Ensuring patient treatment in Europe and worldwide / Cooperation and dialogue - but also Plan B if necessary

"The first drug for the treatment of Covid-19 is officially approved in Europe as of today. The European Commission granted conditional marketing authorization for Remdesivir for the European market." This was pointed out by MEP Peter Liese, health spokesman of the largest group in the European Parliament (EPP-Christian Democrats). Conditional marketing authorisation means that the experts believe that the drug is probably effective and has a low level of side effects, but that it is necessary to continue to examine carefully during treatment whether this assumption is correct. In order to better prove the efficacy and safety of Remdesivir, the company must submit the final reports of the Remdesivir trials to the European Medicines Agency (EMA) by December of this year. The data on Remdesivir have been evaluated in an exceptionally short period of time through a so-called rolling review, an approach that the EMA uses in public health emergencies to evaluate the data as soon as they become available. "The crisis mechanisms for a fast yet safe conditional approval of medicines in extraordinary crises like this one are a very important tool. Research so far has shown that Remdesivir can reduce the course of the disease, perhaps even reduce the death rate, and that the side effects are acceptable," said the doctor and MEP.

However, Liese pointed out that once the drug has been approved for marketing, it must now also be made available to European patients in a timely manner and in sufficient numbers. He expressed concern about reports that the United States has bought up almost all stocks of the drug. "These reports show once again that we must make all necessary efforts to ensure that European patients also have access to medicines against Coviod-19. The Gilead company keeps approaching Members of the European Parliament and the European Commission with concerns and Remdesivir is of course not the only drug they produce. I have made it quite clear to the company that they can now possibly do very good business with Remdesivir for twelve months, but if there is a vaccine then, and I assume that this may well be the case in a year's time, then the company will have to live off its other products again. How the European institutions view this company now depends very much on whether we are treated fairly. I think it is necessary for Gilead to share its knowledge with other companies and also to let them enter the market as competitors, so that care can be provided for the largest possible number of patients worldwide. We are committed to cooperation and dialogue. This also applies to other drugs or a vaccine. However, if Gilead or any other company is not prepared to do everything possible to ensure supply in the EU and around the world, we also have a plan B. It is possible for the Member States to jointly grant compulsory licences, which means that even against Gilead's will, other companies will be able to produce the medicine in the EU, and we are also considering trade policy measures. This is the approach my group unanimously adopted this week in a paper on health policy," concluded Mr Liese