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.
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.
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:
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:
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.
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.
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 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.
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).