A New, Less Friendly Normal Looms for European Drugmakers

While the world faces an unprecedented challenge in the shape of COVID-19, the pharmaceutical industry is facing its own challenge-an unprecedented level of expectation and scrutiny. Why hasn’t this huge and hugely profitable industry got any answer to the disease, the world is asking. And if it can’t deliver reliable tests and treatments, isn’t there something wrong with the system, the world wants to know.

The naivety of the questions may shock. But the widespread public dismay and public disappointment at the

current apparent impotence are going to play a powerful role in the inquests on the other side of the pandemic. In Europe, the fallout could mean fundamental shifts both in the pharmaceutical sector and in the policy context.

The stakes are high-and so is the visibility. “Societies will have to live with the virus until a vaccine or treatment is found,” stated  European Commission President Ursula von der Leyen, as she delivered the EU’s proposals for lifting COVID-19 containment measures in mid-April. A compliment to the power of therapeutics, but also turning the attention of the whole of locked-down Europe onto the research community and the healthcare industries. The pressure on the sector has never been so intense.

And this is only the start. Even when treatments or preventive agents are found, any jubilation will rapidly turn to resentment if the prices charged are considered too high, or the patent protection around them limits their availability. Expectations about wide access have been driven by establishment figures as much as by health campaigners. French President Emmanuel Macron insists that medicines and vaccines against the virus must be made available to Africa “without any question of protecting intellectual property or of money.” The World Health Organization is exploring the development of a COVID-19 patent pool. António Guterres, the UN secretary general, says a COVID-19 vaccine “must become available and affordable for everyone, everywhere,” and “be considered a global public good.” The EU’s chief diplomat, Spain’s Josep Borrell, said: “We must pool resources to produce new treatments and a vaccine, which should be regarded as a global public good.” And even the center-right European People’s Party group in the European Parliament is urging EU coordination to ensure availability of “hundreds of millions of vaccines.”

At the same time, seismic rumblings presage changes in the regulatory and political environment. With cooperation as the new mantra, WHO Europe is urging “strong international cooperation and a coordinated response in the public interest,” and EU Health Commissioner Stella Kyriakides has urged G7 health ministers to work together on COVID-19 vaccines development. European authorities are acquiring a new status in centralizing activities hitherto the preserve of national authorities-from observational studies of real-world data for COVID-19 medicines to procurement and stockpiling of therapies, and from investigation of convalescent plasma transfusion to tackling drug shortages. The European Parliament is openly called for EU institutions to be given greater powers to act on health issues, and for repatriation of EU medicines production, and members of the European Parliament are warming to promoting affordable access to medicines, guarantees of public returns on public investment, and compulsory licenses. Even asset managers, pension funds, and insurers are calling for international cooperation within the pharmaceutical industry to combat the virus.

The attention is fuelling earlier criticisms of monopolistic “price gouging”-and Andreas Mundt, head of Germany’s powerful anti-trust agency, the Kartellamt, has warned: “Companies can work together to get over difficulties caused by COVID-19, but don’t you dare go fixing prices.” Meanwhile, claims by campaigners multiply that promising treatments in clinical trials could be priced between 30 cents and $3 for a full course.

The biopharmaceutical industry in Europe has constantly reiterated its commitment to collaborative efforts to fight the outbreak. It is likely to find itself, once the outbreak has been successfully fought, working just as hard to defend its former autonomy, as the general determination to make Europe less vulnerable to the next pandemic translates into a new and less friendly normal. A radical review of the political infrastructure and business model for healthcare seems an inevitability for next year-with the prospect of “a new understanding of vaccines and pharmaceuticals as common goods.” 

Reflector is Pharmaceutical Executive’s correspondent in Brussels