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The regulation of xenotransplantation in Germany and in the European Union
Author(s) -
Straßburger J.
Publication year - 2008
Publication title -
xenotransplantation
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.052
H-Index - 61
eISSN - 1399-3089
pISSN - 0908-665X
DOI - 10.1111/j.1399-3089.2008.00488_8.x
Subject(s) - directive , xenotransplantation , context (archaeology) , european union , harmonization , authorization , business , political science , transplantation , medicine , computer science , international trade , geography , computer security , physics , surgery , archaeology , acoustics , programming language
Since the middle of the 1990, xenotransplantation has been the object of regulatory work. In this context, the point of main emphasis is the issue of protection of the individual and the general public against the risks of xenotransplantation, especially against the risks of infection associated with xenotransplantation. International organizations, such as the WHO and the Council of Europe have issued a series of publications dealing with xenotransplantation ( inter alia , [1–3] below), which, however, are not legally binding. Yet, there are legally binding provisions at EU level. First the general regulations on medicinal products are applied [4–6]. Provisions specifically relating to xenogeneic medicinal products are included in Part IV Annex I of Directive 2001/83/EC [4] and in Directive 2001/20/EC [5]. In addition, the document entitled “Points to Consider on Xenogeneic Cell Therapy Medicinal Products” [7] by the EMEA comprises basic considerations on the development and evaluation of xenogeneic cell therapy medicinal products. Regulation (EC) No 1394/2007 on advanced therapy medicinal products [8] which entered into force at the end of 2007, will soon introduce further specific provisions concerning the authorisation, supervision, and pharmacovigilance of xenogeneic medicinal products as well. For the purpose of adjustment to the gain in scientific knowledge and harmonization of the regulatory framework, currently various Community rules are being further developed and/or elaborated. Moreover, a Committee on Advanced Therapies is to be established at the EMEA. In Germany, the legal framework of xenotransplantation is substantially determined by Community rules, particularly by ordinances and directives. Ordinances directly apply to all member states and thus they have the force of law. However, directives first have to be incorporated into national law, which, as far as the above‐mentioned directives are concerned, was substantially effected in the German Medicinal Products Act [9] and in the German GCP‐Ordinance [10]. Moreover, in the context of xenotransplantation further provisions are relevant, inter alia , provisions of the genetic engineering legislation, of the animal welfare legislation, the professional standards and the code of professional conduct of physicians and of the protection against infection legislation.