MEPs drop ethical debate in gene-therapy vote

Amendments regarding human-animal hybrids and other ethical considerations will be put directly to plenary vote after Parliament’s Environment Committee decided to leave the issue to member states.

The Parliament’s Environment Committee voted, on 30 January 2007, on first- reading recommendation regarding draft EU regulation designed to encourage the development of gene therapy, cell therapy and tissue engineering. 

The report backs the EU draft regulation in that it rejects a number of ethical amendments which prevented the first draft report being adopted. The rejected amendments asked for “the regulation to specifically reject any commercialisation of the human body, of products that modify the human germ line (which contains each individual’s own genetic material) as well as products derived from human-animal hybrids or chimeras (created by introducing cells of another species into an embryo)”. 

However, amendment number 12 of the Opinion given by the Legal Affairs Committee on ‘prohibition of commercialisation of the human body’ will be put directly to the plenary vote, which means that the debate on the ethical aspects of advanced therapies has been transferred to EP plenary.

The ENVI Committee’s report is also demanding guarantees about the safety of the advanced therapy products and techniques used in them, and MEPs would like to see more support for small companies working in this field, as most of the EU biotech companies are SMEs.

BioIndustry Association (BIA), the trade association for innovative enterprises in the UK's bioscience sector "welcomes the positive vote on the Advanced Therapies Regulation by the Parliament's ENVI Committee, while maintaining member states' responsibility for ethics". The association calls on the Parliament to adopt a similar approach at its plenary vote.  

"Advanced therapies have the potential to provide treatments in areas such as cancer and heart disease. The decision today is a step towards the introduction of a regulatory framework for the development and approval of safe and effective therapies for patients," said Aisling Burnand, chief executive of the BIA

EuropaBio, the European Association for Bioindustries also welcomes the ENVi committee's support for the centralised regulation of advanced therapies and for strengthening member states' responsibility for ethics. "A centralised procedure through the EMEA is the best way to ensure that patients have access to high-quality, safe and effective products, and will help companies by providing them with universal access to the European market," said Andrea Rappagliosi, of EuropaBio.

Eurordis, the European Organisation for Rare Diseases is "very happy" with the outcome of the ENVI Committee vote, in particular with the rejection of the so-called "ethical amendments". However, "we are extremely disappointed with the decision of the ENVI Chair, MEP Karl-Heinz Florenz, to put the amendments 2 and 12 of the Legal Affairs committee opinion to vote in plenary without ENVI committee's approbation", said Flaminia Macchia from Eurordis.

"Advanced therapies" covers three new approaches of modern medicine - gene therapy, somatic cell therapy and human tissue engineering. They are based on complex, highly innovative manufacturing processes aiming at modifying genetic, physiological or structural properties of cells and tissues and are expected to change medical practice significantly.

The current lack of an EU-wide framework leads to divergent national approaches as to the legal classification and authorisation of advanced therapy products, which ultimately negatively affects the EU's innovative capacity and competitiveness in this key area of biotechnology. 

A Commission proposal for a new advanced therapies regulation was adopted in November 2005. The Parliament's Environment Committee rejected the committee's first draft report in September 2006 because the MEPs could not agree on the inclusion of amendments calling for ethical safeguards. 

The Commission's draft regulation does not include ethical safeguards as the Commission refers ethical issues to member states.

  • Parliament plenary vote (1st reading) is expected to take place on 13 March 2007.

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