Council of the EU Agrees on Mandate on Measures to Advance Biotechnology Innovation in the EU

position on targeted amendments to health legislation that seek to boost innovation in the EU’s biotechnology sector. The European Commission (EC) drafted a directive that would amend two existing directives to streamline the rules on placing certain genetically modified microorganisms (GMM) on the market and to update the rules on organ processing to reflect certain scientific advances. The proposed changes are intended to enable the EU to introduce a more efficient regulatory process for certain GMMs that comply with predetermined safety standards and to create opportunities for innovative approaches to processing organs in recognition of scientific and clinical developments, extending the amount of time that can elapse between procurement and transplant.

According to the Council of the EU, its mandate increases the clarity, precision, and level of detail of the proposed directive by:

• Aligning the terminology with that used in other relevant legislative acts;

• Reorganizing text elements and clarifying provisions to ensure effective implementation; and

• Clarifying the respective competences of the EC and the EU member states.

Regarding organ processing, the Council clarified the distinction between the “autologous” use of organs (i.e., transplantation within the same person) and the transplantation of organs to another person. The Council’s position also clarifies the rules relating to the validity of consent with regard to GMMs. Under the EC’s proposed directive, once consent has been granted to place a GMM on the market, such consent would be valid indefinitely. The Council notes that it “has introduced an added safeguard, by limiting the validity of the initial consent to a maximum of 10 years. Upon renewal, and unless certain exceptions apply, the consent will be granted indefinitely.” The Council’s position introduces new provisions that take account of the fact that, in the context of organ transplants, personal data may need to be processed to ensure patient safety and high healthcare standards, as well as to facilitate cross-border data sharing to help analyze transplant outcomes across a wider group of patients. Once the European Parliament establishes its position, the two institutions will enter into negotiations to agree on the final text.