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Brussels, 8 February 2006
Q: What power does the European Commission have to regulate tissues and cells?
The Amsterdam Treaty (Article 152) gave the EU the mandate to pass laws on the quality and safety of human tissues and cells, human organs and blood used in medical treatment. Each year in Europe, hundreds of thousands of patients undergo some form of therapeutic treatment based on the use of tissues and cells of human origin. These tissues or cells are frequently acquired through cross-border exchange. Having a common set of high standards helps facilitate cooperation between healthcare systems. It also assures EU citizens that if they go for treatment in another EU country, they will benefit from the same protection from transmissible diseases as they would in their own Member State. Member States also have the option to apply stricter standards than those set down by the EU should they wish to do so.
Q. What has the EU done to date with regard to ensuring the quality and safety of human tissues and cells?
In 2002, the Commission put forward a framework legislative proposal to set binding requirements for the safety and quality of human tissues and cells from patient to donor. These were adopted by Council and Parliament in March 2004 and must be transposed by Member States by April 2006. Directive 2004/23/EC also provided for the Commission to elaborate on the rules laid down, by setting technical standards for blood and tissue donation, procurement and storage, through the Regulatory Committee and in line with scientific advice. The implementing Directive adopted today covers the first phase of the donation and procurement process, and will be followed up with a proposal for a second Directive in the 2nd half of 2006, which will cover the second phase, including storage, processing and preservation criteria for tissues and cells.
Q: What is provided for in the implementing measures?
The implementing Directive aims to cover all human cells and tissues and all manufactured products derived from them, which are used for application to the human body, during the first phases of the process – donation, procurement and testing – in order to ensure their quality and safety.
Among the implementing rules set out are the standards which establishments or organisations must meet in order to be authorised and accredited to procure human tissues and cells. For example, staff must be properly trained, the facilities must be appropriately maintained to prevent contamination of the donated tissues, and proper, sterile instruments must be used for procurement. Standard operating procedures must be followed for the donation and testing process, during transport, and at the point of reception in tissue establishments.
Conditions are also established for the selection of tissue and cell donors, live or deceased. These include exclusion criteria, for example, for people with HIV, Hepatitis or Variant Creutzfeldt-Jakob disease (vCJD). Obligatory tests will need to be carried out before donations are accepted, as will thorough medical history checks. A unique identifier code will be given to each donor, to ensure proper identification and traceability of donated material.
Q: Why are implementing measures being issued so long after the adoption of the main Directive?
The 2004 Tissues and Cells Directive established a general framework of principles and common rules for the safety and quality of these substances. This must be fully implemented by April 2006. However, detailed implementing measures needed to be developed which would give these general provisions effect and ensure that they were applied in a harmonised way throughout the EU. In order to ensure that these implementing measures would be effective, a process of consultation and consensus-building with EU government officials and tissues and cells safety experts was required. This consultation process required adequate time to be able to gather all input and feedback, and to be able to draw on the latest scientific and technical advice.
Q: What are the next steps?
The Commission will work with Member State authorities to ensure the new measures on donation, procurement and testing of tissues and cells can be put in place smoothly. Member States have until November 2006 to put in place national measures implementing the new rules. Another Directive covering the second stage of tissue and cell procurement i.e. storage, processing and preservation, will be adopted in the second half of 2006.
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