MEP Nathalie Colin-Oesterlé (EPP, French), the European Parliament’s rapporteur on the regulation on standards of quality and safety for substances of human origin intended for human application (or Substance of Human Origin (SoHO) regulation), answered some questions from EUROPE. Work on this European Commission proposal (see EUROPE 12993/9) is currently underway in the European Parliament’s Committee on the Environment, Public Health and Food Safety (ENVI). (Interview by Émilie Vanderhulst)
Agence Europe - Can you give us a brief update on the state of negotiations after the deadline for the tabling of amendments on 8 March?
Nathalie Colin-Oesterlé - For the moment, obviously, we are still in the early stages. I don’t know if you are aware of my priorities on this European Commission proposal. My draft report is based on these three pillars: better protecting donors and recipients, harmonising national surveillance and collection systems and building European autonomy in SoHO.
What I am proposing is to put in place a real strategy for the promotion of European autonomy, the development of the practice of personalised blood capital management, in order to optimise the use of SoHO and to give priority to the use of SoHO for therapeutic purposes when there are tensions in supply within the European Union.
Today, one third of Europe’s plasma needs, also used to produce pharmaceuticals, are imported from third countries where donors are paid. This could lead to them giving more than they should, impacting their health or lowering the quality of the product obtained.
What we want is for the European Union to put an end to this situation and, above all, to build its autonomy in accordance with the fundamental principle of voluntary and non-remunerated donation, which is enshrined in Article 3 of the Charter of Fundamental Rights of the Union and in the clause relating to the prohibition on the commercialisation of the human body.
My proposals, of course, aim to protect donors and recipients with the highest standards of quality and safety, by harmonising the implementation of the principle of voluntary and non-remunerated donation in order, in particular, to prevent discrepancies between Member States and between national regulations from encouraging citizens to donate in a country other than their own for financial reasons.
In addition, compliance with the principles of impartiality, independence and transparency in supervisory activities should be strengthened to protect the competent authorities from interference and other influences.
What about the issue of compensation for donations?
There are some issues on which there may be differences [within the ENVI committee].
Nicolás González Casares (S&D, Spanish) and Tilly Metz (Greens/EFA, Luxembourger) both argued for a stricter definition of compensation, in order not to go towards financial incentives and financial compensation. Andreas Glück (Renew Europe, German) is more liberal. That is to say, he takes the example of four institutions that compensate for donations and collect more than the others. However, beyond the ethical arguments, such compensation presents risks for both donors and recipients.
We also realised that there is not necessarily an obvious link between the establishment of a compensation scheme and the collection of plasma. There are counter-examples, such as Belgium and Denmark, which have recently achieved plasma self-sufficiency, but which have achieved this self-sufficiency by considerably increasing collection over the last ten years, without resorting to the private sector or compensation.
The Czech Republic is often cited because there is compensation and it is said that they do collect more. But I was looking at the figures, I think there are 50, I’ll tell you again, but there are 50 collection centres for the Czech Republic. When there are about ten for Belgium. So, inevitably, the more collection centres you have, the better the collection. There are several things that are being put in place as well, such as a strategy to increase collection.
In this financial compensation, there is the problem of donor safety. Since in fact it has been found, after various studies, that in states where there is a compensated collection system, the number of authorised donations is higher. Because obviously, this is the only condition to make the activity profitable, since the compensated collection system is set up by the private sector. A higher frequency of donations decreases the level of protein in the blood of donors. This poses a risk to donor safety, donor health and patient safety.
Is this voluntary and non-remunerated donation and the principle of neutrality of donation really the red line for you?
Yes! This is the Commission’s red line too.
If I have understood correctly in the EU Council, to date, the principle of voluntary and non-remunerated donation will not be called into question. Do you think there is any danger of that?
I insist on a very strict definition. Because, you understand, depending on the definition you give in the report, you leave room for manoeuvre.
Would you like to see a harmonised implementation of the principle at European level?
Yes, and a very strict definition of ‘fair compensation’. That is to say: I don’t mind if someone who has travelled 100 kilometres to donate is reimbursed for their mileage. Now, that there is a financial incentive, that bothers me. We are therefore in favour of a strict definition to avoid financial abuses.
Do you think that with the proposals contained in the report, including personalised blood management, the expansion of the donor base and the SoHO platform, we can realistically achieve this European autonomy in SoHO?
This is one of my amendments which concerns the strategy to promote European self-sufficiency in SoHO supply. I have asked the European Commission to publish, within 2 years of the adoption of this regulation, a strategy to promote European self-sufficiency in SoHO supply. And that ambitious targets are set by SoHO, respecting, of course, the principle of voluntary and unpaid donation. With communication actions at European level on the different types of SoHO donations that can be made, the establishment of a European Day dedicated to essential SoHO donations, incentives to extend the opening days and hours of SoHO collection facilities outside traditional working hours, this is very important...
Do you think there is a pool of donors that can be activated? Because the population will also age and there are age limits for donations. These are also data which change.
Yes, but again, if you communicate and raise awareness... Today, the majority of donors come because they have friends who are concerned. This is really altruism. I think we have a pool of donors, but they need to know what the donations are for. Not only to treat their friends, but also to manufacture medicines that will help cure cancers, serious diseases... And that, honestly, I think that today, our fellow citizens are not fully aware of it.
Do you already have an idea of the timetable for the next steps in Parliament?
Quite honestly, I hope it goes quickly. When I saw Stella Kyriakides [European Commissioner for Health], she really wanted all this to be done and validated before the end of the mandate. I think that the Spanish Presidency of the EU Council will also act on this. Today, the desire is for things to go fast enough so that everything is validated before the end of the mandate.
I would have liked to know if you have a personal affinity with the subject, perhaps on donation?
No, I’ve been working on health issues since I arrived in Parliament and it’s an extremely interesting subject, because once again it combines health, but also ethics. This is an extremely interesting subject and very important from a societal and health point of view.
Link to the draft report: https://aeur.eu/f/675