Challenges for the Regulatory Industry in times of COVID-19
Challenge 1: The current epidemiological situation is unprecedented. This gives rise to very serious concerns and radical changes to every aspect of our lives. There are clearly, therefore, challenges to any overall coordination at the EU level against COVID-19. Harmonisation hasn’t always been the EU’s strong suit. Countries have improved from the early days of the pandemic, when they imposed export bans and fought over personal protective equipment. But they’re still not deploying the same testing policies, quarantine rules, travel guidance or tracing apps. Most recently, countries couldn’t agree to harmonized travel restrictions after more than a month of negotiations.
Challenge 2: The overall coordination effort. This is based on the best available science and applies to many strategies, notably regarding testing (testing strategies, the joint assessment of testing methods, the mutual recognition of tests) but also cross-border relations (quarantine regulations, cross-border contact tracing). It’s difficult to devise more targeted strategies. In September, Andrea Ammon (Director of the European Centre for Disease Prevention and Control [ECDPC]) declined to recommend that all EU countries close bars and restaurants. Instead, she urged countries to be vigilant in surveillance, identifying hotspots, reducing opening hours and limiting capacity.
Challenge 3: The EU has virtually no legal authority over health policy. National governments remain unwilling to take cues from Brussels. The push by national politicians to resume normal life seemed to clash with scientific advice and defy the visible increase in reported infections. Scientific advice was clear — impose lockdown or face catastrophe — but unfortunately government ministers around Europe repeatedly ignored these calls. This pattern was repeated as a second wave approached, when again strong advice and scientific proposals were not acted upon by government. Across the EU, public health experts had long warned that the virus would continue to pose a grave threat until the arrival of a vaccine (or vaccines) — which still remain many months away, at least.
Challenge 4: Rising caseload in Europe. One reason for this is that countries have drastically increased testing. Another clear trend is that the virus is now circulating largely among healthier young people, which has meant overall fewer hospitalization rates and fatalities. Moreover, doctors know much more about how to treat COVID-19 with drugs. However, a rise in deaths is still almost certain — it’s simply a matter of numbers. At least 9 in 10 of us remain uninfected and therefore are assumed to be susceptible. If governments do not act now to reduce cases, we are facing an even larger epidemic than during the first wave, with catastrophic consequences not just in terms of direct Covid-related deaths but also on the ability of health services to meet needs.
Challenge 5: Issues around potential vaccines. This applies not just to their development and distribution, but also the need for a robust authorisation and monitoring process, the building of vaccination capacity in the EU, and ensuring fair and affordable access for all. In June, the Commission unveiled its first vaccine strategy to secure advance purchase terms for possible vaccines. After months of talks, the Commission completed contracts with three producers and is in the process of completing three more. Rolling out a vaccine will be one of the next major tests of countries’ willingness to coordinate. The Commission’s latest communication seeks to synchronise vaccination plans, primarily to ensure a vaccine will be given free and first to key populations incl. flexible ways to label and package vaccines, which industry has said would make it quicker to distribute their jab. Countries also need to fight vaccine hesitancy head-on by stressing the EU safety standards required; get systems in place to share data; and prepare to study the safety and effectiveness of vaccines independent from pharma companies.
References
At Legal writing experts, we would be happy to assist in preparing any legal document you need. We are international lawyers and attorneys with significant experience in legal drafting, Commercial-Corporate practice and consulting. In the last few years, we have successfully undertaken similar assignments for clients from different jurisdictions. If given this opportunity, we will be able to prepare the legal document within the shortest time possible.