Saturday, 28 November

The recently approved transplantation law has already have a lot of myths and fiction among which the kidnapping for organs, the uncontrolled use of bodies, etc. Regarded by some as a real chance and victory, by others as betrayal and insecurity. Opinion found out how the new system will work, what changes should be expected, why the new law is so important for Ukrainians, who could be a donor, on what basis ‘lucky men’ will be selected for getting organ and if the government be ready by the beginning of the next year.

How does The Ministry of Healthcare comment on The Law?

On the website of the Ministry of Healthcare it is reported that The Bill was registered by The Verkhovna Rada in August 2015, about 3 years ago. Noting the importance of the national system developing of organs, tissues and cells transplantation, The Ministry decided to join in the preparation and refinement of the bill. It states that there is no point to expect fast changes: in the last 20 years no considerable changes have occurred.

‘Transplantation is a civilized marker of the development of the medical assistance in a country and the citizens` willingness to give the anatomical material in a case of death or in life (in cases of bone marrow transplant) is an indication of enhanced public awareness and activism. It needs to be understood that there won`t be kidney or heart transplantation and bone marrow won`t come to Ukrainian hospitals from foreign donors the day after the law will be adopted. In the last 20 years no considerable changes have occurred: modern equipment was not bought, transplant coordinators didn`t have special seminars, information systems about donors and recipients were not organized, normative acts for regulating the issues including the question about quality and safety of processes which are involved into the process of transplantation were not adopted.

Today the issue of the determination of death of bone marrow has been already resolved, the instructions for transplant coordinators have been adopted, and the pilot project dedicated to funding of organs and other anatomic materials transplantation has been provided. Also such points as the organization of a national register of donors, the adaptation of training programs for transplant coordinators and the implementation of the provisions of the EU Directive about tissues and cells transplantation into national laws and regulations are in process.

Despite the fact that according to The MOH the adopted law is imperfect and has controversial provisions, the transplantation development is one of the most important points of The Ministry of Health, so the Ministry`s team do their utmost to implement the provisions of the law and to develop national transplantation system’ – they explain in The Ministry.

How will the new system wok? And what key changes does the new law provide for?

Yurii Andreiev, the leader of the National Movement ‘For Transplantation’, explained to Opinion that those 20 years without changes, which were mentioned by The Ministry of Health, could be simply explained: there is no public authority which is responsible for the transplantation. The new system can change this and the mechanism for creating this system is laid down in the text of the law.

‘The new transplantation law provides for the creation a single national information system of transplantation. Imperfections of the single national information system it the transplantation sphere and the absence of one single authority responsible for the transplantation have been delaying the transplantation development for 20 years.

The new system will include 9 registers: Ukrainians` applications expressing consent or wavier of donarship, register of recipients (those who need transplantation), transplant coordinators, donors of bone marrow, etc. Also, the term of transplant coordinator is legislated – a person who has access to the information system and searches a pair ‘donor-recipient’. The law regulate who can`t be a donor. They are orphans, ATO fighters, and unidentified people. These are the basics which couldn`t be arranged since 1999 when the current transplantation law was adopted. The new law which will enter into force on 01.01.2019 regulates the transplantation system better and demonstrates how it will work’ – explains Yurii Andreiev.

Olga Bogomolets, the People`s Deputy and the bill`s sponsor also tells us about the creation of a single national system. According to her, the adaptation of the law can save a lot of lives: after a death each donor can help about 8 people. That is why the text of the document provides for introduction of government information policy which forms a positive attitude to transplantation of anatomic materials.

‘Adaptation of this law will allow us to save over 5000 Ukrainian’s lives which need the organs transplantation annually. Among them 2500 patients need kidney transplantation, 1500 patients – liver transplantation, over 1000 patients – heart transplantation and 300 – bone marrow transplantation. All the needs of these people will have been maintained in two years.

For this purpose, according to the law, the networks of transplant coordinator will be created and a single national information system with the data about recipients and potential donors will be launched.

This system automatically determine immunologically compatible donor and patient, and in a case of donor`s death the surgery will be done as soon as possible. Such system exists in many developed countries of the world and allows providing prioritization and fairness in distribution of anatomic material, to avoid mistakes and corruption risks.

Great strides have been made and now it`s up to us. Each of us can save 8 lives as a donor after a death. So the bill provides for introduction of government information policy which forms a positive attitude to transplantation of anatomic materials in our society. This law introduces a new era in the Ukrainian development of health protection system and gives hope to patients and doctors that the future of medicine exists!’ – notes the people`s representative.

The transplantation law: why it is important?

Yurii Andreiev noted in his comments to Opinion that a lot of people have to go abroad for treatment at the state`s expense because doctors don`t do the transplantation. According to Yurii Andreiev, 208 people were cured abroad last year but there are much more people who need transplantation.

‘Today there are about 5000 people who need organ transplantation. If there aren’t such surgeries in Ukraine, the government will have to pay a treatment abroad. 608 millions of hrivnas were spent from the State budget in 2017. With that money 208 patients were cured. And now let`s count how much money should be allocated for the treatment of 5000 Ukrainians.  We sponsor foreign hospitals because of simple fear. All European countries, Asia and USA carry out the operations of transplantation. Why is Ukraine worse? They make fun of our country because even India do heart transplants for our citizens. That`s why I think that the transplantation development is important. That is not just a citizens` saving. It`s more cost-effective than treat Ukrainians abroad. This is an image of a country’ – the leader of the National Movement ‘For Transplantation’ is sure.

Vasyl Lazoryshynets, a heart surgeon, Doctor of Medicine and Director of Amosov Institute also thinks about the importance of the approved law. He thinks that Ukraine is a cradle of transplantation for the whole world but unfortunately, this branch didn`t develop. That is why the new law should be considered as an important challenge and chance.

‘This law is a kind of a test of civility. In many countries organ transplantation is a standard of treating diseases. The amount of transplants is growing every year and it influences on life expectance and quality.

Achievements in the before-transplantation therapy, selection of donors, development of the operational equipment, and progress into modern immunosuppression have improved the organ transplantation for children. Oblivious to the fact that Ukraine is a cradle of transplantation for the whole world, because the first clinical transplantation was carried out by an Ukrainian surgeon Yurii Voronyi  in 1993, and Nil Filatov laid the main theoretical and practical underpinnings of cells and tissues transplantation, this branch of medicine wasn`t developed in our country. So, we have to take a chance to create a modern transplantation system in Ukraine. And give a chance to live for many people’ – Vasyl Lazoryshynets points out.

‘Living’ and ‘dead’: who can be a donor and what are the conditions to make it possible?

Yurii Andreiev believes: there are a lot of myths and mistakes in interpretation of the law text. The most common among them are assumptions about kidnapping ‘for organs’. In fact, not everybody can be a donor while alive, everything is regulated and defined, and it`s worth examining the document before spread panic. The same is about ‘dead’ donors.

‘Both new and old law regulate that there exist ‘living’ and ‘dead’ donor. Who is a ‘living’ donor? This question worries people because there are a lot of myths about kidnapping for organs. Speaking of organs, only a relative can be a donor while living for seriously ill person.

The only operation when any person could be a donor is bone marrow transplantation. But I should explain that bone marrow is person`s stem cells. It is stem cells produce all blood elements: red blood cells, white blood cells and platelet count. In fact it is the element of blood. Such operations are done for blood cancer and lymphatic system treatment. For a donor it is like a simple blood drive. And donor`s stem cells are restored in one or two weeks. So, there is no risk for health.

Regarding organs, it needs to be understood that not everybody can be a donor while living. It is a myth that every person can be used as a donor. Before this more than 20 different laboratory tests and clinical trial should be run. For this purpose a laboratory shall be equipped and the reagents for these analyses shall be available. It should be an access to the database of those who need a new organ. But the access to this database should be restricted. And each login is fixed.

As to a ‘dead’ donor. If a person while living doesn`t write a declaration of consent for donorship, or the relatives of a dead person don`t give a written agreement on donorship, nobody will take a dead person`s organs. Also a person can write a declaration of disagreement of donorship in life. The government gives a right to a person to choose. Also a person could change his mind many times.

It is very important to every person to understand if he wants to save somebody`s life after death. In many countries donorship is an honor. For example, in India. Here it also exists presumption of non-consent. But the relatives bravely give an agreement for donorship. Many of them say: ‘My relative lives while his heart beats. So, why doesn`t this heart beat in somebody`s chest? In India where the most people live below the poverty line, nobody thinks about ‘black transplantation’. Doctors are surprised how it is possible to carry out an operation by such crude methods.

Once again I remind the law regulates that ATO fighters, orphans and unidentified people can`t be organ donors. People like making up scary stories on these subjects. And now we know that information about ATO activities or residential institutions by a layman isn`t truth’, – the expert results.

How do you choose who`ll get a needed organ?

Denys Periatka, a managing partner of a law firm ‘Legal continent’, in his comments to Opinion points out that the adaptation of the law is just a beginning, among important aspects – a recipients` queue setting  and who will be included in this queue.

‘Such operations were very expensive for Ukrainians as well as past-operative care. They cost from some tens up to some hundreds of thousands of euros and very few people can afford them.

The situation might change after the adaptation of a law. But this is just the beginning. The procedural instructions which will regulate the issue of transplantation must be elaborated. It is necessary to set a queue and decide who will be in the queue primarily. It should be settled the issue of recipient`s movement in the queue in a case of declining health and the issue of graduation in a case of violation of the rules to be followed to get a donor`s organ.

Also this law gives impetus to doctors in Ukraine to improve their professional level and skills, and to carry put the operations they never dreamed of. Finally, the law shall stop the staff retention from Ukraine who doesn’t see development perspectives in Ukraine’, – the lawyer thinks.

Yurii Andreiev answered the question about who will get an organ. According to him, there will be a number of criteria but the final choice will be made by an electronic system.

‘The selection of a pair ‘donor – recipient’’ is done in a single national system of transplantation. There is a number of criteria according to which the system selects who will get an organ. The most important points are the genetic compatibility and the size of an organ. It must be not only genetically compatible but should not be too large or too small. Antigens must match in order to minimize the risk of rejection. And then the system checks how far is the hospital where is the organ from the recipient. Because, for example, a heart can live 4 hours out of donor`s body. It is impossible to deliver it from Lviv to Kharkiv. That is why the system would not select a compatible recipient who is too far or wold select him as a backup plan.

Also the recipient`s health status is taken into consideration. For example, two recipients are in close proximity from a base are compatible. But one of them feels good and the other is in intensive care and his heart is about to stop. In such case an organ will be given to a person to the brink of death. Also I mention that all these steps (the selection of a pair, recipient, etc.) are fixed in an electronic base. If there are violations it will be easy to know who made them and at what stage. It minimizes risks’, – the expert is sure.

Be ready before the beginning of the next year: could the government ensure the creation of system at such short notice?

It was announced that in a case of the signing of the law by the President its realization will start on the 1st of January 2019. Yurii Andreiev, the leader of the National Movement ‘For Transplantation’ explains that in reality the law should come into force at the beginning of 2020 but overconfidence of The Ministry of Healthcare representatives changes the situation. Now within the Ministry has to make every effort to establish a single national information system of transplantation and establish criteria for the health protection institutions which would engage in activities connected with transplantation.

‘I am noting that the law has to come into force on 01.01.2020. But The Ministry of Healthcare representatives assured people`s deputies that they will have kept pace by the beginning of 2019. So, from the 1st of January the law shall start working. For this purpose The Ministry of Healthcare has to make every effort for preparing. Because b that time the legal framework should be revised and reconciled with the new law. This is a pile of paperwork for the Ministry. Also it is necessary to establish a single national information system of transplantation. I remind that there have to be 9 different registers including a register of recipients. The government has to unite the information of all health facilities where the patients need the transplantation of heart, liver, kidney, bone marrow, etc. How such information doesn’t exist.  The Ministry of Healthcare can`t give information about a number of such patients in a country. Foe several month our organization National Movement ‘For Transplantation’ has been fulfilling a register of patients. Now we have about 500 Ukrainians who need transplantation. And we have declared that we are ready to give this register to the Ministry in order to facilitate their work.

An important element: The Ministry of Healthcare has to establish criteria for the health protection institutions which would engage in activities connected with transplantation. It should be defined how the hospital must be equipped. And, of course, such institutions have to be accredited. There is only one Centre of Transplantation of bone marrow in Ukraine where the operations for adults are carried out.  But for many years there were no funds and all equipment is outdated. Under such conditions it is impossible to transplant stem cells because a patient would die’ – believes Yurii Andreiev.

There exist a number of factors that can prevent. Namely the reluctance of doctors and officials to change something. The expert is convinced that doctors can be afraid of myths.

‘I think that the worst is the reluctance of doctors and officials to change something or do something. The first law of transplantation was adopted in Ukraine in 1999. And what can we see? Every year Ukrainians have to go abroad for treatment. Because local officials don`t want invest money, build and repair hospitals, buy equipment to develop the branch of transplantation. Doctors are afraid because the population is fearful of different myths and the word ‘transplantation’ is considered as something scary and criminal. While for the civilized world it is a simple medical procedure.

In all countries where the transplantation is developed the government not only legalized such operations but also promoted donorship. It doesn`t exist in our country. The government abstracts from this process. Since the adaptation of the law we observe no post in social media where Acting Minister for Health dispels the myth about transplantation. She posts about manicure, PPD but not about donorship. Our organization every day dispels myths about transplantation, every day we speak to journalists. And we try to explain that nobody in the world receives money for organ, that we pay for treatment (medical services, medicine, hospital room, intensive care), but not for donor`s organ. If it happens on the government level the society will have more trust in the law of transplantation’, – comments on Yurii Andreiev.

Text: Dmytro Zhulavel

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