Quality and safety standards for human tissues and cells

Brussels, 19 June 2002

The Commission has proposed new quality and safety standards for human tissues and cells used in therapy throughout the European Union. The measure aims to ensure comprehensive binding requirements for these human substances from donor to patient.

The proposed Directive will mean that for the first time there will be a register of the entities operating in this field across the EU, minimum quality and safety systems which must apply, what professional requirements and training are needed, provisions for Member States inspections and penalties and mandatory minimum standards and procedures for the tissues and cells chain: donation, testing, procurement, processing, storage, distribution and preservation.

The Directive sets out clear safety and quality standards on donation, testing and procurement for human tissues and cells regardless of final use, including transplantation and related medical applications. EU action in this area is needed because each year in Europe, hundreds of thousands of patients undergo some form of therapeutic treatment based on the use of human tissues and cells. The establishment of quality and safety standards throughout the EU will help to reassure the public that human tissues and cells derived from donations in another Member State nonetheless carry the same guarantees as those in their own country. It falls under the responsibility of Member States to decide which cells are permitted.

These safety and quality standards will only be applied to the cells and tissues which Member States decide to permit. This is in keeping with the specific requirement of the Amsterdam Treaty to ensure a high level of public health protection for substances of human origin and in full respect of subsidiarity as Article 152 of the Treaty also states that EU action "shall not affect national provisions on the donation or medical use of organs or blood". The proposal fully respects the existing ethical orientations of the Charter of Fundamental Rights, the advice of the European Group on Ethics and the Council of Europe. However, binding ethical rules are strictly the responsibility of the Member States.

The increased use of human tissues and cells for therapeutic purposes has focused attention on the need to ensure their quality and safety. Health and Consumer Protection Commissioner David Byrne said: "Our aim is to protect human patients. The Amsterdam Treaty provides the EU with an opportunity as well as an obligation to implement binding measures laying down high standards of quality and safety of blood, organs and substances of human origin. This is the Commission's second initiative in this field and the drafting of the cells and tissues quality and safety proposal has benefited greatly from our experience gained in the co-decision procedure with the European Parliament and the Council for the Blood Safety Directive." (see IP/01/1594 ) "The proposed Directive will increase public confidence in the use of human tissues and cells for application in the human body."

The Commission's proposed Directive sets out quality requirements related to the donation, procurement and testing of tissues and cells as well standards for tissue establishments in order to ensure a comparable level of safety throughout the EU. Traceability standards, which will ensure that tissues and cells can be followed from donor to patient and back, are also introduced. When used for human transplantation, common donation, procurement, processing, preservation, storage and distribution, requirements are introduced. When the tissues and cells are to be used for other purposes, such as industrial applications and medicinal products and treatments, these latter processes will be covered by other EU legislation.

The proposal calls on Member States to collaborate in implementing the proposed measures and to establish accreditation and monitoring structures. It sets high standards for the suitability of tissues and cells donors and makes provision for the training of staff who are directly involved in any part of the process.

Technical standards will be updated by a Regulatory Committee, following the structure of the Blood Safety Directive, as agreed in co-decision. All relevant scientific committees will be consulted as appropriate.

DN: IP/02/894 Date: 19/06/2002