Paediatric medicines

Produced in partnership with Tine Carmeliet of A&O Shearman , Eline D’Joos of A&O Shearman , Rafi Allos of A&O Shearman and Dr Jacqueline Bore of A&O Shearman

Practice notes

Paediatric medicines

Produced in partnership with Tine Carmeliet of A&O Shearman , Eline D’Joos of A&O Shearman , Rafi Allos of A&O Shearman and Dr Jacqueline Bore of A&O Shearman

Practice notes

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 for Use in children from birth until (but not including) the age of 18.

In the past decades, little to no research and development into paediatric medicines took place. Many medicines were indeed not studied nor authorised for paediatric use, thereby forcing physicians to adapt dosage and form of medicinal products for the adult population based on their personal experience.

It should not cause surprise that such large-scale off-label use entailed an increased risk of ineffective treatment and adverse reactions in children. A report from the European Medicines Agency (EMA) describes that while little data is available, harm did occur and was often underreported.

There are several reasons for the lack of research and development of paediatric medicines, such as the fact that it

Tine Carmeliet

Senior Associate (Lawyer), 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 regulations (new breeding techniques and Nagoya Protocol).

She also has a sound life sciences policy understanding thanks to her secondment to the European Federation of Pharmaceutical Industries Associations legal team, where she focused on regulatory and IP policy.

Eline D’Joos

Junior Associate, 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

Lawyer (Partner), 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 categories in the Euromoney LMG Europe Rising Star Awards 2019.

Dr Jacqueline Bore

Senior Professional Support Lawyer - Life Sciences, 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 Justice of the European Union.

Jacqueline practiced medicine for 8 years before qualifying as a solicitor.

Jurisdiction(s):

United Kingdom

Key definition:

IA definition

What does IA mean?

See Investment Association.

Paediatric medicines

Produced in partnership with Tine Carmeliet of A&O Shearman , Eline D’Joos of A&O Shearman , Rafi Allos of A&O Shearman and Dr Jacqueline Bore of A&O Shearman

Paediatric medicines

Produced in partnership with Tine Carmeliet of A&O Shearman , Eline D’Joos of A&O Shearman , Rafi Allos of A&O Shearman and Dr Jacqueline Bore of A&O Shearman