Russia Makes Amendments to Legislative Acts on Health Care
OREANDA-NEWS. November 29, 2013. The President of the Russian Federation Vladimir Putin signed the Federal Law “On Introducing Amendments to Some Legislative Acts of the Russian Federation and on Invalidating Particular Provisions of the Legislative Acts of the Russian Federation on Health Care in the Russian Federation”. The Law introduces amendments to several legislative acts that regulate or concern health care. The amendments clarify the legal structure of medical organizations, and adjust the norms on the types, forms and conditions for providing medical aid in line with the Federal Law “On the Fundamental Principles of Health Care in the Russian Federation”.
Already in 2009, investigating the largest pharmaceutical companies operating in the Russian Federation, FAS exposed some facts of improper cooperation of pharmaceutical companies with the medical community and government officials compiling registers of patients and applications for purchasing medicines with the budgetary funds.
To execute the instructions of the Government of the Russian Federation of 9th October 2009, FAS together with the expert community devised the norms regulating prevention and management of conflicts of interests between medical and pharmaceutical workers in rendering medicines to the population as well as setting mandatory requirements to medical doctors and pharmaceutical companies and liability for breaching these requirements.
However, the Federal Law “On the Fundamental Principles of Health Care in the Russian Federation” included only the norms restricting professional activities of medical and pharmaceutical workers (Article 74), and the norms on preventing a conflict of interests between medical and pharmaceutical workers (Article 75).
Amendments are made to the Federal Law “On Circulation of Medicines” to establish restrictions for pharmaceutical companies and their representatives who initiate bribing medical doctors and pharmacists. Unfair marketing policy in the form of offering monetary remuneration to doctors, organizing vacations (including trips abroad in the guise of taking part in scientific events) at the companies’ expense is prohibited. Possibilities for medical workers to promote medicines through “point” interaction with certain doctors and heads of medical organizations are curtailed significantly.
At the same time, as pointed out by the Head of FAS Department for Control over Social Sphere and Trade, Timophey Nizhegorodtsev: “The Code on Administrative Violations does not have sanctions for violating the requirements and restrictions set for medical and pharmaceutical workers, as well as pharmaceutical companies, which, in our opinion, makes enforcement impossible”.
The new Federal Law also clarifies the procedures for state registration of medicines and medications expertise procedures.
The Government of the Russian Federation is responsible for establishing the procedures for compiling various lists of medicines. Namely: the list of vital and essential medicines, the minimum mix of medicines that pharmacies and individual entrepreneurs must provide (Articles 55 and 60 of the Federal Law “On Circulation of Medicines”), a list of medicines centrally purchased with the funds from the federal budget for treating patients with seven rare and the most expensive nosologies (7 nosologies) (Article 15 the Federal Law “On the Fundamental Principles of Health Care in the Russian Federation”), a list of medications and medical products provided to socially disadvantageous categories of individuals under the Federal Law “On State Social Aid”.
The new Law incorporates the following FAS proposals:
- On excluding restrictions for private medical organizations from some federal laws regulating health care
- On providing equal opportunities for all pharmaceutical companies producing or selling similar (substitute) medicinal products to inform medical workers about their medicines as part of scientific events, and on prohibiting pharmaceutical companies that initiate scientific events to create discriminatory conditions for participants of these events
- Assigning Roszdravnadzor the powers for issuing mandatory determinations to eliminate violations in health care, initiating and investigating cases on violating the law of the Russian Federation on health care, establishing liability for failure to execute the determinations issued by Roszdravnadzor and for prevention of monitoring activities of Roszdravnadzor
- On establishing administrative liability for doctors and pharmacists for failure to report about a conflict of interests, failure by a medical organization to inform citizens about a possibility to obtain free medical assistance (under the programme of state guarantees for free medical care and regional free medical care pgrammes), failure to publish or late publishing of a mandatory medical insurance program and the rates for medical aid in the Internet (this norm shall enable private medical organizations to make timely decisions on participating in the system of mandatory medical insurance).
The Federal law “On Introducing Amendments to Some Legislative Acts of the Russian Federation and on Invalidating Particular Provisions of the Legislative Acts of the Russian Federation on Health Care in the Russian Federation” is passed by the State Duma of the Russian Federation on 15th November 2013 and approved by the Council of Federation on 20th November 2013.