Healthcare Regulation in the Process of Integration of Ukraine with the European Union
Alina O. Mishkur
The State Program On Adapting Ukraine’s Legislation to the Legislation of the European Union determines the mechanism of reaching accordance with Copenhagen and Madrid criteria for acquiring membership in the EU. The purpose of the adaptation is reaching accordance of the legal system in Ukraine to acquis communautaire with the account of criteria that are provided by the EU for countries wishing to join it.
Adaptation of Ukrainian legislation to EU legislation is a priority component of the process of integrating Ukraine into the EU. The adaptation of legal acts in the sphere of healthcare is an indispensable element of the Program.
The countries wishing to join the EU have to demonstrate political, legal and technical compliance with EU standards and norms. Healthcare issues receive significant attention in the European Union. The EC Treaty1 requires the internal market to be based on a high level of health protection. The Community Health Strategy2 sets out the goal of achieving a coherent and effective approach to health issues across all the different policy areas.
EU healthcare legislation
Current EU legislation on healthcare is characterized by wide ramification and scoping of all the most important issues in this sphere.
The main areas of healthcare regulation in the EU are issues regarding use of tobacco, addiction to alcohol, virulent diseases, cancer, blood, tissues, cells issues, doping in sport.
The main EU documents on healthcare regulation are the Tobacco Products Directive3, which regulates the levels of tar, nicotine and carbon monoxide, warnings (textual and graphic) and tobacco ingredients and misleading statements on tobacco packs; the Tobacco Advertising Directive4 that regulates cross border tobacco advertising and sponsorship in the media other than television; the Council Recommendation on Smoking Prevention that covers age limits, sales to minors, "imitation" tobacco products, using tobacco brand names in non-tobacco products, sales promotion, billboards, advertising in cinemas and any other promotion of tobacco products, etc.
To ensure the quality and safety of human blood, tissues and cells, EU legislation — seven Directives in total — on quality and safety standards for blood, tissues and cells have been adopted.
All member states must comply with those standards.
At international level, the EC plays a leading role in negotiations on the WHO Framework Convention on Tobacco Control protocol on illicit tobacco trade and plays an active role in the implementation process of the FCTC.
Ukrainian healthcare legislation
The basic document in the area of health protection in Ukraine is the Fundamentals of Health Legislation of Ukraine Act of 19 November 1992.
The Act provides for general principles of legal regulation in this sphere. The provisions of the Act are developed in other special acts and regulations which are the main object of adaptation measures taking into account the fact that EU law regulates separate issues of healthcare. The special documents include the Concept of Development of HealthCare in Ukraine5, On Adoption of the National Program on Immunoprophylaxis and Protection of Population from Infectious Diseases for 2009-2015 Act of Ukraine;
On the Quality and Safety of Food Products Act of Ukraine; Resolution On the State Program of Support for Families until 20106; Resolution On State Program Reproductive Health of the Nation for the Period till 20157; State Program Paediatric Oncology 2006-20108; Resolution of Cabinet of Ministers On Adoption of the State Program of the System of Rehabilitation and Employment of People with Restricted Physical Abilities, Mental Afflictions and Mental Backwardness until 2011, etc.
Plenty of issues on healthcare regulation need improvement in order to harmonize Ukrainian legislation with the provisions of EU law.
The issues of harmonization
The following issues are among those that mostly need harmonization:
- psychiatric aid;
- judicial system (creation of special courts to consider the complaints of patients);
- voting of the ailing;
- rights of expectant mothers;
- tobacco use;
- HIV/AIDS issues;
- drug addiction;
- donation;
- GMO;
- etc9.
In particular, the following amendments should be made to Ukrainian legislation:
The On Psychiatric Aid Act of Ukraine10 needs to provide that:
persons who gain psychiatric aid should have the right to treatment near their houses or houses of their relatives;
persons who gain psychiatric aid should have the right to return to society as soon as possible;
asexualizeation should never be applied.
The On Judicial System of Ukraine Act of Ukraine needs to provide that:
special courts be created to consider the claims of patients regarding the necessity of further treatment.
The On Measures of Prevention and Reduction of Use of Tobacco Products and their Harmful Influence on People’s Health Act of Ukraine11 should provide:
a definition of tobacco of oral use;
that advertising of tobacco products should be directed only to professionals in the tobacco sector;
The On AIDS Prevention and Social Protection of Population Act of Ukraine12 should provide:
the encouragement of role of non-governmental organizations in combating AIDS.
The On Donation of Blood and its Components Act of Ukraine13 should provide:
the definitions of cell, autological application under EU law;
the necessity of notification on serious unfavorable incidents and reactions;
provisions on anonymity;
the definitions of blood for donation, product of blood, component of blood, potential donor, active donor.
The On Measures to Counteract the Illegal Traffic in, and the Abuse of, Narcotic Drugs, Psychotropic Substances and Precursors Act of Ukraine14 should provide:
the possibility for a person who is sick in drug addiction and gains treatment to transfer from day tuition to tuition by correspondence, academic vacation during treatment, etc.;
the possibility of a person who is ill due to drug addiction to gain free treatment;
measures for preventing illegal traffic in substance substitutes;
the possibility for convicted people to get treatment from drug addiction;
the availability of relevant equipment and education for special expert bodies in the event of overdose.
The On Advertisement Act of Ukraine15 should provide:
the application of sanctions to legal entities that do not create the conditions for preventing drug substances on their territories.
The On Protection of Childhood Act of Ukraine16 should provide:
the development of approaches to early discovery and further interference with the aim of prevention of conversion of youth to persons with alcoholic dependence.
Healthcare regulation in Ukraine faces the following problems:
- absence of support for effective planning of public healthcare;
- implicitness of taxation system;
- absence of support of contractual staff arrangements;
- absence of support to reorganization of public healthcare providers, etc.17
Current cooperation between Ukraine and EU
Currently, the cooperation between Ukraine and the EU in the sphere of healthcare lies within the European Neighborhood Policy. The cooperation is envisaged, in particular, in such fields as health sector reform and health policy dialogue, health information and knowledge, communicable disease monitoring and health security.
Since 2000, the EU has provided substantial assistance in the field of healthcare through the TACIS Program. The Primary Healthcare Support project developed a model for introducing an effective network of family doctors. The Healthcare Financing and Management developed a set of recommendations for the further development of the legal and administrative framework. The Project on Support to the Development of the System of Medical Standards supported the Ministry of Health in setting up a centre for development of standards.
The EU funded a project to develop a mid-term strategy for the development of the healthcare sector. One of the projects is entitled “Support for secondary healthcare reform”. Healthcare also forms an important element of the EU’s support for local and regional development in Ukraine, including the Community-Based Approach project18.
Conclusion
Problems with healthcare in Ukraine are significant due to inefficiency in planning and regulation. Ukraine has created a legal platform, in particular, in the healthcare sector, that is characterized by complexity and ambiguity. The attempts to reform the healthcare system have been largely unsystematic and inconsistent. Taking into account Ukraine’s course to integrate into the EU, it is necessary to improve the healthcare management system.
The development of the healthcare system requires coordination, cooperation and qualified application of EU norms and standards.
1 Treaty establishing the European Community (Treaty of Rome of 1957).
2 Communication from the Commission of 16 May 2000 to the Council, the European Parliament, the Economic and Social Committee and the Committee of the Regions on the health strategy of the European Community [COM(2000 285 final].
3 Directive 2001/37/EC of 5 June 2001 on the approximation of the laws, regulations and administrative provisions of the Member States concerning the manufacture, presentation and sale of tobacco products.
4 Directive 2003/33/EC of 26 May 2003 on the approximation of the laws, regulations and administrative provisions of the Member States relating to the advertising and sponsorship of tobacco products.
5 Decree of the President of Ukraine of 7 December 2000.
6 Resolution of the Cabinet of. Ministers of Ukraine of 19 February 2007, No.244.
7 Resolution of the Cabinet of Ministers of Ukraine of 27 December 2006.
8 Resolution of Cabinet of Ministers of Ukraine of 19 July 2006.
9 Comprehensive Comparative Law Analysis of Conformity of Legislation of Ukraine to EU Legislation in the Sphere of Healthcare of Human Beings, Beast, Plants of 15 January 2008.
10 Act of Ukraine of 22 February 2000, No1489-III.
11 Act of Ukraine of 22 September 2005, No.2899-IV.
12 Act of Ukraine of 12 December 1991, No.972-XII.
13 Act of Ukraine of 23 June 1995, No.239/95-ВР.
14 Act of Ukraine of 15 February 1995, No.62/95-ВР.
15 Act of Ukraine of 03 July1996, No.270/96-ВР.
16 Act of Ukraine of 26 April 2001, No.2402-III.
17 http://www.eu-shc.com.ua/en/shc_reform.html
18 www.europa.eu.int
