Medical products, vaccines, infrastructures and equipment
A well-functioning health system ensures equitable access to essential medical products, vaccines and technologies of assured quality, safety, efficacy and cost effectiveness, and their scientifically sound and cost-effective use.
To achieve these objectives, the following are required:
- national policies, standards, guidelines and regulations that support policy;
- information on prices, international trade agreements and capacity to set and negotiate prices;
- reliable manufacturing practices and quality assessment of priority products;
- procurement, supply, storage and distribution systems that minimize leakage and other waste;
- support for rational use of essential medicines, commodities and equipment, through guidelines, strategies to assure adherence, reduce resistance, maximize patient safety and training.
Major components of the medicines market are shown in the figure.
This section of the health system profile is structured as follows:
Nine countries still have to develop a national medicines policy. It is important for countries to systematically revise, update and harmonize their medicines policies with those of other countries and to integrate traditional medicine policies and strategies where these are used. Regulatory systems for medicines are inadequate in many countries, which is an issue of serious public health concern.
A recent survey showed that only 4% of countries have an acceptable level of regulatory capacity. All countries need to take measures against the entry and circulation of medicines of unacceptable quality, which occurs all too frequently with limited and complex registration procedures. A limited number of quality control institutions are operational, but more are needed.
About 50% of the population in sub-Saharan Africa lacks regular access to essential medicines, while traditional medicine remains insufficiently integrated into conventional health services. Problems of insufficient access can be attributed to:
- inadequate human resources
- insufficient financing
- high medicine prices, particularly in the private sector
- inadequate management of public sector procurement and supply management systems
- an inadequately regulated pharmaceutical markets.
To ensure universal access, medicines must be suitably priced and regularly available. Causes of irregular supplies include:
- inadequate procurement budgets
- delays in payment and delivery
- unreliable quantification of needs
- weak supply management and distribution systems.
Also, more countries need to implement strategies to promote the rational use of medicines and improve prescribing practices.
The traditionally low priority accorded to health laboratories has now been recognized as inappropriate, but strong support for laboratory networks is needed if they are to play their critical role. Most laboratories now belong to external quality assessment schemes to ensure high performance standards and obtain further training and guidance where needed. Unsafe patient care is recognized as a public health issue of concern across the WHO African Region and present measures need to be maintained and strengthened.
Efforts to improve access to safe blood and blood products should be maintained. In respect of blood safety, the regional target of 80% for voluntary, non-remunerated blood donation has been attained by 20 of the 46 countries of the Region. However, 21 countries have still to collect even half their total blood supply from voluntary, non-remunerated blood donation.
In summary, focus needs to be kept on:
- the further development and updating of national medicine policies;
- the development of national policies and strategic plans to ensure adequate laboratory capacity;
- the development of guidelines, norms and standards on safe health care practices to protect patients in health care settings.
- blood safety programmes need active support.
These activities will enable countries to strengthen their national health systems.
The figures show consumer price ratio and availability of selected generic medicines in a sample of health facilities in the WHO African region.
Organization and management of pharmaceuticals
National medicine policies
To date, 37 African countries have developed national medicines policies. To assist this work, regional guidelines for the formulation, implementation, monitoring and evaluation of national medicine policies have been revised. With WHO support, countries of the Economic and Monetary Commission of Central African States (Cameroon, Central Africa Republic, Chad, Congo, Equatorial Guinea, Gabon) have harmonized their national medicines policies.
Access to essential medicines
Improving access to affordable and high-quality essential medicines, and ensuring their rational use, are among the main objectives of national medicines policies. However, about 50% of the population in sub-Saharan Africa lacks regular access to essential medicines, while traditional medicine remains insufficiently integrated into conventional health services. Problems of insufficient access can be attributed to:
- inadequate human resources
- insufficient financing
- high medicine prices
- inadequate management of public sector procurement and supply management systems
- inadequately regulated pharmaceutical markets.
Over the past 5 years, using the WHO/Health Action International Project on Medicine Prices and Availability standard methodology, 18 countries (Burkina Faso, Cameroon, Chad, Congo, Democratic republic of the Congo, Ethiopia, Ghana, Kenya, Malawi, Mali, Mauritius, Nigeria, Niger, Rwanda, Senegal, United Republic of Tanzania, Uganda, Zimbabwe, Zambia) have undertaken surveys to measure prices, availability and affordability of selected medicines in the public and private sectors.
Survey findings revealed that medicine prices vary widely within and across countries, and that availability of medicines in the public sector is limited. The survey stressed that prices paid in the private sector are generally higher than public sector charges. For example, patients in Chad on average paid 4.3 times more than the international reference price for a generic medicine in the public sector, but 15 times more if they bought the same medicine from a private retailer (see figures).
The figure illustrates the high prices of medicines in the private sector. Generally, the prices for originator brands were higher than the lowest-priced generic medicines in the private sector. About 60% of African countries have annual per capita pharmaceutical expenditure of less then US$ 2. To ensure access for all to affordable and high-quality treatment, medicines should be suitably priced and regularly available.
Health insurance coverage in African countries remains low and people usually pay for their medicines out of pocket. Out-of-pocket payments are highest where medicines in public health facilities are not available and prices in the private sector are not appropriately regulated. To ensure consistent availability of essential medicines:
- the procurement and supply system should be efficient
- medicines should be used rationally
- sufficient funding should be allocated and effectively used.
To ensure regular availability and sustainable access to essential medicines, innovative ways of medicines financing, including social health insurance schemes, should be fostered and strengthened. To this end, selected national health insurance schemes in Ghana, Kenya, Nigeria, Uganda,and United Republic of Tanzania were assessed in order to gain information on the design, implementation and performance monitoring of health insurance schemes in these countries. With WHO support, Uganda is developing a benefit package for medicines coverage and Nigeria is strengthening its national health insurance capacity.
Regulation, quality and safety of the pharmaceutical sector
The quality of medical products is a critical public health issue in African countries. Both registered and unregistered medical products are commonly in use, as regulatory systems are inadequate in many countries.
In 2004, WHO carried out a survey of countries in the WHO African Region. The results showed that only 4% of countries possessed an appropriate level of national regulatory capacity. A total of 33% had moderate regulatory capacity and 24% had basic regulatory capacity – meaning that they can carry out only minimum functions. In 39% of the countries with limited regulatory capacity, inspection of manufacturing premises, distribution outlets and ports of entries was found to be weak or lacking. This increases the likelihood of medical products of unacceptable quality and safety entering a country and circulating within it.
In response, campaigns against counterfeit medicines have been carried out in 18 francophone countries, while the West African Economic and Monetary Union has drawn up a common position paper against counterfeit medicines.
Given the limited availability of trained human resources, registering medicines with the appropriate regulatory authorities is a complicated procedure. To accelerate the process and improve the information management system, six countries have now started using the WHO computer-assisted medicines registration software. Other measures undertaken to strengthen the capacity of national regulatory authorities include exchanges of country experience and training on regulation of herbal medicines.
Two conferences for African medicines regulators have taken place. These conferences:
- facilitated exchanges of experience
- identified gaps and priorities
- discussed strategies to address the challenges of regulating pharmaceutical markets and ensuring the quality, safety and efficacy of essential medicines.
A Traditional Medicine Programme at the West African Health Organization is taking steps to strengthen the implementation of policies and regulatory frameworks in the subregion.
Two quality control laboratories in Algeria and South Africa function as WHO Collaborating Centres for Quality of Medicines. The Centres provide support to countries in a variety of ways as well as assisting in the development of national medicines regulatory capacity. In 2009, the Centre for Tropical Clinical Pharmacology and Therapeutics at the University of Ghana Medical School was designated as the WHO Collaborating Centre for Pharmacovigilance. Among other things, this Centre focuses on the integration of pharmacovigiliance into public health programmes, advocacy for pharmacovigiliance across Africa and provision of technical support to national pharmacovigilance centres.
Drug procurement system
An assessment of supply within the pharmaceutical sector carried out in Africa in 2007 indicated an increase in the number of countries providing free medicines in public facilities for a number of conditions. It revealed that although access to essential medicines remains limited, over 90% of countries provide free treatment for HIV/AIDS at public health facilities, 100% provide free drugs for tuberculosis and 55% provide free drugs for malaria. Major beneficiaries of freely distributed medicines at public health facilities are pregnant women in 72% of countries, and children aged under 5 years in 68% of countries.
In general, essential medicines are not regularly available in public health facilities, which severely restricts effective health services delivery. Underlying causes include:
- inadequate procurement budgets
- delays in payment and delivery
- unreliable quantification of needs
- weak supply management and distribution systems.
To address these constraints, WHO is supporting Member States in taking measures to assess and strengthen their medicines procurement and supply systems. In-depth assessments of the procurement and supply systems have been carried out in 14 African countries, while 11 have mapped the supply and distribution pathways and partners involved in the medicines supply chain. The assessments revealed the existence of multiple and uncoordinated parallel procurement and supply systems.
In the United Republic of Tanzania, following the in-depth assessment of the procurement and supply system and mapping of partners, a stakeholders’ meeting was held and measures to improve coordination formulated. These will be factored into the third national health sector strategic plan. Other countries are using the assessment results to advocate for better coordination and collaboration among partners supporting the pharmaceutical sector, and to identify priority areas for action. Furthermore, 20 countries, with WHO support, are strengthening their medicines’ procurement and supply management capacity at facility level.
The feasibility of establishing pooled procurement schemes for essential medicines is currently being considered. The Southern African Development Community has developed a 5-year pharmaceutical business plan in this direction and implementation has started.
Rational use of medicines
Essential medicine lists are developed in line with national standard treatment guidelines. Of the 46 countries in the WHO African Region, 40 have developed a national list of essential medicines. To accommodate emerging public health needs and new therapeutic options, 18 countries (Burkina Faso, Cape Verde, Central African Republic, Chad, Comoros, Congo, Gambia, Guinea, Liberia, Mali, Mauritania, Senegal, Seychelles, South Africa, United Republic of Tanzania, Uganda, Zambia, Zimbabwe) have updated their lists of essential medicines over the past 5 years. Sixteen countries have implemented strategies to promote the rational use of medicines through:
- enhanced training of doctors, pharmacists, nurses and health workers
- the establishment of medicines information centres and of hospital drug and therapeutic committees.
With WHO support, the Central African Republic, Chad, Ethiopia, Mali, Senegal and Zambia have strengthened the capacity of national staff in good prescribing practices. The United Republic of Tanzania has developed communication strategies to improve rational use of medicines in the community.
Qualitative assessments indicate that antibiotics and injections can be obtained without prescription in most African countries. This can be attributed to inadequate skills to ensure the rational use of medicines. Widespread and indiscriminate use of antibiotics leads to antimicrobial resistance but despite this growing problem public health challenge, preliminary assessments indicate that only 21% of countries in the Region have a strategy to address it.
Infrastructures and equipment
Organization and management of blood products
Efforts are currently being made in African countries to improve access to safe blood and blood products, diagnostic imaging services, diagnostic technologies and laboratory services.
Collection and distribution system of blood products
A strategy has been developed to assist African countries in increasing blood collection from voluntary, non-remunerated blood donors and testing blood against transfusion transmissible infections and other mandatory tests, including blood grouping and compatibility testing. The strategy sets targets to be achieved by the year 2012, covering:
- organization and management
- blood donor recruitment and collection
- testing of donor bloods
- the appropriate clinical use of blood.
To date, 40 countries have developed guidelines on the appropriate clinical use of blood.
The regional target of 80% for voluntary, non-remunerated blood donation has been attained by 20 of the 46 countries of the WHO African Region, while four more are on track. However, 21 countries have still to collect even half their total blood supply from voluntary, non-remunerated blood donation. For these countries, the yearly collection index (collection ratio per 1000 population) is still at 4.15, ranging from 0.39 to 34.77.
Quality and safety of blood products
Transfusion-transmitted infection testing in the WHO African Region has significantly improved, with 40 countries reporting 100% of their blood supply tested against HIV, 34 of the 46 countries testing against hepatitis B virus and 23 against hepatitis C virus. However, gaps remain.
Priorities and ways forward
In line with the 2008 Ouagadougou Declaration on Primary Health Care and Health Systems, priority areas of intervention include the following:
- support implementation of effective medicine policies and interventions aimed at improving the availability and affordability of medicines;
- promote good governance in pharmaceuticals;
- strengthen national medicines regulatory authorities, monitoring their performance and human resource capacity;
- scale-up multisectoral approaches to combating counterfeit medicines;
- strengthen national pharmacovigilance systems and human resource capacity;
- scale-up harmonization of medicines regulation by working with regional economical communities;
- strengthen procurement and supply systems;
- develop appropriate pricing policies through monitoring medicines prices and availability;
- scale-up promotion of evidence-based medicines selection, development of national essential medicines lists and standard therapeutic guidelines;
- support the implementation and monitoring of national strategies for rational use of medicines, including traditional medicines;
- support countries in conducting research to generate evidence on safety, efficacy and quality of traditional medicines;
- promote institutionalization of traditional medicine in health systems and protection of traditional medicine knowledge.
Focus needs to be kept on the further development of national policies and strategic plans to ensure:
- adequate laboratory capacity;
- the development of guidelines, norms and standards on safe health care practices to protect patients in health care settings;
- active support for blood safety programmes
. These activities all provide opportunities for countries to strengthen their national health systems.
Traditional medicine policy and strategy
Traditional medicine is widely used in a number of African countries. Hence policies and regulation measures, and appropriate methods of interface with allopathic systems, are required. Thirteen countries (Cameroon, Central African Republic, Congo, Cote d’Ivoire, Democratic Republic of the Congo, Ghana, Kenya, Nigeria, Rwanda, United Republic of Tanzania, Uganda, Zambia, Zimbabwe) have developed national policies on traditional medicine, legal frameworks for the practice of traditional medicine, codes of ethics and strategic plans.
Guidelines for the clinical study of traditional medicines have been developed for adaptation to specific country situations. Research and development has been carried out to generate evidence on the safety, efficacy and quality of traditional medicines, with some encouraging results. A strong focus in traditional medicine research has been on medicinal plants, particularly for the treatment of malaria, opportunistic infections in people living with HIV/AIDS, diabetes, hypertension and sickle-cell disease. Some African countries are developing national herbal pharmacopoeias to scientifically document useful medicinal plants that have been found efficacious in the management of various ailments.
Advocacy for traditional medicine, networking and information exchange is promoted through the annual African Traditional Medicine Day. This event raises the profile of traditional medicine, creating opportunities for improving the interface between traditional medicine and conventional medicine, and enhancing efforts to integrate traditional medicine into national health systems.
Role of strong laboratory facilities
Health laboratory services are a critical component of the health system. Despite their central role, strengthening nationally coordinated laboratory services has, until recently, received inadequate attention in many countries. Laboratory services have therefore received very low priority in respect of financing, planning and service delivery.
Given the emphasis on evidence-based medical and public health practices, it is imperative that health laboratories, and laboratory systems and networks, are strengthened if they are to provide critical inputs to informed decisions. For this reason, the WHO Regional Committee for Africa adopted Resolution AFR/RC58/R2 on Public Health Laboratory Strengthening in 2008. This has led to work on establishing effective regional public health laboratory networks. These networks include regional reference laboratories with the capacity to diagnose a variety of viruses, including influenza.
Most of the national reference laboratories are involved in external quality assessment schemes, which validate laboratory capacity to perform diagnostic tasks. As needed, technical guidance on topics such as on-site training, and development and dissemination of standard operation procedures are provided to laboratories found to be performing poorly.
Lack of national health laboratory policies and plans is one of the most important challenges for African countries. To address this issue, a guidance document has been developed and published in collaboration with Centers for Disease Control and Prevention and other partners. Technical support has been provided to over 15 countries to develop national laboratory policies and strategic plans.
To build capacity in laboratory biosafety and biosecurity, more than 200 nationals from all 46 countries in the WHO African Region have been trained. The aim of the training workshops was to enhance Africa’s capacity to diagnose dangerous emerging and re-emerging pathogens, including haemorrhagic fever viruses and the highly pathogenic influenza virus H1N5.
In the area of patient safety, most African countries lack national guidelines, norms and standards. Although much of the evidence on the burden of harm from medical care is derived from developed nations, enough evidence exists in developing countries and countries with economies in transition to suggest that unsafe care is a universal problem.
Prevalence studies on hospital-wide health care associated infection from some African countries have reported high infection rates (18.9% in Mali, 14.8% in the United Republic of Tanzania and 9.8% in Algeria), those most affected being patients undergoing surgery. Hospital-associated infections generate considerable additional health care expenditure, representing a significant burden to patients, health care workers and health systems alike. To address this, a regional network for patient safety has been established in West African French-speaking countries. This network has organized national campaigns to improve hand hygiene as a measure to limit or prevent infections in health care settings.
The WHO African Region, through document AFR/RC58.8 adopted by the WHO Regional Committee in September 2008, has prioritized 12 action areas for strengthening patient safety. The prevention and control of infection is at the heart of these actions. Since early 2009, hospital-to-hospital partnerships between the UK and mainland Europe, and hospitals in African countries, have been established. Each partnership is committed to systematic action to improve patient safety.
Regarding safety in respect of clinical procedures, the WHO situational analysis tool to assess essential and emergency surgical care was employed in 15 countries. Baseline emergency and surgical conditions for evidenced-based planning were identified and severe shortages were noted in all aspects of infrastructure (including hospital beds), personnel and supplies required for delivering surgical care. If the Basic Package of Health Services, including emergency surgical care, is to be delivered, additional resources and manpower will have to be generated.
In connection with clinical procedures, a regional consultation on organ donation and transplantation was organized. This meeting provided an opportunity to review the topic, and promote national responsibilities on donation and transplantation of cells, tissues and organs.
Endnotes: sources, methods, abbreviations, etc.
The English content will be available soon.
Liste des tableaux, figures
Fig. 1: les prix du patient pour le moins cher des médicaments génériques dans les secteurs privé et public (des paires de même médicament)
Fig. 2: Prix Patient du marque d'origine et la version générique (paires de mêmes médicaments) dans le secteur privé
Fig. 55 de l'Atlas : Les lits d'hôpitaux pour 10 000 habitants dans la Région africaine, 2000-2009
Liste des références
1. Cameroun, République du Congo, République Centrafricaine, le Tchad, la Guinée équatoriale et le Gabon
2. Cameroun, RCA, Congo, Côte d'Ivoire, RDC, Ghana, Kenya, Nigeria, Rwanda, Tanzanie, Ouganda, Zambie et Zimbabwe
3. Organisation mondiale de la Santé (2004). Lignes directrices pour l'étude clinique des médicaments traditionnels dans la Région AFRO. Bureau régional OMS de l'Afrique, Brazzaville (AFR/TRM/04.4).
4. M. Traoré, Diallo A., Nikiema JB, H. Tinto, Dakuyo ZP, Ouédraogo JB, IP Guissou et Guiguemdé TR, (2008). In vitro et in vivo de l'activité antiplasmodiale «Saye», une plante médicinale utilisée au Burkina Faso la médecine traditionnelle. Phytother. Rés. 22, 550-551.
5. Nikiema JB, Djierro K, J Simpore, Sia D, S Sourabié, Gnola C, IP Guissou (2009) Stratégie d'utilisation des substances naturelles La DANS la prix de fr chargé des Personnes Vivant with HIV le: Expérience du Burkina Faso. Dossier spécial: Médecine traditionnelle en Afrique. Ethnopharmacologie: Non, 43 juillet, 2009.
6. Le Gouvernement du Ghana. La deuxième édition de la Pharmacopée ghanéenne Herbal, 2007.
7. Le gouvernement du Nigeria. La première édition de la Pharmacopée nigériane Herbal, 2008.
8. Directives pour la réglementation des médicaments traditionnels / base de plantes (locales) en Ouganda, l'Ouganda Registration Services Bureau, 2009
9. Registre des médicaments autorisés et des herbes médicinales au 31 Octobre 2008 "par l'Autorité réglementaire des produits pharmaceutiques, Ministère de la Santé, de la Zambie, (lancé en avril 2009)
10. Burkina Faso, Cameroun, Tchad, Congo, RDC, Ethiopie, Ghana, Kenya, Malawi, Mali, Maurice, Nigéria, Niger, Rwanda, Sénégal, République-Unie de Tanzanie, l'Ouganda, le Zimbabwe et la Zambie.
11. Burkina Faso, Cap Vert, République centrafricaine, Tchad, Comores, Congo, Gambie, Guinée, Libéria, Mali, Mauritanie, Sénégal, Seychelles, Afrique du Sud, Tanzanie, Ouganda, Zambie et Zimbabwe)
12. Résolution AFR/RC58/R2: Renforcement des laboratoires de santé publique dans la Région africaine de l'OMS: un besoin essentiel pour la prévention des maladies et le contrôle. En cinquante-huitième session du Comité régional pour l'Afrique, Yaoundé, Cameroun, 1-5 Septembre 2008, Rapport final. Brazzaville, Organisation mondiale de la Santé, Bureau régional pour l'Afrique, 2008 (AFR/RC58/20), pp 11-13.
14. Document AFR/RC58/8: la sécurité des patients dans les services de santé en Afrique: enjeux et solutions. Dans: Cinquante-huitième session du Comité régional de l'OMS pour l'Afrique, Yaoundé, Cameroun, 1-5 Septembre 2008. Rapport final. Brazzaville, Organisation mondiale de la Santé, Bureau régional pour l'Afrique, 2008.
16. www.who.int / chirurgie : Outil d'évaluation des soins chirurgicaux essentiels et d'urgence. OMS de gestion intégrée pour des urgences et des soins chirurgicaux essentiels (IMEESC) trousse à outils.
17. Sécurité du sang: Une stratégie pour la Région africaine: AFR RC51 / 9; Bureau régional pour l'Afrique, 2001.
- ↑ Everybody’s business. Strengthening health systems to improve health outcomes. WHO’s framework for action (pdf 843.33kb). Geneva, World Health Organization, 2007
- ↑ The world medicines situation (pdf 1.03Mb). Geneva, World Health Organization, 2004
- ↑ The Ouagadougou Declaration on primary health care and health systems in Africa: achieving better health for Africa in the new millennium (pdf 2.94Mb). Brazzaville, World Health Organization Regional Office for Africa, 2010 http://ahm.afro.who.int/issue12/pdf/AHM12Pages10to21.pdf
- ↑ Guidelines for clinical study of traditional medicines in WHO African Region. Brazzaville, World Health Organization Regional Office for Africa, 2004 (AFR/TRM/04.4)
- ↑ Traoré M et al. In vitro and in vivo antiplasmodial activity of “saye”, an herbal remedy used in Burkina Faso traditional medicine. Phytotherapy Research, 2008, 22:550–551
- ↑ Nikiema JB et al. Stratégie d’utilisation des substances naturelles dans la prise en charge des personnes vivant avec le VIH : expérience du Burkina Faso. Dossier Spécial: médecine traditionnelle en Afrique. Ethnopharmacologie, 2009, 43
- ↑ Patient safety in African health services: issues and solutions. In: Fifty-eighth session of the WHO Regional Committee for Africa, Yaoundé, Cameroon, 1─5 September 2008. Final Report (pdf 449.11kb). Brazzaville, World Health Organization Regional Office for Africa, 2008 (AFR/RC58/8) http://apps.who.int/iris/bitstream/10665/19987/1/AFR-RC58-8.pdf