COVID Drives Cinderella to the European Ball-But Will the Slipper Pinch?

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Applied Clinical Trials

Europe was quick to claim, “world leadership” in the coronavirus outbreak. But with little evidence of any slowdown in diagnoses, the scrutiny that will accompany the greater appreciation, may prove to pinch like an ill-fitting slipper in the aftermath of the ball.

Europe was quick to claim, “world leadership” in the novel coronavirus outbreak (‘Europe claims “leading role” in combating COVID-19’, ACT 24 February 2020)-but its leadership at present appears to be mainly hosting the highest number of current new cases, and with scant evidence of any slowdown.

One of the consequences of the crisis, however, is that health-for long time considered a side issue in European policy circles-has been thrust into the spotlight as never before. In the European Union, which has never taken health seriously, because its treaties relegate nearly all health questions to national governments, the subject is now top of the agenda every day. Even for policy professionals close to the scene, it is becoming almost impossible to keep up with the flood of official reports, meetings, declarations, and proposals that emerge from the EU’s institutions even-in unprecedented fashion-late at night and during the weekends.

Just in the last week the European Commission has created its first ever stockpile of medical equipment, launched a COVID-19 advisory panel of epidemiologists and virologists to formulate EU guidelines on risk management, presented guidelines on health-related border management to keep medicines flowing across the continent, offered close to $100 million to Germany’s CureVac to scale up development and production of its candidate vaccine (and fought off a rival bid from US President Donald Trump to secure a US monopoly to the results), imposed restrictions on exports beyond the EU of personal protective equipment so as to maintain stocks at home, and announced a cornucopia of measures to counter the economic and social impact of the pandemic.

At the same time, there has been an almost constant stream of emergency health-related meetings in the EU Council (now routinely conducted by videoconference in a major break from tradition), ranging from summits of government leaders through to discussions among national ministers for transport, health, economy, or internal affairs.  Ambassadors and officials on numerous health-related EU committees have been in almost continuous session. And the European Medicines Agency, which says the rapid response to COVID-19 is its “number one priority”, has just issued a call for pooling research into large multi-center, multi-arm clinical trials “to generate sound evidence on COVID-19 treatments”. This follows up on its offer this week of free scientific advice to applicants for authorization of potential therapeutics or vaccines, and on the international workshop it co-chaired on global collaboration on vaccine development.

All this activity has propelled Stella Kyriakides, an obscure Cypriot psychologist, into international prominence in her recently-acquired role as the EU’s health commissioner-a distinction never attained by any of her predecessors, who have been largely ignored both by the public and also by their fellow commissioners with more meaty portfolios such as anti-trust, industry affairs, or trade. And it has given the subject of health a status in European policymaking that it has never before held.

 

Health advocates who have long complained of Europe’s neglect of health policy find-amid the general dismay at the catastrophe threatening most of the world-find some small crumb of comfort at this belated recognition of the significance of health, and will be unlikely to let it slide away once the crisis is eventually resolved. Health professionals who have often patiently labored in obscurity in under-resourced facilities are rightly now being hailed as heroes for their dedication in even worse conditions and much more pressing circumstances. Developers of medicines and vaccines also find some satisfaction in the sudden attention being paid to the role their work plays in in restoring, maintaining and protecting health.

But the new reality that will emerge on the other side of this pandemic may not be just a return to normality, augmented by a heightened appreciation for health workers and gratitude for medicine makers. The crisis is exposing wide-ranging deficiencies in health preparedness, even in the most advanced economies. One of the responses is likely to be a shift towards greater collaboration on health policy among national authorities in Europe-something conspicuous by its absence until now among governments jealous of their own sovereignty. Another will be a development of pan-European infrastructure in areas ranging from surveillance systems to specialist care facilities. And another foreseeable move-perhaps of greatest significance for people working in clinical trials-is a profound review of the entire process of developing health technology.

The lack of a preventive vaccine or an effective treatment for COVID-19 has come as a real shock to many policymakers, until now ignorant and even uncaring of the underlying science and innovation effort required in research and development. Even the president of the European Commission, Ursula von der Leyen, herself a physician, had to be corrected by the European Medicines Agency when she optimistically pronounced this week that an effective vaccine would be available this autumn. Awareness of the havoc wrought by COVID-19, because of the limited armamentarium available to counter the virus, will drive new efforts at averting a repetition. That will doubtless translate into welcome new funding for research. But the desire for results may also translate into new readiness to impose guidance on that research, which may not be so welcome. Dissatisfaction and impatience with the business model for private-sector drug development-already bubbling vigorously before the outbreak-will have been compounded by what will doubtless be painted as a dysfunctional system focusing on profit rather than health, and the policy outcome could well be demands for greater public control. A combination of closer collaboration among governments and a reworking of infrastructure could even see such state control elevated to European level. Already the president of the European Parliament, David Sassoli, has called for the creation of a European medicines’ product facility.

At present minds are-correctly-focused on tackling and overcoming the immediate health challenge and the longer-term challenges that will result for the economy and for society at large. But for many working in the health sector, the closer scrutiny that is certain to accompany the greater appreciation may prove to pinch like an ill-fitting slipper in the aftermath of the ball.

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