11.5. Tissue, cell and organ transplants

11.5.1. Introduction

Over the past 50 years, organ transplantation has become established worldwide, bringing benefits to hundreds of thousands of patients The excellent results of organ transplants, in terms of life years gained and improvement in the quality of life, have multiplied the indications of these therapies. The use of human organs for transplantation has steadily increased during the past decades. Organ transplantation is now the most cost-effective treatment for end-stage renal failure, while for end-stage failure of organs such as the liver, lung and heart, it is the only available treatment. About 250.000 individuals are now living in Europe with a transplanted organ. Transplant procedures continue to develop and in the future may offer practical treatment for other unmet medical needs. Every year, a number of organs are exchanged between EU Member States. Cross-border exchanges mean that the transplantation process is carried out by hospitals or professionals falling under different jurisdictions. Organ donation and transplantation are sensitive and complex issues that have an important ethical dimension and require the full participation of the societies for their development. Several aspects are dealt with differently in different Member States depending on cultural, legal, administrative and organisational issues.

The European scenario of deceased organ donation is extremely varied (Figure 11.10):

·           a few nations with yearly donor rates over 20 per million population (pmp);

·           a major block of countries with yearly rates between 10 and 19 pmp;

·           and a few, whose deceased donor rates fall below 10 pmp.

Two different models are present in the EU:

·         one consists of law-approved, institutional centred, national transplant organizations (NTOs) based on the principle of local and regional coordination,

·         whereas the other consists of multinational organ exchange organizations (OEOs) whose main objective it is to allow for adequate donor-recipient matching through international organ sharing.

In the light of these two different models, the EU transplant geography can be split into two areas: countries with NTOs based on the principle of local and regional coordination - such as Spain, Italy, France, and Portugal - and countries grouped into multinational exchange organizations, such as Eurotransplant (Germany, Austria, Belgium, The Netherlands, Luxembourg, Slovenia, and Croatia) or Scandiatransplant (Denmark, Sweden, Finland, and Norway). Even among those nations that have recently joined the EU, some have opted for a NTO-like model (Poland, Hungary), while other, smaller countries have gathered in an OEO-like fashion (Balttransplant for Estonia, Latvia and Lithuania).

In a NTO model, transplantation is a complex healthcare process requiring active participation from healthcare professionals, stakeholders and local/regional/central authorities. With the exception of UKTSA (the UK Transplant Service Authority), virtually all major NTOs are centrally-governed, institutional organizations, officially endorsed by public laws and/or bills and in charge of disciplining, monitoring and planning all donation and transplantation activities within their borders.

On the contrary, OEOs operate mainly to assure appropriate donor-recipient matching and the resultant favourable results of organ transplantation, by enlarging the recipient pool. The principle OEOs were founded upon was that the larger the organ recipient pool on file, the better the possibility of appropriate HLA donor-recipient matching. This idea led to the birth of international transplant exchange organizations in Central and Northern Europe, initially limited to renal transplantation and later expanding to the field of liver, heart, lung and tissue transplantation.

Figure 11.10. International Figures On Organ Donation and Transplantation

Success of transplantation indeed depends on several factors, related in part to recipient health conditions and in part to donor characteristics. The organ may come from a deceased or a living donor. Each donated organ should have an acceptable quality and should not expose the recipient to unacceptable risks. The evaluation of donors suitability is largely influenced by the limited availability of organs, the balance between risks and expected benefits for the recipient and time constraints due to ischemia of organs. Despite these limitations and taking into account the risk of transmission of infectious or neoplastic diseases, establishing a consensus about common basic guidelines and methodologies is of primarily importance. Expanding the limits of criteria for older or other donors should also take this aspect into account.