AGAINST THE WAIVER OF PATENTS

ANTI-COVID-19 VACCINES ?

According to the CEO of Moderna, Stéphane Bancel, who has himself already opened his patent, the lifting of the patents "will not improve the supply of messenger RNA vaccines in the world neither in 2021 nor in 2022". This project is also globally rejected by pharmaceutical companies. German industry has indeed lined up like one man behind its national champion. Raising a patent will create a precedent to "the devastating effect on research and innovation in our country and not only in the pharmaceutical sector", immediately warned the president of the chemical federation, Wolfgang Grosse Entrup. "The impact on the long term is dangerous", also argued the CEO of Moderna, Stéphane Bancel while the boss of Pfizer, Albert Bourla added, saying noto be "not at all" in favor of such a decision.

However, the profits of the pharmaceutical industry would not be affected "especially in the months to come", assures Ian Gendler, of the research firm Value Line. So why do vaccine manufacturers oppose this suspension of their intellectual property rights ?

Vaccine manufacturers would lose their monopoly

For the time being, the patents on vaccines against Covid-19 are held by a few laboratories, especially Americans, which have discovered them or which have joined forces with laboratories which have discovered them. If these patents were lifted, it would mean that other manufacturers around the world could produce and market these vaccines, without the companies that developed them being able to do anything about it. Manufacturers are therefore afraid of being deprived of the return on the significant investment they had to make during the research phase.

No production acceleration

First, because producing messenger RNA vaccines is more complex than using a recipe book. The lifting of patents would indeed have no effect "in the short and medium term", argued the German laboratory BioNTech, because patent protection is not the factor limiting the production and supply of its vaccine. developed with the American Pfizer. "Giving countries that need it a cookbook without the ingredients, guarantees and skilled labor will not help people waiting for the vaccine," said Michelle McMurry-Heath, patron of the corporate lobby. of BIO biotechnology. Factories with the right equipment and know-how are saturated; it is not enough to give the authorization and the recipe to others for them to become capable of making it overnight.

Indeed, mastering the messenger RNA technology, which is the basis of the Pfizer-BioNTech and Moderna vaccines, buying the machines, carrying out clinical trials, launching large-scale manufacturing, "does not happen in 6, 12 or 18 months. », Defended the CEO of Moderna, Stéphane Bancel. The novel messenger RNA technology requires a "very long" process and a sharp "technical expertise" to set up a manufacturing site, says Albert Bourla. As these vaccines “had never been produced before, the problem is that there are no such factories in the world apart from the ones we have built,” he says.

In addition, the complexity of the production and supply processes for raw materials further explains the current bottlenecks. Vaccines require 289 components, from 86 suppliers in 19 countries, argues Pfizer. The real problem is production capacity in developing countries, as well as the transfer of technology and know-how necessary to be able to manufacture these vaccines. vaccines of an extremely innovative model. India, for example, has a large pharmaceutical industry and manufactures its version of the Astra zeneca vaccine under license, but lacks the technology to produce the messenger RNA vaccines.

Raw materials are already on the brink of scarcity

Pfizer also highlights the bottleneck for raw materials of vaccine components. “Currently, every gram of raw material produced in the world arrives directly at our factories, and does not stay a day in the warehouse before being transformed into a vaccine - and each dose, once the quality has been checked, is not stored. one day before being delivered, ”pleads Albert Bourla, the boss of Pfizer. "This means that if other places start ordering raw material as well, it may remain in their warehouses until they find a way to convert it into doses of vaccine," he warns.

Stephen Ubl, president of the Federation of American Research-Based Pharmaceutical Companies (PhRMA), also argues that such a decision could "further weaken already strained supply chains and encourage the proliferation of counterfeit vaccines."

A limited legal advantage

The specialist lawyer, Tim Reinhard, partner of the commercial law firm Osborne Clarke, recalls in an interview with “Echoes”, that there is “no precedent for raising a patent in this way”. "The only existing legal provision is the possibility for the government to impose a license, against the payment of 'adequate' fees," he notes. This provision of the World Trade Organization on licenses has already been used twice by India in 2006 for a Novartis treatment for AIDS and in 2012 as part of a Bayer treatment for cancer, he recalls. Raising a patent would also have a limited geographic impact, says Claudia Milbradt, a lawyer at Clifford Chance, specializing in technology transfer and technology transfer.t patent law: “As patents are national, revocation of patent rights in the United States would only allow unlicensed production and distribution in the United States. "

A precedent has the devastating effect ”

For the boss of the New York biotech Acorda Therapeutics, Ron Cohen, in supporting the temporary lifting of patents, "Joe Biden is entering a dangerous and slippery slope." "What will be the next patents on the list to no longer be protected once this precedent has been set ?" ", He warns on Twitter, noting that cancer or Alzheimer's disease can also be considered" global crises ".

"Where will the ideas come from during the next pandemics and who will finance them if the inventors know that they will be stripped of their patents anyway ?" ", Continues Jan Steufel, president of the German pharmaceutical association VfA in an interview with" Handelsblatt ".

Above all, raising patents could have a catastrophic effect: diverting research capital. Who will still take the risk of investing hundreds of millions in the development of a molecule, if it is to be deprived of any return in the event of success (outcome less frequent than failure)? Raising patents for Covid-19 "sets a precedent for future health crises," says Farasat Bokhari, an economist specializing in competition and health issues at the British University of East Anglia. Pharmaceutical companies, helped or not by public funds, "would no longer have any incentive to invest the next time there is an emergency".

For technology transfers and targeted licensing

As an alternative to the lifting of patents, Pfizer-BioNTech favors technology transfers and the issuance of targeted licenses to increase the production of its vaccine. He emphasizes being in close collaboration with more than 15 partners, including Merck, Novartis, Sanofi and Baxter. Associated with Pfizer for the production of one of the first mRNA vaccines, the boss of BioNTech, Ugur Sahin, has already indicated that he does not rule out granting licenses to producers, if he is sure that the drug would be produced with the required quality.

If it is a question of helping poor countries, with a double aim of solidarity and effectiveness against the pandemic, the richest can offer them more doses. And we note a certain hypocrisy of the United States which, not long ago, blocked the exports of a vaccine which they did not even use...