11.5.4. Organ shortage

 

The severe shortage of organ donors remains the main challenge that EU Member States face with regard to organ transplantation of humans organs by organized criminal groups.

 

The disparity between the demand for organs and the current supply is a growing problem in Europe. More than 60.000 patients are now on waiting lists in Europe. About 10 people waiting for an organ donation die everyday in Europe waiting for a transplant. Mortality rates while waiting for a heart, liver or lung transplant usually range from 15 to 30%. Despite the burgeoning demand for transplanted organ, the number of available cadaveric organs has remained essentially static over the past decade.

 

Even in cases where there have been sustained increases in the number of donors, it is very difficult to reduce the number of patients and time spent on waiting lists. Demand for transplants is increasing faster than organ donor rates.

There are different reasons for the shortage of donors. There are also large differences between Member States’ successes in increasing their donor pool. Donor rates vary widely in different European countries (see Figure 11.10). These differences cannot be easily explained. They are probably due to a complex mix of cultural, historical and social factors combined with aspects related to the characteristics of the health service and the organisational aspects of the donation system within each country.

 

One of the adverse consequences of the scarcity of organs for transplant is trafficking of human organs by organized criminal groups.

 

Organ trafficking is not a new problem worldwide. In the 1980s, experts began to notice what was to become known as “transplant tourism” when prosperous people began travelling to poor countries to receive organs from poor donors. Since then other routes have opened up. While current estimations indicate that organ trafficking remains on a relatively modest scale in Europe, the issue is nevertheless of serious legal political and ethical concern.

 

Some Member States have put in place different initiatives focusing on the organisation of donation systems and current practices that have been shown to increase organ availability.

The establishment of an efficient system for identifying people that could become organ donors upon their death, once all mandatory consent requirements in Member States have been met, has been identified as a key element in increasing the donation rate. It has been indicated that many donors are lost due to lack of evaluation, lack of referral or because the option of donation is not presented to relatives.

In some Member States, the training and employment of healthcare professionals responsible for identifying persons that could become organ donors upon their death and organising the donation process has increased efficiency in the procurement of organs and improved the functioning of transplant systems.

In order to expand the donor pool, it could be important to explore the promotion of altruistic donations from living donors, on the basis of appropriate safeguards concerning the protection of the living donors and the prevention of organ trafficking. Living donation in Europe represents 17% of kidney transplant activity and 5% of liver transplantation. Although living donors have always been critical for transplantation, the donations from living donors has dramatically increased over recent years. The increase in living organ donation can be due to multiple factors, including pressure created by the shortage of deceased donors, surgical advances, strong evidence of favourable transplant outcome and low donor risk.

The extent to which living donors volunteer for donation also varies widely within Europe.

In specific circumstances an additional option is to consider other potential donors

(“expanded donors”) who are not ideal donor candidates due to positive serology, congenital and inherited disorders, history of malignancy or other characteristics such as donor age or a history of hypertension and diabetes.

 

Public awareness and opinion also has an important role to play in increasing organ donation.

Organ donation and transplantation are medical treatments that require the full participation of society for their development. There are many complex and sensitive ethical issues in this area, and it has become clear that several of these aspects are dealt with differently in different countries depending on cultural values.

In 2006, 56% of Europeans declared themselves ready to donate their organs to an organ donation service after their death. Answers to the question differ widely between countries.

Family refusals to donate organs of their deceased relatives fluctuate in Europe from 6% to 42%. Again, these differences are not easy to understand. They could be explained by the wide variability of procedures in the law of donor consent, for living and deceased donors, different organisational practices, and also other important cultural, economic or social factors that influence the society’s perception of the benefit of donation.

The most cost-effective means of increasing public willingness to donate seems to be improving the knowledge of health professionals and the media about transplantation issues.

Because both positive and negative messages can affect the public’s willingness to donate, there is a need for a professional attitude towards donation and support from experts in the field of communication.

Continued education should form an essential element of any communication strategy. People should be encouraged to speak about organ donation and to communicate their wishes to their relatives. Only 41% of European citizens have discussed organ donation within the family. There is an important positive correlation between having discussed it within the family and willingness to donate organs.

The creation of a European organ donor card which indicates the willingness of the holder to donate organs or not, will contribute to increasing public awareness. 81% of European citizens support the use an organ donor card to make it easier to identify people willing to donate organs after their death. In spite of this, only 12% of Europeans currently have an organ donation card.

 

Comparison between countries shows that final national donation rates do not always correlate with the percentage of people who have previously declared themselves ready to donate in these countries. This clearly indicates the importance of having an efficient transplant system in place ensuring that the organs of people willing to donate become available.

A prerequisite for any action in this area is the establishment of adequate transplant systems at national level. This system needs an appropriate legal framework, a good technical approach and organisational support. The role of competent authorities is crucial in the organisational system. These authorities must ensure compliance with basic standards and organise the donation and transplantation activities.

The different organisation systems in Europe are the result of their origin and history. Even among EU countries with well-developed services, there are considerable differences in organ donation and transplantation activity, with some organisational models seem to be performing better than others.

Organ transplants are subject to time pressure. The process from procurement to transplantation should be completed in a few hours (in order to preserve organ viability). In addition, for organs to be transplanted the donor has to match with the recipient. This makes the organisational structure a key element of organ donation/transplantation systems.

As part of this organisation, an effective allocation system is essential. This system has to take into account the short time that organs can be maintained and the need to ensure that the organ is assigned to the most suitable recipient, according to predefined criteria.

The new Member States face greater health problems than the rest of the Union but have less economic means to address them. Their health systems are therefore under particular pressure, notably when it comes to the process from organ donation to transplantation, whose complexity may make it particularly difficult to address. This leads to huge differences between Member States in terms of accessibility to transplants and length of waiting lists.

Collaboration at EU level can bring particular benefits to those systems. It has been accepted that the larger the pool of donors, the better the match. Urgent patients and difficult recipients (children, highly sensitised patients, etc.) cannot be treated efficiently within the scope of a small organisation; this is of particular concern for small Member States.

At the same time, on the donation side, involvement of the local actors (hospital transplant teams and transplant coordinators) in the decision-making process has helped to motivate the professionals concerned and produced more efficient results.

A flexible system combining a decentralised network formed by local organisations mainly focused on organ procurement, and the promotion of donation with large organisations focused on promoting organ sharing and cooperation, seems to be the most effective organisational approach.

The Council of Europe’s Agreement No 26 on the exchange of therapeutic substances of human origin in 1958 became the starting point for cross-border activities in this field. The work of the Council of Europe, Eurotransplant, Scandiatransplant, European Transplant Network or the regular meetings of the European organ exchange organisations are good examples of the need of European cooperation.

 

Quality and safety of organ donation and transplantation

 

Transmission of HIV/AIDS, hepatitis B and C, bacteria, fungi and parasites through transplantation, as well as of for different types of cancers has been described in scientific literature. The transmission of disease by a deceased donor organ can result not only in the loss of the allograft but also in the death of the immune suppressed recipient. Despite the shortage of deceased organ donors, every organ must be evaluated thoroughly.

 

A number of measures can be introduced into every stage of the transplant process in order to improve the quality and safety of organs. Pre-transplant evaluation of potential donors is an essential part of solid organ transplantation.

This evaluation must provide enough information to undertake a proper risk-benefit analysis by the transplant team. Risks and characteristics of the organ must be identified and documented to allow allocation to a suitable recipient.

The maintenance of donor records and quality systems have been identified as key steps towards quality and safety. Standard procedures for procurement and requirements for organ preservation and transport must be in place.

An effective transportation of organs must be guaranteed in order to minimise ischemic times and avoid organ damage. While maintaining medical confidentiality, the organ container must be clearly labelled and must contain the necessary documentation.

The transplant system must ensure traceability from donor to recipient(s). The system must have an alert capacity for any unexpected complication ane be able to detect and investigate serious or unexpected adverse events.

Many times an organ donor is also a tissue donor. Quality and safety requirements for organs shall complement and be linked with the existing community system for tissues and cells. An adverse reaction in an organ donor recipient should be traced and reported on the tissue vigilance system if needed.

The key role of national competent authorities in ensuring the quality and safety of this process has already been stressed, as well as the importance of establishing systems for the authorisation of establishments and programmes of organ donation and procurement based on common quality and safety criteria. This system would provide a complete list of authorised centres throughout Europe, accessible to the public and professionals.

Binding safety and quality criteria should not have as a consequence a reduction in the actual number of donors. It is important to have a clear understanding of the disease transmission risk inherent in each case. Although a definition of risk based upon the donor’s profile is critical to rational decision-making, each decision also depends upon the recipient’s characteristics. In every case there is a balance of risks and benefits to be considered: the risk associated with the organ versus the consequences of not getting a transplant.