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Budget battle threatens efforts to bolster Europe’s pharma strategy.
The day that the European Union’s leaders decided to slash planned spending on health may seem an odd choice for commenting on European aspirations for better access to medicines—but writers react to events, they do not dictate them.
It came as a shock to the health community that the battles over the next long-term EU budget should be resolved in part by cutting new health spending to the bone, but that is what happened as dawn broke over Brussels on July 21—the Belgian national holiday, by coincidence. After five days locked up in the EU’s headquarters, the heads of government emerged to announce that a compromise had been struck between those countries wanting more spending on the recovery from the pandemic, and those wanting less. And right in the middle of that collision was the recently-announced plan for a multi-billion dollar program to give Europe a meaningful engagement with health policy—a response to COVID-19 and to longstanding calls from health advocates. At a stroke, all the jubilation that greeted the plan’s unveiling in May evaporated. Instead of the budget initially proposed of $10 billion, the harsh negotiations among member states left it with less than $2 billion—and with a wave of dismay.
The EU leader’s decision seemed all the more discordant with the rest of their conclusions, which opened with grandiose statements of sympathy for COVID victims and commitment to remain focused on protecting public health, and went on to extol at length the importance of European renewal. Their approach has also thrown cold water over a burgeoning sense in Europe that a real health policy was about to emerge. Recent weeks had seen not only promises of a multi-billion dollar program, but also plans for EU acquisition of vaccines and drugs for coronavirus, detailed discussion of an EU-led renaissance of pharmaceutical manufacturing, and the promise of a pharma strategy—discussed at length by Europe’s health ministers only a week before the leaders’ summit.
A public consultation on what the pharma strategy should focus on has just been completed by the EU, and the enthusiastic responses—nearly 250 of them from healthcare organizations, government bodies, and private individuals—provide an intriguing snapshot of what Europeans want from medicines.
What the pharma industry wants is predictable. The major European association, EFPIA, welcomed the consultation document’s complimentary comments about the importance of the pharma sector, and the commitment it appears to give to “to support the European pharmaceutical industry to ensure that it remains an innovator and world leader.” But it also insisted on the need revealed by the coronavirus crisis “for an infrastructure and policy environment that supports medical research in Europe,” for “incentives for innovation,” and for “faster processes for drug approval and reimbursement, length, processes, and evidence requirements preceding a national product launch.” EUCOPE, which represents smaller research-based firms with a strong focus on rare diseases, particularly highlighted the importance of strong intellectual property protection to attract investment to Europe. But Medicines for Europe, the generic industry association, focuses its hopes on policies that prioritize off-patent medicines policies, and wants to see tighter limits on patent protection.
Different priorities are on display from other influential players in the European pharma drama. The international health insurance agency AIM puts “fair prices” and “affordable medicines” as the top of its list and insists on retention of randomized clinical trials in regulatory procedures. A European insurance body, ESIP, says any incentives for innovation should be “linked to market launch obligations that ensure equitable access across the EU as well as continuous supply.” Doctors share these views. Their European body, CPME, says “Europe needs a pharmaceutical strategy that provides citizens with medicines they need at a price they are able to pay. The strategy must enable the EU to tackle the unaffordability of innovative therapies as well as shortages and other problems with the availability of off-patent medicines.” And the Association of European Cancer Leagues also takes a skeptical view of drug pricing, with a focus on ensuring timely access to affordable medicines and financial sustainability of national health systems, and with the introduction of “robust methods for the calculation of R&D and production costs.”
What will happen to these multiple (and disparate) hopes if funding—and powers—for EU engagement in health policy are going to be reduced is impossible at this stage to predict.
REFLECTOR is Pharmaceutical Executive’s correspondent in Brussels