Jurisdiction(s):
European Union

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

Published by a LexisNexis EU Law expert

Practice notes

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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...

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Tine Carmeliet

A&O Shearman

Tine heads A&O Shearman’s Belgian life sciences team. She specializes in life sciences patents litigation and advises clients on regulatory issues and commercial transactions in the life science sector. Her litigation experience includes both representing clients before the Belgian and European courts and assisting clients with multi-jurisdictional proceedings. She advices multinational companies and start-ups as well as research institutes in the pharmaceutical, biotech and medical devices sectors on a variety of complex matters, including clinical trials, product approvals, regulatory incentives, market access, promotion and advertising, post-market obligations, MDR and IVDR, digital health solutions, artificial intelligence, real world data and transparency regulations. She regularly assists clients with drafting and negotiating high value IP licenses, R&D collaborations, tech transfer and spin-out deals and has particular expertise with cell and gene therapy products. In addition, Tine has extensive experience advising on agro(bio)tech and food and feed...

Eline D’Joos

A&O Shearman

Eline is a junior associate in the IP department of Allen & Overy Belgium, and a member of the Belgian life sciences practice. She focusses on IP, life sciences regulatory law and data protection, and assists clients both in non-litigious and litigious matters in these areas. She has expertise in advising on biosimilars, orphan drugs, Belgian supplementary protection certificates and the regulatory approval pathway to bring vaccines to market. She has also assisted with mergers and acquisitions of life sciences companies, as well as patent infringement proceedings and preliminary injunctions in relation to strategic drugs....

Rafi Allos

A&O Shearman

Rafi is a Partner in the IP Litigation practice in London. Rafi specialises in contentious life sciences patents work and advising clients on regulatory issues in the life sciences sector. Rafi's patent litigation experience includes both representing clients in U.K. proceedings and assisting clients with multi-jurisdictional proceedings and preparation for potential litigation. In addition, Rafi has a particular interest in the impact of life sciences regulatory issues on patent litigation.Rafi has spoken on life sciences regulatory matters at the Pharmaceutical Law Academy in Cambridge from 2014 to 2017. He has been recognised since 2017 as a “rising star” in the Patents section of Managing Intellectual Property's IP Stars and as a Next Generation Lawyer / Rising Star in Legal 500 (both in Life Sciences and Healthcare and in Patents). Rafi was also awarded a European Rising Star Award in the Life Sciences and UK...

Dr Jacqueline Bore

A&O Shearman

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...

Web page updated on 22/05/2026

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