We have come a long way in a short period of time since the adoption of the groundbreaking June 2016 Council Conclusions on pharmaceuticals. The conclusions were a milestone for the access to medicines debate as they signaled the political acknowledgment of the series of imbalances in pharmaceutical systems in Europe. Since then, much has happened in this area and much more since the start of the current pandemic. On one hand, it is true that in light of the pandemic, never before had pharma CEOs had the ear of heads of states and top government officials as they do today but at the same time, the public health emergency has acted as a catalyst for procedures that would normally take years. For example, it is indeed an important success to see governments working together, exchanging information, negotiating jointly and even buying vaccines against COVID19 together.
The use of the Joint Procurement Agreement instrument for the purchase of remdesivir is another impressive precedent. In light of the high prices of most new medicines as well as the pandemic experience, working together appears to be an irreversible political choice for some Member States and an even more appealing one for some others. Joint procurement efforts should therefore be facilitated by the European Commission. The work of BeNeLuxa might have slowed down during the past months due to the COVID19 crisis management but there is no reason to believe that it will not pick up again once the pandemic is behind us or when the next excessively priced oncological product is on the market.
The cost and impact of patent-based monopolies-exclusivities on competition and the public (health) expenditures is another area the European Commission should look at when thinking of rewarding manufacturers with incentives. The correlation between corporate mergers-acquisitions across pharma, the quality of innovation and the affordability, and access to medicines also need to be carefully analysed. Moreover, the performance and business conduct of pharmaceutical industries (inputs, activity, outputs) needs to be examined. This would look at how pharma responds to health care needs, taking into account their resources and how they are used. It would contribute to much-needed transparency in the pharma systems. Moreover, the EU should strengthen pharmacovigilance to guarantee patient safety. In the immediate future, the European Commission and Member States should invest in putting a strict monitoring system in place to assess the safety and effectiveness of potential COVID19 vaccines.
In addition, the pandemic points to the fact that biomedical innovation is a result of public and private investment. It demonstrates that transparency is not a “nice-to-have” but a fundamental pillar of public trust in the handling of the emergency, the safeguard of public health and the protection of patient safety. Overall, governments should work hand in hand with the industry, without writing a blank cheque. The current circumstances should not pave the way for deviations nor negative precedents (lowering of evidentiary standards, secrecy, waste of public funds etc) with lasting consequences beyond COVID19.
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