EUCOPE reacts to the vote on the provisional agreement on the EU General Pharmaceutical Legislation (GPL)

EUCOPE, representing mostly small and mid-sized innovative pharmaceutical companies in the EU, acknowledges today’s vote on the compromise text of the EU General Pharmaceutical Legislation (GPL) by the European Parliament’s Committee on Public Health (SANT). Following endorsement by Member States in COREPER on 6 March, the legislation will now undergo the needed procedural steps before formal adoption by the Ministers of Health in the Employment, Social Policy, Health and Consumer Affairs Council (EPSCO) and the European Parliament Plenary.

The reform represents the most significant overhaul of the EU pharmaceutical framework in over two decades and will shape the conditions for innovation, investment, and access to medicines in the EU for years to come.

Overall, the compromise text reflects a mixed outcome for the European life sciences ecosystem. While the legislation includes welcome reforms to modernise the EU regulatory system – such as shorter regulatory timelines, regulatory sandboxes, and the introduction of a platform technology master file – it also reduces baseline incentives and introduces new obligations that will increase complexity and uncertainty for innovative companies.

In parallel, the introduction of a new access requirement creates an additional burden for companies, without addressing the main root causes driving access delays, which remain at national level. In the context of the US Most Favoured Nation (MFN) pricing mechanisms, these provisions will have unintended consequences, including possible delays in launching novel therapies in the EU.

In addition to reducing the baseline orphan market exclusivity (OME), the legislation also introduces significant changes to incentives for OMPs through the creation of a Global Orphan Marketing Authorisation (GOMA), which grants a single, extendable, period of OME linked to the active pharmaceutical ingredient rather than separate exclusivity period for each indication. This will significantly reduce incentives for follow-on orphan indications.

The introduction of a voluntary subscription model sends an important signal that the EU recognises the need to stimulate investment into new antimicrobials, although its ultimate impact will depend on how it is implemented. However, EUCOPE is cautious regarding the impact of the transferable exclusivity voucher (TEV) as part of the EU’s response to antimicrobial resistance.

Dr. Alexander Natz, Secretary General of EUCOPE, said:

“The new framework introduces significant changes to incentives for innovative medicines, including the Global Orphan Marketing Authorisation, which fundamentally alters how exclusivity works for orphan medicines. For medicines with multiple potential indications, this reduces the commercial viability or research priorities to continue investing in follow-on research once a product has reached the market.

More broadly, the EU must ensure that new legislative initiatives do not further constrain businesses.  While the revised GPL introduces many new obligations, future EU proposals must actively promote investment decisions and strengthen European attractiveness as a location for pharmaceutical innovation.”

With the political agreement now reached, the focus turns to implementation, which will be decisive for the success of the new framework. Clear guidance and pragmatic implementation will be essential to ensure that the legislation supports both innovation and patient access.

At the same time, the EU must continue to strengthen its global competitiveness in life sciences. The Biotech Act is a step in the right direction, but additional measures will be needed within the next two years to address increasing global competitive pressures and ensure the EU remains an attractive destination for pharmaceutical and biotechnology investment.

EUCOPE Press Contact: Matthias Heck, heck@eucope.org.