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The Chairman's report for the period 2012-2013



The Council of Representatives meting 07.05.2013 in Oslo.

The Chairman's report for the period 9.5.2012-30.4.2013


1. General
In the past twelve months we have experienced
- Diversification of the transplantation activities
- Changes in the Scandiatransplant office personnel
- Discussions on the implementation of the EU-53/2010 Directive
- Increased interest of neighbour countries to use our skill in transplantation

A record number of utilized deceased donors (n=440) were seen in 2012. The number of
transplantantations for most organs were pretty much the same as in the previous year.
Due to a decrease in the number of living kidney donors the total number of
transplantations in 2012 was slightly below the record amount last year. The waiting list
had the same length as last year.

The implementation of the Action plan of the EU53/2010 Directive has led to new
transplantation laws in most Nordic countries. It is certainly a very central issue for
Scandiatransplant as well.

The Council of Representatives is the supreme authority of Scandiatransplant. The annual
meeting in May 9, 2012, laid the basis for activities in the next 12 months.

2. The Board
Krister Hockerstedt, chair, Finland
Kaj Anker Joergensen, Denmark, until 30.10.2012
Finn Gustafson, Denmark, from 01.11.2012
Helena Isoniemi, Finland
Margret Birna Andresdottir, Iceland
Pål-Dag Line, Norway
Lars Wennberg, Sweden

The Board had three official meetings and numerous discussions by email and phone. In
addition the Board had two meetings with the Representatives of the Nordic national
health authorities, i.e. the Nordic Transplant Committee (NTC). The main issues debated
were related to the EU-53/2010 Directive, which led to modifications of the National laws
on transplantation and organ donation in the five Nordic countries.

3. The Scandiatransplant office
Niels Grunnet, who has been the Medical Director (MD) for 14 years, left this post in
30.10.2012. During his time Scandiatransplant has developed quite a lot and the activities
have increased in the transplant centers and in the Scandiatransplant office, both
internally and externally. With the possibility to work only a short time of the week for
Scandiatransplant he has made the decision to leave this position and concentrate on his
main job as the head of the blood bank in the Aarhus University Hospital (AUH).

Since November 1st the new Medical Director is Kaj Anker Joergensen. He is the head of
Renal Transplantation at the AUH and has recently served as the Danish representative in
the Scandiatransplant Board. He will be working 50% for Scandiatransplant and
continues his original work leading the nephrology department at the AUH, also on a
50% basis. As MD and boss of the Scandiatransplant office Kaj has with great
enthusiasm made himself acquainted with his new job and already produced new plans to
improve the activities. Some of the written working systems and duties of
Scandiatransplant are looked over in order to comply with the changing requirements.

With the implementation of the EU53/2010 Directive the office personnel has been very
active in the planning of new duties to serve the transplant centers accordingly. No less
than four Newsletters have been produced since May 2012.
I hope everyone has noted that the office has produced a new Scandiatransplant website,
which started in August 2012. The MD will inform more about the office.

Frank Pedersen is to be gratulated for having served no less than 25 years in the office!

4. Activities in 2012
In the Nordic countries the number (10) of transplant hospitals was maintained in 2012.
Activities in organ donation and transplantations in the Nordic countries are presented on
the website.
The following observations may be pointed out:
- The total number of Utilised Deceased Donors (DD) was 440 (17 pmp), which is just a
few more than in 2011, with Norway again at the top (23.3 pmp).
- The number of transplantations (1808) showed a slight decrease from 2011, mainly due
to a falling activity in kidney transplantations. However, also a slight drop was seen in the
number of patients entering the waiting list compared to the previous year (2104 versus
2149 patients).
- The organ exchange rate between the Nordic countries was this time highest for livers
(24%) and lowest for hearts (14 %).
The organ exchange change rules are regularly up-dated, see the homepage.

Activities of the Scandiatransplant committees
The 12 Scandiatransplant working committees and groups have held their regular
meetings 1 -2 times. The latest activities will be presented at the Council meeting by
members of the committees.

5. Grants
Scandiatransplant Research Grant, 40.000 €
In 2012 the Research Grant of 20.000€ was won by Lars Beckman, Uppsala with the
project: Analysis of the true incidence of post-transplant malignancies in renal recipients.
For 2013 the Research Grant has been raised to 40.000€. Four applications have arrived.
The winner will be announced at the Council meeting, 07.05.2013.

The Scandinavian Travel Grant, DKK 100.000.
The office has received only 1 application. The Board will present its decision for the
Council meeting. Apparently more advertising actions should be put on this issue.

6. Directive EU53/2010/45/EU on standards of quality and safety of human organs
intended for transplantation.

The Directive contains an Action Plan with 10 Articles. The Action Plan is a
recommendation and not a mandatory text. It should be stressed that the Directive is
directed to the EU-member states and Scandiatransplant is an observer at the EUmeetings.
As an Association with experience in multinational organ exchange, which
includes practical rules with traceability and security, its role is to facilitate the
implications for the transplant centers and for the Nordic patients.

In three EU-meetings in Brussels a high number of issues have been discussed,
which affects the Member States, but no clear effect on the activity of Scandiatransplant
has been presented. Activities in six areas of organ donation and transplantation in the
member states have been recorded annually from 2009-2011. The majority of countries
have produced their data, but a few are still missing.

To fulfil the issues of this Directive each Nordic country —also Norway and Iceland by
their own choice - should
a) adjust the law and appropriate regulations accordingly
b) select the appropriate data to be collected
c) produce a national register on suitable variables.

a) National laws. In accordance with this EU Directive all five Nordic countries
(including the non-EU countries) have passed a new law on organ donation and
The role of Scandiatransplant as an Organ Exchange Organisation of the five Nordic
countries is acknowledged by the Nordic Health authorities and the transplant centers.
- All participants have agreed that the present activities of Scandiatransplant should
continue, and be adjusted according the Directive when necessary.

b) Data collection. The Directive includes an Annex Part A with a minimum list of data
for organ and donor characterisation to be collected for each organ donation. In Part B an
additional Complementary data set characterisation of grouped data are suggested, which
may be collected based on the decision of the national medical teams.

c) National registries. Finland and Norway have national registries. Following a decision
at an EU-meeting it is not obligatory to have a specific national registry with data from all
centers. The main thing is that such data are annually collected. As both Denmark and
Sweden have many transplant centers it has been suggested that the data needed are
collected in the Scandiatransplant registry. So, the present system would mainly continue.
In Scandiatransplant data security includes a main rule: any personnel should
only have access to data on patients that is needed for a specific task. Final data security
checking is ongoing. Particularly in Sweden this issue is still under debate in a national

d) Serious Adverse Events (SAE) and Severe Adverse Reactions (SER) should bee listed.
The obvious goal is to make sure that any of these observed in the donor are reported
without undue delay. Please note that only late in 2012 it was acknowledged at an EUmeeting
that only the transplant centers have the knowledge and possibility to act fast
enough to prevent any possible damage and complication in the selected recipient —
preferably before transplantation or at the latest after transplanted with organs from such
a particular donor with SAE/SAR. It is for the Competent Authorities (Health
Ministry/Socialstyrelsen) etc. to organise this in each EU Member state. The task can be
delegated to transplant centers, which function as a Delegated Body, (DB).
Sweden has a AE registry. Norway (Oslo UH) has a list of AE and SAE registration and
sent it to the National health authorities. The discussion on the SAE and SAR goes on.

- The changes which might be needed in the Scandiatransplant registries have still not
been clearly specified.
- The discussions between Scandiatransplant, the National health authorities of the Nordic
countries and the transplant centers will continue with an aim to reach solutions
acceptable to all parties.

7. Agreement of organ exchange between Scandiatransplant and Estonia undersigned
At the previous Council meeting in 2012 the Tartu University Hospital in Estonia was
accepted as an official Organ Exchange Organisation (OEO) of Estonia. The agreement
signed 04.12.2012 between Scandiatransplant and Estonia follows the same lines as the
existing agreements Scandiatransplant has with the different OEOs in Europe. In practise
the exchange concerns Estonian organs of brain dead donors, for which no suitable
recipient in Estonia can be can be found. And vice versa, Scandinavian organs from brain
dead donors from which no suitable recipients can be found in the Nordic countries.
The first organ exchange took place earlier this year, when a team from Gothenburg
harvested the lungs from a donor in Estonia and transplanted them in their own center to a
Swedish recipient.

8. Estonia's application to become a member of Scandiatransplant.
In December 2011 the Director of the Tartu University Hospital Urmas Siigur sent a letter
to Scandiatransplant with an application of Estonia to become a full member of
Scandiatransplant. At the Council meeting in 2012 the application was discussed
extensively. It was concluded to create a working group to investigate this issue. Krister
Höckerstedt declared himself biased for this task, due to his 20-year engagement in
teaching liver transplantation to the colleagues and the personnel in the Tartu.

Pål-Dag Line was elected chairman for the working group with 10 members, i.e.
one member from each transplant center (the owners of Scandiatransplant). The task of
the group was enlarged to discuss not only Estonia but a larger principle: a possible
expansion of Scandiatransplant. The working group concluded in the report that "its role
was not to make any decision for or against this issue. Instead the main objective was to
provide the Council with as much relevant information as possible" before the next
Council meeting in Oslo, 2013. The report of the working group was 23.4.2013
distributed to the Council members.
This issue is open for discussions and decisions at the Council meeting, 07.05.2013.

9. Transplantation of non-Nordic patients in the Nordic Countries.
This is an very actual issue. The background is:
- A Polish lung patient with CF has earlier this year been transplanted with a lung graft
from Poltransplant by the Danish thoracic surgeons in Copenhagen.
- Gothenberg lung surgeons would like to transplant in Gothenburg a German lung patient
with a German lung.
- Estonian and Finnish heart surgeons want to perform a heart transplantation to an
Estonian patient with an organ from Estonia

"The Scandiatransplant Guidelines for deceased organ transplantation Non-Nordic
nationals within Scandiatransplant and the use of non-Nordic organs for
Scandiatransplant recipients" are from 2005.

The Council of EU "Council conclusion in organ transplantation, 2012", welcomes:
- Setting up cooperation agreements between member states
- Sharing of expertise on transplant systems between member states CA and exchange
organisation like Eurotransplant and Scandiatransplant.

Directive 2011/24/EU on the application of patient's right in cross border healthcare
includes the following statement on transplantation. "Given their specificity, access to
and the allocation of organs for the purpose of organ transplants should fall outside the
scope of this Directive." Active from January 1, 2014.

Application from Estonia for cooperation agreement with Finland in the field of heart

Since 2010 the Estonian and Finnish heart surgeons have presented plans for
collaboration in heart transplantation between Estonia and Finland.
In April 30, 2012 Hannu Pevkur, The Estonian Health Minister and Urmas
Siigur, the Chairman of the Executive Board of Tartu University Hospital sent a letter to
the Health Minister in Finland, Maria Guzenina-Richardsson and the Head physician of
Helsinki Hospital District of Helsinki and Uusimaa, dr Markku Mäkijävi entitled:
Application of Estonia for cooperation agreement with Finland in the field of heart
transplantation. They suggest that until Estonia is ready to perform heart transplantations,
the Estonian patients could undergo heart transplantation in Helsinki. A copy was sent to
the Scandiatransplant Council of Representatives
At the Scandiatransplant Council meeting 09.05.2012 the heart surgeon Karl
Lemstrom from Helsinki raised a question: "Can we help transplanting an Estonian heart
patient in Helsinki with an Estonian heart graft?" The issue was concluded to be unclear
and involves unsolved questions.
Since then both Estonian and Finnish heart surgeons and hospital administrators have
continued to prepare this activity.
In April 16, 2013, The new Estonian Health Minister Taavi Roivas and the
chairman of the Executive Board of Tartu University Hospital, Urmas Siigur sent a letter
to Scandiatransplant, chaurnan KH: Application for performing heart transplantations in
Finland to Estonian patients with an Estonian heart graft. They suggest a program with
organisational details to be involved. This letter was also sent to the Finnish Health
Minister (MG-R) and the head physician (MM) in Helsinki, asking for support for their
application to Scandiatransplant.
In Apri122, the Nordic Thoracic Transplantation Study Group (NTTSG) has sent
a letter to the Board of Scandiatransplant, in which the members unanimously support
that Helsinki University Hospital should develop a bilateral contract with Estonia which
ensures that Estonian recipients can have a cardiac transplant in Helsinki.
This issue is open for discussions and decisions at the Council meeting, 07.05.2013.

Krister Höckerstedt
Chair, Board of Scandiatransplant