Work
07.September 2005 - 00:00
Impact of the technical requirements of the human tissue directive (2004/23/EC) on the availability of IVF treatment
The human tissue directive (2004/23/EC)(1) was adopted primarily with cell and tissue transplants in mind, but it also regulates in vitro fertilisation treatment (IVF). IVF treatment differs from other cell and tissue transplants in many ways. The cells to be treated and implanted in normal IVF treatment are those of the couple concerned. Thus the most likely source of contamination of the cells is the patient in person or their partner's cells. The technical annex to the directive (draft 29.3.2005) lays down technical requirements for handling tissue, inter alia regarding laboratories' quality control systems and the hygiene classification of premises.
The hygiene requirements proposed in this annex are virtually impossible for IVF treatment centres to comply with. According to the requirements, cell samples must be handled at laboratories primarily in Class A laboratory units (= laminar flow cabinets), and the background air in the laboratory must be suitable for this. At IVF laboratories, cells are treated almost exclusively under microscopes, which in practice changes the hygiene classification of a laminar flow cabinet from Class A to Class B or C. Class A facilities where work is carried out are not permitted to contain any microbial contamination at all. Yet sperm samples given by men are never themselves free of microbial contamination and the way in which they are given cannot be checked either. It is not permitted to introduce non-sterile samples into a Class A environment, thus making it impossible to treat sperm there and at the same time preventing the entire undertaking. The maintenance of Class A laminar flow cabinets requires virtually continuous disinfection of surfaces (cleaning with 70 % alcohol), which is known to damage gametes and embryos. The proposal that the laboratory as a whole should be at least Class C is also impossible for IVF laboratories to comply with. For example, the catheter to be used in implanting the embryo has to be brought back to the laboratory quickly for inspection, and is no longer free of microbes after an embryo has been implanted. When/if these provisions enter into force, laboratories which provide IVF treatment will have to completely renew their premises, and even then will be unable to guarantee compliance with the requirements. Rather, there is a danger that they will have to cease to operate or that patients undergoing such treatment will be charged more, while the availability of the treatment declines.
Is the Commission aware of the impact which the strict hygiene requirements of the human tissue directive will have on the work of IVF laboratories? What will the Commission do to ensure that IVF treatment remains available in future?
Answer given by Mr Kyprianou on behalf of the Commission
The Commission is well aware of the specificities of the area of reproductive medicine with respect to other tissues and cells for transplantation.
During the co-decision procedure of the Tissues and Cells Directive (2004/23/EC)(1), the Parliament and the Council decided to widen the scope of the directive to all applications of tissues and cells in the human body.
The Commission is currently in the process of defining the technical requirements needed to implement the Tissues and Cells Directive. Intense work has been done during the last months with experts in reproductive medicine to accommodate the original technical annexes of the Commission proposal(2) to the field of assisted reproduction. The draft mentioned in the Honourable Member’s question is the result of these efforts.
In the process of drafting the technical requirements for processing, preservation, storage and distribution of the tissues and cells, the Commission launched in June 2005 an open consultation on its public health website(3). As result of the consultation, 50 contributions were received from organisations at European and national level, tissue establishments and individuals.
Among these contributions, the European reproductive medicine sector was well represented with 12 national associations and the European Assisted Conception Consortium (EACC), which was created to bring together national regulators and practitioners for professional cooperation and joint action.
The Commission is currently analysing the contributions received to determine the best level of quality and safety requirements without undermining the availability of treatments. These issues will also be taken into account in the next stages of the process, which include the consultation of technical and national experts in early autumn 2005.
The human tissue directive (2004/23/EC)(1) was adopted primarily with cell and tissue transplants in mind, but it also regulates in vitro fertilisation treatment (IVF). IVF treatment differs from other cell and tissue transplants in many ways. The cells to be treated and implanted in normal IVF treatment are those of the couple concerned. Thus the most likely source of contamination of the cells is the patient in person or their partner's cells. The technical annex to the directive (draft 29.3.2005) lays down technical requirements for handling tissue, inter alia regarding laboratories' quality control systems and the hygiene classification of premises.
The hygiene requirements proposed in this annex are virtually impossible for IVF treatment centres to comply with. According to the requirements, cell samples must be handled at laboratories primarily in Class A laboratory units (= laminar flow cabinets), and the background air in the laboratory must be suitable for this. At IVF laboratories, cells are treated almost exclusively under microscopes, which in practice changes the hygiene classification of a laminar flow cabinet from Class A to Class B or C. Class A facilities where work is carried out are not permitted to contain any microbial contamination at all. Yet sperm samples given by men are never themselves free of microbial contamination and the way in which they are given cannot be checked either. It is not permitted to introduce non-sterile samples into a Class A environment, thus making it impossible to treat sperm there and at the same time preventing the entire undertaking. The maintenance of Class A laminar flow cabinets requires virtually continuous disinfection of surfaces (cleaning with 70 % alcohol), which is known to damage gametes and embryos. The proposal that the laboratory as a whole should be at least Class C is also impossible for IVF laboratories to comply with. For example, the catheter to be used in implanting the embryo has to be brought back to the laboratory quickly for inspection, and is no longer free of microbes after an embryo has been implanted. When/if these provisions enter into force, laboratories which provide IVF treatment will have to completely renew their premises, and even then will be unable to guarantee compliance with the requirements. Rather, there is a danger that they will have to cease to operate or that patients undergoing such treatment will be charged more, while the availability of the treatment declines.
Is the Commission aware of the impact which the strict hygiene requirements of the human tissue directive will have on the work of IVF laboratories? What will the Commission do to ensure that IVF treatment remains available in future?
Answer given by Mr Kyprianou on behalf of the Commission
The Commission is well aware of the specificities of the area of reproductive medicine with respect to other tissues and cells for transplantation.
During the co-decision procedure of the Tissues and Cells Directive (2004/23/EC)(1), the Parliament and the Council decided to widen the scope of the directive to all applications of tissues and cells in the human body.
The Commission is currently in the process of defining the technical requirements needed to implement the Tissues and Cells Directive. Intense work has been done during the last months with experts in reproductive medicine to accommodate the original technical annexes of the Commission proposal(2) to the field of assisted reproduction. The draft mentioned in the Honourable Member’s question is the result of these efforts.
In the process of drafting the technical requirements for processing, preservation, storage and distribution of the tissues and cells, the Commission launched in June 2005 an open consultation on its public health website(3). As result of the consultation, 50 contributions were received from organisations at European and national level, tissue establishments and individuals.
Among these contributions, the European reproductive medicine sector was well represented with 12 national associations and the European Assisted Conception Consortium (EACC), which was created to bring together national regulators and practitioners for professional cooperation and joint action.
The Commission is currently analysing the contributions received to determine the best level of quality and safety requirements without undermining the availability of treatments. These issues will also be taken into account in the next stages of the process, which include the consultation of technical and national experts in early autumn 2005.