The International Association of Mutual Benefit Societies (AIM) acknowledges the political agreement reached on the revision of the EU pharmaceutical legislation, a reform that will have a significant impact on access to medicines, market dynamics, and the sustainability of healthcare systems across the European Union. While the agreement contains positive elements, the agreement represents a missed opportunity to further strengthen affordability through shorter and more targeted incentive periods.

Mutuals and solidarity based not for profit health insurance funds need predictability of the costs
From a health and insurance funds perspective, AIM underlines the importance of a balanced and predictable incentive framework. The agreed cap on regulatory data and market protection is a positive step, as it provides legal certainty while preserving timely competition from generics and biosimilars, which is an essential driver of affordability and long-term system sustainability. Greater ambition on reducing incentive durations could have further enhanced cost predictability for not-for-profit health insurers.

Early access to generics and biosimilars is key for patients
AIM welcomes the reinforcement of the Bolar exemption and the clearer patent-related provisions supporting the earlier entry of generics and biosimilars. These measures are essential to ensure that effective competition can begin promptly once protection periods expire. AIM also welcomes the strengthened EU approach to the prevention and management of medicine shortages. The enhanced role of the European Medicines Agency in monitoring and responding to critical shortages represents a meaningful improvement in coordination and transparency, to the benefit of both payers and patients.

Incentive mechanisms should not undermine affordability
At the same time, AIM remains concerned about the potential budgetary and sustainability implications of new or extended incentive mechanisms if they are not strictly targeted, proportionate, and clearly linked to public health benefit. Incentives that are insufficiently conditioned or monitored risk undermining affordability and limiting the capacity of healthcare systems to finance innovation over the long term. This concern is particularly relevant in the context of incentives that extend market exclusivity without sufficient safeguards for affordability.

In this context, AIM underlines the importance of ensuring that any new or rebranded incentive categories, including references to so-called “breakthrough” orphan designations, are clearly and narrowly defined. Incentives intended to address high unmet medical needs must be closely linked to well-established criteria to prevent unintended consequences such as orphan slicing or the extension of orphan incentives to non-orphan indications. Clear definitions and robust safeguards will be essential to ensure that such mechanisms genuinely target unmet needs while preserving affordability and system sustainability.

Added therapeutic value of innovation needs robust clinical evidence
AIM stresses that incentives for pharmaceutical innovation must remain firmly linked to robust clinical evidence and demonstrable added therapeutic value. Comparative clinical trials should continue to play a central role in regulatory and reimbursement decision-making, rather than being used primarily as a mechanism to extend market exclusivity.

New incentive mechanisms must ensure access for patients and safeguard sustainability of health care systems
The revised framework must ultimately deliver equitable access to medicines for patients while safeguarding the financial viability of Europe’s solidarity-based healthcare systems. Any new incentive mechanisms should be carefully designed, transparently governed, and closely monitored to ensure proportionality between public rewards, public health benefit, and budgetary impact. In the specific case of antimicrobials, AIM recognises the need to address market failures, but stresses that any dedicated incentives must ensure affordability, responsible use, and clear public value, without creating unsustainable cost pressures for healthcare systems.