Legal Guidance and Research / Experts / Sally Shorthose
Sally Shorthose#4140
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Sally Shorthose

Bird & Bird
As one of our firm's most experienced intellectual property partners, specialising in transactional IP matters, Sally offers a wealth of knowledge to businesses at the cutting edge of research, development and technology, in a variety of sectors for which IP is of prime importance.

As a transactional IP lawyer, Sally provides advice on the protection and exploitation of IP rights, both in standalone transactions and as part of acquisition, divestment or investment activity. She leads the team delivering licensing, partnering and exploitation agreements, and research, development and marketing collaborations. She also advises our clients on regulatory and 'freedom to operate' issues and manage significant due diligence matters. Sally is joint head of the International Life Sciences Regulatory Group.

Before joining Bird & Bird in 2006, Sally was head of IP & Life Sciences at another global law firm, after spending 11 years in-house firstly as senior legal adviser at ICI/Zeneca and latterly as Legal Director of Novartis UK. This experience has given her significant insight into the need for pragmatic commercial advice.

As well as speaking on IP generally, and regulatory life sciences topics particularly, Sally contributes to leading publications, and she co-edits The Guide to EU Pharmaceutical Regulatory Law (Kluwer Law International), which is written entirely by the team at Bird & Bird with contributions from many offices.

Sally was named a Global Elite Thought Leader in the 2025 Whos Who Legal/Lexology Index Healthcare & Life Sciences report.

Practice Area

Panels

  • Consulting Editorial Board
  • Contributing Author

Qualified Year

  • 1988 (England & Wales); 2017 (Ireland)

Experience

  • Eversheds (2003 - 2006)
  • Clyde & Co (2001 - 2003)
  • Novartis (1997 - 2001)
  • ICI/Zeneca (1989 - 1997)
  • Herbert Smith (1986 - 1989)

Membership

  • Licensing Executive Society
  • Law Society England and Wales
  • Law Society Ireland
  • BIA

Qualification

  • LLB Hons, Law (1985)

Education

  • University of Manchester (1981–1985)

1 Contributions by Sally Shorthose

UK and EU regulation of unlicensed and off-label medicines: Specials, EAMS, NIMAR, compassionate use, supply, advertising, case law and liability
PRACTICE NOTES
UK and EU regulation of unlicensed and off-label medicines: Specials, EAMS, NIMAR, compassionate use, supply, advertising, case law and liability
This Practice Note examines unlicensed medicines and the routes by which they can reach patients across the EU and the UK, such as via the UK Specials regime. It then looks at deploying authorised medicines beyond the scope of their licence (commonly termed off-label use). Lastly, the Practice Note addresses liability questions linked to using medicines without a licence. The UK’s regime governing unlicensed products is largely rooted in EU legislation. Numerous EU-derived principles and obligations remain in UK domestic law, save where particular measures provide otherwise. The Note surveys both EU and UK frameworks: analysis of EU requirements should be treated as relevant to the UK system unless distinct UK rules departing from EU law are set out separately. It also summarises pertinent EU case law; for guidance on the extent to which UK courts and tribunals are bound after the Brexit implementation period, see Q&A: Are UK courts and tribunals bound by decisions of the Court of Justice of the European Union post-Brexit? The discussion covers availability routes, authorisation status, scope of permitted use, and resulting liability under applicable law in both jurisdictions where relevant and explained. An introduction to unlicensed medicinal products and off-label use of medicinal...
Life Sciences
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