Embracing a pro-innovation approach can help close the EU health gap

While improvements in healthcare services across Central and Eastern Europe have increasingly become a political priority, there continues to be an East versus West disparity in healthcare access. EFPIA’s annual Patient W.A.I.T. Indicator underscores this issue – averaging an 84% variance in availability of innovative medicines between Western and Eastern Europe.

Massimo Visentin is the Eastern Europe Cluster President at Pfizer. 

The European Commission’s upcoming pharmaceutical legislation has the intended goal of levelling the playing field when it comes to medicines access in Europe, yet questions remain as to whether this can be achieved through the current recommendations. 

Among the legislation to improve medicines access in Europe, are proposals that will limit pharmaceutical industry incentives, including a reduction in baseline Regulatory Data Protection (RDP). RDP provides companies that develop innovative new medicines with the certainty that their pre-clinical and clinical trial regulatory data cannot be referenced by generic applicants for a certain period of time. Any reduction in RDP runs the risk of eroding confidence among European pharmaceutical investors, with a resulting reduction in innovation and patient access – an outcome contrary to the stated aims of the legislation.  

In fact a report from Copenhagen Economics has even suggested that 2 billion Euros of R&D investment and 50 pipeline products could be lost within the EU if RDP is reduced. On average, countries with a strong RDP have access to three times more innovative medicines and better access to clinical trials, so legislation which curtails innovation will ultimately be detrimental for patient access across Europe.  

While the health gap between East versus West is entirely unacceptable and must be addressed, it is important to acknowledge that this is a complex issue rooted in the history of national healthcare systems in Europe. EFPIA has already documented the root causes of these issues and found ten interrelated factors.  These include barriers like the local economy, national pricing and reimbursement processes, lower government funding for healthcare and reliance on insurance-based systems. To address these local challenges requires a targeted response, and region-wide legislation that limits innovation is unlikely to get to the heart of the many local factors that influence access to medicines.  

However, an example of a local solution in action can be seen in Romania, a country in Eastern Europe that has historically encountered challenges with medicines access. Romania's National Cancer Plan was recently updated to include free healthcare services for uninsured people. This will grant them access to prevention services, including early detection and diagnostics, as well as access to ongoing treatment plans. This multi-stakeholder initiative is a huge step forward in a country that has the lowest cancer survival rates in Europe, with significant gaps in screening, diagnosis, and treatment. While this is not an all-encompassing solution, tackling access barriers in Eastern Europe does require multiple strategies that address these types of nuanced national issues. 

Ultimately, I believe in an approach that focuses on understanding and finding solutions to the interrelated causes of access, and it is critical that we work closely at a regional and national level with other stakeholders. This is something we achieved together during COVID-19, and we continue to explore ways to apply these learnings across other therapeutic areas. I believe it is also important that at this time of political change, that healthcare remains a top political priority, as demonstrated by the Romanian example. 

Over the next year, it is likely that the European Council, European Commission, and newly elected Parliament will enter a make-or-break trialogue to ratify the details of the proposed pharmaceutical legislation. This is a once in a lifetime opportunity to shape both the future of patient access and the life sciences industry across Europe. We must work together to embrace a pro-innovation approach, recognising healthcare investment as a fundamental ingredient for improving healthcare access for patients from East to West.  At the same time, we must press forward with initiatives at the local level to tackle the root causes of these issues.