079

Nicolás González Casares, Tiemo Wölken

Proposal for a directive

Article 81 – paragraph 2 – subparagraph 3

Text proposed by the Commission

Amendment

The prolongation referred to in the first subparagraph, point (d), may only be granted once.

deleted

Or. en

Amendment 1080

Erik Poulsen, Asger Christensen, Morten Løkkegaard

Proposal for a directive

Article 81 – paragraph 2 – subparagraph 3

Text proposed by the Commission

Amendment

The prolongation referred to in the first subparagraph, point (d), may only be granted once.

The prolongation referred to in the first subparagraph, point (c) may only be granted once. The prolongation referred to in the first subparagraph, point (d) may be granted twice. These prolongations may only be granted during the period of regulatory data protection referred to in paragraph 1.

Or. en

Amendment 1081

Massimiliano Salini, Francesca Peppucci

Proposal for a directive

Article 81 – paragraph 2 – subparagraph 3

Text proposed by the Commission

Amendment

The prolongation referred to in the first subparagraph, point (d), may only be granted once.

The prolongation referred to in the first subparagraph, point (b), (c) and (d), may each only be granted once and may exclusively be authorized within the regulatory data protection duration specified in paragraph 1.

Or. en

Amendment 1082

Christel Schaldemose

Proposal for a directive

Article 81 – paragraph 2 – subparagraph 3

Text proposed by the Commission

Amendment

The prolongation referred to in the first subparagraph, point (d), may only be granted once.

The prolongation referred to in the first subparagraph, point (d), may only be granted twice.

Or. en

Amendment 1083

Edina Tóth

Proposal for a directive

Article 81 – paragraph 2 a (new)

Text proposed by the Commission

Amendment

2 a. In case of the marketing authorisation is granted in relation to a disease in respect of which there has already been a medicinal product authorised in the Union, the initial marketing authorisation application shall use a relevant and evidence-based comparator in accordance with scientific advice provided by the Agency.

Or. en

Amendment 1084

Adam Jarubas, Ewa Kopacz, Elżbieta Katarzyna Łukacijewska

Proposal for a directive

Article 81 – paragraph 3

Text proposed by the Commission

Amendment

3. The Agency shall set the scientific guidelines referred to in paragraph 2, point (c), on criteria for proposing a comparator for a clinical trial, taking into account the results of the consultation of the Commission and the authorities or bodies involved in the mechanism of consultation referred to in Article 162 of [revised Regulation (EC) No 726/2004].

deleted

Or. en

Amendment 1085

Margrete Auken

Proposal for a directive

Article 81 – paragraph 3

Text proposed by the Commission

Amendment

deleted

Or. en

Amendment 1086

Stelios Kympouropoulos

Proposal for a directive

Article 81 – paragraph 3

Text proposed by the Commission

Amendment

3. The Agency shall set the scientific guidelines referred to in paragraph 2, point (c), on criteria for proposing a comparator for a clinical trial and/or for accepting real world evidence including in particular patient reported outcomes, taking into account the results of the consultation of the Commission and the authorities or bodies involved in the mechanism of consultation referred to in Article 162 of [revised Regulation (EC) No 726/2004].

Or. en

Amendment 1087

Jessica Polfjärd

Proposal for a directive

Article 81 – paragraph 3

Text proposed by the Commission

Amendment

3. The Agency shall set the scientific guidelines referred to in paragraph 2, point (c), on criteria for proposing a comparator for a clinical trial, taking into account the results of the consultation of the Commission, the authorities and bodies involved in the mechanism of consultation referred to in Article 162 of [revised Regulation (EC) No 726/2004].

Or. en

Amendment 1088

Margrete Auken

Proposal for a directive

Article 81 – paragraph 3 a (new)

Text proposed by the Commission

Amendment

3 a. All product-specific regulatory protection periods shall be made publicly available in the medicine repository on the website of the national competent authority and the Agency.

Or. en

Amendment 1089

Adam Jarubas, Ewa Kopacz, Elżbieta Katarzyna Łukacijewska

Proposal for a directive

Article 81 a (new)

Text proposed by the Commission

Amendment

Article81a

Market protection periods

1. Subject to a scientific evaluation by the relevant competent authority, the market protection period referred to in Article 80 paragraph 2 shall be prolonged by:

a. six months, for medicinal products containing a new active substance, where the clinical trials supporting the initial marketing authorisation application use a relevant and evidence-based comparator in accordance with scientific advice provided by the Agency;

b. 12 months, where the marketing authorisation holder obtains, during the data protection period, an authorisation for an additional therapeutic indication for which the marketing authorisation holder has demonstrated, with supporting data, a significant clinical benefit in comparison with existing therapies.

The prolongation referred to in the first subparagraph, point (b), may only be granted once.

2.The Agency shall set the scientific guidelines referred to in paragraph 1, point (a), on criteria for proposing a comparator for a clinical trial, taking into account the results of the consultation of the Commission and the authorities or bodies involved in the mechanism of consultation referred to in Article 162 of [revised Regulation (EC) No 726/2004].

Or. en

Amendment 1090

Annalisa Tardino, Maria Veronica Rossi, Rosanna Conte

Proposal for a directive

Article 82

Text proposed by the Commission

Amendment

[...]

deleted

Or. it

Amendment 1091

Andreas Glück, Erik Poulsen, Asger Christensen, Morten Løkkegaard

Proposal for a directive

Article 82

Text proposed by the Commission

Amendment

[...]

deleted

Or. en

Justification

Amendment 1092

Margrete Auken

Proposal for a directive

Article 82

Text proposed by the Commission

Amendment

[...]

deleted

Or. en

Justification

Please see Article 58a

Amendment 1093

Edina Tóth

Proposal for a directive

Article 82

Text proposed by the Commission

Amendment

[...]

deleted

Or. en

Justification

To change the Commission’s proposal we would propose the followings: if the RDP remains as today (with market protection 11years) it should be modulated in the following manner: 6 years for all innovative medicines +2 years if a) the medicine is the first in the given therapeutic indication OR b) in case there is already an authorised medicinal product in the therapeutic indication if the marketing authorisation holder presents comparative studies. +1 years following the current regime (new indication with significant clinical benefits). +2 years market protection (in this respect no further amendment is needed) This way the RDP would remain as today with conditions that support informed decision making related to public pharma expenditures (see. comparative studies) but that are also more predictable for all the stakeholders. (We note that according to the COM proposal +1 year RDP would come with the transferable exclusivity voucher, if it lands on an innovative medicine. But we see this element highly problematic). On the issue of making medicines available in all the MSs where there is need, we propose the followings: - During the marketing authorisation process, the applicant should present and availability plan that describes how the medicine will be available if it is needed in a Member State. Such a plan could describe, if necessary, measures tailored to specific Member States, in order to guarantee timely availability for patients in all Member States. - The availability would not be linked to pricing and reimbursement decisions as this is national competence. - The availability is not linked with regulatory data protection, but would be ensured via the marketing authorisation (see amendment proposed to the draft regulation)

Amendment 1094

Adam Jarubas, Ewa Kopacz, Elżbieta Katarzyna Łukacijewska

Proposal for a directive

Article 82

Text proposed by the Commission

Amendment

[...]

deleted

Or. en

Amendment 1095

Maria Angela Danzì

Proposal for a directive

Article 82

Text proposed by the Commission

Amendment

[...]

deleted

Or. en

Justification

The Union should leverage existing legislation, such as the Transparency Directive, the Cross-border healthcare Directive and the S2 Regulation, to make products available and improve access to innovative therapies across the EU. The launch conditionality should be removed from the proposal as it will not address the desired aims.

Amendment 1096

Margarita de la Pisa Carrión

Proposal for a directive

Article 82

Text proposed by the Commission

Amendment

[...]

deleted

Or. en

Amendment 1097

Christel Schaldemose

Proposal for a directive

Article 82

Text proposed by the Commission

Amendment

[...]

deleted

Or. en

Amendment 1098

Margarita de la Pisa Carrión

Proposal for a directive

Article 82 – title

Text proposed by the Commission

Amendment

Prolongation of the data protection period for medicinal products supplied in Member States

Guarantee the submission of Price and Reimbursement in the Member States

Or. en

Amendment 1099

Nicolás González Casares, Tiemo Wölken

Proposal for a directive

Article 82 – paragraph 1 – subparagraph 1

Text proposed by the Commission

Amendment

The prolongation referred to in the first subparagraph shall apply to medicinal products that have been granted a centralised marketing authorisation, as referred to in Article 5 or that have been granted a national marketing authorisation through the decentralised procedure, covering all the Member States entered into the decentralised procedure, as referred to in Chapter III, Section 3.

The prolongation of the data protection period in regards medicinal products which obtained marketing authorisation in accordance with Articles 5 and 6 of [revised Regulation (EC) No 726/2004] as referred to in Article 81(2), first subparagraph, point (a), shall apply to medicinal products if they are released and continuously supplied into the supply chain in a sufficient quantity and in the presentations necessary to cover the needs of the patients in the Member States concerned in which the marketing authorisation is valid.

Or. en

Amendment 1100

Ondřej Knotek, Billy Kelleher

Proposal for a directive

Article 82 – paragraph 1 – subparagraph 1

Text proposed by the Commission

Amendment

The prolongation of the data protection period referred to in Article 81(2), first subparagraph, point (a), shall only be granted to medicinal products if they are released and continuously supplied into the supply chain in a sufficient quantity and in the presentations necessary to cover the needs of the patients in the Member States in which the marketing authorisation is valid. Following the filing for pricing and reimbursement by the marketing authorisation holder, the timelines set Directive 89/105/EEC shall apply. Where a Member State has not complied with the timelines laid down in Directive 89/105/EEC, the obligation on the marketing authorisation holder set out in this Article shall be considered to be fulfilled in that Member State.

Or. en

Amendment 1101

Erik Poulsen, Asger Christensen, Morten Løkkegaard

Proposal for a directive

Article 82 – paragraph 1 – subparagraph 1

Text proposed by the Commission

Amendment

The prolongation of the data protection period referred to in Article 81(2), first subparagraph, point (a), shall only be granted to medicinal products if upon request by a Member State in which the marketing authorisation is valid, the marketing authorisation holder submits in good faith and within the limits of its responsibility an application for pricing and reimbursement. Member States shall make their request within two years of the granting of a marketing authorisation.

Or. en

Justification

Linking extra years of RDP period to releasing and continuously supplying a medicinal product is disproportionate because it is not alone within the control of marketing authorisation holders. The release and continuous supply of medical products also relies on Member States competent authorities.

Amendment 1102

Susana Solís Pérez

Proposal for a directive

Article 82 – paragraph 1 – subparagraph 1

Text proposed by the Commission

Amendment

The prolongation of the data protection period referred to in Article 81(2), first subparagraph, point (a), shall only be granted to medicinal products if they are made available to patients or prescribing doctors who requested the medicinal product, in the Member States in which the marketing authorisation is valid.

Or. en

Amendment 1103

Jessica Polfjärd

Proposal for a directive

Article 82 – paragraph 1 – subparagraph 1

Text proposed by the Commission

Amendment

The prolongation of the data protection period referred to in Article 81(2), first subparagraph, point (a), shall only be granted to medicinal products if they were being made available to patients or prescribing doctors who requested the medicinal product patients in the Member States in which the marketing authorisation is valid.

Or. en

Justification

The proposed conditionality for launching a medicinal product risks having a negative impact on access of medical products and therapies. To launch in all Member States within 2 – 3 years from marketing authorization cannot be seen as feasible, especially for small and mid-sized pharmaceutical companies struggling or being unable to do that due to their limited resources. Equally challenging is it with specific products where patient population or appropriate infrastructure and knowledge may not be present in all Member States.

Amendment 1104

Joanna Kopcińska

Proposal for a directive

Article 82 – paragraph 1 – subparagraph 1

Text proposed by the Commission

Amendment

The prolongation of the market protection period referred to in Article 81(2), first subparagraph, point (a), shall only be granted to medicinal products if they are released and continuously supplied into the supply chain in a sufficient quantity and in the presentations necessary to cover the needs of the patients in the Member States in which the marketing authorisation is valid.

Or. en

Amendment 1105

Marian-Jean Marinescu

Proposal for a directive

Article 82 – paragraph 1 – subparagraph 1

Text proposed by the Commission

Amendment

Or. en

Justification

The incentive`s objective is to launch the medicines in all markets of the EU Member States.

Amendment 1106

Erik Poulsen, Asger Christensen, Morten Løkkegaard

Proposal for a directive

Article 82 – paragraph 2 – subparagraph 2

Text proposed by the Commission

Amendment

The application for a variation shall be submitted between 34 and 36 months after the date when the initial marketing authorisation was granted, or for entities referred to in Article 81(2), first subparagraph, point (a), between 46 and 48 months, after that date.

The application for a variation shall be submitted within 12 months after the last filing for pricing of reimbursement has occurred, provided the filing process has occurred within the timelines set out in Article 81(2), first subparagraph.

Or. en

Amendment 1107

Jessica Polfjärd

Proposal for a directive

Article 82 – paragraph 2 – subparagraph 2

Text proposed by the Commission

Amendment

The application for a variation shall be submitted between 60 and 62 months after the date when the initial marketing authorisation was granted, or for entities referred to in Article 81(2), first subparagraph, point (a), between 72 and 74 months, after that date.

Or. en

Justification

Amendment 1108

Susana Solís Pérez, Catherine Amalric

Proposal for a directive

Article 82 – paragraph 2 – subparagraph 3 – introductory part

Text proposed by the Commission

Amendment

The application for a variation shall contain documentation from the Member States in which the marketing authorisation is valid. Such documentation shall:

The application for a variation shall contain documentation from the Member States competent authority in which the marketing authorisation is valid. Such documentation shall:

Or. en

Amendment 1109

Erik Poulsen, Asger Christensen, Morten Løkkegaard

Proposal for a directive

Article 82 – paragraph 2 – subparagraph 3 – point b

Text proposed by the Commission

Amendment

(b) waive the conditions set out in paragraph 1 in their territory for the purpose of the prolongation.

(b) confirm that the competent authority has waived the conditions set out in paragraph 1 in their territory for the purpose of the prolongation.

Or. en

Amendment 1110

Nicolás González Casares, Tiemo Wölken

Proposal for a directive

Article 82 – paragraph 2 – subparagraph 4

Text proposed by the Commission

Amendment

Positive decisions adopted in accordance with Articles 2 and 6 of Council Directive 89/105/EEC74 shall be considered equivalent to a confirmation referred to in the third subparagraph, point (a).

Where the conditions set out in paragraph 1 have not been fully satisified due to duly justified circumstances out of the control of the marketing authoristisation holder the Member State shall confirm the conditions in paragraph 1 have been satisified in their territory, subject to guarantee that these conditions will be fulfilled in an acceptable period of time agreed between the marketing authorisation holder and the Member State.

Positive decisions adopted in accordance with Articles 2 and 6 of Council Directive 89/105/EEC[1] shall be considered equivalent to a confirmation referred to in the third subparagraph, point (a), as long as the medicinal product is effectively continuously supplied on the market.

_________________

74 Council Directive 89/105/EEC of 21 December 1988 relating to the transparency of measures regulating the prices of medicinal products for human use and their inclusion in the scope of national health insurance systems (OJ L 40, 11.2.1989, p. 8).

Or. en

Amendment 1111

Marian-Jean Marinescu

Proposal for a directive

Article 82 – paragraph 2 – subparagraph 4

Text proposed by the Commission

Amendment

Positive decisions adopted in accordance with Articles 2 and 6 of Council Directive 89/105/EEC74 shall be considered equivalent to a confirmation referred to in the third subparagraph, point (a).

Positive decisions adopted in accordance with Articles 2 and 6 of Council Directive 89/105/EEC74 shall be considered equivalent to a confirmation referred to in the third subparagraph, point (a), as long as the medicinal product is effectively continuously supplied on the market.

_________________

Or. en

Justification

A proof of actual supply cannot be completely replaced by a reference to pricing and reimbursement decisions, since the granting of a pricing or of a reimbursement status does not guarantee actual supply. Hence the need to specify the need for effective continuous supply

Amendment 1112

Erik Poulsen, Asger Christensen, Morten Løkkegaard

Proposal for a directive

Article 82 – paragraph 3

Text proposed by the Commission

Amendment

3. To receive the documentation referred to in paragraph 2, third subparagraph, the marketing authorisation holder shall make a request to the relevant Member State. Within 60 days from the request of the marketing authorisation holder, the Member State shall issue a confirmation of compliance or, a reasoned statement of non-compliance or alternatively provide a statement of non-objection to prolong the period of regulatory data protection pursuant to this Article.

3. To receive the documentation referred to in paragraph 2, third subparagraph, the marketing authorisation holder shall make a request to the relevant Member State competent authority. Within 60 days from the request of the marketing authorisation holder, the competent authority shall issue a confirmation that the conditions set out in paragraph 1 have been fulfilled or, a reasoned statement as to why they have not been fulfilled with reference to objective and verifiable criteria or alternatively provide a statement of non-objection to prolong the period of regulatory data protection pursuant to this Article. Where a competent authority issues a reasoned statement of non-fulfilment, it shall set out the necessary steps that will allow the marketing authorisation holder to fulfil the conditions and to resubmit its request for confirmation of fulfilment within a further period of six months. Within 60 days from such request, the competent authority shall issue a confirmation of fulfilment or a reasoned statement of non-fulfilment.

Or. en

Amendment 1113

Susana Solís Pérez

Proposal for a directive

Article 82 – paragraph 3

Text proposed by the Commission

Amendment

3. To receive the documentation referred to in paragraph 2, third subparagraph, the marketing authorisation holder shall make a request to the relevant Member State competent authority. Within 60 days from the request of the marketing authorisation holder, the competent authority shall issue a confirmation of compliance or, a reasoned statement of non-compliance based on objective and verifiable criteria, or alternatively provide a statement of non-objection to prolong the period of regulatory data protection pursuant to this Article. When a competent authority issues a justified statement of non-fulfilment, it must detail the requisite actions that would allow the conditions to be met and enable the resubmission of a request for confirmation of fulfilment within a reasonable time frame. The competent authority shall subsequently provide a confirmation of fulfilment or a reasoned statement of non-fulfilment within two months from the date of the resubmission request.

Or. en

Amendment 1114

Joanna Kopcińska

Proposal for a directive

Article 82 – paragraph 3

Text proposed by the Commission

Amendment

Or. en

Amendment 1115

Susana Solís Pérez

Proposal for a directive

Article 82 – paragraph 3 a (new)

Text proposed by the Commission

Amendment

3 a. The Commission is tasked with creating a mediation mechanism via implementing acts. This mechanism will support dialogue between developers and Member States to address disputes arising from a declaration of non-compliance by a Member State after earnest negotiations, or due to negotiation delays. Within this framework, there will be an option for a Commission decision that can supersede the documents referred to in paragraph 2.

Or. en

Amendment 1116

Kateřina Konečná

Proposal for a directive

Article 82 – paragraph 4 – subparagraph 1

Text proposed by the Commission

Amendment

Where a Member State has not complied with the timelines laid down in Articles 2 and 6 of Directive 89/105/EEC, the conditions set out in paragraph 1 shall no longer apply in the territory of the Member States for the purposes of the prolongation.

Or. en

Amendment 1117

Susana Solís Pérez

Proposal for a directive

Article 82 – paragraph 4 – subparagraph 1

Text proposed by the Commission

Amendment

In cases where a Member State has not replied to the application of the marketing authorisation holder within the deadline referred to in paragraph 3, it shall be considered that a statement of non-objection has been provided. Should a Member State fail to adhere to the deadlines specified in Articles 2 and 6 of Directive 89/105/EEC, the conditions outlined in paragraph 1 will cease to be applicable within that Member State's jurisdiction with regard to the extension period.

Or. en

Amendment 1118

Erik Poulsen, Asger Christensen, Morten Løkkegaard

Proposal for a directive

Article 82 – paragraph 4 – subparagraph 1

Text proposed by the Commission

Amendment

In cases where a Member State has not replied to the application of the marketing authorisation holder within the deadline referred to in paragraph 3, it shall be considered that a statement of non-objection has been provided. Member States shall ensure that reasoned statements of non-fulfilment are subject to the right of appeal.

Or. en

Amendment 1119

Joanna Kopcińska

Proposal for a directive

Article 82 – paragraph 4 – subparagraph 2

Text proposed by the Commission

Amendment

For medicinal products granted a centralised marketing authorisation the Commission shall vary the marketing authorisation pursuant to Article 47 of [revised Regulation (EC) No 726/2004] to prolong the data protection period. For medicinal products granted a marketing authorisation in accordance with the decentralised procedure, the competent authorities of the Member States shall vary the marketing authorisation pursuant to Article 92 to prolong the data protection period.

Or. en

Amendment 1120

Nicolás González Casares, Tiemo Wölken

Proposal for a directive

Article 82 – paragraph 5 a (new)

Text proposed by the Commission

Amendment

5 a. The Commission shall check the application referred to in paragraph 2, subparagraph 2, and grant approval or rejection to the prolongation referred to in Article 81(2). In those cases in which one or more Member States have issued a reasoned statement for refusal of the prolongation, the Commission shall ensure that the reasons described are justified and substantiated. The Commission shall ensure that Marketing Authorisation Holders are not unduly prevented from receiving the incentives for actions beyond their control.

Or. en

Amendment 1121

Nicolás González Casares, Tiemo Wölken

Proposal for a directive

Article 82 – paragraph 5 a (new)

Text proposed by the Commission

Amendment

5 a. The Commission shall make publicly available any information related to the decision taken on the grant or refusal of the prolongation of the data exclusivity period.

Or. en

Amendment 1122

Nicolás González Casares, Tiemo Wölken

Proposal for a directive

Article 82 – paragraph 5 b (new)

Text proposed by the Commission

Amendment

5 b. Following the extension of the regulatory data protection as referred to in Article 81(2), the medicinal products should be released and continuously supplied into the supply chain in a sufficient quantity and in the presentations necessary to cover the needs of the patients in the Member States in which the marketing authorisation is valid, for the entire duration of the protection time.

Where the marketing authorisation holder fails to comply with this obligation, penalties should be established including the revocation of the extended regulatory protection period.

Or. en

Amendment 1123

Susana Solís Pérez

Proposal for a directive

Article 82 – paragraph 6

Text proposed by the Commission

Amendment

6. The Commission, based on the experience of Member States and relevant stakeholders, may adopt implementing measures relating to the procedural aspects outlined in this Article and regarding the conditions mentioned in paragraph 1. Those implementing acts shall be adopted in accordance with the procedure referred to in Article 214(2).

Or. en

Amendment 1124

Nicolás González Casares, Tiemo Wölken

Proposal for a directive

Article 82 – paragraph 6

Text proposed by the Commission

Amendment

6. The Commission, based on the experience of Member States and relevant stakeholders, may adopt delegated measures relating to the procedural aspects outlined in this Article and regarding the conditions mentioned in paragraph 1. Those delegated acts shall be adopted in accordance with the procedure referred to in Article 215.

Or. en

Amendment 1125

Susana Solís Pérez

Proposal for a directive

Article 82 – paragraph 6 a (new)

Text proposed by the Commission

Amendment

6 a. The Commission, via implementing acts, shall compile a list of products that, either due to their nature or other duly justified and accredited limiting factors or technical specificities, shall be exempt from the stipulations outlined in Article 81(2), point (a), and within this same Article 81, paragraphs 1 to 7. These specified products will be granted an automatic extension of the data protection period for 12 months, as detailed in Article 81(2), point (a). The adoption of these implementing acts shall proceed in line with the examination procedure described in Article 214(2) and (3).

Or. en

Amendment 1126

Marian-Jean Marinescu

Proposal for a directive

Article 82 – paragraph 6 a (new)

Text proposed by the Commission

Amendment

6 a. The Agency should publish on a dedicated webpage all the relevant steps of the procedure outlined in this Article, including: (a) a receipt of the submission of an application for a variation, as soon as the submission is received; (b) any subsequent decision taken on the grant or refusal of the conditional market protection; (c) the date of expiry of the relevant market exclusivity.

Or. en

Amendment 1127

Margarita de la Pisa Carrión

Proposal for a directive

Article 82 a (new)

Text proposed by the Commission

Amendment

Article 82a

Pricing and refund request

1. Within an agreed period following the granting of a marketing authorization, a Member State in which such authorization is valid may request the marketing authorization holder to submit an application for pricing and reimbursement.

2. Within that period following receipt of an application in accordance with paragraph 1, the marketing authorization holder shall submit an application for pricing and reimbursement in that Member State.

By way of derogation from paragraph 2, the following entities may submit an application for pricing and reimbursement within an extended period of time from the date of receipt of the application from the Member State:

(i) SMEs;

(ii) entities not engaged in an economic activity ("non-profit entity"); and

(iii) companies which, at the time the marketing authorization is granted, have not received more than seven centralized marketing authorizations for the company concerned or, in the case of a company belonging to a group, for the group of which it is a member, since the creation of the company or the group, whichever condition is met first.

3. The Commission shall, after consulting the Agency and relevant stakeholders, as patient’s representatives or MHAs, establish a list of products exempted from the conditions. Products shall be included in the list on the basis of relevant criteria, including cases where the administration of a medicinal product in the majority of Member States is impracticable, where the regulatory processes related to the application for pricing and reimbursement of a product are considered to be beyond the control of the marketing authorisation holder, or where for an orphan medicinal product or an advanced therapy medicinal product the product can be made available to patients without an application for pricing and reimbursement.

4. Time limits other than those set out in paragraphs 1 to 3 may apply if a Member State and a marketing authorization holder reach an agreement to that effect.

Or. en

Amendment 1128

Nicolás González Casares, Tiemo Wölken

Proposal for a directive

Article 82 a (new)

Text proposed by the Commission

Amendment

Article82a

Prolongation of the data protection period for medicinal products developed within the Union

1. A regulatory data protection period of one year shall be granted for a medicinal product if the marketing authorisation holder can demonstrate that its preclinical development was perfomed in the Union, even if another independent legal entity performed those studies, in initial stages of development, before the marketing authorisation holder acquired it.

2. One year after the date of entering into force of this Directive [OP please insert the date =12 months after the date of entering into force of this Directive], the Commission shall publish a study on the most adequate indicators to evaluate that the provision in paragraph 1 is met. When performing the study, the Commission shall prioritize those indicators that could bring better outcomes for the promotion of research and development within the Union, specially that performed in SMEs.

3. The Commission shall adopt delegated measures relating to the procedural aspects outlined in this Article and regarding the conditions mentioned in paragraph 1. Those delegated acts shall be adopted in accordance with the procedure referred to in Article 215. When setting up the conditions mentioned in paragraph 1, the Commission shall take into account the conclusions drawn from the study mentioned in paragraph 2.

Or. en

Amendment 1129

Margarita de la Pisa Carrión

Proposal for a directive

Article 82 b (new)

Text proposed by the Commission

Amendment

Article82b

EU Access to Medicinal Products Notification System

1. The Commission, in collaboration with the Member States shall establish an electronic notification system ("EU Access to Medicinal Products Notification System"). The EU Access to Medicinal Products Notification System shall be interoperable with other Union data registers on medicinal products.

2. The marketing authorisation holder shall use the EU Access to Medicinal Products Notification System to report its compliance with the commitment set out in in Article 82a.

3. The Commission and Members States and Medicament Agencies shall submit an evaluation report to the European European Parliament and the Council on the use and functioning of the EU Access to Medicinal Products Notification System within the EU.

Or. en

Amendment 1130

Rosanna Conte, Annalisa Tardino

Proposal for a directive

Article 83 – paragraph 1 – introductory part

Text proposed by the Commission

Amendment

1. A medicinal product shall be considered as addressing an unmet medical need if at least one of its therapeutic indications relates to a life threatening or severely debilitating disease and the following conditions are met:

1. In assessing unmet medical need, a holistic and ethical approach should always be followed, in consultation with all stakeholders, including patients, to take into account all factors with an impact onunmet medical need, for example, the burden and impact of existing therapies on patients and their carers, their impact on quality of life, their scope (for example, for subsets of adiseaseonly) and their suitability (for example, for subpopulations), along with ease and access to them.

A medicinal product shall be considered as addressing an unmet medical need if at least one of its therapeutic indications relates to a chronic, life threatening or severely debilitating disease and the following conditions are met:

Or. it

Amendment 1131

Margarita de la Pisa Carrión

Proposal for a directive

Article 83 – paragraph 1 – introductory part

Text proposed by the Commission

Amendment

1. A medicinal product shall be considered as addressing an unmet medical need if at least one of its therapeutic indications relates to a progressive, life threatening, severely debilitating or chronic disease and the following conditions are met:

Or. en

Amendment 1132

Cristian-Silviu Buşoi

Proposal for a directive

Article 83 – paragraph 1 – introductory part

Text proposed by the Commission

Amendment

Or. en

Amendment 1133

Fulvio Martusciello

Proposal for a directive

Article 83 – paragraph 1 – introductory part

Text proposed by the Commission

Amendment

1. A medicinal product shall be considered as addressing an unmet medical need if at least one of its therapeutic indications relates to a progressive, life threatening, severely debilitating or cronic disease and the following conditions are met:

Or. en

Amendment 1134

Dolors Montserrat, Nathalie Colin-Oesterlé, Tomislav Sokol

Proposal for a directive

Article 83 – paragraph 1 – introductory part

Text proposed by the Commission

Amendment

Or. en

Amendment 1135

Nicola Procaccini

Proposal for a directive

Article 83 – paragraph 1 – introductory part

Text proposed by the Commission

Amendment

Or. en

Amendment 1136

Massimiliano Salini, Francesca Peppucci

Proposal for a directive

Article 83 – paragraph 1 – introductory part

Text proposed by the Commission

Amendment

1. A medicinal product shall be considered as addressing an unmet medical need if at least one of its therapeutic indications relates to a progressive life threatening, severely debilitating or chronic disease and the following conditions are met:

Or. en

Amendment 1137

Maria Angela Danzì

Proposal for a directive

Article 83 – paragraph 1 – introductory part

Text proposed by the Commission

Amendment

Or. en

Justification

Unmet medical need exists when no disease-specific therapy is available and only supportive care is possible or when an established treatment does not significantly improve quality of life or provide significant or substantial additional benefit.

Amendment 1138

Susana Solís Pérez

Proposal for a directive

Article 83 – paragraph 1 – introductory part

Text proposed by the Commission

Amendment

1. A medicinal product shall be considered as addressing an unmet medical need if at least one of its therapeutic indications relates to a life threatening, chronic, or severely debilitating disease and the following conditions are met:

Or. en

Amendment 1139

Kateřina Konečná

Proposal for a directive

Article 83 – paragraph 1 – introductory part

Text proposed by the Commission

Amendment

Or. en

Amendment 1140

Erik Poulsen, Asger Christensen, Morten Løkkegaard

Proposal for a directive

Article 83 – paragraph 1 – introductory part

Text proposed by the Commission

Amendment

1. A medicinal product shall be considered as addressing an unmet medical need if at least one of its therapeutic indications relates to a life threatening, chronic or severely debilitating disease and the following conditions are met:

Or. en

Amendment 1141

Adam Jarubas, Ewa Kopacz, Elżbieta Katarzyna Łukacijewska

Proposal for a directive

Article 83 – paragraph 1 – introductory part

Text proposed by the Commission

Amendment

1. A medicinal product shall be considered as addressing an unmet medical need if at least one of its therapeutic indications relates to a life threatening, severely debilitating or chronic disease and the following conditions are met:

Or. en

Amendment 1142

Billy Kelleher, Ondřej Knotek

Proposal for a directive

Article 83 – paragraph 1 – introductory part

Text proposed by the Commission

Amendment

1. A medicinal product shall be considered as addressing an unmet medical need if at least one of its therapeutic indications relates to a chronic, life threatening or severely debilitating disease and the following conditions are met:

Or. en

Amendment 1143

Rosanna Conte, Annalisa Tardino

Proposal for a directive

Article 83 – paragraph 1 – point a

Text proposed by the Commission

Amendment

(a) there is no or a limited number of medicinal product authorised in the Union for such disease, or, where despite medicinal products being authorised for such disease in the Union, the disease is associated with a remaining high morbidity or mortality, with a considerable negative impact on patients' and their families' quality of life and mental health, with a high burden and with adverse reactions to existing treatment; or when the existing treating is only for subpopulations of a particular disease;

Or. it

Amendment 1144

Billy Kelleher

Proposal for a directive

Article 83 – paragraph 1 – point a

Text proposed by the Commission

Amendment

(a) there is no or a limited number of medicinal product(s) authorised in the Union for such disease, or, where despite medicinal products being authorised for such disease in the Union, the disease is associated with a remaining high morbidity or mortality, high negative impact on quality of life due to treatment burden and negative side effects; or when existing treatments only address subpopulations of a certain disease;

Or. en

Amendment 1145

Sunčana Glavak

Proposal for a directive

Article 83 – paragraph 1 – point a

Text proposed by the Commission

Amendment

(a) there is no medicinal product authorised in the Union for such disease, or, where despite medicinal products being authorised for such disease in the Union, the disease is associated with a remaining high morbidity or mortality, or significant negative impact on quality of life, or has significant negative implications on long-term development and maturation of paediatric patients;

Or. en

Amendment 1146

Susana Solís Pérez

Proposal for a directive

Article 83 – paragraph 1 – point a

Text proposed by the Commission

Amendment

(a) there is no medicinal product authorised in the Union for such disease, or, where despite medicinal products being authorised for such disease in the Union, the disease is associated with a remaining high morbidity or mortality; the product lessens the complexity or frequency of treatment or administration, or the profile of adverse reactions; the product enhances patients' quality of life;

Or. en

Amendment 1147

Andreas Glück, Catherine Amalric

Proposal for a directive

Article 83 – paragraph 1 – point a

Text proposed by the Commission

Amendment

(a) there is no medicinal product authorised in the Union for such disease, or, where despite medicinal products being authorised for such disease in the Union, a new form of administration leads to treatment of patients who previously had no access to the product or the disease is associated with a remaining high morbidity or mortality;

Or. en

Justification

In some cases the form of administration presents a hurdle for treatment . For example, the step from oral to intravenous administration . Therefore, the definition of unmet medical needs should include the development of a new form of administration.

Amendment 1148

Margrete Auken

Proposal for a directive

Article 83 – paragraph 1 – point a

Text proposed by the Commission

Amendment

(a) there is no medicinal product, medical device or SoHO preparation authorised in the Member States or the Union or other therapeutic option available for such disease, or, where despite products being authorised or therapeutic options available for such disease, the disease is associated with a remaining high morbidity or mortality; and

Or. en

Justification

While we carefully considered requests of many patient organisations calling for inclusion of quality of life aspects in the definition of UMN, given that it is very vaguely interpreted, we think it would be counterproductive to add here for the purpose of extension of regulatory protection and agree with the Commission’s approach. We acknowledge the importance of quality of life and included such data as obligatory for marketing authorisation, but for the purpose of adding further exclusivities we find it would serve as a loop hole and many products could be eligible for extra protection based on a vague interpretation of what meaningful QoL actually means

Amendment 1149

Cyrus Engerer

Proposal for a directive

Article 83 – paragraph 1 – point a

Text proposed by the Commission

Amendment

(a) there is no medicinal product authorised in the Union for such disease, or, where despite medicinal products being authorised for such disease in the Union, the disease is associated with a remaining high morbidity, mortality or high prevalence with a particular attention to treatment-resistant diseases;

Or. en

Amendment 1150

Heléne Fritzon

Proposal for a directive

Article 83 – paragraph 1 – point a

Text proposed by the Commission

Amendment

(a) there is no satisfactory method or other treatment for the relevant disease, or where, despite the existence of a method or established treatment options for the patient group concerned, the disease is associated with a remaining high morbidity or mortality;

Or. sv

Justification

The Commission's original proposal for a definition of unmet medical needs is too sweeping and is based only on whether or not other medicines are authorised in the EU. Equating the absence of European authorised medicines for a specific indication with unmet medical needs is therefore considered misleading as it does not necessarily mean that there are actual treatment gaps for patients. Instead, this amendment bases the definition on real treatment gaps in healthcare and steers the development of medicines towards real needs.

Amendment 1151

Erik Poulsen, Asger Christensen, Morten Løkkegaard

Proposal for a directive

Article 83 – paragraph 1 – point a

Text proposed by the Commission

Amendment

Or. en

Amendment 1152

Dolors Montserrat, Nathalie Colin-Oesterlé

Proposal for a directive

Article 83 – paragraph 1 – point a

Text proposed by the Commission

Amendment

Or. en

Amendment 1153

Cristian-Silviu Buşoi

Proposal for a directive

Article 83 – paragraph 1 – point a

Text proposed by the Commission

Amendment

Or. en

Amendment 1154

Adam Jarubas, Ewa Kopacz, Elżbieta Katarzyna Łukacijewska

Proposal for a directive

Article 83 – paragraph 1 – point a

Text proposed by the Commission

Amendment

Or. en

Amendment 1155

Margarita de la Pisa Carrión

Proposal for a directive

Article 83 – paragraph 1 – point a

Text proposed by the Commission

Amendment

Or. en

Amendment 1156

Massimiliano Salini, Francesca Peppucci

Proposal for a directive

Article 83 – paragraph 1 – point a

Text proposed by the Commission

Amendment

Or. en

Amendment 1157

Nicola Procaccini

Proposal for a directive

Article 83 – paragraph 1 – point a

Text proposed by the Commission

Amendment

Or. en

Amendment 1158

Fulvio Martusciello

Proposal for a directive

Article 83 – paragraph 1 – point a

Text proposed by the Commission

Amendment

Or. en

Amendment 1159

Kateřina Konečná

Proposal for a directive

Article 83 – paragraph 1 – point a

Text proposed by the Commission

Amendment

(a) there is no medicinal product authorised in the Union for such disease, or, where one or several medicinal products are authorised for such disease in the Union, the disease is associated with a remaining high burden;

Or. en

Amendment 1160

Margarita de la Pisa Carrión

Proposal for a directive

Article 83 – paragraph 1 – point b

Text proposed by the Commission

Amendment

(b) the use of the medicinal product results in a meaningful reduction in disease morbidity or mortality for the relevant patient population.

(b) the use of the medicinal product results in

(i) a meaningful reduction in disease morbidity, mortality, severity or side effects; or

(ii) a meaningful positive impact on quality of life;or

(iii) a meaningful prevention, delay of the onset, or delay of progression of the disease or its complications;or

(iv) improvements in dosing and facilities for the administration of the medication, including improvements in treatment compliance.

Or. en

Amendment 1161

Adam Jarubas, Ewa Kopacz, Elżbieta Katarzyna Łukacijewska

Proposal for a directive

Article 83 – paragraph 1 – point b

Text proposed by the Commission

Amendment

(b) the use of the medicinal product results in a meaningful reduction in disease morbidity or mortality for the relevant patient population.

(b) the use of the medicinal product results in at least one of the effects:

i. meaningful reduction in disease morbidity, mortality, severity or side effects for the relevant patient population;

ii. significant positive impact on quality of life;

iii. significant prevention, delay of the onset, or delay of progression of the disease or its complications.

Or. en

Amendment 1162

Dolors Montserrat, Nathalie Colin-Oesterlé

Proposal for a directive

Article 83 – paragraph 1 – point b

Text proposed by the Commission

Amendment

(b) the use of the medicinal product results in a meaningful reduction in disease morbidity or mortality for the relevant patient population.

(b) the use of the medicinal product results in:

(i) a meaningful reduction in disease morbidity, mortality, severity or side effects for the relevant patient population; or

(ii) a meaningful positive impact on quality of life;or

(iii) a meaningful prevention, delay of the onset, or delay of progression of the disease or its complications.

Or. en

Amendment 1163

Fulvio Martusciello

Proposal for a directive

Article 83 – paragraph 1 – point b

Text proposed by the Commission

Amendment

(b) the use of the medicinal product results in a meaningful reduction in disease morbidity or mortality for the relevant patient population.

(b) the use of the medicinal product results in

(i) a meaningful reduction in disease morbidity, mortality, severity or side effects for the relevant patient population; or

(ii) a meaningful positive impact on quality of life;or

(iii) a meaningful prevention, delay of the onset, or delay of progression of the disease or its complications.

Or. en

Amendment 1164

Nicola Procaccini

Proposal for a directive

Article 83 – paragraph 1 – point b

Text proposed by the Commission

Amendment

(b) the use of the medicinal product results in a meaningful reduction in disease morbidity or mortality for the relevant patient population.

(b) the use of the medicinal product results in:

(i) a meaningful reduction in disease morbidity, mortality, severity or side effects for the relevant patient population; or

(ii) a meaningful positive impact on quality of life;or

(iii) a meaningful prevention, delay of the onset, or delay of progression of the disease or its complications.

Or. en

Amendment 1165

Rosanna Conte, Annalisa Tardino

Proposal for a directive

Article 83 – paragraph 1 – point b

Text proposed by the Commission

Amendment

(b) the use of the medicinal product results in a meaningful reduction in disease morbidity or mortality for the relevant patient population.

(b) the use of the medicinal product results in a meaningful reduction in disease morbidity or mortality, in burden and access to existing treatments, and in the severity or long-term side effects for the relevant patient population and an improvement in the quality of life of patients and their families.

Or. it

Amendment 1166

Sunčana Glavak

Proposal for a directive

Article 83 – paragraph 1 – point b

Text proposed by the Commission

Amendment

(b) the use of the medicinal product results in a meaningful reduction in disease morbidity or mortality for the relevant patient population.

(b) the use of the medicinal product results in a meaningful reduction in disease morbidity or mortality for the relevant patient population, and minimizes the long-term side effect on growth and maturation in paediatric patients.

Or. en

Amendment 1167

Kateřina Konečná

Proposal for a directive

Article 83 – paragraph 1 – point b

Text proposed by the Commission

Amendment

(b) the use of the medicinal product results in a meaningful reduction in disease morbidity or mortality for the relevant patient population.

(b) the use of the medicinal product results in a meaningful reduction in disease morbidity, severity, mortality or provides a significant added therapeutic value for the relevant patient population or a specific subpopulation.

Or. en

Justification

The proposed definition of what constitutes an ‘unmet medical need’ should be significantly improved as it is solely based on considerations of mortality and morbidity excluding the burden of chronic diseases on patients and carers. To drive pharmaceutical innovation where it is most needed, ‘unmet medical need’ should take into account criteria that matter to patients, such as the severity of the disease, adherence, concordance, quality of life and economic burden of the disease at the macro level and individual level.

Amendment 1168

Maria Angela Danzì

Proposal for a directive

Article 83 – paragraph 1 – point b

Text proposed by the Commission

Amendment

(b) the use of the medicinal product results in a meaningful reduction in disease morbidity or mortality for the relevant patient population.

(b) the use of the medicinal product results in a meaningful reduction in disease morbidity or mortality or significant increase in quality of life as measured with validated tools for the relevant patient population.

Or. en

Justification

Amendment 1169

Erik Poulsen, Catherine Amalric, Asger Christensen, Morten Løkkegaard

Proposal for a directive

Article 83 – paragraph 1 – point b

Text proposed by the Commission

Amendment

(b) the use of the medicinal product results in a meaningful reduction in disease morbidity or mortality for the relevant patient population.

(b) the use of the medicinal product results in prevention of or a meaningful reduction in disease morbidity or mortality for the relevant patient population or a part of that population .

Or. en

Amendment 1170

Kateřina Konečná

Proposal for a directive

Article 83 – paragraph 1 – point b

Text proposed by the Commission

Amendment

(b) the use of the medicinal product results in a meaningful reduction in disease morbidity or mortality for the relevant patient population.

(b) the use of the medicinal product results in a meaningful reduction in disease morbidity or mortality for the relevant patient population, or a meaningful increase in quality of life.

Or. en

Amendment 1171

Alessandra Moretti

Proposal for a directive

Article 83 – paragraph 1 – point b

Text proposed by the Commission

Amendment

(b) the use of the medicinal product results in a meaningful reduction in disease morbidity or mortality for the relevant patient population.

(b) the use of the medicinal product results in a meaningful reduction in disease morbidity or mortality for the relevant patient population, or a meaningful increase in quality of life.

Or. en

Amendment 1172

Heléne Fritzon

Proposal for a directive

Article 83 – paragraph 1 – point b

Text proposed by the Commission

Amendment

(b) the use of the medicinal product results in a meaningful reduction in disease morbidity or mortality for the relevant patient population.

(b) the use of the medicinal product results in demonstrated clinical added value in the form of a meaningful reduction in disease morbidity or mortality for the relevant patient population.

Or. sv

Justification

The Commission's proposal is fine, but it is reasonable that the concept should include a clearer focus on a significant reduction in morbidity and/or mortality in the patient population concerned so that medicines that qualify as medicines for unmet medical needs have also been able to demonstrate value in terms of reducing morbidity and mortality.

Amendment 1173

Ondřej Knotek, Catherine Amalric, Billy Kelleher

Proposal for a directive

Article 83 – paragraph 1 – point b

Text proposed by the Commission

Amendment

(b) the use of the medicinal product results in a meaningful reduction in disease morbidity or mortality for the relevant patient population.

(b) the use of the medicinal product results in a meaningful reduction in disease morbidity, mortality, severity or long term side effects for the relevant patient population.

Or. en

Amendment 1174

Billy Kelleher

Proposal for a directive

Article 83 – paragraph 1 – point b

Text proposed by the Commission

Amendment

(b) the use of the medicinal product results in a meaningful reduction in disease morbidity or mortality for the relevant patient population.

(b) the use of the medicinal product results in a meaningful reduction in disease morbidity, mortality, severity or long term side effects for the relevant patient population.

Or. en

Amendment 1175

István Ujhelyi

Proposal for a directive

Article 83 – paragraph 1 – point b

Text proposed by the Commission

Amendment

(b) the use of the medicinal product results in a meaningful reduction in disease morbidity or mortality for the relevant patient population.

(b) the use of the medicinal product results in a meaningful reduction in disease morbidity, acute or long-term toxicity or mortality for the relevant patient population.

Or. en

Amendment 1176

Susana Solís Pérez, Catherine Amalric

Proposal for a directive

Article 83 – paragraph 1 – point b

Text proposed by the Commission

Amendment

(b) the use of the medicinal product results in a meaningful reduction in disease morbidity or mortality for the relevant patient population.

(b) the use of the medicinal product results in a meaningful reduction in disease morbidity or mortality for the relevant patient population or specific subpopulation.

Or. en

Amendment 1177

Marian-Jean Marinescu

Proposal for a directive

Article 83 – paragraph 1 – point b

Text proposed by the Commission

Amendment

(b) the use of the medicinal product results in a meaningful reduction in disease morbidity or mortality for the relevant patient population.

(b) the use of the medicinal product results in a meaningful reduction in disease morbidity, acute or long-term toxicity or mortality for the relevant patient population.

Or. en

Justification

A medicinal product should also be considered as addressing a UMN or high UMN when it reduces acute or long-term toxicity for children with cancer

Amendment 1178

Massimiliano Salini, Francesca Peppucci

Proposal for a directive

Article 83 – paragraph 1 – point b

Text proposed by the Commission

Amendment

(b) the use of the medicinal product results in a meaningful reduction in disease morbidity or mortality for the relevant patient population.

(b) the use of the medicinal product results in:

Or. en

Amendment 1179

Cristian-Silviu Buşoi

Proposal for a directive

Article 83 – paragraph 1 – point b

Text proposed by the Commission

Amendment

(b) the use of the medicinal product results in a meaningful reduction in disease morbidity or mortality for the relevant patient population.

(b) the use of the medicinal product results in:

Or. en

Amendment 1180

Massimiliano Salini, Francesca Peppucci

Proposal for a directive

Article 83 – paragraph 1 – point b – point i (new)

Text proposed by the Commission

Amendment

i) a meaningful reduction in disease morbidity, or mortality, severity or side effects for the relevant patient population; or

Or. en

Amendment 1181

Cristian-Silviu Buşoi

Proposal for a directive

Article 83 – paragraph 1 – point b – point i (new)

Text proposed by the Commission

Amendment

i) a meaningful reduction in disease morbidity, mortality, severity or side effects for the relevant patient population; or

Or. en

Amendment 1182

Massimiliano Salini, Francesca Peppucci

Proposal for a directive

Article 83 – paragraph 1 – point b – point ii (new)

Text proposed by the Commission

Amendment

ii) a meaningful positive impact on quality of life; or

Or. en

Amendment 1183

Massimiliano Salini, Francesca Peppucci

Proposal for a directive

Article 83 – paragraph 1 – point b – point iii (new)

Text proposed by the Commission

Amendment

iii) a meaningful prevention, delay of the onset, or delay of progression of the disease or its complications.

Or. en

Amendment 1184

Cristian-Silviu Buşoi

Proposal for a directive

Article 83 – paragraph 1 – point b – point iii (new)

Text proposed by the Commission

Amendment

iii) (ii) a meaningful positive impact on quality of life; or

Or. en

Amendment 1185

Cristian-Silviu Buşoi

Proposal for a directive

Article 83 – paragraph 1 – point b – point v (new)

Text proposed by the Commission

Amendment

v) (iii) a meaningful prevention, delay of the onset, or delay of progression of the disease or its complications.

Or. en

Amendment 1186

István Ujhelyi

Proposal for a directive

Article 83 – paragraph 1 – point b a (new)

Text proposed by the Commission

Amendment

(b a) patients’ immediate therapeutic needs, defined as needs perceived by the patients that are not met by currently available treatments, and longer-term societal needs, including impacts on carers and future public health threats

Or. en

Amendment 1187

Billy Kelleher

Proposal for a directive

Article 83 – paragraph 1 – point b a (new)

Text proposed by the Commission

Amendment

(b a) a meaningful increase in quality of life or contribution to patient care for the relevant population.

Or. en

Amendment 1188

Marian-Jean Marinescu

Proposal for a directive

Article 83 – paragraph 1 – point b a (new)

Text proposed by the Commission

Amendment

(b a) the use of the medicinal product results in a substantial improvement of patients` quality of life.

Or. en

Justification

Improving the quality of life for patients.

Amendment 1189

Billy Kelleher

Proposal for a directive

Article 83 – paragraph 1 – point b b (new)

Text proposed by the Commission

Amendment

(b b) a meaningful delay of the on-set of the disease or its complications

Or. en

Amendment 1190

Margrete Auken

Proposal for a directive

Article 83 – paragraph 2

Text proposed by the Commission

Amendment

2. Designated orphan medicinal products referred to in Article 67 of [revised Regulation (EC) No 726/2004] shall be considered as addressing an unmet medical need.

deleted

Or. en

Amendment 1191

Kateřina Konečná

Proposal for a directive

Article 83 – paragraph 3

Text proposed by the Commission

Amendment

3. The Agency shall adopt scientific guidelines for the application of this Article in consultation with the Commission and the authorities, or bodies and other stakeholders referred to in Article 162 of [revised Regulation (EC) No 726/2004].

The Agency shall consider adopting a list of diseases for which, based on the criteria outlined in paragraphs 1 and 2, there is an unmet medical need.

Or. en

Justification

The adoption of a list of diseases for which there is an unmet medical need should be considered, to further guide R&D efforts and avoid that these are too industry driven.

Amendment 1192

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

Proposal for a directive

Article 83 – paragraph 3

Text proposed by the Commission

Amendment

3. In close cooperation with HTA bodies, 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].

Or. en

Amendment 1193

Susana Solís Pérez, Catherine Amalric

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 take into account the effect of the condition on life expectancy with the provision of standard care; the influence of the condition on patient experience, encompassing quality of life, after administering the current standard of care; and the suitability of the present standard of care for the patient. In formulating these guidelines, the Agency shall include members from patient organizations related to the pertinent disease areas, and consult the Commission and the authorities or bodies referred to in Article 162 of [revised Regulation (EC) No 726/2004].

Or. en

Amendment 1194

Kateřina Konečná

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 consider the impact of the condition on life expectancy after providing standard of care treatment; the patient experience after providing the current standard of care; and appropriateness of the current standard of care for the patient. When developing these guidelines, the Agency shall consult the Commission, representatives of patients’ organisations in the relevant disease areas, and the authorities or bodies referred to in Article 162 of [revised Regulation (EC) No 726/2004].

Or. en

Justification

It will be of utmost importance to define the concept of "unmet medical need" in cooperation with patients, in particular, to avoid the "orphanisation" of new medicines, where more and more drugs are labelled as "unmet medical need" only to apply for accelerated approval and justify higher prices. At the same time, prioritising promising products should not translate into deprioritising certain diseases, with some patients considered as less “worthy” of innovation despite identified therapeutic needs. A relevant definition should include criteria that are crucial for patients.

Amendment 1195

Nicola Procaccini

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], representatives of patients’ organisations in the relevant disease areas, healthcare professionals, representatives of pharmaceutical industry and other relevant stakeholders.

Or. en

Amendment 1196

Cristian-Silviu Buşoi

Proposal for a directive

Article 83 – paragraph 3

Text proposed by the Commission

Amendment

Or. en

Amendment 1197

Fulvio Martusciello

Proposal for a directive

Article 83 – paragraph 3

Text proposed by the Commission

Amendment

Or. en

Amendment 1198

Margarita de la Pisa Carrión

Proposal for a directive

Article 83 – paragraph 3

Text proposed by the Commission

Amendment

Or. en

Amendment 1199

Adam Jarubas, Ewa Kopacz, Elżbieta Katarzyna Łukacijewska

Proposal for a directive

Article 83 – paragraph 3

Text proposed by the Commission

Amendment

Or. en

Amendment 1200

Dolors Montserrat, Nathalie Colin-Oesterlé, Stelios Kympouropoulos, Tomislav Sokol

Proposal for a directive

Article 83 – paragraph 3

Text proposed by the Commission

Amendment

Or. en

Amendment 1201

Massimiliano Salini, Francesca Peppucci

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], healthcare professionals, pharmaceutical business representatives, agents of patient organizations in the pertinent disease areas, and other relevant stakeholders.

Or. en

Amendment 1202

Nicolás González Casares, Tiemo Wölken

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], and where relevant, representatives of patients’ organisations in the relevant disease areas, healthcare professionals, academics and experts.

Or. en

Amendment 1203

Maria Angela Danzì

Proposal for a directive

Article 83 – paragraph 3

Text proposed by the Commission

Amendment

Or. en

Amendment 1204

Ondřej Knotek, Catherine Amalric, Billy Kelleher, Susana Solís Pérez

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, the authorities or bodies referred to in Article 162 of [revised Regulation (EC) No 726/2004], and representatives of relevant stakeholders including patient's organisations, healthcare professionals and industry.

Or. en

Amendment 1205

Erik Poulsen, Catherine Amalric, Asger Christensen, Morten Løkkegaard

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 patients, medicine developers, healthcare professionals, industries and other stakeholders referred to in Article 162 of [revised Regulation (EC) No 726/2004].

Or. en

Amendment 1206

Rosanna Conte, Annalisa Tardino

Proposal for a directive

Article 83 – paragraph 3

Text proposed by the Commission

Amendment

Or. it

Amendment 1207

Billy Kelleher

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 – e.g. representative patient organisations - to in Article 162 of [revised Regulation (EC) No 726/2004].

Or. en