After the Member States, it is now up to MEPs to decide on the export of generic medicines. Meeting in the Committee on Legal Affairs on 23 January, they introduced an additional derogation to allow the manufacturer to build up a stock of generic medicines that can be marketed directly upon expiry of the Supplementary Protection Certificate (SPC).
The draft regulation, presented in May 2018, aims to address the competitive disadvantage faced by EU-based generic and/or biosimilars manufacturers compared to their non-EU counterparts. Indeed, the current rules (Regulation 469/2009) prevent the former, unlike the latter, from working on a product as long as a supplementary protection certificate (which extends the duration of a patent) relating to it has not expired. The Committee's proposal therefore introduces a derogation allowing export to countries outside the EU where CCP protection has expired or does not exist.
Two major changes
Against the opinion of the rapporteur, Luis de Grandes Pascual (EPP, Spain), and his group, MEPs have chosen to introduce a second derogation allowing manufacturers to build up, during the last 2 years of validity of the certificate, a stock of generic medicines that can be directly marketed when it expires. This provision should be the biggest stumbling block in negotiations with the Council (see EUROPE 12174).
Another important change is the time from which the new derogation will apply. While the European Commission proposed to follow the date of entry into force of the new regulation (3 months), MEPs propose to apply it to certificates applied for after the entry into force of the new rules and to certificates "for which the basic patent expired on or after 1 January 2021".
"The new rules we have backed today will benefit European consumers by making drugs cheaper and will help EU manufacturers by creating a level playing field with those producing generic drugs in the rest of the world", said S&D shadow rapporteur Tiemo Wölken. However, these changes should not please the pharmaceutical industry, EFPIA (European Federation of Pharmaceutical Industries and Associations).
The rapporteur's negotiating mandate was adopted at the same time. (Original version in French by Sophie Petitjean)