Blood safety and self-sufficiency in the European Community

The draft report by Mr Christian CABROL (UFE, F) was adopted. On the question of safety, the Commission communication (COM (94) 652) reflects the efforts made by the European Union to promote quality and safety in the collection of blood, with particular regard to preventive measures against AIDS and other transmissible diseases. It points out that while blood has many therapeutic uses, it can also be a purveyor of disease. To achieve maximum safety in the transfusion chain, the Commission focuses on three key elements: the selection of donors, the testing of donations and the removal or inactivation of infectious agents in donated blood. Surveillance should be based on the existing network of blood transfusion centres linked to European Union epidemiological agencies. On the question of sufficiency, the committee's rapporteur, Mr Cabrol, who is a heart surgeon by profession, points out that a distinction should be made between whole blood and plasma donations. While most Member States were self-sufficient in whole blood, there was a Community deficit in plasma obtained from non-remunerated voluntary donors. This had to be made good by obtaining blood from paid donors in third countries, particularly the United States, where there were no laws against payment. Speaking before the vote, Mr Cabrol told the committee: "Paid donors may not always be honest [about any diseases they might have]. There is always a risk. So it is best to rely on unpaid donors. Hence publicity should be made to encourage citizens to give their blood as often as possible." The motion for a resolution adopted by the committee called on the Commission to take the necessary measures to guarantee maximum safety in the supply and use of blood and its derivatives and to urge the Member States to take appropriate action to achieve self-sufficiency on the basis of voluntary unpaid donations. However, against the wishes of the rapporteur, the committee also called on the Commission and the Member States to remove rules, policies and practices preventing the free circulation of plasma-derived products in the Union. This decision reflected the committee's support for the view of the private sector that regulations which impeded the placing on the market of medicinal products derived from paid plasma created a monopolistic environment that could lead to increased cost for medicinal products to the detriment of patients and doctors. At the same time, however, the committee reaffirmed the fundamental principle of the inalienability and non-marketability of the human body and its parts and hence the need to select voluntary unpaid donors. In particular, donors should be selected on the basis of: * questionnaires identifying factors linked to a possible transmission of disease or endangering the health of the donor (medication being taken, the presence of diseases, recent surgery or childbirth, visits to endemic areas, recent vaccinations, dangerous sexual practices or drug addiction); * the examination of key physical parameters, such as blood pressure and haemoglobin level; * the psychological preparation of donors; * a comparison with the blood parameters of any previous donation. The committee stressed the need to guarantee absolute confidentiality for data supplied by donors. Test should be devised to screen for transmissible viral infections and to identify bacteria and parasites. Storage and maintenance conditions were important and the strictest standards of hygiene should be applied in laboratories and blood donation centres. Self-transfusion should be promoted wherever possible. The committee stressed the need for appropriate training for health professionals. Transfusion should be included in university medical courses and in training programmes for all health professionals involved in the blood transfusion chain. The Commission should support research into screening tests for blood and blood products in the Community. The committee also called for Commission support for publicity campaigns, including the dissemination of information in schools. It called for recognition of the significant safety benefits that arose from blood and plasma donors who donated repeatedly. It called on the Commission and Council to work towards the setting up of a European Blood Safety Supervisory Body to monitor blood and blood derivatives from the time of collection and conservation to the time of use. The Commission and Council should also look into the possibility of harmonizing the grantof licences to organizations involved in the collection, treatment, processing and distribution of blood and blood derivatives in the Community. �