Opinion on of the Committee on Legal Affairs on the Proposal for a Directive of the European Parliament and of the Council on the Union code relating to medicinal products for human use, and repealing Directive 2001/83/EC and Directive 2009/35/EC -

13.2.2024

Mr Pascal Canfin

Chair

Committee on the Environment, Public Health and Food Safety

BRUSSELS

Subject: Opinion on of the Committee on Legal Affairs on the Proposal for a Directive of the European Parliament and of the Council on the Union code relating to medicinal products for human use, and repealing Directive 2001/83/EC and Directive 2009/35/EC - (COM(2023)0192 – C90143/2023 – 2023/0132(COD))

Dear Mr Chair,

At its meeting of 29 November 2023, the Coordinators of the Committee on Legal Affairs decided to give an opinion in letter form on the Proposal for a Directive of the European Parliament and of the Council on the Union code relating to medicinal products for human use, and repealing Directive 2001/83/EC and Directive 2009/35/EC (2023/0132(COD). The Committee on the Environment, Public Health and Food Safety and the Committee on Legal Affairs agreed that the latter will have shared competences under Rule 57 with the lead committee over Article 85 of the Directive (so-called “Bolar exemption”).

At its meeting of 13 February 2024, the Committee on Legal Affairs accordingly decided, by 23 votes in favour, 0 votes against and 0 abstentions, to call on the Committee on the Environment, Public Health and Food Safety, as the committee responsible, to take into account the elements outlined in this opinion, when preparing their report.

The proposed directive accompanies the proposal for a Regulation of the European Parliament and of the Council laying down Union procedures for the authorisation and supervision of medicinal products for human use and establishing rules governing the European Medicines Agency, amending Regulation (EC) No 1394/2007 and Regulation (EU) No 536/2014 and repealing Regulation (EC) No 726/2004, Regulation (EC) No 141/2000 and Regulation (EC) No 1901/2006, where the Committee on Legal Affaires decided not to give an opinion. Both Committees nevertheless agreed that the wording of article 168 (Confidentiality) should not be substantially altered.

In parallel to this revision of the general pharmaceutical legislation issued by the Commission on 26 April 2023, the Commission adopted, on 27 April 2023, four legislative proposals providing for a comprehensive reform of the regime of supplementary protection certificates (SPCs) - an intellectual property right - for both medicinal products and plant protection products. The Committee on Legal Affairs adopted the four reports at its meeting of 24 January 2024. The Committee on Legal Affairs believes it is therefore important for the European Parliament and the Council to look at all the related instruments together as part of the same package to ensure coherence and consistency. The Committee on Legal Affairs invites the Committee on the Environment, Public Health and Food Safety to carefully consider the SPC reports on medicinal products (the “Unitary” one and the recast) in the context of the pharma reform, in particular Article 35 related to the ban of patent linkage in order to ensure alignment within all legislative acts.

In that regard, the Committee on Legal Affairs takes note of the Commission’s proposal for the Directive and the suggested Article 85 known as the “Bolar exemption”. The aim of the exemption is to facilitate faster market entry of generics and biosimilars medicinal products, thereby increasing competition, after patent or SPC protection has expired to enable the entering into the Union’s or Member States’ markets on EU Day-One (recital 64). As explained in the related recital 63 of the proposal for the Directive, the application of this limited exemption is fragmented across the Union and this is why the Commission proposes “to clarify its scope in order to ensure a harmonised application in all Member States, both in terms of beneficiaries and in terms of activities covered “.

Article 85 of the proposal for Directive clarifies that the studies, trials and other activities, using the reference medicinal product, in order to obtain a marketing authorisation of generic or biosimilars, or for health technology assessment or for pricing and reimbursement, shall not be regarded as infringing patent rights or SPCs. The provision then specifies that those activities may encompass the submission of the application for a marketing authorisation and the offer, manufacture, sale, supply, storage, import, use and purchase of patented medicinal products, including by third party suppliers and service providers. Finally, its last paragraph states that the Bolar exemption shall not cover the placing on the market of the medicinal products resulting from such activities. The accompanying recitals proposed by the Commission provide additional background as well as interpretative information helping in the understanding of the scope of the exemption.

The Committee on Legal Affairs fully shares the Commission’s objective of ensuring greater harmonisation and legal certainty when it comes to the application of the Bolar exemption with a view to encouraging health research and promoting generics, while not affecting IP rights of patent and/or SPC holders. The proposed exemption, meant to avoid legal uncertainty, strikes a good balance between providing legal certainty as regards the activities authorised with the objective of bringing new generic/biosimilar products to the market and the objective of ensuring that the protection and enforcement of IP rights of patent and/or SPCs holders are not unduly undermined. Indeed, in line with Articles 28 and 30 of the TRIPs agreement, it is necessary to guarantee that exceptions to the exclusive rights conferred by a patent do not unreasonably conflict with a normal exploitation of the patent and do not unreasonably prejudice the legitimate interests of the patent owner, taking account of the legitimate interests of third parties.

Therefore the Committee on Legal Affairs considers that no amendments are needed neither to Article 85 of the Commission proposal nor to the related recitals. Additionally, the Committee on Legal Affairs would welcome alignment with article 35 of the SPC reports on medicinal products relating to the ban of patent linkage.

Yours sincerely,

Adrián Vázquez Lázara