NIK about the organisation and financing of organ transplantation
More and more people are waiting for organ transplants, however the number of donors is going down. Reasons included permanent shortage of transplant organs, underestimated and outdated transplant pricing which had an adverse impact on hospitals’ activity in terms of organ procurement. The condition of the Polish transplantology got even worse along with the outbreak of the COVID-19 epidemic. As a consequence, record-breakers had to wait as long as 12 years for a transplant. NIK points out that the Minister of Health suspended works on the draft Transplantation Act (started in 2017) for an indefinite period. No changes have been made ever since to improve the organisation and financing of organ transplantation in Poland.
An organ transplant is a health- and life-saving procedure used in case of an end-stage organ failure. Organs used in transplantology come mainly from deceased donors. Only kidneys and liver fragments may be taken from living donors but the percentage of such transplants is relatively low. In Poland the rate of kidney transplants from living donors totals 0.8 and is among the lowest in Europe. Kidney transplants are three times more frequent in Czech Republic, seven times more frequent in Germany, Spain and France, not to mention the Netherlands where such procedures are performed 27 times more often.
Key audit findings
The Minister of Health carried out a long-term programme called the National Programme for the Development of Transplantation Medicine for 2011-2021. The Programme outlays went up from PLN 450 million to 620 million. NIK has negatively evaluated the execution of four out of eight Programme objectives related to organ transplants.
The Programme assumed an increase in the number of organ transplants from deceased donors by at least 100% and kidney transplants from living donors by at least 500% against 2009. The objectives were not met, though. Until 2019 (one year before the epidemic outbreak), the number of organ transplants went up only by 40% and the number of kidney transplants from living donors increased by 126%. According to NIK the Minister’s efforts in this area were ineffective.
The Minister of Health’s works to develop telecommunications and IT transplant registries were also ineffective. After 10 years, conceptual and analytical works on a new telecommunications and IT system were still pending.
At the end of 2020, there were 1799 persons on the transplant waiting list. Most of them waited for kidney transplants (1007 persons), heart transplants (415 persons) and lung transplants (168 persons). The average transplant waiting time was: for kidneys – 430 days (emergency – 30 days), for heart – 603 days (emergency – 91 days), for lungs – 225 days (emergency – 1 day), for liver – 121 days (emergency – 1 day). As of 30 June 2021, 1630 persons were waiting for an organ transplant (including 58 individuals waiting for an emergency surgery).
The audit findings show that in 2016-2021 (1st half), the transplant waiting time was getting longer and longer. In 2016, record-breakers waited over four years for a surgery, whereas in 2020 it was as long as 12 years.
In 2016-2020, the total of 7882 organs were harvested from dead donors (in whom brain death was confirmed) and 7344 organs were transplanted (93% of the harvested ones). At the same time, 352 organs were harvested from living donors and the same number was transplanted. The majority of the transplanted organs were kidneys – 4881 (61.9%) and liver - 1690 (21.5%).
The COVID-19 epidemic outbreak in March 2020 had a negative impact on the Polish organ transplantology. One of the reasons was the need to adapt medical facilities to treat COVID-19 patients. In the first year of the epidemic, as compared with the previous year, the number of hospitals offering organ procurement went down by 13% and thus the number of real donors decreased by 26%. As a result, in the first year of the epidemic the number of all harvested organs plummeted by nearly 20%. In the epidemic fewer patients reported for transplants and at the same time there were more deaths among persons from the waiting list.
In 2016-2021 (1st half), the number of potential organ donors (i.e. dead persons reported by hospitals) totalled 3442. The total number of real donors in that period (i.e. dead persons from whom organs were harvested) was 2666.
In 2016-2020, the organ donation ratio (i.e. the number of real donors per 1 million inhabitants) was declining successively. In 2016, the ratio was about 14 and in 2020 it went down to about 10.
The difficult situation of the Polish transplantology could be improved by the new Transplantation Act. Unfortunately, the Minister of Health suspended works on the draft Act which started on his initiative in 2017. As a result the changes which could help streamline the organisation and functioning of the transplantation system in Poland were not made.
The number of donations and transplants was largely influenced by the underestimated transplant pricing: the prices of transplant procedures remained unchanged since 2013. The audit results showed that costs incurred by hospitals due to transplantation procedures were usually higher than the hospitals’ revenue in this area. From 2016 to 2020, the Minister of Health received annual information from Poltransplant which recommended increasing the costs of procedures related to harvesting organs from donors. However, he updated the transplant pricing only after eight years (in 2021).
NIK has emphasised that medical community is not sufficiently involved in the organ harvesting procedure, mainly in hospitals located outside transplantation facilities. In the audited period, the hospitals reported only 1.5 percent of all deceasad patients in units with the so-called donation potential. Besides, the great majority of the audited hospitals did not have standing committees (only ad hoc ones) to confirm brain death and irreversible cardiac arrest being a pre-requisite for organ procurement.
Poltransplant is an institution responsible for organising and coordinating transplants in Poland. One of its key tasks was to appoint organ procurement coordinators to harvest organs from deceased donors in hospitals with the donation potential. Another basic task was to build the national system of transplant coordinators. As of 30 June 2021, there were 388 hospitals with the donation potentials nationwide but coordinators were appointed only in 255 of them.
The audit findings show that the 19% increase in the number of transplant coordinators did not have any significant impact on the number of harvested and transplanted organs.
Poltransplant kept four registries of organ transplants which had some drawbacks, though, i.e. they did not facilitate preparing a broad spectrum of aggregate reports.
The Minister of Health failed to control the statutory transplant registries kept by Poltransplant in the telecommunications and IT system, which was in breach of the Transplantation Act. Another breach of the Act was that the Minister did not present the European Commission with reports on activities taken on the territory of Poland to propagate organ donation.
Recommendations
De lege ferenda proposals to the Minister of Health
- to consider changing the Transplantation Act to make sure information duties of the Minister of Health towards the European Commission are adapted to the developed practice of that executive body of the EU, in compliance with the 2004/23/EC Directive;
- to consider changing the law on the obligation to keep the national transplant waiting list both in written and electronic form.
Other recommendations addressed to the Minister of Health
- to renew and intensify works to introduce legislation in view of improving the organisation and functioning of the transplantation system in Poland;
- to take effective measures with regard to persons responsible for implementing the National Programme for the Development of Transplantation Medicine to ensure timely completion of the Programme;
- to take effective organisational measures to control telecommunications and IT transplant registries;
- to exercise efficient supervision over works related to telecommunications and IT transplant registries;
- to develop mechanisms to motivate hospitals to broader and more frequent identification and reporting of the dead, meeting required conditions as organ donors, at the same time to propagate the view that non-identifying donors represents a medical and ethical negligence;
- to take account of actual costs in transplant pricing;
- to strengthen the position and rights of transplant coordinators by facilitating access to medical documentation of potential donors;
- to appoint one payer for organ transplant procedures.
