Ramy prawne transplantacji
Legal framework for transplantation

Summary/Abstract: The Act of 1.07.2005 on collection, storing and transplanting cells, tissues and organs came into force on 1.01.2006. The Act implemented, among others, the regulations of the European Parliament and the Council’s Directive 2004/23/WE of 31.03.2004, on establishing quality norms and safe giving [donating], collecting, testing, processing, preserving, storing and distribution of human cells and tissues. A review of normative acts concerning transplantation suggests that the regulations by law regarding this issue lag behind the progress in medical sciences. The Act of 1.07.2005 insufficiently protects also the rights of minors while not very clearly determining the objectives of transplantation from a living donor. It fails as well in not offering a solution in the case when cells, tissues and organs are to be collected from a deceased person not with the intention to use them for transplantation but for some other purpose (article 5, part 1 of the Act). Numerous and very detailed implementation rules as well as the verbiage of EU norms render the legal solutions – in the eyes of lawyers, let alone health professionals – as a very complicated system, easily exposing to a risk of liability, even the criminal one. It is therefore suggested to include physicians in the training programmes on the regulations concerning transplantation issues. Such courses should by no means be limited to dry relating the content of the appropriate normative acts but illustrate them with specific cases. The procedure concerning the application for a licence to operate cells and tissue banks is also unclear, as in the case of applications submitted to the National Cell and Tissue Bank Centre or when such application is submitted to “Poltransplant”. The role of the National Transplantation Council, in the light of the two examples mentioned above, appears to be different to the one originally planned.

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