The EU Commission is taking an important first step to strengthen Europe as a production location

29.05.2018 12:48

Yesterday, the European Commission presented a proposal for a so-called SPC Manufacturing Waiver with which it would like to strengthen the production of generics and biosimilars in Europe - without shortening existing intellectual property rights.

According to the current legal situation in Germany, generic drug companies are not only legally prohibited from selling medications as long as the corresponding preparation from the original manufacturer is still protected by patents or by patent-extending SPCs (Supplementary Protection Certificates), but even from producing these medications in this country . Therefore, production must systematically take place abroad.

The EU Commission has recognized that this regulation is absurd. The federal government also made it clear in the pharmaceutical dialogue that production facilities in this country are a very important asset for security of supply. Therefore, the EU Commission now wants to resolve this obvious contradiction and today presented the proposal for a so-called SPC manufacturing waiver.

This is intended to enable generic drug companies to produce SPC-protected drugs domestically - but only to export them to countries where patent or SPC protection has already expired. “This is an initial, important and, above all, overdue signal,” says Bork Bretthauer, Managing Director of Pro Generika. “This can lead to Germany being a stronger production location and more generics being produced in accordance with German social and environmental standards. However, the EU Commission has so far only taken half a step. In order to strengthen security of supply, generic and biosimilar companies must, of course, be enabled to produce those drugs in this country that are needed for supply in Germany the day after all intellectual property rights expire. Otherwise, an almost absurd situation would be created: Medicines would then be allowed to be manufactured in Germany and exported. However, medicines that are sold in German pharmacies after all protection periods have expired would still have to be manufactured abroad. Nobody can seriously want that. We therefore expect the federal government to also support this proposal.”