Tine Carmeliet
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.
Practice Area
Panel
- Contributing Author
Qualified Year
- 2015
Experience
- Allen & Overy (Belgium) LLP (2015 - 2024)
- Allen Overy Shearman Sterling (Belgium) LLP (2024 - Present)
Membership
- AIPPI
- ChIPs
- KU Leuven
- Vrijdaggroep
Qualifications
- Master of Laws (2013)
- Master of Arts (2015)
- Admitted to the Brussels Bar (2015)
Education
- University of Leuven, Master of Laws (2008-2013)
- The Johns Hopkins University School of Advanced International Studies, Master of Arts in European Studies and International Economics (2013-2015)
- Harvard Medical School Online Medical Courses (2019)
- Middlesex University, The mechanics of health economics, IFF training (2021)
3 Contributions by Tine Carmeliet
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
EU pharmaceutical exclusivities and incentives: SPCs, regulatory data and market protection, orphan and paediatric regimes; interactions, key case law, SPC waiver and unitary SPC, and pending legislative reforms
What are pharmaceutical incentives?
In the EU, protection mechanisms and incentives for medicinal products, grouped under the term pharmaceutical incentives (PIs), are in place. PIs comprise legislative measures that give originator pharmaceutical companies (originators) a degree of advantage over companies selling medicines with the same active substance at far lower prices (generic or biosimilar companies)-ranging from market protection (MP), through extensions of patent rights, to several years of market exclusivity for a medicinal product.
Rationale behind PIs
PIs were introduced in the EU to encourage and support originators in discovering and developing new medicinal products. While innovation and discovery typically require considerable time and financial investment, only limited effort is needed to use the knowledge generated afterwards. When a generic or biosimilar company reproduces an invention, it often does not bear the substantial research and development (R&D) costs of creating it and can therefore sell the resulting medicinal product at a price well below the originator’s. The prospect of this may discourage originators, who cannot recover the initial outlay incurred during the R&D process. PIs help originators in maintaining certain benefits and...
Life Sciences
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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