The Covid-19 pandemic has highlighted the weaknesses of the pharmaceutical systems in Europe. Both Member States and lobbies are calling for strong measures to address drug shortages. In response to this pressure, the European Commission has revised its work schedule. According to a provisional timetable, it is expected to present its solutions on 29 July, instead of at the end of the year.
This strategy was at the heart of the Health Ministers’ videoconference on Tuesday 12 May. According to our information, all delegations stressed the need to find common solutions to common problems.
“The crisis has amplified or exacerbated the problems we already knew existed and were already discussing, but it is now more than ever evident that we need a strategic approach to limit dependency on single manufacturers or countries and that we establish the means to produce essential medicines within the EU”, said Commissioner Stella Kyriakides, in her introduction. “This will be a key focus of the new pharmaceutical strategy, which will address availability, affordability, sustainability and security of supply”, she continued.
A more sustainable platform for dialogue
During the round table, it seems that the EU27 supported the idea of a more structured dialogue with the pharmaceutical industry. In a preparatory document, the Croatian Presidency of the EU Council asked the ministers about the way forward, i.e., creating a new structure or to rely on existing structures (see EUROPE 12484/3). “Nobody is against it, but nobody really asked for anything new. On the other hand, a few Member States have asked to use existing structures and recalled the importance of not duplicating the work of the European Medicines Agency (EMA)”, says a well-informed source.
In the European Parliament Committee on the Environment, the Executive Director of the EMA recalled that he was fully mobilised during the Covid-19 crisis. “Although drug shortages are managed by national authorities, the EMA has been asked to activate its programme of support to Member States”, said Guido Rasi, referring to the EU Executive Steering Group on shortages of medicines caused by major events, set up in March. He indicated that, so far, this work is going quite well, but that longer-term solutions are needed.
The pharmaceutical strategy is eagerly awaited
And this is precisely what the future pharmaceutical strategy currently being prepared by the European Commission is expected to propose. Parliament, for its part, intends to fuel the debate with an own-initiative report prepared by Nathalie Colin-Oesterlé (see EUROPE 12482/1).
On the stakeholders’ side, ideas are coming to fruition. For the European Public Health Alliance (EPHA), high drug prices remain a real problem for patients and health systems across the EU. “The scarcity of resources and financial constraints post-Covid will only make this worse”, notes Yannis Natsis. According to him, the pharmaceutical strategy should address the lack of transparency in the pharmaceutical industry as well as the imbalances (notably in terms of power and information) in the pharmaceutical systems in Europe. And he goes on to say, “The supply chain disruptions we are experiencing today could have been predicted and prevented by the industry.”
The European Association of Hospital Pharmacists (EAHP) hopes that the new European strategy will provide a tailor-made response to the different causes of shortages (which 95% of hospital pharmacists identify as a major problem). It wants a pharmaceutical strategy that will allow, among other things, “diversifying the sources of active pharmaceutical ingredients”, stresses Stephanie Kohl.
For the Standing Committee of European Doctors (CPME), the importance of the affordability of medicines, in particular innovative medicines, is highlighted when discussing the issue of accessibility. “The upcoming pharma strategy should address the abuse of the current model of pharmaceutical incentives and restructure the untransparent R&D model that results in a diminishing rate of pharmaceutical innovation and high prices. Any EU funding should have public-interest conditionalities attached to it ”, notes Miriam D’Ambrosio. The CPME calls for greater transparency in pricing and recommends a multidimensional approach, ranging from the added therapeutic value to the ability to pay and the costs of a treatment.
The European Federation of Pharmaceutical Industries and Associations (EFPIA) did not respond to our questions, unfortunately. However, at an online conference in April, industry experts called for more regulatory flexibility (see EUROPE 12470/7). (Original version in French by Sophie Petitjean)