The export potential of Russian pharma products is growing

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Recently, the Chamber of Commerce and Industry of the Republic of Tatarstan signed an MoU with the Council for Economic Development of Andhra Pradesh to promote development and diversification of economic cooperation between the two regions. On the sideline of iPhex 2018, in New Delhi, Alexey Petrovich Savelchev, Ministry of Industry and Trade of the Republic of Tatarstan, talks about the business opportunities and regulatory friendly environment in Tatarstan

What is the overall size of the pharmaceutical market in Tatarstan, Russia and how fast is the sector growing?

The volume of the pharma market in Russia in 2017 reached $28.7 billion, which is eight per cent higher than the year before. The share of imported drugs in the market as a whole in 2017 was 70 per cent in money and 38 per cent in packages. The volume of the pharma market of the Republic of Tatarstan also showed growth in 2017 by eight per cent and amounted to $594.3 million.

What steps have been taken to promote pharma research in the country?

Thanks to the implementation of the state programme of the Russian Federation “Development of the pharma and medical industry for 2013-2020,” today we have a competitive, sustainable and structurally balanced pharma and medical industry.

Over the past five years, the industry has attracted more than 150 billion rubles of private investment by foreign and domestic companies with a federal budget of 35 billion rubles. Under state support, 70 import-substituting Russian drugs were registered and brought to the market. In general, within the framework of the state programme, the development of about 400 innovative drugs have been supported. There are 35 production sites, 500 enterprises of the pharma industry work in the country. As part of the transfer of high technologies, foreign pharma companies built seven plants. At the sites of domestic manufacturers, their products were localised by 78 foreign companies, among them such manufacturers as Bayer, Janssen, Merck, Roche. According to the state register of medicines, more than 360 international non-proprietary names have been localised. For five years, we have created a good base for the development of technological competencies in the field of biotechnology. The export potential of Russian pharma products is growing.

A regulatory and legal infrastructure is developed. The institute of licensing has grown, the inspectorate of foreign productions have appeared.

The regulatory and legal infrastructure for supporting research in the country has been developed.

A portion of the costs of implementing projects for organisations and conduct of clinical trials of medicinal products is subsidised (up to 400 million rubles) (Decree of the Government of the Russian Federation No. 1045 of 01.10.2015);A portion of the costs is subsidised for the implementation of projects for the organisation of medicines and (or) the production of pharma substances (up to 200 million rubles) (Decree of the Government of the Russian Federation No. 1047 of October 1, 2015). The bill, drafted by the Federal Antimonopoly Service, proposes to abolish the requirement for local clinical trials.

Tell us about the current state of clinical trials in Tatarstan.

In 2017, Russia approved 700 clinical studies, 410 of which were initiated by foreign companies.The Republic of Tatarstan currently occupies the third place among the Russian regions in terms of the number of international clinical trials conducted.

To date, 45 medical organisations have been accredited in the Republic of Tatarstan for the right to conduct clinical trials.

The established research infrastructure currently has a great potential for the development and commercialisation of activities in the provision of services for the development of innovative medicines, pre-clinical and clinical studies, testing of innovative medical products.

How do you encourage foreign investment in the pharma sector?

The Republic of Tatarstan is one of the three most attractive regions of the Russian Federation. Having a developed, diversified industry, in the strategic plan, the main emphasis in the republic is on developing competencies in such modern industries as pharma, bio and nanotechnologies. The Government of the Republic of Tatarstan actively supports progressive companies developing priority areas by supporting and financing scientific research, applying additional measures of tax incentives for these sectors of the economy.

In addition, there is comprehensive support for investors in the placement of new production facilities in the special economic zones ‘Alabuga’, ‘Innopolis’, as well as in the areas of priority social and economic development: Naberezhnye Chelny, Chistopol, Nizhnekamsk, Zelenodolsk. Residents of these zones receive not only the finished engineering infrastructure, but also substantial tax preferences. For example, the tax on profit in the Republic of Tatarstan is 18 per cent, in the special economic zone the first five years the tax is zero per cent, in the next five years – five per cent, and until 2055 the tax will be 13.5 per cent. In the territories of priority social and economic development in the first five years, the profit tax will be five per cent, further 10 per cent.

Taking into account the measures of support described by the Ministry of Industry and Trade of the Republic of Tatarstan, the project ‘FarmMedPolis of the Republic of Tatarstan’ was developed in the format of a project office for targeted attraction and placement of residents in the Republic of Tatarstan.

The project provides for such a format for business cooperation, in which sites are defined for comfortable placement of new pharma productions, taking into account sanitary norms and GMP standards, appropriate engineering infrastructure and logistics, special conditions of economic activity (preferential taxation, special customs regime, etc.)

What regulatory requirements are needed to manage the growth of the pharma market? How many premises were built according to GMP standards?

GMP Rules (“Production Rules and Drug Quality Control”) – are analogous to the European GMP EC Rules, covering all stages of drug circulation: good laboratory practice, good clinical practice, good manufacturing practice, proper distribution practice, proper pharmacy practice, proper pharmacovigilance practice and other practices.

Starting from September 1, 2010, the Ministry of Industry and Trade of the Russian Federation is licensing the production of medicines and licensing control.

Starting from January 1, 2014, under the licensing control, the Ministry of Industry and Trade of Russia verifies licensees for compliance of production of medicines with the requirements of the Rules of Good Manufacturing Practice. At present, on the basis of applications from manufacturers, conclusions have been issued on compliance with the requirements of good manufacturing practices for 274 Russian pharmaceutical manufacturers.

According to the forecast of Frost & Sullivan, the demand for pharma  products is likely to double in the next 10 years. What steps have been taken by the Ministry of Industry and Trade of the Republic of Tatarstan?

Currently, the Ministry of Industry and Trade of the Republic of Tatarstan is actively working to develop the pharma industry of the Republic of Tatarstan and attract large bio and pharma companies to the republic and localise their production in our territory.

To this end, the definition of prospective land plots in use of the territories of advanced socio-economic development, special economic zones and in the territories of the municipal regions of the Republic of Tatarstan for the placement of pharma industries is being carried out. The next stage will be work on creating, where necessary, an industrial infrastructure for pharma production.

For residents of the pharma industry, an online resource “Farmatlas” will be prepared on the basis of geomarketing, with the help of which they will be able to determine (select) a site suitable for the construction of their production.

Also, work is under way to organise public large-scale industry-specific events, plans also include the organisation of educational programmes designed to meet the needs of existing pharma manufacturers and future residents.

In addition, the financial institutions of innovation business support are effective in the republic. We are talking about the Technopark “Idea”, which has experience in investing in pharma production, and a foreign company that implemented a project to build a laboratory and production complex in Kazan. According to the investment agreement, the Idea Technopark took a share in its implementation (construction and equipment of cleanrooms, purchase, installation and qualification of technological equipment, equipping with laboratory equipment), after which the share of the Idea technopark was bought out by the owner.

This scheme can be applied to other projects.

Rustam Minnikhanov, President of the Republic of Tatarstan, recently visited India, and the Chamber of Commerce and Industry of the Republic of Tatarstan signed a memorandum of understanding with the Council for Economic Development of Andhra Pradesh. Tell us more about the MoU.

The cooperation agreement between the Andhra Pradesh Chamber of Commerce and the Union of the Chamber of Commerce and Industry of the Republic of Tatarstan was signed on April 16, 2018 to promote development and diversification of economic cooperation and expand trade ties between its companies on a mutually beneficial basis. The parties will encourage and facilitate actions aimed at developing economic cooperation and promoting trade exchange between companies and enterprises of the two countries. The priority area of cooperation for Tatarstan is the pharma industry. Impressive successes in the field of pharma and bioindustry in India, an efficient system of state support for innovative companies, including through cluster activation and the creation of a supporting infrastructure, are the benchmark for the Republic of Tatarstan.

The signing of this Memorandum has strengthened the confidence that the existing huge potential of cooperation should be realised by our joint efforts.

The III All-Russian GMP Conference is planned in Kazan. What is the purpose of organising an international conference?

III All-Russian GMP-conference, with international participation under the name “Russia and the world. Management of the growth potential of the pharma market “is one of the important events of the pharma industry, is organised by the Ministry of Industry and Trade of the Russian Federation and the FBU” The State Institute of Medicines and Good Practices”.

The choice of Kazan for the conference is not accidental – now Kazan has a significant experience in holding iconic events of various subjects of Russian and international dimensions. The cultural and business environment, social stability and inter-ethnic harmony are attractive factors for external partners.

It is expected that the conference will bring together leading international and Russian experts in the pharma industry, representatives of public authorities, managers and specialists in pharma industries, representatives of professional associations and communities – a total of about 1,000 participants from Russia and abroad. The programme of the event provides for discussion of the most topical issues related to building the capacity of the Russian pharma industry, the processes of integrating industry into the global pharma industry, and developing cooperation with the international industry community.

Within the framework of the GMP-conference, the plenary session “Potential of the Republic of Tatarstan for residents of the pharma industry” is planned with the participation of representatives of federal and republican bodies of executive power. At the initiative of the Ministry of Industry and Trade of the Republic of Tatarstan, the Tatarstan-Indian biopharma forum is also included in the programme of the conference, during which it is planned to hold B2B meetings with the heads of republican enterprises and scientific and educational organisations, as well as a meeting with the main industry specialists of the Republic of Tatarstan.

During such events, the republic can express its public position of supporting biopharma and the medical industry, and representatives of the pharma  business will be able to make sure that Tatarstan is a window of opportunity to enter not only the Russian pharma market, but also the markets of the countries of the Eurasian Economic Union.

u.sharma@expressindia.com