Legislative changes in Europe’s pharmaceutical field have prompted alarms across the sector. Analysts warn that new rules rolled out by the European Commission could dampen the pace of drug development on the continent. Recent studies indicate a potential decline in Europe’s leadership in research and development within the pharmaceutical industry. The alliance Farmaindustria emphasizes that these shifts threaten Europe’s competitiveness, potentially slowing the ability to attract investment, bring new treatments to patients, and keep up with more assertive regions like the United States, China, and Japan.
The report projects that, under current policy directions, Europe’s pharmaceutical R&D footprint could shrink by about one third, dropping from 32% today to roughly 22% by 2040, a 35% contraction overall. This trend would translate into an annual loss of around 2 billion euros in R&D funding across Europe, with far-reaching implications for innovation and patient access to new therapies.
The analysis examines in detail a key component of the proposal: reducing the protection period for data submitted for drug registration. The plan envisions shortening the regulatory data protection timeframe, a cornerstone of intellectual property protection that is especially crucial for advanced, complex treatments. Such a change would likely weaken the incentives for companies to invest in these medicines, potentially reducing investment activity by as much as 55% over the coming decade and a half. In turn, a significant share of R&D projects focused on novel molecular therapies could become economically unviable in Europe.
Consequently, the study suggests Europe could lose a substantial portion of its planned 225 new medicines within the next 15 years, threatening access to potential cures for many patients. The projected drop in pharmaceutical innovation would tallied at about 8%, with an estimated 16 million years of life lost across the European Union due to higher mortality and premature deaths associated with slower medical progress.
Research feasibility
According to the research, Europe’s biotechnology sector—dominated by small and medium-sized companies—would bear the brunt of the proposals. The shifts would accelerate a trend where European biotech activity gravitates toward the more predictable funding environments found in the United States and China. Assessments indicate that nine out of ten biotechnology drug projects based on these advanced therapies might face viability challenges under the new regime.
The European pharmaceutical industry faces a tension between defending its interests and addressing a damaged image that has intensified since the pandemic. A major concern is the heavy reliance on producing key active ingredients, much of which is manufactured in India and China. Another fear is that parallel trade and medicine shortages could rise gradually. In response, the European Commission recently requested information from a major online marketplace to assess compliance with consumer protection rules against counterfeit medicines.
Aliexpress surveillance
Within the context of digital services legislation, Brussels has asked the Chinese e-commerce platform to provide more detail on measures adopted to meet obligations related to risk assessment and consumer protection. An official statement notes that European authorities are monitoring the spread of illegal products, including counterfeit medicines.
The European administration has set a deadline for a full reply and may take further steps after reviewing the information. If the platform fails to respond, Brussels could open a formal process that may lead to penalties for providing false or incomplete information. Non-response within the specified timeframe could trigger periodic payment obligations as part of an enforcement mechanism.