7 Organ donation and transplantation
| Committee's assessment
| Politically important
|
| Committee's decision
| Cleared |
| Document details
| Commission Staff Working Document: mid-term review of the Action Plan on Organ Donation and Transplantation 2009-15
|
| Legal base
| — |
| Department
| Health |
Summary and Committee's conclusions
7.1 During 2012, 4,000 patients within
the European Union died while on a waiting list for an organ transplant.
By the end of that year, 64,000 patients remained on a waiting
list. The demand for organs continues to outstrip supply. In
2008, the Commission published an Action Plan covering the period
2009-15 which includes ten "priority actions" to help
Member States increase the availability of organs for donation,
enhance the efficiency and accessibility of transplant systems
throughout the EU, and improve safety and quality. We reviewed
the Action Plan early in 2011 and were told by the Government
that steady progress had been made in implementing the priority
actions. We noted that the exchange of information and best practice
between Member States, particularly on ways to increase the number
of organ donors, could produce tangible benefits and indicated
that the mid-term review of the Action Plan, in 2012, would be
a suitable opportunity to evaluate how effective it had been in
increasing the supply of organs for donation and improving the
quality and safety of organ donation and transplantation systems
across the EU.
7.2 The Commission Staff Working Document
sets out the findings of the mid-term review and identifies a
small number of priority actions on which the EU and Member States
should focus their efforts for the remaining two years of the
Action Plan.
7.3 The Action Plan establishes a
non-binding framework to encourage cooperation between Member
States and promote the exchange of best practice. The outcome
of the mid-term review indicates that good progress has been made,
particularly in increasing the number and skills of transplant
donor coordinators, developing living donor programmes, improving
the monitoring of health outcomes, and adapting organisational
models to reflect best practice. During the period covered by
the mid-term review, there has been a net increase in the number
of organs available for transplant and the number of transplants
performed, although rates of progress vary between Member States.
7.4 We endorse the Minister's positive
assessment of the Action Plan and consider that the emphasis placed
on the sharing of expertise, within a structured framework, has
yielded tangible benefits. We note, for example, that the UK
is one of several Member States with effective living donor programmes
working together to create a "toolbox" to support the
development of similar programmes in other Member States. We
look forward to examining the final evaluation of the Action Plan,
once it has expired at the end of 2015, as well as any successor
programme. Meanwhile, we are content to clear the Commission
Staff Working Document from scrutiny.
Full details of the
documents: Commission Staff
Working Document on the mid-term review of the Action Plan
on Organ Donation and Transplantation (2009-2015): Strengthened
Cooperation between Member States: (36031), 9258/14, SWD(14)
147.
Background
7.5 The EU has a limited competence
to act in the field of public health and, in most cases, the scope
for EU action extends only to encouraging cooperation between
Member States, including initiatives concerning "the establishment
of guidelines and indicators, the organisation of exchange of
best practice, and the preparation of the necessary elements for
periodic monitoring and evaluation". The EU may, however,
adopt legislative measures "setting high standards of quality
and safety" for human organs "in order to meet common
safety concerns". These measures must not affect national
provisions on the donation or medical use of organs.[27]
7.6 In 2007, the Commission published
a Communication on organ donation and transplantation which suggested
ways in which the EU and Member States might increase the supply
of organs and improve the quality and safety of transplantation.[28]
The Commission advocated the preparation of an Action Plan to
encourage coordination and cooperation, as well as EU legislation
to establish basic principles of safety and quality.
7.7 A further Communication published
in December 2008 set out an Action Plan to strengthen cooperation
between Member States in addressing three main challenges:
· increasing the number and
availability of organ donors;
· making systems for the transplantation
of organs more efficient and accessible; and
· improving the quality and
safety of organ donation and transplantation.
7.8 At the same time, the Commission
proposed a Directive establishing rules to ensure high standards
of quality and safety for human organs intended for transplantation.
The Commission considered that common EU-wide standards were
necessary to protect donors and recipients from infection, increase
trust in the systems for donation and transplantation and facilitate
the cross-border exchange of organs. The Directive was adopted
in July 2010 and Member States were required to implement its
provisions by the end of August 2012.
7.9 In December 2012, the Health Council
adopted a set of Conclusions on organ donation and transplantation
which welcomed the progress made in implementing the Action Plan,
identified the common challenges facing Member States, and highlighted
the areas in which they should focus their efforts with a view
to increasing organ availability, enhancing the efficiency and
accessibility of transplant systems, and improving quality and
safety.[29]
Previous scrutiny of the Action Plan
7.10 The Action Plan spans a six-year
period from 2009-15 and identifies ten "priority actions"
which provide a framework for action at EU and national level,
supported by funding from the EU's Health and Research Framework
Programmes. The Government told us that steady progress had been
made during the first two years of the Action Plan in developing
a common set of indicators covering various aspects of donation
and transplantation which would provide the basis for monitoring
progress across Member States, sharing good practice and identifying
possible improvements. The Government expected future work to
focus on three work streams: encouraging and supporting organ
donation by living donors; increasing rates of organ donation
through collaboration between emergency medicine, intensive care
and donor transplant coordinators; and extending the criteria
for organ donation (for example, to include older donors).
7.11 We noted the progress made and
considered that the mid-term review of the Action Plan, in 2012,
would provide a suitable opportunity to evaluate whether the ten
priority actions were adequate to meet the challenges of increasing
the supply of organs and improving the quality and safety of organ
donation and transplantation across the EU.
The mid-term review of the Action Plan
7.12 The Commission Staff Working Document
reviews progress made against each of the ten priority actions
during the period 2009-2012 and identifies areas in which the
EU and Member States should seek to focus their efforts until
the expiry of the Action Plan at the end of 2015. The review
is based on information provided by national authorities and a
study commissioned from an external contractor evaluating the
relevance and impact of the Action Plan.
7.13 In the following paragraphs, we
summarise the Commission's assessment of progress made against
each priority action and conclude with its analysis of the overall
impact of the Action Plan and the areas in which EU support and
funding should be concentrated for the remaining two years.
Priority action 1: promoting the role of transplant
donor coordinators in every hospital where there is potential
for organ donation
7.14 The Commission highlights the essential
role of transplant donor coordinators in increasing donation rates
and the quality and safety of organs for transplantation, as well
as the support provided at EU level for the establishment of transplant
coordination systems, training, and enhanced cooperation between
transplant donor coordinators and intensive care units. It suggests
that the role of transplant donor coordinators has been widely
recognised and promoted by Member States and that these efforts
should be continued for the remaining period of the Action Plan,
but with the emphasis placed on national roll-out rather than
new EU-funded projects.
Priority action 2: promoting Quality Improvement
Programmes in every hospital where there is potential for organ
donation
7.15 Quality improvement programmes
are based on methodologies and indicators to measure and evaluate
the quality of all elements of the organ donation and transplantation
process. The EU has supported a variety of projects to assist
Member States in developing national programmes and to test quality
criteria and indicators at hospital level. Whilst most Member
States have started to develop their own quality improvement programmes,
their coverage remains patchy. The Commission therefore recommends
focussing more efforts on this priority action in 2014-15.
Priority action 3: exchange of best practice on
organ donation by living donors and the development of registers
for living donors
7.16 This priority action seeks to increase
the number of living donors — in 2012, 21% of kidney transplants
were from living donors, compared with 16.9% in 2007. Nearly
all Member States have living donation programmes. A number of
EU-funded projects have developed tools to enable Member States
to evaluate and select suitable living donors and to ensure that
health outcomes are monitored. The Commission suggests that EU
support for the remaining period of the Action Plan should focus
on the development of registers to record information on living
donors and ensure long-term follow-up.
Priority action 4: improving the knowledge and
communication skills of health professionals and patient support
groups
7.17 Public awareness of the opportunities
for living and deceased organ donation is essential to increase
the availability of organs for transplant. The EU has supported
projects to improve the communications skills of donor transplant
coordinators and other health professionals and to raise public
awareness of organ donation. The Commission considers that there
is scope for improvement, including through the use of social
media, and suggests that existing efforts at EU and national level
should be developed further.
Priority action 5: facilitating the identification
of organ donors across the EU and cross-border organ donation
7.18 There are significant variations
in the laws and practices governing organ donation across the
EU, particularly in determining who may be a donor, how donor
consent should be given, and what role the next-of-kin play.
The EU has funded projects to facilitate mutual understanding
of different legal requirements and national consent systems with
a view to facilitating cooperation between Member States and cross-border
organ donation. The Commission says it will consider the feasibility
of establishing national contact points in each Member State to
strengthen cooperation and help identify potential donors.
Priority action 6: enhancing organisational models
of organ donation and transplantation
7.19 Different donation and transplantation
models co-exist across the European Union, often harbouring examples
of expertise and excellence in particular aspects of the organ
donation and transplantation process. This priority action seeks
to encourage the exchange of best practice, through twinning projects
and peer reviews, so that Member States are able to adapt their
organisational models to achieve better outcomes. The Commission
considers that EU-funded projects have had a positive impact on
organ transplant activities and proposes to continue existing
efforts on this priority action.
Priority action 7: promoting EU-wide agreements
on aspects of transplantation
7.20 This priority action covers patient
mobility and transplantation, other aspects of transplant medicine
(including the treatment of non-EU patients), monitoring of organ
trafficking, and research strategies. The Commission notes that
no data are available on the number of patients who receive transplants
in another Member State, and that data on trafficking for the
purposes of organ removal are limited. No EU-wide agreements
have been concluded, and the Commission accepts that the scope
and meaning of this priority action are too broad to provide meaningful
policy direction. It nevertheless highlights agreements between
smaller clusters of Member States, as well as EU-funded projects
to support the exchange of organs, establish indicators and guidance
to identify trafficking activities, and collaborate on innovative
research. The Commission expects existing projects to continue,
but does not envisage this priority action becoming a major focus
at EU level for the remainder of the Action Plan.
Priority action 8: facilitating the exchange of
organs between national authorities
7.21 The purpose of this priority action
is to optimise the use of organs by facilitating organ exchange
agreements between Member States, drawing on the experience of
established organ exchange organisations such as Eurotransplant
and Scandiatransplant. The EU has funded research to develop
an IT platform for the exchange of organs that cannot be allocated
in their country of origin, as well as procedures to offer organs
across borders in cases of urgent need or for difficult-to-treat
patients. The Commission considers that this priority action
should be an important focus for the period 2014-15.
Priority action 9: improving the evaluation of
post-transplant results
7.22 The Commission underlines the importance
of post-transplant follow-up to evaluate the results of transplantations
(including any risks associated with the use of organs from so-called
'expanded criteria' donors — those who are older than 60
or have a specific disease) and to promote good medical practice.
The EU has funded projects to assess the safety of transplanted
organs from these higher risk donors and to develop registries
recoding information on pre- and post-transplant outcomes. However,
not all of the information collected is comparable across Member
States. The Commission highlights work underway to develop a
common methodology and says it will consider the feasibility of
establishing a European register of national registries.
Priority action 10: promoting a common accreditation
system for organ donation and transplantation programmes
7.23 There are significant differences
in the accreditation systems already in place in Member States,
often reflecting differences in educational and health systems.
Little progress has been made in developing a common accreditation
system and the Commission suggest that this should not be a priority
for 2014-15. Instead, it advocates a broader "mapping"
exercise to enable Member States to identify the various tools
available for training, certification, evaluation and audit.
The Commission's analysis of the impact of the
Action Plan
7.24 The Commission concludes that Member
States have made good progress in implementing the Action Plan,
adding that the total number of organ transplants in the EU increased
from just over 28,000 in 2007 to more than 30,000 in 2012. It
suggests that the Action Plan has:
· provided a comprehensive
framework enabling each Member State to proceed at its own pace
and to take account of its own national situation;
· "leveraged" the
expertise available in some Member States to share knowledge of
different aspects of transplant medicine and disseminate best
practice more widely; and
· provided a focus for support
and funding at EU level.
7.25 Whilst Member States are expected
to continue to implement the Action Plan for the remaining two-year
period to the end of 2015, the Commission says it will focus its
efforts on two priority actions which have demonstrable "EU
added value" and "strong potential to support Member
States in tackling organ shortages". These are:
· support for living donation
programmes, including through the development of registries recording
information on long-term follow-up; and
· support for the exchange
of organs across borders through the use of a dedicated IT tool
and the development of procedures for urgent cases or difficult-to-treat
patients.
7.26 The Commission will continue to
support other priority actions, but anticipates that most activity
will be undertaken at national rather than EU level.
The Minister's Explanatory Memorandum of 4 June
2014
7.27 The Parliamentary Under-Secretary
for Public Health (Jane Ellison) notes that the UK is a member
of the Commission's technical working group overseeing implementation
of the Action Plan and accepts that there is a role for the EU
in establishing a clear framework for standards governing the
safety and quality of organs donated for transplantation. She
welcomes the opportunity to work with the Commission to:
"develop a framework for the sharing
of expertise among EU Member States and for cooperation between
countries designed to help maximise organ donation and to promote
greater access to transplantation. The approach has highlighted
the benefits of identification and development of common objectives;
quantitative and qualitative indicators and benchmarks; regular
reporting; and identification and sharing of best practices."
7.28 She continues:
"The severe shortage of organs
donated for transplant remains the main challenge that all EU
Member States face. Across the European Union, the number of
people requiring a transplant is far greater than the number of
organs available for transplant and in no Member State is there
a surplus of donations. Clearly there are potential benefits
of a pan-Europe approach to increasing donor rates and optimising
safe, high quality organs, for transplantation that need to be
considered."
7.29 The Minister considers that collaborative
work with the Commission and other Member States has helped to:
"raise the profile of organ donation
across Europe and to build on existing partnerships to identify
appropriate strategies and strengthen donation frameworks to enable
more people to benefit from a transplant. Over the years, the
UK has actively contributed to ongoing work to increase donation
rates across Europe, all of which have proved helpful in developing
donation programmes in Member States."
7.30 The Minister notes that NHS Blood
and Transplant has received funding to lead a project across 17
Member States to strengthen the interface between intensive care
and organ donation and to increase donation and transplant rates.
She continues:
"Over the past few years, steps
have been taken in the UK to emulate the best transplant programmes
in the world, by implementing changes and reflecting best practice.
This has resulted in the number of donated organs being some
60% higher than donation rates in 2008. This has been achieved
by the implementation of the Organ Donation Taskforce recommendations
published in 2008 to strengthen the donation infrastructure including
increasing the number of specialist nurses for organ donation
and an increase in referral of potential organ donors."
7.31 The Minister recognises that "there
is much more to do", adding:
"NHS Blood and Transplant published
their new strategy, Taking Organ Transplantation to 2020,
on 11 July 2013. To produce the best strategy possible they undertook
a comprehensive engagement exercise, including a series of meetings
with international experts on transplantation as well as donor
families, transplant recipients, those waiting on the transplant
list, religious and community leaders and the general public.
The strategy builds on the successes of the last few years, but
also seeks to address the barriers that remain in place and calls
for a revolution in public attitudes and behaviours. The aim,
by the end of 2020, is for the UK to be one of the best in the
world."
Previous Committee Reports
None; but see: Thirteenth Report HC
428-xii (2010-11), chapter 15 (12 January 2011) is relevant.
27 Article 168 TFEU. Back
28
(28686) 9834/07: see Twenty-seventh Report HC 41-xxvii (2006-07),
chapter 6 (27 June 2007). Back
29
See http://www.consilium.europa.eu/uedocs/cms_data/docs/pressdata/en/lsa/134095.pdf Back
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