Healthcare and Pharmaceutical Industry
As one of the recent developments attention is being increasingly focused on the growth of the level of responsibility of manufacturers of pharmaceuticals and service providers for the quality, state supervision over the activities of the entities operating in this sector has been strengthened, regulatory requirements and rules for the industry are being tighten up.
ALRUD Law Firm renders legal support to foreign and Russian companies in their entering Russian market, and provides general advice on the companies’ day-to-day activities. Our qualified experts advise on a wide range of issues including regulatory requirements for the participants of the pharmaceutical market, as well as on the contract law issues, participate in negotiations with clients’ contractors, take part in drafting of and agreeing on contracts (including distribution, supply, storage, marketing and other contracts), give advice on the issues of structuring of the product supply chain from the manufacturer to the patient.
Our services
Regularly support related to
- conducting clinical and pre-clinical trials, including the preparation of agreements with medical institutions, clinical trials organizations, healthcare professionals, providing advice on import of medical products for clinical trials;
- advising on R&D and pre-clinical trials;
- consulting on registration, amending registration dossiers, recall programs;
- supporting localization programms, including import issues, commercial contracts and relations with state authorities (e.g., participation in state procurement and public sector projects);
- advising on relations with state authorities and consumers, including licensing of the manufacturing medicines and medical activity, disputes with consumers, state inspections;
- supporting distribution, storage, transportation, importing into Russia and exporting from Russia, retail of medicines and medical products.
IP matters
- management of IP rights, licenses and assignments;
- IP rights protection, enforcement and risk assessment;
- IP advisory, including copyright and know-how;
- anti-counterfeiting advisory and implementation;
- inventions in the sphere, researches, disclosure of know-how and technology;
- marketing and advertising, including misleading, unfair advertising;
- clearance of marketing and advertising materials;
- trademark and patent filings, prosecuting and management.
Providing support in M&A transactions, including
- advice on structuring transactions;
- full due diligence with specifics to pharmaceutical industry;
- drafting and preparing all transaction documents;
- negotiating on behalf of clients with other parties to transactions;
- filings with the Russian anitimonoply authorties for clearance of transactions;
- advising on tax matters in the context of M&A transactions and on other issues.
Competition&Antitrust matters
- advising on Russian and CIS competition and regulatory aspects of acquisitions, mergers and joint ventures;
- conducting audits, risk assessment, preparing for inspections and challenging dawn raids, coordinating legal strategy, negotiating leniency and settlement agreements;
- antitrust counseling in Russia, EAEU and CIS, including due diligence of commercial, distribution and other agreements, as well as preparation of risk assessments;
- antitrust litigation in Russia and CIS, involving allegations of monopolization, price fixing, bid rigging, exclusive dealing, claims pertaining to vertical restraints.
Discover our insights
Highlights of recent domesticand international work include advising:
Bayer AG
with regard to its acquisition of Monsanto Company, a publicly traded American multinational agrochemical and agricultural biotechnology corporation.
SICPA
in establishing of a joint venture with Russian partners for conducting business in labelling of pharmaceutical products in the territory of the Russian Federation.
Taisho Pharmaceutical
as a part of global team on the purchase of UPSA SAS and the acquisition of the certain assets of Bristol-Myers Squibb Company and its affiliates exclusively related to the global UPSA business with regard to the Russian subsidiary.
Shire PLC
with regard to acquisition of 100% of shares of Baxalta GmbH, largest producer of the pharmaceuticals for rare diseases ($32 bln. deal).
Shire PLC
on regulatory requirements and distribution agreements, including antitrust aspects of the distribution channels in Russia, agreements with HCPs, laboratories, institutes, advice on localization project for one of the products, clearance of marketing materials and marketing strategy, advice on launch of new products, product liability, certification process, etc.
Shareholders of Veropharm
(one of the leading generic products producer in Russia) in the sale of the company to Abbott Laboratories for 600 mln USD (largest Russian healthcare M&A deal to date).
A shareholder of Solopharm
(one of the largest liquid manufacturing plants in Russia) on minority stake sale to the PE fund Barring Vostok including deal structuring and negotiations on preparation of all documents under the project.
Pharmacy Chain 36.6 and its shareholders and founders
on all M&A deals since 2000 till 2013 including purchases and sales of pharmacy chains, attraction of investors, on the acquisition of shares in EMC health followed by their sale in the amount of USD 110 mln.; as well as on the sale of 52% of shares in the pharmaceutical company Veropharm and founders' (shareholders') withdrawal from the business.
GlaxoSmithKline
on a wide range of issues regarding advertising of pharmaceuticals.
CSL
on entering into clinical trials agreement with the Russian partner.
Dompe
on entering into license and collaboration agreement with the Russian partner.
Heel
on license and distributor agreement termination
