Dr Jacqueline Bore
Jacqueline is a senior lawyer with many years’ experience in advising companies in the life sciences sector on the challenges they face in developing and bringing new medicines and medical devices to the market. She has advised clients on the regulatory pathway for medicines and medical devices in Europe, in particular advising on:
Clinical trials, including transparency issues
Paediatric investigation plans,
Marketing authorisations,
Orphan medicinal products,
Manufacturing and wholesale distribution authorisations,
Supply chain issues including novel direct to patient solutions,
Parallel trade
Advertising and promotion
Relations with healthcare professionals, including bribery and corruption
Pricing and market access, including NICE submissions and appeals
Product liability, including managing substantial multiparty actions.
Jacqueline has advised on a number of judicial reviews challenging regulatory decisions of both MHRA and the EMA and has defended product liability claims in the House of Lords, Supreme Court and the Court of Justice of the European Union.
Jacqueline practiced medicine for 8 years before qualifying as a solicitor.
Practice Area
Panel
- Contributing Author
Qualified Year
- 1995
Experience
- Trainee solicitor, Theodore Goddard (1993 - 1995)
- Assistant solicitor, Theodore Goddard (1995 - 1999)
- Senior assistant solicitor, CMS Cameron McKenna (1999 - 2005)
- Senior associate, Arnold & Porter (2005 - 2011)
- Partner, DLA Piper (2011 - 2012)
- Director, Senior Regulatory Lawyer, Celgene International, Switzerland (2013 - 2017)
Membership
- Full registration with the General Medical Council (1981)
- Member of the Royal College of General Practitioners (1995)
Education
- Kings College London, Postgraduate diploma in European Union law (2011)
- College of Law, York and London (1990-1991)
- Guy’s Hospital, M.B., B.S. (1983)
- Oxford University, MA in Jurisprudence (1980)
2 Contributions by Jacqueline Bore
PRACTICE NOTES
EU paediatric medicines regime: PIP obligations, waivers and deferrals; SPC paediatric extensions; PUMAs; sanctions; and 2023–2026 reform proposals, with comparative US and international developments
Also prepared in partnership, with contributions from Marylis Clerc of Bird & Bird and Sapna Palla of White & Case LLP.
What are paediatric medicines and why do we need them?
Paediatric medicines are medicinal products intended for children from birth up to, but not including, 18 years of age. Over recent decades, very limited research and development in this area occurred. Numerous medicines were neither studied nor authorised for paediatric use, compelling clinicians to modify dosage and presentation of adult medicines according to their own judgement. Unsurprisingly, such widespread off-label practice carried a higher likelihood of poor efficacy and adverse reactions in children. A report by the European Medicines Agency (EMA) states that, despite scarce data, harm did occur and was frequently underreported. Multiple factors explain the shortfall in paediatric R&D, including the perception that enrolling children in clinical trials was unethical. Creating medicines for children is also far more complicated than for adults, because children are not a single homogeneous subgroup, but have differing requirements and biological and physiological profiles. Physicians relied on personal experience to tailor adult formulations to children, adjusting strengths and forms without formal guidance. Such practice became widespread in routine clinical care. This inevitably...
EU Law
PRACTICE NOTES
Paediatric Medicines: EU and post‑Brexit UK regimes on PIPs, waivers, deferrals, incentives (paediatric extensions, PUMA), enforcement and reforms; plus US overview and international standards (ICH E11A, WHO)
Also produced in partnership with contributions from Marylis Clerc of Bird & Bird and Sapna Palla of White & Case LLP.
What are paediatric medicines and why do we need them?
Paediatric medicines are medicinal products intended for children from birth up to, but not including, 18 years of age.
For decades, research and development in this field was minimal. Numerous medicines were neither studied nor authorised for paediatric use, leaving clinicians to modify adult formulations and doses using their own judgement. Unsurprisingly, such widespread off‑label prescribing brought a higher risk of poor efficacy and adverse reactions in children. According to a report by the European Medicines Agency (EMA), despite limited available data, harm did occur and was frequently underreported.
Several factors explain the lack of paediatric R&D, including the view that enrolling children in clinical trials was unethical. Creating medicines for younger patients is also far more challenging than for adults, as children are not a uniform group and have varied needs alongside distinct biological and physiological profiles. This inevitably requires additional...
Life Sciences
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