Bioindustry and patient groups have warmly welcomed the European Parliament’s clear backing for European Commission proposals to establish a European Union (EU)-wide regulatory framework and single marketing authorisation (MA) for gene therapy, cell therapy and tissue-engineered products.
Members of the European Parliament also voted to reject a controversial package of “ethical” amendments put forward by an alliance of centre-right and Green MEPs which sought to ban products derived from human embryonic stem cells from the regulation’s scope, and they supported the Commission’s plan to leave decisions as to whether such treatments should be used up to the individual member states.
The proposed Advanced Therapy Medicinal Products Regulation (COD/2005/0227) will remove the problem for industry of addressing 27 different EU regulatory systems, say its supporters. The current lack of an EU-wide regulatory framework leads to divergent national approaches which hinders patients’ access to treatments, hampers the growth of this emerging industry and ultimately affects EU competitiveness, they add.
Specifically, the Regulation seeks to create: – a centralised MA procedure, to benefit from the pooling of expertise at EU level and direct market access; – a multidisciplinary expert Committee for Advanced Therapies within the European Medicines Agency (EMEA), to assess such products and follow scientific developments; – tailored technical requirements, adapted to each product’s particular characteristics; risk management and traceability requirements; and special incentives for small and medium-sized enterprises (SMEs).
Commission vice president Guenter Verheugen welcomed the MEPs’ action, saying the vote “paves the way for an early adoption of this eagerly-awaited Regulation, which patients and industry have been waiting for too long.”
“With this Regulation, we unleash the EU potential for innovation, often driven by SMEs, while respecting member states’ decisions on ethical concerns,” he added.
A joint statement from the European Federation of the Pharmaceutical Industries and Associations (EFPIA) and the European Biopharmaceutical Enterprises (EBE) called the vote “good news for Europe’s patients, industry and research base,” and they urged the European Council to finalise the regulation and adopt it as rapidly as possible.
Aisling Burnand, Chief Executive of the BioIndustry Association (BIA), added that the vote was “tremendously significant. It will enable patients to access ground-breaking new therapies and ensure that these treatments fulfill high standards of safety, efficacy and quality,” she said.
The Commission, which first presented its proposals for the Regulation in November 2005, acknowledges that there is a wide range of views on the ethical issues surrounding advanced therapies. “Therefore, the Regulation guarantees that all products given to patients meet the same harmonised EU standards, but does not affect member states’ right to reject certain products on ethical grounds,” it says. By Lynne Taylor
