Changes from plenary report to adopted text

RemovedEXPLANATORY STATEMENT

RemovedDonations of substances of human origin (SoHOs) are used in a range of medical procedures that are essential to helping patients recover and people have children throughout the EU.

RemovedAs many as 25 million blood transfusions, 35 000 stem cell transplants and 1 million medically assisted reproduction cycles are carried out each year on our continent.

RemovedThe European Commission’s proposal is good and comes at just the right time. It will contribute to the overall target of building a strong Europe of Health that is able to offer EU citizens the best health security in the world and is prepared to tackle any future pandemics. More specifically, this proposal, repealing the Blood Directive (2002/98/EC) and Tissues and Cells Directive (2004/23/EC) and their implementing legislation, aims to:

Removed● Ensure safety and quality for patients treated with SoHO therapies and fully protect them from avoidable risks linked to SoHOs;

Removed● Ensure safety and quality for SoHO donors and for children born from donated eggs, sperm or embryos;

Removed● Strengthen and allow for the harmonisation of oversight practices among Member States;

Removed● Facilitate the development of innovative, safe and effective SoHO therapies;

Removed● Improve the sector’s resilience by reducing the risk of shortages.

RemovedSoHO therapies require special attention as there are ethical factors to consider and they rely on the charity of voluntary citizens. The main challenge is ensuring the availability of SoHOs for recipients while reducing to the maximum extent possible the risks for donors.

RemovedThis is especially important for plasma, which is essential for the production of medicines to treat immune deficiencies, cancers and more. One third of EU plasma needs are currently imported from third countries where people are paid for donations, potentially inciting them to give more than a reasonable amount and damage their health.

RemovedThe EU needs to put an end to this situation and build up its self-sufficiency while respecting the fundamental principle of voluntary and unpaid donation in line with Article 3 of the EU Charter of Fundamental Rights and the clause on the prohibition on making the human body a source of financial gain.

RemovedThe current EU legislative framework, adopted 20 years ago, needs to be adapted to harmonise collection and distribution systems, which remain too nationally oriented.

RemovedBy the Commission’s own admission, there are shortcomings in the current legislation:

Removed● Patients are not fully protected from avoidable risks because of outdated technical rules;

Removed● Blood, tissues and cells donors and children born from donated eggs, sperm or embryos (offspring) are exposed to avoidable risks;

Removed● Member States have different approaches to oversight, hampering cross-border exchanges of blood, tissues and cells.

RemovedThere is a need for greater coordination on many levels. Among other things, it would allow for SoHOs to be transported to patients living in countries without or with low quantities of the required donations, alerts to be sounded about outbreaks of communicable diseases, and the Member States’ regulatory frameworks for a given SoHO to be aligned.

RemovedThis last point is crucial: if we want to be able to develop SoHO-based therapies in Europe, the same SoHO cannot be considered a medicinal product in one Member State, an advanced therapy in another and a medical device in another still.

RemovedWith this in mind, the following measures are recommended to complement the Commission’s proposal:

RemovedHarmonisation of national systems to facilitate cross-border exchanges:

Removed● Make more systematic use of the SoHO Coordination Board and EU SoHO platform established in this regulation to optimise the exchange of information between national and EU authorities;

Removed● Limit the risk of a given SoHO being subject to different legislative frameworks in the Member States by providing more incentive for Member States to comply with the opinions of the Coordination Board and by strengthening cooperation with equivalent advisory bodies established in other relevant EU legislation, such as the European Medicines Agency (EMA) and Medical Device Coordination Group (MDCG);

Removed● Ensure that any Member State that decides to apply stricter measures regularly reassesses its stance and does not use these measures to restrict intra-EU exchanges of SoHOs.

RemovedProtection of donors and recipients through the highest quality and safety standards:

Removed● Harmonise the implementation of the principle of voluntary and unpaid donation, with a view in particular to stopping differences in national rules from encouraging citizens to donate in other countries than their own for financial reasons;

Removed● Make greater efforts to harmonise donation frequency rules between the Member States by giving the European Commission the power to adopt delegated acts on this specific matter;

Removed● Promote the use of the most innovative technologies to mitigate the risk of human error and improve the quality of SoHOs;

Removed● Strengthen respect for the principles of impartiality, independence and transparency in oversight activities to protect the competent authorities from undue interference and influence;

Removed● Create a legislative framework that fosters coordination among Commission services, EU agencies and competent authorities on serious adverse events to prepare, prevent and respond to outbreaks of communicable diseases via SoHOs.

RemovedBuilding-up of EU SoHO supply self-sufficiency:

Removed● Adopt a proper strategy for promoting EU self-sufficiency that sets ambitious collection targets and assesses how this can be achieved (communication, establishment of a European day dedicated to essential SoHO donations, better management of available SoHO stocks, etc.);

Removed● Develop the practice of patient blood management to optimise the use of SoHOs while promoting less invasive treatment alternatives for patients;

Removed● Prioritise therapeutic uses of SoHOs in the event of EU supply shortages in the national SoHO emergency plans.