EU experts analyse the regulation of the quality and safety of use of human cells and tissues

Brussels, 05 February 2002

This topic will be discussed by the Ministers of Health of the EU, due to meet in Malaga on Friday.

EU experts are to meet, over a period of two days starting tomorrow, in Malaga, to analyse the regulation, in the European context, of the quality and safety of use of human cells and tissues, a priority topic for the Spanish Presidency.

The transplant of cells and tissues is a technology with significant future prospects in Medicine, since it opens the doors to Regenerative Medicine. Spain, a country with considerable experience in the field of transplants, considers the guarantee of the safety and quality of the tissues and cells used for this purpose to be a matter of great importance, at a time when this material also crosses borders, for which reason harmonisation on a European level is necessary.

This topic will subsequently be discussed on February 8th, during the meeting to be held, also in Malaga, between the Health Ministers of the EU.

TISSUES USED

The term tissue is understood to mean any constituent part of the human body, including surgical remains but excluding vascular organs, blood and blood derivatives, and reproductive tissues: sperm, ovules and embryos. Nails and hair are also excluded.

Among the tissues which are currently used for implants are bones, tendons, skin, blood vessels, heart valves and corneas.

The process followed until the point where the tissue is implanted into the recipient is long, complex and involves the participation of a great number of professionals. It starts with the evaluation of the donor and the obtaining of consent. Subsequently, the tissues are extracted and sent to a tissue bank, where they are processed and from there they are sent to the centre in which the recipient receives the tissue implant.

The entire process entails a series of ethical considerations inherent to donation, and it is of vital importance to ensure that these tissues are of a high standard and that there is a certainty that they will not be liable to transmit disease from the donor to the recipient.

LEGISLATION

The legislation of the different countries of the European Union in this area varies greatly. It is also necessary, from the legislative point of view, to refer to Article 152 of the Treaty of Amsterdam, in which one of the stated objectives of the health policies and actions of the European Community is the adoption of measures which enable the establishment of high levels of quality and safety of organs and substances of human origin.

Programme of the Meeting of Experts (Málaga, 6 and 7 February 2002)

06/02/2002 Ministerial Seminar "Therapeutic use of human tissue and cells in the European Union"

Implants of human cells and tissue are becoming increasingly common. Both the number of therapeutic procedures being carried out and the range of therapeutic indications have expanded, and a whole variety of processes have been developed. Every year more than 300,000 people in the European Community are eligible to receive some type of implant of tissue and/or cells, and this figure is set to rise.

With exchanges of tissue and cells between different EU Member States on the increase, we need to achieve a degree of regulatory homogenisation such as will provide proper protection for both recipients and donors and ensure the quality and safety of the tissues and cells being extracted, stored and implanted. On 6 and 7 February, EU experts will be meeting in Malaga to examine the kind of regulation Europe requires regarding the procurement and use of human cells and tissue and to guarantee quality and safety in the course of therapeutic treatments.

On 8 February, the EU Health Ministers will also be meeting in Malaga to examine this issue. They will take the opportunity to hold a special session on the Free Movement of Patients. Entitlement to health care is included in the Charter of Fundamental Rights of the European Union.

At present, each Member State has full autonomy and responsibility for deciding what health care to offer to its citizens and how that care should be organised, funded and provided in accordance with its own historical, political and social traditions. Various agreements and procedures have gradually been introduced to ensure health care for EU Member State nationals during temporary or permanent stays in other EU countries. With prior authorisation from their country of origin, EU citizens can receive health care when they travel to other EU countries.

In addition, collaboration agreements and other specific arrangements have been established in respect of specific situations such as crossborder health care for workers, border regions, emergencies and disasters. Recent rulings of the European Court of Justice recognising the right of Community citizens to receive health care in other EU countries without the need for prior authorisation have created a new situation which is bound to impact the organisation of health systems and the free movement of patients between EU Member States.

Accordingly, a process of discussion and analysis needs to be launched regarding people’s right to move freely and their entitlement to receive health care in any EU country.

Starting date: 06/02/2002
Ending date: 08/02/2002
Place: Málaga

Spanish Presidency Website http://www.eu2002.es