Medical Items

The BGP Litigation Pharmaceuticals and Life Sciences Practice team supports companies on projects involving development, production, sale and circulation of medical items.

The team of BGP Litigation lawyers have a profound understanding of the specifics of the sector thanks to active collaboration with regulatory bodies, including the Ministry of Health, Roszdravnadzor, the Federal Antimonopoly Service and others, as well as knowledge of the fine points of regulatory requirements on medical item circulation. The team also possesses rich experience of drafting and negotiating life sciences agreements and acting for clients in administrative and judicial disputes with the regulator. We help arrange compliance processes in companies, develop anti-corruption policies and perform due diligence, while competently organising risk management.

A competitive advantage of the healthcare and technologies practice lies in its extensive expertise in working with companies in the sector. Alongside the firm’s broad specialisation, this enables the Practice to take the lead as a team providing advice on the full life cycle for pharma companies and manufacturers of medical items.

Our clients include major Russian and international pharmaceutical businesses, manufacturers of medical items, providers of medical services, and so on.

We can help through:

Legal support for company R&D

  • Elaboration of contract strategies during development of medical items, advice on regulatory aspects
  • Legal support for transfer of exclusive rights to innovations, including any form of licensing (in / outlicensing)

Registration of medical items

  • Legal support in structuring a registration strategy
  • Assistance in preparing documentation
  • Advice on liaising with regulatory bodies

Commercial circulation of medical items

  • Drafting, checking and finalising of commercial agreements
  • Help in selecting the commercial model for production, distribution and sale of medical items
  • Advice on structuring, maintenance and observance of a quality management system during distribution of medical items, including specialised quality issues
  • Elaboration of commercial policies and counterparty selection procedures
  • 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 medical items
  • Disputes with consumers, other matters of consumer law

Promotion of 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 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.)

Pharmaceutical and medical item intellectual property

  • Patent disputes
  • Licensing agreements (drafting, checking, etc.)
  • Legal anti-counterfeit items and anti-“grey supplies” support
  • Legal support in relation to trade marks, advice on private label legal issues

GR – collaboration, state control and supervision

  • Advice on control over medical item circulation
  • Representation and protection of interests in interaction with the FAS of Russia, Roszdravnadzor, Rospotrebnadzor and other controlling bodies
  • Licensing advice
  • Regulatory audit 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).