The constant medical innovation and patents evolution, the advancement of biotechnology and the increased number and sophistication of stakeholders are few of the trends in the pharmaceutical and healthcare sector we rely our expert advice on.
In this context, we take a proactive approach to guide clients on how to effectively address the increasingly varied and complex regulatory aspects related to their on-going activities. In doing so, we keep them connected to developments that may impact their business strategies.
Our experienced team of lawyers focuses on dealing with regulatory and compliance issues, as well as with current or anticipated commercial and legislative developments in IP, competition, privacy or commercial and contractual aspects that may impact the day-to-day activity in this sector.
Our lawyers add value through insightful understanding of this industry’s business model that shifted towards increased niche-based care and redesign of portfolios and target markets. This positions us as the optimum choice for providing sound legal advice on regulatory and legal matters, including:
- license and supply agreements
- pricing of medicinal products
- claw-back system
- clinical trials
- donation, sponsorship of medicinal products
- distribution of medicinal products and of medical devices
in the context of multi-faced commercial projects or before government agencies and authorities.
Challenges faceted by the industry increasingly require multidisciplinary approaches, which our pharmaceutical and healthcare team takes on in an integrated manner, combining its industry specific capabilities with the wealth of experience of our dedicated legal & tax practices, including corporate, data protection, tax or dispute resolution.
Regulatory Advice and Representation
Our pharmaceutical and healthcare clients rely on our ability to combine industry knowledge with a proficient assessment of each business, to help them make informed decisions from a legal, tax and operational stand point.
We regularly assist clients explore, identify and select the most suitable path for each of their business initiatives and we assess
- the impact of the specific regulatory requirements regarding permits and authorizations,
- compliance with specific provisions on 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 and medical services,
- clinical trials, pricing, reimbursement, claw-back, recall of medicinal products, parallel trade and so on,
to propose instrumental alternatives and innovative solutions, as feasible.
We believe in “anticipating” rather than just “solving“; thus, we stay attumed to the national and EU pharmaceutical and healthcare legislative developments and immediately evaluate and communicate their potential impact on the pharmaceutical market in general and on our clients’ businesses in particular, as integral part of our commitment to their success.
Compliance of our clients’ commercial strategies and policies with Romanian anti-corruption legislation is among our primary concerns.
We aim at identifying each client’s specific set of vulnerabilities and we present them with practical, cost-effective policies to help mitigate the potential risks or avoid them completely, where feasible.
We are called to take part in FCPA/compliance audits at local subsidiaries of market participants to test, build or respond to compliance programmes, as business maker or breaker in this current business environment. This allows our clients to focus more on business objectives and less on potential regulatory and compliance challenges – which sometimes may go unnoticed in everyday business operations – confident that our team guards their interests.
We are equipped to assist market participants during each phase of their products’ life-cycle and put particular emphasize on our clients’ promotional strategies, marketing policies and related materials conformity with the legislation in force and with the codes of practice promoted by the associations advocating for the this industry, including EFPIA, ARPIM , IFPMA and APNGR.