The European Council approved on 4 June 2025 its mandate to negotiate on the proposed revision of the European General Pharmaceutical Legislation (GPL). The Trilogue, which also includes the EU Commission and Parliament, is now tasked with discussing and reaching the final agreement on the new directive and regulation that will completely redesign the framework for the development, production and commercialisation of pharmaceutical products.
The Pharma package aims to balance several strategic objectives, among which is the competitiveness of a key industrial sector for the EU’s economy and the improvement of patients’ access to innovative treatments.
The main amendments made by the Council
The amendments approved by the Council followed those endorsed by the EU Parliament in April 2024 (link).
One of the more debated issues of the different proposals is the length of the regulatory data protection period, which according to the Commission should have been reduced to only six years, plus two years of market protection (for a minimum total of eight years of protection, compared to the current 8+2+1 system). Further extensions would have been possible according to different criteria (e.g. unmet medical need, paediatric medicines, orphan medicines, etc.).
However, according to the Council’s endorsed text of the directive (Art. 80), regulatory data protection should remain at eight years (+ 1 year for unmet medical needs, Art. 81), starting from the date of the first European marketing authorisation. Orphan medicinal products should be granted an additional year of exclusivity compared to the Commission’s proposal for products for highly unmet medical needs, bringing the total to 10 years.
The Transferrable Exclusivity Vouchers
Transferrable Exclusivity Vouchers (TEVs) are another debated point of the Pharma package. Aimed at supporting the development of innovative antimicrobials, TEVs would grant the right to transfer the extension of the exclusivity period to another product chosen by the beneficiary company. TEVs could also be transferred to other companies for an agreed sum.
Compared to the Commission’s proposal of an additional year of regulatory data exclusivity, the Council indicated that TEVs could only be used during the fifth year of regulatory data protection, and only upon achieving some specific turnover criteria in the previous four years. The Parliament position indicated TEVs should apply only to priority antimicrobials.
Obligation to supply and entry of generics on the market
The mandate to negotiate endorsed by the Council has introduced stringent requirements to ensure that medicines approved in the EU are effectively available in all Member States. The Commission’s initial proposal included an obligation to launch a newly approved medicine in all 27 EU countries within two years from the date of the marketing authorisation (MA), for products addressing unmet medical needs. This was intended to prevent “launch sequencing”, which typically leads to new products being launched in more favourable markets first and often leaves behind smaller markets.
According to the Council (Art. 56a), regulatory data protection should not apply to products that failed to be launched in all EU countries within four years from date of the initial MA, or if the product was not supplied continuously “in sufficient quantities and in the presentations needed to cover the needs of patients in a Member State” that requested the marketing authorisation holder (MAH) to supply the specific medicinal product.
To support the request to supply, Member States may take action such as requesting that the MAH to submit a valid pricing and reimbursement application. Member States may also introduce specific requirements in procurement procedures and establish a roll-out plan.
Information on products that failed the obligation to supply should be made publicly available by Member States without undue delay. In this instance, applications for marketing authorisation of generic and biosimilar medicines may be submitted and assessed by the European Medicines Agency or national competent authorities starting six years after the beginning of the data protection period of the reference product. In any case, the MA should not be granted before the expiry of regulatory data protection.
Reactions from the associations
Both EFPIA, representing the research-based pharmaceutical industry, and EuropaBio, on behalf of the biotech industry, commented on the Council’s position on the Pharma package as a “missed opportunity” to improve European competitiveness.
According to EFPIA, despite some improvements the negotiating mandate adopted by the Council is still not suited to tackle the competitive gap with other geographical regions. “In the face of a highly disruptive and unpredictable global environment, Europe needs clarity, stability, and a future-proof regulatory framework to support pharmaceutical innovation”, states EFPIA’s note. The choice to reduce intellectual property protection is considered particularly critical, and long-term consequences should be considered in order to support the sector.
Simpler and predictable rules are also central to EuropaBio’s comment, as a supportive General Pharmaceutical Legislation would allow for the development of a robust EU Biotech Act.
Medicines for Europe welcomed the Council’s position, as it would help to ensure more equitable access to medicines and support security of supply across the EU. “We will oppose attempts to extend incentives and intellectual property rights which are already provide the longest monopoly protections in the world”, stated the generic industry association. Other requests include harmonising the Bolar exemption to encourage the development of active pharmaceutical ingredients within the EU.
The Startup and Scaleup Strategy
In May, the Commission also presented its “Choose Europe to Start and Scale” strategy (link). The initiative aims to make the EU more attractive to technology-based global companies looking to develop their businesses, which are considered essential for boosting the European competitiveness.
Central to the entire strategy is the simplification and reduction of administrative burdens for startups and scaleups, which includes harmonisation of administrative procedures across Member States, digitalisation of processes for registration and compliance, and reduction of the time needed to obtain authorisations.
A key aspect of the strategy is the proposed establishment of the 28th business regime, which would enable startups and scaleups to operate across the EU under a unified legislative framework. This new regime would also harmonise fiscal rules and incentives for cross-border investment.
Several financial tools would support the European startup and scaleup ecosystem, including European venture capital, public mechanisms to support private investments and EU-regulated crowdfunding platforms. Horizon Europe programmes should be extended to include deep-tech projects, and funds should be available to support seed and early stage development. The Commission is also planning to create a specialised stock market for startups, on the example of the US’ NASDAQ, with simplified listing procedures.
The Lab to Unicorn initiative, announced for 2026, aims to favour connections between academic ecosystems across the EU. It should include a blueprint for licensing, royalties, revenue sharing and participation in capital, so to improve the transfer of innovation from universities to industry. Regulatory sandboxes should be used to facilitate the experimentation with emerging technologies. Other planned actions include the European Network for Innovation, which will connect research centres with investors, as well as measures to support intellectual property protection and talent attraction.
