An unprecedented opportunity to make Europe a front-runner for innovation in medicines 

The European Commission is about to publish its proposal for a revision of the General Pharmaceutical Legislation, the most comprehensive legislative overhaul of the operating environment for innovation in medicines ever undertaken. The revision is a chance to assess and improve the lifecycle of a medicine, from discovery in the laboratory through to delivery to the patient. But our understanding of some proposed measures is that they risk undermining the European biopharmaceutical industry’s complex business model. 

Bringing a medicine to patients is costly and uncertain, requiring significant private investment that builds on advances in academic science. As medical science progresses, machine learning, artificial intelligence and new data analytics tools contribute to the development of complex biological medicines, as well as cell and gene therapies. Europe should be at the heart of this new era of science and that will require an enabling policy environment. The revision to the General Pharmaceutical Legislation is an opportunity to back innovation, earning back a larger share of global medicines discovery and development for Europe. 

One proposed change - the shortening of the Regulatory Data Protection (RDP) period - could be the most damaging. RDP is a regulatory incentive that protects an inventor’s clinical trials data for eight years. The European Commission wants to cut that period to six years. The move would increase uncertainty for biopharmaceutical companies. It would damage confidence in Europe as a location for research and manufacturing investments, and as a place where innovation is adopted at scale and speed. Governments that support strong RDP send a message that innovation is valued as a cornerstone of the scientific and healthcare ecosystem. The legislative proposals put forward by the European Commission will need to be debated and agreed by the European Parliament and the Council of the European Union. This process will take years to complete. It is never too late to change course. 

The European Commission’s plans to streamline and accelerate regulatory processes will enable a more efficient review and approval of scientific breakthroughs. These administrative and governance improvements are very welcome. Clearly, industry and governments share a goal of improving access to new medicines for Europe’s citizens. But this cannot be achieved by undermining key elements of the industry’s business model, especially by reducing RDP. If Europe is to maintain a strong life sciences innovation ecosystem to develop and deliver medicines faster to patients, then protecting regulatory incentives must be a shared priority. 

The biopharmaceutical industry contributes more to the trade surplus of the European Union than any other sector. In Europe, the industry directly employs around 840,000 people and it supports 2.5 million jobs¹. Yet, the European Commission has not assessed the impact that a loss of competitiveness would have on access to the latest treatments, jobs, research and development, manufacturing and economic growth. This uncertainty damages confidence in Europe as a location to site investments in research and manufacturing and to conduct clinical trials. In the past 30 years, the share of new treatments originated in Europe has dropped from one in two to one in five². The US spends $25 billion more on biopharmaceutical research and development than Europe³. 

BMS is an innovative biopharmaceutical company whose science is transforming patients’ lives in areas like oncology, cardiovascular disease, haematology and immunology. We have one of the youngest and most diverse pipelines in the industry, positioning us for multiple waves of innovation that will support long-term growth. Like other innovators, we rely on the right policy environment to translate scientific leadership into the delivery of treatments for patients.  

We urge European policymakers to be cautious about adopting legislative measures that would unnecessarily fray the links between medicines discovery, development, manufacturing and delivery. The unintended consequences risk undermining the European Commission’s own objectives in pursuing the revision of the General Pharmaceutical Legislation in the first place. The existing delicate business model, with RDP as its heart, is a game-changer for healthcare innovation.    

References:
1. EFPIA, The Pharmaceutical Industry in Figures
2. EFPIA, Back innovation, Boost Access
3. Charles River Associates, Factors Affecting the Location of Biopharmaceutical Investments and Implications for European Policy Priorities