Our Life Sciences Practice includes a wide range of specialists focused on pharmaceutical and medical law, healthcare services and consumer’s protection, foods & cosmetics, medical devices.
For the last years we have advised some of the major international pharmaceutical companies on any regulatory and corporate aspects, reimbursement and prices, compliance, manufacturing, marketing, promotion, advertising and distribution, protection of intellectual property rights, antitrust and competition matters, employment. Our clients appreciate our knowledge of the market, understanding of the business needs and our practical approach in providing solutions and legal advice.
The law firm also represents clients before the local regulatory authorities – the National Council on Pricing and Reimbursement, the Transparency Commission, the National Health Insurance Fund, the Bulgarian Drug Agency, etc. with respect to price approvals, reimbursement, advertising and donation matters. Our lawyers provide court representation in challenging procedures against acts of the local regulatory authorities, appeal of legal acts, as well as representation before the Commission for Protection of Competition in unfair competition and antitrust procedures, as well as in competition advocacy cases.
Some of the lawyers in this Practice Group specialise in issues related to dietary supplements, foodstuffs and medical devices.
We have significant expertise in providing legal services to wholesalers of pharmaceutical products and pharmacy chains.
The law firm advises on a wide range of complex cases, including running a number of multi-jurisdictional matters. We are also experienced in transactions in the healthcare sector, including M&A and restructurings.
The development of healthcare infrastructure, registration and operating of hospitals and medical institutions is a hot topic in the country and attracts many investors. We are able to successfully guide clients through all stages of such projects from leasing or purchase of land plots to planning and construction, regulation, public private partnerships, public procurement, employment issues, commercial agreements, data protection and privacy.
As a member of the Advisory Council to the Minister of Healthcare the managing partner at the law firm – Prof. Dr. George Dimitrov – is among the drafters of the Bulgarian е-Health Strategy. Lawyers from the Practice Group have participated as experts in numerous working groups that have developed the contemporary Bulgarian legislation in the healthcare area. They have been national correspondents for Bulgaria in a couple of healthcare projects, assigned and financed by the European Commission.
For our clients we provide a Healthcare Bulletin which monitors and informs on the recent legislative and regulatory updates and developments in the healthcare and pharmaceutical sector.
Dimitrov, Petrov & Co. assisted all of its clients – pharmaceutical companies, in the implementation of the requirements of Ordinance No. 10 of the Minister of Healthcare on the negotiation of compulsory discounts for products reimbursed by the National Health Insurance Fund.
The law firm has successfully represented the marketing authorization holder of a US-based pharmaceutical company in a number of court appeal procedures against acts of the National Council on Pricing and Reimbursement and the Transparency Commission which resulted in entering and keeping of their unique pharmaceutical product on the Bulgarian market.
In 2014 the lawyers at Dimitrov, Petrov & Co. advised the local affiliate of a leading pharmaceutical company on the restructuring of their operations in Bulgaria and implementation of a new selective distribution model.
Dimitrov, Petrov & Co.’s lawyers have provided legal assistance to many pharmaceutical companies and organisations carrying out clinical trials with regard to conducting clinical trials on the territory of Bulgaria, including advice on various matters regarding indemnification, insurance, personal data protection and privacy in the healthcare environment.
The team at the law firm has rendered legal services with regard to the e-Health regulation and the data protection in the medical sector to a premiere German company and its Bulgarian subsidiary.
A leading UK pharmaceutical company was assisted during the merger notification procedure at the Commission for Protection of Competition.
Since 2011 Dimitrov, Petrov & Co. has been advising a leading wholesale drug distributor on regulatory matters. The experts of the law firm drafted suggestions for amendment to an ordinance in order to provide equal conditions for all wholesale distributors to supply pharmacies with drugs reimbursable by the National Health Insurance Fund, which were subsequently adopted.
Among the law firm’s clients is one of the largest retail pharmacy chains in the country, which seeks our services mainly for appealing infringement acts issued by the National Health Insurance Fund. On behalf of the client the law firm’s experts have also been involved in the struggle for amendments of the applicable regulations regarding the registration and activities of pharmacies, aiming at more favourable terms for opening a pharmacy and а more flexible approach of the competent authorities with respect to the ongoing business issues concerning the pharmacies.
We have successfully advised a pharmaceutical company in a discrimination case initiated by an ex-employee before the local anti-discrimination authority.
Dimitrov, Petrov & Co.’s experts represented a major US pharmaceutical company in a proceeding before the national competition authority regarding unfair competition practices in the advertising of pharmaceutical products.
Regular legal services in the area of data protection have been provided to a leading global information and technology services company providing solutions to clients in the healthcare industry.