Meeting in the Employment, Social Policy, Health and Consumer Affairs Council (EPSCO), on Tuesday 16 June in Luxembourg, European health ministers adopted a political agreement (“general approach”) on targeted amendments to European legislation on genetically modified micro-organisms (GMMs) and the processing of organs. They then held a first policy debate on the regulation establishing European Biotech Act I, presented by the European Commission on 16 December last year (see EUROPE 13773/7, 13774/14).
The draft directive accompanies the biotechnology regulation and seeks to facilitate the transition of innovations “from the laboratory to the market”.
It amends Directives 2001/18/EC and 2010/53/EU in order to adapt them to certain GMMs and to take account of scientific progress made in the field of organ transplantation.
“Today’s agreement sends a clear signal that Europe is committed to remaining a global leader in biotechnology,” the Cypriot Minister for Health, Neophytos Charalambides said, according to an EU Council press release.
According to him, modernising the rules applicable to genetically modified micro-organisms and organ processing should both support innovation and maintain “high standards of safety, transparency and public trust”.
In the Council’s mandate, several provisions of the initial proposal are clarified, including, in particular, the replacement of the concept of “low-risk GMMs” with that of “GMMs eligible for an expedited procedure”, in order to avoid any interpretation whereby the other categories of micro-organisms would, by default, be high-risk.
The text also provides clarifications as to the division of competences between the European Commission and the Member States, as well as the validity conditions for market authorisations for GMMs. These would now be limited to 10 years, before any possible renewal.
As regards organs, the Council drew a clearer distinction between the autologous use of an organ, that is to say its removal and reimplantation in the same patient, and transplantation to another person. It also introduced provisions relating to the processing of personal data, taking the view that sharing them may fall within the public interest where it contributes to patient safety and the analysis of transplantation outcomes at European Union level.
During the discussions, several Member States, such as Italy and Belgium, supported the balance sought between innovation and the protection of public health.
Others, such as Austria, Hungary and Slovakia, voiced concern about the potential consequences of an expedited procedure for certain GMMs and asked for the precautionary principle to retain a central place. Germany also abstained, considering that certain provisions relating to organ transplants could lead to additional administrative burdens.
The Commissioner for Health, Olivér Várhelyi, supported the general approach and considered that this legislative step was essential to improve the European biotechnology sector’s capacity to respond to crises and to ensure patients have access to cutting-edge innovations. He stated that the common rules relating to organs could, by 2035, make it possible to carry out between 200 and 250 additional cross-border organ exchanges in the European Union, meaning an equivalent number of lives saved.
See the general approach: https://aeur.eu/f/mdl
European Biotech Act I regulation. Following the adoption of this “general approach”, the ministers held a first policy debate on the European Biotechnology Act I regulation. It provides for a set of measures aimed at strengthening the sector’s competitiveness, facilitating the industrialisation of biotechnological innovations and improving patients’ access to innovative treatments.
Olivér Várhelyi recalled that the European Union’s share in international clinical trials had fallen sharply and that US biotechnology start-ups had benefited from investments nine times higher than those received by their European counterparts.
The Commission proposes, in particular, reducing the authorisation periods for clinical trials to 75 days for multinational trials and 47 days for trials conducted in a single Member State. It also plans to mobilise €10 billion this year and next year in order to support European research and production.
The Member States, by a large majority, called for faster procedures, regulatory simplification and better access to funding, while also asking for high levels of safety, quality and data protection to be maintained.
Several countries also stressed the importance of ensuring that innovations developed in Europe are also produced and marketed there.
Legislative work on the regulation will continue under the Irish Presidency of the EU Council. (Original version in French by Nithya Paquiry)