The quality of treating Russian patients is at stake

Draft documents limiting the state purchases of foreign medication do not take into account the Russian Federation citizens’ rights for affordable and high-quality treatment. It has been announced by the participants of the press conference devoted to the discussion on the draft RF Government Decree “On introducing additional requirements to order placement participants in case of placing orders for the provision of medications" and draft Law prepared by the Ministry of Industry and Trade of Russia and devoted to the criteria in accordance to which medications can be attributed to medicinal products of the Russian origin.

According to the first draft document, only medications of the Russian origin will be allowed to take part in state and municipal purchases, if the Russian Register of Medications contains 2 and more domestic pharmaceutical manufacturers of products in relation to which an order is placed. The second document specifies that, since January 1, 2014, only products produced in the territory of the Russian Federation in the form of substances or drug formulations will be attributed to the medication of the Russian origin.    

“These documents are antihuman and oriented against patients”, - said Yan Vlasov, Professor, the President of the All-Russian Public Organization of Disabled People with Multiple Sclerosis, the Head of the Public Council for patient right protection of the Federal Service for Supervision in the Sphere of Health Care. “The problem consists in the quality and availability of Russian medications. We’re aware of the cases, when Russian pharmaceutical companies have necessary documents to produce medications, but do not manufacture them. And the absence of medications leads to disability and death”.

The participants of the press conference have mentioned that the documents under discussion do not take into account a variety of important factors and conditions necessary for high-quality conduction of tenders for the purchase of medications.

“These documents might have a negative influence approximately on 500 international non-proprietary names within the structure of the list of vital and essential drugs”, - marked Vladimir Shipkov, the CEO of the Association of International Pharmaceutical Manufacturers.

“There is a question: to what extern are certain local manufacturers able to guarantee the coverage and availability of these medications in terms of the quality, volume and terms. However, these documents don’t mention the quality criterion. A determinant criterion is presence in the Register of medications rather than the availability of a medication in the market and its efficacy”.  

Nowadays only the products manufactured in compliance with the Good Manufacturing Practice (GMP) standards are attributed to high-quality medications. Only 10% of Russian pharmaceutical companies correspond to these standards. All Russian pharmaceutical enterprises should adopt the Good Manufacturing Practice standards by January 1, 2014. However, achieving this goal requires, at least, developing accreditation mechanisms, specifying authorized people responsible for product quality and inspecting enterprises with respect to their compliance with the GMP standards, which has not been realized yet.

“Most anti-tumor medications we use to treat children are foreign ones”, - added Aleksey Maschan, Professor, the Deputy Head on Science of the D. Rogachev Federal Scientific and Clinical Center of Pediatric Hematology, Oncology and Immunology. “Some of these medications have Russian analogs. At the same time, the difference in the price of domestic and foreign medication is insignificant, but they differ considerably in terms of the quality. We have a lot of examples of complications and side effects caused by Russian analogs”.

The experts have highlighted that the top priority of the provision of medicines should be patient care rather than care of the domestic industry. 

“As a citizen, I support protectionism in relation to Russian manufacturers”, - noted Larisa Popovich, the Head of the Institute of Health Economics “NRU Higher School of Economics”. “But as an economist, I understand that any protentionistic measures are costly. These special market management mechanisms should be used very carefully in order not to harm consumers’ interests. It becomes especially important, when it comes to life-saving medications. Protectionism in the pharmaceutical industry should be focused on patient protection rather than protection of a specific factory’s products. Protectionism measures should be used, and Russian medications should be purchased, only if this factory produces actually high-quality and safe medications that don’t differ from foreign options in terms of efficacy and, at least, aren’t more expensive than foreign products. It is necessary to define the balance between the interests of the entire society and those of pharmaceutical manufacturers. An attempt of this abnormally straight approach taken by the Ministry of Industry and Trade with respect of the protection of the industry’s interests only can be explained specifically by the absence of such a balance. However, this decision can have very negative consequences for the population. When purchasing medications, it is impossible to take into account only a place of origin. One should consider a significantly larger list of factors that influence the quality and efficacy of the provision of medicines”. 

The participants of the press conference believe that developing the Russian pharmaceutical industry and increasing the share of high-quality medications made in Russia are possible, but these processes should be step-by-step and systematic. One of the ways contributing to the implementation of this objective is localizing the production of medications from international manufacturers. According to the АIPM, the total volume of investments in the establishment of production facilities in Russia, as well as joint projects between companies being the members of the Association and Russian manufacturers has already exceeded 1 billion dollars. However, the incoherence of the state policy on provision of medications might negatively affect this process.   

“Many pharmaceutical companies are interested in localization”, - thinks Marina Veldanova, the Head of the Russian branch of the Ipsen Company. “However, they do not give us enough time. The Strategy on Provision of Medications specifies a goal, which implies that 90% of the medications must be of the Russian origin by 2025. This is a normal way of the national economy development, but it is planned for 12 years. The market should evolve in a step-by-step way and structurally, as it is planned in strategic documents. What we have come across now is called jumping over market development stages”.

The participants of the press conference have emphasized that the documents under discussion contradict the key trends of the Russian pharmaceutical industry development reflected in strategic state documents and expressed confidence that these initiatives will not be implemented.      

Additional information:

Aleksey Shavenzov, Director of Communications, AIPM

Tel.: +7 (495) 933 7040, e-mail: a.shavenzov@aipm.org

Marina Rozhdestvina, AG-Loyalty

Tel.: +7 (499) 788 91 57, mobile: +7 985 250 54 64, e-mail: mroz@ag-loyalty.com 

Sergey Makarov, AG-Loyalty

Tel. +7 (499) 788 91 57, mobile: +7 (925) 357 82 34, e-mail: smak@ag-loyalty.com