Regulating under constraint: the case of EU pharmaceutical policy

This study is concerned with the making of regulatory policy for pharmaceuticals in the European Union. It proposes that an ad hoc development of Community competencies which does not amount to coherent strategy, far less a single medicines market, has resulted in a regulatory framework which favours the interests of industry. This is important on two fronts. First, it appears to run counter to contemporary research into EU regulation, which finds that consumer interests prevail over those of producers generally. Second, this pro-industry leaning seems not to be in keeping with member states' regulatory frameworks at home, which developed primarily as a means of protecting consumers' health (patients) following the Thalidomide tragedy. In providing support for this contention, rather than adopting an economic frame of analysis to assess - quantitatively - how the industry benefits, the study instead proposes a political perspective to understand how policy decisions have been taken. Specifically, the study examines how supranational policy for pharmaceuticals is made with the context of a clash between the European Community's free movement of goods principles and, via the principle of subsidiarity, the right of the member states to decide their national healthcare priorities. The agenda and roles of the European Commission, the member states, consumer interests, and the industry as the sector's four primary stakeholders are scrutinised within this context. The analysis concentrates on policy level interactions, examining how the political considerations at stake over medicines have affected policy outcomes in specific instances. It is shown that the incomplete development of competencies is not just a result of the policy clash, but also because different policy impetuses (and stakeholders) have spurred different aspects of the framework. This involves the development of a multi-faceted theoretical lens in order to capture the complexities of making pharmaceutical policy at EU level. This lens is based on the understanding that EU pharmaceutical policy is made within policy networks consisting of the four stakeholders. To gain a better grasp of the dynamics at play, these networks are tied to a regulatory policy-making framework known as the 'politics of policy'. It is a view which identifies different modes of regulatory politicking on the basis of the perceived costs and benefits the proposed intervention would bring to affected interests. Linked with wider European integration and policy-making theories, including neo-functionalism, intergovernmentalism and multi-level governance, this allows for a more complete perspective on how policy is made for the sector. Via its broader approach, therefore, the study provides insight into the complexities of making supranational policy for medicines, especially with regard to the need to balance conflicting interests within the harmonisation process

Placing Trust at the Heart of Health Policy and Systems

Trusted interactions are crucial in health systems. Trust facilitates effective healthcare by encouraging patients to seek and adhere to treatment, enabling teamwork among health professionals, reducing miscommunication and medical errors, and fostering innovation and resilience. The COVID-19 pandemic underscored the importance of trust, highlighting the challenges in establishing and maintaining it, especially during crises when trust in authorities and health systems is vital for compliance and safety. However, trust is complex, varying with context and experiences, and is dynamic, easily lost but hard to regain. Despite its importance, trust is often overlooked in health policy and difficult to measure. Health systems and policymakers must recognize the importance of trust, measure it effectively, understand how it is built or eroded, and act to maintain and restore it. This involves acknowledging the past experiences of marginalized groups, involving communities in decision-making, and ensuring transparency and integrity in health practices and policies

Validity and usability testing of a health systems guidance appraisal tool, the AGREE-HS

Health systems guidance (HSG) provides recommendations to address health systems challenges. No tools exist to inform HSG developers and users about the components of high quality HSG and to differentiate between HSG of varying quality. In response, we developed a tool to assist with the development, reporting and appraisal of HSG - the Appraisal of Guidelines for Research and Evaluation-Health Systems (AGREE-HS). This paper reports on the validity, usability and initial measurement properties of the AGREE-HS.; To establish face validity (Study 1), stakeholders completed a survey about the AGREE-HS and provided feedback on its content and structure. Revisions to the tool were made in response. To establish usability (Study 2), the revised tool was applied to 85 HSG documents and the appraisers provided feedback about their experiences via an online survey. An initial test of the revised tool's measurement properties, including internal consistency, inter-rater reliability and criterion validity, was conducted. Additional revisions to the tool were made in response.; In Study 1, the AGREE-HS Overview, User Manual, quality item content and structure, and overall assessment questions were rated favourably. Participants indicated that the AGREE-HS would be useful, feasible to use, and that they would apply it in their context. In Study 2, participants indicated that the quality items were easy to understand and apply, and the User Manual, usefulness and usability of the tool were rated favourably. Study 2 participants also indicated intentions to use the AGREE-HS.; The AGREE-HS comprises a User Manual, five quality items and two overall assessment questions. It is available at agreetrust.org

SUPPORT Tools for evidence-informed health Policymaking (STP) 13: Preparing and using policy briefs to support evidence-informed policymaking

This article is part of a series written for people responsible for making decisions about health policies and programmes and for those who support these decision makers

Exploring the evidence base for national and regional policy interventions to combat resistance

The effectiveness of existing policies to control antimicrobial resistance is not yet fully understood. A strengthened evidence base is needed to inform effective policy interventions across countries with different income levels and the human health and animal sectors. We examine three policy domains—responsible use, surveillance, and infection prevention and control—and consider which will be the most effective at national and regional levels. Many complexities exist in the implementation of such policies across sectors and in varying political and regulatory environments. Therefore, we make recommendations for policy action, calling for comprehensive policy assessments, using standardised frameworks, of cost-effectiveness and generalisability. Such assessments are especially important in low-income and middle-income countries, and in the animal and environmental sectors. We also advocate a One Health approach that will enable the development of sensitive policies, accommodating the needs of each sector involved, and addressing concerns of specific countries and regions