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EKHA Response to Consultation on Organ Donation and

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EKHA Response to Consultation on Organ Donation and Powered By Docstoc
					                             POSITION PAPER – September 2007

         European Kidney Health Alliance welcoming of and response
   to the European Commission Communication COM (2007) 275 on Organ
          Donation and Transplantation: Policy Actions at EU Level:

       A significant dossier for kidney donation and transplantation in the
                                  European Union


Introduction

The European Kidney Health Alliance (EKHA) was formed in 2007 to combine the expertise of European
organisations representing patients with kidney disease and their families, health care professionals
responsible for their treatment and clinical investigators and scientists dedicated to finding ways to prevent
kidney disease and to find better treatments for it. Accordingly, the EKHA is ideally placed to respond to the
European Commission’s Communication on Organ Donation and Transplantation: Policy Actions at EU level,
and is delighted to have the opportunity to do so.

As the first consultation took place before the formation of EKHA, EKHA members felt the importance of
responding to the Communicaton COM (2007) 275 and would like to thank DG Sanco for offering the
opportunity for this participation.

One of the founding principles of the EKHA is that maintenance of kidney health and the treatment of kidney
disease when it occurs must be considered at European level. The EKHA feels that both the European
Commission and the European Parliament have vital roles to play in assisting national governments with these
challenges. Accordingly, the EKHA applauds the interest taken by the European Union in organ donation
through its various initiatives since the Prague Conference of European Health Ministers in 1987.

The EKHA identified kidney transplantation as a priority area that needs urgent action to ensure equality of
access to high quality transplant services throughout Europe, to increase the opportunities for patients to
receive kidney transplants and to maximize the long term health of the patients and their transplanted organ.
Consequently we welcome unreservedly the recent stakeholder consultation and the subsequent proposal for
action on Organ Donation and Transplantation at EU level.

Based on our initial dialogue with DG Sanco, the purpose of this EKHA position paper is to make
informed suggestions for a legal instrument on quality and safety standards for organ donation and
transplantation and to deliver ideas so that the future EU Action Plan focuses on the real priorities for
organ donation and kidney transplantation in the EU.




European Kidney Health Alliance response to European Commission Communication            Page 1/4
COM (2007) 275 Organ Donation and Transplantation: Policy Actions at EU Level
EKHA suggestions in relation to the policy suggested in the Communication on Organ Donation and
Transplantation

The EKHA believes three fundamental objectives with regard to renal transplantation should be to improve:

    1) The quality of transplant services throughout Europe and equal access to them
    2) The chances of being offered a kidney transplant
    3) The health of patients after kidney transplantation

The EKHA supports the goals set out in the Communication on Organ Donation and Transplantation: Policy
Options at EU level, in that it believes that an EU legal instrument is necessary to ensure the quality and safety
of organ donation and transplantation throughout the EU and that an Action Plan is needed to strengthen
cooperation between Member States to ensure rapid progress towards defined objectives for transplantation.


1) Legal instrument: Improving quality of and access to transplant services throughout Europe

Quality of service and levels of access vary greatly throughout Europe and the EU could significantly facilitate
the development of transplantation in Europe. This would be achieved first by helping Member States to
develop a legal framework for organ donation and transplantation that would ultimately result in self sufficiency
for organ donation, and second through the establishment of National Authorities to operate the legal
framework.

EKHA agrees with the principles set out in the Communication regarding the proposal that the legal instrument
should establish a basic quality and safety framework. In particular, EKHA believes that National Transplant
Authorities should be established which have responsibility for:

       Ensuring transparency of the transplantation practice and accountability to the national health
        authorities under the terms of national legislation;
       Ensuring effective preservation and transportation of organs – a number of organs are lost each year
        during removal, preservation and transportation. Therefore, sharing of best practice in this area is
        imperative.
       Establishing a mandatory reporting system for all potential donors so that the number of organs that
        are available but not considered for transplantation could be assessed.
       Maintaining a mandatory data registry of transplantation outcome to which there is a compulsory
        comprehensive reporting of all transplantation data.
       Being responsible for an annual independent review of all transplant data collected.
       Ensuring that the characteristics for each potential donor organ are fully assessed and noted.

The data collected from all Member States could be used for the assessment of performance in each member
state and for the development of transplantation policy in Europe.




European Kidney Health Alliance response to European Commission Communication               Page 2/4
COM (2007) 275 Organ Donation and Transplantation: Policy Actions at EU Level
2) EKHA recommendations for the EU Action Plan on organ donation and transplantation

2. Addressing Organ Shortage

Organ donation rates and transplantation from available donors vary greatly throughout Europe. However, the
examples of first Spain and latterly some other Member States have shown that establishing a well-organized
and highly motivated National Transplant Authority can result in a sustained increase in donation rates to very
high levels. The EKHA recognizes the added value of Community Action with regard to addressing this issue:
with the correct approach, the EU could greatly assist National Transplant Authorities in Member States to
develop common strategies to increase transplant and donation throughout Europe. Therefore the EKHA
suggests that the Action Plan includes increasing organ availability as a top priority, and proposes the
inclusion of the following objectives:

       The establishment of common standards for diagnosing cerebral and cardiac death throughout
        member states.

       The encouragement of dissemination of best practice with regard to identifying potential donors and
        extending the range of potential donors both to non-heart beating donors and through greater use of
        living donors.

       Increasing public awareness of transplantation and the need for more donors.

       The establishment of systems to ensure that physicians determining the death of a potential donor
        should not be directly involved in cell, tissue or organ removal from the donor and subsequent
        transplantation procedures, or be responsible for the care of potential recipients of such organs.

       Developing donation from deceased individuals to its maximum therapeutic potential; including the
        concept of ‘treatment’ rather than ‘management’ of the donor. The introduction of this concept as a
        specialist topic into clinical training programmes in intensive care.

       Ensuring that care and follow up are provided for all living donors as outlined in the Amsterdam and
        Vancouver Forums of The Transplantation Society.

       The establishment of a common dataset for transplantation within the EU based on aggregating data
        from the individual National Transplant Registries.


3. Preventing Organ Trafficking


The EKHA welcomes the result of the stakeholder contribution with regard to the EU’s key role in combating
organ trafficking, and advocates initiatives to combat organ trafficking, which it believes should be banned and
common penalties introduced in EU-27 states.




European Kidney Health Alliance response to European Commission Communication             Page 3/4
COM (2007) 275 Organ Donation and Transplantation: Policy Actions at EU Level
3) Conclusion

The EKHA and its members are committed to playing an active role to improve all aspects of kidney
health in the European Union, including donation and transplantation. For this reason, it welcomes the
European Commission’s Communication on Organ Donation and Transplantation and fully supports
the proposal of a legal instrument on quality and safety standards of organ donation and
transplantation and an Action Plan on strengthened cooperation between Member States.

Specifically, the EKHA believes that the legal instrument should set out key responsibilities for
National Transplant Authorities who will be responsible for transparency in transplantation and
donation and will keep a record of potential donors, organ characterization and transplantation
outcome as well as ensuring effective preservation and transplantation of organs.

With regard to the Action Plan, the EKHA appreciates the Communication’s acknowledgement of the
problem of shortage of organs for transplantation in the EU and recommends developing common
strategies, largely based on dissemination of best practice, to address the problem. Areas that should
be focused on include the definition of the diagnosis of cerebral and cardiac death, identification of
donors, increasing public awareness of donation, development of specialist training programmes,
establishment of a common dataset of transplantation within the EU, and recognition of the
importance of care and follow-up of living donors and transplanted recipients.

The EKHA strongly supports the need to end organ trafficking in the EU.


For more information about EKHA and this position paper, please contact:
Anna Rouillard, EKHA Brussels office, tel : +32 2 639 6230




European Kidney Health Alliance response to European Commission Communication     Page 4/4
COM (2007) 275 Organ Donation and Transplantation: Policy Actions at EU Level

				
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