AseBio brings together 300 entities and represents the entire Spanish biotechnology sector. Its mission is to lead the transformation of the country by positioning science,[...]

The European Parliamenthas adopted proposals to renew the General Pharmaceutical Legislation of the European Union (GPL) presented on April 26, 2023, with the aim of promoting innovation and improving the safety of supply, accessibility, and affordability of medicines. The legislative package, covering medicines for human use, includes a new Directive (approved with 495 votes in favor, 57 against, and 45 abstentions) and a Regulation (adopted with 488 votes in favor, 67 against, and 34 abstentions).

From AseBio, we consider that, following the negotiation of amendments, improvements have been made regarding the original proposal of the European Commission, but these remain insufficient for the protection, development, and promotion of biotechnological innovation in Europe.

The version voted on by the European Parliament of the GPL will not be positive for the European biotechnology industry and will likely lead to a reduction in investment potential for European innovation, as well as a decrease in the maturity levels of innovations due to collaboration obstacles, as we have previously warned.

This situation leads us to an even more concerning scenario in which European patients will see reduced access to innovative medicines compared to other regions, as biotechnological innovations have laid the foundation for the present and future treatment of many diseases, as demonstrated by the fact that 68% of the drugs currently in development globally are biotechnological.

Biotechnology has radically transformed the discovery of new drugs: over 300 biotechnological drugs have been approvedto date for around 250 indications. Additionally, there are thousands of molecules in various stages of research worldwide with the aim of finding new therapeutic active ingredients or new applications for existing ones.

Biotechnology has enabled significant advances in improving and protecting people's health, and is responsible for the extraordinary momentum it has experienced in recent years in areas such as advanced therapies, personalized medicine, advanced diagnostics, vaccine development, combating antimicrobial resistance, or the discovery of new drugs and therapeutic options that have revolutionized disease treatment.

"The GPL represents an opportunity to improve the current regulatory framework and provide the European Union with effective tools to position it as a leader in innovation, and ensure faster access to innovative medicines for European patients," says Ion Arocena, CEO of AseBio.

"The problem is that the GPL is not aligned with the vision of the European Commission, which has identified biotechnology as one of the key 'deep tech' areas for the future of the European Union and its strategic autonomy. This reform jeopardizes biotechnological innovation in Europe, responsible for up to two-thirds of biomedical innovations. We hope that a dialogue will be opened to improve the proposals and that the GPL empowers European biotechnological innovations, especially in the case of small and growing companies in the sector," concludes Arocena.

Changes in regulatory data protection periods to drive innovation

With the aim of incentivizing innovation, Members of the European Parliament wish to introduce a minimum regulatory data protection period (during which other companies cannot access product data) of seven and a half years, in addition to two years of market protection (during which generic, hybrid, or biosimilar products cannot be sold), starting from marketing authorization.

In this regard, pharmaceutical companies could opt for additional data protection periods in cases where the drug addresses an unmet medical need (12 months more), if comparative clinical trials are being conducted on the product (six months more), and if a significant part of the product's research and development is carried out in the European Union and, at least in part, in collaboration with EU research entities (six months more). Members of the European Parliament also want to set a limit for the combined data protection period of eight and a half years.

A one-time extension (twelve months more) of the two-year market protection period could be granted if the company obtains marketing authorization for an additional therapeutic indication that provides significant clinical benefits compared to existing therapies.
Orphan drugs (developed to treat rare diseases) would benefit from up to eleven years of market exclusivity if they address a "significant unmet medical need".

Prioritizing the fight against antibiotic resistance

With the aim of boosting research and development of new antimicrobials, Members of the European Parliament want to introduce market entry rewards and pay-for-performance systems (for example, financial support in the early stages when certain R&D milestones are achieved before market approval).

These would be complemented by a subscription model through voluntary joint procurement agreements to encourage investment in antimicrobials.

The Parliament supports the introduction of a "transferable data exclusivity bonus" for priority antimicrobials, which provides for a maximum of twelve additional months of data protection for an authorized product. The bonus could not be used for a product that has already benefited from maximum regulatory data protection and could be transferred once to another marketing authorization holder.