BioWorld International Correspondent

BRUSSELS, Belgium Yet more new legislation impacting the biotechnology industry is under preparation in the European Union. Health ministers and senior officials from the 15 EU member states agreed on the need for new EU rules governing the therapeutic use of tissues and cells.

The agreement was reached during a three-day meeting in Malaga, Spain, last week.

Every year more than 300,000 people in the EU are eligible to receive some type of implant of tissue and/or cells, and this figure is set to rise particularly as biotechnology starts to open up the possibilities of new sources for transplant material. At present, only Spain, France, Belgium and Denmark have legislation specific to tissues, while in Germany they are treated merely as health products, and in most other member states legislation covers only the transplant of solid organs.

EU ministers decided they need a measure setting high standards of safety and quality for the procurement, testing, processing, storage and distribution of human tissues and cells to be used for human transplantation. It would explicitly extend to “all constituents of the human body to be used for transplantation” except for tissues used as autografts within the same surgical procedure, transplanted organs, and blood and blood components.

One of the particular targets is the perceived need to establish and supervise standards for facilities, personnel and processes used in tissue procurement and banking. A register for tissue and cell procurement, processing and distribution activities will be set up, and a list of accredited centers and the activities they are authorized to carry out will be compiled. The EU is planning to set up a system of inspection and control to make sure the new standards stick. It also wants to put in place a system of bio-vigilance to guarantee anonymity and confidentiality, while allowing for the traceability of tissues and cells. A system of communication for adverse events also will have to be established, ministers and officials agreed. And the new rules also would cover tissue and cell importation into the EU.

Selection and evaluation procedures for donors are also envisaged, to avoid transmissible diseases, and the new rules would require that tissue and cell retrieval are performed so as to minimize contamination and guarantee their required biological qualities.

The Spanish Health Cooperation secretary of the Ministry of Health, Rubén Moreno in the chair for the meeting, since Spain currently holds the rotating presidency of the EU said the basic objectives are to ensure the safety of cells and tissue exchanged between the EU member states, to make it easier to determine the origin of material, and to introduce the technology needed to process this type of material in those countries that lack the technology.