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Biotech industry welcomes outcome of ENVI vote on products regulation

The European biotechnology industry has welcomed the endorsement by the European Parliament's ENVI Committee to support the centralised regulation of advanced biotechnology therapies and to strengthen member states' responsibility for ethics

The European biotechnology industry has welcomed the endorsement by the European Parliament's ENVI Committee to support the centralised regulation of advanced biotechnology therapies and to strengthen member states' responsibility for ethics.

The majority of the ENVI members voted to support the Draft Regulation. The biotech industry supports the same approach for the plenary vote in parliament in March 2007. The regulation proposed in the Draft Advanced Therapies Report will provide one single centralised procedure, run by the European Medicines Agency (EMEA), for the whole of the EU for assessing the safety, efficacy and quality of advanced therapies.

While a single marketing authorisation procedure under the EMEA already exists for cell- and gene-based therapy products, the regulation will now bring Tissue-Engineered Products into the system for the first time.

Andrea Rappagliosi, chairman of EuropaBio's Healthcare council, said of the outcome: "A centralised procedure through the EMEA is the best way to ensure that patients have access to high-quality, safe and affective products, and will help companies by providing them with universal access to the European market."

"This centralised procedure will only succeed if EMEA is adequately funded to carry out its new duties," warned Rappagliosi, however.

Before the regulation, the lack of an EU-wide framework had lead to divergent national approaches to the legal classification and authorisation of advanced therapy products, which had negatively affected the EU's innovative capacity and competitiveness in the biotechnology arena. 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 MEPs could not agree on the inclusion of amendments calling for ethical safeguards. The commission's draft regulation did not include ethical safeguards, as the commission refers ethical issues to individual member states.

The Advanced Therapies Regulation should facilitate the availability of treatments for patients in the different countries of the EU, by unifying the "bewildering framework" of guidelines, regulations and procedures relating to advanced therapies. Some countries currently have no specific regulatory framework at all.

Eurordis, the European Organisation for Rare Diseases was "very happy" with the outcome of the ENVI Committee vote, in particular with the rejection of the ethical amendments. It added, however, that it was "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."

Read the commission's proposal here: http://ec.europa.eu/enterprise/pharmaceuticals/advtherapies/docs/com_2005_567_en.pdf

7th February 2007

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