The responsibility for setting rules on infectious disease screening in MAR will most likely move to the European Centre for Disease Prevention and Control (ECDC) following the current revision of the EU legislation on Substances of Human Origin. To support this process, the ECDC has established a new network and invited ESHRE to participate in its first in-person meeting last week.
The responsibility for setting rules on infectious disease screening in MAR will most likely move to the European Centre for Disease Prevention and Control (ECDC) following the current revision of the EU legislation on Substances of Human Origin. To support this process, the ECDC has established a new network and invited ESHRE to participate in its first in-person meeting last week.
The risk of infectious disease transmission is one of the main reasons why substances of human origin (SoHO) are regulated at EU level. After tens of thousands of people were infected with HIV and hepatitis C through blood donations in the 1980s and 1990s, the EU adopted its Blood Directive in 2002. This Directive sets out requirements for screening potential donors for infections and deferring people with a high risk of carrying an infection from blood donation. Only two years later, the Tissues and Cells Directive was adopted, which sets out similar requirements for the field of tissues and cells, including gametes and embryos used for medically assisted reproduction (MAR). While there have been no cases of widespread infectious disease transmission in MAR comparable to those in the blood sector, there is still a risk of infection, mainly through sperm.
Currently, the requirements for infectious disease screening in the SoHO field are described in legal acts of the European Commission. However, updating a legal act takes a lot of time and, as we have recently witnessed in the COVID-19 pandemic, infectious diseases move fast. An evaluation of the EU legislation on blood, tissues and cells from 2019 highlighted the failure to provide for a timely update of the rules whenever a new threat arises as one of the main shortcomings of the current legal framework. Following this evaluation, the EU started an initiative to revise its legislation on SoHO. In July last year, the Commission published a proposal for a new regulation , which states that the most recent technical guidelines by the ECDC should be followed for the prevention of communicable disease transmission through SoHO. The reasoning for this change is that these guidelines can be updated more quickly and with less bureaucratic effort.
The proposed Regulation is currently still under negotiation and will most likely be adopted in 2024. However, it will only apply after a transition period of two to three years. In preparation for the new framework, the ECDC has set up a network for cooperation with experts from different EU/EEA Member States, which will be consulted in the development of new ECDC guidelines for the SoHO field. The network is called ECDC SoHO-Net and consists of four subgroup areas: blood, organs, tissues and cells, MAR. Full members of the network are experts nominated by the EU Member States, but professional societies, including ESHRE, have received an observer status for the relevant subgroups.
Last week, Kersti Lundin and Thomas Strowitzki, both members of ESHRE’s EU Affairs Committee, travelled to the ECDC headquarters in Stockholm to participate in the first in-person meeting of the ECDC SoHO-Net. This was a joint meeting for the subgroups on MAR and tissues and cells, but there was one parallel session where the groups split up and ESHRE was invited to organise and chair the MAR session.
Kersti Lundin took over the moderation of the session, which started with a remote presentation on the ESHRE guideline on MAR in patients with a viral disease by Edgar Mocanu, who had chaired the guideline development group. Subsequently, Thomas Strowitzki provided an overview of the current screening requirements in MAR and explained the substantial differences between MAR and other tissues and cells: while most tissues and cells are donated by people who are not known to the recipient, the gametes used in MAR most often come from the couple itself. Strowitzki highlighted that the risk of infectious disease transmission needs to be assessed very differently in these cases, since after all, the couple has sexual intercourse.
In line with these differences, the current rules clearly distinguish between the use of gametes for a couple’s own treatment or for a third-party donation. While third-party donors need to be screened before each donation, partners providing gametes for their own treatment only need to be screened prior to the first treatment, after which the results will remain valid for 24 months. Moreover, couples undergoing MAR with their own gametes need to be tested for fewer diseases. The ESHRE experts emphasised that the current requirements are sufficient in light of the very low risk of infections, but that it would be valuable to assess possibilities for further harmonisation, since many countries have implemented more stringent requirements.
After two days with a packed programme of presentations, group work and discussion, the meeting ended. Kersti Lundin had a positive impression: “The audience was very interested and very active. I feel that we have managed to get our messages through regarding the similarities and differences between MAR and the other tissue and cell sectors.” The next ECDC SoHO-Net meeting will take place next year and ESHRE will surely be represented again to voice the views of the professional community in MAR.
1. European Commission. (2019). Evaluation of the Union legislation on blood, tissues and cells. https://health.ec.europa.eu/system/files/2019-10/swd_2019_376_en_0.pdf
2. European Commission. (2022). Proposal for a Regulation of the European Parliament and of the Council on standards of quality and safety for substances of human origin intended for human application and repealing Directives 2002/98/EC and 2004/23/EC. https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX%3A52022PC0338
3. Commission Directive 2012/39/EC of 26 November 2012 amending Directive 2006/17/EC as regards certain technical requirements for the testing of human tissues and cells. https://eurlex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2012:327:0024:0025:en:PDF
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