The Committee on Environment and Public Health (ENVI) discuss how to ensure fast approval of safe COVID-19 vaccines and treatments in the EU with Guido RASI, Executive Director of the European Medicines Agency (EMA), in the European Parliament in Brussels.

Brussels

exchange of views

Committee on Environment, Public Health and Food Safety

LIESE, Peter (EPP, DE)

healthcare safety (T)

European Medicines Agency

WALLACE, Mick (The Left, IE)

ZACHAROPOULOU, Chrysoula (Renew, FR)

PAULUS, Jutta (Greens/EFA, DE)

Coronavirus outbreak (T)

EMA’s activities on COVID-19 and prospects for the future: extracts from the exchange of views with Guido RASI, Executive Director of European Medicines Agency (EMA)

SOUNDBITE (English), Peter LIESE (EPP, DE), It's very interesting what EMA said about the medicine remedies. It may also be a showcase for the development when we have a vaccine. But I would like to understand a bit better. You gave a recommendation to use remedy this year on what kind of basis and what kind of legal status does this have? And it said already the conditional licensing that people expect. And what kind of information do you have on the availability of this truck? Because there has been talk that the United States may get priority not only in vaccine, but also in this medicine. And what is your information, how this drug is available in Europe? Under what circumstances?

SOUNDBITE (French), Chrysoula ZACHAROPOULOU (RE, FR), Once we will have the vaccine discovered the production problem will be even bigger. The construction and homologation of production sites takes years normally. We have to maximize the existing production capacities when the request will be huge. Other vaccines productions can maybe become less prior, like, I don't know, the pediatric vaccines. How do you think that Europe and member states can optimize the production capacities.

SOUNDBITE (English), Jutta PAULUS (Greens/EFA, DE), We should learn from the swine flu vaccine which was not properly scrutinized before it was brought into public. And the second question was will there be an assessment of the chance of the vaccine being produced in many places of the Earth?

SOUNDBITE (English), Mick WALLACE (GUE/NGL, IE), Do you not think at this stage that we're very much at the mercy of the pharmaceutical industry? And do you not think that this crisis has taught us that public health is actually too important to be left to an entity that is driven by profit, not national service and that really the public bodies have got to take control of health matters again? They've been moved away from the public bodies a lot in the last few years, and we now find ourselves really at the mercy of the private sector . There's no doubt, but in many areas of Europe, our public service has been undermined, our health our public health service has been undermined!

SOUNDBITE (English), Guido RASI, EMA Director , Guidance for those countries who can use the compassionate use has been issued once and updated a little bit after the first news coming from the new trial round in the DNH ( Directorate Medical &amp; Health Service) in the United States and now under evaluation of FDA (Food and Drug Administration) . So we think our way out. Compassionate use is more or less mirroring what the US have done with their emergency use.

SOUNDBITE (English), Guido RASI, EMA Director , Whatever will come, there will never be a production able enabling for worldwide the availability of vaccine doses. Therefore, we need to have at least that a one holistic modeling, that's all that a European country and maybe beyond Europe will use the same approach to go in waves of identifying the populations that are most likely to to benefit. And then by vaccinating them, we create the first ring of defense for the general population.