Deirdre Fehily from the European Commission outlined likely developments in the EU’s tissue and cells directives.
Published 07 July 2020
Following an assessment of proposals, updates to the EU’s directives are expected to be finalised between 2021 and 2022 to take account of technological, epidemiological and clinical developments in ART.
New policy options to overhaul current EU laws on blood, tissues and cells, including for ART, are set to be published in the coming weeks. Deirdre Fehily, a European Commission policy officer, said a Commission (EC) ‘inception impact assessment’ document will set out ideas for ‘what should be in legislation, what should not and what new systems should be put in place’; ESHRE members, she said, would have the opportunity to submit their views. New legal initiatives to arise from the full assessment are expected to be finalised between 2021 and 2022.
The introductions will provide an improved framework, she added, which will be more effective for the field of medically assisted reproduction and other substances of human origin (SoHO).
This marks a major development in an area of EU legislation that Fehily acknowledged has real current shortcomings and gaps. ‘We realise there are issues to address and we do plan to address them,’ Fehily assured the online audience.
Existing regulations and directives were largely adopted following the ‘scandals of the 80s and 90s’ with infected commercial plasma and blood which triggered widespread secondary HIV and hepatitis C transmission. Since 2002, there have been three broad sets of laws (contained in a total of ten directives) covering blood, tissues and cells (including transplants and ART), and organs.
Fehily emphasised that the deficiencies of the laws governing SoHO arise mainly from their inability to keep pace with rapid technological and social change in a dynamic sector with changing risks. In addition, their shortcomings relate to ensuring that all EU citizens affected by the BTC chain are protected, to providing appropriate and robust oversight, keeping pace with BTC innovation for patient benefit, and achieving sufficiency to meet patient need. These are the five challenges identified by a comprehensive evaluation process carried out between 2017 and 2019 in which ESHRE was closely involved.
Fehily, a member of EC’s SoHO team, outlined the areas for improvement as identified by this evaluation. Technologies such as vitrification or gamete donation are not addressed by the original directives, such that the recipients of donor gametes have no protection from infection. Donors too are another key omission; Fehily said requirements are currently limited for testing gamete donors for genetic conditions. If gaps are not addressed in this area then individuals ‘either won’t donate or riskier ones will.’
As for questions of oversight, Fehily’s presentation acknowledged that this is currently not robust enough to regulate today’s BTC activities. Two-year inspections are inefficient, she pointed out, and there is no formal mechanism to verify the effectiveness of these checks. Work by the Council of Europe suggests that activity data reporting is an essential tool to adapt and appropriately fund donation programmes.
On a positive note, the 2017-2019 evaluation has provided a sound evidence base for considering the need for any legislative changes, according to Fehily. Initiatives that resulted from this include a roadmap, public consultation, in-depth meetings with stakeholders and member states, and culminating in a full evaluation report published in October 2019.
Looking to the future of SoHO legislation, Fehily emphasised the importance of continued and active collaboration between the EC, ESHRE and its members. She said: ‘This will ensure what is put in place builds on the achievements of the past and is best for patients and children.’