A supportive and future-proof EU Pharmaceutical Legislation is critical to ensure that Europe can fully benefit from healthcare biotechnology innovations for patients, society, and economic development. Global healthcare challenges and accelerating scientific capability require legislation that can harness science for breakthrough therapies within the European Union to better address the health needs of European patients and to regain EU’s global leadership in R&D and cutting-edge biotechnology-based therapies and manufacturing.

EuropaBio welcomes provisions aimed at improving the EU’s regulatory framework and promoting novel technologies. However, it concerns us that a number of other provisions may undermine the predictability and stability of Europe’s incentives regime that has successfully supported our transformative innovation from industry for the past 20 years, improved patient access to innovative medicines, and enabled countless biotech companies in all European countries to emerge and play their critical role in the ecosystem.

EuropaBio Director-General Dr. Claire Skentelbery commented: “As we welcome the proposals to revise the EU Pharmaceutical Legislation, we must recognise and acknowledge its profound impact for the whole biotech industry. European countries have worked hard to create a thriving industry from SMEs upwards, with benefits for patients and economic development. We urge policymakers to enable legislation that continues these strengths for a resilient and capable global Europe.”

EuropaBio Healthcare Public Affairs Director Vlad Olteanu said: “The revision of the EU Pharmaceutical Legislation is an important step forward to improve patient lives across Europe. It is essential that EU policies meaningfully improve patient access to medicines across the EU without undermining the EU’s attractiveness for life science investments.”

Valentin Plouchard, Regulatory Affairs Manager at EuropaBio said: "The revision of the EU Pharmaceutical Legislation comes at a crucial moment for Europe to secure access to safe, qualitative, and innovative medicines to its citizens. We are facing a unique opportunity to make our regulatory system more agile and competitive to develop decisive medicines for European patients."

Adrien Samson, Healthcare Policy & Public Affairs Senior Manager at EuropaBio said: "The proposed revision of the EU pharmaceutical legislation risks destabilising a framework that enables biotech companies to bring disruptive innovation to patients. For rare diseases and advanced therapies, Europe needs to do more to ensure European patients have timely access to life-changing therapies."

Yordan Aleksandrov, EU Government Affairs Senior Manager, representing Pfizer said: “The revision of the EU Orphan Regulation is an opportunity to support Europe’s thriving innovation ecosystem that delivers life-changing therapies to patients. It is critical the EU retains a positive approach to incentivise R&D in rare diseases to enable the next generation of therapies to reach patients.”

Matt Moran, Director, representing BioPharmaChem Ireland said: "Ireland’s economic growth and its commitment to industry 5.0 is fundamentally connected to the competitiveness and growth of innovation within Europe for medicines development, with the sector accounting for over 60% of goods exported. The pharma legislation must ensure that medicines development is strongly rooted within Europe and that means a clear pathway for innovation."

Tineke Van hooland, Deputy Secretary General, representing Bio.be said: "Belgium leads the way in biotech innovation, clinical trials, and manufacturing. It is critical that the EU pharmaceutical legislation enables these strengths to anchor SME cutting-edge research into new products made out of Europe, to stay competitive with other regions worldwide. Only smart legislation will make this possible."

Neil Mulcock, Vice President Government Affairs & Policy, representing Gilead Sciences said: "Pharmaceutical legislation needs to be updated to reflect the enormous changes in science which have taken place over the last 20 years and to meet the needs of European Patients. If Europe is to regain its competitiveness and be world leader in discovering and developing innovative treatments to address unmet medical needs, it is vital Europe has the right incentives to attract investments and reward innovation. The draft legislative text unfortunately lacks these measures."

Thomas Bols, Head of Government Affairs and Patient Advocacy, EMEA & APAC, representing PTC Therapeutics said: "The Commission has come out with its proposals for the revision of the EU pharmaceutical legislation. Whilst one can detect some positive elements, there are several areas which require further work to strengthen Europe’s innovation ecosystem. We urge policymakers to work together with the biotech industry to deliver cutting-edge treatments for patients and regain EU’s innovation leadership."

Ion Arocena Velez, General Manager, representing the Spanish Bioindustry Association (ASEBIO) said: "95% of the Spanish biotech sector are SMEs, often created through strong translational research spinning-out from universities, research centres and hospitals. SMEs are at the origin of the majority of disruptive innovations which are transforming the way patients are being diagnosed and treated, in areas of clear unmet medical need. The pharma legislation now on the table will define the future for many companies in Spain and it is critical that it continues to enhance SMEs ability to attract the financing they need to innovate and provide the solutions patients need."

Pedro Franco, Director for Global Regulatory & Scientific Policy, representing Merck said: "The adoption of the revision of the EU Pharma Regulation is an important step forward to help rare disease patients find therapeutic solutions across Europe. The EU must build on its successes and continue to support further innovation for rare diseases. It is urgent that EU preserves the EU Ecosystem of orphan drugs during this revision of the EU Pharma legislation in order to promote new treatments in the area of rare diseases."

EuropaBio remains committed to working with policymakers and other stakeholders to ensure the revision of the EU’s Pharmaceutical Legislation continues to reward innovation and incentivise scientific progress, foster investments in R&D, skills, and infrastructure and open growth pathways for small and mid-sized biotech companies.