Healthcare and Pharmaceuticals

Legal services to pharmaceutical companies and other organizations of the pharmaceutical industry, manufacturers and distributors of medical devices (medical equipment), manufacturers and distributors of dietary supplements

BRACE Law Firm, within the framework of the “Healthcare and Pharmaceuticals” practice, provides legal services to manufacturers and distributors of medicines, medical devices, dietary supplements, and other healthcare organizations on issues of Russian and international law. The main directions of the provision of legal services are legal assistance in the areas of supporting commercial activities, resolving disputes and litigation, public and corporate procurement, regulatory issues in the field of healthcare, compliance, antitrust law, and international trade law.

Key clients of BRACE Law Firm are concentrated in the healthcare and pharmaceutical sectors. Providing legal services in this area, we cooperate with pharmaceutical companies, manufacturers and distributors of medical products, pharmacy chains, as well as organizations engaged in the sale and production of cosmetic products and dietary supplements. Our clients are both residents and non-residents, as giants included in the Big Pharma group, as well as medium and small Russian and foreign companies.

The activities of both Russian and foreign pharmaceutical companies and companies engaged in the circulation of medical devices are governed by both general rules of law for all legal entities and special laws relating to the circulation of medicines and medical devices. Because these goods have their specifics and uniqueness, the current legislation establishes the specifics of the legal regulation of their circulation in the market.

Certain legal issues may arise in almost every business entity participating in the circulation of medicines and medical devices. Moreover, often, with the development of international relations, the legal relations of these companies are complicated by a foreign element. Solving a large volume of diverse legal issues can be very difficult without the provision of qualified legal assistance.

BRACE Law Firm conducts active research, takes part in the activities of the Center for the Study of the Normative Environment of Pharmaceuticals and Biotechnology.

Besides, we carry out specialized events for pharmaceutical industry employees, as well as in researching regulatory issues in pharmaceuticals and healthcare, the results of which are published in leading pharmaceutical journals. Our experts regularly monitor changes in legislation and law enforcement practices, the results of which are reflected in monthly digests.

We provide quality, effective and timely solutions. In each case, the BRACE team strives to ensure that the best result is achieved with the least possible means. The quality of our services is based on industry expertise, an understanding of the functioning of the legal system, individual and partnership relations with each client, compliance with high professional and ethical standards, and technological effectiveness in working with information.

Our experience

1. Advising a large Russian pharmacy chain on the organization of distance selling of medicinal products, medical devices and dietary supplements
2. Conducting a comprehensive audit of the inspection for compliance with regulatory requirements for medical equipment, representing the company’s interests during inspections by the Federal Service for Surveillance in Healthcare
3. Providing legal support to a Russian pharmaceutical company in connection with the implementation of a number of projects, including scientific cooperation with leading American and European pharmaceutical companies in terms of new product development, clinical research, import of biomaterials, as well as contract manufacturing
4. Advising a Russian vaccine manufacturer on various issues of legal regulation in terms of concluding an agreement on contract manufacturing of a new drug and drafting a contract manufacturing agreement
5. Advising a client on a wide range of legal regulation issues related to contract manufacturing of medical equipment with the preparation of a contract manufacturing agreement
6. Advising a major distributor of medicines on issues related to various procurement schemes for innovative medicines for the treatment of cancer, including under special investment and offset contracts
7. Advising the Russian office of a large company from Big Pharma on issues related to the localization strategy for the list of essential medicinal products, including on complex pricing issues
8. Providing legal support to a large international pharmaceutical company in all types of activities of a clinical research center in Russia
9. Advising an Australian pharmaceutical company to obtain legal control over the registration dossier for a medicinal product and to amend the registration dossier
10. Legal expertise of a special investment contract for the construction of a plant for the production of medicinal products, including those that have no analogues, as well as legal support for the implementation of this project
11. Accompaniment of a large pharmaceutical distribution company during an inspection by the Federal Antimonopoly Service of Russia as part of an investigation into a cartel conspiracy
12. Legal audit of a pharmaceutical company for compliance with the legislation on the circulation of precursors of narcotic drugs and psychotropic substances
13. Advising an Indian pharmaceutical company on online drug promotion, including online advertising, personal data processing and project risk assessment
14. Advising one of the world leaders in the production of innovative medicinal products on the localization of production of medicines in Russia, as well as restrictions and preferences in the field of procurement for state needs
15. Legal analysis of the rules for price regulation, advertising and promotion of medicines, as well as other rules in Russia and the EAEU countries for an Austrian pharmaceutical company
16. Ongoing legal support for one of the world's leading companies in the field of innovative pharmaceuticals on the organization of relationships with medical and pharmaceutical workers
17. Advising a Russian subsidiary of one of the largest American manufacturers of medical devices on the legislative regulation of advertising and interaction with medical professionals, drafting a supply agreement with distributors
18. Legal support for a Russian subsidiary of a leading Austrian drug manufacturer, including analysis of agreements with medical and pharmaceutical workers and supply agreements, drafting marketing and advertising services, as well as bonus agreements
19. Advising a Russian subsidiary of a Russian biopharmaceutical company on structuring incentive payments to distributors
20. Legal support of one of the leading Russian developers and manufacturers of innovative drugs and vaccines in the process of developing and negotiating with foreign counterparties an agreement on post-registration clinical trials
21. Ongoing legal support of a leading international manufacturer of medical devices on various issues related to doing business in Russia, including structuring relationships with distributors, licensing the maintenance of medical devices
22. Advising a European company providing comprehensive services to the pharmaceutical business on licensing pharmaceutical activities, wholesale trade in pharmaceuticals, exclusivity of clinical trial data
23. Advising an American manufacturer of dietary supplements on the organization of out-of-store retail trade in the Russian market

Legal services

1. Legal support of pharmaceutical companies
2. Legal support for manufacturers and distributors of medical devices
3. Legal advice on the circulation of drugs, medical devices, dietary supplements
4. Compliance on issues related to the activities of pharmaceutical and medical product companies
5. Legal support in public procurement in healthcare
6. Development and legal examination of contracts (in the implementation of pharmaceutical activities and activities in medical devices business)
7. Development and legal examination of internal policies (anti-corruption, antitrust, and others) for pharmaceutical companies and companies in the field of medical products
8. Legal advice on the protection of personal data in the field of healthcare
9. Legal support for the promotion of drugs, medical devices, dietary supplements
10. Consulting during inspections (pharmaceutical companies and companies dealing with the circulation of medical devices)
11. Advocacy against unfair competition
12. Legal advice on the formation of lists of medicines
13. Legal advice on state registration and re-registration of drug prices
14. Preparation of draft licensing agreements and agreements on the alienation of exclusive rights
15. Legal support for the development of medicines and medical products, dietary supplements
16. Legal support of manufacturing of medicines, medical products and dietary supplements
17. Legal support of clinical and preclinical studies
18. Advice on the import / export of medicines, medical products, dietary supplements
19. Legal support of technology transfer deals in healthcare and pharmaceuticals
20. Legal support of investments in healthcare and pharmaceuticals
21. Legal support for the distribution of medicines, dietary supplements and medical devices
22. Legal support of interaction with medical and pharmaceutical workers
23. Legal support of public-private partnership projects in healthcare and pharmaceuticals

Healthcare and pharmaceutics (Brochure of BRACE Law Firm)