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EU Life Sciences
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.
EU Life Sciences 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)
- 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)
- The Queen on the application of Association of British Pharmaceutical Industry v. Medicines & Healthcare Products Regulatory Agency(2010)
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)
- 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 BVv. Licensing Authority ex parte Smithkline Beecham(2004)
- Sepracor Pharmaceuticals Ltd v. Commission of the European Communities Case T-275/09
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)
- 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)
- The Queen on the application of Association of British Pharmaceutical Industry v. Medicines & Healthcare Products Regulatory Agency(2010)
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)
- 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 BVv. Licensing Authority ex parte Smithkline Beecham(2004)
- Sepracor Pharmaceuticals Ltd v. Commission of the European Communities Case T-275/09
Chambers Global: The World's Leading Lawyers for Business 2011-2013 for Life Sciences: Regulatory/Compliance (Globally)
The Legal 500 UK 2012 - Recommended for TMT: Pharmaceuticals & Biotechnology
The Legal 500 UK 2012 - Recommended for Product Liability: Defendant
Who's Who Legal Awards Global Life Sciences Lawyer of the Year 2012
PLC Which lawyer? 2012 - Recommended for Life Sciences: Regulatory
PLC Which lawyer? 2012: Recommended for EU Life Sciences: Regulatory
Chambers UK: A Client's Guide to the UK Legal Profession 2012: Named a "Star Individual" for Life Sciences: Regulatory; and ranked in the No. 1 band for Life Sciences: Product Liability and Product Liability: Mainly Defendant
The International Who's Who of Life Sciences Lawyers 2011 and 2010: Named to the "Most Highly Regarded Individuals - Global" list
The International Who's Who of Product Liability Defense Lawyers 2011: Named to the "Most Highly Regarded Individuals - Global" list
The Legal 500 UK 2011: Leading Individual for Insurance - Product Liability: Claimant
The Legal 500 UK 2011: Leading Individual for TMT: Pharmaceuticals and Biotechnology
Named a BTI Client Service All-Star in 2011
PLC Which lawyer? Yearbook 2011: Endorsed for Life sciences: product liability (England); Life sciences: regulatory (England); and EU Life sciences: regulatory (European Union)
The Legal 500 UK 2010: Named a "leading individual" for product liability and pharmaceuticals & biotechnology
The International Who's Who of Business Lawyers "Global Life Sciences Lawyer of the Year" 2010
The International Who’s Who of Business Lawyers “Life Sciences Lawyer of the Year” 2009
Elected Honorary Fellow of The Organisation for Professionals in Regulatory Affairs (TOPRA), 2006
Chambers UK: A Client's Guide to the UK Legal Profession 2013 - Top Ranked for Life Sciences: Product Liability
Chambers UK: A Client's Guide to the UK Legal Profession 2013 - Top Ranked for Life Sciences: Regulatory
Chambers UK: A Client's Guide to the UK Legal Profession 2013 - Recommended for Product Liability: Mainly Defendant
PLC Which lawyer? 2012 - Recommended for Life Sciences: Product Liability
The Legal 500 UK 2011 for Insurance - Product Liability: Defendant
The Legal 500 UK 2011 for TMT: Pharmaceuticals and Biotechnology
Legal Media Group's Guide to the World's Leading Product Liability Lawyers 2010
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
Ian Dodds-Smith, Lincoln Tsang, Jacqueline Mulryne and Christopher Stothers "SPCs and Paediatric Obligations: The Need For Coordination" (PDF: 180 kB) International Law Office, January 23, 2013
Ian Dodds-Smith, Christopher Stothers and Jacqueline Mulryne "Court Rejects Challenge to Paediatric Extension of SPC for Lipitor" (PDF: 169 kB) International Law Office, January 9, 2013
Alison Brown and Ian Dodds-Smith "EU Developments in Relation to Cross-border Actions for Collective Redress" (PDF: 308 kB) Chapter 1 - 2013 edition of The International Comparative Legal Guide to: Class & Group Actions; published by Global Legal Group Ltd, London. www.iclg.co.uk Online. November 1, 2012
Alison Brown and Ian Dodds-Smith "A practical cross-border insight into class and group actions work" (PDF: 339 kB) Chapter 13 - 2013 edition of The International Comparative Legal Guide to: Class & Group Actions; published by Global Legal Group Ltd, London. www.iclg.co.uk Online. November 1, 2012
Alison Brown and Ian Dodds-Smith "The International Comparative Legal Guide to - Product Liability 2012" (PDF: 267 kB) Chapter 1, 2012
Ian Dodds-Smith "The International Comparative Legal Guide to - Product Liability 2012" (PDF: 288 kB) Chapter 18, 2012
Ian Dodds-Smith and Michael Spencer QC "England & Wales" (PDF: 313 kB) The International Comparative Legal Guide to Product Liability (London: Global Legal Group Limited) 2011
Ian Dodds-Smith and Alison Brown "Recent Developments in European Product Liability" (PDF: 300 kB) The International Comparative Legal Guide to Product Liability (London: Global Legal Group Limited) 2011
Ian Dodds-Smith and Alison Brown "England & Wales" (PDF: 196 kB) The International Comparative Legal Guide to Class and Group Actions (London: Global Legal Group Limited) 2011
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 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 Allison 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 "England & Wales" (PDF: 1.08 MB) The International Comparative Legal Guide to Product Liability (London: Global Legal Group Limited) 2007
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
"Interim relief granted in challenge to EMA's decision to disclose pre-clinical and clinical information from an application for a centralised marketing authorisation" (PDF: 439 kB) May 2013
"UK Court Rejects Challenge to Paediatric Extension of SPC for Lipitor" (PDF: 574 kB) Dec 2012
"Post-Neurim SPCs and Paediatric Obligations: The Need for Coordination" (PDF: 465 kB) Dec 2012
"Key Amendments and Expanded Scope of the Revised IFPMA Code of Practice" (PDF: 652 kB) Mar 2012
"Better Protection for Innovative Pharmaceuticals in Europe?" (PDF: 308 kB) Jun 2011
"UK Government Issues Guidance on the Bribery Act" (PDF: 410 kB) Mar 2011
"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