Zapalenie wątroby typu C a prawa człowieka: porównanie doświadczeń prawnych Ukrainy i Gruzji
Iryna Y. Senyuta
Department of Medical Law, Danylo Halytskyi Lviv National Medical University, Lviv, Ukraine
A comparative legal research of human rights provision in Ukraine and Georgia, in the aspect of combating viral HCV, was conducted. Ukrainian advocacy experience and Georgian strategic litigation experience with regard to human rights and HCV was analyzed. Key international instruments, which lay the conceptual foundations as well as outline the measures, which are directed at human rights in patient care provision and fighting viral hepatitis, were elucidated. Attention was paid to the Global health sector strategy. Viral hepatitis, 2016 – 2021 , which, for the first time, defined a global strategy on fighting viral hepatitis, in particular HCV and envisaged the advocacy vectors. The frames of interaction of the human rights in patient care concept and public health, which consists in realization of certain human rights were elucidated and the necessity to embody the human rights in patient care concept into the state policy in the field of public health was determined.
It was found out that a common international problem in combating HCV is a deficiency of financial resources, which are necessary for effective fighting the epidemics and guarantee equal access to treatment for every person. The international community outlined five most important spheres, which require investments and will catalyze the measures, which need to be taken in order to fight hepatitis. Analysis of the Ukrainian experience was focused on the issue of donated blood safety and successful advocacy campaigns, which were carried out in order to promote the adoption of programs on prophylactics, diagnostics and treatment of HCV both on national and regional levels. Examples of ensuring the rights of the marginalized groups during HCV treatment, in particular of the people who inject drugs, people living with HIV, participants of the antiterrorist operation were provided. Interesting and important is the experience of Georgia concerning human rights protection in the ECtHR, which has a legal effect for other countries which ratified the Convention for the Protection of Human Rights and Fundamental Freedoms, for instance for Ukraine, where the EctHR judgments are recognized as a source of law.
Comprehensive prevention strategies for both hepatitis B virus and hepatitis C virus should include assurance of safe blood products, safe injection practices, harm reduction services for people who inject drugs and promotion of safe sex. (Global health sector strategy. Viral hepatitis, 2016 – 2021)
Wiad Lek 2018, 71, 2 cz. II, -388
Various issues related to the legal status of medico-legal relations subjects (patients, providers, insurance companies etc.), legal regulation of medical drug advertisement and selling, organ donation and transplantation, legal liability for damages, caused in the sphere of medical care provision etc., which fall under the scope of medical law are actively researched and discussed by various scholars nowadays [2, 3]. Despite this, the issues relating to the concept of human rights in patient care, in particular the right to access to medical care, right to good quality medical care and treatment, link between public health measures and provision of human rights in patient care, remain undiscovered and need more attention from the side of a scientific community of legal scholars.
The concept of human rights in patient care and the institute of public health share a joint sphere for their provision, namely enforcement of human rights to preventive measures, safety and accessibility. This joint “road map” is proved both in the international standards and opinions of the international institutions. According to the WHO definition (1978) public health is the art of science of preventing disease . Hence creation of maximum effective barriers to fighting viral hepatitis is in the basis of the wide-spectrum measures of the WHO.
The problem of ensuring human rights under the conditions of a world pandemic of viral hepatitis is one of the most important for the international community and needs joint efforts and measures to be taken in order to solve the key issues, which will impact the state of public health both in each state and in the whole world. It is crucial that nowadays there have been developed numerous international standards, which have a program and conceptual character and which outline the directions for each country to follow in order to ensure human rights on the national level.
On the 25 of September 2015 the UN General Assembly on its 70th session adopted Resolution A/RES/70/1 “Transforming our world: the 2030 Agenda for Sustainable Development” . The tasks of the agenda came into force on 1 January 2016 and include achieving universal health coverage, including financial risk protection, access to quality essential health-care services and access to safe, effective, quality and affordable essential medicines and vaccines for all. On the 28 of May 2016 the World health Assembly on its 69th session adopted a “Global health sector strategy. Viral hepatitis, 2016 – 2021” . As it is foreseen in the Strategy, viral hepatitis is an international public health challenge, comparable to other major communicable diseases, including HIV, tuberculosis and malaria. This is the first global health sector strategy on viral hepatitis that contributes to the achievement of the 2030 Agenda for Sustainable Development. It covers the first six years of this Agenda. The WHO outlined five main intervention areas for investing the resources which will favor the strengthening and widening of the measures aimed at combating viral hepatitis: 1) vaccination; 2) prevention of mother-to-child transmission of hepatitis B virus; 3) injection, blood and surgical safety; 4) harm reduction for people who inject drugs; 5) treatment.
The coordination of the system, which was suggested by the WHO, is important for the formation of a national policy on fighting viral hepatitis and implementation of the human rights in patient care concept into the field of public health.
The concept of “human rights in patient care” refers to the application of human rights principles to the context of patient care Human rights principles that apply to patient care include both the right to the highest attainable standard of health, which covers both positive and negative guarantees in respect of health, as well as civil and political rights ranging from the patient’s right to be free from torture and inhumane treatment to liberty and security of person. They also focus attention on the right of socially excluded groups to be free from discrimination in the delivery of health care . General principles of human rights in patient care shall be applied in the course of formation of the state policy in the sphere of public health in the course of creating conditions, including normative, for the realization of rights in particular of the marginalized groups of the population. In particular it is providing access to services of treating hepatitis in the places of deprivation of liberty, establishing shelters for refugees, providing access to antiretroviral therapy for the people living with chronic viruses B and C.
Since 2007 Open Society Foundations and its partners started to apply the human rights in patient care concept to fight inequalities and human rights in patient care violations in the 10 countries of the Eastern Europe and Central Asia. This large-scale and wide-spectrum work continues to be fulfilled by ASPHER HRPC core network, which multiplies and extends the implementation of the human rights in patient care concept in the European Region.
In this research, based on the dialectic and hermeneutic-linguistic approach by using comparative, statistic, specific and social (document analysis) methods, the experience of ensuring certain human rights in patient care was elucidated. In the focus of this research the experience of combating HCV in Ukraine and Georgia, which, notwithstanding the complexity of each country situation in this sphere, made crucial steps that are important for the international community and not one country only. The research focus is in two countries which have been actively illustrating the positive intentions both from the side of state bodies as well as of the civil society with regard to fighting problems related to human rights protection and which were generated by the growth of viral hepatitis morbidity.
ReVIEW and Discussion
Experience of Ukraine in ensuring human rights and combating hepatitis C
In the current stage of health care system reform, Ukraine is actively developing its system of public health, which is connected with Ukraine’s European integration steps, stipulated in the 2014 Association Agreement between the European Union and the European Atomic Energy Community and their Member States as one Party and Ukraine as the other3 (hereinafter – Association Agreement) as well as with the national vector of strategic transformations. Article 22 of Chapter 22 of the Association Agreement foresees that the Parties shall develop their cooperation in the public health field, to raise the level of public health safety and protection of human health as a precondition for sustainable development and economic growth. Applicable cooperation areas include: prevention and control of communicable diseases, such as HIV/AIDS and tuberculosis, increased preparedness regarding highly pathogenic disease outbreaks, and implementation of the International Health Regulations (“b”), and quality and safety of substances of human origin, such as blood, tissues and cells (“d”) . It is clear that now Ukraine has an international regulatory basis to be followed during the development of the national public health system; and it seems that the key task of the state is prevention and control of infectious diseases, including HCV.
A draft of the Concept of Public Health System Development in Ukraine (hereinafter – draft of the Concept) has been developed. Among the tasks of the Ministry of Health of Ukraine, the draft of the Concept includes the following: determination of the preferable directions of providing sanitary and epidemiological welfare of the population, combating HIV-infection/AIDS, tuberculosis and other infectious and non-infectious diseases.
Nowadays in our country there was adopted a Concept of the Development of the Public Health System in Ukraine (2016) (hereinafter – Concept), which includes to the sphere of public health the establishment of priorities of securing sanitary and epidemiological welfare of the population, fighting infectious and non-infectious diseases as well as securing the development of state programs and plans of activities in the sphere of public health.
Epidemiologically, viral hepatitis, in particular hepatitis C, is one of the national infectious threats. Therefore in the State Social Program on Prophylactics, Diagnostics and Treatment of Viral Hepatitis for the period lasting by 2016, approved in 2013 (hereinafter State program), it is stated that by its level of negative influence on the population’s health and the sickness rate, viral hepatitis is dominating among other infectious diseases.
According to the research conducted by the International HIV/AIDS Alliance in Ukraine and International Treatment Preparedness in Eastern Europe and Central Asia, “Hepatitis C in Eastern Europe and Central Asia. Civil Society Response to Epidemic” (Jun 2016) (hereinafter Report) , the number of people of Ukraine is 42 708 647 (2016), among whom 2 135 400 people are living with the HCV. Among the vulnerable group of people who inject drugs, the amount of those living with HCV is 55%. The group at risk includes the following: people who inject drugs, people suffering from hemophilia, patients receiving hem dialysis, men who have sex with men and mother-to-child transmission of the virus.
In the State program, 17,60,462,2 Ukrainian hryvnias were allocated for treatment of HCV. It should be noted that during 2013 – 2016 the sum of money was allocated in a limited amount only for purchasing of medical drugs while other measures included in the State Budget were not financed. The insufficient funding of measures included in the State program is 79% of the amount of funds provided in the budget for 2013. According to the Report [2, p. 43], based on the data provided by the Regional Departments of Health, 1575 people received treatment paid for with money from the State Budget and 83 people with the money paid from local budgets . Additionally, 157 people living with HIV received treatment paid for with public money.
In Ukraine there are functioning donor programs aimed at HCV . Since 2015 a program of the Global Fund to Fight AIDS, Tuberculosis and Malaria has been implemented by the International HIV/AIDS Alliance in Ukraine. This program provides free diagnostics and treatment of vulnerable groups of the population. For instance participants of the first stage of the treatment program were: a) 93% of people living with HIV, 94 % of whom receive antiretroviral therapy; and b) 80% of people who inject drugs. among whom 8% receive substitution maintenance therapy. Within the first stage (April 2015 – January 2016), 450 patients received treatment. HCV treatment was integrated into the above-mentioned harm reduction programs with a general coverage of 270 000 people.
In 2012 the International HIV/AIDS Alliance in Ukraine (hereinafter – Alliance) initiated a national campaign “Demand Treatment”, which is realized together with partner organization in all regions of Ukraine. The main objective of the campaign is to widen access to diagnostics and treatment of viral hepatitis C in Ukraine. Since 2015 the Center of best practices on HIV/AIDS issues, drug addiction and hepatitis of the Alliance has been implementing a global campaign “Unite in order to fight hepatitis C: get to know, test and treat”. Within Alliance programs during the first half-year of 2017 51 688 tests for hepatitis C were made and 8 925 positive results were determined, but hepatitis C is a curable disease, since more than 94% of patients, who received treatment using modern medicines provided within programs of the Alliance to health care facilities were cured from hepatitis C.
There is also experience of providing free treatment on the regional level, based on the local budgets. Besides the State program, some of the regions adopted local programs on prophylactics, diagnostics and treatment of viral hepatitis or incorporated such a component into wider programs such as in Lviv region. On February 2, 2016 the Lviv Regional Council passed a decision by which a “Comprehensive Program on Providing Medical Care to the People Living in the Lviv Region for the year of 2016” was adopted. For the first time, in such a program the money for treatment of people living with hepatitis B or C was envisaged within the line “Diagnostics, Treatment and Rehabilitation of People who Suffered during the Revolution of Dignity and Anti-terrorist Operation” in the amount of 3,300,000 Ukrainian hryvnias; 22 patients will receive treatment by the medical drug “Sovaldi” (brand name)”.
Article 14 of the UNESCO Universal Declaration on Bioethics and Human Rights (2005) states that progress in science and technology should advance access to quality health care and essential medicines, especially for the health of women and children, because health is essential to life itself and must be considered to be a social and human good. On the level of the Main Law of Ukraine, it is envisaged that an individual, his life and health, honor and dignity, inviolability and security shall be recognized as the highest social value (Article 3 of the Constitution) . Hence the content and the direction of the State activities is human rights oriented.
According to the Law of Ukraine on Infectious Diseases, people suffering from infectious diseases, including viral hepatitis, shall be entitled to free treatment, medical observations and screenings in state and communal health care facilities . But this right has a declarative character, since the State does not fulfill its duties in terms of providing free access to medical care, which, in conjunction with the high price of medical drugs, creates real threats to life and health of the people.
Consequently, in Ukraine there is a synergy of different sources of financing aimed at treating hepatitis C on a free basis, but the real amount of financial resources is too small in comparison with the needs. Currently there are nearly 90,000 people who need treatment. Hence, the problem of access to treatment for hepatitis C remains acute, which necessitates a wide-spectrum approach to resolving. It can be done by combining financial resources of the State Budget and of the local budgets, by prolonging the national program on fighting viral hepatitis.
Another human rights problem in the sphere of protection from infectious disease, in particular hepatitis C, was highlighted by the State bodies. In the opinion of the Minister of Health of Ukraine  “In Ukraine there is an epidemic of HCV, and in spite of spending huge sums of money for treatment of HCV, we can more effectively monitor the quality of donated blood. Now this is not like that and the majority of children suffering from cancer and who receive donated blood are infected with HCV. We need to implement such system of blood control that can allow us to be sure that the donated blood is clean and that such blood is free from HIV and hepatitis and it can be freely used for transfusion. Such system was developed last year, but it hasn’t been implemented yet”.
Unfortunately, during blood donation there are real problems and threats and many examples of human rights violations, first of all the right to safety and the right to high-quality medical care . For instance in regional hospital X., babies were infected with HCV because of the obsolete equipment used at the blood transfusion station, which could not establish the viability of a virus in donated blood. Blood donors are supposed to undergo complex blood screenings – immunochemiluminometric assay (ICMA) and polymerase chain reaction (screening which enables identification of viruses in blood). However, ICMA medical equipment is planned but not yet purchased for the blood transfusion stations; and in the city of X., only private laboratories can conduct ICMA. Hence, it became necessary to allocate money from the budget to screen donors in private laboratories. In our opinion the sticking point here the lack of financing necessary to buy the equipment, which could become an effective prophylactic measure to prevent the infection.
According to Article 9 of the European Charter of Patients’ Rights (2002), each individual has the right to safety: to be free from harm caused by the poor functioning of health services, medical malpractice and errors, and the right of access to health services and treatments that meet high safety standards . Safety of donated blood and observing human rights in this respect are properly regulated by the national laws but in reality many practical problems occur. Due to Article 16 of the Law of Ukraine “On Donation of Blood and its Components” , taking of blood from a donor is conducted after a donor undergoes medical screening; and Article 18 provides the responsibility to monitor the observance of the relevant safety and quality indicators of blood, its components and drugs. According to the Procedure of Medical Examination of Donors of Blood or its Components (2005)  , further screening of blood taken from a donor shall be conducted in the laboratories of the blood transfusion stations, in particular by using the HCV marker. An absolute contraindication for donation of blood, notwithstanding the disease duration and results of treatment, is viral hepatitis, positive results of screening using the viral hepatitis marker.
To conclude, it should be noted that bodies of state power should act as a system in order to provide funds not only for prophylactics of HCV. Within the structure of the public budgets there shall be allocated funds for prophylactics, treatment and diagnostics. Nowadays public organizations along with the Center of Public Health of the Ministry of Health work on creation of a Strategy of the elimination of viral hepatitis in Ukraine, which is very topical taking into consideration that in 2016 the national program in this sphere ended. It is clear that the deficit of financing creates numerous challenges for the state and its citizens, among which is the impossibility to influence the epidemic situation in Ukraine, which favors HCV turning into a real threat to national security of Ukraine.
Experience of Georgia with regard to HCV treatment
After Egypt and Mongolia, Georgia ranks as 3rd globally in HCV prevalence  Under the study⃰ conducted by the National Center for Disease Control and Public Health, more than 200,000 persons (7.1% of the population) carry the virus . The prevalence of HCV is especially high amongst (HIV) (47%) patients,  injecting drug users (70%),  and prisoners (50%) . Due to the high price of lifesaving medicine, for years only 1% of persons infected with HCV could afford treatment.
The stark situation of the lack of access to treatment for HCV started to change with the decision of the European Court of Human Rights in the case of Poghosyan v. Georgia in 2009 (application N9870/07). In this case, applicant Khvicha Poghosyan, from Bodbiskhevi, Georgia, argued that his right to protection from inhumane and degrading treatment had been violated under Article 3 of the European Convention on Human Rights. After receiving post-operative care in the prison hospital for acystectomy, the plaintiff was transferred to Prison No. 6 in Rustavi, Georgia, where blood tests revealed that Poghosyan had contracted HCV.
Upon learning of his condition, the prison staff failed to transfer Poghosyan to the prison hospital to access the necessary care. In response, Poghosyan’s attorney filed a complaint with the Governor of the prison. This request was repeatedly denied. The applicant argued that his right to be protected from inhuman treatment, under Article 3 of the European Convention on Human Rights, was violated because of the absence of treatment for HCV.
At the time of the application, over forty other applications against Georgia were pending before the Court concerning the lack of medical care in Georgian prisons, eighteen of which concerned applicants suffering from HCV. The numbers of these applications were an indication to the Court that the absence of medical care for prisoners suffering from HCV was a structural one. This, under the Court’s assessment, not only aggravated the responsibility of the Georgian Government under the Convention, but also posed a threat to the future effectiveness of the Convention machinery.
Based on the above, the Court considered that general measures were necessary at the national level for the enforcement of the judgment in the case. The Court, therefore, considered that necessary legislative and administrative measures should be taken without delay in order to prevent the spread of viral HCV in Georgian prisons. In particular, the Court stated that the government should introduce a screening system for HCV and guarantee the prompt and effective treatment of the disease . As a result of the Court’s decision, coupled with civil society activism and the pressure from internal and international actors, the Government of Georgia started to recognize the problem and take action to ensure treatment for HCV not only in prisons, but also for the civilian sector in Georgia:
In 2013-2014, in the framework of the Government program for prevention, diagnostic and treatment of HCV, the Government started to provide diagnostics and treatment for prisoners infected by HCV. In 2013 access to treatment for patients in the civilian sector also increased, as the Ministry of Labor, Health and Social Affairs negotiated with private companies As a result, HCV medication (Ribavirin and Interferon) began to be sold to patients involved in the State program with 60% reduction of price .
In 2014 the Government created a working group to set up a strategic action plan for the elimination of HCV and started to negotiate with Gilead for this purpose. On 21 April 2015 a memorandum was signed between Gilead and the Georgian government to ensure access to prevention, diagnostics and treatment of HCV in Georgia for the purposes of reducing morbidity and mortality associated with the disease and spreading of the disease. Currently the beneficiaries of the program are the citizens of Georgia, prisoners and persons involved in the Government’s HIV/AIDS program .
In the framework of the Government program the treatment is administered with Sofosbuvir and Harvon – the newest generation of medicines for HCV. Under the date of the Ministry of Health, the HCV elimination program has brought about significant change in the lives of patients – from April 2015 up until today, 21500 patients have been registered in the database of the Social Service Agency, of which 18000 were involved in the treatment. In 90% of the cases the treatment resulted in the recovery of patients .
Diagnostics of the disease also proved to be a financial obstacle for the patients who could be involved in the Government program and receive the treatment for free. To remove this obstacle, the Government started to cover 70% of the costs of diagnostics for the socially vulnerable population and 30% of the costs are covered for the general public .
Initially the patients were given priority for the enrolment in the program based on the state of their disease. However, starting from 10 June, any Georgian citizen who carries HCV can be enrolled in the program without having to comply with any other criteria.15 The Ministry of Health indicates that the removal of the criteria for the entry into the program has contributed to the significant increase in the number of patients involved in the program. According to the information of the Ministry of Health, during the months of June-August more than 9000 patients were registered in the program. The Government plans to provide treatment to 20 000 – 30 000 patients annually until the virus is completely eradicated .
The landmark decision of the Court in the case of Poghosyan v. Georgia, together with the series of cases brought to the Court, demonstrates how strategic litigation can influence the actions of the Government to ensure access to treatment and remove price barriers in access to medicine. The actions taken by the Government ultimately went beyond what was required to implement the decision of the Court – legislative and policy changes were made and HCV treatment programs started not only in prisons, but also in the civilian sector. This effectively removed the barriers for thousands of Georgian HCV patients who otherwise would not have had any chances for accessing life-saving medicine.
Political commitment to start the treatment program for HCV did not only result from the obligation to enforce the Court decision, but also from a great amount of internal and external pressure stemming from the civil society, patient organizations and lobby groups. This also was the result of the openness of the pharmaceutical companies to cooperate with the Georgian government and reduce prices of the medicine. Therefore, the biggest barrier towards treatment – the price of the medicine – was removed as a result of strategic litigation, advocacy and the Government’s subsequent commitment to implement change.
As a result of the research, taking into account the Ukrainian and Georgian experience, international standards in this sphere in order to follow the human rights in patient care concept in the sphere of public health, it is necessary to take certain measures, which will be useful in order to fight viral hepatitis and will be an effective instruments for the state bodies and civil society organizations, including
1. Advocacy of the formation of public policy in line with the principle “health in all policies approach” and social responsibility before a person.
2. Paying special attention to combating viral hepatitis when developing national public health concepts.
3. Implementation of the human rights in patient care concept when creating a state policy in the sphere of public health.
4. Implementation of the WHO guidelines into the national plan of actions, which are necessary to combat viral hepatitis and which define the sphere that need wide spectrum investment resource in order to secure positive results of combating viral hepatitis.
5. Approval and implementation, first of all in terms of financial provision, of the national programs for the elimination of viral HCV.
6. Providing mandatory insurance of medical professionals by the owner of the health care facility in case of harm caused to their health while performing professional duties.
7. Carrying out legal educational activity, which is directed at increasing the level of awareness with the regard to viral hepatitis issues of the population in general (general prevention) and medical professionals in particular (special prevention).
8. Providing equal access to HCV treatment, in particular for the marginalized groups of the population.
9. Strengthening the role of civil society and improvement of the methods of its activity, which is aimed at human rights protection through the prism of strategic litigation cases, involving the civil society organizations, first of all patients organizations, to the decision making process with regard to combating viral hepatitis.
In this article two main human rights in patient care were elucidated: right to access, in particular the right to access treatment, and the right to safety, first of all safety of donated blood. Taking as a basis these two rights, a set of problems which exist in these two countries were analyzed in detail as well as the measures taken by the countries to combat viral hepatitis. Ukrainian experience demonstrated an effective algorithm of raising and allocating financial resources on combating HCV through the long-term fruitful collaboration of the state authorities and the civil society sector. At the same time it is clear from the Georgian experience that strategic litigation is an effective tool of protecting human rights in the ECtHR, with a result of national and international impact.
A list of measures which should be taken by the international community was suggested based on the national experience of both states and the international instruments. Owing to the synergy of state and civil society efforts these measures will impact the dynamics of the epidemics, spread and optimization of human rights in this sphere.
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21. Ministry of Labor, Health and Social Affairs, Social Service Agency web-page: http://ssa.gov.ge/index.php?lang_id=GEO&sec_id=804
EctHR = European Court of Human Rights
HCV = Hepatitis C virus
HIV = Human immunodeficiency virus
WHO = World Health Organization
HIV/AIDS = Human immunodeficiency virus infection and acquired immune deficiency syndrome
Conflicts of Interest: None declared.
Address for correspondence
Department of Medical Law
Danylo Halytskyi Lviv National medical University