Organ Donation & Transplantation across the EU: the work of the European Commission
By Stefaan Van der Spiegel, Belgium. Team Leader ‘Substances of human origin’, DG Santé, European Commission
Organ donation and transplantation is considered by the European Commission as falling under the theme “substances of human origin”. As per art 168 of the Treaty of the functioning of the EU, Health is a competence of the Member States (MS), therefore the EC’s role is limited mainly to complementing national policies, foster cooperation between MS and third countries. However, Art 168 4(a) calls to set ‘measures setting high standards of quality and safety of organs and substances of human origin, blood and blood derivatives; these measures shall not prevent any Member State from maintaining and introducing more restrictive standards’.
Based on this legal mandate, the EC does develop directives on the matter. Three groups of legislations have so far been adopted addressing the following topics: blood transfer, human tissue transplant and human organ transplant. In 2012, the EC adopted a Directive to support organ exchange between Member States.
With these directives, the European Commission is organizing the framework for the safety and quality of the organ donation process.
With a view to supporting Member States in the organ procurement and allocation process, the European Commission adopted an Action Plan on Organ Donation and Transplantation around 3 objectives with 10 priority actions:
- Improving quality and safety
- transplant coordinators
- quality improvement programmes
- living donation programmes
- communication skills of professionals
- information on citizens rights
- Making transplantation systems more efficient and accessible
- enhance organisational models
- EU-wide agreements
- interchange of organs
- Increasing organ availability
- evaluation of post-transplant results
- common accreditation system
Based on an evaluation in 2015 of the EU Action Plan on Organ Donation and Transplantation, it could be demonstrated that the EU Action Plan helped spur a 17% increase in organ transplants between 2008 and 2015 (4600 additional transplants: from 28100 to 32700) with an increase in organ donors from 12000 to 15000 and Spain, France, UK, Poland and the Netherlands being the five main contributors. Bulgaria, Lithuania, Finland, Croatia, Hungary, Czech Republic, Slovenia, Latvia and Denmark demonstrated the sharpest overall increase with some exceptions like Germany where numbers fell with 20%. The Action Plan lead to appointment of local coordinators for deceased donation and registries for living donors.
Key Benefits of the Action Plan:
- A shared agenda, addressing issues with a common perspective
- Helps obtaining political support
- Alignment with other international positions (CoE, WHO)
- Facilitates EU-wide collaboration
- Exchange best practices
- Develop new ideas/knowledge and support tools through exchange
- Overcome problems jointly
- Build closer relations amongst MS
- Allows to leverage potential of twinning and organ exchange
- Bottom-up agenda-setting, engaging professionals, administrations, politicians, public opinion
- Fewer objectives, with a stronger impact
- Clearly defined objectives, with tangible outcomes
- Bring together groups of countries with similar issues and situations.
- Learn from/collaborate with adjacent areas of expertise (e.g., tissues&cells, devices)
- More focus on MS with less developed transplant systems
- Reflect on implementation and sustainability, including IT.
The European Commission supports a wide variety of actions on these matters with a view to identifying good practices from Member States and sharing these across the EU. The EC sees the diverse EU landscape as a potential for MS to learn from each other.
One of these actions is the FOEDUS Joint Action which aims to facilitate the exchange of organs donated in the EU Member States. A pilot project involving 8 countries was conducted during 9 months.
In addition, the EC holds regular meetings of EU-28 National Competent Authorities for organ transplantation, undertakes funded projects (PHP) on living donation, has created a dedicated working group on living donation which developed a “toolbox for authorities on living kidney donation” –to support this activity.
As for the European Parliament, two pilot projects have been implemented in the last two years: the EDITH project (under the patronage of MEP Karin Kadenbach, see above) and the EUDONORGAN project (under the patronage of MEP Gabriel Mato) on social awareness on organ donation.
EUDONORGAN is Consortium led by the University of Barcelona in partnership with donation and transplantation institutes from Spain, Republic of Slovenia and Croatia and Italy. It aims not only to train health professionals but also to organize “awareness raising“ events with the support of the trained professionals and to propose and implement dissemination actions as well as monitoring and evaluation strategies.
Download Stefaan Van der Spiegel presentation slides here.