Lay summary of a paper published in 'Humanities and Social Sciences Communications'

Summary 

We collected information on all the groups who have made a submission to the recent EU public consultation on regulation of blood, tissues and cells, and compared this to the list of groups who made a submission to the public consultations on regulation of advanced therapies (medicines made from cells, tissues or genes). It could have been expected to find the same groups contributing to both pieces of legislation because these two pieces of legislation apply consecutively when developing a medicine based on genes, cells or tissues. However, this proved not to be the case, even over time. This fragmented landscape should be taken into account by any policy or regulatory strategy to support the development of those medicines for the benefit of patients.

Scope of the paper

This paper is a work of social science, including law, and data science. It concerns public consultation, which is a process for interested groups or individuals to comment on proposals for the adoption of binding regulation or of guidance. The consultations we looked at concern human tissues, cells and blood used for therapeutic purposes (so-called ‘substances of human origin’ or SoHO) and medicines based on these materials (so-called Advanced Therapy Medicinal Products or ATMP in Europe). The paper focused on European regulation, but the results have shown that many international groups (beyond Europe) have participated in the public consultations. 

Key aspects of the paper

The most significant result is the very low overlap among groups making a contribution to both a SoHO and an ATMP consultation. More particularly, here are a few of the key results:

• Few organisations participated in both SoHO and ATMP consultations.
  • Only 5.4% of groups contributed to both at least one SoHO and at least one ATMP consultation.
  • This suggests different groups are responsible for collecting of biological materials, compared to those responsible for the commercialisation stages of medicinal products.
  • In contrast to other types of organisations, National Bodies have participated equally in SoHO and ATMP consultations which can be explained by their functions.
• Discrepancies in the countries of organisations participating in SoHO and AMTP consultations respectively
  • Belgium, France, Germany, the Netherlands, and Italy are the countries that contributed the most to both SoHO and ATMP consultations respectively.
  • The UK and US each make a significant contribution to the ATMP consultations but less so to SoHO consultations.
  • The SoHO consultations involved more EU countries and a greater diversity of participating countries overall than the ATMP consultations.
• Discrepancy in the types of organisations participating in SoHO and ATMP consultations.
  • Companies and National Bodies are the two types of groups most participating in both SoHO and ATMP consultations.
  • For the ATMP Regulation we can see a high proportion of private sector groups
  • Academia contributed roughly equally to both SoHO and ATMP consultations
  • Patient Associations have contributed in similar proportions to both sets of consultations but the overall numbers taking part in SoHO was larger (as part of a larger total volume of contributions). 

This strongly suggests that there is significant institutional fragmentation between groups collecting human biomaterials and groups developing ATMP for market. Given that collection of biomaterials is a necessary first step in the development of most ATMP, European policy makers wishing to support ‘homegrown’ innovation with ATMP should give greater consideration to building better links between organisations collecting biomaterials and ATMP developers.

Structure of the paper

• Introduction
• Methods
  • Detailed description of organisational typology
  • Allocation of country of origin
• Results
  • Profile of organisations participating in SoHO and ATMP respectively
  • Contribution of National Bodies
• Discussion
  • Few organisations participated in both SoHO and ATMP consultations
  • Discrepancies in the countries of organisations participating in SoHO and AMTP consultations respectively
  • Discrepancy in the types of organisations participating in SoHO and ATMP consultations
• Conclusion

Further information and links

Full reference of the paper: 

M. MORRISON, V. BRUNEL, & A. MAHALATCHIMY, Participation in SoHO and ATMP public consultations: a fragmented institutional landscape. Humanities and Social Sciences Communications 12, 262 (2025). https://doi.org/10.1057/s41599-025-04552-1