Expertise

We provide ongoing assistance to major producers and distributors of medical products with respect to various legal and regulatory matters and also to major international law firms with respect to their clients’ business in Romania related to harmonization of Romanian pharmaceutical law with EU pharmaceutical law, biotechnology, donation of medicinal products for compassionate use, clinical trials, claw back, pricing, reimbursement, etc.

Our advice encompasses:

Regulatory

Our team’s extensive experience in the pharmaceutical and health care field and deep understanding of our clients’ business models enable us to provide solutions to complex problems and to assist our clients in structuring their business strategies in order to mitigate the risks and ensure compliance with the legal provisions in force.

We provide assistance and legal guidance to our clients in all pharmaceutical and health care law matters, as part of merger and acquisition projects or as part of our clients’ internal compliance reviews, in structuring business models and in implementing legislative measures, especially in relation to specific permits and authorizations, compliance with specific provisions regarding the marketing and advertising of medicinal products and medical devices, national health programs and the relationships between the health insurance houses and the medicinal products providers, clinical trials, pricing, reimbursement, claw back, recall of medicinal products, export mechanisms for medicinal products, transplants, etc.

We provide constant and timely assistance to all of our clients in relation to major changes in the Romanian pharmaceutical sector, such as, among others, legislation regarding the method of calculating prices for medicinal products for human use, the claw back legislation and amendments of conditions for reimbursement.

We perform regular surveys of national and EU pharmaceutical and health care legislation, provide interpretations of these legal provisions and assess their impact on the business pharmaceutical market, as part of the assistance provided to one of our clients.

Anticorruption aspects

We provide experienced assistance to our clients in relation to compliance of commercial strategies and policies with the anticorruption legislation in Romania, by minimizing the risks and ensuring at the same time compliance with the legal provisions in force.

Promotional activities

We review our clients’ promotional strategies, marketing policies and materials for compliance with the specific legislation in force, as well as with the different codes of practice of various associations in this field, e.g. EFPIA, ARPIM, IFPMA, etc., as the case may be. We assist our clients in structuring their promotional strategies and policies considering the specific legal provisions in force and, ifnecessary, the different codes of practice to which our clients have adhered.

Representation before the competent authorities

We constantly represent our clients before the competent authorities in this field, e.g., Ministry of Health, National Health Insurance House, National Medicines and Medical Devices Agency, etc., in relation to a wide range of aspects regarding the pharmaceutical and health care fields, including requests for clarification and interpretation of relevant legal provisions.

Key projects