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.

Insights

A new IMI2 call (JU Call 21) for the development of therapeutics and diagnostics to combat coronavirus infections da coronavirus

The World Health Organisation (“WHO”) recently declared COVID-19 a pandemic. European institutions are thus pulling out the stops to gain a greater understanding of the virus, above all to help develop clinical and public health measures to improve patient health and contain the spread o …

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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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News

Covid-19: BonelliErede launches a task force

The Covid-19 outbreak in Italy has led to a public health emergency and unforeseen challenges for businesses. It has also led to uncertainties, including from a tax/legal perspective. Especially in light of the measures being issued by the government, BonelliErede las launched a multidisciplina …

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BonelliErede makes up four new partners

BonelliErede’s partnership continues to expand. At the partners’ meeting on Saturday, four promotions to the partnership were approved: Barbara Concolino, Sara Lembo, Matteo Fanni and Giovanni Muzina. Barbara Concolino (38) joined BonelliErede in 2014. She specialises in international arbit …

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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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