Tag Archives: Organ transplantation

Action plan on Organ Donation and Transplantation

Action plan on Organ Donation and Transplantation

Outline of the Community (European Union) legislation about Action plan on Organ Donation and Transplantation

Topics

These categories group together and put in context the legislative and non-legislative initiatives which deal with the same topic.

Public health > Threats to health

Action plan on Organ Donation and Transplantation

Document or Iniciative

Communication from the Commission of 8 December 2008 – Action plan on Organ Donation and Transplantation (2009-2015): Strengthened Cooperation between Member States [COM(2008) 819 – Not published in the Official Journal].

Summary

The European Commission is presenting an Action Plan with the aim of strengthening cooperation between Member States in terms of organ donation and transplantation. This plan is also accompanied by a Proposal for a Directive on standards of quality and safety of human organs intended for transplantation.

This Action Plan lays down ten priority actions grouped under three challenges:

  • increasing organ availability;
  • enhancing the efficiency and accessibility of transplantation systems;
  • improving quality and safety.

Priority Actions for increasing organ availability

It is essential to increase the number of organ donors. To this end, the Plan advocates the appointing of transplant donor coordinators in all hospitals practising organ donation.

Hospitals must also promote Quality Improvement Programmes for organ donation, through a specific methodology. Existing methods are to be compared and those giving most results will be promoted.

Exchange of good practice is also strongly encouraged in the field of organ donation from living donors (concerning deceased donors, it is recommended that the potential of donations be maximised). In this regard, altruistic donation programmes should be set up, whilst storing personal data on donors in line with Directive 95/46/EC.

Good communication within families can have positive consequences on willingness to donate organs by family members. This is why health professionals and patient support groups are to strengthen communication and organise training in this field with families in order to increase organ donation potential.

Mobility of patients and donors should also be prioritised as part of cooperation between Member States. It should be possible to identify all donors in the Union. Tools are to be made available by the Commission to this end.

Priority Actions for enhancing the efficiency and accessibility of transplantation systems

Each Member State should prepare a national programme of priority actions to enhance the efficiency of transplantation systems. In particular, a series of common indicators shall be established to monitor organ donation policy.

The Action Plan strongly supports the drawing up of Community agreements on various aspects of transplant medicine. Cooperation is the best framework to generate joint solutions and monitoring mechanisms.

The Action Plan also invites Member States to establish Community agreements on the monitoring of the extent of organ trafficking in Europe. This trafficking is indeed a scourge in that it is one of the causes of the lack of available organs.

Member States are also invited to introduce a system or structure for the exchange of organs in particular for urgent cases and difficult to treat patients (such as children or patients requiring specific treatment).

Priority actions for improving quality and safety

Information concerning organ donations and transplantation should be compiled in registers to facilitate the evaluation of post-transplantation results. This information will be used in particular to develop good medical practices and to prepare a method to compare performance for the monitoring of organ recipients.

An accreditation system for organ donation, procurement and transplantation programmes should be established as part of a common methodology.

Context

As the Communication Organ donation and transplantation: Policy actions at European Union level had already pointed out, demand for organs outweighs supply all over the European territory. There are currently more than 56 000 patients waiting for an organ from a suitable donor. These shortages generate organ trafficking which is a violation of human dignity and fundamental rights. It is for this reason that Member States should strengthen cooperation in order to preserve organ quality and safety.

Related Acts

Proposal for a Directive of the European Parliament and of the Council of 8 December 2008 on standards of quality and safety of human organs intended for transplantation [ – Not published in the Official Journal].

This Proposal for a Directive on quality and safety standards for human organs intended for transplantation establishes a legal framework in this field.

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Organ donation and transplantation in the European Union

Organ donation and transplantation in the European Union

Outline of the Community (European Union) legislation about Organ donation and transplantation in the European Union

Topics

These categories group together and put in context the legislative and non-legislative initiatives which deal with the same topic.

Public health > Threats to health

Organ donation and transplantation in the European Union

Organ transplantation remains essential for the treatment of certain diseases. However, several factors must be taken into consideration where this therapeutic method is concerned: the risk of transmission of disease, the limited supply of organs and organ trafficking. This communication therefore aims to present the various potential options to ensure the quality and safety of organs, increase their availability and combat organ trafficking.

Document or Iniciative

Communication from the Commission to the Council and the European Parliament of 30 May 2007 entitled “Organ donation and transplantation: Policy actions at EU level” [COM(2007) 275 final – Not published in the Official Journal].

Summary

During the past decades, organ transplantation has increased and become widespread. It is a form of treatment that is indispensable for certain diseases, and the results in terms of life years gained and improvement in quality of life are often positive.

Nonetheless, organ donation and transplantation are sensitive topics, dealt with differently throughout the EU in accordance with the cultural values and legal, administrative and organisational issues of each Member State.

Moreover, these topics present three major obstacles that the Commission intends to deal with. These are the risk of transmission of disease, the limited supply of organs and organ trafficking.

The Commission therefore plans measures to improve the quality and safety of organs, increase their availability in the EU and combat organ trafficking.

Improving quality and safety

HIV, hepatitis B and C, bacteria, fungi, parasites and various types of cancer can be transmitted when an organ is transplanted. The transmission of disease by a donor organ can result in the death of the recipient.

It is therefore essential that measures be introduced into every stage of the transplant process in order to improve the quality and safety of organs. A risk-benefit analysis must be carried out so that the organs can be allocated to suitable recipients.

This entails defining the risks to which the recipient is exposed in view of his/her characteristics and the profile of the donor, and determining the consequences of not performing transplantation. Following this analysis, a rational decision will be taken concerning the transplantation.

There is also a need for effective transportation of organs to avoid their deterioration. While maintaining medical confidentiality, the organ container must be labelled and contain the necessary documentation.

It is important to ensure traceability from the donor to the recipient. Any transplantation system must also be able to highlight unexpected complications and detect serious or unexpected adverse events.

Given that an organ donor is often also a tissue donor, the quality and safety requirements for organs will be associated with the existing community system for tissues and cells.

It is essential to set up systems for the authorisation of establishments and programmes of organ donation based on common quality and safety criteria.

However, the legislation concerning quality and safety differs from one Member State to another. A high level of protection for patients must therefore be ensured throughout the EU.

Increasing the availability of organs

The Member States are facing a serious shortage of organ donors on the one hand and an increase in the demand for organs on the other.

Rates of donors differ from one Member State to another. These differences may stem from cultural, social and historical factors in each country, and the organisational characteristics of the donation system and certain aspects of their health service.

Furthermore, families are not always made aware of the possibility of making a donation, and many potential donors are lost because they are not registered as such. The establishment of an effective system making it possible to find people who can become donors after their death thus remains essential to increase the rate of donations. This system must ensure that the organs of people who wish to become donors will really be available.

Training and employing health professionals involved in organising the donation process and identifying people who could become donors after their death has resulted in an increase in organ donations in several Member States.

Another method of increasing the number of donors is to encourage donations from living donors. These have increased in recent years, particularly because the risk to donors is low and the results of the transplants have been positive.

Donors who are not ideal because of disease and a history of malignancy (“marginal donors”) can also be taken into consideration under certain circumstances.

Raising public awareness also has a role to play in increasing donations. Society still does not take a positive view of organ donations, and some families refuse to donate the organs of deceased relatives. However, messages can influence individuals’ decisions. Effective communication therefore needs to be established. The help of communication experts is important here, and the media and health professionals need to have a better knowledge of transplantation issues.

Another way of raising public awareness is the use of a European donor card stating whether the holder wishes to donate his/her organs or not.

Fighting organ trafficking

Criminal organisations have recognised the lucrative opportunity presented by the gap between the supply of and demand for organs. As a consequence, such organisations may induce poor people to sell their organs.

Several international and Community legal instruments condemn and outlaw organ trafficking, such as the European Charter on Fundamental Rights and the Oviedo Treaty on Human Rights and Biomedicine and its Additional Protocol on the Transplantation of Organs and Tissues of Human Origin.

The Commission makes frequent reference to these instruments.

Follow-up actions

The Commission aims to make transplantation systems more efficient and more accessible. It is therefore necessary to identify the most efficient systems at EU level, promote best practice and help countries with less-developed systems to improve these.

It will also encourage the Member States to work together on establishing efficient systems aimed at identifying individuals who can become donors after their death, promoting training for professionals, encouraging donations from living donors and evaluating the use of organs from “marginal donors”.

The Commission proposes two mechanisms for action: an action plan on strengthened cooperation between Member States and a legal instrument on quality and safety of organ donation and transplantation.

The action plan will enable countries to increase organ donations and to provide fair access to transplantation, as well as exchanging expertise to improve organisational aspects.

As far as the legal instrument is concerned, a European directive setting standards of quality and safety for organs could be adopted. This instrument could, among other things, include quality and safety standards for the authorisation of establishments and programmes of organ donation, ensure a complete characterisation of the organ and establish authorisation structures.

Related Acts

Proposal for a Directive of the European Parliament and of the Council on standards of quality and safety of human organs intended for transplantation [ – Not published in the Official Journal].

This Proposal for a Directive on standards of quality and safety of human organs intended for transplantation lays down rules aiming to ensure high standards of quality and safety for organs intended for transplantation into the human body.

It applies to the:

  • donation;
  • procurement;
  • testing;
  • characterisation;
  • preservation;
  • transport;
  • and transplantation of organs.

To achieve that objective, the Proposal plans to rely on national quality programmes which ensure the traceability of organs at each stage in the chain from donation to transplantation or disposal.

Member States shall ensure that procurement of organs takes place in specialised procurement organisations and facilities. All organs must be characterised before transplantation.

Member States shall also attend to the conditions of transport of organs, ensuring traceability from donor to recipient. Their responsibility shall also extend to the personnel and the systems for the reporting of serious adverse effects and reactions.

It is also reiterated that organ donation must be voluntary and unpaid. Member States must provide donors with all the information necessary while guaranteeing their right to anonymity.

Member States shall designate the relevant competent authorities. The latter shall be responsible in particular for controlling the procurement organisations or transplantation centres and for supervising the exchanges of organs with other countries.

Codecision procedure ()

Directive 2004/23/EC of the European Parliament and of the Council of 31 March 2004 on setting standards of quality and safety for the donation, procurement, testing, processing, preservation, storage and distribution of human tissues and cells [Official Journal L 102, 07.04.2004].

Directive 2002/98/EC of the European Parliament and of the Council of 27 January 2003 setting standards of quality and safety for the collection, testing, processing, storage and distribution of human blood and blood components and amending Directive 2001/83/EC [Official Journal L 33, 08.02.2003].