The choice of the brand
Specialists of the Institute of legislation and comparative law under the government (SISP) propose to reform the procurement system of biological medicines and medicines for rare (orphan) diseases. SISP specializiruetsya on the study of the legal problems and increasing the efficiency of public administration and its study form the basis of government bills.
In SISP sure that the drugs included in the essential drugs list (vital and essential drugs), should be bought not in the name of the active substance of the drug, and its market name (brand). This conclusion contains a “Scientific analysis of normative legal framework for the regulation of procurement of drugs by brand names and the development of proposals for its improvement”, which read RBC. To improve the system of procurement of medicines, the Institute analyzed five Federal laws regulating the procurement, and the Russian Constitution.
Under the current rules prescribed in the law “On contract system”, all medicines must be procured by a state under international non-proprietary name (INN). This allows officials to purchase the medications from different manufacturers, not focusing on their market brand.
The current procurement system increases competition and allows the state to choose medications with the lowest price, explained RBC development Director of the analytical company RNC Pharma Nikolay Bespalov. Rules of procurement of medicines, which proposes to introduce SISP, playing into the hands of private pharmaceutical companies that have invested in the brand promotion of their products and are keen to retain market share, says the expert.
But in SISP came to the conclusion that the existing approach limits the choice of supplier and the possibility of describing the characteristics of the medication. Medicines prescribed by brand, take into account the individual characteristics of the patient, the history of its treatment (the use of certain specific drugs) and contraindications, the authors of the study.
International nonproprietary name (INN) is the name of the main active ingredient of the medicine. It is used to harmonize drugs in medical practice.
Trade name — the name assigned to the medicine by its manufacturer. Within the same INN can be represented by dozens of different trade names.
Experts do not agree with the practice of prescribing by the INN in those cases where the patient buys drugs on their own. Then the decision on the choice of the drug takes not a doctor and pharmaceutical worker in the pharmacy.
Biological and chemical drugs
In SISP sure that all medicines must be legally divided into chemical and biological. Second and should purchase solely on brand names.
Biological medicines are medicines derived from a biological source. For example, from tissues or cells. These include vaccines, insulins, blood products, allergens, etc.
Chemicals — drugs obtained by chemical synthesis.
In addition to biological drugs SISP offers to buy the brand medicines to treat rare diseases. The reasons for choosing these categories of drugs in the study are not spelled out. The Institute did not respond to a request RBC.
The SISP study was prepared by the Institute in September of this year, but in the relevant departments it has not yet been reported. The Ministry of economic development, which oversees public procurement legislation, refused to comment on the proposals SISP. The Ministry of health to a request to RBC did not answer.
The Federal Antimonopoly service (FAS) against the proposals of governmental experts. In a press-service of the FAS told RBC that the proposals do not meet Institute of modern international approaches in this sphere and not relevant to the Russian legislation.
The opinions of experts and market participants are divided.
The approach of SISP experts will take into account the interests of industry and patients who are interested in how to get really necessary for them and quality products, says the Deputy General Director of the pharmaceutical company STADA CIS Ivan Glushkov. SISP has a great reputation, if a government based on his analysis, decide on the change of the procurement system, the Ministry of health will not be to challenge it, he said.
The Ministry of economic development to consider issues such as drug purchasing approach formally, therefore, the only authority that will uphold the existing rules of the game, will the FAS service is not satisfied with the reduction in competition, said Glushkov.
SISP in their study about the current system of procurement of medicines raised the desired subject, said Executive Director of the Association of international pharmaceutical manufacturers (AIPM) Vladimir Shipkov. The need for inventory of drugs purchased under trade names, dictated by the legislation and by the decree of President Vladimir Putin. “But the creation of a list of successful “swing”, — says the expert. He also hoped that the high credibility of SISP will do the trick and change the current situation.
The proposal of the Institute fully contradicts international approaches to the interchangeability of medicines within the same INN, I do not agree with colleagues the Director of business development of the Russian pharmaceutical company BIOCAD Dmitry Mordvintsev. He, like Bespalov from RNC Pharma, believes that the drugs by brand can only be purchased in the interests of Western companies that invest a lot in promotion of its brands.
Initially, patient organizations have advocated the purchase of biological medicines by brand, told RBC, the founder of the all-Russian Union of patients Yuri Zhulev. But now there’s no need, he says. If you are hypersensitive patient always has the right to substitute to another drug within the same INN.