Sarah Faircliffe

I work as a Legal Director in London. As a member of our International Life Sciences Group, I specialise in European regulatory law concerning medicinal products, medical devices and related areas.

Bringing a wealth of industry and policy knowledge to my role here at Bird & Bird, I offer unique insight into the law and procedures concerning the regulation of medicines, having spent 10 years as Legal Adviser with the European Medicines Agency (EMA). During my time at the EMA, I advised on many areas, including orphan drugs, paediatrics and generics of centrally authorised products, as well as advising the EMA's scientific committees on legal issues.

I also played a key role ensuring that the new EU member states joining in 2004 brought their pharma legislation and procedures into line with EU requirements. Working closely with the European Commission, I assisted with a number of pieces of litigation and the drafting and implementation of various pieces of legislation.

I also have knowledge and experience of the workings of other key EU regulators including the European Food Safety Authority, and take a particular interest in borderline products such as nutraceuticals and cosmeceuticals.

Since joining Bird & Bird, I have used my 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.

Strategies and disputes concerning regulatory data protection and orphan exclusivity are a particular focus of my current work, as well as monitoring the potential implications of Brexit for life sciences companies.

I am a regular speaker at conferences and workshops and contribute to a number of publications. I also co-chair the firm's Life Sciences Regulatory Group.

• I have advised numerous clients, both innovative and generic industry, on the legislation and case law governing regulatory data protection and orphan drug market exclusivity, enabling them to identify or anticipate potential competition in the market and, where appropriate, challenge decisions that have been taken.
• I also frequently advise on issues such as advertising/promotion of medicines and 'borderline' products, where guidelines need to be interpreted on a case-by-case basis and knowledge of the policy objectives is important.
• Past experience of working with a trade association has included challenging a European Medicines Agency's guideline and helping to secure amendment to it.
• The growth of the on-line pharmacy sector has provided recent opportunities to advise clients on the relevant regulations, including discussions with the UK regulatory body regarding how these rules apply in the context of various different business models.
• Recent litigation experience centres on representing clients in the European court, in two different cases concerning regulatory data protection issues; both these are currently ongoing.