Shuna Mason

Work Highlights

Evolving lifesciences business models to include eHealth products or connectivity, including advice on borderlines between manufacturer and healthcare provider regimes and triggers for healthcare provider registration requirements (Care Quality Commission or equivalent) and remote healthcare and cross-border healthcare regulatory and liability issues.

The legal status of clinical use software and potential medical device / IVD (or accessory) status for a wide variety of different software products, including surveys of legal status across multiple regions.

A US-based orphan medicinal product manufacturer on the commercialisation, reimbursement and compliance processes across G5 group countries.

A UK R&D company on the implications of the EFPIA Disclosure Code.

Takeda Pharmaceutical Company Limited on the integration of its business with that of acquired Swiss drug company, Nycomed A/S.

Product borderline issues (drug / device / cosmetic / human tissue / biocide / “unclassified” borderlines) and appropriate product development and marketing strategies, including surveys of viability of different product claims across multiple jurisdictions.

A Japanese global pharmaceutical company on the clinical trial insurance requirements across 18 jurisdictions and also for a clinical trials insurer on multi-jurisdictional insurance requirements, policies and certificates.

A Japanese pharmaceutical company on the EU labelling implications for generic companies of EU usage patents.

Merger partners in the context of a competition inquiry about API and excipient GMP manufacturing requirements.

Various pharmaceutical and medical device companies on compliance with the UK Bribery Act and with the ABPI Code of Practice / MedTech Europe Code of Ethical Business Practice and in relation to investigation of violations and complaints, including coordinating compliance systems reviews across multiple jurisdictions.

Practice Areas

Shuna Mason is a partner in the Lifesciences group at CMS UK and is the firm’s lead on regulatory and product liability issues.

She specialises in the lifesciences and consumer products sectors, covering pharmaceuticals, medical devices, in vitro diagnostic devices, human tissue, cosmetic and plant protection products.

Shuna advises companies on regulatory, compliance and liability issues in relation to product lifecycles as well as business models, on both international as well as national issues. She frequently manages and co-ordinates international regulatory, compliance and liability / litigation advice. She is also actively involved in UK and European trade associations in the medical devices and diagnostics sectors, including as an invited member of the MedTech Europe legal affairs focus group and its ethical business code committee and brings a broad perspective on healthcare sector issues when advising clients.

Shuna’s team advises in relation to pre-market development, market authorisation or conformity assessment as well as in relation to (pharmaco-)vigilance and other post-market compliance issue, including postmarket surveillance, field safety corrective action, labelling/IFU and all types of promotional materials and activities, including compliance.

Shuna has extensive experience in handling English product liability disputes and other litigation, including regulatory enforcement and judicial review administrative challenges. She is also familiar with co-ordinating and managing product liability litigation and recalls across Europe and beyond for manufacturers and insurers.