Regulation of healthcare market in russian federation
- 1. State regulation of the healthcare market in the Russian Federation Presented to Prof. Tretiakova O. S. Done by Kulanthaivel ShanmugaRaj
- 2. Legal background • The legal basis for health care reforms at the federal level is provided by a variety of legislative acts (Codes, Federal laws), Presidential decrees, Decisions and Proposals of the Government of the Russian Federation, and Orders of the Government and of the Ministry of Health and other ministries. • The legal basis at the regional level is provided by legislative instruments enacted by the governments of the subjects of Russian Federation. • The most important instruments are listed below; it should be stressed that this list is not exhaustive.
- 3. Federal Legislation in the Healthcare Sector Constitution of the Russian Federation The Constitution of the Russian Federation was adopted at national voting on 12 December 1993. It contains two articles related to the healthcare system: Article 7 1. The Russian Federation is a social state whose policy is aimed at creating conditions for a worthy life and a free development of man. 2. In the Russian Federation the labor and health of people shall be protected, a guaranteed minimum wages and salaries shall be established, state support ensured to the family, maternity, paternity and childhood, to disabled persons and the elderly, the system of social services developed, state pensions, allowances and other social security guarantees shall be established. Article 41 1. Everyone shall have the right to health protection and medical aid. Medical aid in state and municipal health establishments shall be rendered to individuals gratis, at the expense of the corresponding budget, insurance contributions, and other proceeds. 2. In the Russian Federation federal programmes of protecting and strengthening the health of the population shall be financed by the State; measures shall be adopted to develop state, municipal and private health services; activities shall be promoted which facilitate the strengthening of health, the development of physical culture and sport, ecological and sanitary-epidemiological well-being. 3. The concealment by officials of the facts and circumstances posing a threat to the life and health of people shall entail responsibility according to the federal law. As you can see the main law inherited the guarantee of free healthcare services to population. It is also very important to stress that it stipulated equal rights of public and private healthcare which is sometimes missing in other legislation acts.
- 4. MARKETING AND PROMOTION OF SERVICES • Advertising issues are governed by Federal Law No. 38-FZ on advertising, dated 13 March 2006 (the Advertising Law). • Where competition issues are concerned, in the absence of specific rules applicable to the healthcare sector, the general rules of Federal Law No. • 135-FZ on the Protection of Competition, dated 26 July 2006 (the Competition Law), will apply. • The FAS is the regulatory body with responsibility for enforcing compliance with competition and advertising legislation.
- 5. The Advertising Law provides detailed rules for advertising medicines, medical services and medical devices, including, in particular, the following restrictions: • advertising must not give an impression that it is unnecessary to visit doctors; • advertising must not contain allegations or assumptions that consumers have certain diseases or impairments of health; and • advertising must not contribute to making an impression of the necessity for a healthy consumer to use the advertised item.
- 6. COMMISSIONING AND PROCUREMENT • The process related to public purchases in the health sector (e.g., supply of medical devices, equipment, pharmaceuticals and some types of medical services) is regulated primarily by Federal Law No. 44-FZ19 and Federal Law No. 223-FZ, applicable to public healthcare providers depending on their type of organisational form. • There is a single information platform for procurement in the public sector containing updated information on the existing goods and services under public procurement contracts, ongoing public tenders and other information. • Generally, tender rules apply, although the legislation provides an opportunity to use other procurement methods or a single-supplier procedure. • Note that some restrictions may apply to foreign companies willing to participate in tenders under Federal Law No. 44-FZ, although some of the prohibitions or limitations do not apply to suppliers coming from the Eurasian Economic Union Member States.
- 7. OWNERSHIP OF HEALTHCARE BUSINESSES • Healthcare institutions under public ownership (e.g., state-budget healthcare institutions) currently represent the largest part of all healthcare providers in Russia, although the number of private medical organisations is constantly increasing. • The private medicine market in Russia is characterised by a low degree of consolidation. Most of the current market is taken by commercial departments of state medical institutions, as well as thousands of small private clinics and offices. However, there are a number of large holdings successfully operating in Russia in the area of private medicine (including in the DMS sector), mostly in the area of multi-profile, laboratory and reproductive-related activities.
- 8. Regulators Licensing of different types of activities is governed by Federal Law No. 99-FZ on Licensing Specific Types of Activities, dated 8 August 2011, and subordinate legal acts. As a general rule, medical activity (except for specified activities carried out by medical organisations and other organisations within the private healthcare system in the territory of the Skolkovo Innovation Center), the use of ionising radiation sources, production and technical operation of medical equipment, the use of pathogens of infectious diseases of humans and animals (with the exception if this activity is carried out for medical purposes) and genetically modified organisms of certain degrees of potential danger are subject to licensing. Roszdravnadzor, which is subordinate to the MoH, carries out licensing of: medical and other organisations subordinate to the federal executive bodies; organisations of federal executive bodies, in which military and equivalent service is done in accordance with federal laws; and medical and other organisations engaged in providing high-tech medical care. Authorised executive bodies of the Russian constituencies carry out licensing of: activity of medical and other organisations, except for those whose activities are licensed by Roszdravnadzor; and individual entrepreneurs.