EU reaches landmark pharma deal after marathon overnight talks
In the early hours, the Parliament and Council managed to reach a deal on one of the EU's most complex legislative proposals, the Pharma Package
When most of us were sleeping, the European Parliament and Council were hammering out a deal on the Pharma Package - a combined 400 articles in a regulation and directive. After eleven hours of intense negotiations on the fifth floor (5G3, to be precise), the deal was delivered.
The last eleven hours were the endgame in over two years of negotiations, starting in the last mandate and a previous parliament. In the meantime, the EU has been faced with profound geopolitical challenges. In 2025, this has taken the form of a chilling in trans-Atlantic trade relations and concerns over what Trump terms “most favoured nation pricing”, claiming that European countries are receiving an unfair price advantage in medicines.
Council maintain 11-year cap on protection periods
One of the most contentious issues was the length of regulatory data and market protection. Under the agreement, a medicine will receive eight years of regulatory data protection and one year of market protection during which generics and biosimilars cannot enter the market. This period may be extended in three circumstances, but not beyond eleven years.
An extra year can be granted to medicines that address an unmet medical need. A further extension is possible for products introducing a new active substance, subject to conditions such as conducting clinical trials across multiple EU countries. An additional year may be awarded for new therapeutic indications of existing medicines.
Negotiators also clarified the scope of the Bolar exemption, ensuring that generic and biosimilar manufacturers can prepare alternatives during the protection period. Parliament secured explicit confirmation that this includes participation in procurement procedures, health technology assessments, and pricing and reimbursement processes.
Dolors Montserrat (EPP, Spain), rapporteur for the Directive, said this clarity meant “the day after a patent expires, there will be market access for generics”. Tiemo Wölken (S&D, Germany), rapporteur for the Regulation, said he would have preferred a shorter baseline period but argued that the strengthened Bolar exemption and measures to improve access “struck the right balance”.
Adrian van den Hoven, Director General of Medicines for Europe, which represents the generic and biosimilar producers, described the compromise as progress, acknowledging the limitations of what was politically achievable. He noted that harmonized Bolar rules are crucial for preventing frivolous litigation and artificial delays to competition.
Van den Hoven also expressed disappointment that the reform did not go further in addressing inequalities in access, particularly affecting Central and Eastern Europe and smaller member states, but said the industry would continue working with EU institutions to address those gaps.
Voucher plan for antimicrobials agreed
Another major problem the Pharma Package aims to address is the need for new antimicrobials. The negotiators agreed to the transferable exclusive voucher (TEV) proposal, adding a year of data protection. The extension may be used once, for the priority antimicrobial or for another centrally authorised medicinal product by the same company (marketing authorisation holder) or traded with another marketing authorisation holder.
The Council and Parliament agreed on a “blockbuster clause” that will prevent the TEV from being used on products of gross sales of more than €490 million in the four preceding year, limiting the potential cost to healthcare systems.
Wölken said he wasn’t wholly in favour of the voucher scheme, preferring a subscription model, but added that MEPs had ensured that VET would not be misused and that the possibility of a subscription remained. The so-called ‘Netflix’ model being piloted in the UK and Sweden involves healthcare systems paying pharmaceutical companies a fixed annual subscription fee for access to new antibiotics, decoupling payment from the volume used.
Wölken said that companies would also need to provide an antimicrobial stewardship plan and include an evaluation of the risk for antimicrobial resistance as part of the compulsory environmental risk assessment. Both rapporteurs welcomed new measures to curb the use of antimicrobials by making them available only on medical prescription and by imposing tougher information requirements in the package leaflet, including an “awareness card”.
Shorter timelines and voting rights for patients
Wölken said that the revised legislation integrates crucial lessons learnt from the pandemic, particularly by streamlining regulatory timelines. The European Medicine Agency's (EMA) Committee for Human Medicines will now have 180 days instead of 210 to issue scientific opinions, a change Wölken described as one of the most difficult points of negotiation, but important for the Parliament.
The reforms also modernize EMA procedures by mandating electronic submissions using common formats and by making marketing authorisations valid indefinitely by default, except in cases where safety concerns justify time limits.
Crucially, Parliament secured membership and voting rights for patient organizations and healthcare professionals within key EMA committees. Wölken said this was essential to preserving the integrity of the European model, “voting rights are not a formality, they are a foundation of the inclusiveness of the EMA that strengthens its credibility and reliability.”
Danish Minister for Health Sophie Løhde welcomed the deal as a demonstration of Europe’s commitment to access and innovation: “The package marks a crucial step towards making a more resilient and dynamic life science sector in Europe, and it shows that Europe is able to make the necessary decision to protect European interests.”
The provisional agreement now needs to be formally endorsed by both the Council and the European Parliament. It enters into force on publication in the Official Journal and must be applied within 24 months, though the provisions on medicine shortages and TEV will be applicable from the date of publication.