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Human Fertilisation and Embryology (Quality and Safety) Regulations 2007

rose to move, That the draft regulations laid before the House on 25 April be approved. The noble Lord said: My Lords, the regulations provide an important opportunity to introduce a harmonised regulatory framework in the UK to ensure the quality and safety of tissues and cells intended for transplantation and other human applications. They will contribute to the introduction of safety standards throughout the European Union, facilitating safer and easier exchange of tissues and cells and securing public health protection for tens of thousands of people receiving human tissue and cell treatments every year in the United Kingdom. Human tissue and cells from both living and deceased donors are transplanted in an increasing range and number of procedures. One estimate undertaken a few years ago concluded that some 10,000 patients per year benefit from NHS treatments involving a human tissue transplant. This is now thought to be a considerable underestimate of current usage of tissues and cells. The British Association for Tissue Banking has estimated that bone alone is used in 7,500 operations a year. In 2005-06, a total of 3,819 corneas were donated and 2,622 grafts were carried out. Annually, there are some 2,000 bone marrow transplants, approximately 38,000 IVF cycles and 7,000 donor insemination procedures, all of which fall within the regulations’ scope. Other tissues that may be transplanted include skin, heart valves, tendons and cartilage. The UK already has or has had systems in place to improve the safety and quality of tissue and cell transplantation. For example, in April 2001 the UK health departments launched a voluntary accreditation scheme for all tissue banks that stored and processed human tissue for therapeutic use within the NHS. Under this scheme, the MHRA inspected applicant tissue banks against the UK Code of Practice for Tissue Banks. The voluntary code of practice required tissue banks to have appropriate facilities and to undertake staff training; it also set out high standards for donor screening, process control and record keeping. Similar standards are reflected in the regulations before the House. For over 15 years the Human Fertilisation and Embryology Authority has regulated the fertility sector in line with the Human Fertilisation and Embryology Act 1990. The authority is the UK’s independent regulator and oversees safe and appropriate practice in fertility treatment, tissue storage and embryo research. The HFEA licences and monitors centres carryingout IVF, donor insemination, storage and human embryo research and provides a range of detailed information and guidance for patients, professionals and Government. The Human Tissue Authority was set up to regulate the removal, storage, use and disposal of human bodies, organs and tissue for a number of scheduled purposes, such as transplantation. The Human Tissue Act 2004 covers England, Wales and Northern Ireland. There is separate legislation in Scotland—the Human Tissue (Scotland) Act 2006—but the HTA performs certain tasks on behalf of the Scottish Executive, such as approval of living donation and licensing of establishments storing tissue for human application. Since 2006 theHuman Tissue Authority has licensed those establishments storing human tissue and cells for human application. The main benefit of the regulations is that they will require all establishments dealing with tissues and cells for human applications to be regulated and so ensure that they meet high standards of quality and safety. This will maximise the benefits and minimise the risks for patients arising from infected, contaminated or poor quality tissues and cells. It is proposed to do this by requiring the two competent authorities to regulate establishments carrying out procurement processing, storage, testing and distribution of human tissues and cells intended for human applications such as transplantation. In many respects, the provisions within the regulations will build upon existing legislation and guidance, but in a small number of areas the regulations will require new provisions to be introduced. For example, all human tissues and cells intended for transplantation in the EU will be traceable and have to meet the same high standards. Currently, apart from the assisted reproductive sector, there are no controls on the importation—or exportation—of human tissues or cells. NHS or independent sector clinicians can import tissues and cells from anywhere, controlled only by their own ethical duty to patients. The regulations will regulate imports and exports of tissues and cells imported from outside the EU and ensure that such tissues, together with those supplied from within the EU, will be of a high standard and traceable. Infertility clinics in the UK are already regulated by the HFEA. However, few, if any, other member states have so effective a system of regulation in this area. Some member states had no system of regulation at all. Infertility clinics in the UK are licensed and regularly inspected by the HFEA to ensure that they operate appropriate practices to safeguard patient safety. In several areas the HFEA has already implemented measures that are similar to or serve the same purpose as the regulations—for example, the need for a system to report adverse events or reactions and dissemination of lessons to other establishments. Another similarity is the need for a ““person responsible”” at each licensed centre. The HFEA and the bodies representing infertility clinics have worked together during the negotiation of the directive to agree appropriate practice standards. I place on record much government gratitude to the HFEA and those bodies. Since April 2006, tissue and cell establishments storing human tissue and cells for human application have been required to be licensed by the Human Tissue Authority under the Human Tissue Act 2004. To date, some 150 establishments and 118 satellites have been licensed. In addition, to enable establishments to prepare for the implementation of these regulations, the HTA has made it a condition of the licence that establishments meet the requirements of the first two directives by April 2007 and work towards meeting the requirements of the third directive as reflected in the regulations before the House. The regulations set out the requirement for a uniquely identifiable coding and labelling system for human tissues and cells, which will underpin both the traceability and quality control of tissues and cells. An EU-wide coding system is being developed to ensure that tissues and donors, the tissue banks they originate from, as well as processes or storage requirements, can be instantly identified no matter where in the EU they originate from or are used. The regulations also require the introduction of a monitoring system for adverse incidents and reactions to transplanted tissues and cells and the establishment of a system to monitor serious adverse events and reactions. Such a scheme is already in place for blood and blood products and for the fertility sector through the HFEA. The HTA has developed an online system for notification of serious adverse events and reactions, which is now operational. Gametes and embryos are within the scope of the directive and are therefore included within the regulations. The regulations also extend the remit of the HFEA to cover a range of treatments using a couple’s own sperm. Feedback from UK-licensed clinics and professional bodies to date has indicated a broad welcome for the regulations as a means to further raise and maintain standards and best practice. The final costs of implementing the regulations are set out in the regulatory impact assessment. They are divided into administrative and policy costs. Many establishments have already introduced the measures necessary to comply with the regulations and we do not anticipate a significant impact on business in either the public or private sector. The regulations impose clear standards of quality and safety for the donation, procurement, testing, processing, storage, processing and distribution ofall human tissue and cells used for any human application, including fertility procedures across the European Union. We believe that the regulations are proportionate and should be supported. I beg to move. Moved, That the draft regulations laid before the House on 25 April be approved. 16th Report fromthe Statutory Instruments Committee.—(Lord Hunt of Kings Heath.)