Undeniably, the power and influence of pharmaceutical companies has increased in the context of the current pandemic. The politicization of pharmaceuticals is unprecedented. CEOs of the pharmaceutical industry pick up the phone and speak directly to EU heads of state and government. Businesses are elevated to the rank of key political interlocutors, with disproportionate weight and little accountability. During the process of supplying the EU with COVID-19 vaccines, the EU has repeatedly found itself dependent on the business plans of companies.
Meanwhile, the debate over access to medicines is enriched by new topics arising from the pandemic, such as the need for a resilient and diverse supply chain. Governments are trying to develop expertise on 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 information asymmetry between business and government. These are based almost exclusively on business input, which raises questions about the comprehensiveness and impartiality of the debate and possible policy recommendations. Industries set the agenda, highlight bottlenecks and steer the debate towards solutions tailored to their business interests.
This is another illustration of the excessive concentration of power in this sector of activity, which adds to the series of imbalances already recognized in 2016 in the revolutionary conclusions of the Council of Health Ministers of the EU. The ongoing structured dialogue illustrates another potentially worrying trend accelerated by the ongoing pandemic. There is a convergence of health and industrial policies, the second prevailing over the first. Businesses are pushing for flexibilities, public guarantees, more financial incentives and rewards, and using healthcare as a convenient entryway to getting what they want. Governments, however, have a glimpse, perhaps for the first time, into the manufacturing and pricing processes of companies.
In the meantime, unjustified prices remain a major concern for healthcare systems across Europe. This is why the emphasis placed by the Portuguese Presidency and the recent Council conclusions on the availability, accessibility and affordability of medicines are a welcome development. It is important not to lose sight of the debate on access to medicines in Europe. The EU should direct significant, needs-driven innovation towards better and affordable medicines and treatments. In the aftermath of the seismic events caused by COVID-19, the focus seems to be once again on providing faster and earlier access to whatever qualifies as innovation. It’s already seen. Pharma advocated for these programs not too long ago. He has now returned to these hackneyed themes, encouraged by the dynamic created by the pandemic.
Rigorous evaluation of innovation is the answer. The conclusion of the EU Health Technology Assessment (ETS) Regulation under the Portuguese Presidency is a success, but the long road to implementation is only starting now. Hypertension took a step back during the health emergency, most aspects having already been decided at the time of approval by the European Medicines Agency (EMA). This shouldn’t be the new normal. On the contrary, there is a need to intensify collaboration between ETS, patients, buyers and regulators to set the bar high for drug approval. Another excellent opportunity to lobby for comparative efficacy data is the review of drug legislation. This will give us a much better idea of how drugs work and their true therapeutic benefit. In the same vein, the review of EU legislation on orphans and pediatrics should not be delayed any longer.
All of the above highlights the need to strengthen DG Health and its public health mission. The explicit reference to the need for affordable medicines in the Health Commissioner’s mandate is more relevant than ever and should be a strong reminder of what the DG’s goal should be in the months and years to come.