EU draft regulation on advanced therapies poses problem

The draft European regulation on advanced therapies has hit a legal problem over an opt-out provision for ethically problematic products, according to the European Parliament's legal service.

In an internal memo addressed to the Parliament's environment and public health committee, the legal service says that there are problems with the wording of one article, and suggests modifying it, a Parliament source has told APM.

The European Commission proposed this regulation, currently being examined in the Parliament, in November 2005 with the aim of creating a legal framework for treatments based on genes, cells and tissues.

However, member states are divided on ethical questions related to the use of embryonic stem cells. Germany and Italy have adopted legal restrictions, whilst Austria, Poland, Latvia and Ireland have forbidden their use.

The EP's legal service, acting at the behest of the draft law's rapporteur, EU parliamentarian from Slovakia, Miroslav Mikolasik (EPP-ED), has issued reservations over a part of the text concerning member states' possibility to ban treatments based on certain kinds of human or animal cells.

The second paragraph of article 28 stipulates that the new law will not affect the application of national legislation "prohibiting or restricting the use of any specific type of human or animal cells, or the sale, supply or use of medicinal products containing, consisting of or derived from these cells".

The Parliament's legal service says that article 28, paragraph 2 is incompatible with the legal base which the Commission used for the regulation.

The issue now lies with the public health committee. Members have until June 20 to propose amendments, as the committee needs to adopt the draft in mid-September in order to present it at a plenary Parliament session at the end of October.