Invitation

E-kiri.eml

Tere,

Edastan Ungari eesistumise kÃµrgetasemelise konverentsi kutse.

Tervitades

Agne

Agne Nettan-Sepp
Permanent Representation of Estonia to the EU
Counsellor for Health Affairs
+32 2227 3926 | +32 491 992 799

Rue Guimard 11/13 | 1040 Brussels

*** ATTENTION *** This e-mail and its attachments may contain official information. If you are not the intended recipient, please notify the sender immediately, delete this e-mail and destroy any copies. Any dissemination or use of this information by a person other than the intended recipient is unauthorized and may be unlawful.

From: VÃ¡radi KornÃ©lia dr. - BEU <[email protected]>
Sent: Friday, June 7, 2024 3:56 PM
To: Agne Nettan-Sepp <[email protected]>
Cc: HUPRES_HC_SOC (BM) <[email protected]>; Kontor Csaba - BEU <[email protected]>; Almer Kitti - BEU <[email protected]>; Szepessy Edit - BEU <[email protected]>
Subject: Invitation to HU PRES High Level Conference on Organ Donation and Transplantation

Dear Agne,

Attached you will find our invitation to the high-level conference on organ donation and transplantation, scheduled for the 11th of July in Budapest, under the auspices of the Hungarian Presidency.

We would greatly appreciate your assistance in forwarding this invitation to your Minister of Health and relevant departments at your earliest convenience.

Kind regards,

The Hungarian Presidency Team

HU2024_Invitation_Transplant_EE.pdf

HU2024_PIN_TRANSPLANT.pdf

PRACTICAL INFORMATION NOTE “EVERY LIFE-SAVING ORGAN TRANSPLANT BEGINS WITH THE

DECISION OF AN ORGAN DONOR!"”

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LIST OF CONTENTS

List of Contents ......................................................................................................................2

General Information ................................................................................................................3

Deadlines ...............................................................................................................................3

Accreditations .........................................................................................................................3

Badges ...................................................................................................................................4

Liaison Officers.......................................................................................................................4

Interpretation ..........................................................................................................................5

Arrival and Departure .............................................................................................................5

Transportation ........................................................................................................................5

From the airport to the city ......................................................................................................5

Facilities .................................................................................................................................6

Bilateral Meetings ...................................................................................................................7

Security ..................................................................................................................................7

Accommodation......................................................................................................................7

Venues .................................................................................................................................12

Venue of the Conference ......................................................................................................13

Venue of the Welcome Reception and Networking ...............................................................13

Preliminary Programme ..........................................................................................................8

Programme Details ...............................................................................................................12

Media ...................................................................................................................................14

Other Practical Information ...................................................................................................14

Contact Information ..............................................................................................................14

3

GENERAL INFORMATION

The Hungarian Presidency of the Council of the European Union is pleased to provide the

following practical information to help you to prepare for the High-Level Ministerial

Conference on Organ Donation and Transplantation (Transplantation), to be held in

Budapest on the 10th and 11th July, 2024.

DEADLINES

When? What? Where/who?

10th June The Novento Presidency

accreditation platform opens.

Novento presidency

accreditation platform.

30th June, 23:59 The Novento Presidency

accreditation platform closes.

Novento presidency

accreditation platform.

At the airport Distribution of accreditations

for ministerial delegations.

By LIO (Liaison Officer).

During registration, at

the conference venue

Distribution of accreditations

for non-ministerial

delegations.

By LOC (Local Organizing

Committee).

DELEGATION FORMAT

Ministerial delegations are limited to one Head of Delegation and 2 accompanying

delegation (3 in total).

ACCREDITATIONS

Delegations are kindly asked to appoint a Delegation Accreditation Officer (DAO) who

will be responsible for the accreditation of every member of their delegation. Please

communicate the name, cell phone number and e-mail address of the DAO and the

title of the event to [email protected] as soon as possible.

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The appointed DAO will receive an e-mail containing a link and necessary credentials (log-in

information) for the official presidency accreditation platform to register the members of their

delegation.

We kindly ask you to register at your earliest convenience via the accreditation platform. The

online accreditation platform will be open from 10th June until 30th June.

Please make sure that personal details are correctly entered on the platform, as certain

information (e.g. your name) will appear on the badges. Please note that only accredited

delegates will have access to the official meeting and other official programme venues. If you

have any questions regarding your registration, please contact

[email protected].

All personal information provided for accreditation will be processed in accordance with the

EU General Data Protection Regulation (GDPR), which can be found at the accreditation

system.

BADGES

Access to the meeting venue requires a valid personalized badge, which can be

obtained after the registration request had been approved and the accreditation is confirmed

by a confirmation message through Novento. Badges will be distributed at the conference

venue upon arrival, or by the designated Liaison Officer (in case of ministerial delegations).

Delegates will receive one single badge for a several-day event. Please make sure to

wear your badges visibly at the meeting venue and official programme venues.

Please note that all participants are required to carry on their ID cards or passports, in order

to comply with the on-the-spot identification process.

In case of loss of a badge, please report it immediately to: [email protected]. The

validity of the badge will be immediately terminated, while the organisers will create a new

badge upon your request.

For further information regarding the badges of any delegate, please contact

[email protected].

LIAISON OFFICERS

Ministerial delegations will be escorted by a Presidency Liaison Officer to ensure that the visit

runs smoothly and to provide any logistical assistance that might be required on site.

Supervised by a coordinator, the Liaison Officer will:

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• serve as a single point of contact;

• welcome and accompany the delegation during the Presidency events;

• assist the delegation to ensure successful participation in the meeting;

• provide logistical assistance and administrative support at the venue;

• provide and distribute accreditation pins and badges on arrival.

INTERPRETATION

The Conference will be held in English, without the use of interpretation services.

ARRIVAL AND DEPARTURE

All delegations are kindly asked to provide the arrival and departure details in the

accreditation system:

• for delegations travelling by car or train: date and time of arrival, the border crossing

point to Hungary, and arrival destination point,

• for delegations travelling by plane: date and time of arrival and departure, as well as

the flight number and the airline.

TRANSPORTATION

FROM THE AIRPORT TO THE CITY

Delegates who arrive with a commercial flight will arrive to Terminal 2A or 2B of Budapest

Liszt Ferenc International Airport.

Ministerial delegations will be provided a VIP car for the HoD and a minibus for his/her

delegation members. Ministerial delegations are kindly asked to mark their luggage with

a national-coloured ribbon.

Non-ministerial delegation participants are responsible for their own travel arrangements.

• Budapest Airport Shuttle Service

Budapest Airport itself offers an airport shuttle service for an extra fee, called MiniBUD

(www.minibud.hu).

• Public Transport (Budapest Transport Centre – BKK)

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Public transport bus line 100E Airport Express provides a direct and fast connection to

the city centre. Single ticket costs 2.200 HUF, tickets can be purchased at the ticket

machines at the airport.

For more information regarding public transportation within the city, please consult the

website of BKK, where you can also learn about the costs of different types of tickets and

information on public transport routes: https://bkk.hu/en/

• Taxi

At your landing spot, Budapest Liszt Ferenc International Airport, you have the

opportunity to book a taxi to get you to your accommodation. The official partner of

Budapest Airport is Főtaxi (tel. +36 1 222 2 222, https://fotaxi.hu/en/). Főtaxi operates a

designated office outside of the arrival terminal.

FACILITIES

The Hungarian Presidency will provide all necessary services, such as a cloakroom, internet

connection, and working facilities for delegations at the Ministry of Interior, the official

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meeting venue. The Wi-Fi password will be provided at the location. It is allowed to bring

your luggage into the Ministry of Interior, which can be stored in the cloakroom.

BILATERAL MEETINGS

A limited number of bilateral meeting boxes will be available at the Ministry of Interior.

Reservations will be handled on a „first come-first served” basis. The Hungarian Presidency

does not provide interpretation for bilateral meetings. You can book a meeting in advance by

sending an e-mail to [email protected].

Please indicate

• preferred time slot (the standard duration is 30 minutes, however it can be

prolonged);

• the number of participants.

SECURITY

Providing a safe environment for our delegations is of paramount importance to the

Hungarian Presidency. For security reasons, badges must be worn visibly during the

official programme. Access to the meeting venue will be denied in the absence of a visibly

worn badge.

Please note that all delegates except the HoD will have to go via security check while

entering the meeting venue.

ACCOMMODATION

The Hungarian Presidency will book and cover the costs of accommodation for the

participating ministers (suite) + 1 delegate (standard) for the night of the two-day conference

at the Kempinski Hotel.

Non-ministerial delegations are responsible for their own reservation arrangements and

covering the cost of their hotel rooms. Any additional expenses (beverages, minibar, parking,

meals, laundry services, etc.) must be covered by the delegates themselves.

In case you have questions or need hotel recommendations, please contact us at the

following email address: [email protected].

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PRELIMINARY PROGRAMME

Please note that this programme is subject to change.

10TH OF JULY, 2024 (MONDAY)

18:00-20:30 Welcome Reception and Networking at Marriot Hotel Budapest

11TH OF JULY, 2024 (MONDAY)

09:30-09:45 Ministerial Opening

A welcome speech by Dr. Sándor Pintér Minister of Interior, and Dr. Péter

Takács, Minister of State for Health, highlighting the importance of organ

donation and transplantation, followed by a brief overview of the day's

objectives.

09:45-10:30 First panel – Institutional and Policy Framework

Exploring the regulatory, legal, and institutional frameworks that support or

hinder organ donation and transplantation.

Keynote speakers:

• Dr. Stefaan van der Spiegel, Head of Sector, Substances of Human

Origin, European Commission DG-SANTE, Belgium

• Mirela Busic Ph.D, Head of SoHO Standard Section, Council of

Europe, European Directorate for the Quality of Medicines and

HealthCare (EDQM), France

Moderator:

• Judit Bidló, Deputy State Secretary for Professional Healthcare

Management, Ministry of Interior, Hungary

Panelists:

• Prof. Michel Tsimaratos, Deputy Director, Agence de la biomédecine

in charge of medical and scientific policy, France

• Dr. Martina Anušić Juričić, Head of Sector, Transplantation and

Biomedicine, Ministry of Health, Croatia

10:30-10:50 Coffee break

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10:50-11:50 Second panel – Optimisation of Processes

Discussion on improving the efficiency and effectiveness of organ donation

and transplantation processes.

Keynote speaker:

• Dr. Beatriz Domínguez-Gil González, General Director, National

Transplant Organization, Spain

Moderator:

• Dr. Sándor Mihály Ph.D, Director of Transplantation, Hungarian

National Blood Transfusion Service, Hungary

Panelists:

• Prof. Derek Manas, Medical Director Organ & Tissue Donation &

Transplantation, NHS Blood and Transplant (organ utilization), United

Kingdom

• Dr. Jacqueline van de Wetering Internist, Nephrologist and Expert in

Living Kidney Donation at Erasmus Medical Center, (living donation),

the Netherlands

• Dr. Serge Vogelaar, Head of Allocation, Eurotransplant (international

organ exchange), the Netherlands

11:50-12:35 Third panel – Funding for Programmes and Research

Strategies for securing funding for organ donation and transplantation

programmes and research, including public and private sector partnerships.

Keynote Speaker:

• Dr. Giuseppe Feltrin, General Director, National Transplant Center,

Italy

Moderator:

• Prof. Zsolt Molnár, Director of the Department of Intensive Therapy at

Semmelweis University, Hungary

Panelists:

• Dr. Axel Rahmel, Medical Director, German Organ Procurement

Organization (DSO), Germany

• Mélanie Yammine, Vice Chair of the European Federation of

Pharmaceutical Industries and Associations (EFPIA) Presidency Task

Force

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• Prof. Luciano De Carlis, President of the Italian Transplantation

Society, Italy

12:35-13:35 Lunch break

13:35-14:15 Ministerial roundtable

Speakers:

• Dr. Monica García Gómez, Minister of Health of Spain

• Dr. Vili Beroš, Minister of Health of the Republic of Croatia (TBC)

• Dr. Péter Takács, Minister of State for Health of Hungary

• Dr. Petra Doerr, EDQM Director, Council of Europe

• Dr. Hans Kluge, WHO Regional Director for Europe (TBC)

14:15-15:15 Fourth Panel – Education and Training on Organ Donation

Addressing the need for education and training among healthcare

professionals and the general public to increase organ donation rates.

Keynote Speaker:

• Prof. Marti Manyalich, President, DTI Foundation, Spain,

Moderator:

• Dr. habil István Hartyánszky Ph.D, Former President, Hungarian

Transplant Society,

Panelists:

• Dr. Luca Toti, University of Rome Tor Vergata, Italy, ESOT Education

Committee Chair 2021-2024 (ESOT Hesperis course)

• Prof. André Baranski, Donor Surgery Masterclass, Leiden Medical

University, Netherlands

• Olive McGowan, Chief Nurse, Organ and Tissue Donation and

Transplantation, NHS Blood and Transplant (public awareness), UK

• Judit Berente, President, Hungarian Transplant Federation, Hungary

(patient education)

15:15-16:00 Fifth panel – Inequities in Organ Donation and Transplantation

Examining disparities in access to organ transplantation and strategies to

ensure equity.

Keynote Speaker:

• Prof. Raymond Vanholder, President, European Kidney Health

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Alliance, Retired Professor, Nephrology section, University Hospital,

Ghent, Belgium

Moderator:

• Prof. Ferenc Rényi-Vámos, Director, Department of the Chest Surgery,

Semmelweis University, Hungary

Panelists:

• Dr. Luciano Potena, Past President, European Society for Organ

Transplantation (ESOT), Italy

• Dr. Guenadiy Vatachki, Executive Director, Romanian Transplant

Agency, Romania

16:00-16:20 Coffee break

16:20-17:05 Sixth panel – Benchmarking

Sharing best practices, lessons learned, and innovative approaches in

organ donation and transplantation from around the world.

Keynote Speaker:

• Prof. Vassilios Papalois, Past-President, European Society for Organ

Transplantation (ESOT), Secretary General of the European Union of

Medical Specialists (UEMS), Head of Specialty for Transplantation

Surgery, Consultant Transplant and General Surgeon at Hammersmith

Hospital, UK

Moderator:

• Prof. Attila Szabó, Head of the Clinical Center and Vice-Rector for

Clinical Affairs, Semmelweis University and Head of the Pediatric

Centre, Semmelweis University, Hungary

Panelists:

• Efstratios Chatzixiros, Adviser for Transplantation, World Health

Organization

• Prof. Frans Claas, Medical Director, Eurotransplant, the Netherlands

17:05-17:10 Closing remarks

A wrap-up of the day's discussions, with a closing speech by the Hungarian

conference organizer, highlighting key takeaways and the path forward.

Speaker:

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• Dr. Sándor Mihály Ph.D, Director of Transplantation at the Hungarian

National Blood Transfusion Service, Hungary

PROGRAMME DETAILS

PANEL DISCUSSIONS

Each panel will consist of:

• 15 (20) Minute Keynote Speech: An expert or leader in the field will set the stage for

the topic with a focused presentation.

• 20 (30) Minute Moderated Discussion: A moderator will facilitate a dialogue among

panelists (including speakers), exploring different perspectives on the topic.

• 10 Minute Q&A: Audience members will have the opportunity to ask questions and

engage directly with the panelists.

VENUES

The High-Level Ministerial Conference on Organ Donation and Transplantation will be held at

two locations, all within walking distance of each other.

When? Venue Address

10 July 2024 Ball Room

Marriot Hotel Budapest

Apáczai Csere János utca 4

1052 Budapest

11 July 2024 Marble Hall

Ministry of Interior

József Attila utca 2-4

1051 Budapest

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VENUE OF THE CONFERENCE

The Ministerial Conference will be held at the Marble Hall of the Ministry of Interior.

The main building of the Ministry of Interior is located in the former headquarters of the

Hungarian Commercial Bank of Pest, a huge block facing the Danube with four internal

yards, built in the beginning of the 20th century. This part houses the offices of the Minister

and the State Secretaries along with the Marble Hall, the main venue of the ceremonial

events. The buildings show features of multiple styles, ranging from neo-Classicism through

Art Nouveau, while the interior spaces suggest elegance through the richly coloured marble

surfaces and the embossed copper designs.

VENUE OF THE WELCOME RECEPTION AND

NETWORKING

The Welcome Reception and Networking

on 3rd July will be organized in the Ballroom

of Marriot Hotel Budapest, which is a 10

minute walk from the conference venue. It

offers a spectacular panoramic view on the

Danube and the Buda side as well as an

elegant location for the welcome dinner.

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MEDIA

Photographs and video footage from events organised by the Hungarian Presidency will be

available on its official channels and the channels of the EU institutions.

Photos will be published on the official website of the Presidency and may be used free of

charge with a clear mention of the photographer.

For any media-related questions, please contact us at the following email address: [email protected].

OTHER PRACTICAL INFORMATION

Emergency number: 112 (fire brigade, medical assistance)

Electricity: The voltage in Hungary is 230V, 50 Hz.

Local time: Central European Summer Time Zone (CEST) – GMT +2:00

Country code: Hungary +36

Currency: The official currency of Hungary is the Hungarian Forint. For official daily

exchange rates, please consult the website of the Magyar Nemzeti Bank (National Bank of

Hungary): https://www.mnb.hu/en/arfolyamok

Weather in Hungary: https://met.hu/en/idojaras/

Tap water: Hungarian water is regularly tested for quality and is safe to drink.

Smoking: Smoking is only allowed in the designated area of the official meeting spaces.

CONTACT INFORMATION

Should you have any questions regarding the logistical aspects of the event, or about the

details of the programme, please contact us at the following e-mail address:

[email protected].

HU2024_Transplant_Concept paper.pdf

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Concept Paper

on Organ Donation and Transplantation

Hungarian EU Presidency

2

Ministerial Foreword

As we stand at the cusp of a transformative health landscape, it is with profound

awareness of our shared responsibilities and opportunities that we present this

Concept Paper on Organ Donation and Transplantation.

Hungary, with a rich history of pioneering achievements in transplantation, embodies

the spirit of innovation and dedication that is essential for advancing this vital area of

medicine. Since the first kidney transplant in 1962, Hungary has developed a

comprehensive and efficient transplantation system, underscored by an opt-out

legislation framework and the support of the Hungarian National Health Insurance

Fund.

The 2009-2015 EU Action Plan on Organ Donation and Transplantation led to

significant impacts, such as 21% increase in the number of donations. After the expiry

of the plan, with the European Union at a crossroads, the imperative for a renewed and

vigorous approach to organ donation and transplantation has never been clearer. The

statistics speak volumes: thousands of lives saved, improved quality of life for patients,

and the undeniable economic benefits that transplantation offers to our health systems.

As we articulate a vision for the future, this paper outlines a comprehensive strategy

that encompasses increased organ availability, enhanced efficiency and accessibility

of transplant systems, and the improvement of quality and safety standards. It is a call

to action for the European Union to embrace innovative practices, improve legal and

ethical frameworks, and foster education and public awareness. Through collaboration,

we can overcome the barriers that currently hinder the full realization of transplantation

potential in the EU.

The Hungarian Presidency envisions a future where every European citizen in need

has timely access to life-saving transplants, where the generosity of donors is

honoured and maximized, and where our health systems are strengthened by the

efficiency and cost-effectiveness of transplantation.

In conclusion, this Concept Paper is not merely a policy document; it is a manifesto for

hope, solidarity, and life. As we navigate the complexities of health in the 21st century,

let us be guided by the principles of equity, innovation, and compassion. Together, we

can achieve a milestone in medical science and public health, reaffirming our

commitment to improving the lives of citizens across the European Union. The time for

action is now.

Dr Péter Takács

Minister of State for Health

3

Improving organ donation and transplantation in the European Union Paving the way towards a renewed EU action plan

Concept Paper of the 2024 Hungarian EU presidency

Table of content

Introduction ............................................................................................................................ 4

Organ donation and transplantation in Hungary .................................................................. 4

Current overview of organ donation and transplantation in Europe ..................................... 4

Action plan on Organ Donation and Transplantation (2009-2015): Strengthened

Cooperation between Member States and Study on the uptake and impact of the EU

Action Plan on Organ Donation and Transplantation (2009-2015) in the EU Member States

– FACTOR Study .............................................................................................................. 11

FACTOR-study key considerations for a new Action Plan: ............................................. 12

The following actions could be considered by the EU Member States .................................. 13

EU Member States should: ............................................................................................... 13

The following actions could be considered by the European Commission ........................... 19

Options for the European Commission to support Member States: ................................... 19

Conclusion ........................................................................................................................... 21

Sources: ............................................................................................................................... 22

References: .......................................................................................................................... 23

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Introduction

Organ donation and transplantation in Hungary

In Hungary the first human kidney transplantation was performed in 1962, but the

programme started in 1973. Hungary currently has 7 transplant centres in 4 cities,

where 4 kidney, 1 liver, 2 heart, 1 lung and 2 pancreas transplant programmes are

available.

The opt-out system for deceased donation was firstly introduced in 1972, then the

current, same type of legislation became available in 1997 by the Act on Health.

Authorisation of procurement and transplant centres are defined in a Ministerial

Decree.

Financing of organ donation in donor hospitals, organ procurement by centres,

transplant procedures and transport costs are reimbursed by the Hungarian National

Health Insurance Fund and by the Government by law.

The Hungarian National Blood Transfusion Service (HNBTS, in Hungarian: Országos

Vérellátó Szolgálat, OVSz) is entitled by the Ministerial Decree as National Competent

Authority (NCA) in the field of organ donation and transplantation. HNBTS operates

the National Organ Donation and Transplant Follow-up Registry and the EFI

(European Federation for Immunogenetics) accredited Transplant Immunology

Laboratory with full national responsibility. HNBTS participated in several EU co-

funded projects in the field of organ donation and transplantation: DOPKI, MODE,

COORENOR, ACCORD, FOEDUS, EDITH, BRAVEST. HNBTS is the Hungarian

contracting partner of the Eurotransplant International Foundation since the full

membership introduced in 2013.

The Transplantation Directorate of the HNBTS builds up from 4 departments:

 Organ Coordination Office is the National Organ Procurement Organization

(OPO) and responsible for the central coordination of the organ donation

process, in accordance with Governmental Decree by operating three levels of

the transplant donor coordination network,

 Central Waiting List Office, as the HNBTS is responsible for the national waiting

list management with the involvement of 9 Organ Transplant Waiting List

Committees,

 Hungarian Bone Marrow Registry,

 Hungarian National Organ and Tissue Donation Opting-out Registry.

A National Action Plan was presented at a Competent Authority meeting on the 28th of

February 2011.

Current overview of organ donation and transplantation in Europe

Organ transplantation improves patient survival and quality of life and has a major

beneficial impact on public health and the socio-economic burden of organ failure. In

the European Union (EU), a relatively coherent and structured approach exists to

transplantation with well- developed national programmes, international schemes to

facilitate organ sharing and well-defined exchange policies, making Europe a leader in

5

the field. The added value in this field of EU collaboration has been widely

demonstrated by the success of the EU legislative framework on organ donation and

transplantation1 and the 2009-2015 EU Action Plan in particular, which contributed

significantly to the strengthening of the European organ donation and transplantation

landscape. Since the Action Plan’s adoption, as the European Commission’s FACTOR

Study on the Action Plan’s uptake and impact notes, the total number of organ donors

at the EU level has considerably increased, i.e. from 12.3 thousand in 2008 to 14.9

thousand in 2015. This accounts to a 21% increase over the period. This overall

increase includes an increase in living organ donors of 29.5% and increase in

deceased organ donors of 12%. An encouraging trend was observed in the number of

transplants over the period of the Action Plan. Overall, there was an increase with

4.641 transplants, from 28.066 transplants in 2008 to 32.707 in 2015. This accounts to

a 17% increase over the period. The number of transplants was increasing for all types

of organs over the period of the Action Plan, except for small bowel transplants. There

was a 16% increase in kidney transplants (the most transplanted organ), and liver

transplants increased by 16%, heart transplants by 10%, pancreas transplants by 7%

and lung transplants even by 41%.

Since the Action Plan’s conclusion, the need of organ donation and transplantation has

not waned.

Non-communicable (chronic) diseases (NCDs) impose a substantial burden on

healthcare systems, economies, quality of life, employment status and social activities.

In Europe, NCDs are responsible for 77% of the disease burden and 86% of deaths2,

many of which are in young individuals3. Changes in population demographics and the

growing prevalence of risk factors have contributed to an increase in the demand for

organ replacement therapies. Artificial organ support is an option in some instances

but is only available on a large scale for kidney failure in the form of dialysis. Hence,

transplantation is for many patients the only solution to restoring organ function and

preventing premature death. The WHO has urged countries to progress towards self-

sufficiency in transplantation, first by preventing NCDs and their progression to end-

stage organ failure, but also through the provision of sufficient numbers of life-saving

transplants to match their need4,5. The WHO further emphasizes that deceased

donation should be developed to its maximum therapeutic potential.

Advanced NCDs continue to present a substantial burden for individual patients and

overall healthcare systems alike. As of late 2022, 52,000 persons awaited a transplant

in the EU6 and for some of these patients the availability of donor organs can be a life-

or-death matter. For most vital organs (liver, heart, lungs), transplantation is the only

life-saving therapy. In the case of advanced kidney disease (kidney failure), where

alternative treatment by the means of dialysis is available and used on a large-scale,

kidney transplantation remains by far the preferred option, both in terms of quality of

life and cost-effectiveness.

Although some studies demonstrate the cost-effectiveness of heart and liver

transplantation7,8, it remains overall difficult to fathom the health economic impact of

these procedures as no large-scale alternative long-term therapy is currently available

6

(the alternative is the patient’s death). The reduction of costs is particularly striking

when it comes to the comparison between kidney transplantation and dialysis.

(Figure 1) In France, recent data from 2021 show that dialysis represents 82% of all

costs related to the treatment of kidney failure, versus 18% for transplantation one year

after surgery.

Figure 1: Annual spending on different treatments for kidney failure, France, 20219

Source: Graph produced by EKHA based on the 2023 economical assessment of the French

National Social Security Authority (Caisse Nationale d’Assurance Maladie).

7

(Figure 2) In the UK, the comparison of costs between patients after one year on

dialysis and patients one year after transplantation including post-transplant

medication estimated that transplantation led to a striking saving of £25.800 per

patient. If we extend this figure to the number of patients (23.000), we can estimate

that kidney transplantation helped save £512 million in dialysis costs.

Figure 2: Costs per patient of treatment option for end-stage kidney failure, UK, 200910

Source: Graph produced by the European Commission based on the cost-effectiveness

analysis undertaken by the 2009 NHS Blood and Transplant.

8

(Figure 3) In the EU, dialysis represents 1% of all healthcare expenditure (For only 0.1-0.2%

of the population) versus 0.10% for transplantation.

Figure 3: Estimation of the impact of kidney replacement therapy expenditure in

Europe, 2016

(The Effect of Differing Kidney Disease Treatment Modalities and Organ Donation and

Transplantation Practices on Health Expenditures and Patient Outcomes (EDITH project)11

HD: Haemodialysis

PD: Peritoneal dialysis

DKD: Kidney transplantation from a deceased donor

LKD: Kidney transplantation from a living donor

Source: Graph included in the final report of the EDITH project.

9

(Figure 4) According to the Spanish Transplant Organisation ‘Organización Nacional

de Trasplantes’ (ONT), the savings created by transplantation (estimated at EUR 400

million per year)12, amply cover the annual costs of transplant programmes for all solid

organs (EUR 240.36 million per year). More recent data from the ONT (table below

Figure 4), estimate that kidney transplantation helped save more than EUR 700 million

within the last ten years13.

As population continues to age, so does the strain on our economy, it is pivotal to

consider transplantation not only as a life-saving or preferred option for patients, but

also as a preferred option for the health systems and a crucial investment for the

resilience of healthcare systems in the EU. Beyond financial costs, an uptake in

transplantation would also be beneficial for the planet. For example, in the case of

kidney failure, the environmental impact of transplantation can be as much as 90%

lower compared to that of dialysis.14

Figure 4: Annual cost of solid organ transplant, Spain, National Transplant

Organisation (ONT)12

Source: Graph produced by the European Commission based on data from the Spanish

National Transplant Authority

10

Estimated savings per year per kidney transplant patient: 30,000€

Estimated savings during the last 10 years: 800 million €

Number of kidney transplants in 2021 3,000

Cost of dialysis per patient per year 41,120 €

Cost of kidney transplant per patient (first year) 26,729 €

Cost of kidney transplant per patient (subsequent years) 10,516 €

Savings per patient per year from 2nd year of kidney transplant 30,604 €

Number of kidney transplants in the last 10 years 30,000

Excluding the transplants performed in the last year, 27,000 patients with a

kidney transplant. Considering a graft survival of 90%, savings are estimated

on a number of 24,000 transplanted patients

Spanish cost savings in the last 10 years 734,496,000 €

*2021 data

Table 1: Savings by kidney transplantation in Spain*

11

Action plan on Organ Donation and Transplantation (2009-2015): Strengthened

Cooperation between Member States and Study on the uptake and impact of the EU

Action Plan on Organ Donation and Transplantation (2009-2015) in the EU Member

States – FACTOR Study

The first EU Action Plan aimed to address three main challenges:

1) Increase organ availability

2) Enhance efficiency and accessibility of transplant systems

3) Improve quality and safety

Across these three challenges, the EU Action Plan defined 5 objectives and 10 priority

actions:

Source: Study on the update and impact of the EU Action Plan on Organ Donation

and Transplantation (2009-2015) in the EU Member States, Factor Study15

As the FACTOR study presents, progress was achieved in Member States on five of

these ten priority actions (all included in this paper as important priorities that should

continue to be leveraged):

 The appointment of transplant coordinators

 The development of quality improvement programmes

 The set-up and/or development of living donation programmes

 The building of public awareness

 The facilitation of organ exchange between countries

12

While progress was made, the Action Plan’s five remaining priority actions were not

addressed as intensively enough during the 2009-2015 timeframe:

 The identification of organ donors across Europe and cross-border

donation in Europe, for which this concept paper provides clear objectives and

recommendations such as the activation and expansion of cross-border kidney

exchange programmes (KEP) and mismatch programmes, the facilitation of

best practices’ exchange between countries and the organisation of meetings

between national competent authorities under the umbrella of the European

Commission.

 The involvement in twinning of projects and peer review programmes, for

which this concept paper recommends further peer-to-peer exchange between

countries/hospitals performing well and countries/hospitals lagging behind

which could be facilitated by the European Commission via, for example, the

ERASMUS + programme, the EU Structural Reform Support Service, the EU

Best Practices Portal and EU-funded programmes. For the latter, the

development of solutions to sustain outcomes and infrastructures after the end

of the project will be crucial.

 EU-wide agreements and initiatives, which this concept paper suggest

leveraging via, for example, the development of EU transplant centres of

excellence (modelled on the EU network of comprehensive cancer centres) and

the continuation of the European Reference Networks, in particular the ERN

Transplant Child.

 The collection of data regarding post-transplant outcomes, and the

reporting of that data to relevant European agents, for which we suggest

facilitating the implementation of current initiatives of the European Society of

Organ Transplantation (ESOT) for EU-wide registries and to support the

collection and sharing of data between Member States.

 Regular auditing efforts for procurement organisations and

transplantation centres, for which this concept paper suggests the

development of EU-wide guidelines.

Moreover, donation and transplantation rates have now stalled or even declined in

many EU Member States since the Action Plan ended in 2015. The COVID pandemic

drew attention to the different levels of resilience and vulnerability of the Member

States, in addition to the 17% decrease in deceased organ donation activity from 2019

to 2020, as pandemic hit. Against this backdrop, this concept paper presents possible

interventions that could be part of a second EU action plan. A renewed focus on organ

donation and transplantation is imperative to ensure that the progress made since

2009 is maintained and that remaining challenges are addressed. These possible

measures divided into specific categories, take account of references listed at the end.

FACTOR-study key considerations for a new Action Plan:

1. Invest more in defining clear objectives of the new Action Plan by using a

bottom-up approach. Ensure that the representatives of different levels are

13

involved: professional, administrative, political and the public. There should be

fewer objectives but aiming for a stronger impact.

2. Build further upon the power of mutual learning and knowledge exchange.

Individual countries that face similar issues can be given support jointly. The

Competent Authority meetings could also be organised on this basis, and other

relevant stakeholders could be invited more regularly to contribute.

3. Seek opportunities to share with and learn from adjacent areas of expertise, like

tissues and cells, to increase the participatory and absorptive capacity of each

country.

4. Support countries with less developed donation systems to bring their topics

forward and have a more explicit role in the agenda.

5. Reflect more on implementation and sustainability, including the maintenance

of IT components in projects, for more of a long-term impact, by commitment of

involved parties (government, professional organisations, etc.).

The following actions could be considered by the EU Member States

At present, the EU’s organ donation and transplantation landscape faces multiple

challenges, and the further increase in donation and transplantation activity continues

to be hampered by a diverse array of barriers.

To increase the uptake of organ donation and transplantation in the EU Member

States, an improvement of both the EU’s and Member States’ institutional and policy

frameworks, with the removal of legal and institutional obstacles are crucial.16

EU Member States should:

a) Develop institutional, legal and ethical frameworks that facilitate the uptake of

organ donation and transplantation, in line with EU guidance. Here, the focus

should be on:

a. Reducing financial and infrastructural barriers

b. Legislation

i. The implementation of opt-out versus opt-in policies (The latter is

still applied in several EU countries), keeping in mind that opting-

out policies are not the only solution and should only be seen as

a fundament on which other measures in this document can be

further developed.

ii. Address existing loopholes in organ trafficking legislation by:

1. Sign and ratify the Council of Europe Convention against

trafficking in human organs, which remains unratified by

several EU countries.

2. Endorse and implement the recommendations of the

Declaration of Istanbul Custodian Group.

14

3. Establish a general reporting system of all out-of-country

organ transplantations and non-resident donor and/or

recipient donations/transplantations to a centralised

registry.

iii. Develop incentives to favour transplantation over dialysis for end-

stage-kidney-failure patients.

c. Deceased organ donation

i. Establishment and maintenance of national organ donation

organization

1. Create and strengthen donor coordinator networks, for

which the 2009-2015 EU Action Plan provided a strong

foundation, at the national, regional, and hospital levels,

and incorporate key stakeholders in the identification and

reporting of potential organ donors, both deceased and

living. Here, specific attention should be devoted to:

a. The collection of a defined set of reliable and

granular data on organ donation and transplantation

and their transparent communication.

b. The central role of specially trained and committed

ICU healthcare professionals as donor coordinators.

c. The integration of organ donation into the end-of-

life-care practices.

2. Analyse and target regional differences in organ donation

rates including identifying the reasons why specific

hospitals have significantly higher or lower retrieval rates.

3. Ensure the strength of overall health systems to make

donation and transplantation processes resilient to health

crises, as they were heavily impacted during the COVID-

19 pandemic.

ii. Maximizing the role of donor coordinators in all hospitals with

potential for organ donation.

iii. Optimizing the role of intensive care professionals by the

development of intensive care unit (ICU) programmes in

collaboration with donor coordination organisations to enable an

increase in the number of potential donors identified and the

numbers of actual and utilised deceased donors.

iv. Minimizing and/or optimizing the duration of the donation process.

v. Promote expanded criteria donation (donors that are not

considered ideal or standard but are still of sufficient quality for

transplantation and as such, can significantly shorten the waiting-

time to receive a transplantation), which is currently under-

developed or even non-existent in most EU Member States. This

should be supported by novel perfusion and preservation

technologies.

15

vi. Consider the development of DCD (Donation after Circulatory

Death) programmes by the development of consensus-based

negotiations on the implementation.

vii. Development of special health care services if required, e.g. infant

ABOi heart transplant programmes.

viii. Implementation of national machine perfusion programmes.

d. Activation and expansion of living-donation programmes

i. Activation and expansion of living kidney donation programmes in

kidney transplant centers.

Create and maintain frameworks to ensure that donation does not

result in financial loss for the living donor, that foster greater

spouse/emotionally related donation, and that allow for uniformity

in the procedures for the recruitment and provision of information

regarding donors and recipients. Specific attention should be paid

on ensuring that donation remains an altruistic act based on

genuine consent.

ii. Use the EU ‘Toolbox Living Kidney Donation’ when setting up

ethical frameworks for unrelated living donation.

iii. National patient and family information programmes about

possible treatment options for patients with ESRD

iv. Implementation of national kidney paired exchange and AB0i

programmes

v. Open discussion on the altruistic living kidney and liver donation

option

vi. Implementation of living donor liver transplantation programmes

e. International organ exchange:

Increase official cross-border cooperation agreements on organ donation

and transplantation within the EU (found to be important for the

optimisation of the use of the limited number of available organs in the

FACTOR study). Here the potential of organ perfusion systems, which

can allow for longer transport time, and which are currently underused,

should be fully unlocked.

f. Education and training

i. Training of healthcare professionals:

1. Organ donation

a. Actively encourage healthcare professionals (from

primary to specialist care) to receive specific

education in donation and transplantation activities,

for example by:

i. Including basic information on donation and

transplantation in the undergraduate

curriculum for physicians and nurses, whilst

continued education should be provided.

16

ii. Offering reimbursement of fees and/or

support schemes for participation in

accredited professional training programmes

on organ donation.

iii. Supporting the implementation of educational

quality-assurance programmes.

iv. Clustering educational programmes targeted

to different healthcare professional

specialties.

v. Mandating periodic renewal of training in

clinical areas where patients with devastating

brain damage are treated.

vi. Appointing a responsible organisation to

coordinate nationally these training sessions.

2. Organ procurement: Support the establishment and

continuous training of dedicated teams for the retrieval of

organs, for example by investing in surgery units and ICU

capacity (taking account of the fact that for living donation,

two operating rooms are simultaneously needed).

3. Organ transplantation surgery

ii. Public education and public awareness:

1. Support efforts to facilitate public education, for which the

2009-2015 EU Action Plan proved instrumental, including:

a. The provision of education on organ donation and

transplantation in schools, with a particular focus on

high schools.

b. Information about donation and transplantation via

public-awareness campaigns, the press and social

media, with a particular focus on communication

about the quality of life of living donor.

c. Showcase the uniqueness of donors (for directed

and non-directed organ donation), as an inspiring

example of solidarity in society.

2. Increase transparency of living and deceased donation

processes to enhance public trust in the system.

iii. Patient education

1. Improve information on pre-transplant stage and on post-

operative care for:

a. ESRD patients for better knowledge and

acceptance of organ donation,

b. transplant patients to prevent organ loss and

enhance patient recovery,

c. living donors and their families to improve donor

recovery.

17

g. Funding for programmes and research

i. Actively make use of opportunities to secure EU funding for

transplant-related research, focused on increasing the number

and quality of organs available for transplantation.

ii. Obtain EU technical support, by applying to programmes with,

specifically, a focus on the development and continued shaping of

infrastructure, education and training, digitalisation, and research

in healthcare.

iii. Implement policies towards dedicated cost reimbursement to

hospitals for donor management (ICU work) and organ retrieval.

iv. Steer funds to increase the number of transplantation units and

the number of medical personnel involved in transplantation.

v. Encourage and support the use of organs that could not be

allocated nationally or internationally, for research purposes

(currently discarded in most cases).

vi. Reflect, together with the European Commission, on ways to

sustain EU-funded projects, including the maintenance of Pan-

European Organ Transplantation Registries, currently developed

by the European Society for Organ Transplantation (ESOT), to

measure long-term results and identify differences between

therapeutic alternatives in order to improve effectiveness, quality

and safety.

h. Inequities

i. Develop national strategies and actions designed to combat

inequities related to organ donation and transplantation, which

may focus on supporting efforts to increase registration for

patients who are not systematically registered on transplant

waiting lists.

ii. Review the allocation criteria used by the national organ allocation

systems to ensure inequities are identified and tackled.

iii. Develop systems to reduce waiting times for highly sensitized

transplant candidates.

iv. Support the collection of data on non-waitlisted patients in need of

a transplant from transplant centres (i.e. numbers of patients on

dialysis, waitlisted versus not waitlisted), including baseline

characteristics to identify areas of inequities.

v. Develop kidney exchange programmes as well as mismatch

programmes to increase chances to find a compatible donor.

vi. Develop targeted communication schemes and educational

initiatives, together with patient organisations and representatives

of target groups that allow the socially deprived, those with lower

education attainment, and those from minority communities to

receive tailored information about donation and transplantation,

considering different cultural, lingual and religious backgrounds.

18

vii. Provide guidance on measures to prevent living donors’ financial

or employment loss due to donation.

viii. Develop and facilitate implementation of programmes to

reintegrate transplanted patients into employment.

ix. Clustering of countries.

i. Benchmarking

x. Work in concert with national transplantation organisations and

European transplant societies to guarantee the proper registration

and analysis of all transplant outcomes (including on survival after

transplantation) in an actionable manner. Here, it is crucial to

engage in a collaborative exercise to ensure a predefined

common dataset (Recommendation CM/Rec(2023)7) and

validated data collection.

xi. Support activities aimed at encouraging the sharing of

anonymised summary data between hospitals and comparing

their performance.

xii. Use Patient-Reported-Outcome-Measures (PROMs) to assess

quality of life and wellbeing of patients and living donors before

and after transplantation.

19

The following actions could be considered at European level

Adopt EU actions to support organ donation and transplantation, based on the

achievements and lessons learned from the 1st EU action plan, and involve relevant

stakeholders (healthcare professionals, professional organisations, administrators,

national competent authorities (NCAs), researchers and relevant patient

organisations) in its preparation and implementation.

Develop recommendations and guidelines to support Member States’ activities to

enhance their institutional and policy frameworks and support the involvement of the

above-mentioned stakeholders in the development of such guidance.

Encourage and support cross-border cooperation between Member States on organ

donation and transplantation, including the activation and kidney exchange

programmes (Kidney exchange programmes involve two living donors and two

recipients, located in different countries. If the recipient from one pair is compatible

with the donor from the other pair, and vice-versa, the programme can arrange for a

‘swap’ for two simultaneous transplants to take place, in different territories) and

mismatch programmes (such as the Acceptable Mismatch programme initiated by

Eurotransplant)17 and the exchange of best practices.

Further develop the system of national focal points (NFPs) and central reporting to

provide facts for legal responses and to increase transparency on travel for organ

donation and transplantation, including a framework for regular reporting mechanisms.

Collaborate with Member States to improve systems of registration on waiting lists and

facilitate the creation of EU-wide waiting lists.

Options for the European Commission to support Member States:

a) Encourage and support the clustering of Member States that face comparable

process-related issues and facilitate peer-to-peer exchange.

b) Support studies to understand obstacles that critical care face to incorporate

donation in end-of-life care plans and how these could be overcome.

c) Make use of the expert knowledge and planning capability on organ donation

and transplantation contained within the EU Structural Reform Support Service,

particularly to provide expert advice and plan for reorganisation and

investment.16

d) Facilitate increased investment in national transplant programmes, for example

via the European Semester or the InvestEU programme.

e) Make available funding opportunities, which were shown to be invaluable in the

implementation of the 2009-2015 EU Action Plan, for national, regional and local

programmes using the European Structural Investment Funds (ESIF), the

European Regional Development Fund (ERDF), the European Structural Fund

(ESF) and the European Social Fund Plus (ESF+).

f) Identify and rank, in collaboration with Member States, regions and hospitals

with higher or lower organ donation rates, understand their specific strengths

20

and weaknesses, define target numbers for donation and provide specific,

tailored funding to reach these targets.

g) Ensure that organ donation and transplantation prominently feature among the

topics covered by the strategic plan of the future Horizon Europe programme,

so as to dedicate appropriate funding to this field of research.

h) Develop and strengthen a network of centres of excellence on donation and

transplantation research, modelled on the EU network of Comprehensive

Cancer Centres18, 19, so as to foster cross-border research collaboration.

i) Support the provision of education and training of relevant stakeholders in

Member States, including through the facilitation of best-practice exchange (for

example via the EU Best Practices Portal), and particularly the continued

organisation of meetings of national competent authorities.

j) Support the establishment of training and education initiatives, including through

the Erasmus+ programme (for example, by facilitating the short-term exchange

of healthcare professionals in hospitals or countries with low donation and

transplantation rates, to hospitals or countries performing best).

k) Examine and develop different aspects of communication to assess and

improve their effectiveness (such as public awareness campaigns, use of the

press and social media, education in schools).

l) Join forces with the European Directorate for the Quality of Medicines &

Healthcare of the Council of Europe (EDQM) to support international

cooperation in the field of (organ) biovigilance and to promote the European

Donation Day on official EU channels.

m) Support programmes and initiatives to help Member States tackle inequities and

increase access for the specific sub-groups.

n) Facilitate the social reintegration and rehabilitation of transplant patients by

supporting employment and education possibilities, for example via the

European Pillar of Social Rights.

o) Further leverage the European Reference Networks, in particular the ERN

Transplant-Child (ERN TRANSPLANT-CHILD brings together experts in post-

transplantation care to improve outcomes for children and their families. The

network aims to reduce hospitalisation time and the use of complex and long-

lasting treatments. It is working to improve psychological support services as

children transition to adulthood. TRANSPLANT-CHILD aims to make available

the latest techniques and medical, pharmacological and therapeutic advances),

and guarantee sustainable and appropriate funding for these networks.

p) Encourage and support Member States in registering, analysing, and acting

upon all donation and transplantation outcomes (including pre-donation and

pre-transplantation data).

q) Develop EU-wide guidelines for the standardisation of data collection

(Recommendation CM/Rec(2023)7), evaluation, auditing, and hospital-

performance comparison.

r) Facilitate the establishment of current ESOT initiatives for EU-wide registries,

and actively support the collection and sharing of data between Member States.

Here, the sets of key data collected and shared by all Member States, that allow

meaningful comparisons, should be defined.

21

s) Support for the implementation of international kidney paired exchange

programmes.

t) Develop recommendations and guidance for the development and/or

implementation of informed-consent donation procedures in Member States.

Conclusion

These possible measures deserve further exploration, which should remain flexible

and tailored according to individual country needs, could form the basis of further EU

action on organ donation and transplantation, including a second EU action plan. The

FACTOR study notes that Member States strongly valued the opportunities brought by

the first EU action plan, such as having a common set of priorities, a shared-agenda

and the possibilities of exchanging know-how15. The advantages of transplantation, in

particular cost-effectiveness, living quality, safety, environmental sustainability, and

survival outcomes are undeniable. The upcoming Hungarian presidency of the Council

of the EU in 2024 is the perfect opportunity to have a renewed EU action plan on organ

donation and transplantation, in which cross-border collaboration and EU guidance

remain essential. Only prolonged and coordinated action will result in sustained efforts

to improve conditions for patients and society.

Hungary is ready to support the preparation and implementation of any future EU and

national initiatives in the field of organ donation and transplantation.

22

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