EU health ministers approve advanced therapies regulation
The European advanced therapies regulation has been approved by the health ministers of the EU's 27 member states, bringing a controversial dossier to a legislative conclusion.
The European advanced therapies regulation has been approved by the health ministers of the EU's 27 member states, bringing a controversial dossier to a legislative conclusion.
At a Health Council in Brussels, ministers approved the regulation unanimously. It had already been adopted on first reading by the European Parliament on April 25.
The regulation, which provides an EU-wide legislative framework for treatments based on genes, cells and tissues, should come into effect in mid-2008, once a new expert committee has been set up in the European Medicines Agency (EMEA).
The regulation lays down EU-wide rules for these types of product and also establishes a centralised approval procedure, with marketing authorisation applications examined by the specialised committee.
The regulation does not deal with ethical questions, which remain a prerogative of member states under the principle of subsidiarity. So while the regulation provides a unified legislative framework for member states that allow such research, those that forbid it will not be obliged to raise their restrictions.
Ethical issues - particularly concerning the use of human embryonic stem cells - had given rise to a heated debate in the European Parliament when the regulation was debated.