Today, the Council agreed its negotiating mandate on the proposed regulation on blood, tissues and cells.
The new regulation ensures better protection of donors, recipients and children born following medically assisted reproduction. The proposed new rules aim to strengthen the existing legal framework and to add additional flexibility in order to keep up with scientific and technical developments.
Member states can choose to apply stricter measures to protect their citizens.
For the past 15 years, EU rules have ensured the safety of millions of patients undergoing blood transfusion, transplantation and in vitro fertilisation. Through this new regulation, we will create more harmonised and flexible provisions, strengthening the already existing system and making it future-proof. Up-to-date and high safety and quality standards for blood, tissues and cells are essential in order for citizens to have confidence in their health care systems.
José Miñones Conde, acting Spanish Minister for Health
Substances of human origin: more than just the protection of blood, tissues and cells
In this new regulation, the term “substances of human origin” (SoHO) is introduced to also include human breast milk and intestinal microbiota, as well as any other substances of human origin to be used for therapies in the future.
Activities covered by the proposed regulation range from registration and testing of donors to collection, processing and human application of substances of human origin.
Common framework for oversight, authorisation and information sharing
The compromise text guarantees increased harmonisation to facilitate cross-border exchanges and access to therapies prepared with substances of human origin, including through the creation of an EU SoHO coordination and advisory body.
This includes common EU-wide procedures for the authorisation and assessment of preparations of substances of human origin intended for clinical use.
It also provides for strengthened oversight systems. The national competent authorities, staffed with qualified and experienced personnel, will supervise activities related to substances of human origin in an independent and transparent manner. They will also be responsible for the authorisation of the organisations performing those activities. Additional authorisation and inspection requirements will apply for entities that both process and store, release, import or export substances of human origin.
The principle of voluntary and unpaid donation is also stressed in the compromise text, in order to safeguard this important principle.
The EU SoHO Platform, a new common IT platform to register and exchange information on related activities, will be a crucial digital tool for the effective implementation of the new framework.
Supply continuity and swift response to emergency situations
The draft regulation also provides for a rapid alerts system to cope with serious incidents or reactions that are likely to pose a risk for recipients or donors. Member states will also have to monitor the sufficient supply of substances of human origin in their countries, including national emergency plans, in order to be able to respond to any critical shortage.
The existing directives on bloods, tissues and cells were adopted in response to the transmission of communicable diseases in the 1980s and 1990s. Their recent evaluation showed that patients, donors and children born from donated eggs, sperm or embryos were not fully protected from avoidable risks, as the current framework is not up to date with scientific development. Moreover, member states have been applying different oversight systems. This has hampered the cross-border exchange of blood, tissues and cells and has not promoted innovation in this sector.
On 19 July 2022, the European Commission presented a proposal of regulation on standards of quality and safety for substances of human origin intended for human application. The proposal builds upon lessons learnt, including from the recent Covid-19 pandemic. It addresses the risk of disease transmission by blood, tissues and cells and the need for sufficiency of supply.
The agreement on the Council’s negotiating mandate allows the presidency to start talks as soon as possible with the European Parliament on the final text. The Spanish presidency aims to reach a provisional agreement with the European Parliament before the end of the presidency term.
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