On 26th April, the EU Commission presented the “EU Pharmaceutical Laws Package” in Brussels which included a variety of measures aimed at stimulating the development of new medicines in Europe (read about it in our article here).
One item in the package is shorter regulatory data protection which has been designed to allow more equal care across Europe, however, it causes weakened protection of intellectual property for innovative medicines. European and German pharmaceutical associations have already begun to call out the flaws in the package.
EFPIA Director General Nathalie Moll said “Over the past two decades, the competitiveness of European life sciences has declined while other parts of the world have stepped up: investment in pharmaceutical R&D has fallen by 25% on a global basis. The overall effect of today’s proposals weakens intellectual property rights and can only lead to a further decline in research investment, which is increasingly shifting to the US and China. Incidentally, the same applies to clinical studies and production,”
“In continental Europe, a regulatory pattern is establishing itself that is characterized by one thing in particular: by its complexity! We saw that last year with German healthcare legislation [GKV financial stabilisation act] and now we’re seeing it again with the EU pharmaceutical package of measures. Europe is thus increasingly decoupling itself from international developments and, on top of that, allows itself the luxury of not setting any signals for an innovation-friendly location. Unfortunately, that’s not good at all for an industry that is globally positioned,” comments VFA President Han Steutel.
The EU Pharmaceutical Laws Package is still up for discussion and will still need to be approved in the European Parliament and in the Council of Ministers of the European Union for it to be able to come into force.
Vertane Chance. VFA. https://www.vfa.de/de/presse/pressemitteilungen/pg-003-2023-vertane-chance.html. Accessed 27th April 2023