Russia. Promotion of Pharmaceuticals

[May 31st., 2013] On February 28, 2013, the Strategy for the Provision of Pharmaceuticals to the Russian Public through 202511 (the “Strategy”) was adopted by the Ministry of Healthcare. The Strategy provides an analysis of the current situation with respect to the provision of pharmaceuticals in Russia and declares goals for fostering and measuring improvement in this process, including legislative changes. The main goal of the Strategy is to improve access to high-quality, effective and safe pharmaceuticals. To achieve this goal, the Strategy, among other things, declares the need for:

• improvements to the process of compiling lists of pharmaceuticals made available to the public through the program of state guarantees of free medical care and social security assistance;
• improvements to state regulation of pricing for pharmaceuticals made available to the public through the program of state guarantees of free medical care and social security assistance;
• the establishment of a unified register of persons entitled to free or discounted pharmaceuticals while undergoing outpatient treatment;
• the creation of a list of pharmaceuticals that can be used for the treatment of the same illness (so-called “interchangeable” pharmaceuticals);
• improvements to the system of state registration of pharmaceuticals used for the treatment of rare illnesses (so-called “orphan” pharmaceuticals);
• the launch of pharmaceutical procurement projects, including procurement at the expense of the obligatory medical insurance fund;
• the introduction of co-payments by patients for pharmaceuticals, as well as cumulative payments from the obligatory medical insurance fund;
• improvements in the availability of qualified healthcare and pharmaceutical professionals; and
• the establishment of a system of so-called “reference prices” for pharmaceutical products.

The Strategy has already been criticized for not being sufficiently concrete. The success of its implementation will depend in large measure on exactly what specific actions will be undertaken by the Russian government and other stakeholders to actually achieve the goals identified by the Strategy.

Advertising

On March 15, 2013, the Government of the Russian Federation approved a bill amending the Federal Law on Advertising. If passed, the bill would provide, among other things, for mandatory notices in advertisements of bio-active supplements indicating that they are not pharmaceuticals, as well as for the extension of liability for improper advertising not only to the advertiser, but also to any distributor. On May 14, 2013, the bill was adopted by the State Duma in the first reading and is currently scheduled to be considered in the second reading on June 21, 2013.

The Bill would also add to the Code on Administrative Offenses a new provision prohibiting the improper advertisement of pharmaceuticals, medical goods, medical services and bio-active supplements, with penalties for such violations consisting of a fine in the amount of up to RUB 500,000 (approximately US$16,000) for legal entities and up to RUB 20,000 (approximately US$650) for individuals.

In addition, quite remarkably, the Government has asked the Ministry of Health and the Federal Antimonopoly Service to study the impact of simply prohibiting advertising of any pharmaceuticals in the mass media all together. A report was due by May 20, 2013. As of today, it has not been officially published.

Source: Debevoise & Plimpton LLP