How one court could prolong global COVID misery

With new coronavirus cases and deaths spiking across the globe, much-needed welcome news about combatting the pandemic is finally coming — not from government officials but rather pharmaceutical companies. Pfizer and Moderna have announced clinical trials results indicating that their respective prototype COVID-19 vaccines have a 90 percent-plus effectiveness rate against the coronavirus. 

Those encouraging trial results are especially good news for Americans, as this past summer the federal government placed over 1 billion orders in total for the two different vaccines. When combined with procurement commitments from at least six other drug makers, the U.S. has cemented contracts for nearly 2 billion doses of promising COVID-19 vaccine candidates.

The European Union on the other hand, despite having a larger population than the U.S., has only secured less than half as many orders for vaccine doses. How could it be that the EU — perpetually hailed by public health experts as the model for government pandemic response planning — is so far behind obtaining one of the most integral components for stamping out COVID-19? The answer is simple: liability fears.

Extraordinary courtroom payouts for pharmaceutical-related injuries is typically considered a uniquely American phenomenon. Europe, however, currently has the dishonor of being the venue most terrifying to pharma companies thanks to a 2017 European Court of Justice decision that made it substantially easier to hold drug makers liable for damages allegedly caused by their products.

In N.W. et al. v. Sanofi Pasteur MSD, the ECJ reviewed the case of a French man who claimed that a defective hepatitis vaccine shot caused him to develop multiple sclerosis. The drug company defended itself by arguing that there was no scientific consensus on a link between its vaccine and the plaintiff’s injury, a fact that typically defeats liability claims. But not so for the ECJ. It instead held that in the absence of a scientific consensus linking the drug to the injury, vaccine makers could still be held liable when a drug defect is the “most plausible” explanation for the plaintiff’s injury.

The ECJ’s Sanofi decision — and the liability fears it sparked — has been repeatedly cited as one of the key reasons why the EU lags so far behind the U.S. in finalizing COVID-19 vaccine contracts. Vaccine makers have made it clear that they will not sell to the EU without some sort of government-backed liability guarantee.

EU officials in turn have refused to offer any blanket liability protection to promising vaccine candidates, instead choosing to haggle with each individual vaccine maker over liability limits terms. Those negotiations have delayed vaccine contract negotiations for months, leaving the average European at the back of the vaccine queue.

The EU’s failure to proactively address liability issues is all the more stunning considering that the United States wrapped up that same issue nearly two decades ago.

Back in 2005, having foreseen the need to prepare the U.S. government to respond to a massive public health crisis like a bioterrorist attack or a pandemic, Congress and the George W. Bush administration crafted the Public Readiness and Emergency Preparedness, or “PREP” Act.

Included in the PREP Act is the federal government’s ability to suspend multiyear testing requirements and approve emergency use of desperately needed novel drugs, including vaccines. Even with that emergency approval, PREP Act drafters knew pharma companies would still be loath to ship new drugs due to fears of endless litigation over alleged defects not teased out by the otherwise required clinical trials. So, they added into the PREP Act the extra carrot of barring legal claims against makers of those same emergency-approved drugs.

The firmly established liability protections of the PREP Act have made all the difference when it has come to the U.S. finalizing vaccine contracts. Unlike with the EU, COVID-19 vaccine manufacturers knew that when selling to the U.S. market, they would have the full backing of a tested law that will keep all but the most egregious bad actors out of court. Hence America’s relative ease in securing COVID-19 vaccine orders

Make no mistake though, the EU’s stubborn refusal to implement PREP Act-style protections is not just an “over there” problem. Global pandemics requires global solutions, and the defeat of COVID-19 will undoubtedly only happen with a successful worldwide vaccination campaign. The EU therefore needs to rectify the egregious judicially engineered Sanofi obstacle and implement uniform liability protections for vaccine makers.

It has to be humbling for the EU to know that any gains made by its presumptively superior anti-pandemic lockdowns and mask mandates will evaporate as self-inflicted legal mistakes cause it to fall shockingly behind in the vaccine race. That problem could quickly be unwound by EU politicians — and the quicker that happens, the closer the world will be to ending this horrendous pandemic.

Finch is a partner at Pillsbury Winthrop Shaw Pittman LLP in Washington D.C.. Follow him on Twitter @BrianEFinch