Pharmaceuticals

The BGP Litigation Pharmaceuticals and Life Sciences Practice team supports businesses on projects associated with the full cycle of pharma company activities.

We help businesses observe the complex regulatory requirements of Russian and foreign regulators at different stages of working with medicines: development, preclinical and clinical trials, selection of medicine production and distribution systems, promotion of medicines, public procurement or disputes with consumers, as well as creation of biotechnical venture funds and start-ups, and sale of assets.

We assist in arranging compliance processes in pharma companies, elaborate anti-corruption policies and carry out Due Diligence. Our lawyers’ extensive knowledge of this sensitive sector allows them to organise risk management competently, which helps companies minimise the risk of fines and reputational harm. This is particularly important considering the social significance of the pharmaceutical business.

We also advise clients in crises and help mitigate the risk of litigation over claims by public bodies or other counterparties and, if necessary, act for them in court.

The Technology Practice’s lawyers take part in creating legal regulation of research unique for the Russian Federation as part of federal programmes involving processing of big masses of personal data, work through the legal aspects of the work of aggregates, service companies, digital health projects and digital ecosystems, help arrange risk-free and legally appropriate collaboration with consumers, including by ensuring reliable protection of users’ sensitive data.

We can help through:

Legal support for company R&D

  • Elaboration of contract strategies during development of medicines and medical items, advice on regulatory aspects
  • Legal support for transfer of exclusive rights to innovations, including any form of licensing (in / outlicensing)
  • Advice on preclinical trials, including regulatory issues and contractual relations
  • Legal support for biotechnical venture funds and start-ups

Clinical trials of medicines

  • Model-building of contractual relations between the parties in organising clinical trials
  • Drafting of agreements with contracted research and medical institutions, and other research participants
  • Search for solutions to complex regulatory and ethical-legal questions faced by clinical trial institutions, including with respect to informing patients, protecting data, receiving and disposing of biomaterials

Commercial pharma and medical item circulation

  • Preparation, checking and finalising of any forms of commercial agreement
  • Help in selecting the commercial model for production, distribution and sale of medicines and medical items
  • Advice on structuring, maintenance and observance of a quality management system during distribution of medicines and medical items, including specialised quality issues
  • Elaboration of commercial policies and counterparty selection procedures, policies for working with pharmacy chains, bonus policies and agreements
  • Legal support for collaboration with distributors and pharmacy chains
  • Representation of clients in relations with regulatory bodies on commercial matters
  • Advice on public procurements of medicines and medical items
  • Disputes with consumers, other matters of consumer law

Promotion of medicines and medical items

  • Inspection of marketing events for compliance with the Russian legislative requirements, risk identification and mitigation
  • Drafting and finalisation of agreements on creation and/or distribution of marketing materials

Compliance in the sphere of pharmaceuticals and medical items

  • Structuring of company internal compliance processes (grading systems, hospitality limits, etc.)
  • Organisation of a company’s collaboration with medical and pharmaceutical personnel
  • Anti-corruption audit, development and checking of anti-corruption policies, provisions in agreements with counterparties, other by-laws in the compliance sphere
  • Anti-corruption due diligence of counterparties in consideration of industry specifics
  • Investigations into potential breaches of the Russian legislation, analysis of FCPA and UKBA risks
  • Holding of a broad range of events for personnel, including stress tests and checks on compliance measure effectiveness
  • Compliance function outsourcing
  • Industry research (NCP salary levels, etc.)

Legal regulation of cosmetics and dietary supplement circulation

  • Technical regulation of the cosmetics sector and dietary supplements
  • Support for commercial activities (commercialisation model-building and analysis, distribution agreements, agreements with retail chains, etc.)
  • Promotion of cosmetics and dietary supplements
  • Consumer law issues

Transactions with pharmaceutical assets

  • Due diligence of target companies and assets, structuring of transactions in consideration of industry specifics and particular sector requirements
  • Assistance with M&A transactions: preparation of transaction documents (SHA, SPA, Call-Option, Put-Option, Default-Option, etc.), agreement of transactions with the FAS of Russia
  • Advice on observance of the anti-trust legislation as part of preparing for M&A transactions
  • Support at all stages of negotiations and transaction closing
  • Comprehensive support for establishing legal entities (including pharma JV), branches and representative offices
  • Corporate law

GR – collaboration, state control and supervision

  • Advice on control over medicine and medical item circulation
  • Representation and protection of interests in interaction with the FAS of Russia, Roszdravnadzor, Rospotrebnadzor and other controlling bodies
  • Pharma and medical activity licensing advice
  • Regulatory audits to identify potential risks
  • Organisation of training as part of preparing a company for an audit, mock audits, direct participation
  • Law-making activity (drafting amendment to the LSI, legal support during development of GOST (state standards) and more).

Medicine and healthcare

  • Introduction of innovative medicine supply models
  • Support for market access strategies of pharma companies (registration of prices, inclusion on lists, and others)
  • Comprehensive support for public private partnership projects of all forms (PPP, concession agreements, SIC, offset agreements, Lifecycle contracts)
  • Mandatory medical insurance
  • Operations of private and public medical institutions
  • Healthcare non-profits (charitable foundations, etc.)