Impact of the EU's General Pharmaceutical Legislation on Europe’s innovation ecosystem and biotechnology companies
The study ‘Impact of the EU’s General Pharmaceutical Legislation on Europe’s innovation ecosystem and biotechnology companies’ highlights the consequences for EU patients and economies within a global race towards healthcare resilience and competitive positioning. By taking an in-depth look at the biotechnology ecosystem in Europe, the study demonstrates that:
- Reducing incentives and certainty for early programmes is a barrier to the delivery of innovative medicines
- Small innovators are at greatest risk and with them the EU’s engine for novel medicines
- Rare disease goals are less likely to be met, impacting clinical trials and treatment options for patients
- EU biotechnology companies are strongly inter-dependent for successful development of medicines, with changes negatively impacting partnerships
- The EU must reprioritise biotechnology innovation and competitiveness and grow its significant life sciences sector
Solving the challenge
The GPL must be central to the EU’s strategy for healthcare resilience through global biotechnology competitiveness. It has to empower Europe’s innovators, especially small and growing biotechnology companies, and reprioritise our significant life science sector. We should increase rather than decrease baseline incentives, remove the seven-year time limit for Orphan Designation, increase Orphan Market Exclusivity and avoid definitions that restrict Europe’s rare disease progress. This enables Europe to grow as a global hub for research excellence and be a home for novel medicines, with the beneficiaries being patients, economies and healthcare systems.
Europe is at the crucial point facing a choice between becoming a global biotechnology innovation hub or a follower. With the revision of the Pharmaceutical Legislation it is imperative for the EU to promote an enabling environment for biopharmaceutical innovation in order to remain competitive in the global context and ensure that groundbreaking treatments are accessible to European patients.
This study confirms the concerns of the Life Sciences Acceleration Alliance that the life sciences ecosystem will suffer under the proposed EU pharma legislation. It highlights the longstanding issue of a weaker VC sector that continues to affect the EU life sciences eco-system, creating a 'death valley' for European biotech companies and affecting the IPO landscape. We need more incentives not less and better access to private capital to support emerging and growing life sciences companies in Europe.
Action is needed now to avoid the risk that millions of future European patients could miss out to the US and China on the next wave of innovation in biopharma. This report shows the importance of getting the revision of the EU’s pharmaceutical legislation right. To boost the competitiveness of the European innovation ecosystem, Europe now needs to scale up scientific advice to developers who request it, maintain strong and predictable IP, and deliver regulatory flexibility and speed to drive faster access for patients.
SMEs in the biotech sector are the engines of innovation. The study's insights into the impact of GPL revisions are a wake-up call for policymakers, investors, and the industry as a whole.
Where innovation happens, it matters! The study alerts policymakers on the vulnerability of the European innovation ecosystem, including for orphan medicines, and the impact on patients’ access. It is time for Europe to champion a continuous flow of innovation, boosting partnership between emerging and small biotech startups, and established industry to faster patients access to biological medicines that have a profound impact on creating, improving or prolonging lives of European patients!
In the world of biotech, orphan drug designation is the lifeline for many small companies. This study highlights the regulatory changes that could stifle innovation and disrupt investment flows in the industry for regions such as those in Spain that are a strong interface to patients.
Biotechnology is the future of healthcare innovation in Europe. From startups to large pharma, biopharmaceutical companies participate in a vibrant R&D ecosystem that turns science into medicines to the benefit of European patients. The revision of the EU pharmaceutical legislation will make or break this strategic ecosystem. Let’s remember that there’s no access without innovation first. If well designed, the reform of the EU pharma legislation can help us achieving both objectives.
Diving into the future of Europe’s biotech innovation, this study reveals concerns how the proposed changes of market exclusivity and data protection would negatively impact investors and small companies, ultimately hindering progress and undermining Europe’s ability to provide a complete development process to patients here.
- Small and mid-cap biotech companies, the lifeblood of innovation, face increased challenges with the modulation of regulatory data protection and market exclusivity period proposals – it creates uncertainty. The changes in the GPL need to improve to support their growth prospects and ability to bring therapies to patients.