2023-09-13 19:16:34
Harmonize quality and safety standards for donations of “human substances” – blood and its components, tissues and cells, but also breast milk and the microbiota – to better protect donors and recipients, but also promote exchanges between States and strengthen European autonomy: these are the main objectives of the new legislation being implemented by the European Union.
This strategic review reached a decisive milestone on Tuesday September 12 with theapproval by the European Parliament of a draft regulation supported by a large majority: 483 for, 52 against, 89 abstentions. This was immediately welcomed by French MEP Nathalie Colin-Oesterlé (PPE group, right), rapporteur of the text: “This legislation is crucial for the safety of donors, the well-being of patients, the security of supply and the development of innovative medical techniques in Europe. »
The shock of the contaminated blood scandal
The need to strengthen the supervision of donation practices became evident in the 1980s and 1990s following the contaminated blood scandal which revealed the serious failures of the health system in several countries, including France. Since then, European regulations on substances of human origin used for transfusions or therapies have been based on two directives, one from 2002 on blood, the other from 2004 on tissues and cells, organ donations solids which are the subject of a separate text.
But this corpus, now twenty years old, presents a double weakness. First, it does not take into account technical progress and new risks, particularly those linked to the emergence of infectious diseases. Then, it leaves member countries wide room for maneuver in its implementation. “Thus, the same product can be considered as a substance, a medical device or an innovative therapy, according to national rules, which is an obstacle to its circulation”underlines Nathalie Colin-Oesterlé.
Ensuring the autonomy of the Union
From where the Commission’s proposal, launched in July 2022, to repeal these two directives and replace them with a single regulation, with stricter requirements and uniformly applicable in all Member States. A proposal largely amended on July 18 by the ENVI (Environment, Public Health and Food Safety) Commission of Parliament before its vote in plenary on Tuesday September 12.
Among the points most discussed by MEPs is that of the European Union’s supply autonomy. “Today, almost 40% of European needs for plasma, this liquid part of the blood which contains proteins of major therapeutic interest, are covered by imports from third countries where donors are paid”underlines Nathalie Colin-Oesterlé.
A model to follow if Europe wants to ensure its independence on these substances? This is the debate which opposed, in the European Parliament, the supporters of the financial incentive system and the defenders of voluntary and unpaid donation before the two camps ended up finding a compromise.
The free gift reaffirmed
In accordance with the Charter of Fundamental Rights of the European Union which prohibits the commercialization of the human body, the principle of free donation has been reaffirmed, but without excluding the possibility of compensation for the donor “for quantifiable losses and expenses incurred during the process”specifies the text. “A form of compensation, but which must respect the financial neutrality of the donation and prevent the donor from making a profit », defends Nathalie Colin-Oesterlé.
It remains to be seen whether this strategy is up to the challenges posed when, each year, in the Union, more than 25 million units of blood are transfused, 940,000 in vitro fertilizations are carried out, 14,500 corneal transplants are carried out and demand continues to increase? The rapporteur of the text wants to believe it. “Health remains a reserved domain of the States and the Union only provides support. But by sharing common objectives, by ensuring greater safety of medical practices, we arrive at a winning agreement for donors, patients and Europe of health”she emphasizes.
But a few steps remain to be taken. From the end of October, the trilogue dialogue will begin – Commission, Council and Parliament – which must result in the final text which will be submitted to the vote of MEPs before the end of this legislature, in June 2024, as the current Spanish presidency is engaged in it. Once adopted, the regulation will then enter into force, but most of its provisions will only apply after a transition period of two years.
#Europe #harmonize #rules