en.Wedoany.com Reported - The European Union plans to introduce the Biotech Act to enhance the global competitiveness of Europe's pharmaceutical industry. The European Commission is seeking a balance between incentivizing biomedical innovation through strengthened intellectual property protection and ensuring competitive development in the generic and biosimilar drug markets.
The European Federation of Pharmaceutical Industries and Associations (Efpia) has called for extending the duration of Supplementary Protection Certificates (SPCs). The industry association claims that extending these mechanisms could increase R&D investment within the EU tenfold. SPCs are intellectual property tools designed to compensate innovative companies for the time lost between patent filing and marketing authorization, allowing temporary extension of exclusive rights for certain drugs after the main patent expires.
Efpia's demands reflect industry concerns over Europe's declining attractiveness for biomedical investment. The business organization has called for a "less restrictive" Biotech Act, warning that European regulations must provide sufficient incentives to attract research and production of advanced therapies.
EU sources explained to the media that the Commission's initiative proposes "rewarding key innovations in human and veterinary biotechnology in the EU through targeted patent extensions," while considering support measures for strategic areas such as biosimilar development and manufacturing. The proposal plans to grant an additional 12 months of SPC for certain highly innovative biotech products, including Advanced Therapy Medicinal Products (ATMPs, i.e., gene therapies, cell therapies, and tissue-engineered therapies). The Commission stated that these therapies are "often revolutionary curative treatments," and the Biotech Act aims to incentivize their research and authorization within the EU.
The extension of protection is not automatic. Brussels has set several conditions for obtaining this incentive, including that clinical trials must be conducted in more than two member states, and at least one production stage (excluding activities such as packaging or quality control) must take place within the EU. The extension is limited to products containing clearly new active substances and equally novel mechanisms of action. The European Commission stated that conducting clinical trials in the EU will ensure patients gain early access to these innovative products and increase the likelihood of these products being marketed in Europe. The measure will also apply to certain veterinary biotech drugs used to treat animal diseases with zoonotic potential, i.e., diseases capable of transmitting to humans and triggering future pandemics.
Brussels continues to push forward another SPC-related reform, proposed in April 2023 and currently under negotiation between the European Parliament and the Council. The goal is to address the fragmentation of the current system, which businesses and administrations consider complex and costly. The proposal considers creating a unitary SPC linked to the European unitary patent, as well as a centralized review process for national applications. The Commission stated that the new model "will simplify procedures, reduce administrative burdens, and enhance legal certainty for operators."
The European Commission's proposal has drawn certain reservations from the generic and biosimilar industry. The European Medicines Association "Medicines for Europe" opposes the extension of certificates, arguing that it will delay biosimilar market entry and increase drug spending for healthcare systems. The organization believes that Europe's competitiveness should be enhanced through regulatory modernization, promoting manufacturing and innovation investment, "rather than through extending exclusivity periods."
In this debate, the EU is attempting to address one of the key demands of the innovative industry while not abandoning the promotion of subsequent competition through generics and biosimilars. The final outcome will depend on negotiations among European legislators.
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