The proposal concerned human tissue engineering, gene and cell-based therapies. Hitherto, tissue engineering has lain outside the regulatory framework, resulting in divergent national standards that have
negatively affected efforts to innovate and compete in this potentially lucrative market.

The main points of the proposal were

• a requirement for a centralised marketing authorisation procedure
• the creation of a new, multidisciplinary expert Committee for Advanced Therapies, within the European Medicines Agency (EMEA), to provide scientific advice
• technical requirements to ensure quality, safety and efficacy
• risk management and traceability requirements
• special incentives for small and medium-sized enterprises (SMEs).
  

The proposed Regulation would have left to individual Member States the decision to use or prohibit particular types of cells (such as embryonic stem cells) on ethical grounds. Industry is now recognizing that application of the “subsidiary” principle in this way will allow some EU countries to prevent the sale, use or supply of these products thereby fragmenting the single market and casting doubt over the integrity of single European marketing authorization.

Pro-progress MEPs rejected the proposed regulation because amendments that were adopted during the debate would have restricted its scope of application. The ENVI committee proposed in its amendment 15, creating an article 1bis, to exclude from latter “any advanced therapy medicinal product which is prepared in full in a hospital on a one-off basis according to a specific, non-standardised and non-patented process, and used in a hospital, in order to comply with an individual medical prescription for an individual patient”.

This and ethical considerations seem to be the reason why the draft regulation was rejected by the Committee.

It is extremely rare for a report to be rejected by a Committee. The Rapporteur (who chaired the drafting of the report) or the person who will replace him, if he resigns from this function, will have to present an entirely new report.