Federal Law № 317-FZ “On Amendments to Certain Legislative Acts of the Russian Federation and the Rescinding of Certain Provisions of Legislative Acts of the Russian Federation on Matters Concerning Citizens’ Healthcare in the Russian Federation” (“Law № 317-FZ”) entered into force on November 25, 2013. The said amendments to legislative acts governing specific aspects of healthcare are aimed at bringing various other laws applicable in the healthcare area into conformity with Federal Law № 323-FZ “On the Principles of Citizens’ Healthcare” of November 21, 2011 (“Law on Healthcare Principles”). Most of the new amendments are effective as of November 25, 2013, with the exception of several amendments effective from January 1, 2014.
Similar amendments have been made to a broad range of healthcare-related laws. In particular, the definition of the term “medical organization” and the types, forms, and conditions for providing medical assistance to individuals have been standardized and brought into conformity with the Law on Healthcare Principles.
At the recommendation of the Federal Antimonopoly Service of Russia (“FAS Russia”), the Ministry of Healthcare of the Russian Federation has been given the authority to issue legally binding instructions to cure violations in the healthcare sector, to initiate and consider cases involving violations of Russian Federation healthcare legislation, and to determine liability for failure to comply with the instructions of state authorities and for obstructing their actions in the course of them performing supervisory activities.
The Russian Federation Government has been authorized to establish the procedure for forming various lists of medicinal products, namely:
- The list of vital and essential medicines, and the minimum range of medicines to be provided by pharmacy organizations and sole proprietors;
- The list of medical products approved for implantation in the human organism within the framework of state guarantee programs;
- The list of medicines and medical products provided to socially vulnerable categories of citizens, etc.
Procedures for state registration and expert examination of medicines revised
The respective federal authorities have been given the authority to send requests for information to applicants in the event that inaccurate or insufficient information is found in the materials submitted for expert examination or for the registration of a medicine, or for the reregistration of specific information on the medicine. The time period and form for sending such requests, and the time period for the applicant’s response, are also established, and influence on the time period for considering an application for registration or expert examination of a medicine.
Access-to-doctors rules for pharmaceutical companies mirrored
Express restrictions on the interaction between pharmaceutical companies and medical and pharmacy workers introduced by Law 317-FZ to Federal Law № 61-FZ on the Circulation of Medicines of April 12, 2010 (“Law on the Circulation of Medicines”) mirror the restrictions previously imposed as of January 1, 2012 on medical and pharmacy workers by the Law on Healthcare Principles. The Law on Circulation of Medicines now prohibits pharmaceutical companies (which include not only pharmaceutical producers but also wholesalers and retailers of medicines) from any of the following in direct interaction with medical and pharmacy workers:
- giving such workers gifts, paying for entertainment or travel to a vacation destination, holding entertainment events;
- entering into agreements on the prescription of specific medical products for patients;
- supplying medical or pharmaceutical workers with medicines to be provided to patients;
- personal meetings with the said employees during working hours;
- encouraging the use of prescription forms that include advertising information, and others.
Some of the restrictions above do not apply to clinical trials and pedagogical or research activities.
Notably, although there is now an express prohibition on pharmaceutical companies giving gifts to doctors and other direct interaction with medical or pharmacy workers (in addition to previously established mirror restrictions for medical and pharmacy workers themselves), Russian applicable law still does not provide for administrative liability for the breach of such prohibitions for pharmaceutical companies, their officers, and/or for medical or pharmacy workers. In practice, this means that many pharmaceutical companies continue to breach these prohibitions in order to maintain competitiveness. However, the fact that Russian law does not provide penalties for the breach of certain rules should not lead to unlawful activities by companies operating on the Russian market.
In addition to the above, the said amendments implement FAS Russia’s recommendations with respect, in particular, to ensuring an equal playing field for all producers of similar medicinal products. It was FAS Russia that recommended the introduction of a ban on discriminatory conditions with respect to participants in scientific events organized by pharmaceutical producers. A pharmaceutical company that wishes to hold a scientific or other event for the professional development of medical and/or pharmacy workers must publish an announcement of the event on its website at least two months in advance and at the same time notify the Ministry of Healthcare of the Russian Federation.
The said amendments entered into force on November 25, 2013.
Amendments to the rules on advertising of medical services
Amendments to Federal Law № 38-FZ on Advertising of March 13, 2006 (“Advertising Law”) take effect on January 1, 2014 and extend cases where it is admissible to refer to the therapeutic properties of the subject of the advertisement to include not only pharmaceuticals, medical services (including treatment methods) and medical products, but also preventative, diagnostic, and rehabilitation methods, as well as traditional medicine. At the same time, the requirements for pharmaceutical advertising (for example, a ban on implying that it is not necessary to consult a doctor or suggesting that a healthy person should use the advertised product) will also apply to advertisements for preventative, diagnostic or rehabilitation methods.
On the basis of a literal interpretation of the new version of the Law on Advertising, preventative, diagnostic and rehabilitation methods are captured by the definition of “medical services”. However, considering absent practice and guidance on this subject it is possible to expand the application of the new rules, for example, to advertising of hygienic and cosmetic items. This means that there may also be more opportunity to advertise the preventative benefits of such goods.
The new edition of the law introduces a complete ban on pregnancy termination (abortion) medical services.