Amendment of supplementary protection certificates on home stretch
Competitiveness of European manufacturers of generics to be boosted.
SJS – 05/2019
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
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
1 2022, German manufacturers of generics or biosimilars will no longer have to
produce them abroad in order to import them into Germany.
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.
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