Will 2020 Just be The Year of COVID-19?


Applied Clinical Trials

After 2019 was defined by Brexit, 2020 threatens to be defined by another novel virus, wreaking damage across the world.

In Europe, 2019 was the year of Brexit-a virus in its own right, infecting the body politic in Europe with a new strain of institutionalized, mendacity, and deluded self-interest. That disease may never be cured: the UK is still on course to pursue its self-destructive ideology, and finally depart the European Union at the end of this year. Its unhappy fate has been decided by a slender majority, and its citizens are destined to suffer the consequences their ill-advised leaders have led them into. And the European Union too has been severely damaged by the UK’s withdrawal, both materially, and by the divisions and distractions that it has generated.

2020 is the year of Covid-19-another novel virus, wreaking damage across the world in personal, social, economic, and political terms. But here there is hope that the disease may be contained, prevented, and even cured. Although the initial responses it provoked in parts of Europe (and indeed elsewhere in the world) were largely self-protective, with border closures and private and public hoarding of food, medicines and medical equipment, a more cooperative trend is now apparent, which is already palliating some of the worst effects of the virus, and might in time lead to a more durable sense of common purpose extending far beyond the specific challenge of the virus itself. The widespread readiness of populations to accept the trade-off of personal freedom against the interests of the common good is perhaps the most striking example.

There is a comparable engagement in a common cause in the new readiness of private sector drug companies across much of the world to work together, even pooling their data in the search for prevention and cures-a development already widely reported on and rightly lauded.

Another significant shift among private sector manufacturers (even those considered among the most aggressive defenders of intellectual property rights) is the recognition that – at least in certain circumstances-monopolies over innovations are not always and necessarily a good thing: the overwhelming reality is dawning that customary patent protection and related rights licensing would not serve to meet the scale and urgency required for production of adequate quantities of a vaccine to combat Covid-19.

Similarly, new ground is broken by the international acknowledgement that provision of effective therapies against the virus should not be governed by the usual pricing arrangements-a message clearly enunciated by government after government, but also  now boldly signaled by the US industry’s PhRMA member companies’ commitment “in these unprecedented times” to ensure that new treatments and vaccines will be “available and affordable”, and by the echo in almost exactly the same words from the European industry’s EFPIA.

But in Europe the recognition of new ways of working to deal with new circumstances goes further than that. It is evident in the acceptance by European leaders that they must forsake their accustomed cozy gatherings in Brussels and take decisions instead by video-conference. It is evident in easing of anti-trust rules to help drug makers adapt production to meet new demands: in early April the European Commission gave companies new flexibility to exchange information on sales and stocks to reallocate stocks, to share aggregate information on gaps in supply, and even to re-organize production to increase output of urgently-needed medicines without causing under-production for other medicines-normally deemed anti-trust behavior.

Perhaps most remarkably, the concept of sharing has received a boost from the European Medicines Agency, with a powerful plea to the EU research community to conduct themselves in a way that will maximize the chances of finding treatments for COVID-19. The request ranges from prioritizing large randomized controlled studies (“because they are most likely to generate the conclusive evidence needed”) to following a harmonized European approach to data collection and a robust methodology for clinical trials “to make best use of the available supply of investigational agents.” In a daring intrusion into the hallowed world of autonomous clinical research, it says it is “concerned that clinical trials with a small number of participants or compassionate-use programs might not generate the data required to draw firm conclusions.”

The unprecedented nature of the pandemic challenge is profoundly altering mindsets and demonstrating the evident merits of greater coordination. This is making thinkable what has until now been unthinkable. The harsh-and in many places unwelcome-realization that everyone is in this together, whether they like it or not, is obliging even the most stubborn to consider that that the old ways are not the only ways. The crisis is forcing open many hitherto locked-down positions, breaking many traditional taboos. The implications are as wide for international affairs generally as they are for clinical trials and for healthcare organizations. A successful response to this coronavirus could be more than a cure for one new disease: it could also open new directions and release new energies for more efficient, more collaborative-and yes, even for more equitable-ways of organizing human behavior. That could mean 2020 being remembered not so much as the year of Covid-19 but as the year of new collaboration.

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