The Council of the European Union is ready to start interinstitutional negotiations with the European Parliament regarding new rules on supplementary protection certificates (SPCs) for medicines after getting the green light on Wednesday, 16 January, by Member States’ EU ambassadors (Coreper). MEPs are expected to adopt their position on 23 January in the Committee on Legal Affairs.
The main change that was introduced by Member States on this draft regulation concerns the timetable for implementing this text, which aims to facilitate the export of generic medicines. According to our information, three Member States have expressed an unfavourable opinion (including Denmark). Moreover, one State abstained, and two States entered a scrutiny reservation.
As a reminder, the supplementary protection certificate extends the term of patent protection for a medicinal product from one day to a maximum of 5 years so as to allow the pharmaceutical industry to offset the costs of their research. Yet, the current rules prevent EU-based generic and/or biosimilar manufacturers from working on a product until the SPC has expired. As a result, their products often enter the market late, unlike those of non-EU manufacturers who are not subject to this impediment.
The Council’s general approach retains key features of the original proposal, namely providing for a derogation that would allow export to countries where SPC protection has expired or does not exist. On the date of application, whereas the Commission proposed to implement these measures after the new regulation’s entry into force, the Council proposes to allow a 3-year transitional period. Thus, upon its adoption, the new derogation will only apply to medicines that have received a SPC at the time of or after the regulation’s entry into force. After a period of 3 years (or around 2022), it will also apply to SPCs that were granted before the text’s entry into force but became valid after the regulation’s entry into force.
Despite requests by several Member States, the Council’s mandate does not introduce an additional derogation that would allow the manufacturer to build up a stock of generic medicines directly marketable upon the expiry of the certificate.
The European Federation of Pharmaceutical Industries and Associations was pleased with the status quo. Nevertheless, the organization – unconvinced by the proposal in general – rejects the idea of retroactive implementation. (Original version in French by Sophie Petitjean)