Most women who travel from the United Kingdom to other countries for infertility treatment do so because of the long wait and shortage of donor gametes at home, show the results of a survey of “fertility tourists” from the UK. Of 51 women interviewed for the ongoing research project, more than 70% needed donor treatment, most of them with donor eggs or embryos but some with donated sperm, the principal investigator, Lorraine Culley, told a conference in London.
In 2007, the European Union adopted a lex specialis, Regulation (EC) No. 1394/2007 on advanced therapy medicinal products (ATMPs), a new legal category of medical product in regenerative medicine. The regulation applies to ATMPs prepared industrially or manufactured by a method involving an industrial process. It also provides a hospital exemption, which means that medicinal products not regulated by EU law do not benefit from a harmonized regime across the European Union but have to respect national laws. This article describes the recent EU laws, and contrasts two national regimes, asking how France and the United Kingdom regulate ATMPs which do and do not fall under the scope of Regulation (EC) No. 1394/2007. What are the different legal categories and their enforceable regimes, and how does the evolution of these highly complex regimes interact with the material world of regenerative medicine and the regulatory bodies and socioeconomic actors participating in it?
The therapeutic use of organs poses certain risks which should be limited by a judicial framework covering all stages of the process from donation to transplantation. The safety and quality of organs should be guaranteed, as should the protection of donors and recipients through the competent authorities. ACT Directive 2010/53/EU of the European Parliament and of the Council of 7 July 2010 on standards of quality and safety of human organs intended for transplantation.
Although the number of patients seeking treatment elsewhere in the European Union is small,3 this could easily change, especially if people are faced with growing waiting lists or other forms of rationing as the new groups seek to control their budgets. British residents have had the right to obtain treatment in another EU country since 1971.4 Initially, the opportunities were limited mainly to people who fell ill when abroad or, less often, when the NHS agreed that there were good reasons for patients being treated abroad (for example, a citizen of another country resident here returning home to give birth
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