Healthcare and Life Sciences

We are one of the few firms around that understands the challenges and risks faced by the healthcare sector: our multidisciplinary team can offer unrivalled advice on every single one.

We’ll give you outstanding support on every stage of your value chain, including by:

  • assisting in the initial phase of product development (drafting joint development agreements, R&D, and licensing/acquisition/sale of intellectual property rights
  • advising on the carrying out of clinical trials (including through CROs) and managing the relationships with the regulatory authorities to obtain commercial authorisations
  • negotiating and drafting sales agreements for distribution, joint promotion, franchising and procurement, and usage agreements for medical devices
  • managing relations with healthcare workers (doctors, medical sales representatives, medical facility managers)
  • planning and managing extraordinary acquisitions, including international ones
  • handling regulatory, administrative and environmental issues at national and European level
  • liaising with the administrative authorities, including with regard to calls for tenders
  • patent cross border litigation and other litigation involving administrative, regulatory, intellectual property and competition issues
  • preventing and managing anticorruption concerns
  • managing tax risks and resolving transfer pricing issues

Besides large Italian and international companies, we also represent SMEs that want the same high quality service.

 

Here’s what sets us apart

  • We are a multidisciplinary team who combine renowned legal expertise with in-depth knowledge of the pharmaceutical and biomedical markets
  • Our professionals are experts in various practice areas, including competition/EU law, litigation, environmental law, administrative law, corporate law and M&A, IP and tax law. Our approach is designed to make the most of our legal and sector know-how to pinpoint the issues, understand your objectives and come up with the best solutions

 

Learn about our Focus Teams.

Case Studies

SPC manufacturing waiver comes into play 1 July

On 11 June, the SPC manufacturing waiver was published in the Official Journal of the European Union (Regulation (EU) 2019/933, which introduces the waiver to Regulation (EC) No. 469/2009). The approved text allows EU-based companies to manufacture generics and biosimilars throughout the lif …

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African Medicines Agency

The health ministers of the 55 states that form the African Union unanimously adopted the text of the treaty establishing the African Medicines Agency. The new regulatory agency will play a key role in coordinating member states’ activities, including by establishing commo …

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Insights

Francesca Mastroianni joins BonelliErede’s Healthcare and Life Sciences Focus Team

BonelliErede further strengthens its Healthcare and Life Sciences Focus Team with the addition of Francesca Mastroianni, who joins the Rome office. Francesca has intimate knowledge of regulatory and compliance issues in the pharmaceutical sector, having worked at the Italian Medicines Agency fo …

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A new team leader for the Healthcare and Life sciences Focus Team: Vincenzo Salvatore

BonelliErede renews the leadership of its Healthcare and Life sciences Focus Team with the appointment of Vincenzo Salvatore as the new Team Leader. Vincenzo Salvatore, Full Professor of European Union Law, joined BonelliErede in 2015, bringing his specific regulatory and compliance skills in t …

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BonelliErede boosts international footprint with launch of Dubai office

Major international law firm BonelliErede today announced the firm’s latest milestone in its international expansion, with the launch of a new office in the heart of the prestigious Dubai International Financial Centre. Combined with the recent openings in Cairo and Addis Ababa, the firm now …

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