Commission proposes new legal framework for advanced therapies
The European Commission has tabled a proposed regulation on advanced therapy medicinal products, which aims to provide a single, integrated European regulatory framework for gene therapy, somatic cell therapy, and tissue engineering. All three are emerging therapies that are expected to have a major impact on public health by improving the quality of life of patients and introducing fundamental changes to medical practices. Commission Vice President Günter Verheugen said: 'Advanced therapies have a huge potential, both for patients and industry. With this proposal we guarantee the highest level of health protection for patients. At the same time we give the biotech industry a coherent EU-wide framework which allows them to innovate, grow and create jobs.' The proposal is designed to bridge the current regulatory gap by addressing all advanced therapies - particularly tissue engineering products, not currently covered by Community legislation - within a single, integrated framework. This current lack of an EU-wide framework leads to different national approaches to the legal classification and authorisation of advanced therapy products, which negatively affects the EU's innovative capacity and competitiveness in this key area of biotechnology. According to the Commission, the proposal fully takes into account the scientific and technical characteristics of advanced therapies, as well as the specificities of the economic operators concerned. The Commission developed its proposal following an extensive impact assessment, which included a three-year consultation process with all stakeholders, including patients, industry, hospitals, doctors, regulators, and the research community. Two supporting studies were also carried out by the Commission's Joint Research Centre to assess the potential impact of the proposal on the tissue engineering market. The overall policy objective is to improve patients' access to advanced therapies by supporting the research, development and authorisation of these products. More specifically, the proposal is intended to fulfil the following key objectives: - to guarantee a high level of health protection for European patients treated with advanced therapy products; -to harmonise market access and ensure the free movement of these products by establishing a tailored and comprehensive regulatory framework for their authorisation, supervision and post-authorisation vigilance; - to foster the competitiveness of European companies operating in this field, in particular small and medium-sized enterprises; - to provide overall legal certainty, while allowing for sufficient flexibility at technical level, in order to keep pace with the evolution of science and technology. To address these problems, the Commission proposes a centralised marketing authorisation procedure for all advanced therapy products; a new committee for advanced therapies within the European Medicines Agency (EMEA) to assess advanced therapy products and follow scientific developments in the field; new technical requirements, which are adapted to the particular characteristics of these products; strengthened requirements for risk management and traceability; a system of low-cost, top-quality scientific advice provided by EMEA; and special financial and administrative incentives for small and medium-sized enterprises. Regarding the ethical issues raised by certain advanced therapy products based on human cells, the European Commission has decided that the proposed regulation will not interfere with decisions made by Member States on the use or prohibition of any type of cells, including embryonic stem cells. Moreover, the proposal observes the principles reflected in the EU Charter of Fundamental Rights and takes into account the Convention for the protection of human rights and dignity of the human being with regard to the application of biology and medicine ('Oviedo' Convention). Human tissue- and cell- based products should be founded on the philosophy of voluntary and unpaid donation, anonymity of both donor and recipient, altruism of the donor and solidarity between donor and recipient. The proposal will now be forwarded to the European Parliament and to the Council for co-decision, and also be transmitted to the European Economic and Social Committee and to the Committee of the Regions for consultation.