The European Economic and Social Committee:
- welcomes the European Commission's proposal and supports the initiative to ensure that clinical trials with medicinal products that contain or consist of GMOs and are intended to treat or prevent COVID-19 can start as speedily as possible;
- believes it is of utmost importance that such clinical trials ensure the rights, safety, dignity and well-being of those individuals taking part, the reliability and robustness of the data generated, and adequate protection of human health and of the environment;
- agrees that the development of vaccines and therapies against COVID-19 is of major relevance to the public. However, additional measures are required to ensure optimal immunisation;
- considers that the development of vaccines in general and the proposed Regulation in particular should go hand in hand with the EU vaccines strategy for COVID-19 vaccines but also with an EU vaccination strategy as outlined in the comments made in the present opinion;
- recommends that the Commission develop "Good Simulation Practices" so that industries have a definite regulatory framework within which to act when deploying computer modelling and simulation solutions in healthcare and in particular, in pre-clinical activity and in clinical trials, which is even more critical in times of public health emergency such as the COVID-19 pandemic;
- considers that the pharmaceutical and medical device industries should be encouraged to present real-time data to the authorities on a day-to-day basis to ensure the prompt development of therapies against COVID-19.