According to the Treaty on the Eurasian Economic Union on 29th of May 2014 was supposed the launch of the single drugs market of the Union, which had to start operating from 1st of January 2016

Under the common market of drugs is meant that drugs, complying with standards of good pharmacy practice of EAEU (laboratory, industrial, clinical, pharmacovigilance and others) and registered in accordance with uniform rules of registration and examination, will be free to move within the Union.

It is necessary to take into account the high specificity of the pharmaceutical market. Thus, the production of a drug, in addition to technical and technological aspects, to a large extent depends on the ownership of the right of patent issues and affects areas such as national health, social security and national security.

Accordingly, the creation of legal "foundation" for the functioning of the common market, became one of the first steps in this direction.

In late 2014 an agreement was signed, which establishes common principles and rules for the circulation of medicines in the framework of the new common market. However, the agreement itself does not cover all the legal gaps in the future of the common market and the next stage of settlement are 19 projects of decisions, designed to detail the various issues of cooperation between its members.

As explained Deputy Chair of NCE RK "Atameken" Dana Zhunusova, draft decisions taking into account the areas of regulation can be grouped into 4 blocks:

- General documents defining the requirements for a medicinal product (hereinafter - MP), including the rules for registration and examination of drugs for medical use, rules for forming and maintaining the register of registered drugs;

- Security documents defining the safety of drugs prior to registration and in the process of circulation on the market;

- Documents on the effectiveness used for evaluation and proof of the effectiveness of drugs;

- Documentation on the quality.

However, further progress with the harmonization of the regulatory framework was unexpectedly complicated by the Russian side initiated an additional draft document providing for the right of the state - member of the Union to carry out a procedure for determining the interchangeability of medicines in accordance with the national law of a member State.

Interchangeability of medicines, according to the Russian legislation, is an opportunity to complete substitution of one drug by another, which are identical by a number of parameters, such as the equivalence of the qualitative and quantitative characteristics of pharmaceutical substances, equivalence dosage form, identical application and others.

In other words, easily interchangeable - is a potential for discrimination of drugs involved in the competition based on their substitution analogs.

Draft decision on interchangeability of medicines in the end turned out to be a stumbling block in the work on the launch of common drugs market of the Union, due to strong opposition of other countries - participants of the EAEU, foreseeing in the inclusion of this procedure by the Russian side the creation of the administrative tools, which will restrict access to the pharmaceutical market of the Russian Federation.

At the same time, it should be noted that even if there is a right in the Union to introduce such restrictions, it contradicts the fundamental principle of the functioning of the common market of drugs of EAEU.

The Chamber, on its part, is concerned about Russia's initiative, and sees in the procedure of interchangeability the conditions limiting access to the Russian market of medicines.

However, the work on creation of conditions for the opening of the common drugs market, which lasted about a year, as well as any integration process, meant bringing production to a new common denominator.

In this case the costs incurred by entrepreneurs would  pay off through a potential yield from the pharmaceutical market of the Russian Federation, the financial volume of which is 10 times more than the volume of the Kazakhstani pharmaceutical market.

Along with this, the Department of Economic Integration of NCE RK "Atameken" conducted analysis of the potential output of Kazakhstani producers of drugs on the pharmaceutical market of the Russian Federation.

According to the analysis, in 2015 the market volume of drugs of Russia amounted to 19.8 billion US dollars, while the volume of the market of Kazakhstan is only 1.8 billion US dollars. At the same time, according to the Ministry of Health and Social Protection of Kazakhstan, of the general nomenclature of drugs produced in the Republic of Kazakhstan (more than 500 original drugs), only 10 are registered in the Russian Federation, and none of the registered drugs is involved in the state procurement of Russian medicines. Medications of Russian production on the contrary account for about 25% of the procurement market of RK and 9% of the commercial market.

At the same time, taking into account the fact that produced in Kazakhstan medicines are not of innovative nature and relate to drugs of "social basket", procured from the state budget, the creation of artificial barriers for market access for state procurements of drugs of the Russian Federation is a significant financial loss for domestic manufacturers.

"Actually, why Kazakhstan's business took an active part in the work to create a common legal framework of medicines market. Objectively assessing their capabilities, we understand that, first and foremost, entrepreneurs are interested and need the market of public procurement of EAEU member-countries", - said Dana Zhunusova.

In addition, as the Chamber always emphasizes, the Union – is an organization of equal opportunities on an equal basis. In this regard, if some participants have the opportunity to discredit the other partners, the other players should have the same right to use protection tools.

However, according to Dana Zhunusova such opportunities parity "closing" the total market questioned the very purpose of integration, in particular, in the sphere of circulation of drugs.

In light of the fairly "protracted" launch of a common drugs market of EAEU, the Chamber finds it necessary to emphasize the senselessness of its formal launch in the presence of administrative tools in the Union that allow in practice to limit access to the internal market of a country, thereby nullifying the main objectives of opening common market as a whole.