As the United States undergoes significant shifts in healthcare policy under the new administration, the ripple effects are being felt far beyond its borders. For the life science industry, these changes present a mix of uncertainty and opportunity. In a recent webinar hosted by Kintiga, industry leaders gathered to discuss the evolving landscape of the pharmaceutical and biotech sectors in light of recent US policy changes and their implications for Europe. The panel, moderated by Steve Glass, Chief Executive Officer at Kintiga, included Hilary Stiss, Alexander Natz, and Prof. Matthias Schönermark, who shared their insights on the challenges and opportunities facing the industry.
The Impact of US Policy Changes
Hilary Stiss, Senior Director of International Affairs at the Biotechnology Innovation Organization (BIO), provided a comprehensive overview of the current environment in the US. She highlighted the uncertainty and significant changes under the Trump administration, particularly in the areas of Regulatory, Pricing, and Manufacturing. First, the FDA’s leadership changes are most concerning, with the firing of so many FDA employees with institutional knowledge spanning many administrations followed by additional resignations that have created a void in the scientific and regulatory rigour of the agency.
Stiss highlighted the potential impact on vaccine approvals due to Secretary Kennedy disbanding of the Center for Disease Control (CDC) Vaccine Advisory Panel, as an example, and noted that the new FDA Commissioner will need to address these significant issues as well as fill the many vacant roles in order move forward and continue to serve the American public. The loss of NIH funding will also have long-lasting negative implications, a gap that Europe could fill in early-stage research. Stiss pointed out that Trump’s initiation of a Most Favoured Nations (MFN) pricing principle is a threat to drug pricing within the public sector, Medicare and Medicaid, which will have an impact on the US private market pricing, ultimately negatively impacting patients.
Finally, the administration’s approach to manufacturing for healthcare will significantly impact trade, noting that, ‘he can’t also expect industry to then spend billions of dollars bringing manufacturing back’ to the US and at the same time lower prices.
Stiss emphasised that the US remains the largest market for the biotech industry, and any policy changes affecting trade and collaboration between the US and Europe could be detrimental to the sector globally. Stiss also mentioned a survey conducted by BIO, indicating that Europe, including the UK, is the most significant trading partner for the US in pharmaceuticals, making it crucial to maintain strong trade relations. BIO is working with US legislators and policy makers, to ensure transparency and stress the importance of the European pharma, biotech, and medical device industry on short-term access and long-term innovation.
Europe's Response to US Changes
Alexander Natz, Secretary General of the European Confederation of Pharmaceutical Entrepreneurs (EUCOPE), discussed the evolving landscape in Europe. He noted that the EU has shifted towards a more industry-focused policy approach due to potential US tariffs and MFN policies. Natz highlighted discussions in Brussels 1-2 years ago focussed on the importance of intellectual property rights and the challenges of launching products across multiple EU countries, shifting now to industry policies and the complexities and the burden of navigating 27 EU countries. Natz commented, “Imagine you’re a small company. Wherever you are coming from in the world, that’s a big burden because many of those small companies, whether they’re from the US or from Asia… they have a small team, but they by far don’t have the resources to launch in all 27 EU countries”. The focus now is on remaining competitive globally, simplifying access and clarifying and addressing topics such as tariffs, MFN pricing and US policy shifts impacting patient access in Europe.
Natz pointed out challenges in Europe, including consistency in implementation and price confidentiality and transparency. Pricing and reimbursement across Europe is complex and disjointed, and while changes are in progress, particularly with the EU Health Technology Assessment (HTA) process now underway, it is not a ‘one size fits all’ route at the moment and not all countries are implementing the joint procurement policies uniformly.
There are significant positives within the European healthcare industry, he noted, including an extremely stable regulatory environment with the European Medicines Agency in Amsterdam and the high value placed on scientists and scientific discovery. The EU platform thrives on innovation and is leading the discussion on evidence-based medicine and pricing, closing the data gaps to generate data, particularly in rare diseases.
Natz emphasised the importance of the evolving EU legislation and the collaboration between US and European stakeholders to ensure innovative treatments and increased patient access.
Opportunities and Challenges in Europe
Matthias Schönermark, Chief Strategy Officer at Kintiga, discussed the opportunities for healthcare companies amidst the uncertainties in the US market. He echoed Alex’s assertion that Europe has a stable regulatory environment and a strong infrastructure for managing innovative therapies. Schönermark observed that while there are challenges, such as the fragmented pricing and reimbursement systems across EU countries, the potential for growth remains high, especially in personalised medicine and advanced therapies.
Europe has extensive experience in pricing regulation and cost containment, especially as it relates to standard of care. The EU HTA process will ideally strike a balance between scientific innovation and patient access and affordability. While not perfect, the European system works and can be a model for other regions. Dr. Schönermark remarked that Europe is an attractive market with 450 million people just in the EU (with an additional nearly 80 million in the UK and Switzerland), and the robust and time-tested system is predictable and transparent in policy and infrastructure, versus the meandering uncertainty in the US. He noted that ATMP and biologics call for outstanding infrastructure in academic centres and registries, something Europe can deliver on with a high level of sophistication.
Schönermark advocated for early engagement in market access strategies and emphasised the need for companies to align their regulatory and evidence generation strategies with market access requirements. He pointed out that understanding the nuances of the European market is crucial for successful product launches. While big pharma may be equipped, the majority of small and mid-sized companies do not have the internal resources and need a ‘sherpa’ to guide them through the launch journey.
Conclusion
The panel concluded that while the current landscape presents challenges, there are also significant opportunities for growth and collaboration between the US and Europe now and in the future. The experts agreed that maintaining open communication and working together will be essential for navigating the evolving regulatory and pricing environments, remaining focussed on the work done every day across the industry to bring lifesaving technologies to patients. They expressed optimism about the future of the pharmaceutical and biotech sectors in Europe, despite the uncertainties stemming from US policies. And finally, that while protecting the US system is vital, the European market is and will remain highly attractive for pharma and biotech despite the complexities.
