Selling drugs trading companies
In the state Duma received the draft law "On amendments to certain legislative acts of the Russian Federation in implementing the sales organizations of drugs". The essence of this document is to provide the right companies engaged in retail trade in food products, to carry out retail sale of medicinal products issued without a prescription, storage, transportation and vacation. It is planned that this activity will only be possible if you have a license for pharmaceutical activity.
As explained by the developers, the purpose of this bill is creation of conditions for availability of purchasing over-the-counter medicines and reducing the cost of a separate category of drugs due to the development of competition with the pharmaceutical and medical organizations. This assumes that "compliance with required conditions of storage and realization of medicines in the shops will be controlled by the organs of Roszdravnadzor in the framework of ongoing control measures and inspections".
In our opinion, the authors of the bill did not provide a clear mechanism for the implementation of its provisions. In particular, the developers do not consider that the current rules on licensing of pharmaceutical activities include a number of binding requirements and conditions, the combination of which in retail trade with food products is questionable. So, the license for carrying out pharmaceutical activities in the sphere of circulation of medicines for medical use may be issued only to such an organization, whose head has higher pharmaceutical education and work experience on a speciality not less than 3 years or secondary pharmaceutical education and work experience on a speciality not less than 5 years, graduate certificate (podp. "and" section 5 of the regulations on licensing of pharmaceutical activities approved by Resolution of the RF Government of 22.12.2011, № 1081 (hereinafter — the "Regulation on licensing")). Not every leader of a company engaged in the retail sale of food, can boast of such a diploma in your Arsenal.
In addition, the staff of the organization — applicant of license should be the workers with higher or secondary pharmaceutical education and graduate certificate. And the head, and such employees of the company should 1 in every 5 years to undergo training.
Accordingly, these requirements will automatically narrow the range "of potential clients — license applicants," and the purpose of the bill "about increase of level of availability" is questionable. However, it is impossible "to ignore" and the emergence of leaders desire in circumvention of the legislation of the Russian Federation "to acquire the necessary education and workers" that, too, rather a "minus" than "plus" result of the implementation of the bill.
Another important condition for the implementation of pharmaceutical activity is the observance of rules of storage of medicines from the performance of which depends directly on their quality. Given that grocery stores not always have time to keep track with the storage conditions and the shelf life of food, "fair" solution to the question of strict adherence to these entities sales of temperature, humidity and conditions for the protection of drugs from the effects of gases contained in the environment, and other requirements outlined in the Rules of storage of medicines, approved by Order of the health Ministry of the Russian Federation dated 23.08.2010 No. 706 n, is also in doubt.
Laying the developers of the draft law on the organs of Roszdravnadzor responsibilities for control over execution of the store storage conditions and realization of drugs in itself may not serve as a guarantee of strict compliance for the following reasons:
o after obtaining a license for pharmaceutical activity stores can be included in the routine inspection only after one year (clause 9 of article 19 of Federal law dated 04.05.2011 No. 99 — FZ "On licensing certain types of activities";
o periodic "raids" pharmacy organizations, is closely involved in only pharmaceutical activities, do not allow to exclude the use in the sale of counterfeit medicines.
Given the above, we believe that the bill in the specified revision rather has "veiled" the goal is to enable companies that already have a license for pharmaceutical activity, to engage in both activities retail sale of food products. Based on the experience of foreign countries, we believe that, if we were to allow stores to market pharmaceutical activities: 1) list of drugs that they will be able to trade, must be strictly limited and composed of those who retain their physical and chemical properties under normal conditions of storage; 2) it is necessary to establish a simplified licensing procedure for such activities.
It seems that the idea forming the basis for the development of this bill, relevant to modern society. However, the fundamentals of its implementation require significant improvements, because not only do not serve the interests of consumers and businesses, but also pose a potential threat to the health and lives of people.