Table 2 Characteristics of the studies included in the review sample size, study design and settings

Ali and Yahia, 2012 [36]

Sudan

To compare national pricing with retail prices, adherence of prices, comparison of generic medicine pricing, demonstrate violations and put forward recommendations

Cross-sectional survey

Survey of 174 medicines

Pharmacy and Poisons Act (2001)

Regulation of pharmaceutical prices using the current fixed mark-ups of 15% and 20% of the total cost for wholesalers and retailers, respectively

Wholesalers, National Medicines and Poisons Board, manufacturers and retailers

N/A

N/A

-Shortage of trained personnel and resources to assess cost and freight (C&F) prices

-Lack of scrutiny on medicine pricing information by regulators

-No pricing control, e.g. medicine prices of certain generics higher than their originators

-23% of C&F prices approved by NMPB were over 10 times the international reference price

-The wholesale and retail prices were 40% and 47% less than that approved by NMPB respectively

-E leven out of 12 originator medicines were ≥ their retail prices published in the British National Formulary

-Prices distributed by Central Medical Supplies was 2-fold their C&F price

N/A

Ali, 2009 [48]

Sudan

To evaluate the revolving drug fund (RDF) effect on accessibility of essential medicines and its impact on the utilization of public health services

Mixed methods: structured interviews and documentary analysis

Ninety-three patients at the exit points of selected public health facilities. Ninety-three health facility users in hospitals and health centres, 5 with the RDF and 2 without. One teaching hospital outpatient department, 1 rural hospital and 3 health centres (urban, peri urban and rural)

Revolving drug fund

N/A

Ministry of Health

Save the Children (UK)

N/A

Initial funding support from donors

N/A

-Cost of RDF prescription was perceived as affordable by users with improved quality compared to previously free medicines

-Medicines for chronic diseases were considered expensive

-Patients in non-RDF facilities spent more than those in RDF facilities, with 67% able to afford their medicines and 8% discontinued due to cost

RDF facilities had increased access to essential medicines, with 97% availability during the past 12 months

Ashigbie et al., 2016 [49]

Ghana

To examine medicines managements policies under Ghana’s NHIS, from perspectives of public and private sector providers

Qualitative study using semi-structured interviews

Public and private sector providers (government and mission hospitals, private hospitals and private standalone pharmacies), pharmaceutical suppliers and NHIS district office

Reimbursement of medicines to health facilities

Reimbursement for cost to private and public health facilities

-Public and private health facilities

-Pharmacies

-Licenced chemical shops

-Christian Health Association of Ghana Facilities

N/A

An essential medicines list facilitates reclaim costs of a wide range of medicines

-Lack of standardization of mark ups (25–50%) and high market prices of medicines

-Reimbursement delays

-Lower prices at CMS does not apply in pricing in retail pharmacy

-The current pricing system, in both public and private sectors, is of limited benefit in controlling escalating medicine prices

Patients may not have access to medicine because not all facilities participate in the scheme and not all medicines are captured in the NHIS reimbursable list

Bangalee and Suleman, 2016 [45]

South Africa

To examine cardiovascular originator and generic drug prices using international reference prices

Quantitative study — secondary data analysis

Five classes of cardiovascular disease drugs

Generics and single exit price (SEP) legislation

Manufacturers could sell their medicines at uniform prices

N/A

N/A

Prices lowered based on market availability

N/A

-The SEP policy has not resulted in competitive prices

-75% of generic drugs were 40% or more cheaper than the branded ones

N/A

Bangalee and Suleman, 2019 [46]

South Africa

To compare prices among originator, pseudo-generics and generics

Quantitative study based on private sector prices of medicines

Prices taken from 18 medicines in study

Generic medicines and SEP

SEP mandates manufacturers to sell at a uniform price

N/A

N/A

N/A

-Lack of prices regulation

-Established relationship for originator companies creating challenges for generic manufacturers

N/A

N/A

Cassar and Suleman, 2019 [50]

South Africa

To assess whether international benchmarking of medicines (IBM) with comparator countries would lower medicine prices locally

Quantitative economic — observational analysis

Not documented

External reference pricing (ERP) [39] policy

SEP aimed to regulate, pricing, remove rebates and discounts

-Pricing committee

-National Department of Health

N/A

N/A

-The use of ERP does not adopt a multidimensional approach

-Emergence of negotiated confidential discounts

Ex-manufacturer price reduced by 68%, 85% and 85% of products in 2016, 2017 and 2018, respectively

N/A

Cohen et al. 2013 [51]

Tanzania

To assess the first 1.5 years of Affordable Medicines Facility for malaria (AMFm) use in Tanzania

Household longitudinal survey and interview, surveys and customer exit interviews

Sixty-four ADDO shop owners. Sixty-four sub villages, Seven-hundred households in round 1 and 756 in rounds 2 and 3. Total = 3900 individuals

N/A

N/A

N/A

N/A

Awareness campaigns

People not being aware that artemisinin combination therapies (ACTs) were a better treatment option

N/A

ACT use from round 1 to 3 increased

d'Almeida, et al. 2011 [47]

Cameroon

The study presents lessons learnt from provisions of second-line treatments for HIV and AIDS

Mixed methods — interview; semi-open questionnaires

Not stated

Free medicines

Free second-line treatments for HIV/AIDs

National Council for the Fight Against HIV/AIDS, National Direction to Fight Diseases, Provincial Centers for Treatment

N/A

Free second-line treatment facilitated by external funding

-Lack of integrated information systems on HIV/AIDS patients

-Deficiencies in the supply chain/logistics for 2nd-line treatments

N/A

Problems led to very limited number of patients getting 2nd-line treatments

de Jager and Suleman, 2019 [44]

South Africa

To determine the impact of generics and generic reference pricing on candesartan and rosuvastatin

Quantitative, retrospective

Beneficiaries from registered medical schemes who were contracted with the PBM for the entire study period

Generics and reference pricing

N/A

Government, pricing committee, pharmacists, Pharmaceutical Society of South Africa and Retailers

N/A

N/A

A small number of generics manufacturers in South Africa

Average price reductions range from 13.9 to 31.0% for rosuvastatin and candesartan, respectively

Utilization of rosuvastatin increased from 24.0 to 63.9% and then 76.4% following the introduction of the generic reference pricing

Fink, et al. 2014 [41]

Uganda

To determine the effect of AMFm on the use of ACTs

Cross-sectional survey-baseline survey

Targeted retail outlets including small, informal, unlicensed shops and vendors to licensed pharmacies

Affordable Medicines Facility for malaria

N/A

-Global fund

-UNITAID

-Gates Foundation

N/A

N/A

-Public sector stock outs, high prices in drug shops and pharmacies

-Limited geographic coverage

AMFm benchmark was achieved even prior to the arrival of the program and sustained throughout

-ACT increased from 51 to 68%

-More shops stocked ACTs, leading to 52% AMFm

Guimier et al. 2005 [52]

Senegal

To highlight differences between the price of drugs in Senegal and the population’s ability to pay for them

Wholesale distributors and 532 private pharmacies operating through a network of pharmaceutical depots and the National Supply Pharmacy

Reimbursement policy

Reimbursement of medicines in the public sector

Private and public pharmacies, wholesalers, manufacturers, laboratories, distributors

N/A

N/A

N/A

-The components of the public price vary only slightly between the four categories of medicines: taxes (1.3–1.4%), freight, insurance and local transit (5–6%), distribution margins (40–48%) and PGHT (46–54%)

Only 5% of patients had not taken their prescribed drugs for financial reasons

Honda and Hanson, 2013 [53]

Madagascar

To assess the outcomes of the equity funds in Madagascar from three perspectives

Household survey

Households. Three case studies

Case 1 — urban (all amenities)

Case 2 urban/rural (suburban)

Case 3 rural (few basic amenities)

Pooled procurement & user fees: equity fund

Community participatory approach

Government and Community representatives

N/A

Knowledge of implementation status

Financial and geographical constraints accessing health centre

Out-of-pocket payments lower for members than non-members

Equity fund members have increased access to the public health facility

Liu and Galárraga 2017 [54]

Angola, Botswana, DRC, Lesotho, Malawi, Zambia Mozambique, Namibia, South Africa, Swaziland Tanzania and Zimbabwe

This study aims to (i) analyse global ARV prices from 2004 to 2013 and (ii) examine the relationship of national drug policies to ARV prices

Price survey

Descriptive drug price trends 2004–2013

No participants

-Essential medicines list

-National or social health insurance

-Procurement strategy

N/A

N/A

N/A

-Transaction volume

-HIV prevalence

N/A

-Generic status 8/10 ARVs had lower prices than originat

-All six first-line ARV drug unit prices decreased over time, from a 46% price decrease for lamivudine to 90% price decrease for efavirenz

N/A

Maiga, et al., 2010 [55]

Mali

To analyse the role of government intervention and market forces in price regulation, private sector pricing of essential medicines and pricing process in Mali’s private pharmaceutical sector

Qualitative study

Not documented

Government price regulation policy

Set up a commission, price ceilings, monitoring and evaluation system and define working methodology for access to medicines

Managers, pharmaceutical companies, employers’ council, union workers and pharmacy professionals

N/A

High involvement of private and public sector stakeholders

Disagreement between the public and private sector

Estimated 25% theoretical reduction on the basket of 107 medicine

N/A

Maïga, and Williams-Jones 2010 [40]

Mali

To assess the impact of the national pharmaceutical policy on supply system for generic essential medicines

Price survey, a cross-sectional descriptive survey

Sixteen wholesalers and 30 private drugstores

Generic essential medicines

N/A

-Government

-Private and public healthcare sectors

N/A

Education and creating awareness

N/A

The median wholesale price of the 49 drugs was 14.3% and 25.6% cheaper than the maximum price in 2006 and 2009, respectively

The availability was judged to be the same before and after the policy

Maı̈ga, et al., 2003 [56]

Mali

To study cost recovery and generics policies

Price survey and observations of customers

Pharmacies and public health centres

Cost recovery and generics

N/A

N/A

N/A

N/A

N/A

Costs of prescriptions were lower where public health facilities had been revitalised

Access to drugs was improved affordable generics were widely available, even in private outlets

Moodley, R. and Suleman, F., 2019 [57]

South Africa

To evaluate the impact of SEP on a basket of originator medicines, in terms of costs, and impact on prices

Longitudinal before and after evaluation study

No participants — data used ‘The Global Core of fourteen items (14) originator and forty-six (46) generics

Single exit price policy

N/A

N/A

N/A

N/A

N/A

Upon introduction of the intervention, the medicines showed an immediate drop in price with a subsequent rate of increase being much less than before

N/A

Moodley, R. and Suleman, F., 2019 [58]

South Africa

To examine the impact of the regulatory change, the SEP, on a basket of generic medicines from 1999 to 2014

Quantitative study

Prices of 50 originator medicines were assessed from 1999 to 2014

Single exit price policy on generics prices

N/A

-Manufacturers

-Pricing committee

-Ministry of health

N/A

N/A

N/A

The SEP had a larger effect on generics pricing than originator. Most medicines showed a smaller yearly increase in price compared to before regulations

N/A

Nicolosi, E. and Gray, A., 2009 [59]

South Africa

To assess the potential savings by substituting generics for brand

Economic evaluation study

All the medicines listed in 25 chronic disease algorithm made by the Council for Medical Scheme

Generic medicines policy

N/A

N/A

N/A

N/A

N/A

67.5% were more than 40% cheaper than branded medicines. All generics were priced lower

N/A

Ongarora, et al. 2019 [60]

Kenya

To assess retail pricing, availability and affordability of medicines in private facilities

Survey using standardized electronic questionnaire

Forty-five private healthcare facilities in 14 of Nairobi’s low-income settlements (18 clinics, 7 hospitals, 2 health centres, 4 medical centres, 2 nursing and maternity homes, 12 pharmacies)

28 innovator products were included

Generic medicines Policy

N/A

N/A

N/A

N/A

The lack of regulation of prices

Clients paid higher prices than the median IRPs for 68.6% of generic medicines selected

N/A

Ponsar, et al., 2011 [39]

Mali

To assess the impact of abolishing user fees on utilization of essential health services and mortality

Survey

Pregnant women and children under five

Subsidized/free medicines for malaria treatment

N/A

-MSF (doctors without borders)

-Health centres

-Ministry of Health

N/A

Free provision medicines

Payment of user fees

Savings in drugs reduced the overall consultations cost

Utilisation of healthcare increased fourfold for under 5 s; by the end of the period, 3.5 × more pregnant women were being treated for fever

Rothberg, et al. 2004 [61]

South Africa

To measure the impact of reference-pricing programme covering items for available generic equivalents

Prospective and retrospective analyses of prices of medicines

Quantitative — price survey

All medicines for which generics products were available

Reference pricing for generic medicines

N/A

-Medscheme’s medicines management

-Interpharm teams

-Government

N/A

Willingness of some manufacturers to drop prices

Low enrolment into the programme

Price movement for eligible products for the 12-month period showed that 19.6% of products dropped prices, 16.8% increased by up to 10%, 19.5% by 11 — 15%, 7.8% by 16 — 50%, 1.7% up to 100% and 1.0% by more than 100%

N/A

Sabot, et al. 2009 [38]

Tanzania

To evaluate the extent to which patients use recommended ACTs and its implications for AMFm implementation

Cross-sectional study — exit interviews, retail audits, mystery shoppers, and public facility audits

Drug shop customers, retail audits

Affordable Medicines Facility-malaria

N/A

Wholesalers and retailers

N/A

-Popularity of designated retail outlets

-Global policy and funding

-Cost is still a barrier for poorer customers

-Stock-outs and challenges with the supply chain

Consumers purchasing ACTs for children under 5 paid significantly less than those buying for adults

Increase in the proportion of shops stocking ACTs in the intervention districts, from 0/133 in August 2007 to 109/151 (72.2%) in August 2008

Smith, et al. 2011 [37]

Kenya

To measure accessibility, availability and affordability of ACT

Survey

All public health facilities and malaria medicine retailers, including private clinics, chemists, pharmacies and other specialized drug stores

Affordable Medicines Facility-malaria

N/A

Government

Global fund

N/A

-Proximity to and flexible business hours of retail facilities

-Most of the drug outlets were unlicensed

-Frequent stock-outs in public facilities

Brands purchased under the AMFm programme cost 40% less than non-AMFm brands

Increased access for those buying drugs at weekends from private outlets

Steyn, et al. 2007 [43]

South Africa

To determine the influence of implementing SEP on the prescribing prevalence and cost of antidiabetic medicine

A retrospective drug utilisation study conducted in 2005 and/or 2006

Private sector healthcare

Reference-based pricing system (single exit price).

N/A

-Manufacturers

-Wholesalers

-Retailers

-Government

N/A

1997 Medicine and Related Substances Amendment Act

N/A

The average cost of antidiabetic medicine on the database decreased from the pre-SEP period and interim period in the post-SEP period

Prescribing frequency of antidiabetic medicine showed an increase

Tougher, et al. 2014 [62]

Ghana, Kenya, Madagascar, Niger, Nigeria, Tanzania

To examine the potential for further reductions in the prices of subsidized medicines

Quantitative, price survey

Retail outlets

Affordable Medicines Facility -malaria (AMFm)

N/A

N/A

N/A

-Already existing ACT subsidy policy

-Accessibility of private retail facilities

Lack of standardized mark-ups for retail pharmacy

Prices reduced in most countries

N/A

Tran et al. 2020 [42]

Kenya

To describe how the evolution of the RFP programme increased access to essential CVD medications for patients across different levels of the public sector healthcare system in western Kenya

Retrospective study using administrative data

Inventory audit reports, essential CVD medicines list

Revolving fund pharmacy model

Donations or purchase sold at a small mark-up price sufficient to replenish drug stock and ensure sustainability

Kenya

MOH

Health facilities [community), level 2 (health dispensaries), level 3 (health centres), level 4 (subcounty hospitals), level 5 (county hospitals), to level 6 (tertiary referral hospitals)]

N/A

Kenya MOH, local leadership and facility administrators’ effort to integrate CVD and diabetes clinical services as well as essential medications into the lower primary care-level facilities

Creation of local adoption mechanisms

Early engagement of key stakeholders

Developing affordable patient co-pays, waivers and accountability mechanisms through inventory, financial and accounting systems

Transportation costs to health facilities, opportunity cost of missed work and distance from health facilities

Significant operating costs associated with running the pharmacies including staff, co-pay waivers, supervisory audits and transportation of medicines and supervisors

Patient volumes at each of these lower-level facilities were not sufficient to sustain a full RFP

Clinical officers or nurses were too overwhelmed to dispense and maintain the inventory of RFP medicines

N/A

The availability of essential medicines improved from an average of 30–40% to > 90%, 18. In the period of the current analysis (2018), this model was run in 15 facilities within the AMPATH catchment area

Most tracer medicines were present 94–100% of the time at health facilities across levels 2–6 (the availability of insulin (Humulin 70/30) at levels 5 and 6 was 97% and 100%, respectively, and 81–85% at levels 2–4)

An increase in the availability of generic CVD medications from the historical 30% or less to 90% or higher across all levels of the health system

Walwyn and Nkolele, 2018 [63]

South Africa

To evaluate whether private-public partnership (PPP) of the Biovac Institute provided value for money for vaccine procurement and distribution over the period 2010–2016

Concurrent mixed methods

Quantiative — prices from secondary sources

Qualitative — ‘key stakeholders’ representatives from BI, National Treasury, National Department of Health (NDoH), provincial departments of health, the Technology Innovation Agency, the Industrial Development Corporation, the Department of Science and Technology and the Department of Trade and Industry were invited; of these, 5 agreed to be interviewed

Public-private partnership (PPP) policy for vaccine procurement and distribution

N/A

National Treasury, Department of Health, Technology Innovation Agency, Industrial Development Corporation, Departments of Science & Technology and Trade & Industry

N/A

-Uninterrupted/reliable supply chain

-Political support for PPP

Slow establishment of a vaccine manufacturing centre

Forex fluctuation (depreciation of the local currency

Biovac Institute has been successful in containing the cost of procurement for the EPI vaccines, and that this competence has been strengthened over the period of this study

The margin averaged at approximately 13%, corresponding to a total value of US $85.7 million over the period of the evaluation or about US $17million per year

No interruption in the supply of vaccines to any location in the country

Wiedenmayer, 2019 [64]

Tanzania

To develop a successful pilot of a prime vendor system with the potential for national scale-up.

Baseline survey and M&E reports

National Coordination Committee was formed, composed of members from ministries and agencies. Regional and district stakeholders and health care workers

Jazia prime vendor system (public-private partnership)

Engaging one private sector pharmaceutical supplier as the prime vendor to provide the complementary medicines needed by public health facilities in Tanzania

-Private sector

-Government

-Medical stores department

-Health facilities

-National Coordination Committee

N/A

-Partnership with private sector

-Culture of transparency and accountability

-Regional leadership

Delayed payment by the districts for their PV consignments (up to 90 days)

N/A

Tracer medicines availability in the region (mean availability of all districts) increased from 69% in 2014 to 94% in 2018

Wilson, 2012 [65]

Tanzania

To assess the manufacturing capacity to produce ARVs locally

Mixed-methods case study: quantitative data from document review, qualitative data from semi-structured interviews and document review

Representatives from government agencies, the pharmaceutical industry and international, bilateral organizations and NGOs

Generics and domestic production policy (TRIPS and Doha Declaration)

N/A

Tanzania Pharmaceutical Industries

Government

N/A

Existing international polices supporting domestic production of drugs

-Lack of a coherent policy strategy for the development of its pharmaceuticals industry

-Weak patent enforcement

-High costs of importing supplies

N/A

N/A

Ye, 2015 [66]

Ghana and Kenya

To assess the availability, price and market share of quality-assured artemisinin-based combination therapy in remote areas compared with non-remote areas at end line of the AMFm intervention

Cross-sectional

Data collected from drug outlets in Kenya and Ghana

Affordable Medicines Facility -malaria

N/A

-Government

-Global fund

N/A

-Available funding to subsidize the drugs on a global level

-Reliable distribution systems

-Community awareness

Remoteness of private outlets

-In Ghana, the prices in remote and non-remote areas did not differ public health facilities

-In Kenya, private for-profit outlets in remote areas were selling QAACT at nearly twice the price as in non-remote areas

Medicines were available in both Kenya and Ghana