Govin Permanand

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.

Constitutional asymmetry and pharmaceutical policy-making in the European Union

Abstract This paper offers a theoretical perspective on pharmaceutical policy-making in the European Union, and shows the lack of a single European market in medicines to be the result of a clash between the supranational free movement rules and national healthcare policy competencies. The paper considers the roles of the European Commission, the member states, the industry and consumer interests (patients) as the main stakeholders, and frames the discussion within an integrated macro- and meso-level approach. Here we draw on Wilsons ‘politics of (regulatory) politics’ typology, tying it to Scharpfs ‘constitutional asymmetry’ perspective on EU policy. This enables the development of a broad sphere of analysis, allowing us to make observations on the EU regulatory arrangement for medicines as a whole. Specifically, the paper shows the extent to which industrial rather than health(care) policy interests have driven the development of regulatory policy in the sector, and seeks to understand the political dynamics shaping the on-going evolution of the regulatory framework.

The EU’s new paediatric medicines legislation: serving children’s needs?

In new legislation for paediatric medicines which came into effect on 26 January 2007, the European Union (EU) has attempted to address several unresolved issues relating to children’s needs for medicines in Europe. This article reviews the legislation’s main proposals and makes some comparisons with equivalent legislation in the USA. We argue that the legislation suffers from several gaps and uncertainties in relation to the specific proposals and their intended aims. As the establishment of new legislation in this area offered the EU an opportunity to set some clear guidelines and objectives, and had the potential to go beyond the equivalent American rules, we thus see the proposals as something of a disappointment.

Europe's migration challenges: mounting an effective health system response.

Health systems are at the forefront of the response to the ongoing humanitarian crisis facing refugees and other migrants fleeing to Europe, both as a first point of contact for arrivals and later during their resettlement and beyond. (The term ‘migrant’ is used here with the understanding that there are numerous groups that fall within this categorization, but which are distinct in terms of their status, e.g. asylum-seeker, refugee, undocumented migrant, economic migrant, family-reunited migrant, etc., where a specific group is mentioned by name, it is in a context where this specificity is required.) Yet even if the scale of migration is new, at least in the post-war period, some European countries have considerable experience of sudden large-scale immigration, whether from Algeria to France in the 1960s, East African Asians coming to the United Kingdom in the 1970s, refugees from former Yugoslavia in the 1990s and, more recently, across the Mediterranean to Italy, Malta and Spain. However, few lessons seem to have been learnt, and European health systems vary greatly in their ability to respond to this new challenge.1The situation is complicated further by differences in formal entitlement to health care,2 even though it is now clear that restricting access costs more money in the long run.3 The challenges facing undocumented migrants are particularly alarming, as many of those now moving either fall into this category already or will soon do so if their applications for asylum are rejected. Even where migrants are entitled to care they may face many barriers. These include language barriers and inadequate information about their rights and how to claim them. At the …

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

BackgroundHealth 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.MethodsTo 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.ResultsIn 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.ConclusionsThe AGREE-HS comprises a User Manual, five quality items and two overall assessment questions. It is available at agreetrust.org.