The Russian practice of Berwin Leighton Paisner
(BLP), an award-winning international law firm
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Healthcare and Pharmaceuticals

Regulatory

Advising on markups for non EDL medicines. more deals

Analysing the legislation on identification of the concept of local producer/local product in relation to medicines partly manufactured in the Russian Federation.

Identifying anatomo-therapeutic-chemical classification groups in which a medicine may be included for the purpose of determining whether it is an EDL medicine.

Developing a global policy for a company with respect to interaction between medical representatives and medical/pharmaceutical workers/heads of medical/pharmaceutical organisations in light of the law "On the Fundamentals of Public Healthcare“.

Advising on specific registration of biological medicines and their generics.

Adapting for the Russian Federation the global format of the agreement on conducting clinical trials and pre-registration clinical trials.

Help a pharma company which was held liable for exceeding the maximum permissible wholesale markups on medicines.

Prepared analytical notes on compliance/non-compliance by a series of provisions of the draft Federal Law "On the Fundamentals of Public Healthcare" with the anti-corruption legislation of the Russian Federation.

Advising a global pharma company on various aspects of localisation of medicine manufacture within the Russian Federation.

Sales and distribution support

We successfully defended the position of Bio-Rad Laboratories, a big medical device and medicament producer and supplier, thereby depriving a distributor of the possibility of continuing to use its exclusive status for distributing the goods in the Russian Federation. In addition, as a result of the successful judicial work, the debtor was convinced to conclude an amicable agreement to repay a debt of over RUB 52 m to our client. more deals

Drafted a set of standard contract templates for a major international healthcare & pharmaceuticals company. Assisted with localising standard international contracts and adapting the standard contracts to Russian legislative requirements.

Analysed the global internal marketing policy of a major international healthcare & pharmaceuticals company and its model distribution agreement to verify compliance with the Russian legislation.

Developed Russia-wide distribution systems (drafted or analysed draft distribution agreements, provisions on incentive systems and payment of rebates, paperwork systems, etc.) for a number of FMCG clients.

Competition & Antitrust

Advised Johnson & Johnson’s medical devices division on competition law compliance and trade terms development. more deals

Support during antitrust dawn raids, including liaisons with antitrust inspectors, support for provision of documents and information, participation in all procedures.

Comprehensive internal antitrust audit, including email search, interviews, market analysis based on Company’s data.

Preparation and implementation of various training programmes to alert the Company’s management and provide for timely  cooperation with in-house department (e-learning, facilitated trainings, trainings on legislation development, "practical preparation to dawn raid").

Advise on contractual provisions regarding prices, exclusivity, territories and other terms in sales and distribution agreements.

Advice on pro-competitive pricing and marketing policy, and general compliance programme. Preparation of internal policies and contractual provisions on requirements to distributors and suppliers.

Representation of clients towards FAS in cases concerning presumed cartel agreements and/ or concerted practices, abuse of dominance and illegal coordination.

Representation of clients towards FAS in cases concerning unfair competition and misleading advertising.

Representation of clients towards FAS in relation between financial organizations, cooperation between banks,  insurance companies, appraisers, etc.

Corporate/M&A

Advising Sun Pharma Global FZE, a group company of Sun Pharmaceutical Industries Limited, on prospective brand acquisition from a Russian competitor. Our mandate included comprehensive due diligence of the assets and related business (with particular focus on regulatory, contractual and IP), advice on structuring of the transaction, documenting and hands-on negotiating the deal. more deals

Advising JSC Freight One in relation to preparation and registration of an initial bond issue of RUB 40 bn.

Public Procurements

Legal support for a baby food subdivision of a major international food producer in challenging tender results in a key Moscow tender both through the antitrust authorities and arbitration courts. As a result, the tender documentation for 2012 aligned with the Customs Union technical regulations. more deals

Comprehensive support for the leading international pharmaceutical company in challenging Federal tender results, appeals to antitrust authorities and medical authorities. Supply of competing pharmaceuticals put on hold for half a year owing to lack of the requisite documents.

Preparation of internal guidelines for participation in a tender through distributors, for legal communication with KOL, preparation and provision of information for tenders for major FMCG and medical equipment producer.

Advised and acted for employees of the world leader in consumer electronics, healthcare and lighting, from engineers to top managers, within the scope of multiple investigations conducted by the Investigation Committee of the Russian Federation and other bodies in connection with violations during state tenders and auctions for purchase of tomographs and other medical equipment.

Tax

Conducted the benchmark study of profitability margin of pharmaceutical distributors for a major global pharmaceutical company. more deals

Developing and advising on the tax aspects of sales promotions system (bonuses, rebates, marketing services) for a major medical company.

Advised the global pharma company on sustaining the reduced VAT tax rate applicable to sale of medicines in case of absence of registration certificates.

Prepared recommendation for leading cosmetics distributor on tax risks of it’s business model relying on multi-level direct selling model.

Successfully defending a major foreign investor in the claim to recover more than US$20 mln in input VAT related to construction of new facilities.

Advising on the tax advantages and disadvantages of various options for restructuring the Russian legal structure for one of the global leaders in manufacturing and distribution of baby food.

Advising on PIT implications  and risks of relationship between global pharmaceutical company and medical workers.

Tax support on everyday business one of biggest producer of healthcare products and equipment.

Legislative and other regulatory work

Participated in discussion of the legal contents and practical enforcement of Article 41 of the Constitution of the Russian Federation concerning the right to health care and medical assistance. more deals

Drafted the international mutual recognition agreement on clinical trials of medicines.

Delivered expert opinions on certain chapters and participated in discussion of the draft Federal Law "On the Fundamentals of Public Healthcare in the Russian Federation".

Provided a legal assessment of the liability provisions and certain other rules of the draft federal law on amendments to the Russian legislation in connection with adoption of the Federal Law "On the Fundamentals of Public Healthcare in the Russian Federation".

Drafted the Federal Law "On Amendments to the Federal Law "On Circulation of Medicines"" with a view to eliminating the possibility of fast track expert examination of reproduced medications for specific origin medicines intended for medical use.

Formulated amendments to the Federal Law "On the Quality and Safety of Food Products" called on to ensure public healthcare, appropriate packaging and labelling of foodstuffs.

Developed and presented amendments to a number of Technical Regulations of the Customs Union.

Took part in discussion and improvement of draft amendments to the Federal Law "On Technical Regulation" to enable technical regulations of other Customs Union and EU members to be applied in Russia.

Delivered suggestions on certain aspects of protecting the health of animals in connection with development of a new draft federal law on veterinary medicine.

Drafted and provided legal support in the State Duma for the Federal Law "On Responsible Treatment of Animals".

International Experience

Allergy Therapeutics. Flotation on AIM. Allergy Therapeutics, the European based specialty pharmaceuticals company raised £16m and, on admission, had a market capitalisation of £46m. more deals

Lombard Medical. Sale of PolyBioMed to Bayer AG

Medical Solutions: Sale of a key division carrying on the development of software for research in the biomedical market.

Merrill Lynch: Purchase of 100 doctors’ clinics for a total consideration of £150m.

Close Ventures: Management buy out of a medical imaging business from Siemens Medical Solutions USA, Inc.

Intavent Orthofix Limited: Intellectual property issues including research agreements, patent infringement and medical advertising compliance.

InterHealth Canada:

  • Successful bid for the provision of clinical services in the Cheshire & Merseyside area under the Government’s Independent Sector Treatment Centre outsourcing programme.
  • The Turks & Caicos Islands Hospitals project. Under this $124m project, Interhealth assume long-term responsibility for provision and maintenance of hospital facilities, medical equipment and also the provision of clinical and diagnostic services.

MDY Healthcare:

  • Establishment of joint venture relating to glucose monitoring system and subsequently unwinding the arrangement.
  • Acquisition from 3i Group plc of stakes in UK listed ProStrakan Group plc and SWX listed Santhera Pharmaceuticals Holding AG.

NHS Trust:

  • The procurement of major medical equipment in conjunction with our advice on the Trust’s £330m PFI project. Additionally, we advised the Trust in relation to the provision of a PACS solution.
  • A managed service for radiotherapy equipment. This saw a managed services contract for the provision of three new linear accelerators within the Trust’s newly constructed maternity and oncology development.

SurgRx Inc 

  • European merger control aspects of its completed acquisition by Ethicon Endo-Surgery Inc, a Johnson & Johnson company.

The Royal Bank of Scotland. Financing of the construction and commissioning of privately operated medical research facilities at Keele University. The facilities are involved in the manufacturer and provision of radioactive isotopes for clinical use.

Vidapulse. Proposed licensing agreements, commercialisation and funding in relation to unique woundcare technology.

Lombard Medical. Complex agreements granting US medical giant, Medtronic, licensing and distribution rights for some of Lombard's cutting edge stent-graft implant technology.

The Information Centre. Its innovative health informatics joint venture, Doctor Foster Intelligence, with specialist health informatics provider Dr Foster.

Behalf of Ultradent, liaised with the European Commission and with national authorities in several Member States; influenced legislative proposals before European Parliament; and conducted litigation in national and European courts.

Advised Agfa Healthcare on a contract with Nuffield Hospitals for the provision, integration and support of a group of imaging and radiology systems that will serve the 40 hospitals and nine mobile x-ray facilities of the Nuffield Group across the UK.

Assisted Dentsply and its many subsidiary companies in the protection of its trade mark and brands before the UK and Community Trade Mark Offices. Dentsply is the largest dental manufacturer in the world.

We advised UK pharmaceuticals company on issues relating to rights to confidential information in relation to clinical trials.

US and Australian companies on the regulatory regime for cosmetics, including composition issues, dossier requirements and advertising strategies.

Sure Calm Holdings Limited, a newly formed vehicle backed with equity from Apposite Healthcare Fund, one of the leading healthcare investors in the UK, on three simultaneous acquisitions for an undisclosed sum.

US, Canadian and Australian companies on the regulation of herbal remedies, the different regulatory regimes and how their products would be regulated. Also advised on how to comply with legal requirements for staff training, appointment of a responsible person and the necessary licences.

Lydian Capital Partners on numerous regulatory issues relating to the purchase of registered pharmacies, including the acquisition of  wholesale dealers licenses and manufacturers “special” licenses. Also advised on the provision of nursing services for patients at home under the Care Standards Act 2000.

US and UK companies on regulation of medical devices ranging from devices related to snoring, testing kits, contact lenses and sun cream testing equipment.

American private healthcare company in relation to the regulatory issues and registration process in setting up private treatment centres within the UK.

Tesco in relation to its shares in the Nutricentre including reviewing existing systems for OTC medicines, medical devices, food supplements, cosmetics, herbal remedies and aromatherapy products. Also advised on steps that needed to be taken post completion to ensure ongoing compliance

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Vladislav Vdovin
Head of Group Healthcare & Pharmaceuticals / Commercial Practice
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Nikolay Voznesenskiy
Partner, Head of Competition Practice
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