By Benedetta Baldini, Health Policy Lead at the European Social Insurance Platform (ESIP) 

Solidarity. This defining principle of social protection across Europe is what makes our welfare systems citizen-centred and society-conscious. Applied to the healthcare sector, it means ensuring access to the best possible therapies to the widest possible audience. It means rationalising rather than rationing healthcare budgets, and safeguarding public health. Solidarity becomes ever more important in light of the successive crises Europe is currently going through.  

And yet, our health systems face a conundrum between making innovation available on the one hand, maintaining solidarity on the other. When new medicines enter the market with excessive prices and questionable levels of evidence, it is no longer a matter of affordability or cost-effectiveness only. Heath systems’ sustainability is challenged, and so is the capacity to respond to societal and patients’ needs. Decision-makers are confronted with the option of either promoting expensive treatments without adequate proof of value, or they risk being scrutinised for delaying access. This is particularly true for public payers, whose mandate is to defend solidarity by safeguarding sustainability for the benefit of all insured citizens.

Sometimes aggressive business strategies create or worsen imbalances in the European pharmaceutical ecosystem, threatening solidarity. Multi-layered information asymmetry is one of those and should be addressed both in terms of evidence generation and transparency of publicly funded biomedical R&D. This is necessary to ensure public return on public investment and applies to health products beyond pharmaceuticals.

We have a unique opportunity with the upcoming revision of the EU pharmaceutical legislation to reset the bar for regulatory evidentiary requirements and limit fast-track authorisation procedures to specific therapeutic areas and contexts. What has been relevant and necessary during the pandemic – to bring products to the market in the timeliest way – should not become the new normal in the absence of satisfactory proof of value. An adequate level of evidence and research targeting areas where is most needed should be the way forward to support informed decision-making along the a product’s life-cycle. Strongly recommended: dig into the ESIP-MEDEV amendments towards the EU general pharmaceutical legislation and find experts’ recommendations on how this rebalancing could be accomplished.

Access is at the crossroad of innovation, strong evidence, affordable prices and societal needs. Increasing and improving access via the legislative review passes through both availability and affordability of medicines. Importantly, it passes through the commitment of all actors involved to make these principles reflected in the ecosystem. Only this way the legislation could be fit for purpose for a sustainable and innovative future that ensures equitable access to better medicines for all. 

Disclaimer: the opinions – including possible policy recommendations – expressed in the article are those of the author and do not necessarily represent the views or opinions of EPHA. The mere appearance of the articles on the EPHA website does not mean an endorsement by EPHA. 

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