OREANDA-NEWS. November 08, 2012. The Expert Council of the Federal Antimonopoly Service (FAS Russia) on Developing Competition in Social Sphere and Health discussed the draft Decrees of the Government of the Russian Federation “On Establishing the Threshold Value of the Original (Maximum) Contract Price (Lot Price), Exceeding Which Various Drugs with International Nonproprietary Name, or in the Absence of Such Names – with Chemical, Generic Names, Cannot Be the Subject of the Same Contract (the Same Lot)” and “On the Procedures for Approving the List of Drugs, Procurement of Which for the Needs of the Ordering Parties is Exercised in Accordance with Their Trade Names”, reported the press-centre of FAS Russia.

The draft Decrees are prepared by the Ministry of Health Care jointly with FAS Russia and the Ministry of Economic Development to enforce Part 2.2 Article 10, Part 3.4 Article 34 and Part 2.2 Article 41.6 of No.94 Federal Law “On Procurement of Goods, Works, Services for State and Municipal Needs”.

Opening the session, the Head of FAS Department for Control over Social Sphere and Trade, Timophey Nizhegorodtsev, talked in detail about the two draft Decrees.

For instance, the draft Decree on establishing the threshold initial (maximum) contract price requires purchasing drugs through separate lots if the initial contract price exceeds three million Rubles or if purchases of a particular drugs exceeds three million Rubles within a quarter. Such threshold initial (maximum) price was determined in view of the proposals put forward by the constituent territories of the Russian Federation and the current norms of No.94-FZ on simplified procedures for procurement up to this sum. The threshold at three million Rubles can be reconsidered in a year upon the result of the monitoring of Decree enforcement.

Other Clauses of the Decree are designed to exclude narcotic, psychotropic, radiopharmaceutical and innovative drugs from combined lots. For example, FAS frequently faces situations when in order to eliminate competition, the government combine several international nonproprietary drugs in the same lots, including an innovative drug, for which it concluded an exclusive vertical agreement with one of distributors. As a result, this distributor is able to supply the whole lot at the maximum price beyond competition. The Decree will prohibit such unfair actions by the customers and will encourage development of competition at auctions and help save budgetary funds.

The second Governmental Decree concerns the procedures for approving a list of drugs purchases under trade names. The main idea of the draft Decrees is to make the procedure for compiling the list maximum open and public so purchasing of drugs under trade names becomes an exception rather than the rule. The exception will apply for the drugs with patent protection of chemical formula (for the duration of patent), as well as for the drugs that cannot be replaced within the same international nonproprietary name.

Decisions on including drugs in the list will be passed through public discussions involving any persons whose rights can be affected by such decisions. In particular, applicants, competing producers, the chief freelance specialists of the Ministry of Health, the Federal Service for Supervision of Public Health and Social Development [Roszdravnadzor], the federal state budgetary institution for expert examination of drugs, representatives of medical organizations and non-government organizations for protecting patients’ rights. It is planned that all documents, protocols and decisions submitted for consideration will be placed at the official web-site of the Ministry of Health.

Since every decision on including a particular drug in the list creates certain risks, it is proposed that such decisions must be approved by consensus between two bodies - the Ministry of Health and FAS Russia.

The Director of the Property Department, of the Ministry of Health, Olga Tereschenko, stated that the draft Decree on the procedures for approving the list was aimed, first of all, at resolving the problems of the lack of substitutability of some drugs, which affects patients’ health.

Timophey Nizhegorodtsev invited all participants of the session to discuss any concerns and comments to the draft Decrees. As a result of an active discussion, it was recommended that the authors of the draft Decrees should look at reducing the threshold initial (maximum) contract price from 3 million Rubles to 1 million Rubles in view of the analytical materials the experts promises to present; to exclude the requirement that applicants must submit clinical research findings; and to make marginal technical amendments to the documents.

Representatives of international pharmaceutical companies and patient organizations once again expressed their doubts in the quality of generic drugs circulating on the Russian market, which inevitably led to discussing the issues of drug substitutability. However, Timophey Nizhegorodtsev suggested the issue should be discussed by the Expert Council at its meeting in the end of November, which would be fully focused on drug substitutability as part of discussing the amendments to the Law on drug circulation. Timophey Nizhegorodtsev pointed out: “We believe that the public process of compiling the list proposed by the draft Decree will exclude corruption risks and help make decisions on including drugs in the list objective and justified, upon discussion with the expert community and all interested parties. It will also form a new approach and practice of compiling the drug lists”.