Sarah Faircliffe
Sarah works as a Legal Director in London, as part of Bird & Bird’s Life Sciences and Healthcare Group. With over twenty years of experience, she advises clients on EU and UK laws, guidance and codes of practice concerning the regulation of medicines, medical devices and related areas. In 2022, Sarah was short-listed for the Advisory Lawyer of the Year at the LMG Life Sciences Awards, and she was also part of the winning team for the “Impact Case of the Year” at the same awards.
Having spent 10 years as a Legal Adviser at the European Medicines Agency (EMA), Sarah brings a wealth of industry and policy knowledge to her role, offering unique insight into the law and procedures governing medicines regulation. During this period, she advised the EMA and its scientific committees on a wide range of legal issues. She played a key role in ensuring that the new EU member states joining in 2004 brought their pharma legislation and procedures into line with EU requirements and worked closely with the European Commission on several cases litigated in the European Courts and on the drafting and implementation of various pieces of legislation.
Sarah uses her in-depth knowledge of the regulatory framework to assist a wide range of clients on all aspects of the regulation of products in the life sciences sector. This ranges from advising on the correct interpretation of legislation, guidelines and case law to helping to steer clients through procedures and negotiations relating to the marketing of their products, including representing them in discussions with regulatory bodies. Much of this work involves working closely with Bird & Bird colleagues in other offices to provide pan-European regulatory advice.
Complex strategies and disputes concerning regulatory data protection and orphan exclusivity are a particular focus of her work. Over the years, she has been involved in several of the cases shaping the interpretation of these concepts in the European Courts, and she is currently advising clients in a number of ongoing cases.
Sarah is a regular speaker at conferences and workshops and contributes to a number of publications.
Practice Area
Panel
- Contributing Author
Qualified Year
- 1992
Experience
- Bird & Bird (1992 - 1997)
- European Medicines Agency (1997 - 2007)
Membership
- The Organisation for Professionals in Regulatory Affairs (TOPRA)
Qualifications
- MA in Biochemistry (1988)
- Law Society Final Exam (1990)
- LLM in European and International Law (1995)
Education
- University of Oxford (1984-1988)
- European University Institute, Florence (1994-1995)
2 Contributions by Sarah Faircliffe
PRACTICE NOTES
EU Orphan Medicinal Products: Regulatory Framework, Designation Criteria, EMA Procedures, Market Exclusivity and Derogations, Similarity and Clinical Superiority, Off-label Implications, Key Case Law and Proposed Reforms
Orphan medicinal products (OMPs)
Orphan medicinal products (OMPs) are medicines intended to prevent, diagnose or treat rare medical disorders and conditions. Because patient numbers are extremely small, and in the absence of incentives, pharmaceutical firms may doubt whether sales would ever cover the research and development (R&D) costs of creating medical products to diagnose, prevent and treat such rare diseases. In EU law, ‘rare’ means affecting fewer than five in 10,000 people across the EU. Yet most rare diseases impact fewer than one in 100,000 individuals. Although each rare disease is uncommon, they carry notable public health significance and enduring relevance. It is estimated there are more than 6,000 rare diseases; thus, while each is infrequent, together they account for a substantial patient population, in aggregate roughly one in every 12 people in the EU (all rare diseases combined). Without incentives, developing and marketing OMPs is often not commercially feasible for pharmaceutical companies, and only about 5% of rare diseases currently have an authorised treatment option available at present. Guided by the principle that people with rare diseases should access medicines that meet the same standards of quality, safety and efficacy as other patients and communities, the EU introduced, at European level, a regulatory...
EU Law
PRACTICE NOTES
Orphan Medicinal Products: EU and UK Regulatory Frameworks—Designation, Authorisation, Market Exclusivity, Derogations, Key Case Law and Forthcoming Reforms
(OMPs) are medicines that help prevent, identify or treat rare illnesses and medical conditions. Because the number of people affected is very small, without incentives, pharmaceutical companies may doubt whether sales would cover the research and development (R&D) costs of medical products to detect, prevent and treat such disorders. In the relevant EU law, 'rare' is defined as affecting fewer than five in 10,000 people in the EU. Yet most rare conditions impact fewer than one in 100,000 people. Although each individual rare disease is uncommon, they carry major public health importance and significance. There are thought to be more than 6,000 distinct rare diseases; so, while each is infrequent on its own, together they account for a substantial patient population, roughly one in every 12 people in the EU (all rare diseases combined). In the absence of incentives, it is frequently not commercially feasible for pharmaceutical companies to develop and market OMPs, and only about 5% of rare diseases currently have an authorised treatment option available...
Life Sciences
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