OREANDA-NEWS. September 14, 2011. Surrogate concepts of substitute medicines (“reproduced”, ”synonymous”, “analogous”), used in legislation and the issues with access of distributors to the market of drug circulation – are the most important problems preventing development of competition on the pharmaceutical market - stated the Head of FAS Department for Control over Social Sphere and Trade, Timophei Nizhegorodtsev, at the workshop on “Competition Day in Russia”, reported the press-centre of FAS Russia.

While in the whole world medicines that have the same International Non-Patented Name are considered substitutes, the Russian Federation has surrogate concepts (“reproduced”, “synonymous”, “analogous” medicines) that do not clarify substitutability issues. Prescribing such medicines, and state procurement of them is determined by attending medical doctors at their discretion.

It constitutes one of the entry barriers to the medicine market, the main method for discriminating Russian-made drugs and eliminating competition at bidding, as well as infringing the rights of patients who are forced to use similar but more expensive drugs. “Russian law on medicine has many concepts that in one way or another indicate substitutability of drugs, but it is not spelt out anywhere that such drugs can be used to treat the same group of patients according to the same indications with a comparable therapeutic effect. It allows numerous violations by government customers in medicine procurement”, pointed out Timophei Nizhegorodtsev.

FAS Russia has repeatedly exposed the facts of pharmaceutical companies distorting information about the therapeutical effects and counterindications in the directions for drug use, and, therefore, misleading government customers, the medical community and patients with regard to drug characteristics.

According to FAS Russia, relations between the medical community and pharmaceutical companies must be strictly regulated. Amendments aimed at establishing and regulating conflicts of interests in providing medical care to the population, establishing mandatory requirements to medical doctors and pharmaceutical companies in course of their interaction, аs well as liability for violating these requirements have been drafted and are currently being considered by the State Duma of the Russian Federation.

In its practice FAS often finds that pharmaceutical companies are interested in including their drugs in all kind of Lists of medicines. Often unfair compiling of such lists allows a certain company to reach monopolistic position on the market of a particular medicine. When such Lists specify characteristics that determine particular drug names and their producers, dosage forms and doses, it results in restricting competition on the markets of medicines.

Companies operating on Russian pharmaceutical market often coordinate drug supplies to distributors which results in dividing the market according to a geographical principle and the categories of buyers. Most companies do not have a transparent and clear policy for work with their distributors, which prevents entry of counteragents to the market. Some companies do not have a system of paperwork management and written communications with their counteragents, which violates the rights of market participants to complain about their partners who unreasonably refuse to conclude a contract for supplying medicines.

“Pharmaceutical companies devise “commercial policy”, where they spell out unachievable, non-manageable requirements for selecting counteragents. An example of cooperation between FAS and a pharmaceutical company towards developing a transparent policy for work with dealers is a case opened by FAS against “Novo Nordiks” Ltd. Having paid a multi-million fine, the company executed the FAS determination and a new policy enables unlimited number of economic entities to become its dealers if they meet certain standards”, explained Timophei Nizhegorodtsev to the workshop participants.

Summing up his presentation, the Head of FAS Department for Control over Social Sphere and Trade outlined several proposals put forward by FAS to ensure competition on the pharmaceutical market. They include clarifying the concept of substitute drugs, harmonising directions for medical use of original medicines with the original directions registered by FDI and the European Commission. Further on, the directions for medical use of generic drugs should be adjusted in line with the directions for use of the original medicines. FAS also proposes to regulate relations between pharmaceutical companies and medical doctors, introduce mandatory prescription of medicines only on the prescription forms and only according to the International Non-Patented Names. An important measure is developing a state programme to stimulate use of generic drugs, without which “relations between consumers (the patients) and pharmaceutical companies will remain asymmetric and it will provoke imposing expensive drugs upon consumers”.