Adela WilliamsPartner at Arnold & Porter
Adela Williams advises clients in relation to the regulation of medicinal products and medical devices in the UK and at the EU level, particularly in relation to clinical trials, marketing authorisations and advertising, and promotional issues, including legal proceedings arising from the decisions of regulatory bodies. She represents clients before the Appeal Board of the Prescription Medicines Code of Practice Authority in relation to alleged breaches of the Code with respect to promotion and related issues.
Dr. Williams provides advice to clients in relation to pricing and reimbursement issues, including the interpretation and application of the Pharmaceutical Price Regulation Scheme and parallel Statutory Scheme and all stages of health technology appraisals by the National Institute for Health and Care Excellence (NICE), Scottish Medicines Consortium, and the All Wales Medicines Strategy Group. She frequently represents clients at NICE appeal hearings and has acted on behalf of the manufacturer company in two of the three applications for judicial review which have been brought against NICE in the Administrative Court.
She has substantial experience representing pharmaceutical and medical device clients in product liability litigation (unitary actions and group litigation), including claims involving unlicensed medicines in the research context as well as marketed products. Such litigation has often involved co-ordinating proceedings within the EU and advising on forum and other jurisdictional issues.
Dr. Williams is a registered medical practitioner and an Assistant Coroner.
PANEL: New HTA Regulations and Evolving Pharmaceutical Market Access Frameworks, 14:10View Session