Innovative therapies
On 25 April 2007, European MPs approved a regulation harmonising marketing authorisation (MA) procedures for innovative therapies: from now on, products resulting from gene and cell therapies as well as those resulting from tissue therapy will have a single legal framework. These therapies are based on complex and very innovative manufacturing processes, which have the aim of modifying structural, physiological and genetic properties of cells and tissue and should cause a significant evolution in medical practice. The text will come into force in summer 2008 at the latest.
Harmonise MA procedures
The European Commission will issue a common marketing authorisation based on the European Medicines Agency’s scientific evaluation, which will exempt national procedures in each Member State and should facilitate the research, development and the authorisation of products resulting from innovative therapies and improving the patient’s access to them.
Rejection of ethical amendments
Some fundamental ethical amendments were rejected. They demanded the formal prohibition of the marketing of the human body, products that modify the human germinal line (which contain the genetic material of each individual) and medicines resulting from cells of embryos or foetuses, even derived from human-animal hybrids or chimera. The rapporteur of the document, the Slovak Miroslav Mikolasik and the chairman of the Commission on Judicial Affairs, Giuseppe Gargani, had demanded, without success, that stem cells be excluded from the regulation.
Once again, the alliance of socialists and liberals, putting the rights of the patient before better treatment and the advance of science, approved the text despite the opposition of ecologists and those from the pro-life movement denouncing experimentation on the human embryo.
In the name of the principle of subsidiarity
The only safeguard proposed is the freedom for the countries opposed to this research to prohibit the marketing of these products within their territory. MP Adamos Adamou summarises: “This report raises serious ethical questions, however its aim is not to harmonise ethical norms but to respect national jurisdiction of Member States over the use of morally sensitive products. The principle of subsidiarity forms the basis of any decision on this subject; countries can thus decide which types of products can be sold within their borders and which others should be banned”.