The Association of Pharmaceutical Manufacturers of the EAEU Announced a New Course for 2030

27 October 2020

GMP News

Participants of the press conference organized by the Association of Pharmaceutical Manufacturers of the Eurasian Economic Union (APhMEEU) discussed the focal points of collaborative efforts and strategic tasks of the organization for the next 10 years.

The press conference was attended by Stanislav Naumov, Chairman of the APhMEEU Management Board, Andrey Ivashchenko, Chairman of the Board of Directors of ChemRar Group, Dmitry Kudlai, General Director of Generium JSC, Alexey Torgov, Director of the Department for Government Relations at BIOCAD CJSC, Peter Rodionov, General Director of GEROPHARM, Alexander Semenov, President of Aktivny Komponent JSC, Vladimir Khristenko, President of NANOLEK LLC, Grigory Potapov, General Director of Pharmstandart JSC.

All these companies contribute significantly to the growth of the industry, the economy of Russia and the entire nation. Since 2010, the Association’s member companies have built 93 new infrastructure facilities and created more than 13,000 new high-tech jobs , of which almost 1,400 relate to the research and science. The total volume of investments over the past 10 years (2010-2019) made about 71 billion rubles. A significant portion of funds, namely 22.2 billion rubles, is allocated to research projects.

Today, the companies that are members of the Association produce 223 medicines on the VED (vital and essential drugs) list in a variety of nosologies.

The participants of the event focused on the tendencies that are common for all the members of the Association – the markets of Russia and the EAEU as the major ones in investment and development of competencies (R&D and production). These tendencies are adhering to high quality standards and striving for the industry that presents only effective and safe drugs, ambitions to enter the global pharmaceutical market, the desire to create advanced technologies in the prevention, diagnosis, treatment and rehabilitation, likewise the innovative medicines and other medical technologies. The APhMEEU Declaration was unveiled as well.

Stanislav Naumov, Chairman of the Board of APhMEEU: “The Association today brings together Russia’s strongest pharmaceutical manufacturers. Of course we pursue the aim to strengthen the Association’s membership, but we are going to be very picky in this. What is important to us is the integrity of the company as a manufacturer of effective and safe drugs, origination of its fixed capital fr om Russia and the EEU, and the potential member fully sharing the principles of the Association as enshrined in the Declaration. The word “Eurasian” in our name is not accidental: we are the center of expertise for the formation of the unified pharmaceutical market of the EEU.”

Vladimir Khristenko, President of NANOLEK LLC: “It is very important that today we can freely discuss pressing issues. Pharmaceuticals is one of the industries where the government chooses critical points of competence. The drug supply system is built in such a way that drugs for treatment and prevention of life-threatening diseases are purchased by state customers. Therefore, it is extremely important for pharmaceutical manufacturers to know that the product they are developing or localizing will be in demand, and the state should proactively set tasks for pharmaceutical companies in terms of the most pressing issues that need to be addressed. Our company e.g. is focused on the production of vaccines and we are willing to be part of the state policy on the implementation of national projects “Health Care” and “Demography”. On the whole, APhMEEU includes companies united by a common idea, a common strategy; and this is very important as the national pharmaceutical industry can be made truly global by joint efforts only.”

Alexander Semenov, President of Aktivny Komponent JSC: “The advancement of full-cycle development of pharmaceuticals is one of the strategic areas of the Association. APS (Active Pharmaceutical Substances) is the first stage of drug production and so far only about 6.5% of the market is occupied by Russian substances. As part of the Association, we are working to ensure that more players in this country’s market enjoy investing in substance production. An impetus could be given by the national program within the Pharma-2030 strategy encouraging the production of APS, reagents and intermediates in Russia through provision of customs, financial and other incentives, etc. for the local manufacturers. In particular, one of the incentive tools may be state contracts for the production of drugs wh ere the substance manufacturer is one the parties thereto. It is unlikely to create a fully functional pharmaceutical industry in Russia without developing a set of measures to facilitate the production of pharmaceutical components”.

Andrey Ivashchenko, Chairman of the Board of Directors of HemRar Group: “Today, there is no need to explain to anyone why the technological sovereignty of pharmaceuticals and biotechnology is so vital for any nation. With the successful adoption of the Pharma 2020 strategy over the past 10 years, we have created our own industry and lay the groundwork for providing patients with all of the drugs they need during the pandemic, even with all the borders closed. On top of that, we were able to quickly develop and were the first company worldwide to commercialize the new COVID-19 drugs and vaccines. Everyone has seen that if there is an industry, it can get mobilized, respond to the challenges faced and tackle them. In this context, the first part of the Pharma 2020 program concerning the generic substitution of imports has been successfully completed. At the next stage, innovative development should become the main driver of Pharma 2030. This means that Russian companies must learn how to make modern high-tech drugs that will be copyright patented. This will automatically cause our pharmaceutical manufacturers to put high-margin drugs in their portfolios. Indeed, everyone has learned how to make generics, everyone is joining price competition, profits are dropping, therefore no resources for growth will remain. The innovative drugs, on the contrary, will allow the profit to be reinvested in the development of our country, not elsewhere, rather than remitting it abroad to the partners granting exclusive rights to specific innovative drugs. Accordingly, this will gear up the development of the national industry.”

Dmitry Kudlai, General Director of GENERIUM JSC: “APhMEEU puts high demands on the applicant companies for membership in the Association. This organization brings together the most competent and decent participants of the Russian pharmaceutical industry that meet the international standards of GMP Good Manufacturing Practice, have a scientific base and are able to secure sales of high-quality Russian pharmaceuticals on the world’s highly regulated markets. An important event this year was the full-scale introduction of labeling. Notably, the APhMEEU attendees were the first to launch labeling of medicines; something which shows that the manufacturer is 100% confident in its product. GENERIUM is a full-cycle research and production company, being a model of translational biotechnology. It fully meets all the stated requirements and creates today medicines that are first-rate “blockbusters” treating orphan illnesses. Our efforts will be even more effective should our national manufacturers of orphan products be granted more preferences.”

Peter Rodionov, General Director of GEROPHARM: “The Russian market is the key one for the members of the Association, and we are fully answerable for it. Today, there are unresolved issues regarding the quality and effectiveness of certain medicines circulating in the market. Therefore, one of the most important tasks at the moment is to “restore” the market “to a healthy state” and remove all dishonest players. This is the responsibility which lies with the manufacturers themselves, the Ministry of Industry and Trade, and the Ministry of Health. What can we as an Association do is to act as the driver of this process. Moreover, today it is highly important to create competitive products that meet international standards, allowing us to be competitive in international markets. Export is a key growth point and a chance of integration into global competition while offering biosimilars, generics, and innovative products. This is one of the key tools encouraging the national market growth. Indeed, the higher exports help draw more profit and invest it in the development of a portfolio of drugs produced by national manufacturers. But to wheel it out, we need clear and effective mechanisms of state support.”

Alexey Torgov, Director of the Government Relations Department at BIOCAD CJSC: “Pharma 2020 has led to the development of innovative original medicines in Russia. The volume of these innovations can be counted on the fingers of one’s hand, and the innovations are “delicate sprouts beneath the tough regulatory system’s guidelines”. We advocate that innovations are supported by the state. For the inventions to be a success, developers should be in direct contact with the regulatory authority and the expert organization that issues permits and evaluates reports. We believe that the regulator should provide full support for developers all the way from laboratory to industrial production. That is why the companies being part of the APhMEEU have prepared the suggestions for changing the system for scientific consulting and forming an expert committee consisting of several representatives of expert organizations from different countries. This is how these companies will be able to advise developers on the scope and design of clinical trials, innovation-related issues and drug quality test methods.  To speed up the commercialization of innovative medicines, the APhMEEU suggests presenting in more details the conditional registration procedure based on the findings of the second phase of clinical trials.”

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