This is the bottom line of an EFPIA study published on Monday, which assesses the impact of the European Commission's draft pharmaceutical legislation on Europe's competitiveness, the future of its innovative life sciences sector and patient care.

While the Commission has committed to carrying out a European competitiveness check on future legislation it has not done so for the pharmaceutical legislation. Considering its impact on one of Europe’s largest and most strategically significant industries, EFPIA commissioned consultancy Dolon to do a comprehensive competitiveness check on the proposed legislation across a number of areas, including EU innovation, competitiveness, impact on small and medium-sized enterprises (SMEs), patient access and environmental links.

The results show that the Commission's plans would accelerate a trend that has seen Europe's position as a global innovator deteriorate further compared to the leading nations of the US, China and Japan.

EFPIA said that the Commission's proposals to reduce regulatory data protection – an essential component of intellectual property for a large number of breakthrough medicines – could reduce the incentive for companies to invest in these medicines by 55% in Europe over the next 15 years, which would have a significant impact on Europe's innovation and competitiveness.

One in five projects (22%) to research and develop regulatory data protection (RDP) reliant medicines would no longer be economically viable in Europe, the analysis predicts, with about 50 out of 225 expected new treatments forecast to be undiscovered over the next 15 years.

With nine out of ten biotech research projects for RDP reliant medicines at risk due to being no longer economically viable, Europe’s biotech sector – SMEs – would be most impacted by the proposals, worsening a situation which is already seeing Europe’s biotech base moving to the more predictable financial ecosystems in the US and China.

In 2010, Europe accounted for 37% of global R&D; in 2020 that had dropped to 32%. The new research projects that by 2030 that figure would have slumped further, to 25%, and by 2040 to just 21% of research and development activity compared with the other regions. Meanwhile, China’s contribution is expected to leap from 2% in 2010 to 17% in 2040.

The report estimates that Germany will be the hardest hit with a loss of around €626 million in annual R&D revenue, followed by Belgium, which will have to forgo R&D projects worth €381 million, and France with €326 million.

On top of the pharmaceutical legislation proposal, several legislative proposals stemming from the Green Deal – such as a blanket ban on PFAS – could have a substantial impact on the availability, affordability and accessibility of medicines.

The Dolon modelling suggests that heightened environmental requirements could halve the number of RDP-reliant medicines viable to be researched in the EU, with the regions potentially losing 124 of 225 products within the next 15 years if manufacturing costs were to significantly increase.

EFPIA president and CEO of Novo Nordisk, 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.”