Undeniably, pharmaceutical companies’ power and influence have grown in the context of the current pandemic. The politicisation of pharmaceuticals is unprecedented. Pharma CEOs pick up the phone and talk directly to EU heads of state and governments. Companies are elevated to key political interlocutors, with disproportionate clout and little accountability. During the EU COVID-19 vaccines procurement process, the EU has found itself repeatedly dependent on companies’ business plans.
Meanwhile, the access to medicines debate is enriched with new topics arising from the pandemic, such as the need for a resilient and diversified supply chain. Public authorities strive to build expertise over issues that were not previously on their radar. The structured dialogue on supply chain resilience launched by the European Commission is an example of the striking asymmetry of information between companies and public authorities. The latter rely almost exclusively on companies’ input which raises questions of how comprehensive and unbiased the debate and eventual policy recommendations are. Industries set the agenda, highlight the bottlenecks and steer the debate towards solutions tailored to their business interests.
This is yet another illustration of the excessive concentration of power in this business sector, which adds to the series of imbalances recognized already in 2016 in the groundbreaking EU Health Ministers’ Council Conclusions. The ongoing structured dialogue exemplifies another potentially worrisome trend accelerated by the ongoing pandemic. There is a convergence of health and industrial policies with the latter prevailing over the former. Companies are pushing for flexibilities, public guarantees, more incentives and financial rewards, and use health as a convenient entry to get what they want. Governments however have insights, perhaps for the first time, into companies’ manufacturing and pricing processes.
In the meantime, unwarranted prices remain a key concern for health care systems across Europe. This is why the Portuguese Presidency’s emphasis and recent Council Conclusions on the availability, accessibility, and affordability of medicines are a welcome development. It is important not to lose focus in the access to medicines debate in Europe. The EU should steer meaningful, needs-driven innovation towards better and affordable medicines and treatments. Following the seismic events caused by COVID-19, there seems to be renewed emphasis on speedier and earlier access to anything which is branded as innovation. This is déjà vu. Pharma has advocated for these agendas not long ago. It has now returned to these well-worn themes, encouraged by the dynamic created by the pandemic.
Robust evaluation of innovation is the answer. The conclusion of the EU Health Technology Assessment (HTA) regulation under the Portuguese Presidency is a success but the long journey towards implementation only starts now. HTA took a back seat during the health emergency with most aspects being already decided at the time of approval by the European Medicines Agency (EMA). This should not be the new norm. On the contrary, there needs to be intensified collaboration between HTA, patients, the buyers, and the regulators to set the bar high for medicines’ approval. The review of pharma legislation offers another prime opportunity to push for comparative effectiveness data. This will give us a much better idea of how medicines work and their true added therapeutic benefit. On a similar note, the review of the EU orphans and pediatrics legislation should not be further delayed.
All the above point to the need for DG Sante and its public health mission to be strengthened. The explicit reference to the need for affordable medicines in the Health Commissioner’s mandate is more pertinent than ever and should be a strong reminder of what the DG’s focus should be in the months and years to come.