Pharmaceutical, Biotechnology & Medical Devices Law
Pharmaceutical, Biotechnology and Medical Devices Law is a niche area of practice in the Romanian law, in which few Romanian lawyers have consistent expertise, given this domain’s complexity and close connection with other areas of practice such as intellectual property, data privacy, competition, litigation, administrative law, advertising, consumer protection, restructuring and insolvency, employment, mergers & acquisitions.
We have an interdisciplinary team of experienced lawyers with solid and extensive expertise in all relevant matters of the pharma and medical devices industry. This continuity and consistency give our team the necessary edge, and comfort to clients entrusting us with new challenges, no matter how complex. Our clients include leading international companies, their local subsidiaries, and major Romanian companies in the pharmaceutical, biotechnology or medical devices industry.
Our Services
exhaustive review of relevant EU and national regulations and of the global policies applicable to companies locally; interpretation and adjustment of Romanian concepts from the pharma and medical devices industry within the context of EU regulations and of the requirements for the companies to comply with internal policies and procedures and with anti-corruption/AML laws.
legal assistance on the applicable regulations for the establishment of new businesses in the industry (distributors of medicines, medical devices or food supplements, business takeover from own distributors, subsidiaries of international companies, etc.), authorisation and sale of new products, pricing policies and reimbursement issues, clawback tax, promotional and advertising campaigns and instruments, public procurement procedures, reimbursement protocols, protection of legal rights on innovative products, authorization and development of clinical trials or observational studies, preparing and negotiating specific contracts with healthcare professionals, healthcare institutions, distributors or providers of specialized services, revision of voluntary ethical standards by reference to the legal requirements; legal assistance and representation in administrative proceedings, disputes and litigation with the health authorities.
Client Highlights
Legal assistance to some of the largest international medicine manufacturers based in the US, Switzerland, Germany and Japan or their local affiliates in the regulatory and negotiation proceedings with the Romanian health authorities, which have been successfully finalized by the execution of relevant cost-volume (managed entry) agreements for several innovative medicines or the unconditional inclusion of the INN in the official list of reimbursed medicines.
Advising one of the largest Swiss-based international pharmaceutical on various legal matters, including clawback tax, medicine pricing, health technology assessment proceedings, specialised contracts, competition, compliance matters, legal protection of innovative medicines, employment law, policies on the interaction with HCPs/HCOs and the ethical promotion of medicines, data privacy, competition authorities’ investigations, administrative disputes and litigations with health authorities, etc.
Legal assistance to a FORTUNE 500® company and world leading manufacturer of medical devices on the acquisition of own products distribution business from the local distributor, establishment and authorization of the local distribution subsidiary, regulatory issues, HCP interaction policies, specialized contracts and day-to-day legal matters.
Successful assistance and representation of the marketing authorisation holders and the local affiliates within one of the largest international pharma groups headquartered in Basel, Switzerland in several administrative and tax disputes, of several million RON each, concerning the clawback tax notified by the National Health Insurance House and the tax deductibility of marketing and promotion services, respectively.
Legal assistance to the largest German-based medicine manufacturer on clawback tax, pricing and reimbursement of innovative medicines, clinical trials, administrative disputes with health authorities, competition, corporate, data privacy, employment, ethics and compliance, etc.
Advising one of the largest FORTUNE 500® medicine wholesalers on the local loop of its USD 6.47 billion acquisition of another global wholesaler’s pharmaceutical distribution business in Europe together with other specified services, as well as retail pharmacy operations in several European countries.
Legal assistance to one of the largest France-based international pharmaceutical companies in relation to various regulatory matters pertaining to medicine pricing and reimbursement, claw-back tax, clinical studies, sponsorships as well as in connection with administrative litigations against governmental authorities. Our team also provided multidisciplinary legal advice to the client on the intra-group restructuring in Romania and the sale of its European generic products business in a EUR 1.9 billion cross-border transaction.
Advising a major international pharmaceutical company headquartered in Darmstadt, Germany on clinical studies authorization, clawback tax, medicine promotion campaigns, medicine distribution contracts and local distribution systems, specialized services contracts, HTA process, competition, compliance with anti-bribery and anti-corruption regulations and policies, pricing and reimbursement matters, data privacy, audit proceedings initiated by health and competition authorities, etc.
Legal assistance and representation to one of the largest international manufacturers of plasma-derived medicines on various legal matters, including medicines pricing and reimbursement, medicines distribution, commercial disputes, compliance matters.
Legal assistance to one of the largest FORTUNE 500® international pharmaceutical company during the Competition Council’s investigation on the market of oncology products.
Legal assistance to a world leader contract research organization (CRO) in relation to various types of template clinical/observational studies related contracts used within studies carried out in Romania.
Legal assistance to a major European pharmaceutical group in relation to the acquisition of a Romanian medicine manufacturing and distribution company. Our team of lawyers has advised on specific matters concerning import and manufacturing under license of several pharmaceutical products, transfer of manufacturing licenses and trademarks, medicine pricing and reimbursement and assisted then the local subsidiary on various regulatory, commercial, tax and compliance matters in the pharmaceutical sector.