Pharmaceutical market is rightfully one of leading in the structure of national economies. Like any dynamically developing industry, the pharmaceutical industry requires specialized legal support. Moreover, one cannot do without it in context of expansion into foreign markets, construction of new production sites and, as a result, increased regulatory impact on market from the state. The area under consideration requires special competence of legal consultants, therefore a.t.Legal has formed an experienced team of lawyers specializing in working with pharmaceutical companies.
The a.t.Legal's lawyers have significant experience in legal advice to foreign pharmaceutical companies in resolving a variety of issues related to work in the Russian market. We provided legal assistance to largest Japanese, Swedish, Chinese and other pharmaceutical manufacturers. In addition, our specialists have positive practice of applying foreign legislation when protecting interests of clients in the CIS countries.
Introducing narrow specialization in the organizational structure of the a.t.Legal allows us to solve everyday and non-trivial legal problems of domestic and foreign companies operating in the pharmaceutical industry, i.e. manufacturers of medicines and other drugs, wholesalers and retailers of such products and other entities in the industry.WE ARE CONSULTING LEADING INTERNATIONAL AND RUSSIAN COMPANIES OF PHARMACEUTICAL INDUSTRY ON FOLLOWING SPECIAL ISSUES:
- Due diligence of entity for presence of legal risks and development of recommendations for minimization thereof;
- Creation of package of documentation required for operation of entity;
- Ensuring legal use of intellectual property and its protection;
- Interaction with antimonopoly authorities on various aspects arising in course of activities of pharmaceutical enterprises;
- Support of participation in government procurement of pharmaceutical products;
- Full legal support of entity;
- Representation in courts and public authorities.
- Hospitals contacted A.T.Legal regarding manipulation and obstruction of bidding by third parties in state procurement of X-ray contrast agents for intravenous and intra-arterial injection for computed tomography; these are vital means, especially in the period of the COVID-19 pandemic. A.T. Legal managed to defend the hospitals' rights before antitrust authorities, and the complaints of RUSSPROF LLC were found groundless. A.T.Legal proved the necessity of the drugs purchased. Hospitals purchased the drugs they needed to treat COVID-19, and the suspensions in the timing of tenders due to complaints were minimal.
- We drew attention to the problem and, together with Kommersant, we provoked a broad discussion involving representatives of the professional community to analyze the situation and develop effective legal and organizational measures to prevent or significantly impede the activity of professional complainants.
- Representation of company's interests in the Intellectual Rights Court in a dispute with Rospatent. It is important for Pharm-Sintez JSC to protect exclusive rights with patents for invented new methods of drug production. This project is unique because for its successful implementation we had to understand details of drug production, principles of medication action in order to convincingly prove in court independence of the invented composition, differentiate the formula from other medications with the same active ingredient.
- Pharm-Sintez JSC approached us with a case of cancelling a tender and calling a new one with a correct and up-to-date price justification. The essence of our project was a reasoned justification of the contract price and elimination of errors made by the customer. Based on the tasks set by Pharm-Sintez JSC, we were able to promptly resolve the difficulties arising from the recognition of tenders as unlawful. We were able to cancel more than 20 tenders in a period not exceeding two months. What is important, the Customers took into account the mistakes on the basis of our explanations and in the shortest possible time re-published the order on the trading platform. Thus, we were able to optimize client's financial costs for legal support, and to reduce the time to achieve results, which is a direct indicator of the effectiveness of our work.
- At the beginning of October 2020, Pharm-Sintez JSC encountered significant difficulties in selling one of its drugs under the state procurement. The reason for the problem was that the government had forcibly changed the maximum prices for the medicines, significantly lowering them in the state register of prices for vital and essential medicines. These changes were adopted in late September - early October 2020, but did not take effect until the end of the first quarter of 2021. However, state customers - hospitals across Russia - decided not to take into account that the price set in 2020 will only become relevant in 2021. On the basis of which the justification of the initial maximum prices of tenders was inconsistent with the current cost of medicines. The essence of our project was to prove out-of-court and justify mistakes made by the Client, using tools provided by Federal Law No. 44. Our goal was to cancel tenders and reopen them with correct and relevant justification of the initial price, without spending time to contest tenders in antitrust authorities or the court, via competent requests without violating the law. On the basis of questions from Pharm-Sintez JSC we were able to promptly resolve difficulties. A.T.Legal were able to cancel more than 20 illegal tenders for not more than two months.
- Resolution of issues related to participation in state tenders of a distributor/supplier.
- Representation before the Federal Antimonopoly Service and territorial authorities.
- Representation of interests in the Arbitration Court concerning participation in state tenders, invalidation of tenders, contestation of decisions of the Federal Antimonopoly Service.
Representation and defense of shareholders' interests in the Arbitration Court in the case on violation of shareholder's rights.