Yesterday, the European Parliament voted in favour for the proposed amendments to Regulation (EC) No 469/2009 concerning the supplementary protection certificate for medicinal products. Gulliksson notes that the proposal was adopted with a clear majority, with 572 Members in favour.
Under the existing rules, pharmaceutical products subject to market authorisation can obtain additional protection with up to 5 years after expiration of the patent in question. This have resulted in that, during the SPC term, EU-based producers of generic products and biosimilars cannot manufacture their products for export to third countries in which the patent have expired. Further, said manufacturers are not prepared to put their products on the market upon expiration of the SPC (in reality creating a more extensive exclusivity on the market for the patent holder than intended). This has impaired the competitiveness for EU-based producers of generic products and biosimilars.
Under the amended version of the regulation, it will be possible for such producers to manufacture generic/biosimilar products in order to export it to a third country. In addition, it will be possible to manufacture such products within six months before the expiration of the SPC term, in order to create a stock prior to launch onto the EU market, and to perform other measures necessary for manufacture, export and/or storage accordingly. It is expected that the amendments will enter into force already in July 2019 and that pharmaceutical companies will be able to commence production under the new exceptions from July 2022. When effective, the new rules will facilitate the competition for European producers of generics and biosimilars on a global level.
Read the preliminary adopted proposal here
Gulliksson advise pharmaceutical companies on a regular basis. Please contact our partners Magnus Dahlman and Mattias Malmstedt for more information.
Responsible for the article: Emil Ekdahl Norling and Sofia Sjöö.
