On July 15, the European Commission put forward its proposal for new rules on standards of safety and quality on substances of human origin – Blood, Tissues and Cells (BTC). The new initiative aims at updating the existing Blood Directive (2002) and the Tissues and Cells Directive (2004). Following the results of the impact assessment launched in 2019, the Commission, working closely with the relevant parties, flagged major shortcomings in these two directives and decided to revise them.
Specifically, the assessment showed the two directives to be outdated, failing to take into account the latest sociological and health trends. Amongst other issues, it was found that patients, donors, as well as children born from donated eggs, sperm or embryos, would not be totally protected against preventable risks by the almost 20-year-old provisions which had not kept up with scientific and epidemiological advances. Further deficiencies raised by the impact assessment included different monitoring procedures among Member States (MSs), potential obstacles or blocks to cross-border BTC substance exchange, and lack of a common IT infrastructure across MSs.
In light of these findings, by presenting the revised regulation, the Commission has sought to strengthen patient protection and to broaden the scope of the pre-existing provisions to include new categories of substances among those already disciplined by the framework (such as breast milk or microbiota). Furthermore, in the attempt to guarantee high standards for quality and safety, technical guidelines – created primarily by expert bodies using the most recent available scientific data – will be put into practice.
The Commission underlined in its proposal that while the highest level of safety must be guaranteed, it must also be possible to change the technical rules as needed. This because, the proposal was conceived as an instrument that needed to be fit for the future. Its provisions must be in line with ground-breaking research and innovative technologies in the domain, as innovation develops swiftly and the regulatory framework must follow suit.
Moreover, the proposal aims at contributing to the harmonisation of practices related to SoHO substances within MSs, enabling cross-border exchange, and enhancing patient access to the necessary medications. In addition, gathering data for policy, research and supervision on the availability, quality and safety of SoHO substances is another key measure of the proposal.
Lastly, the proposal establishes the SoHO Coordination Board (SCB) as an advisory body to assist MSs in carrying out the regulation in accordance with the proposal. The SCB will establish industry-wide best practices for inspection and vigilance, offering guidance on whether the regulation is applicable.
Looking at the next steps, the Council and the European Parliament will now hold simultaneous discussions about the proposal presented by the Commission. As the framework is an important further pillar of the European Health Union and a much-awaited initiative within the field of medically assisted reproduction and other substances of human origin (SoHO), the debate surrounding the regulation is expected to be quite lively among legislators.