A medicine approved in Brussels can take years to reach patients in Warsaw or Bucharest. A long-awaited compromise on the EU’s pharmaceutical reform aims to narrow the gap between regulatory approval and patient access across the bloc, with new rules on medicine launch obligations and a revised incentive for developing antibiotics. The agreement now heads to the European Parliament’s health committee on 18 March.
Documents endorsed by EU ambassadors in the Committee of Permanent Representatives (COREPER) on 6 March translate the political agreement between the European Parliament and the Council into detailed provisions. The text clarifies how launch obligations will operate, restricts the use of the transferable exclusivity voucher (TEV), and explains how regulators will determine incentives linked to unmet medical need. Several provisions introduce operational safeguards added during the final stage of negotiations.
Stronger tools against delayed launches
Delayed medicine launches across EU member states were among the most politically sensitive issues in the negotiations. Several governments argue that pharmaceutical companies often prioritise larger or higher-price markets when introducing new medicines, leaving smaller or lower-price countries to wait years before products become available.
“We need equal access to medicines in all member states. Differences between EU member states can now reach up to two or more years,” said MEP Dolors Montserrat (EPP, ESP), the European Parliament rapporteur for the directive when presenting the pharma package deal back in December.
New mechanism for market availability
Earlier drafts of the reform referred broadly to improving medicine availability across the EU. The compromise text now introduces a more operational mechanism, defining the steps national authorities may request when a centrally authorised medicine is not marketed in their territory.
Under the new rules, member states may ask the marketing authorisation holder to submit pricing and reimbursement applications, request participation in public procurement procedures, or agree on a supply rollout plan. Such requests must be made within one year after the medicine receives EU marketing authorisation.
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Three-year deadline and territorial loss of protection
The text also clarifies what happens if those steps fail to lead to market availability: a medicine must be made available and continuously supplied within three years after such a request, or regulatory protection may cease to apply in that member state.
The limitation is territorial: the loss of protection would apply only in the member state where the medicine is not supplied, rather than across the EU.
In practice, this could allow generic or biosimilar competitors to enter earlier in countries where the originator product is not available.
If a member state asks the pharmaceutical industry to bring a medicine to its market, the company is obliged to do so. If you are not there, that innovative drug will lose market protection in that country.—MEP Dolors Montserrat (EPP/ESP), European Parliament rapporteur
MEP Montserrat said the mechanism is intended to ensure medicines reach all EU markets. “If a member state asks the pharmaceutical industry to bring a medicine to its market, the company is obliged to do so. If you are not there, that innovative drug will lose market protection in that country,” she said in December.
Patient groups’ access demands
Patient organisations have broadly supported measures aimed at addressing delayed launches. The European Patients’ Forum (EPF) had called for obligations requiring companies to submit pricing and reimbursement applications when requested, as well as clear deadlines and sanctions.
The compromise text reflects part of that demand, introducing a three-year deadline after which regulatory protection may be lifted in countries where medicines are not supplied.
Industry groups warn, however, that linking regulatory protection to supply conditions could create uncertainty for companies navigating national pricing and reimbursement systems.
EUCOPE, which represents small and mid-sized pharmaceutical companies, said the mechanism risks placing responsibility for access delays primarily on companies despite the central role of national reimbursement decisions.
“Ensuring timely access requires addressing the broader market access environment across EU member states, not only modifying regulatory incentives,” the organisation said.
Antibiotic incentive preserved but tightened
The compromise text also introduces additional safeguards for the transferable exclusivity voucher, a key incentive designed to stimulate investment in new antibiotics.
The Commission may grant a transferable data exclusivity voucher for a priority antimicrobial following a scientific assessment by the European Medicines Agency.
The voucher grants its holder an additional 12 months of regulatory data protection, which companies may apply either to the antimicrobial itself or to another centrally authorised medicinal product.
Transparency rules for public funding
The final text also introduces new transparency requirements for companies receiving the incentive: developers applying for the voucher must disclose any direct public funding received for antimicrobial research and publish this information online after marketing authorisation.
Patient organisations had called for stronger transparency provisions in the pharmaceutical reform. EPF argued that public funding supporting the development of new medicines should be disclosed to improve accountability and support equitable access — a demand the compromise text reflects by requiring companies receiving the antimicrobial voucher to report any direct public funding linked to the development of the product.
Restrictions on voucher use
The compromise introduces several limits on how the voucher may be used: the incentive may only be applied once and only to a single centrally authorised medicinal product.
If applied to a product other than the antimicrobial, the voucher may only be used during the fifth or sixth year of the regulatory data protection period, and only if annual gross EU sales during the first four years after authorisation did not exceed €490m.
Companies must demonstrate that those sales figures are accurate and verified by an independent external auditor.
The text also limits secondary trading of the incentive: the voucher may be transferred to another marketing authorisation holder but cannot be transferred further. The value of any transfer must be notified to the European Medicines Agency and will be made publicly available.
The Commission may also revoke the voucher before transfer if requests from member states or the EU to supply the priority antimicrobial are not fulfilled.
Industry warns on predictability
Antibiotic developer Shionogi welcomed the inclusion of both the transferable exclusivity voucher and the proposed subscription-style procurement model, saying the measures signal EU support for antimicrobial innovation.
However, the company stressed that the real impact of the incentives will depend heavily on how they are implemented. “The actual potential of the two tools to boost investment in antimicrobial R&D will depend significantly on their implementation,” the company told EU Perspectives, adding that getting the technical implementation right will require “in-depth consultation with industry stakeholders.”
Companies need clarity on eligibility rules well before submitting a marketing authorisation application in the EU, Shionogi said, as this is necessary for the voucher to support investment.
Shionogi also said the terms of the planned subscription-style procurement model will need to be clearly defined for both member states and companies to ensure that the system is workable.
Predictability remains a central concern for investors in antimicrobial innovation. Developing a new antibiotic typically takes 10 to 15 years from discovery to approval. The most expensive phase occurs five to ten years before market entry. Companies therefore need confidence that the incentive framework will still exist when a product eventually reaches the market, the company said.
Voucher restrictions and economic value
Shionogi also warned that restrictions introduced in the compromise text could affect the economic value of the voucher. “The economic value of the TEV will depend heavily on how it can be used in practice,” the company said.
Limits such as the €490m sales threshold, sometimes described as a “blockbuster clause” and restrictions on when the voucher can be applied may reduce its value, the company noted.
What matters, the company said, is that sufficient economic value remains to support long-term investment decisions in antimicrobial R&D. “Thorough industry consultation will be imperative to ensure the success of the voucher,” it added.
We have strong reservations about the agreed transferable exclusivity voucher, which could result in a significant extension of the protection period for other more expensive medicines, for example cancer treatment.—The Standing Committee of European Doctors (CPME)
Doctors warn of potential cost implications
Public health organisations and medical professionals have also expressed concern about the broader implications of the mechanism. The Standing Committee of European Doctors (CPME) warned in their recent publication that the voucher could extend exclusivity for other high-cost medicines if used on blockbuster products.
“We have strong reservations about the agreed transferable exclusivity voucher, which could result in a significant extension of the protection period for other more expensive medicines, for example cancer treatments,” CPME said in its spring policy magazine.
“We are concerned about a scope-creep. The introduction of the voucher may lead to similar mechanisms being demanded for other types of medicine in future, opening a Pandora’s box resulting in higher costs for healthcare systems,” the organisation said.
Incentives and regulatory assessment
The compromise text also clarifies how incentives linked to unmet medical need will be assessed. While the definition remains broadly consistent with earlier negotiation stages, the final wording confirms that regulators will determine whether a medicine qualifies during the scientific evaluation of the marketing authorisation application.
Industry stakeholders say this timing could create uncertainty for companies planning long-term investments. EUCOPE warned that developers may only learn whether their product qualifies for additional incentives during the final regulatory assessment.
“The proposed modulation of incentives creates more unpredictability for marketing authorisation holders,” the organisation said.
Next steps
Following COREPER’s endorsement, the compromise text will move to the European Parliament. The Public Health Committee (SANT) is expected to vote on the agreement on 18 March, before a plenary vote and formal adoption by the Council of the EU.
