European Pharma Rules Overhaul, Concerns Arise Over Billions In Lost Investment, Undiscovered Treatments

The European Federation of Pharmaceutical Industries and Associations (EFPIA) released new research that evaluates the effects of the European Commission's draft Pharmaceutical Legislation on Europe's competitiveness, the future of its life science sector, and patient care.

The research shows that the Commission's plans would make Europe less innovative than the U.S., China, and Japan.

The numbers reveal that the Commission's ideas to cut down on data protection, which is crucial for protecting new medicines, will decrease the motivation for companies to invest in these medicines by 55% in Europe over the next 15 years.

A major pharmaceutical rules overhaul, proposed by the European Commission in April, could see Europe's share in global research and development decline from 32% to 21% by 2040, translating to €2 billion per year in lost investment, with about 50 out of 225 expected new treatments forecast to be undiscovered over the next 15 years because they would not be economically viable. 

Germany, Belgium, and France would be the hardest hit by the proposed rules, the EFPIA said.

The EFPIA said small biotech companies have already moved to the U.S. and China.

EFPIA President and CEO of Novo Nordisk A/S NVO, Lars Fruergaard Jorgensen, said:

"Policymakers in the EU regularly say that they want to enhance European competitiveness and make Europe a strong global player by ensuring open strategic autonomy. However, overall, the measures currently being considered in the pharmaceutical legislation are likely to harm, rather than strengthen, our joint ability to achieve these goals. This will have a negative impact on the European economy, and most importantly on the lives of millions of people in Europe who need innovation in medicine to transform their lives."

Citing Jørgensen, Financial Times noted that many of Novo's new medicines were already being developed in the U.S. at its Cambridge, Massachusetts, campus near Boston. "When we start clinical development, we start in the U.S. When we start commercial activity, we always start in the U.S. "And the success in the U.S. means that we are slower getting going in Europe because it's just less attractive."

"And it also means that there would be fewer spinouts from universities and less biotech. So this negative ecosystem means that there would be a further acceleration out of Europe. And we've already seen that Europe is missing out on clinical development," Jørgensen added.