Ian Dodds-Smith is co-head of the firm's Food, Drug and Medical Device practice with primary responsibility for the European Union market. In this respect he advises companies and trade associations on all aspects of the regulatory framework within Europe and compliance with it, including all aspects of enforcement and on rights to judicial review of decisions of the competent authorities. He has been instructed in a large number of the cases relating to the scope of the rights of innovators to regulatory data protection under EU law. He has practiced in this field for more than 30 years and was an adviser to the European Commission on regulatory issues that drove its 2004 amendments to the EU legislative framework.

He is also head of the firm's European Product Liability practice advising companies in the pharmaceutical, medical device, chemical and food sectors on the defence of claims and has particular expertise in the defence of multi-claimant cases with cross-border implications.

Experience

  • InterMune: representation as claimant in a judicial review in the European Court of the decision of the European Medicines Agency to disclose certain pre-clinical and clinical data from the company’s application for marketing authorisation for pirfenidone
  • ViiV: representation as interested party in a judicial review by Teva against the European Medicines Agency in the European Court challenging the regulatory data protection applied in respect of one of ViiV’s products
  • Pfizer: representation as claimant in a judicial review in the European Court against the European Medicines Agency in respect of matters surrounding an application for the rewards flowing from successful completion of a paediatric investigation plan for a major product
  • Association of the British Pharmaceutical Industry: representing the Association on a reference to the European Court of Justice, as claimant in judicial review of a decision of the UK Agency to allow payment of inducements to doctors by health authorities to switch patients from branded products to the cheapest generic in class
  • Multi-national company in relation to establishing New Active Substance classification and, therefore, full regulatory data/marketing protection for a novel pro-drug

  • Multi-national pharmaceutical companies in relation to updating and rolling out of EU compliance programmes
  • Multi-national company: conduct of independent internal inquiry concerning non-compliance by a distributor with laws relating to promotion and inducements and alleged acquiescence by company management
  • Start-up company in relation to advantages and disadvantages of conditional marketing authorisations
  • Multi-national pharmaceutical companies in relation to the requirements of the Orphan Drug Regulation
  • Multi-national pharmaceutical companies in relation to the interpretation of the Paediatric Regulation
  • Case references concerning other important decisions of the UK Courts or European Courts on the interpretation of EU law relating to marketing authorisations, parallel imports and pricing and reimbursement

Recognition

Chambers Global
Life Sciences: Regulatory/Compliance (Global-wide) (2009-2018)
Best Lawyers UK
Life Sciences Law (2018-2019)
Product Liability Litigation (2018-2019)
The Legal 500 Hall of Fame
Product Liability: Defendant; Pharmaceuticals and Biotechnology (UK) (2018)
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Credentials

Education
  • MA, Cambridge University, Downing College, 1972
Admissions
  • England and Wales
Activities
  • Former Member, various Royal College and Medical Research Council Working Parties on research and liability issues

  • Fellow, Royal Society of Medicine

  • Member, Defence Research Institute

  • Member, British Institute of International Comparative Law’s product liability forum

  • Member, Legal Expert Network, Association of the British Pharmaceutical Industry

Overview

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