The Biden government’s proposal to suspend vaccine patent rights has sparked international debate – and shocked some experts. “The idea lacks any legal basis or expertise in the production of vaccines,” says lawyer and doctor Alexander Ehlers from Munich to NewsABC.net. Commission President von der Leyen stepped up to Biden yesterday and said the EU was open to a debate on this proposal. Robert Habeck (Greens) joined Biden’s proposal and also called for a suspension.
“First of all, it is not legally possible to break the law and suspend patents. The international Trips Agreement, European patent law and our national patent law protect property rights, ”said Ehlers. Second, the politicians who made this proposal, supported it or signaled willingness to talk, underestimated the serious medium to long-term consequences for the innovations.
Third, such a proposal would not speed up vaccine production at all. Neither in the short nor in the medium term. The quality standards for vaccines are extremely high and the granting of licenses to companies that are not familiar with them could lead to side effects or a weakened effect of the vaccine, ”says Ehlers with conviction. “It is almost absurd to propose something like this,” adds the expert in medical law and doctor.
A complex network of suppliers produces according to high quality standards
Even with compulsory licenses, the world community is not helped. Because these could only be determined under very strict conditions, but these conditions were not present in the current situation.
“Biontech and Curevac started working with many partners early on to increase the production of mRNA vaccines.” Similar to the automotive industry, the companies have created a complex network of suppliers who produce materials or the vaccine according to high quality standards filling (fill & finish). All steps, including filling and packaging as the last step, must comply with the strict rules of the European Medicines Agency. Just ensuring the refrigeration during the transport of mRNA vaccines requires expertise that other companies may not be able to acquire in the foreseeable future.
The idea of enabling other companies to replicate the vaccines and make them available to third world countries or emerging countries such as India is not new, according to Ehlers. India and South Africa have now upset him again. “But just changing the Trips agreement requires the approval of over 100 countries. How realistic would that be? “
Investors have supported companies for decades and invested billions
Innovations such as the corona vaccines are the result of many years of research, for example on mRNA vaccines. The biotech companies Curevac and Biontech have put ten to twenty years of work into developing the technology.
Ingmar Hoerr, the founder of Curevac, started researching mRNA 20 years ago. The private investors Dietmar Hopp (Curevac) and the Strüngmann Brothers (Biontech) as well as investors for other manufacturers such as Johnson & Johnson or AstraZeneca invested billions so that researchers can develop innovative products. It usually takes ten years for the first profit to flow.
In truth, the production of mRNA vaccines such as those from Biontech / Pfizer, Moderna and Curevac is just as complex as the invention and development of serums. But the production of AstraZeneca or Johnson & Johnson not only depends on the patents, but also on special expertise and special production processes that are prone to errors.
“Laws cannot be applied arbitrarily or not”
Production errors occurred in some plants, for example in the USA. In the plant of the company Emergent, which produces vaccine ingredients for both Johnson & Johnson and AstraZeneca, there was a mix-up of ingredients and therefore massive production errors. Millions of cans of AstraZeneca and Johnson & Johnson had to be destroyed as a result.
But Ehlers sees one more argument that puts the moves from Washington and Brussels in a bad light. “For years we fought to ensure that China adhered to our patent law. Now do we question it in one stroke? That shatters the trust of the citizens in the basis of our law. Laws cannot be applied arbitrarily or not, ”says the lawyer.
“It is important that all countries get vaccines, India, Africa and the whole of the Third World. For this we should support the organization Covax, which aims to supply these countries with vaccines. Because we can only solve the problem if everyone is protected. “