Reports and recommendations for resolutions on EU proposals
Proposal for a Regulation of the European Parliament and of the Council on advanced therapy medicinal products and amending Directive 2001/83/EC and Regulation (EC) No 726/2004 (15023/05 + Add 1)
(COM((2005) 567 final; Council document No 15023/05)
Citing the continuing incompleteness of the regulatory framework, the European Commission presented this proposal for a Regulation with a view to guaranteeing a high level of health protection, harmonising market access and fostering competitiveness and a high degree of flexibility with regard to the technical requirements applicable to advanced therapy medicinal products (gene therapy medicinal products, somatic cell therapy medicinal products or tissue engineering products) and proposes specific provisions for marketing authorisation, monitoring and pharmacovigilance. Authorisation by a central agency would be required for all products. Subject to certain conditions, products prepared in a hospital are to remain outside the scope of the proposed Regulation.
Extension of the centralised authorisation procedure to medicinal products for advanced types of therapy raises issues of subsidiarity, ethics and the additional cost and effort it would entail for the biotech industry; the planned exclusion of hospitals from the authorisation requirement could also raise issues relating to competition.
The Committee on Health recommended to the German Bundestag that it take note of the proposal for a Regulation and adopt a resolution calling on the Federal Government to take account of the position of the Bundestag in deliberations within the EU framework and to report to the Committee on Health on the outcome of these deliberations prior to the adoption of the Common Position and before the Council proceeds to final adoption of the draft Regulation. In particular, the Federal Government was asked to engage actively in efforts to prevent overregulation, safety gaps and ethical problems and to uphold the subsidiarity principle.
