How EU Legislation Could Threaten Clinical Trials

In many respects, the Commission’s far-reaching proposal is well intentioned. It aims to provide “attractive incentives for innovation” and support “timely patient access to medicinal products across the EU.”   

Unintended consequences, however, could result in European citizens having reduced access to clinical trials and fewer innovative treatments in the years to come. 

Expanding Access & Encouraging Patient Involvement 

The proposal features several elements that bode well for patients. 

The legislation rightly emphasizes patients’ access to safe, efficient and affordable medications, for example. The European Commission also did well to encourage patient involvement in the regulatory lifecycle of medications, which benefits patients and manufacturers alike. 

Provisions to streamline the approval process, update regulatory systems, enhance supply chain security and address important environmental concerns are also promising. 

Disincentives & Unintended Consequences 

When developing incentives to meet these priorities, however, the Commission narrowly focused on regulatory authorization for marketing medicines that have proven safe and effective. In particular, the proposal rolls back the intellectual property rights that come with breakthrough medical research and drug development. 

As a result, policymakers might disincentivize continued investment in the next generation of treatments for cancers, chronic conditions and infectious diseases.   

By failing to prioritize investment in medical research and clinical trials, the Commission could unintentionally threaten European citizens’ access to new and advanced medications. 

Impact on Clinical Trials & Patients 

The European Commission’s proposal will likely discourage investment in European medical research. Who wins? North America and the Asia-Pacific region are clear contenders. 

But of greater concern are the citizens of Europe who might lose. Consider that: 

• Children with cancer will no longer be able to participate in many advanced and promising clinical trials. 
• Patients with rare diseases won’t have access to the cutting-edge research in gene therapies that can cure conditions long considered medical mysteries. 
• Clinical researchers will have fewer opportunities to participate in the most exciting research in their medical specialty. 
• European patient advocacy organizations will lose the progress they’ve made to ensure that clinical trials address unmet needs and use endpoints that are meaningful to European patients.  
• National taxpayers will continue to pay the costs for increasingly outdated healthcare systems with limited choices among medications and long waits for new drugs to become available.  

Looking to Patients’ Futures 

When patients enroll in a clinical trial, they are making a sacrifice today to help those who might benefit tomorrow. Participants have no way of knowing if they themselves will benefit.  But they enroll to advance society’s knowledge, motivated by the hope that someone else, even years in the future, will benefit. 

EU policymakers might embrace a similar outlook. Instead of prioritizing short-term cost reductions, lawmakers can work with all stakeholders, including patients, clinicians and researchers, to encourage future innovation and investment in clinical trials.  

Europe’s legacy of leadership in medical science and discovery is a point of pride. Preserving it to benefit the patients of tomorrow requires forward-looking policy choices to be made today.