March 28. 2024. 4:29

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Parliament mulls broad stakeholder access to key EU body in new human substances rules


EU lawmakers in the European Parliament are considering opening the doors of a coordination body tasked with implementing the new EU rules on human-origin substances to private companies and civil society, according to a preparatory document obtained by EURACTIV.

In July, the European Commission presented a proposal to overhaul the current legislation on tissues, blood, and cells since rules and parameters on the matter were set more than 20 years ago. The European Parliament has already started working on a draft report featuring amendments to the proposal.

The Commission’s text broadened the scope of the regulatory framework to all substances of human origins (SoHO), namely those collected from the human body in whatever manner, regardless of whether they contain cells and whether those cells are living or not.

The Parliament’s rapporteur on the file, the French centre-right MEP Nathalie Colin-Osterlé, is now in negotiations with the shadow rapporteurs from other political groups to hash out what in parliamentary jargon is defined as compromise amendments.

With a huge figure of 874 amendments filed by all the MEPs in the leading parliamentary committee on the file, a smaller number of compromise amendments to be agreed upon by political groups will constitute the backbone of the Parliament’s position and have the highest possibility to be approved in the end.

The main tweaks which political groups are discussing – and which were included in a draft of compromise amendments obtained by EURACTIV – are about the SoHo Coordination Board.

The set-up of this board is a feature of the Commission’s proposal and is aimed at promoting coordination between member states concerning the implementation of the new rules.

New EU rules on blood, tissue, cells to be adapted to evolving science

The proposed new rules on substances of human origin (SoHO) aim at providing both donors and patients with a future-proof and harmonised framework for transplants and donations while maintaining some limits on the supply side of these therapies.

Multi-stakeholder access

According to the Commission’s plan, the SoHO board will also have a central role in the adoption of the secondary legislation – delegated and implementing act – which is why it is mostly composed of representatives from national authorities and ministries of health.

However, MEPs are considering the possibility for the SoHO Board to invite, in agreement with the Commission, “representatives of the industry, including both the public and private sector, as well as consumers, patients, health professionals and researchers, to participate in certain aspects of the Board’s work”.

The European Parliament itself should have a place at the table, as the Parliament’s draft document suggests a technical representative on behalf of the EU democratic institution participating in the SoHO Board as an observer.

To mitigate this controversial multi-stakeholder access, MEPs are considering another amendment saying that members of the Board “shall not have financial or other interests in related industries which could affect their impartiality”.

At the same time, the Commission “shall ensure the independence and impartiality of experts and observers invited to attend SoHO Coordination Board meetings,” the draft text continues.

For the same reason, the lawmakers want to introduce an amendment to compel the Board to “make available to the public a summary of the topics discussed at the meetings”.

Voluntary unpaid donations

One of the most divisive problems related to the SoHo file – the voluntary unpaid donations (VUD) principle in the EU – is also on the table of the rapporteur and her ‘shadows’.

The VUD principle is in line with the EU Charter of Fundamental Rights, which prohibits the commercialisation of the human body but “does not prevent compensation of living donors for loss of earnings and reimbursement of any other justifiable expenses related to the medical procedure”.

The current regulatory issue is that conditions under which compensation may be granted are left to the member states, while there is no such definition of compensation in the EU law.

Both the national competence and the uncertainty around the term have led to inconsistent approaches among member states, reducing the harmonisation in the EU and undermining the single market.

A compromise amendment discussed by political groups leaves more freedom to member states as they “may maintain or introduce within their territories measures that are more stringent than the ones provided for in this regulation”.

This means in practice that member states “may also aim to reinforce the principle of voluntary and unpaid donation”.

Once Parliament agrees on tweaks to the Commission’s text, they will start negotiations with EU ministers for the final approval of the reform. This timeline makes the SoHo revision one of the last health files to be discussed –and possibly concluded by lawmakers– before the current legislative mandate ends in spring 2024.

The ‘substance’ of the SoHo problem

European lawmakers are focusing their tweaks of the reform of the EU framework for substances of human origins on how donations of these substances should be carried out.