BioWorld International Correspondent

BRUSSELS, Belgium - The European Union imposed additional quality and safety standards for human tissues and cells, covering processing, preservation, storage and distribution. That follows the adoption last February of new safety rules for donation, procurement and testing.

The new rules set out accreditation procedures for tissue banks and processes for tissue and cell preparation - including notification of serious adverse reactions and events to national authorities, and annual reporting to the European Union. A tissue establishment must have an approved organizational structure and operation procedures, and must apply a documented quality management system. The rules detail the requirements for staff, equipment and materials used, for documentation and record-keeping and for reviewing quality through audits.

To ensure traceability of all human tissues and cells from the donor to the end user and vice versa, the rules define the basis for a single European identifying code for all donated material. In Europe, those tissues or cells frequently are acquired through cross-border exchange, and EU citizens also receive treatment in other EU countries.

The aim is to provide the highest possible level of public health protection in all member states, and prevent the transmission of diseases via donated tissues and cells. Member states also would retain the option to apply stricter standards should they wish.

The EU first proposed binding requirements for the safety and quality of human tissues and cells from patient to donor back in 2002. That resulted in new legislation, and those new technical standards must be put into effect at the national level by November 2007 (with a delay until June 2008 for the coding requirements). Further guidelines concerning the single European identifying code for human tissues and cells are currently under preparation and will be released early in 2007.

New Moves For Medicine Innovations

The attempt to build up pan-European public and private sector collaboration for medicines innovation took another step forward Friday with new moves to mobilize participation. The Innovative Medicines Initiative - jointly launched by the European Union and the European drug industry - is trying to bring together patient organizations, universities, hospitals and regulatory authorities, as well as biopharmaceutical companies of all sizes. The professed aim is to support faster discovery and development of better medicines.

According to the initiative's new website, it wants to "enhance communication and information flow between everyone involved in biomedical research across Europe."

According to Octavi Quintana Trias, a senior European Union health research official, the initiative "is key to developing a dynamic and innovative knowledge-based economy in Europe." However, success is dependent on industry agreeing to invest €460 million (US$550 million) per year for seven years, starting in 2007, and on approval of additional research funding by European ministers.

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