Amendment of supplementary protection certificates on home stretch

In February this year, the DSV reported on the progress of discussions on amending the Regulation on Supplementary Protection Certificates (SPC). Previously, manufacturers of generic medicinal products in the EU were not permitted to produce medicines if the original manufacturer’s product was still protected by patents or SPCs. The amendment of Regulation (EC) No. 469/2009 of 6 May 2009 is intended to improve the competitiveness of European manufacturers and eliminate distortions in competition.

Successful debate

The European Parliament adopted the amendment by an overwhelming majority on 17 April 2019, after an intense debate on the subject with the EU Commission and the representatives of the Member States. The Regulation was finally adopted by the Council on 14 May. Niculae Bădălău, Romanian Minister of Economy, praised the result: ‘The new regulation will enable generics manufacturers based within the EU to compete with non-EU manufacturers on equal terms. It will create high-value jobs and boost the availability of generic medicines in the EU.’

Outcome also relevant for Germany

After July 1 2022, German manufacturers of generics or biosimilars will no longer have to produce them abroad in order to import them into Germany.

In addition, the national health budgets of German health insurance funds will also benefit from faster market entry of generics and biosimilars, as they facilitate access to affordable drugs and relieve the burden on their budgets.

The regulation has yet to be signed and published in the Official Journal of the EU, but these are just formalities. It is expected to enter into force on 1 July 2019.