The session “Europe’s Policy Environment and the Impact on the Biotech Sector” at Bio International Convention in San Diego featured a panel of experts who broke down ongoing policy changes in the EU and their potential impact on business in the region.
 
Speakers included:
 

• Matias Olsen, Public Affairs & Policy Manager, EUCOPE
• Claire Skentelbery, Director General, EuropaBio
• Santoke Naal, Managing Director, IGES UK
• Steffen Thirstrup, MD, PhD, Chief Medical Officer, European Medicines Agency (EMA)
• Thomas Bois, Head of Government Affairs and Patient Engagement, EMEA & APAC, PTC Therapeutics

 
The session was moderated by Justin Pine, Senior Director, Biotechnology Innovation Organization (BIO).
 
The panel analyzed the proposed General Pharmaceutical Legislation (GPL) revisions, including changes to regulatory data protection, the ongoing HTA harmonization process, and the health data space. The focus of the discussion was the potential impacts of these policies on the domestic and foreign sectors and avenues to strengthen US-EU collaboration.
 
Revisit some of the highlights below:

General Pharmaceutical Legislation (GPL) Revisions

In 2023, the European Commission proposed revisions to the Pharmaceutical Legislation with the goal of bolstering innovation in areas of clinical unmet medical need, enhancing the sector’s global competitiveness, ensuring timely, equitable and affordable access to medicine, and expanding environmental protection.
 
To meet these aims, the Commission proposed the following:
 

• To modulate the duration of regulatory data protection (RDP) based on conditions of need, access and evidence
• To streamline regulatory procedures
• To introduce a unified definition of unmet critical need
• To create references to environmental policies

 
Like any mission statement that strives for lofty goals, the proposal is ambitious. While some of the proposed changes are anticipated to have a positive impact on the biotech sector, panelists also offered several criticisms and complaints.
 
First, the positive: the Commission wishes to shorten standard timelines to EU approval and bolster the Priority Medicines (PRIME) program. With approval times being shortened, products’ time to patient will be faster.
 
However, the proposal also has its detractors. Two major points of contention are the reduced incentives and access conditionality.
 
Industry experts argue that as a result of reduced incentives to develop medicines, Europe would likely play a lesser role in driving global innovation, and that its share of global biopharmaceutical R&D spending would fall.
 
Furthermore, the legislative revisions would disproportionally impact small and medium enterprises, which already face a more challenging investment proposition than large enterprises. Under the Commission proposals, only a fraction of products relying on RDP would be economically viable in Europe.

HTA Harmonization

The HTA Regulation, which entered into application in January 2024, seeks to streamline health technology assessment (HTA) procedures for certain medicinal products and medical devices throughout the EU.
 
It strives to provide a transparent and inclusive framework by establishing a Coordination Group of HTA national or regional authorities, a stakeholder network and by laying down rules on the involvement in joint clinical assessments and joint scientific consultations of patients, clinical experts and other relevant experts.
 
Unlike the GPL revisions, the deadlines for HTA harmonization are set and companies need to prepare now. In order to be seen as a priority for a joint clinical assessment, engagement with regulators and HTA bodies should happen early—three years before launch.
 
Europe is a very complex market. It is made up of 27 countries, each with different systems, and things are decided at different levels. It is a very complex and intertwined system. Charting a path forward and navigating the framework of pharmaceuticals in Europe will require companies to educate themselves and prepare accordingly.