Source: https://www.arnoldporter.com/en/people/w/williams-adela
Timestamp: 2019-04-20 11:09:44+00:00

Document:
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.
The defence of multi-claimant group actions and individual claims on behalf of Sanofi-Aventis, Wyeth, Bayer, Schering, St. Jude Medical, Novartis, and Du Pont.
Representation before the appeal panel of NICE, including on behalf of Amgen, Bayer, Bristol-Myers Squibb, Eisai, Janssen-Cilag, Eli Lilly, Roche, and Sanofi-Aventis.
Davis v. Jacobs, Camden & Islington Health Authority and Novartis Pharmaceuticals (UK) Ltd  3 Med Law Reports 72 – first case in England and Wales regarding alleged negligent design and conduct of clinical trial).
XYZ & Ors v. Schering Healthcare Limited and Ors  EWHC 1420 – product liability group action arising from increased risk of thrombotic events allegedly associated with third-generation combined oral contraceptives).
Dr. Goran Jamal: represented the General Medical Council before its Professional Conduct Committee, in relation to an allegation of clinical research fraud against the principal investigator in a trial of a treatment for diabetic neuropathy.
Northwick Park clinical trial disaster: acted for TeGenero, the developer of a monoclonal antibody administered to volunteers in a first-in-man phase I clinical trial at Northwick Park Hospital in March 2006, in relation to the investigation by the Medicines and Healthcare products Regulatory Agency (MHRA), the Expert Scientific Group on Phase I Clinical Trials, and claims by trial participants seeking compensation.
R on the application of Eisai Ltd v. the National Institute for Health and Clinical Excellence  EWCA Civ 438 – judicial review of decision by NICE following its appraisal of a treatment for Alzheimer's disease).
R on the application of Bristol-Myers Squibb Pharmaceuticals Ltd v. the National Institute for Health and Clinical Excellence  EWHC 2722 – judicial review of decision by NICE following its appraisal of a treatment for rheumatoid arthritis).
Multiple Claimants v. Sanofi-Synthelabo Ltd. (the Fetal Anticonvulsant Litigation) – product liability litigation brought on behalf of children of mothers with epilepsy alleging congenital abnormalities as a result of exposure to anti-epileptic medication during pregnancy).
InterMune UK and Others v EMA Case T-73/13 - application to General Court challenging decision by EMA to disclose confidential information in response to request for access under Regulation (EC) 1049/2001.

References: v. 
 v. 
 v. 
 EWCA 
 v. 
 v.