The Role of Intellectual Property Rights and Access to Medical Products in the WHO African Region: 25 Years After the Trips Agreement

Marion Motari (  marion.motari@gmail.com ) Daystar University Nairobi Campus Jean-Baptiste Nikiema World Health Organizational Regional O ce for Africa Ossy Muganga Julius Kasilo World Health Organization Regional O ce for Africa Stanislav Kniazkov World Health Organization Regional O ce for Africa Andre Loua World Health Organization Regional O ce for Africa Aissatou Sougou World health organization regional o ce for Africa Prosper Tumusiime World Health Organization Regional O ce for Africa


Background
It is now 25 years since the adoption of the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) and the same concerns raised during its negotiations such as high prices of medical products, market exclusivity and delayed market entry for generics remain relevant as highlighted recently by Ebola and COVID-19 pandemics. The World Health Organization's mandate to work on the interface between intellectual property, innovation and access to medicine has been continually reinforced and extended to include providing support to countries on the implementation of TRIPS exibilities in collaboration with stakeholders. This study analyses the role of intellectual property on innovation and access to medical products in the African Region.

Methods:
We analyze patent data from the African Regional Intellectual Property Organization (ARIPO) and Organisation Africaine de la Propriété Intellectuelle (OAPI) to show trends and to identify the main diseases covered and how they correspond with top causes of morbidity and mortality. We also review legislation to assess how TRIPS exibilities are implemented in countries.

Results
Patenting was low for African countries. Only South Africa and Cameroon appeared in the list of top ten originator countries for ARIPO and OAPI respectively.
Main diseases covered by African patents were HIV/AIDS, cardiovascular diseases, cancers and tumors. 39 countries have applied TRIPS exibilities, with the most common being compulsory licensing and LDC transition provisions. A third of the compulsory licensing application were not executed following voluntary licensing agreements. No country had legislated on research and regulatory review exceptions and patent term extension.

Discussion
There's modest alignment between innovation and health challenges. Compulsory licensing applications may have served to encourage voluntary licensing arrangements. Countries have enacted laws that allow them to deploy TRIPS exibilities for public health needs.

Conclusions
There's need to develop and strengthen health innovation systems in the region. Opportunities exist for WHO to work with ARIPO and OAPI to support countries in reviewing their legislation to be more responsive to public health needs.

Background
The adoption of the Agreement on Trade-Related Aspects of Intellectual Property (TRIPS Agreement) in 1994 by Member States of the World Trade Organization (WTO) was a watershed event, which gave rise to a new global intellectual property protection (IPP) regime with signi cant effects on access to medical products. Some of these effects include high prices of medicinal products, prevention of local manufacture of generic products through reverse engineering of patented products, importation of cheaper medicinal products from off-patent countries or under licensing agreements and delayed market entry for generic products.
The potential impact of the TRIPS Agreement on access to medical products in developing and least developed countries, has caused debate with some commentators arguing that IPP makes it possible for pharmaceutical companies to recoup their Research and Development (R&D) costs and hence act as an incentive for investment in biopharmaceutical research and innovation. However, this incentive structure has failed to spur R&D investments for diseases that predominantly affect poor people, leading to the emergence of alternative product development partnership (PDP) models such as the Drugs for Neglected Diseases Initiative (DNDi), proposals for a global R&D treaty, and the promotion of public health interests by using existing TRIPS exibilities or through revisions of the TRIPS Agreement.
Although this paper focuses on the role of intellectual property rights on access to medicines, it is recognized that limited access to medicines in countries of the WHO African Regionis a multidimensional problem. It is affected by other factors such as lack of public nancing for health care and over-reliance on out of pocket expenditure, fragile logistics, storage challenges and high transport and distribution costs and inadequate or inappropriate medicines regulatory frameworks. These factors are further exacerbated by insu cient scienti c, technological and local manufacturing capabilities in the Region.
The occurrence of public health emergencies of global concern such as Ebola and COVID19, have served to highlight further the tensions between IPP, innovation and access to medical products. For example, in March 2020, Gilead Sciences, the makers of remdesivir which is a drug initially studied in clinical trials for Ebola Virus Disease (EVD) and has received US FDA emergency use authorization for the treatment of adults and children hospitalized with severe COVID-19 disease, made an application for orphan drug status for the drug, which has since been rescinded. Orphan drug designation for remdesivir would have granted seven years of market exclusivity in addition to the standard 20 years of patent protection guaranteed by the TRIPS Agreement. Gilead Sciences has since signed non-exclusive license agreements with manufacturers in Egypt, India and Pakistan for the supply of remdesivir in 127 low and middle-income countries including all countries of the African Region.
The earliest articulation of the World Health Organization's (WHO) mandate to work on the interface between access to medical products, R&D in rare and tropical diseases, and trade can be traced back to 1996, in a World Health Assembly (WHA) resolution on the Revised Drug Strategy which requested the WHO Director-General (DG) to support Member States in their efforts to improve access to essential drugs; to encourage the promotion of R&D of drugs for rare and tropical diseases; and to report on the impact of WTO concerning national drug and essential medicines policies and make recommendations for collaboration between WTO and WHO as appropriate. This mandate has been continually reinforced through assembly resolutions. It has been extended over time to include upon request, providing technical and policy support to Member States, on formulating coherent trade and health polices and the implementation of TRIPS exibilities in collaboration with other relevant international organizations.
Most recent are assembly decisions WHA 71(8) of 2018 on 'Addressing the global shortage of, and access to, medicines and vaccines', which requested the DG to "elaborate a roadmap report, in consultation with Member States, outlining the programming of WHO's work on access to medicines and vaccines including activities, actions and deliverables for the period 2019-2023; and WHA71(9) of 2018 on the 'Global strategy and plan of action on public health, innovation and intellectual property (GSPOA-PHI): overall programme review', which requested the DG to "implement the recommendations addressed to the Secretariat … in an implementation plan, consistent with the global strategy and plan of action on public health, innovation and intellectual property". Additionally, in 2019 resolution WHA72.8 on 'Improving the transparency of markets for medicines, vaccines, and other health products', requested the DG to "continue supporting existing efforts to determine patent status of health products and promote publicly available user-friendly patent status information databases for public health actors, in line with the GSPOA-PHI and to work with other relevant international organizations and stakeholders to improve international cooperation, avoid duplication of work, and promote relevant initiatives". These WHO commitments and the fact that it is 25 years since the adoption of the TRIPS Agreement provide an excellent setting for reviewing the experiences of WHO African Region Member States in implementing the Agreement for public health gains.
This 2019 study aimed at providing an up to date analysis of the role of IPR on innovation and access to medical products in countries of the WHO African Region. The study analyses patent data from the African Regional Intellectual Property Organization (ARIPO) and the Organisation Africaine de la Proprieté Intellectuelle (OAPI), the two African regional patent depositories as an indicator of innovation and knowledge production to address priority health challenges in the Region. The analysis sought to understand the level of patenting activity by African Region countries at ARIPO and OAPI, to identify the main diseases covered by patents granted at ARIPO and OAPI and how these correspond with the top causes of morbidity and mortality in the Region. The study also provides an assessment of the Region's preparedness to respond to public health emergencies using available TRIPS exibilities. The study also provides an analysis of how WHO African Region countries have implemented the TRIPS exibilities and hence provides a baseline for the work of WHO towards the implementation of the Health Assembly's decision WHA 71(8) and resolution WHA72.8 mentioned above.

Methods a. Patenting trends
The patent data used in this study was obtained from the ARIPO and OAPI o ces in April 2019. Face-to-face meetings were organized with o cers of the two organizations to explain the objectives of the study and to clarify that the data required was in the areas/ elds that can potentially be applied in medical innovations using the World Intellectual Property Organization (WIPO) international patent classi cation (IPC) codes. Table 1 presents the codes for patents falling within the scope of this study. Preparations for medical purposes A61P Therapeutic activity of chemical compounds or medicinal preparation A61B Diagnosis -analyzing biological material covering processes for diagnostics.

A01N
Medicinal preparations (for pharmaceutical use) containing materials from mammals or birds C07H Sugars, derivatives thereof; nucleosides, nucleotides, nucleic acids with therapeutic activity further classi ed in subclass A61P, which covers DNA or RNA concerning genetic engineering, vectors or the isolation, preparation or puri cation C12N Micro-organisms or enzymes; compositions thereof; propagating, preserving or maintaining micro-organism, mutation or genetic engineering; culture media C12P Fermentation or enzyme using processes to synthesize a desired chemical compound or composition or to separate optical isomers from racemic mixture; particularly processes for producing enzymes, DNA or RNA concerning genetic engineering, vectors e.g. plasmids or their isolation.

C12Q
Measuring or testing processes involving enzymes or micro-organisms (immunoassays) compositions or test papers thereof; processes of preparing such composition; condition responsive control in microbiological or enzymological process.

C08B
Polysaccharides, derivatives thereof-those with therapeutic activity are further classi ed in subclass A61P.

C01G
Compounds containing metals and whose therapeutic activity is further classi ed under A61P

C07J
Steroids particularly those whose therapeutic activity is further classi ed in subclass A61P.

C08L
Compositions of macromolecular compounds which include pharmaceuticals under A61K

C07G
Organic chemistry/compounds of unknown constitution. Those with therapeutic activity further classi ed in subclass A61P

C07B
General methods of organic chemistry; apparatus therefore (preparation of carboxylic acid esters by telomerization)

C07C
Acyclic or carbocyclic compounds C07D Heterocyclic compounds. Those with therapeutic activity further classi ed in subclass A61P

C08G
Macromolecular compounds obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds.

G01N
Investigation or analyzing materials by determining their chemical or physical properties.

C01B
Non-metallic elements; compounds thereof; whose therapeutic activity is further classi ed in A61P C08F Macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds; which include therapeutic activity under A61K, A61P O cers of both patent o ces conducted a data search using parameters de ned and provided the requisite data as downloaded les in MS Excel. The total number of health-related patents registered in ARIPO and OAPI databases as of April 2019 was 3458 and 2811 respectively. This study only reviewed and analysed patents that had been granted within the past 20 years and were, therefore, within their validity period per Article 33 of the TRIPS Agreement.
Consequently, the patents covered in this analysis are 960 (28%) for ARIPO and 2274 (81%) for OAPI. In order to identify the speci c disease(s) a patent can be associated with, we used the patent short title, and in instances where the short title did not mention the disease, the patent abstract was consulted. Those that did not mention a speci c disease were left out of the analysis. In doing the analysis the diseases covered by the patents were clustered in broad categories namely: in ammatory diseases, cancers, tumors and abnormal cell proliferation, cardiovascular diseases viral infections, neurodegenerative diseases, diabetes and diabetes-related conditions, infections, pain, HIV/AIDS, tuberculosis, malaria, mental disorders, nervous system disease, digestive system disease, weight related disorders, lung diseases, eye diseases and vaccines.

b. Application of TRIPS exibilities
This study conceptualizes exibilities as understood within the context of the TRIPS Agreement, its amending Protocol and the Doha Declaration on the TRIPS Agreement on Public Health (Doha Declaration) [1]. We de ne TRIPS exibilities through the lens of Articles 1.1 [2] and 8.1 [3], which provide policy space for countries to implement the Agreement in a manner appropriate and responsive to their contexts, as different options which consider national interests and can be transposed into national law.
The study used data from The TRIPS Flexibilities Database, found on http://trips exibilities.medicineslawandpolicy.org/, which is a searchable publicly accessible database maintained by the Medicines Law and Policy group [4]. The database contains records of instances when national authorities of WTO member countries have invoked the application of a TRIPS exibility for public health reasons since 2001 to present.
The TRIPS Agreement uses the term exibility in paragraph 6 of the preamble and in Article 66.1 in the context of the need for least developed countries (LDC) to create a viable technological base and their readiness to implement it. Paragraph 4 [5] of the Doha Declaration rea rms the right of WTO members to use full provisions of the TRIPS Agreements and provides a contextual basis for understanding exibilities while Paragraph 5 clari es that they include; applying customary rules of interpretation of public international law so that all provisions of the TRIPS Agreement are read in light of the object and purpose as expressed in its objectives (Article 7) and principles (Article 8 ); the right of each member to grant compulsory licenses and the freedom to determine the grounds for granting such licenses; the right of each member to determine what constitutes a national emergency or other circumstances of extreme urgency, it being understood that public health crises include those relating to HIV/AIDS, tuberculosis, malaria and other epidemics; and the freedom of each member to establish its exhaustion of IPR regime without challenge subject to the national treatment (Article 3) and most-favorednation treatment (Article 4) provisions.
Given that Paragraph 5 does not provide an exhaustive enumeration of exibilities, table 2 below provides a summary of TRIPS exibilities, as well as the legal basis and how and why they should be implemented that can be used by African Region countries. Article 27.1 of TRIPS does not specify what constitutes "new" or how the novelty requirement should be met. According to Para 4 of the Doha Declaration countries may interpret provisions of this Article in a manner that seeks to protect public health and ensure access to medicines.
Countries may opt to interpret 'novelty' in domestic legislation in a manner that excludes new and second uses of medicines. This exibility is applied to prevent patents from new uses of known or previously patented medicines.

Research exception
Article 30 of TRIPS states that "Members may provide limited exceptions to the exclusive rights conferred by a patent, provided that such exceptions do not unreasonably con ict with a normal exploitation of the patent and do not unreasonably prejudice the legitimate interests of the patent owner, taking into account of the legitimate interests of third parties.
The terms limited exceptions have been de ned by the WTO Dispute Settlement Panel as "exception under which use of the patented product for scienti c experimentation, during the term of the patent without consent is not infringement" Countries can therefore allow this exception in their national law in order to allow for the development of local scienti c and technological knowledge and competencies to reverse engineer pharmaceutical products for generic production and for developing them further to better suite local conditions.

Regulatory review exception (Bolar exception)
This is also anchored in Article 30 of TRIPS. This exception allows the use of a patented invention during the patented term without consent of the patent holder for purposes of developing information to obtain market approval. It allows generic producers to use patented knowledge for purposes of attaining regulatory approval for generic products before expiry of the patent(s), while the patent holder has the right to request, within speci ed conditions, an extension of the patent term to compensate for the delay in the drug regulatory and market approval process.
This exception facilitates market entry by competitors immediately after the end of the patent term and is therefore an instrument that is speci cally designed to ensure early access to generic medicines.

Compulsory licensing
Article 31 of TRIPS allows exploitation of patented subject matter through government authorization without the patent holder's consent, for the supply of the domestic market of the member authorizing such license, for reason of national emergency and public non-commercial use.
Paragraph 6 of the Doha Declaration and Article 31(bis) of TRIPS makes it possible, under speci c conditions for compulsory licensing for export through regional trade areas (RTAs), which make it possible for bulk purchases and economies of scale.
Para 5 (b) the Doha Declaration clari es that each member has the right to grant compulsory licenses and the freedom to determine the grounds upon which such licenses are granted.
Article 31 of TRIPS stipulates conditions for the issuance of a compulsory license by a member state. Provisions of Article 31 (f) and (h) make it impossible for countries with insu cient or no manufacturing capacity to use this exibility. Questions of market viability for a single national market made it unattractive to use this exibility.
Para.6 of the Doha Declaration sought a solution to situations where a foreign producer can supply patented pharmaceutical products, which are not available in a country with no su cient manufacturing capacity. This has been addressed through Article 31(bis).

Exhaustion of rights and parallel importation
Article 6 of TRIPS states that "For the purpose of dispute settlement under this Agreement, subject to the provisions of Articles 3 and 4 nothing in this Agreement shall be used to address the issue of the exhaustion of intellectual property rights" Para 5(d) of the Doha Declaration rea rms that countries are free to determine their own regimes for exhaustion of patent rights without challenge This provision allows importation and resale in a country without consent of the patent holder of a patented product put on the market of the exporting country by the patent holder or in a legal manner. International level of exhaustion provides the most exibility, followed by regional and lastly national.
It is a legal doctrine according to which an IP right holder cannot prevent further distribution or resale of goods after consenting to the rst sale. In such a situation the right holder is considered to have exhausted its right over those goods.

Patent term extension
Article 33 of TRIPS provides that the patent term is 20 years from the ling date.
Countries may consider limiting patent term extension in national law for pharmaceutical products.
Limits on test data protection Article 39.3 of TRIPS states that "Members, when requiring, as a condition of approving the marketing of pharmaceuticals …which utilize new chemical entities, the submission of undisclosed test or other data, the origination of which involves considerable effort shall protect such data against unfair commercial use. In addition, Members shall protect such data against disclosure, except where necessary to protect the public, or unless steps are taken to ensure that the data are protected against unfair commercial use." This provision allows countries to determine how to protect test data in the public interest. This provision does not demand data exclusivity, which has the potential of blocking entry of generic versions of patented medicines. Rather, it demands protection from unfair commercial use. TRIPS does not de ne unfair commercial use nor does it provide guidance on how protection can be achieved.
Countries may therefore incorporate in domestic legislation the right of regulatory authorities to rely on available data to assess new drugs for market entry.

Transition periods for LDCs
Article 66.1 of TRIPS states that "In view of the special needs and requirements of least developed country Members, their economic, nancial and administrative constraints, and their need for exibility to create a viable technological base, such Members shall not be required to apply the provisions of this Agreement, other than Articles 3, 4 and 5, for the period of 10 years from the date of application as de ned under paragraph 1 of Article 65. The Council of TRIPS shall, upon duly motivated request by a least-developed country Member in order to enable them to create a sound an viable technological base" In 2013 the TRIPS Council decided to extend the transition period for LDC members to fully comply with the TRIPS Agreement to 1 January 2021. TRIPS Council decisions IP/C/73 and TRIPS General Council decision WT/L/971 stating that LDC members are not obliged to protect pharmaceutical patents or to provide means for ling patents and provide patent protection and exclusive marketing rights until January 2033.
The TRIPS Flexibilities Database analysed for this study only has data on the use of compulsory license provisions (TRIPS Art. 31), patent exceptions (TRIPS Art 30) Least Developed Countries (LDC) transition periods (Para 7 Doha Declaration) and parallel importation (Para 5d Doha Declaration). The database includes instances when exibilities were executed, pending, not executed or suspended. The study retrieved all the available data on countries of the WHO African Region. Additionally, we conducted a desk review of available patent laws of different countries to analyze how they have implemented these exibilities within their national legal frameworks. Results a. Patenting trends Graph 1 below depicts health-related patent application trends at ARIPO and OAPI. Data shows that there was a sharp increase in patent applications at both o ces from 1994 to 1999, which started to decline in the period 1999 -2000.
According to the 2018 Report on the State of Health in the WHO African Region [1], the main ve causes of morbidity and mortality in the Region, are lower respiratory infections, HIV/AIDS, diarrheal diseases, malaria and tuberculosis. Other top causes of morbidity and mortality include stroke and ischemic heart diseases, preterm birth complications, birth asphyxia and congenital anomalies.
An analysis of the top 10 diseases covered by patents granted at ARIPO and OAPI corresponds to a certain extent, with the top 10 causes of morbidity as illustrated by graphs 2 and 3 below. In both repositories the three top categories of diseases covered by granted patents were in ammatory diseases; cancers, tumors and abnormal cell proliferation; and cardiovascular diseases. Within the in ammatory diseases category, there were patents for lower respiratory diseases such as chronic obstructive pulmonary disease and asthma. HIV/AIDS, which was the second cause for morbidity and mortality, was 7th among the top 10 ARIPO patents and 10th for OAPI. Stroke and ischemic heart diseases which ranked 4th and 5th as causes of mortality respectively, fall within the broad category of patents covering cardiovascular diseases, which ranked 3rd on the list of top 10 diseases covered by patents at ARIPO and OAPI.
These observations point to modest alignment of pharmaceutical knowledge production (through R&D and innovation) with addressing health challenges in the Region. Diarrheal diseases, tuberculosis and malaria, which are among top causes of mortality and morbidity did not appear among the top diseases covered by patents in the Region. There were only 23 TB patents at ARIPO and 25 at OAPI, while there were only 37 malaria patents at ARIPO and 47 at OAPI.
The top 10 categories of diseases covered by patents taken at ARIPO and OAPI were the same, the only difference being in the ranking. Another interesting nding is the ranking of cancer-related patents, which was found to rank 2 nd at both patent o ces indicating an increase in cancer research. An analysis of the African country patents shows that the top three disease categories covered are HIV/AIDS, cardiovascular diseases, and cancer and tumors. Table 3 below provides a summary of the main diseases covered by African country patents. The fact that HIV/AIDS, cardiovascular diseases, malaria and tuberculosis which were mentioned as top causes of mortality and morbidity in the Region also feature among African country patents highlights a modest alignment between research and health challenges of the Region. The analysis shows that only three exibilities were applied, namely Article 31 of TRIPS which allows for compulsory licensing including for non-commercial use; paragraph 7 of the Doha Declaration on LDC country transition periods and paragraph 5 (d) of the Doha Declaration allowing for parallel importation. The most commonly applied exibility is paragraph 7 of the Doha Declaration on transition provisions with 27 countries having applied it, followed by Article 31, allowing compulsory licensing, which has been applied by 16 countries. Parallel importation has only been used by Kenya once (in 2002) for the importation of generic medicines.
Some countries have applied exibilities more than once; the highest being ve times by Kenya, four times by Zimbabwe, and three times by Benin, Congo,   Table 5 below provides a snapshot of exibilities that have been enacted into law by African Region countries. Our analysis did not nd any country that had legislated on research exception, regulatory review exception and patent term extension.   [1] of the TRIPS Agreement to fully comply with the TRIPS Agreement by 2021. Unfortunately, these LDC countries in the Region are unlikely to bene t from these waivers since they are signatories to Regional frameworks such as the Harare Protocol on Patents and Industrial Designs (1982) or the Bangui Agreement (1977), which require them to attain a TRIPS -plus standard, where patentability criteria extends to pharmaceutical products and process, hence more onerous than the one required under TRIPS.

Discussion
The ndings of this study show that there is very low health-patenting activity at ARIPO and OAPI by African countries. Should this nding be taken to mean that African countries are not engaging in pharmaceutical R&D and innovation? It has been argued [2] that patent numbers are not su cient indicators of innovation but rather, a better indicator would be how often a patent gets cited. We suggest that it is necessary to further interrogate this nding through further research in order to fully understand reasons for low patenting activity by African countries.
In the years following the adoption of the TRIPS Agreement, developing countries experienced challenges in applying TRIPS exibilities such as compulsory licensing (Article 31) and parallel importation (Article 6) of drugs in their bid to address the HIV/AIDS crisis that was facing most developing countries towards the end of the 20 th century. One such example in the African Region was South Africa, which enacted the Medicines and Related Substances Control Amendment Act 1997 that allowed for parallel importation and compulsory licensing of pharmaceuticals in the country. These amendments to the law led to a backlash from pharmaceutical companies and culminated into legal action against the South African government, which was later withdrawn. Over time and with a lot of public pressure on the pharmaceutical industry African countries exploited some available TRIPS exibilities to address the HIV/AIDS challenge.
Compulsory licensing was a commonly applied exibility by countries, which was most often not executed, hence the conclusion that these may have served to encourage pharmaceutical companies to enter into voluntary licensing arrangements.
We observe that exhaustion of rights and parallel importation is not commonly applied in the Region. This could be due to the fact that some countries have adopted a national exhaustion approach such, while those governed by the Bangui Agreement have precluded international exhaustion and restricts parallel importation to the regional exhaustion regime within OAPI countries. We found that no country in the Region has put in place legislation that allows for research exception and regulatory review exception.

Conclusions
The experiences of the HIV/AIDS pandemic in the nineties, and most recently, the search for an effective treatment and vaccine for COVID-19 highlight the tensions between intellectual property rights and public health interests. There is evidence that learning has taken place from the lessons of the HIV/AIDS be done through policies that support health research systems and a local incentive structure that focuses research on local health challenges. Other aspects of developing health innovation systems would include developing local scienti c and biomedical research capacities and local manufacturing capabilities.
The ndings of this study provide an opportunity for the WHO Regional O ce for Africa to work closely with ARIPO and OAPI to develop and promote a Regional IP framework that is responsive to public health challenges of the Region; and to support countries in reviewing national IP laws taking into account available exibilities such as research exception, regulatory review exception and patent term extension. Availability of data and materials

Abbreviations
The datasets generated and/or analysed during the current study are not publicly available due to the fact that they are held by ARIPO and OAPI patent depositories but are available from the corresponding author on reasonable request.

Competing interests
The authors declare that they have no competing interests.

Funding
This study was supported by unrestricted program funds of the WHO Regional O ce for Africa Universal Health Coverage/Life Course Department. The WHO staff involved in this study are listed as co-authors to the paper and their roles were as follows, JBN who is the Team Leader for the Medicines, Health Infrastructures and Equipment maintenance programme, provided technical guidance for the study and with OMJK contributed to the study conception and design. JBN and OMJK accompanied MM, the lead author, to data collection missions at ARIPO (Harare) and OAPI (Cameroon). SK, AL and AS are members of the Medicines, Health Infrastructures and Equipment maintenance team who read different versions of the manuscript and provided useful suggestions and inputs to the manuscript. PT is the Director of the Universal Health Coverage/Life Course Cluster under whose leadership the Medicines, Health Infrastructures and Equipment maintenance programme falls. PT provided overall leadership and guidance for the project.
Authors' contributions MM contributed to conception and design, data collection, analysis and writing of the manuscript. JBN and OMJK contributed by providing inputs to the study conception and design and in data collection. SK, AL, AS and PT provided inputs in the analysis of the manuscript. All authors read and approved the nal manuscript.