London
tel: +44 (0)20 7786 6216
fax: +44 (0)20 7786 6299
fax: +44 (0)20 7786 6299
Ian.Dodds-Smith@ aporter.com
Practice Focus
Ian Dodds-Smith is a partner and co-head of the firm's food, drug, and medical devices practice group and the head of its European product liability practice group.
He provides advice across the full range of UK and European regulatory matters and has been involved in many major regulatory cases against the centralised regulatory bodies in the European Court and against national agencies before the UK and other Member State courts.
Mr Dodds-Smith is also a recognised professional in the field of product liability and has conducted the defence of many product liability cases for companies in the pharmaceutical, medical device, chemical, and food sectors, including a large number of multiclaimant group actions, that have frequently involved co-ordinating activity throughout the UK and in other European jurisdictions.
Mr Dodds-Smith has written widely on regulatory obligations relating to the supply of medicines and product liability issues and presented many papers at symposia.
Representative Matters
Product liability where representation is in the public domain include multiclaimant cases for Bayer, Du Pont, Schering, Wyeth, Pharmacia, St Jude Medical, Sanofi-Pasteur, SmithKlineBeecham, and Monsanto.
Regulatory cases where representation is in the public domain include cases on various regulatory issues in:
UK
- Regina (Pfizer Ltd) v. The Secretary of State for Health (2002)
- Regina (John Smeaton on behalf of Society for the Protection of Unborn Children [SPUC] v. Secretary of State for Health ex parte Schering (2003)
- Regina v. Secretary of State for Health ex parte Association of Pharmaceutical Importers and Dowelhurst Ltd (2002)
- Regina v. Licensing Authority, ex parte Monsanto plc (1997)
- The Queen, on the application of Merck Sharpe & Dohme Ltd v. Licensing Authority (2005)
- The Queen, on the application of H Lundbeck A/S and Lundbeck Ltd v. Licensing Authority (2008-2009) ex parte Teva, Generics UK, Tiefenbacher, and others
- The Queen, on the application of H Lundbeck A/S and Lundbeck Ltd v. the Licensing Authority, ex parte Synthon, Actavis, Bioorganics, Stada, and Merz (2009)
European Court
- Menarini v. Europe Commission (2002)
- Bristol-Myers Squibb International Corporation v. Commission of the European Communities, Case T-354/02(2002)
- Pfizer v. Commission of the European Communities, Case T-123/03 (2003)
- Regina v. Licensing Authority and Norgine Ltd, ex parte Scotia Pharmaceuticals (1995)
- The Queen v. The Licensing Authority established by the Medicines Act 1968 (acting by The Medicines Control Agency), ex parte Generics (UK) Ltd, The Wellcome Foundation Ltd and Glaxo Operations UK Ltd and Others, Case C-368/96, (1998)
- The Queen, on the application of Approved Prescription Services Ltd v. Licensing Authority, Case C-36/03, (2004)
- Astra Zeneca A/S v. Laegemiddelsttyrelsen and Generics (UK) Ltd, Case-233/01, (2003)
- The Queen, on the application of Synthon BV v. Licensing Authority ex parte Smithkline Beecham (2004)
Representative Matters
Product liability where representation is in the public domain include multiclaimant cases for Bayer, Du Pont, Schering, Wyeth, Pharmacia, St Jude Medical, Sanofi-Pasteur, SmithKlineBeecham, Monsanto
Regulatory cases where representation is in the public domain include cases on various regulatory issues in:
UK
- Regina (Pfizer Ltd) v. The Secretary of State for Health (2002)
- Regina (John Smeaton on behalf of Society for the Protection of Unborn Children [SPUC] v Secretary of State for Health ex parte Schering (2003)
- Regina v Secretary of State for Health ex parte Association of Pharmaceutical Importers and Dowelhurst Ltd (2002)
- Regina v Licensing Authority, ex parte Monsanto plc (1997)
- The Queen, on the application of Merck Sharpe & Dohme Ltd v. Licensing Authority(2005)
European Court
- Menarini v Europe Commission (2002)
- Bristol-Myers Squibb International Corporation v Commission of the European Communities Case T-354/02 (2002)
- Pfizer v. Commission of the European Communities, Case T-123/03 (2003)
- Regina v. Licensing Authority and Norgine Ltd, ex parte Scotia Pharmaceuticals (1995)
- The Queen v. The Licensing Authority established by the Medicines Act 1968 (acting by The Medicines Control Agency), ex parte Generics (UK) Ltd, The Wellcome Foundation Ltd and Glaxo Operations UK Ltd and Others, Case C-368/96, (1998)
- The Queen, on the application of Approved Prescription Services Ltd v. Licensing Authority, Case C-36/03, (2004)
- Astra Zeneca A/S v. Laegemiddelsttyrelsen and Generics (UK) Ltd, Case-233/01, (2003)
Awards
Elected Honorary Fellow of The Organisation for Professionals in Regulatory Affairs (TOPRA), 2006
Rankings
"Global Life Sciences Lawyer of the Year" 2010 by The International Who's Who of Business Lawyers
Chambers Global: The World's Leading Lawyers for Business 2010 for Life Sciences: Regulatory/Compliance (Globally)
The International Who's Who of Life Sciences Lawyers 2010: Named to the "Most Highly Regarded Individuals - Global" list
Chambers UK: A Client's Guide to the UK Legal Profession 2010: Named a "Star Individual" for Life Sciences: Regulatory, Compliance & Competition; and ranked in the No. 1 band for Life Sciences: Product Liability and Product Liability: Mainly Defendant
“Life Sciences Lawyer of the Year” 2009 by The International Who’s Who of Business Lawyers
PLC Which lawyer? Yearbook 2009: Leading for Life sciences: product liability (England), Life sciences: regulatory (England), and EU Life sciences: regulatory (European Union); and Recommended for Dispute resolution (England)
The International Who’s Who of Product Liability Defense Lawyers 2009
The Legal Media Group's Guide to the World's Leading Product Liability Lawyers 2009
The UK Legal 500: Product Liability
Professional and Community Activities
Professional Activity
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Member, British Institute of International Comparative Law’s product liability forum
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Member, Defence Research Institute
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Member, Federation of Insurance and Corporate Counsel Foundation
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Member, Legal Committee of the Association of the British Pharmaceutical Industry
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Former Member, various Royal College and Medical Research Council Working Parties on research and liability issues
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Fellow, Royal Society of Medicine
Books
Ian Dodds-Smith and Silvia Valverde. "The Supply of Unlicensed Medicines for Individual Patient Use 2009." (West Sussex: Wiley-Blackwell Autumn 2009).
Ian Dodds-Smith. "Medical Negligence." Product Liability for Medical Products (West Sussex: Tottel Publishing of Haywards Heath) 2008.
Ian Dodds-Smith. "Data Protection and Abridged Applications for Marketing Authorisations in the Pharmaceutical Industry." Pharmaceutical Medicine, Biotechnology and European Law. Edited by Richard Goldberg and Julian Lonbay (Cambridge University Press, 2000).
Articles
Ian Dodds-Smith, Drew A. Harker, Marcus A. Asner, Jacqueline Bore and Benjamin Kieft. "The New U.K. Bribery Act: An In-Depth Analysis." (PDF: 465 kB) Financial Fraud Law Report July/August 2010.
Ian Dodds-Smith and Alison Brown. "Recent Developments in European Product Liability." (PDF: 203 kB) The International Comparative Legal Guide to Product Liability (London: Global Legal Group Limited) 2010.
Ian Dodds-Smith and Michael Spencer QC. "England & Wales." (PDF: 216 kB) The International Comparative Legal Guide to Product Liability (London: Global Legal Group Limited) 2010.
Ian Dodds-Smith and Alison Brown. "England & Wales." (PDF: 430 kB) The International Comparative Legal Guide to Class and Group Actions (London: Global Legal Group Limited) 2010.
Ian Dodds-Smith and Alison Brown. "Recent Developments in European Product Liability." (PDF: 2.68 MB) The International Comparative Legal Guide to Product Liability (London: Global Legal Group Limited) 2009.
Ian Dodds-Smith and Alison Brown. "England & Wales." and "Recent Developments in European Product Liability." The International Comparative Legal Guide to Product Liability (London: Global Legal Group Limited) 2009.
Ian Dodds-Smith and Alison Brown. "England & Wales," and "EU Developments in Relation to Cross Border Actions for Collective Redress." The International Comparative Legal Guide to Class Actions (London: Global Legal Group Limited) 2009.
Ian Dodds-Smith. "England & Wales." (PDF: 1.08 MB) The International Comparative Legal Guide to Product Liability (London: Global Legal Group Limited) 2007.
Ian Dodds-Smith. "International Comparative Law Guide on Pharmaceutical Advertising." (London: Global Legal Group Limited, 2006).
Ian Dodds-Smith. "International Comparative Law Guide on Product Liability." (London: Global Legal Group Limited, 2005).
Ian Dodds-Smith. "Cost-Effectiveness--The Fourth Hurdle to Market Entry." (PDF: 2.29 MB) Global Counsel Life Sciences Handbook (2004/2005).
Ian Dodds-Smith and Lincoln Tsang. "Medicines for Children II." (PDF: 419 kB) Life Sciences Law & Business (August/September 2004).
Lincoln Tsang and Ian Dodds-Smith. "Medicines For Children»." Life Sciences Law & Business (June/July 2004).
Presentations
Ian Dodds-Smith. "Update on the Current Regulatory Framework-Significant Litigation." Annual Informa Conference, Brussels, Belgium (May 13, 2009).
Ian Dodds-Smith. "Regulatory Developments." Biotech & Pharma Patent Conference, Munich, Germany (January 27, 2009). (January 27, 2009).
Ian Dodds-Smith. "The Synthon Decision and Issues Arising" and "European/Paediatric Issues." Pharmaceutical International Lawyers Seminar (PILLS), Arnold & Porter LLP, London, England (January 15, 2009).
Jacqueline Bore, Ian Dodds-Smith, Tim Frazer and Luc Gyselen. "Pharmaceutical International Lawyers Seminar (PILLS)." Arnold & Porter LLP, London, England (December 5, 2008).
Ian Dodds-Smith. "Data Exclusivity--Are the Outstanding Issues All Resolved?." Pharmaceutical Law-2007, London, England (October 11, 2007).
Ian Dodds-Smith. "Implementation of the New Medicinal Legislation." Annual Informa Conference, Brussels, Belgium (May 24, 2007). (May 24, 2007).
Ian Dodds-Smith. "EU Proposed Paediatrics Regulation--What Are the Implications?." C5 Conference, London, England (September 18, 2006.
Advisories
"UK Government Announces Timing For Implementation of the Bribery Act 2010." (PDF: 414 kB) Aug 2010.
"Product Liability in the European Union-Extinction of the Right to Sue After 10 Years." (PDF: 246 kB) May 2010.
"UK Bribery Act 2010: An In-Depth Analysis." (PDF: 320 kB) May 2010.
"An End to the "English Loser Pays" Rule in Personal Injury Litigation?." (PDF: 227 kB) Mar 2010.
"The SFO Provides Updated Guidance on Its Approach to Enforcing Allegations of Overseas Corruption." (PDF: 267 kB) Dec 2009.
"Transparency, Disclosure, and Sunshine: The Global Push for Stakeholder Accountability." (PDF: 278 kB) Oct 2009.
"Evolving Expectations on Boards of Directors and Management Teams in Corporate Compliance." (PDF: 254 kB) May 2009.
"UK Proposes Sweeping New Anti-Bribery Legislation." (PDF: 240 kB) Apr 2009.
"Judicial Review of Procedural Fairness of NICE Appraisal Process." (PDF: 192 kB) May 2008.
"The Glaxo/Boehringer Case - Court of Appeal's Most Recent Decision, 'For the Present'." (PDF: 273 kB) Feb 2008.
"ECJ Decision in the Glaxo/Boehringer Case." (PDF: 215 kB) Apr 2007.
"Opinion of the Advocate General in the Glaxo Boehringer Case." (PDF: 164 kB) Apr 2006.
"Accession Issues for Supplementary Protection Certificates." (PDF: 147 kB) Apr 2006.
MA, Cambridge University, Downing College, 1972
England and Wales