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Impact of the European Union on access to medicines in low- and middle-income countries: A scoping review.

ABSTRACT: This Scoping Review synthesises evidence of the impacts of European Union (EU) law, regulation, and policy on access to medicines in in non-EU low- and middle-income countries (LMICs), and the mechanisms and nature of those impacts. We searched eight scholarly databases and grey literature published between 1995-2021 in four languages. The EU exerts global influence on pharmaceuticals in LMICs in three ways: explicit agreements between EU-LMICs (ex. accession, trade, and economic agreements); LMICs' reliance on EU internal regulation, standards, or methods (ex. market authorisation); 'soft' forms of EU influence (ex. research funding, capacity building). This study illustrates that EU policy makers adopt measures with the potential to influence medicines in LMICs despite limited evidence of their positive and/or negative impact(s). The EU's fragmented internal and external actions in fields related to pharmaceuticals reveal the need for principles for global equitable access to medicines to guide EU policy.

SUBMITTER: Perehudoff K

PROVIDER: S-EPMC8513155 | biostudies-literature | 2021 Oct

REPOSITORIES: biostudies-literature

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Impact of the European Union on access to medicines in low- and middle-income countries: A scoping review.

Perehudoff Katrina K Durán Carlos C Demchenko Ivan I Mazzanti Valentina V Parwani Pramiti P Suleman Fatima F de Ruijter Anniek A

The Lancet regional health. Europe 20211007

This Scoping Review synthesises evidence of the impacts of European Union (EU) law, regulation, and policy on access to medicines in in non-EU low- and middle-income countries (LMICs), and the mechanisms and nature of those impacts. We searched eight scholarly databases and grey literature published between 1995-2021 in four languages. The EU exerts global influence on pharmaceuticals in LMICs in three ways: explicit agreements between EU-LMICs (ex. accession, trade, and economic agreements); LM ...[more]

PMID: 34693391

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Project description:The 2011 United Nations (UN) General Assembly Political Declaration on Prevention and Control of Non-Communicable Diseases (NCDs) brought NCDs to the global health agenda. Essential medicines are central to treating chronic diseases such as hypertension and diabetes. Our study aimed to quantify access to essential medicines for people with chronic conditions in five low- and middle-income countries and to evaluate how household socioeconomic status and perceptions about medicines availability and affordability influence access. We analysed data for 1867 individuals with chronic diseases from national surveys (Ghana, Jordan, Kenya, Philippines and Uganda) conducted in 2007-10 using a standard World Health Organization (WHO) methodology to measure medicines access and use. We defined individuals as having access to medicines if they reported regularly taking medicine for a diagnosed chronic disease and data collectors found a medicine indicated for that disease in their homes. We used logistic regression models accounting for the clustered survey design to investigate determinants of keeping medicines at home and predictors of access to medicines for chronic diseases. Less than half of individuals previously diagnosed with a chronic disease had access to medicines for their condition in every country, from 16% in Uganda to 49% in Jordan. Other than reporting a chronic disease, higher household socioeconomic level was the most significant predictor of having any medicines available at home. The likelihood of having access to medicines for chronic diseases was higher for those with medicines insurance coverage [highest adjusted odds ratio (OR) 3.12 (95% confidence intervals (CI): 1.38, 7.07)] and lower for those with past history of borrowing money to pay for medicines [lowest adjusted OR 0.56 (95% CI: 0.34, 0.92)]. Our study documents poor access to essential medicines for chronic conditions in five resource-constrained settings. It highlights the importance of financial risk protection and consumer education about generic medicines in global efforts towards improving treatment of chronic diseases.

Project description:ObjectivesTo identify priority policy issues in access to medicines (ATM) relevant for low- and middle-income countries, to identify research questions that would help address these policy issues, and to prioritize these research questions in a health policy and systems research (HPSR) agenda.MethodsThe study involved i) country- and regional-level priority-setting exercises performed in 17 countries across five regions, with a desk review of relevant grey and published literature combined with mapping and interviews of national and regional stakeholders; ii) interviews with global-level stakeholders; iii) a scoping of published literature; and iv) a consensus building exercise with global stakeholders which resulted in the formulation and ranking of HPSR questions in the field of ATM.ResultsA list of 18 priority policy issues was established following analysis of country-, regional-, and global-level exercises. Eighteen research questions were formulated during the global stakeholders' meeting and ranked according to four ranking criteria (innovation, impact on health and health systems, equity, and lack of research). The top three research questions were: i) In risk protection schemes, which innovations and policies improve equitable access to and appropriate use of medicines, sustainability of the insurance system, and financial impact on the insured? ii) How can stakeholders use the information available in the system, e.g., price, availability, quality, utilization, registration, procurement, in a transparent way towards improving access and use of medicines? and iii) How do policies and other interventions into private markets, such as information, subsidies, price controls, donation, regulatory mechanisms, promotion practices, etc., impact on access to and appropriate use of medicines?ConclusionsOur HPSR agenda adopts a health systems perspective and will guide relevant, innovative research, likely to bear an impact on health, health systems and equity.

Project description:IntroductionA majority of low-income (LIC) and lower-middle-income countries (LMIC) were unable to achieve at least 10% population coverage during initial vaccine rollouts, despite the rapid development of the coronavirus disease 2019 (COVID-19) vaccines. Nearly three years into this pandemic, evaluating the impact of inequities in vaccine access, uptake, and availability is long overdue. We hypothesized that a delay in receiving COVID-19 vaccines was associated with an increased toll on cumulative cases and mortality. Furthermore, this relationship was modified by the size of a country's economy.MethodsWe performed an ecological study assessing these relationships, in which a country's economic standing was assessed by world bank income classification, gross domestic product based on the purchasing power parity (GDP PPP) per capita category, and crude GDP PPP.ResultsCountries with the smallest economies reported first vaccination much later than larger economies on all three rankings, as much as 100 days longer. Among low-income countries, a one-day increase until the first vaccination was associated with a 1.92% (95% CI: 0.100, 3.87) increase in cumulative cases when compared to high-income countries (p = 0.0395) when adjusting for population size, median age, and testing data availability. Similarly, among the lowest GDP PPP countries a one-day increase until the first vaccination was associated with a 2.73% (95% CI: 0.100, 5.44) increase in cumulative cases when compared to the highest GDP PPP countries (p = 0.0415). When modeling cumulative mortality, effects in the same direction and magnitude were observed, albeit statistically non-significant.ConclusionEconomic standing modified the effects of delayed access to COVID-19 vaccination on cumulative cases and mortality, in which LMICs tended to fare worse in outcomes than high-income countries despite the eventual rollout of vaccines. These findings highlight the importance of prioritizing equitable and timely access to COVID-19 vaccines across all countries, irrespective of economic size. Future studies should examine the impacts that vaccine inequities had on local transmission dynamics.

Dataset Information

Impact of the European Union on access to medicines in low- and middle-income countries: A scoping review.

Publications

Impact of the European Union on access to medicines in low- and middle-income countries: A scoping review.

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