The European Commission proposed new blood, tissue, and cell guidelines on Thursday in order to safeguard donors and recipients and promote access to novel transfusion and transplant treatments.
The EU executive intends to broaden 20-year-old guidelines to encompass kids born via medically assisted reproduction and donors, including the 15 million people who donate blood each year, as well as over 34,000 stem cell donors and over 39,000 egg donors.
Genetic screening should prevent the 165,000 infants born each year from donated eggs, sperm, or embryos from genetic diseases.
The revised guidelines would strive to safeguard donors from exploitation and health concerns, and would require enhanced follow-up and reporting of negative consequences of giving.
They would also monitor other human-derived compounds, such as breast milk and faecal bacteria, which may be transplanted into patients to enhance their digestive tracts.
The idea would attempt to harmonize legislation throughout the 27-nation European Union to facilitate cross-border exchanges, improve patient access to treatments, and allow for greater innovation.
In the EU, 4.6 million individuals have blood transfusions each year, 36,000 need stem cell transplants, and 2,000 require skin grafts for burns and other ailments.
The initiative also aims to make the EU more self-sufficient by providing access to life-saving therapies even during a crisis. Currently, the EU imports up to one-third of its blood plasma needs, mostly from the United States.
Unlike the US, the EU is still dedicated to unpaid and voluntary donations, which it regards as safeguarding contributors from abuse.
The new laws, which must be approved by the European Parliament and EU states, will serve as a guide for the whole EU, but individual EU nations will be permitted to adopt more rigorous rules.