11.5.6. Policy tools

 

European Commission

 

Since 1999, the EU has had the mandate, under Article 152 of the Treaty, to legislate on quality and safety standards for human tissues and cells, human organs and blood used in medical treatment. EU Directives have been adopted on blood (http://ec.europa.eu/health/ph_threats/human_substance/legal_blood_en.htm), on tissues and on cells (http://ec.europa.eu/health/ph_threats/human_substance/legal_tissues_cells_en.htm). A similar Directive on the quality and safety of organs could be envisaged in the future.

 

The European Commission has already undertaken a number of initiatives in various policy areas.

·         The Health and Consumer Protection Directorate General has been working on two projects to develop a European Training Program on Organ Donation and to contribute to create a consensus on European common standards regarding legal, ethical, protection and registration practices in relation to organ living donors to guarantee the health and safety of the donors.

·         The Information Society Directorate General is supporting the creation of a European registry on organs, cells and tissues through the EUROCET project (https://www.eurodonor.org/eurocet/).

·         In the area of research, a number of projects are being carried out. For example, there is a project to develop a list of national and regional research programmes on organ transplantation in order to maximise the research already being carried out and avoid duplication. A separate European research project is focusing on ways to increase the potential of organ donation, e.g. by promoting cooperation and sharing information and best practices among certain European countries. Another project is focused on reprogramming the immune system to tolerate transplanted organs.

Council of Europe

 

In 1987, the Council of Europe set up the Select Committee of Experts on the organisational aspects of cooperation in organ transplantation (SP-CTO). This group prepared many recommendations for the Committee of Ministers. The Expert Group has now changed into a Steering Committee on Transplantation (CD-PTO) and will continue its work on ethical and organisational aspects.

 

A new step was reached with the Oviedo Convention adopted in 1997 by the Council of Europe since its influence is more significant than a simple recommendation or resolution. The aim of the Convention is, as defined in article 1, to protect the human being in his/her dignity and identity, and to guarantee anybody without discrimination the respect of his/her integrity and other fundamental rights and liberties concerning the application of biology and medicine. This convention has an annex: Additional Protocol relating to human organ and tissue transplantation dated January 24, 2002. Article 21 bans any financial aspect in this domain. The Council of Europe also set up a group of specialists on quality assurance for organs, tissues and cells and drew up a “Guide to Safety and Quality Assurance for Organs, Tissues and Cells” in February 2002, updated in 2006 and 2007.

 

Annex 11.7.1. List of recommendations and publications in the organ transplantation field

 

2005Recommendation Rec(2005)11 on the role and training of professionals responsible for organ donation (transplant “donor co-ordinators”)

2004Guide to safety and quality assurance for organs, tissues and cells – 2^nd Edition (2004)

2004Transplant Newsletter – September 2004 Vol. 9 No. 1

2004Recommendation Rec(2004)19 on criteria for the authorisation of organ transplantation facilities

2004Recommendation Rec (2004)8 on autologous cord blood banks and explanatory memorandum

2004Replies to the questionnaire for member states on organ trafficking

2004Recommendation Rec(2004)7 on organ trafficking

2003Recommendation Rec(2003)12 on organ donor registers

2003Recommendation Rec(2003)10 on xenotransplantation and explanatory memorandum

2003Recommendation 1611 (2003) of the Parliamentary Assembly on trafficking in organs in Europe

2003State of the art report in the field of xenotransplantation

2001Recommendation Rec(2001)5 on the management of organ transplant waiting lists and waiting times  

2001Recommendation Rec(2001)4 on the prevention of the possible transmission of variant Creutzfeldt-Jakob Disease (vCJD) by blood transfusion 

1999 Meeting the organ shortage: Current status and strategies for improvement of organ donation – a European consensus document

1997Recommendation No. R (97) 16 on liver transplantation from living related donors

1997Recommendation No. R (97) 15 on xenotransplantation

1994Recommendation N° R (94) 1 - Human tissue banks

1994Recommendation 1240 of the Parliamentary Assembly on the protection of material of human origin

1994Recommendation (94) 1 on human tissue banks

1992 List of tissue typing laboratories in the member states of the Council of Europe

1987 3^rd Conference of European Ministers of Health (Paris, 16-17 November 1987) - Reports:

         ▪ Ethical and socio-cultural problems raised by organ transplantation
         ▪ Organisational and educational aspects of organ transplantation
         ▪ Legislative measures in relation to organ transplantation and to European co-operation
         ▪ Procurement and sharing of organs for highly immunised recipients
         ▪ Current legislation in Council of Europe member states and Finland and results of European co-operation
1987 Renal transplantation: sense and sensitization by B Bradley and S Gore, Martinus Nijhoff Publishers

1983 Essential aspects of tissue typing

1978 Resolution (78) 29 - Harmonisation of legislations of member States relating to removal, grafting and transplantation of human substances

 

·          Recommendation No. R (99) 21 of the Committee of Ministers to member states on criteria for the management of waiting lists and waiting times in health care (adopted at the 681^st meeting)

·          Convention for the Protection of Individuals with regard to Automatic Processing of Personal Data (ETS No. 108) and to Recommendation No. R (97) 5 on the protection of medical data

·          World Health Organisation Resolution WHA 42.5 condemning the purchase and sale of organs of human origin

 

Transplantation in general has higher measurable quality indicators than other replacement therapies. Results of organ transplantation are progressively improving over time. This improvement is due to the progress made in surgical techniques, the availability of new and more specific immunosuppressive drugs, and the experience acquired by the transplant surgical and medical teams.