HERA-lding More Integration in Health? Examining the Discursive Legitimation of the European Commission's New Health Emergency Preparedness and Response Authority.

CONTEXT: Since COVID-19, the European Commission (EC) has sought to expand its activities in health through the development of a European Health Union and within it the Health Emergencies Preparedness and Response Authority (HERA). METHODS: The authors applied a discourse analysis to documents establishing HERA to investigate how the EC legitimated the creation of this institution. They focused on how it framed health emergencies, how it framed the added value of HERA, and how it linked HERA to existing EU activities and priorities. FINDINGS: Their analysis demonstrates that security-based logics have been central to the EC's legitimation of HERA in alignment with a "securitization of health" occurring worldwide in recent decades. This legitimation can be understood as part of the EC's effort to promote future integration in health in the absence of new competences. CONCLUSIONS: Securitization has helped the EC raise its profile in health politically without additional competences, thereby laying the groundwork for potential future integration. Looking at the discursive legitimation of HERA sheds light not only on whether the EC is expanding its health powers but also how it strategizes to do so. HERA, while constrained, allows the EC to further deepen security-driven integration in health.

Solidarity as a Political Determinant of Health: Insights from EU Competition Policy.

CONTEXT: The connection between law and political determinants of health is not well understood, but nevertheless it is suggested that the two are inseparable, and this represents an upstream level with scope for influencing other determinants of health (particularly social determinants). Solidarity underpins European health care systems, and given its clear link with redistribution, it can be seen as a means for addressing health inequities. As such, solidarity may be seen as a political determinant of health in the specific context of European Union (EU) competition policy. METHODS: A range of EU case law, treaty provisions, and European Commission publications relating to EU competition policy are analyzed. FINDINGS: Solidarity is typically juxtaposed as antithetical to competition and thus as underpinning exceptions to the applicability of prohibitions on anticompetitive agreements, abuse of dominance, and state aid. Case law indicates an additional dynamic between definitions of solidarity at the EU and national levels. CONCLUSIONS: This analysis leads to two groups of considerations when framing solidarity as a political determinant of health in the EU competition policy context: first, the predominance of solidarity suggests it may shape competition reforms; second, the EU-member state dynamic indicates less EU-level reach into national competition reforms in health care than may be expected.

Second Paediatric Strategy Forum for anaplastic lymphoma kinase (ALK) inhibition in paediatric malignancies: ACCELERATE in collaboration with the European Medicines Agency with the participation of the Food and Drug Administration.

The first (2017) and sixth (2021) multistakeholder Paediatric Strategy Forums focused on anaplastic lymphoma kinase (ALK) inhibition in paediatric malignancies. ALK is an important oncogene and target in several paediatric tumours (anaplastic large cell lymphoma [ALCL], inflammatory myofibroblastic tumour [IMT], neuroblastoma and hemispheric gliomas in infants and young children) with unmet therapeutic needs. ALK tyrosine kinase inhibitors have been demonstrated to be active both in ALK fusion-kinase positive ALCL and IMT. ALK alterations differ, with fusions occurring in ALCL, IMT and gliomas, and activating mutations and amplification in neuroblastoma. While there are many ALK inhibitors in development, the number of children diagnosed with ALK driven malignancies is very small. The objectives of this ALK Forum were to (i) Describe current knowledge of ALK biology in childhood cancers; (ii) Provide an overview of the development of ALK inhibitors for children; (iii) Identify the unmet needs taking into account planned or current ongoing trials; (iv) Conclude how second/third-generation inhibitors could be evaluated and prioritised; (v) Identify lessons learnt from the experience with ALK inhibitors to accelerate the paediatric development of other anti-cancer targeted agents in the new regulatory environments. There has been progress over the last four years, with more trials of ALK inhibitors opened in paediatrics and more regulatory submissions. In January 2021, the US Food and Drug Administration approved crizotinib for the treatment of paediatric and young adult patients with relapsed or refractory ALCL and there are paediatric investigation plans (PIPs) for brigatinib and for crizotinib in ALCL and IMT. In ALCL, the current goal is to investigate the inclusion of ALK inhibitors in front-line therapy with the aim of decreasing toxicity with higher/similar efficacy compared to present first-line therapies. For IMT, the focus is to develop a joint prospective trial with one product in children, adolescents and adults, taking advantage of the common biology across the age spectrum. As approximately 50% of IMTs are ALK-positive, molecular analysis is required to identify patients to be treated with an ALK inhibitor. For neuroblastoma, crizotinib has not shown robust anti-tumour activity. A focused and sequential development of ALK inhibitors with very good central nervous system (CNS) penetration in CNS tumours with ALK fusions should be undertaken. The Forum reinforced the strong need for global academic collaboration, very early involvement of regulators with studies seeking possible registration and early academia-multicompany engagement. Innovations in study design and conduct and the use of 'real-world data' supporting development in these rare sub-groups of patients for whom randomised clinical trials are not feasible are important initiatives. A focused and sequenced development strategy, where one product is evaluated first with other products being assessed sequentially, is applicable for ALK inhibitors and other medicinal products in children.

Vet medicines: key post-Brexit changes.

Brexit has resulted in some key changes to the regulation of veterinary medicines, as the Veterinary Medicines Directorate explains.

COVID-19 and the Emerging Regulatory Guidance for Ongoing Clinical Trials in the European Union.

The coronavirus disease 2019 (COVID-19) pandemic and the accompanying control measures have significantly affected clinical trial (CT) conduct, and sponsors have needed to make rapid changes to their CT operations. As a result, regulatory guidance was pivotal during the initial phases of the pandemic. This study aimed to evaluate the regulatory readiness and guidance related to COVID-19 in the European Union (EU). The European Medicines Agency (EMA) and national competent authorities' (NCAs') websites were searched in September and October 2020 for guidances on the management of CTs during the pandemic published from January 2020 onward. "Regulatory readiness" was defined as the number of days from the first European COVID-19 case (January 24, 2020) to the first published guidance by the respective NCA. "Regulatory guidance" was evaluated by coding the guidances for the following predefined operational trial activities important for ongoing CTs: obtaining informed consent, participant information, clinic visits, home health visits, telemedicine visits, self-monitoring, investigational medicinal product (IMP) supply, IMP adherence monitoring, CT monitoring, documentation management, regulatory management, and safety management. Twenty-four of the 27 EU NCAs published country-specific guidance. The time from the first European COVID-19 case to the first published EMA guidance was 56 days and ranged from 47 to 66 days for the first national guidances. Guidance was provided most frequently for regulatory management (24/24), safety management (23/24), documentation management (22/24), and CT monitoring (22/24). The regulatory guidance provided during the pandemic, ensuring participant safety and data integrity, may now be the starting point to innovate future CT conduct.