Issues for countries considering introducing the "fourth hurdle": The case of Hungary

Objectives: This study outlines the needs and current development of the "fourth hurdle" (i.e., requirement of effectiveness and cost-effectiveness data for drug coverage policy decisions) in Hungary, describes the legal background and seeks to address some of the most important questions in this field. Methods: The study draws on international experiences and discusses five issues that a given jurisdiction needs to consider before introducing the "fourth hurdle" for pharmaceuticals. Results: The "fourth hurdle" is very relevant in Hungary because many existing drugs are unevaluated and many new, expensive drugs are becoming available. On the other hand, the existing resources for health technology assessment, including economic evaluation, are quite limited. All the five issues are relevant in the Hungarian setting and were helpful in determining exactly how the "fourth hurdle" should be applied. Conclusions: The most important issue seems to be that the implementation of the "fourth hurdle" needs to be achieved in a way consistent with the limited resources for HTA in Hungary. Specifically this means that, in setting priorities for drugs to evaluate, additional criteria need to be applied. In particular, priority should be given to assessing drugs that have been evaluated in other countries, because this affords the opportunity to adapt existing studies or models to the Hungarian situation

Geographies and politics of localism: the localism of the United Kingdom's Coalition Government

There has always been a localist element to British politics. But recently, a particular version of localism has been moved to the foreground by the 2011 Localism Act. This paper identifies various uses and meanings of localism, maps their geographical assumptions and effects, and critiques their politics. It does this using the localism of the United Kingdom’s Coalition Government as a case study of localism in practice. The rationalities, mentalities, programmes, and technologies of this localism are established from Ministerial speeches and press releases, along with Parliamentary Acts, Bills, White Papers, Green Papers, and Statements – all published between May 2010 when the Coalition Government was formed, and November 2011 when the Localism Act became law. We argue that localism may be conceptualised as spatial liberalism, is never straightforwardly local, and can be anti-politica

Financial interests of patient organisations contributing to technology appraisal at England's National Institute for Health and Care Excellence (NICE): a policy review

Objectives: To investigate the prevalence of financial interests among patient organisations contributing to health technology assessment at the National Institute for Health and Care Excellence (NICE) in England, and the extent to which current disclosure policy ensures decision-making committees are aware of these interests. Design: Policy review using annual accounts, reports and websites of patient organisations, a database of payments declared by pharmaceutical manufacturers (Disclosure UK), other manufacturer declarations, responses from patient organisations, and declarations of interests by nominated representatives of patient organisations. Setting: Appraisals of medicines and treatments for use in the English and Welsh National Health Service. Participants: 53 patient organisations contributing to 41 NICE technology appraisals published in 2015 and 2016, with 117 separate occasions that a patient organisation contributed to the appraisal of a technology. Main outcome measures: (i) Prevalence of specific interests, i.e. funding from manufacturer(s) of a technology under appraisal or competitor products; (ii) Proportion of specific interests of which NICE decision-making committees were aware; (iii) Proportion of specific interests for which disclosure was not required by current NICE policy. Results: 38/53 (71.7%) patient organisations had accepted funding from the manufacturer(s) of a technology or a competitor product in the same or previous year that they had contributed to the appraisal of that technology. Specific interests were 46 present on 92 out of 117 (78.6%) occasions that patient organisations contributed to appraisals in 2015 and 2016. NICE decision-making committees were aware of less than a third of specific interests (36/115, 31.3%). For over half of the specific interests of which committees were unaware (42/79, 53.2%), disclosure by patient organisations was not required by current NICE policy. Conclusions: Specific interests are highly prevalent among patient organisations contributing to health technology assessment. NICE is reviewing its disclosure policy to ensure that decision-making committees are aware of all relevant interests

Paying for "End-of-Life" Drugs in Australia, Germany, and the United Kingdom: Balancing Policy, Pragmatism, and Societal Values

Analyzes British, Australian, and German health systems' policies on covering expensive end-of-life drugs while maintaining equity and efficiency, such as requiring evidence of comparative clinical and cost-effectiveness. Outlines challenges for the U.S

Enhancing the quality of published research on ethnicity and health: is journal guidance feasible and useful?

Researching ethnicity and health presents significant ethical, conceptual and methodological challenges. While the potential contribution of research evidence to tackling ethnic inequalities in health is recognised, there are widespread concerns regarding the ethical and scientific rigour of much of this research and its potential to do more harm than good. The introduction of guidance documents at critical points in the research cycle - including within the peer-review publication process - might be one way to enhance the quality of such research. This article reports the findings from the piloting of a guidance checklist within an international journal. The checklist was positively received by authors and reviewers, the majority of whom reported it to be comprehensible, relevant and potentially useful in improving the quality of published research. However, participation in the pilot was poor, suggesting that the impact of such a checklist would be very limited unless it was perceived to be an aid to authors and reviewers, rather than an additional burden, and was strongly promoted by journal editors

EU Ecolabel for food and feed products – feasibility study

The environmental impacts of the production and processing of food, feed and drinks make up between 20% and 30% of the total environmental impacts of consumable goods in the EU. In the case of eutrophication (the accumulation of nutrients in water causing a reduction in oxygen availability) they account for as much as 58% of the total impacts. The EU Ecolabel is a voluntary scheme that forms part of overall EU policy to encourage more sustainable consumption and production. To date, the EU Ecolabel scheme has developed criteria for products in the non-food sector. The Regulation that governs the scheme (66/2010) aims to extend the EU Ecolabel into new product categories including food. However, the Regulation stipulates that before extending to the food sector, a feasibility study should be undertaken