Biotech: tailored obligations for genetically modified micro-organisms

Genetically modified micro-organisms (GMMs) should have requirements specific to their risk profile

Increase the availability of viable organ transplants by updating relevant rules

The Environment and Health committees support tailored requirements for genetically modified micro-organisms (GMMs), while maintaining the highest safety and ethics standards.

New legislation on genetically modified micro-organisms (GMMs - for example, bacteria, algae, or fungi) would strengthen the EU biotechnology sector by ensuring that GMMs have their own, tailored framework with approval processes adapted to their specific characteristics.

MEPs support the aim of boosting research and innovation in the EU without lowering environmental and safety standards. They agree that certain GMMs could be approved faster, in an expedited procedure, and eventually have an open-ended market authorisation instead of requiring periodic renewals. However, the EP position foresees an open-ended authorisation only after the first renewal after 10 years, rather than from the outset.

MEPs also propose to only grant GMMs a lighter post-market monitoring regime after a detailed assessment by a competent authority. For this evaluation and subsequent reporting, MEPs want to include more detailed criteria, including environmental risk assessment (ERA) criteria.

Ensure that donated organs reach their recipients

The same proposal also adapts EU rules on human organs intended for transplantation to ensure that transplants are safe and reach as many patients as possible. It aims to expand the window of time during which organs stay viable for transplantation by clarifying the rules for their preservation and other processing.

Parliament welcomes the update to the legal framework, bringing it up to date with scientific development. In their proposed amendments, MEPs want to improve cross-border EU cooperation on organ donation. To that end, MEPs ask the Commission to develop an EU-wide paired kidney mechanism modelled on existing agreements between member states, and foresee a simplified authorisation procedure in cases of urgent medical need. The EP position also includes an EU alert system to rapidly share relevant information on complications, including rejections and allergic reactions.

Finally, MEPs want to ensure that the regime maintains donation as voluntary and unpaid, excluding commercial uses of organs.

Quotes

Co-rapporteur Marta Temido (S&D, Portugal) said: "The laws on GMMs should be updated to match the rapid pace of scientific development in this area. To ensure a high level or protection for human and animal health and the environment, we are introducing additional safeguards to the proposal. Streamlined authorisations should reflect environmental risk assessments, and market authorisation should be open-ended only after the first renewal. I'm very pleased with the broad EP support for this approach.”

Co-rapporteur Adam Jarubas (EPP, Poland) added: “New technologies in transplantation give hope that every gift of life may help save even more people. This update ensures that our legal framework keeps pace with medical progress, allowing innovations that increase the number of possible transplants and improve their safety to develop on the basis of clear ethical principles, a high level of patient protection, and public trust. This is a real opportunity to reduce waiting times, save more lives, and strengthen medical innovation across the European Union.”

Next steps

The position was approved by 54 votes to 18, and with 16 abstentions. It will be put to a vote by Parliament as a whole at an upcoming plenary session.

Background

The applications of genetically modified micro-organisms (GMMs) include biofertilisers, biopesticides, biological food preservatives. They can also be used to remove harmful chemicals and gases, including CO2, restore soil health and water quality, and to recover metals like gold or lithium from electronics and battery waste.

MEPs are also working concurrently on the Biotech Act, a sister proposal with horizontal rules for the EU biotechnology sector.