Simont Braun - Avocats advocaten lawyers

Healthcare, Pharmaceuticals and Life Sciences

Dealing with health issues from a legal point of view primarily calls for an in-depth understanding of the numerous applicable EU and Belgian rules covering the manufacture, distribution, marketing and advertising of pharmaceuticals (both generics and biosimilars) and medical devices. Intellectual property and related rights (e.g. documents and marketing exclusivity) play an essential role in protecting the competitive advantages demanded by the significant investment levels. Other related matters also play a key role such as personal data protection, public tenders, research and development contracts, administrative procedures, etc.

Several teams collaborate within Simont Braun to provide assistance to a wide range of operators in this field. Our Intellectual Property team enjoys particular experience in patent and trademark litigation and in all matters relating to advertising and distribution.

We provide the whole range of advisory services: corporate, M&A, governance, real estate, lease contracts, distributorships, anti-competitive practices, labour law, databases, software protection, processing services and other matters of general economic law.

Our specific recent experience in this sector includes:

  • Various labelling and advertising issues relating to pharmaceuticals: opinions, negotiation with regulatory authorities and litigation between competitors;

  • Assistance provided to patent, SPC and trademark proprietors to defend their exclusive rights;

  • Support provided to various operators in the marketing chain against third-party claims relating to IP rights and trade practices;

  • Marketing authorisations for medicines and medical devices, documents and marketing exclusivity;

  • Transactional work and opinions covering outsourcing, marketing data, clinical and other personal data, experiments on humans;

  • Warehousing of health products and sale commissionaire schemes, various forms of supply contracts, agency and other distribution agreements (including issues related to administration of foreign marketing authorisations), e-commerce, drug supply obligations in the context of public tenders;

  • Manufacturer/importer cooperation with health professionals, various forms of cooperation among health professionals.