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Health Ministers back new Directive on human tissue and cell transplants

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Published 12 February 2002 - Updated 29 January 2010
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cell transplants Santé et Pharma
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On 7 and 8 February, the EU Health Ministers held a seminar in Malaga (Spain), to discuss the regulation of the quality and safety in the use of human cells and tissues in the EU.

At the seminar, entitled "Therapeutic use of human tissue and cells in the European Union", the EU Health Ministers supported the idea of developing a Directive to set high safety and quality standards for the procurement, testing, processing, storage and distribution of human tissues and cells. The Directive would apply to all constituents of the human body used for transplantation (except tissues used as autographs within the same surgical procedure).

The Ministers identified the need to develop:

  • a system that guarantees anonymity and confidentiality, whilst allowing for traceability;
  • a communication system in the case of adverse events and an information exchange system;
  • a register for tissue and cell procurement, processing and distribution activities, and a list of accredited centres and authorised activities;
  • a control system for tissue and cell imports into the EU;
  • an appropriate system for selecting and evaluating donors to avoid transmissible diseases;
  • high standards for the facilities, personnel and processes used in tissue procurement and banking, including an inspection system.

The Ministers agreed that tissue and cell retrieval should only be performed by qualified professionals, in the appropriate facilities, under the necessary conditions to minimize contamination and guarantee the required biological qualities. Processing, preservation, storage and distribution should be carried out by accredited tissue banks.

In addition to the therapeutic use of cells and human tissue, the Ministers also discussed the free movement of patients and parallel imports of medicines.

 

Next steps: 
Mr Rubén Moreno, the Health Cooperation Secretary in Spain's Health Ministry, indicated that the Directive would not be approved during the Spanish Presidency, as it still had to go through the various stages of the legislative process. He added that the Directive might also serve to standardise the nomenclature, which would facilitate searches for tissue and cells.

 

Background: 
Since 1981, the use of human tissues in medicine has increased spectacularly and exchanges between hospitals in different Member States and outside the EU have become more frequent. Legislation on the transplant of tissues and cells varies greatly in different EU Member States: only Spain, France, Belgium and Denmark have specific legislation.

One of the objectives of Article 152 of the Amsterdam Treaty is the introduction of measures to establish high levels of quality and safety in organs and substances of human origin. At a meeting on the use of human organs and tissues, held in Porto in June 2000, the EU Member States concluded that there was a need for a European directive on the use of human tissues. This directive would aim to ensure a high level of public health protection and establish quality and safety standards in the process of obtaining and using tissues and cells.

 

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