Open access Protocol BMJ Open: first published as 10.1136/bmjopen-2020-044293 on 23 February 2021. Downloaded from Implementation of medicines pricing policies in sub-Saharan Africa: protocol for a systematic review Tolib Mirzoev ,1 Augustina Koduah,2 Anna Cronin de Chavez,1 Leonard Baatiema,3 Anthony Danso- Appiah,3 Tim Ensor ,1 Irene Akua Agyepong,4 Judy M Wright ,5 Irene A Kretchy,2 Natalie King5 To cite: Mirzoev T, Koduah A, ABSTRACT Strengths and limitations of this study Cronin de Chavez A, et al. Introduction Ensuring universal availability and Implementation of medicines accessibility of medicines and supplies is critical for ► This systematic review protocol follows the Preferred pricing policies in sub- national health systems to equitably address population Saharan Africa: protocol for a Reporting Items for Systematic Reviews and Meta- health needs. In sub- Saharan Africa (SSA), this is a systematic review. BMJ Open Analyses Protocols guidelines. recognised priority with multiple medicines pricing 2021;11:e044293. doi:10.1136/ ► The review addresses a gap in the current knowl- policies enacted. However, medicine prices have remained bmjopen-2020-044293 edge of the determinants and outcomes of success- high, continue to rise and constrain their accessibility. In ful implementation of medicines pricing policies in ► Prepublication history and this systematic review, we aim to identify and analyse sub- Saharan Africa (SSA). additional material for this experiences of implementation of medicines pricing paper are available online. To ► The focus on SSA will help with transferability of les- policies in SSA. Our ambition is for this evidence to view these files, please visit sons across the different countries within the region, contribute to improved implementation of medicines the journal online (http:// dx. doi. though this may lead to omission of important ex- pricing policies in SSA. org/ 10. 1136/ bmjopen- 2020- periences for example from Asia and Latin America Methods and analysis We will search: Medline, Web 044293). and may limit transferability of lessons outside the of Science, Scopus, Global Health, Embase, Cairn.Info SSA. TM and AK are joint first authors. International Edition, Erudit and African Index Medicus, the ► The search will be restricted to peer- reviewed pub- grey literature and reference from related publications. lished articles and grey literature, thus, relevant the- Received 29 August 2020 The searches will be limited to literature published from Revised 16 January 2021 ses and conference abstracts are likely to be omitted the year 2000 onwards that is, since the start of the Accepted 11 February 2021 and may affect the depth of evidence on the topic. Millennium Development Goals. http://bmjopen.bmj.com/ ► The narrative synthesis approach reflects the nature Published peer- reviewed studies of implementation of of published evidence on the topic of policy imple- medicines pricing policies in SSA will be eligible for mentation with no meta- analysis possible, and is a inclusion. Broader policy analyses and documented potential limitation of this review. experiences of implementation of other health policies will be excluded. The team will collaboratively screen titles and abstracts, then two reviewers will independently screen full texts, extract data and assess quality of the included © Author(s) (or their to safe, quality and affordable medicines as employer(s)) 2021. Re- use studies. Disagreements will be resolved by discussion or its key driver.1–3 Increasing access to essential a third reviewer. Data will be extracted on approaches on September 30, 2021 by guest. Protected copyright. permitted under CC BY. medicines through medicines pricing inter- Published by BMJ. used for policy implementation, actors involved, evidence 1 used in decision making and key contextual influences on ventions is an issue of current health policy Nuffield Centre for International 4 5 Health and Development, policy implementation. A narrative approach will be used discourses. In response, various policy University of Leeds, Leeds, UK to synthesise the data. Reporting will be informed by the initiatives have evolved to regulate medicine 2School of Pharmacy, University Preferred Reporting Items for Systematic Reviews and pricing and improve access. of Ghana, Legon, Greater Accra, Meta- Analyses Protocols guideline. Globally, different medicine pricing models Ghana Ethics and dissemination No ethics approvals are 3School of Public Health, and strategies exist. These include: generic required for systematic reviews. or biosimilar price linking to originator University of Ghana, Accra- Results will be disseminated through academic Legon, Ghana products, non-proprietar y prescribing and 4 publications, policy briefs and presentations to national Research and Development policymakers in Ghana and mode widely across countries generic substitutions, tendering and pooled Division, Ghana Health Service, procurements, internal reference pricing, Accra, Greater Accra, Ghana in SSA. 5Leeds Institute of Health PROSPERO registration number CRD42020178166. external price referencing or international Sciences, University of Leeds, price comparisons and managed-entr y agree- Leeds, UK ments.6–8 Implementation of these medi- Correspondence to INTRODUCTION cine pricing policies may be dependent on Professor Tolib Mirzoev; The current agenda of Universal Health in- country manufacturing capacity, pricing t. mirzoev@ leeds. ac. uk Coverage highlights the importance of access levels of the medicines, whether medicines Mirzoev T, et al. BMJ Open 2021;11:e044293. doi:10.1136/bmjopen-2020-044293 1 Open access BMJ Open: first published as 10.1136/bmjopen-2020-044293 on 23 February 2021. Downloaded from are generic or branded, and whether medicines are for 2. How have these policies been implemented (in rela- outpatient or inpatient services.9 tion to implementation approaches, processes, in- Many of these medicine pricing policies are being volvement of actors, role of evidence, etc)? implemented in high-income countries. However, unlike 3. Which key facilitators and barriers affected the imple- in high- income countries, low- income and middle- mentation of medicines pricing policies, and how? income countries have less regulated and developed 4. Which implementation of medicines pricing policies pharmaceutical markets and have different challenges in SSA are effective (in relation to reducing prices of in distribution and production.1 In light of this, multiple medicines and improving access to services)? medicine pricing models and strategies are required to This review is being undertaken during April 2020–May achieve equitable access to safe, quality and affordable 2021 as part of the project on ‘Improving equitable access medicines,10 particularly in sub- Saharan African (SSA) to essential medicines in Ghana through bridging the countries.10 gaps in implementing medicines pricing policy’ (AMIPS project)—an National Institute for Health Research Rationale (NIHR) funded award received jointly by the University Ensuring availability and accessibility of medicines is an of Leeds, University of Ghana and the Ghana Health important mechanism by which national health systems Service. The results of this review will be combined can equitably address health needs of their populations, with results of policy analyses in Ghana and will inform including the poorest and the most vulnerable. In SSA, engagements with key stakeholders on improving the this is a recognised policy priority. For example, in the implementation of the current policies and identifica- last two decades different medicines pricing policies tion of future research and development priorities. Our were implemented in South Africa11 12 and between ambition is for evidence from this review to contribute to 2012 and 2017, the Government of Ghana introduced improved implementation of medicines pricing policies four policies to improve access to medicines through across countries of SSA. This protocol follows the Preferred Reporting Items for medicine price regulation, and ultimately, health Systematic Reviews and Meta- Analyses- Protocols (PRIS- outcomes and quality of life. These policies are currently MA- P) guidelines13 and a PRISMA- P checklist is available at different stages of their implementation and despite as an online supplemental file. these efforts, medicine prices have remained high and continue to rise, making them inaccessible to a large proportion of populations. This raises questions as to METHODS AND ANALYSIS why and how these policies are failing to achieve the Eligibility criteria desired outcomes. Studies In this systematic review, we will explore the effective- We will include empirical studies including Randomised http://bmjopen.bmj.com/ ness of implementation of medicines pricing policies Controlled Trials, quasi- experimental studies and cohort in the SSA context. We want to identify which policies and cross- sectional studies. Reviews (scoping reviews, have been implemented and then explore three broad meta- syntheses, realist syntheses) will also be included dimensions of their implementation. First, we want to and individual primary studies from the systematic understand what happened, that is, identify evidence on reviews will be manually included as empirical literature. effective implementations of medicines pricing policies We will exclude opinion pieces and conceptual/theoret- reflected in a reduction in prices and improvement in ical