European Drugmakers Slam EU Reform Proposals

27.04.2023 - European NGOs have welcomed the EU’s plans for an overhaul of pharmaceutical legislation – the first in two decades – presented this week in Brussels. The drugs industry, however, has expressed sharp criticism.

Unveiling the draft changes on Apr. 26 in Brussels, Health Commissioner Stella Kyriakides said the overhaul, among  other things, is aimed at eliminating large divergences in access and price between countries and making sure all Europeans can get both patented and generic medicines when they need them.

In the EU’s estimate, the new rules "would provide access to new medicines to around 70 million more citizens compared to today,” Kyriakides said.

Additionally, she said the purpose is to offer an “attractive and innovation-friendly framework” for research, development and production of medicines. Other goals are to address antimicrobial resistance and to make medicines more environmentally sustainable.

As a carrot held out to pharma players, the EU aims to speed up time to market for new drugs by limiting authorization times to 180 days. While this could win some praise, other proposed changes are highly unpopular.

Among the most controversial is a proposal that would reduce the length of patent protection from 10 years currently to eight years.

Even if the Commission has promised two years of exclusivity for drugmakers launching a new medicine in all 27 member states within two years, the industry fears that conditions for market access are too different to make the effort worthwhile. They fault the Commission for focusing on over-arching goals without regard to how they will be met.

The European Federation of Pharmaceutical Industries and Associations (EFPIA) slammed the proposals, saying they would “undermine research and development in Europe while failing to address access to medicines for patients.”

Commenting to the Reuters news agency, Novo Nordisk CEO Lars Fruergaard Jørgensen said the proposals were “poison for innovation and competitiveness in Europe,” while GSK’s CEO, Emma Walmsley, commented that weakening market exclusivity protections “could discourage companies from researching and launching treatments in Europe.”

GSK said the EU must "regulate for growth and competitiveness" because companies "have choices on where our capital and resources are focused.”

In the view of the European biotech industry association Europabio, the planned changes to patent protection could also make it harder for biopharma startups to raise money for research and development.

Germany’s chemical industry association Verband der Chemischen Industrie (VCI), which also represent pharmaceutical producers, called the proposed new rules “a bitter pill” for the sector.

Instead of strengthening drugmakers’s innovative potential, the EU in fact is weakening their competitiveness, said director-general Wolfgang Große Entrup. At a time when many countries in other regions are welcoming the industries of the future this is simply “criminal.”

VCI also criticized the EU’s plan to require extensive documentation to avoid shortages of medicines, in particular antibiotics, saying that this would create more bureaucracy.

The EU’s draft will undergo several more revisions before it is finalized, observers predict. First, the European Parliament must pass the proposals, though it probably won’t have the last word.

Author: Dede Williams, Frrelance Journalist