• Draft 2012 List of Essential Drugs is published
• FAS is proposing the state program to give a boost to generics consumption
• FAS plans to tighten control over healthcare
• New version of the Regulation on pharmaceuticals import into the Customs Union
• New pharmaceutical cluster to be set up in the Moscow region
• The State Duma has considered in the 1st reading the draft law on preferences for the Skolkovo participators
• The Ministry for Industry and Trade is collecting proposals for project topics under the “Pharma-2020” program
• Licensing requirements to pharmaceutical activity are specified
   

The Ministry for Healthcare and Social Development placed at its web-site the Draft 2012 List of Essential Drugs for public discussion.

The Draft List includes 563 positions of pharmaceuticals in total; among them, 94 items (16.7%) are produced only by Russian companies, 202 items (35.9%) – only by foreign manufacturers and 267 items (47.4%) are manufactured by both by Russian and foreign pharmaceutical producers.

To avoid potential impairment of fair competition in the market, references to particular pharmaceutical forms are withheld from the Draft List.

This is the announcement made by Timofey Nizhegorodtsev, the Head of the Federal Antitrust Service’s Department for social sphere and trade control.

According to Mr. Nizhegorodtsev, mass distribution of generics in the local pharmaceutical market should give a rise to competition and, consequently, reduce the state budget costs for purchases of pharmaceuticals under governmental programs.

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As per the Head of FAS Department for social sphere and trade control, Mr. Timofey Nizhegorodtsev, the state authorities are developing tools to control the healthcare sphere and the interactions between pharmaceutical companies and doctors. Particularly, the following measures are suggested:

• determining the substitute pharmaceuticals and medical equipment, for avoiding the situations when customers have to acquire more expensive drugs and for mitigating unfair competition in course of state tenders;
• enforcing legislative restrictions for pharmaceutical companies to boost doctors and hospitals management to pharmaceuticals distribution, and implementing the respective sanctions for doctors (presumably, a penalty of kRUB 40 and disqualification up to 3 years). These provisions are to be implemented into the draft laws “On Fundamentals of Public Healthcare” and “On Circulation of Pharmaceuticals” (instead of adopting a separate legislative act as planned earlier);
• 
  re-shaping the approach of the Ministry for Healthcare and Social Development to developing lists of pharmaceuticals for state programs (including the Lists of Essentials Drugs and the DLO Program list). This is driven by the fact that the said lists typically specify not only the formula, but also the dosage and pharmaceutical form of each drug, thus creating preferential conditions for certain producers, whereas producers of similar products are dropped out based on formalistic criteria;
• monitoring conclusion of exclusive vertical agreements between pharmaceutical producers and wholesale distributors, as such agreements result in precluding some customers from purchasing particular pharmaceuticals.

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The Regulation on importation of pharmaceuticals and pharmaceutical substances into the customs territory of the Customs Union (CU) has been redrafted, with the new version entering into force on October 02, 2011 (please refer to the Resolution dd. 16.08.2011 # 748 “On introducing amendments into the Regulation on importation of pharmaceuticals and pharmaceutical substances into the customs territory of the Customs Union”).

The pharmaceuticals may be placed under the customs procedures of release for domestic consumption, processing for domestic consumption, re-import or waiver to the state (hereinafter – “the Procedures”), only if the product is included into the state register of pharmaceuticals of the CU state.

The exemption applies for certain cases; particularly, the following pharmaceuticals may be placed under the Procedures under the permission issued by the authorized state body:

• non-registered pharmaceuticals imported for the purposes of clinical trials, expertise, state registration, medical aid to particular patients in emergency cases or to medical aid to patients with rare or severe pathologies;
• registered or non-registered pharmaceuticals for the purposes of humanitarian aid or emergency situations.

Placing the above pharmaceuticals under any other customs procedures does not require permission of the authorized state body.

In Russia such permissions are issued by the Ministry for Healthcare and Social Development. The deadlines for review of the submitted documents vary depending on the purpose of the importation. For example, in respect of medical aid to particular patients in emergency cases, the permission could be issued upon 5 days after the application submission.

The domestic laws of CU states provide for the reasons for refusal in granting the permission.

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According to the Minister of economics of the Moscow region, Mr. Vyacheslav Krymov, currently there are 3 pilot projects of industry clusters development.

These include a chemical-technology cluster (on the basis of the scientific-technology potential of the Sergiev-Posad district) and a pharmaceutical cluster in the Volokolamsky district. The third cluster is intended for the cultural & creative activities.

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The Draft Federal law “On introducing amendments into certain legislative acts of Russia” (in part specifying the provisions on benefits and preferences for the Skolkovo Project participators) was considered by Duma in the first reading.

The Project participants are entitled for the benefits, inter alia, in terms of the social contributions, immediately after registration in the Project. Previously, this was possible only after 1 year upon the registration.

In addition, the Draft law stipulates the possibility of reimbursing the customs duties paid by the participants not only within the territory of the Skolkovo innovation centre, but outside the area as well.

Also, amendments to the Law “On statutory accounting” are anticipated. As of now, the Project participators are exempt from the statutory accounting bookkeeping if their annual sales revenue does not exceed 1 billion rubles; it is suggested to make this exemption optional.
 

The Ministry for Industry and Trade of Russia has developed forms for collecting proposals for the project topics under the federal program “Pharma-2020”.

The proposals are to be considered by the Research & Technology Council for implementing measures for development of chemical, medical and pharmaceutical industries and the biotechnological complex of Russia.
 

The amendments are mainly of a technical character and relate to the professional qualification of employees.

For the top managers of pharmaceutical companies, there are requirements in respect of the profile work experience. The criteria apply to those employees whose activities are directly associated with the trade of pharmaceuticals (delivery, storage, transportation and manufacturing).

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