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Health Ministers discuss possible new Directive on human tissue and cell transplants

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Published 08 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 are holding a seminar in Malaga (Spain), to discuss how to regulate the quality and safety of 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 will examine what kind of regulation Europe requires regarding the procurement and use of human cells and tissue and the guarantee of uality and safety in the course of therapeutic treatments. The main objectives are to:
  • ensure the safety of cells and tissue exchanged between EU Member States, in order to prevent the transmission of disease
  • make it easier to determine the origin of all material of this type
  • introduce the technology needed to process such material in those countries which lack it

 

Next steps: 
Mr Rubén Moreno, the Health Cooperation Secretary of Spain's Ministry of Health, 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.

Besides the therapeutic use of cells and human tissue, free movement of patients and parallel imports of medicines are also being dicussed in Malaga.

 

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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