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Practice

Life sciences

About the practice

  • The practice is recommended by international and Russian independent directories.
Respondents regularly point out the team's client-oriented approach; one of the references adds that this helps find the right decisions and provide timely legal support.
Chambers Europe
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>100 clients

with the top 10 largest pharmaceutical companies of the world

>300 projects

in the last 3 years

>14 practices

co-working to resolve complex issues

Services

  • Clinical trials
    • Having research results that were obtained abroad recognised; legal nuances of their cross-border transfer, ethical aspects of research and other issues
    • Assisting with the conclusion of contracts with medical institutions and organisations involved in clinical trials (CROs)
    • Providing support for clinical trials with regard to complex medical products the use of which is connected with a medical device
    • Structuring and providing legal support for communication within a group of companies within the framework of multicentre clinical trials
  • Advertising and liaising with the professional community
    • Advising on all issues connected with promoting prescription and OTC medicines, medical devices and biologically active supplements, including checking the content of specific advertising materials
    • Providing support for communication with medical and pharmaceutical professionals, including checking or drafting the relevant contracts, supporting documents and internal policies
    • Assisting in communication with patient organisations: analysing and drafting donation and service agreements, as well as internal policies
  • Wholesale and retail trading
    • Providing comprehensive legal support when selecting, building and changing the distribution model in Russia
    • Drafting and analysing existing contracts, commercial policies, and rules for selecting distributors; communicating with the latter, as well as with pharmacy chains
    • Providing support to remote sales, resolving issues connected with e-commerce, and handling communication with aggregators and marketplaces
  • Localising manufacturing
    • Drafting and concluding agreements on contract manufacturing
    • Advising on a wide range of conditions and measures for supporting domestic manufacturers and foreign investors (preferences, special investment contracts (SPICs))
    • Providing legal support with regard to all aspects of the construction of new manufacturing facilities
    • Providing legal support for the import of equipment, reagents, samples of medicines and medical devices; representing the client in disputes with customs authorities 
  • Transactions with assets
    • Performing due diligence of companies and assets (the right to medicines, pharmaceutical substances and so on)
    • Providing support for the purchase of exclusive rights to intellectual property items (new developments and products circulating in the market)
    • Structuring transactions taking into account the specifics of the regulatory regime and business in the pharmaceutical and medical industries
  • Legal support with regard to other aspects
    • Within the framework of registering drugs, medical devices or biologically active supplements
    • During inspections by supervisory authorities, as well as when subsequently challenging the actions and decisions of such authorities
    • In connection with participating in procedures of the state procurement of medicines and medical devices
    • Public-private partnership projects in the healthcare sphere
    • Projects connected with using digital technologies in medicine, and with using artificial intelligence or large volumes of data; among other things, with regard to telemedicine
    • Introducing consents to the processing of personal data or consents to disclosing privileged medical information
    • Legal support for customs, tax and currency aspects of activities of any player in the pharmaceutical and healthcare market

    Contacts

    Ilya Bolotnov

    i.bolotnov@pgplaw.ru

    Ilya specialises in corporate and contract law. For over 20 years, he has advised Russian and non-Russian clients on investments in Russia, M&A transactions, commercial and contract law and on antimonopoly regulation (including asset acquisitions, restructurings, the formation of joint ventures, and the integrated structuring of contractual relationships in Russia), including when working with Life Science companies. A significant part of Ilya’s practice is dedicated to work with Life Science and FMCG companies

    Ilya specialises in corporate and contract law. For over 20 years, he has advised Russian and non-Russian clients on investments in Russia, M&A transactions, commercial and contract law and on antimonopoly regulation (including asset acquisitions, restructurings, the formation of joint ventures, and the integrated structuring of contractual relationships in Russia), including when working with Life Science companies. A significant part of Ilya’s practice is dedicated to work with Life Science and FMCG companies

    His key achievements
    Ilya has led and been directly involved in a whole range of projects completed for Russian and international companies, of which the most significant are:
    • represented a major transnational producer of pharmaceuticals and consumer goods in a transaction to acquire a business to distribute OTC drugs from an Indian company in Russia, CIS countries and certain other jurisdictions (a total of 14 jurisdictions);
    • represented a private equity fund with a long track record in Russia in transactions to invest in companies in the country, including support in transactions to acquire new companies that held rights to medicines as well as transactions in which key portfolio companies of the fund acquired rights to medicines.
    • provided ongoing legal support (over several years) to two biotechnological start-ups in Russia that were created by foreign investors jointly with a Russian development institution. The work included ensuring all agreed corporate management procedures, the development of a number of internal regulations of companies, and advising with respect to the import of chemical agents, pre-clinical and clinical trials, the transfer of foreign technologies, the obtaining of grants, as well as complicated state budget and legal aspects of performing and terminating state contracts;
    • provided legal support to international and Russian pharmaceutical and healthcare companies on a wide range of issues, for instance, among others:
      • assessing advertising materials for OTC medicines, and evidence that can be used to confirm the statements;
      • devising solutions with respect to problematic aspects of labelling medical products;
      • assessing the procedure of dealing with representatives of the medical community;
      • developing and assessing the provisions of commercial policies and distribution agreements.
    Read more

    Maria Nikonova

    m.nikonova@pgplaw.ru

    Maria specialises in taxation in the pharmaceutical industry and FMCG. She advises on tax risks in sales of medicines, the conduct of clinical trials, the promotion of medicines and food supplements, as well as on other issues of pharmaceutical companies’ business. She has a track record of providing legal support to large international and Russian companies when analysing and structuring their operations with a view to maximising their efficiency and minimising risk exposure. Maria has frequently litigated on behalf of various companies on tax issues in courts of all levels and before other state bodies.

    Maria specialises in taxation in the pharmaceutical industry and FMCG. She advises on tax risks in sales of medicines, the conduct of clinical trials, the promotion of medicines and food supplements, as well as on other issues of pharmaceutical companies’ business. She has a track record of providing legal support to large international and Russian companies when analysing and structuring their operations with a view to maximising their efficiency and minimising risk exposure. Maria has frequently litigated on behalf of various companies on tax issues in courts of all levels and before other state bodies.

    Her key achievements
    Her professional accomplishments include:
    • representing a pharmaceutical company during a pre-audit analysis on the issue of the representative office’s preparatory and auxiliary activity being reclassified as activity conducted in the interests of third parties (manufacturers of medicines and distributors in the Russian Federation);
    • protecting the interests of a large pharmaceutical holding company during a field tax audit focusing on the structure of intra-group payments;
    • developing a contractual model for selling foreign software (a medical item) in Russia (including accepting payments for updates and additional functionality of the software) taking account of the tax risks and providing support to the client at the stage of implementing this model;
    • providing support during the restructuring of a major Indian pharmaceutical company in Russia;
    • completing a number of mandates that included advice on tax and regulatory issues of cooperation with healthcare professionals for producers of medicines and medical products;
    • providing legal support under a project that involved the tax classification of a contract for arranging clinical trials, as well as developing the line of reasoning and a defence file in case the tax authority decided to file claims;
    • advising on tax and regulatory issues of liaising with patient organisations;
    • completing a series of consulting projects that were focused on tax aspects of promoting medicines and food supplements;
    • supporting the client in the process of preparing for and entering into a contract for the production of medicines.
    Maria is a columnist in Pharmvestnik Journal. She is one of the organisers of the tax club for pharmaceutical companies.

    Maria has authored and co-authored multiple published materials on tax law. She is the author of the monograph “Operation of tax law in time” and the course book “Taxation specifics in sales of consumer goods”. She also co-authored the course book “Fundamental legal principles of indirect taxation”.
    She was recognised as the best speaker at the Pharma CFO 2019 forum.
    Read more

    Events

    conference

    Pharmaceutics 2021: legal aspects

    Moscow
    27April
    Meeting

    Antimonopoly recipes for the pharmaceuticals market

    Moscow
    14May
    Meeting

    Automation and compliance. Electronic document management. Personnel management

    Moscow
    8June

    Analytics and news of the practice

    • 11.12.2020
      The Tax Pharmclub has held a meeting at Pepeliaev Group
      Read more
    • 04.06.2020
      Pepeliaev Group has been again recognised as Law Firm of the Year for Tax Law according to Best Lawyers™ 2021*
      Read more
    • 13.03.2020
      Pepeliaev Group has demonstrated exceptional results in the Chambers Europe 2020 ratings
      Read more
    • 14.02.2020
      The National Research University Higher School of Economics has held the annual forum “Legal challenges of the healthcare industry in 2020”, organised jointly with Pepeliaev Group
      Read more
    • 06.12.2019
      Nine of Pepeliaev Group’s practice and sector groups have entered Pravo.ru’s Tier 1
      Read more
    • 24.05.2019
      Pepeliaev Group has been recognised as Law Firm of the Year in tax law according to Best Lawyers™ 2020
      Read more
    • 21.05.2019
      Pepeliaev Group at the IX International Legal Forum: summary of events
      Read more
    • 13.02.2019
      The forum: “Legal challenges of the healthcare industry” organised by Pepeliaev Group and National Research University Higher School of Economics (NRU HSE) gathered over 100 audience members
      Read more

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