Medicines and medical, healthcare and beauty products are part of vital daily needs for billions of people, with thousands of companies involved in their development, production and distribution.

Goltsblat BLP / Berwin Leighton Paisner specialists provide comprehensive legal support for both standalone projects and routine operations of pharmaceutical companies, manufacturers of medical devices and equipment, healthcare products and  cosmetics, pharmacy chains and retailers.

In the past year, our firm has invested considerably in developing a firm-wide healthcare and  pharmaceuticals practice with real strength and depth. Leveraging off the substantial existing client base in this sector and a range of experience spanning several years, the new dedicated healthcare practice has been extremely successful in coordinating different workstreams and using key individuals’ sectoral understanding to interlink such expertise with other areas of specialisation within the firm. New areas of expertise have also been developed, including specific aspects of state regulation of pharmaceutical and medical companies. Healthcare is now an integral part of BLP’s strategy and is fast becoming highly relevant to a number of practice areas across the firm.

This depth in field has enabled the firm to take its healthcare expertise to an international level, resulting in major instructions from key market players.

Goltsblat BLP clients involved in the healthcare sector include major international producers of medications, medical devices and equipment and manufacturers of healthcare products and cosmetics. Internationally, Berwin Leighton Paisner advises NHS Trusts and government bodies, financial  institutions, investment consortia, medical suppliers and independent sector treatment centres (ISTCs) and residential care homes.

We have represented both the public and private sectors on some of the earliest, high profile healthcare pilot projects and have a detailed understanding of the readily accepted market positions that we see today. Our experience of acting extensively for both public and private clients means that we understand the differing key aims, objectives and constraints of both sectors.

Many of our specialist lawyers have worked in the industry for a number of years and offer clients a detailed understanding of the sector, combined with integrated and expert advice on the law. 

Our Services:

• Regulatory

Drugs manufacturers

1. Legal issues arising during registration of drugs on the territory of the Russian Federation.
2. Legal issues arising during clinical trials
3. Advice on pricing of drugs on the essential drug list:

• Registration and re-registration of ceiling ex-manufacturer prices for Russian and foreign drugs on the essential medicine list.
• Application of the methodology for drugs manufacturers to set ceiling ex-manufacturer prices for drugs on the essential medicine list.

    4.  Appeals against refusals to register ceiling ex-manufacturer prices. 

Wholesale companies

1. Licensing 
2. Registration and re-registration of ceiling ex-manufacturer prices for Russian and foreign drugs on the essential drug list.
3. Regulatory issues on import, transportation, storage and release of drugs on the territory of the Russian Federation.

Manufacturers of medical equipments, devices and products

1. Regulatory issues arising on registration of medical equipment and medical products  

Analysis of documents regulating the right to sell medical products and equipment for the purposes of application of a reduced VAT rate when importing and selling medical equipment on the territory of the Russian Federation.  

Distributors and pharmacy chains

1. Application of maximum wholesale and retail price mark-ups to drugs on the essential drug list.
2. Challenging of regulations of constituent entities of the Russian Federation establishing maximum wholesale and retail price mark-ups, if they contain rules that are in conflict with the federal legislation.
3. Regulatory issues arising on import, transportation, storage and release of drugs, medical products and devices on the territory of the Russian Federation. 
4. Legal assistance during audits of companies' relations with government bodies with respect to violation of the rules for pricing, storage and sale of drugs and medical products.  
   

• Business Organisation
  • Comprehensive legal support for organisation of the pharmaceuticals production process, liaisons with government and municipal authorities and bodies. Construction and lease of manufacturing facilities, warehouses and office premises
  • Building up of a distribution network, development of distribution agreements, handling of exclusivity and pricing matters
  • Advice on optimum franchising models
  • All-round legal assistance for arranging clinical trials 

• Corporate
  • Support for business expansion (M&A) and legal due diligence
  • Corporate restructurings
  • Legal assistance in attracting equity and debt finance
  • Setting up and providing legal support for joint ventures, strategic alliances and consortia
  • Corporate finance
  • Corporate governance
  • Corporate dispute resolution
  • Set-up, reorganisation and liquidation of companies of varied legal status
  • Insolvency & bankruptcy

• Intellectual Property and Advertising
  • General IP compliance issues
  • Legal due diligence on existing intellectual assets in a company
  • Forming an IP portfolio of new assets
  • Licensing and franchise agreements, including know-how licensing and use
  • Legal support for combating counterfeit products, including by making the best use of the customs register
  • Advice on how to use IP assets without infringing on third party rights
  • Acting for clients in all disputes over violation of intellectual property rights, including patent disputes
  • Acting before the Russian patent office (Rospatent) on all matters of trade mark   registration and patenting, including in the Patent Dispute Chamber of Rospatent
  • Advice on specifics of advertising medications, medical products and medical devices, including on the Internet
  • Recommendations on holding marketing events, legal analysis of promotional events, advice on implementing advertising campaigns, registration of and legal assistance with lotteries
  • Acting for clients in disputes with the Russian Federal Anti-monopoly Service, in particular, over violation of the advertising legislation
  • Trainings on legal aspects of promoting medications (OTC and prescription medicines)
  • Inclusion of intellectual property items in the customs register of intellectual property items of the Russian Federation and the Common Customs Register of the Customs Union
  • Legal support in administrative, civil and criminal cases against importers, manufacturers and sellers of counterfeit goods on the territory of the Russian Federation

• Customs
  • Legal support for imports of pharmaceuticals and medical equipment into the Russian  Federation
  • Acting for health care and pharmaceutical companies before customs authorities in  appealing against resolutions imposing liability for departures from the customs law
  • Representing clients in appealing against actions/omissions by the customs and foreign exchange control authorities in courts 
  • Assistance in combating import of counterfeit goods into the Russian Federation and on to the territory of the Customs Union. Collaboration with the customs authorities

• Product Liability
  • Requirements on quality and safety of medications, self-medication products, medical devices and medical products
  • Manufacturer’s (seller’s) liability in retail sale of medications, medical devices and medical products
    Liability for any harmful effect of medications on human health
  • Comprehensive legal support throughout interaction with consumers, claim handling and litigation support in consumer disputes
  • Quality certification for medications

• Employment and Immigration
  • Legal aspects of relations between medical representatives and doctors
  • Implications of engaging foreign employees from the immigration viewpoint
  • Paperwork required for LLCs and permanent establishments to hire foreign manpower
  • Employment restructuring, liaisons with trades unions, and corporate pension schemes

• Administrative-Law Support for Business
  • Legal assistance in relations with government authorities as part of audits, certification and licensing
  • Legal advice on state purchases, including on the participation procedure, pricing, contesting the results and preparing tender documentation
  • Acting for clients before foreign exchange control authorities and the Federal Service for Finance and Budget Supervision,  including as defence in proceedings over administrative offences
  • Advice on anti-monopoly control over pharmaceuticals, in particular, manufacturing and distribution of medications, medical products and medical devices 

• Taxation
  • Tax restructuring and tax planning
  • Developing financing alternatives for subsidiaries
  • Acting for clients before tax authorities and in courts 
  • Personal Data Protection
  • Advice on application of the Law “On Personal Data”
  • Legal advice on cross-border transfers of personal data between affiliates
  • Personal data protection as part of pre-clinical and clinical trials 

• Dispute Resolution
  • Representing clients in regional arbitration courts and in courts of general jurisdiction of all levels, including the Supreme Arbitration Court, the Supreme Court and the Constitutional Court of the Russian Federation
  • Litigations contesting issue of registration certificates for medicines

More about our international experience in healthcare & pharmaceuticals, please click here