Brussels, 06 February 2002
Ministerial Seminar on “Therapeutic uses of human tissue and cells in the EU” (6-8 February - Málaga)
In 1881, for the first time, a fragment of bone from a human cadaver was used in the treatment of patient suffering from a bone condition. In 1906 the first cornea transplant was performed, and from the second half of the 20th century onwards, transplants of skin, heart valves and vascular segments began to take place.
From then on and until the current day, the use of human tissues in medicine has increased spectacularly, to become, in many cases nowadays, a commonplace treatment (such as, for example, cornea or bone marrow transplants). Additionally, it is foreseeable that over the next few years this practice will continue to increase, both in the number of transplants performed in the situations currently prescribed, and in the greater number of situations in which transplants will be prescribed.
From the biological point of view, tissue is understood to refer to a set of cells which present a similar structure and function. However, on a legislative level, the concept of tissue is somewhat different. The Council of Europe (1994) define it as “All constituent parts of the human body, including surgical products but excluding organs, blood and blood derivatives as well as tissues from the reproductive system such as sperm, ovules or embryos, nails, hair, placenta or bodily waste products”.
Additionally, in Spain, in accordance with Royal Decree 411/96 on the use of human tissues for transplant, implant or grafts, tissue is defined as “All constituent parts of the human body including surgical products and cells”.
The process followed up to the point where the recipient receives the tissue implant is long and complex. Following the evaluation of the donor and after obtaining consent for the donation, the tissues are extracted and sent to a tissue bank. At this bank the tissue is analysed, to ensure that it complies with quality norms and that it is not liable to transmit any known disease to the recipient.
Sometimes, and after receiving a preservation treatment, the tissues are stored in the bank until they are needed for a recipient; on other occasions, they are sent immediately to an implant centre. This process ends with the implantation of the tissue in the recipient.
The following tissues are currently used on a habitual basis:
Corneas, sclera and amniotic membrane: particularly in cases of corneal damage, keratoconus or keratopathia,
Bones: for substitution in the case of major bone defects, by means of traumatological, tumoral or prosthetic surgery and also to fill smaller bone cavities.
Tendons and Fascias: in reparative traumatological surgery.
Skin: fundamentally in burns and to a lesser extent for skin ulcers
Blood vessels and heart valves: to substitute blood vessels and valves, generally in the case of infection.
Additionally, in recent times and in the majority of cases on an experimental basis, other tissues are also being used, such as pancreatic islets in the treatment of certain forms of diabetes, hepatocytes in hepatic insufficiency, to cure defects in the cartilage of the joints, fibroblasts, mioblasts, keratinocytes, endothelial cells or neuronal cells.
Other aspects of note in the use of human tissues are the following: There are significant ethical conditioning factors, since these tissues are obtained from human beings (generally deceased) and are implanted into human beings, so it is therefore extremely important to ensure that these tissues are of a very high quality and that there exists real certainty that no disease (particularly infectious or neoplastic) will be transmitted from the donor to the recipient. Exchanges between hospitals in different countries within and outside of the European Union are becoming increasingly frequent.
European Legislation
The legislation in the different countries of the European Union varies greatly. Only some European countries, such as Spain, France, Belgium and Denmark have legislation specific to tissues, whereas in others, such as Germany, they are considered to constitute health products and in the remainder, which is the majority, legislation only exists on the transplant of solid organs.
Again from the legislative viewpoint, reference must be made 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 was the adoption of measures which would establish high levels of quality and safety in organs and substances of human origin.
In view of all of the above, a degree of standardisation is required in the regulations, which will ensure on one hand the adequate protection both of recipients and donors, and on the other hand, guarantee standards of quality and safety in the tissues and cells extracted and implanted.
Furthermore, during the meeting held in Porto by the member states of the European Union in June 2000, on the use of human Organs and Tissues, one of the principal conclusions drawn was that there was a need to draft a European directive on the use of human tissues.
The aim of this directive should be to ensure a high level of protection of the public health, establishing standards of quality and safety in the process of obtaining and the use of human tissues and cells. More specifically, the following aspects of the use of human tissues should also be regulated:
* ensure the prevention of the transmission of infectious diseases by these tissues by means of a correct analysis of the donors and the use of the necessary means when obtaining, processing and distributing the tissues.
* homogenisation of the quality and safety of human tissues for use in treatment in the different countries of the European Union.
* tissue transplant programmes must be based on the principles of voluntary donation and unremunerated donation, anonymity of donor and recipient and the non-profit making status of the organisations involved in this process.
* ensure the confidentiality of the administrative and health data of donors and recipients.
* present a system of accreditation of the extraction centres and the tissue banks, as well as a system for the reporting of adverse effects.
* ensure the traceability of tissues and cells, from the moment of their extraction until their implantation.
This, then, is the context of the Conference on the Use in Treatment of Human Cells and Tissues in the European Union, due to be held in Malaga on February 6th –7th 2002. The objective of this meeting is to bring together the experts on this type of treatment, in order to analyse how to regulate, in the European context, the quality and safety of use of human cells and tissues.
At this meeting, among the other topics to be covered, subjects of great importance will be discussed, such as the criteria for accreditation of extraction centres and tissue banks, the evaluation and selection of donors and the quality programmes of the tissue banks.
Spanish Presidency Website http://www.eu2002.es