Human tissues and cells

A new European Commission report on biotechnology inventions refuses to take a clear position on the patenting of human stem cells.
This highly controversial issue covers the protection of biotechnology inventions and a potentially lucrative and large market, but also the ethical aspects of patenting.
These ethical concerns have been at the heart of a 10 year stand-off between EU governments and MEPs that was ended by the adoption of a Directive and a European Court of Justice ruling (...)

A group of MEPs, including Mrs Hiltrud Breyer MEP (Greens/EFA - DE), Mr Peter Liese MEP (EPP/ED - DE), Mr Adamos Adamou MEP (GUE/NGL - CY) and Ms Maria Martens MEP (EPP/ED - NL), have raised concerns about media reports of a trade of human egg cells from Romania to clinics in the UK.
In many European countries there are shortages of donated eggs and long waiting lists for fertility treatment. The news report that young Romanian women are being paid to donate their eggs led the UK (...)

The European Commission encounters a sound opposition from the European Parliament to introducing European funding for research on human embryo and embryonic stem cells in the next 7th Research Framework Programme (FP7).
On the 20 September 2005, a group of 73 MEPs have signed a letter to the European Commission President, Manuel Barroso, calling the Commission to respect the principle of subsidiarity in the matter: Member States should decide if they want to fund research on the human (...)

The European Parliament and of the Council adopted in March 2004 Directive 2004/23/EC that sets standards of quality and safety for the donation, procurement, testing, processing, preservation, storage and distribution of human tissues and cells. This entered into force on 7 April 2004.
The Directive empowers the Commission to establish and update technical requirements in relation to quality and safety of human Tissues and cells. In anticipation of its responsibilities under this (...)

The European Council adopted on 3rd March 2004 a proposal for a directive setting out harmonised safety and quality standards for dealing with human tissues and cells.
The Council adopted all the amendments proposed by the European Parliament in second reading.
The dossier was amended in second reading on the rules for voluntary donation, traceability and types of source material used for transplantation.
Standards of quality and safety of human tissues and cells
UPDATE: On February 2006 (...)

Recognising the need for an EU-wide regulatory framework on human tissue engineering, the Commission started drafting a proposal for common measures in this area (January 2004).
The initiative is designed to guarantee patient safety and to ensure that tissue engineered products can be marketed without obstacles throughout the European Union to those who need the innovative therapies.
It also aims to encourage medical research in an area that can develop new ways of treating diseases by (...)

MEPs adopted a recommendation on the human tissue dossier, which is now in its second reading.
On 4 November 2003, the Committee on the Environment, Public Health and Consumer Policy of the European Parliament adopted a recommendation on the human tissue dossier with amendments on voluntary and unpaid donation, but rejecting amendments on ethical aspects and research. Following an initial discussion on 6 October, the Committee adopted a recommendation on 4 November (drafted by Peter Liese (...)

Common possition on human tissues and cells adopted on 22 July.
The Agriculture Council adopted, under a common position, the political agreement reached by the Health Council on 2 June 2003 on a proposal for a Directive setting quality and safety standards for the donation, procurement, testing, processing, storage and distribution of human tissues and cells.
In accordance with the codecision procedure, this common position will now be forwarded to the European Parliament for a second (...)

On 25 March 2003, the European Parliament’s Environment, Consumers and Public Health Committee adopted the report by MEP Peter Liese (EPP-ED, DE) on the Commission proposal setting quality and safety standards in relation to human tissues and cells.
Article 152 of the Amsterdam Treaty specifically states that the EU will adopt legalisation on blood and blood products (finalised in late 2002) and human tissues and cells.
159 amendments were tabled to the report, which was voted in first (...)

Eucomed, the medical technology industry association co-sponsored a public hearing on the quality and safety of human tissues and cells hsted by Dr Peter Liese MEP and that took place at the European Parliament in Brussels on Wednesday 29 January.
The European Commission - DG Sanco published on 19 June 2002 its proposal for a Directive of the European Parliament and of the Council on setting standards of quality and safety for the donation, procurement, testing, processing, storage, and (...)