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?
Doc. 9404 8 April 2002 Protection of the human rights and dignity of the terminally ill and the dying Recommendation 1418 (1999) Reply from the Committee of Ministers adopted at the 790th meeting of the Ministers’ Deputies (26 March 2002)
The Parliamentary Assembly, referring to its Resolution 1859 (2012) on protecting human rights and dignity by taking into account previously expressed wishes of patients, commends the Committee of Ministers for its foresighted and timely adoption of both the Convention for the Protection of Human Rights and Dignity of the Human Being with regard to the Application of Biology and Medicine: Convention on Human Rights and Biomedicine (Oviedo Convention, ETS No. 164) and Recommendation CM/Rec(2009)11 on principles concerning continuing powers of attorney and advance directives for incapacity.
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.
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.