On July 8, the European Economic and Social Committee (EESC) called for steps to speed up clinical trials that include genetically modified organisms (GMOs). Some vaccines under development are based on genetically modified viruses. Current EU legislation does not take into account the possibility of speeding up clinical trials in a public health emergency. The EESC therefore welcomes a temporary adjustment of EU rules.
In this position paper, sent to the European Parliament ahead of its extraordinary session on 8-10 July, the EESC urges the Parliament and the Council to ensure that clinical trials with vaccines and medicines containing GMOs to treat or prevent COVID-19 are started as soon as possible.
Renate Heinisch, rapporteur for the position paper, underlined:
The COVID-19 emergency calls for an urgent review of our standard rules and regulations to make sure that they don't hold up the development of the vaccines and antiviral drugs that we so urgently need.
Protection of public health must prevail and an exemption from the EU authorisation procedure for medicinal products should be a priority.
What's more, the EESC is calling for additional steps to ensure optimal immunisation of the population.
Broader EU vaccination strategy
The development of vaccines in general should go hand in hand with the EU strategy for COVID-19 vaccines, as well as a broader EU vaccination strategy.
Healthcare workers are at risk of exposure to COVID-19. As an advisory body representing civil society – including workers, employers and other civil society stakeholders – the EESC is urging Member States to ensure full and effective implementation of Directive 2000/54/EC, which provides that if there is a risk to the health and safety of workers due to exposure to biological agents for which effective vaccines exist, their employers should offer those workers vaccinations.
Good simulation practices and real-time data
As regards clinical trials, the EESC notes that there is much regulatory uncertainty surrounding the use of evidence derived from computer modelling and simulation (CMS). This uncertainty is preventing the uptake of CMS solutions that could help prioritise and fast-track promising medicinal products and ensure that taxpayers only fund the safest and most effective treatments. The EESC therefore recommends that the Commission work to develop good simulation practices, to be used when deploying CMS solutions in healthcare, especially in pre-clinical activities and in clinical trials.
The EESC also considers that the pharmaceutical and medical device industries should be expected to present real-time data daily to the authorities in the interest of transparency in order to speed up the development of therapies to counter COVID-19.
Current EU legislation on GMOs consists of two directives (Directive 2009/41/EC on the contained use of genetically modified micro-organisms and Directive 2001/18/EC on the deliberate release into the environment of genetically modified organisms) which provide for an environmental risk assessment and/or consent as a prerequiste for the use GMOs and whose purpose is to protect both human health and the environment.