Accession procedure
Frequently, countries show interest in joining Eurotransplant. For this purpose a transparent accession procedure has been developed. In seven steps candidate member states are assisted to full membership of the Eurotransplant community.
Step 1
A potential member state expresses interest in Eurotransplant. The Ministry of Health and/or the professional transplant community confirm cooperation is considered as beneficial. Preferably both the ministry and the transplant community acknowledge the benefit.
Step 2
A meeting between the potential member state and the Board of Management takes place. During the meeting the prerequisites for new Eurotransplant member countries are discussed and the compliance of the potential new member is screened.
Step 3
If both parties are still interested, then the potential member state implements the prerequisites for joining Eurotransplant. The Eurotransplant Reference Laboratory performs a Risk Assessment of Quality of Human Leukocyte Antigens (HLA) Diagnostics.
The Board of Management assesses the risks with regard to:
- Demographic characteristics of the potential member state
- Safety of Eurotransplant professionals
- Reliability of logistics due to distance, infrastructure and border issues
- Presence or absence of disputes of sovereignty
- Increased costs
- Compatibility of transplant legislation
Step 4
Depending on the outcome of the risk assessments, the Board of Management may conclude that offering a Preliminary Cooperation Agreement (PCA) is appropriate. The Board of Management consults the Supervisory Board and the Ministries of Health or their delegated bodies under national law for their approval (see the Articles of Association, articles 5.8 and 5.10). The Board of Management will start the negotiations with the potential member state.
Step 5
As soon as the negotiations on the PCA are concluded successfully, a ‘professional and scientific’ exchange of views and experiences between professional communities of the potential member state and Eurotransplant is organized. Also the training of key personnel in the potential member state is organized.
Step 6
The Board of Management evaluates the preliminary cooperation with the potential member state.
Step 7
If the cooperation is to the satisfaction of Eurotransplant as well as to the potential member state, the time has arrived for the final step: accession of the potential member state into the Eurotransplant community. This step also requires the approval of the Supervisory Board and the Ministries of Health or their delegated bodies under national law.
Prerequisites
Prior to becoming a member of the Eurotransplant community, countries must fulfill a number of prerequisites.
The following prerequisites in the field of organ donation and transplantation, medical knowledge and legislation represent transparent and objective criteria to be met by Eurotransplant member countries.
The members and candidates for membership work in accordance with:
- The most recent version of the WHO guiding principles on human cell, tissue and organ transplantation
- The Directive on standards of quality and safety of human organs intended for transplantation (EU Directive 2010/53/EU)
(Candidate) member states accept the principles for cooperation described in the:
- Eurotransplant Manual
- Articles of Association of Eurotransplant
- General conditions
The (candidate) member states have regulated the following topics:
- Non-commercialization of organ donation
- Defined brain death definition and diagnostic procedures
- Accreditation of transplant centers
- Data safety and protection principles/legislation
The membership of Eurotransplant requires
- Commitment to collect and deliver transplant follow-up data to improve organ allocation
- Legislation allowing organ exchange with Eurotransplant partner countries based on commonly agreed Eurotransplant allocation principles
- An organ donation rate at the time of full membership of approximately 10 pmp.
If this goal is not yet reached, it must be reasonable to assume – based on the development in organ donation over the preceding years and the measures taken in this area – that a donation rate above 10 pmp will be achieved within the near future - Reporting of all donors to Eurotransplant
To participate within Eurotransplant member states fulfill the following logistical prerequisites
- 24/7 duty for organ procurement, organ offering and HLA-typing and cross-matching (by an European Federation for Immunogenetics (EFI) accredited lab)
- Standardized donor characterization: blood count, clinical chemistry, serology infectious diseases
- Clearly defined contact persons for Eurotransplant
- A good grasp in writing and speech of English, for this is the official language within the Eurotransplant community and organ procurement organizations have to provide all donor related information in English.
- Standardized transport allowing safe and timely (acceptable cold ischemic time according to current medical standards) transport of:
- donor organs to and from other member country centers
- HLA sera to and from the Eurotransplant Reference Laboratory (ETRL) and other HLA labs
- Defined responsibilities and contact institutions for the settlement of registration and procurement costs
Then there are medical prerequisites. (Candidate) member states have:
- Standardized and qualified:
- Brain death definition and diagnostic procedures (according to national regulations)
- The evaluation and pretreatment of donors
- Explantation of donor organs by an experienced team
- The packing and transportation of donor organs
- Accreditation of the HLA-laboratory by the EFI and continuous and successful participation of the HLA-lab in the proficiency testing of the Eurotransplant Reference Laboratory (ETRL).