This report provides an update on the key facets of HIV treatment access, including the latest HIV treatment guidelines from World Health Organization (WHO), an overview on pricing for first-line, second-line, and salvage regimens, and a summary of the opportunities for – and threats to – expand...ing access to affordable antiretroviral therapy (ART).
The report is supplemented by 11 drug profiles that contain more detailed information on pricing trends and patent barriers for key antiretroviral drugs and fixed-dose combinations. Also included is an annex of conditions that define eligibility for reduced prices from 15 pharmaceutical companies.
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Globally each year, millions of people suffer illness or lose their lives because the vaccines, medicines and diagnostic tests that they need are either unavailable or unaffordable – and this lack of access to medicine is acute in low- and middle-in-
come countries (LMICs). While the COVID-19 pan...demic laid this inequity bare, it also saw the pharmaceutical industry develop and bring new vaccines and treat- ments to market at unprecedented speed. As the world emerges from the worst
of this crisis, pharmaceutical companies are now at an important juncture, where lessons learned from the pandemic can prove pivotal in finding solutions to bridge long-standing gaps in access to medicine in LMICs.
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The primary role of Benin’s Department of Pharmacy and Medicines (DPMED) is to develop and apply the national pharmaceutical policy. The main objective of this policy is to ensure the availability and accessibility of quality medicines for the population. To fulfill its mandate, DPMED aims to stre...ngthen its regulatory capacity, including the issuance of licenses to pharmaceutical establishments and the registration of pharmaceutical products. Benin’s current registration system shares core concerns that are common to most developing countries, notably the capacity to evaluate and monitor the security, efficacy, and quality of medicines and other health products. It is currently characterized by 1) poor or inadequate traceability of records or regulations (example: a product’s marketing authorization [MA] is often hard to find); 2) lack of evidence used in the regulatory decision-making process (reasons behind special import authorization, i.e., products without valid MAs); 3) inconsistent and unsecured archiving system; 4) limited human resources; and 5) an inefficient information management system
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Severe Acute Malnutrition (SAM) is one of the greatest child survival challenges in the world today and
reportedly affects more than 16.2 million children each year1. High impact, proven treatment interventions exist
yet sadly approximately only 3.2 million children with SAM have access to treatme...nt each year2. Thus, there
is a need to scale up interventions to improve coverage and access across high burden countries. While efforts
are currently underway to expand services in many countries, obstacles remain.
One critical barrier to expanding SAM treatment services is the acceptance, accessibility and utilisation of
ready-to-use therapeutic food (RUTF). In some countries and contexts, RUTF is still not fully accepted by
community members; while other countries face problems with procurement, storage and supply chain
management which impact on availability and use3. Reports from Ghana and Zambia highlighted that stock-
outs and logistical challenges are often noted as key contributors to high default rates in outpatient treatment
centres4.
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Overcoming barriers in low- and middle-income countries
For the first time, this year’s report includes information on hepatitis C diagnostics. With a focus on selected countries with diverse HCV epidemics, the report provides updates on the various dimensions of access to HCV diagnostics and pha...rmaceutical products, including product pricing, the regulatory environment and patent status, which together shape the national hepatitis response in different settings. It highlights key areas for action by ministries of health and other government decision-makers, pharmaceutical manufacturers and technical partners.
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August 2020.
In December 2018, the President launched the UHC pilot covering four strategically selected counties-Isiolo, Kisumu, Machakos and Nyeri. It isplanned that by the year 2022, all persons in Kenya will be able to use the essential services they need for their health... and wellbeing through a single unified benefit package, without the risk of financial catastrophe. Essential health products are considered an integral part of UHC andare an indispensable element for delivery ofservices andare also a requirement for qualitycare. Despite this realization, a review of the UHC pilot in September 2019 established that whereas the Kenya Medical Supplies Authority (KEMSA) was able to fill up to 80% of pharmaceutical items, the order fill rate for medical supplies was less than 50%for level 2 and 3 facilities and as low as 30%for level 4 and 5 facilities.
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The PHC STGs and EML should be used by healthcare workers providing care at clinics, community health centres, and gateway clinics at hospitals.
Pharmaceutical and Therapeutics Committees (PTCs) are responsible for ensuring the availability of medicines listed in the PHC EML at those facilities, as... well as at higher levels of care.
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Essential Medicines are those that satisfy the priority health care needs of the population. They are selected with due regard to public health relevance, evidence on efficacy, safety and comparative cost-effectiveness. This edition of the Essential Medicines List (EML) 2017 for Ghana has been deriv...ed from its companion Standard Treatment Guidelines 2017 to ensure harmony in treatment, procurement and re-imbursements. The medicines listed have been coded according to the Health Commodity
Codes Catalogue of the Ministry of Health (2008) and their levels of use, based on the type of health facility, including midwifery practice, have been indicated.
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The purpose of these guidelines is to help health workers to participate in the process of continuous surveillance of safety and efficacy of the pharmaceutical products which are used in clinical practice, thus help to achieve the ultimate goal to make safer and more effective treatment available to... patients. This guideline addresses specifically the issues on what to report, why to report, when to report, where to report and how to report.
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Interagency Guidelines - This revised Interagency List of Essential Medicines for Reproductive Health presents
the current international consensus on rational selection of essential reproductive health medicines. The list is intended to support decisions regarding the production, quality assurance..., national procurement and reimbursement schemes of these medicines.
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The Ethiopian Hospital Services Transformation Guidelines (EHSTG) build on and expand the Ethiopian Hospital Reform Implementation Guidelines (EHRIG) and are consistent with the Health Sector Transformation Plan (HSTP). The EHSTG, which is consistent with the national focu...s on quality improvement in health care, contains a common set of guidelines to help hospital Chief Executive Officers(CEOs), managers, and clinicians (care providers) in steering the consistent implementation of these transformational systems and processes in hospitals throughout the country. The EHSTG focused on selected management and clinical functions, including new individual service specific chapters for Emergency Medical, Outpatient and Inpatient Services, Nursing and Midwifery, Maternal, Neonatal and Child Health and Teaching Hospitals’ Management. These guidelines also incorporate recent lessons from the operationalization of the EHRIG, as well as, new national initiatives such as the Guidelines for the Management of Federal Hospitals in Ethiopia, Hospital Development Army (HDA), Clean and Safe Hospital (CASH), and Auditable Pharmaceutical Transaction and Service (APTS).
II10 Pharmacy ChapterIt is expected that the guidelines will continuously evolve as new evidence emerges regarding improved hospital care and practices that are better tailored to needs and circumstances of different tiers of public hospitals. We are grateful to all partners that have participated in the production of these guidelines. Special thanks go to our colleagues at the Clinton Health Access Initiative for their substantial contributions and support throughout the development of these guidelines as well as their dedicated efforts in support of our health reform efforts in so many other capacities
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In the last decade, Timor-Leste has made remarkable progress in strengthening its health system and improving the health status of its population. This has resulted in an increased life expectancy, and the achievement of Millennium Development Goals such as a reduction in infant and under-five morta...lity, an improvement in maternal and child health outcomes, and an increase in immunization coverage. Further, the country has successfully eliminated infectious diseases such as polio, measles, and maternal and neonatal tetanus. There is full political commitment to reducing the incidence of tuberculosis (TB) by 80% and the number of deaths due to TB by 90% by 2030. The country has made great progress in the context of the pandemic, having established numerous quarantine facilities/isolation centres; trained health-care workers; streamlined the procurement and supply of medicines, consumables, personal protective equipment and other equipment; and strengthened the capacity in critical care across secondary and tertiary health care, to better respond to future pandemics and other disaster situations.
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The Pandemic Influenza Preparedness (PIP) Framework is a World Health Assembly resolution adopted unanimously by all Member States in 2011. It brings together Member States, industry, other stakeholders and WHO to implement a global approach to pandemic influenza preparedness and response. The Frame...work includes a benefit-sharing mechanism called the Partnership Contribution (PC). The PC is collected as an annual cash contribution from influenza vaccine, diagnostic, and pharmaceutical manufacturers that use the WHO Global Influenza Surveillance and Response System (GISRS). Funds are allocated for: (a) pandemic preparedness capacity building; (b) response activities during the time of an influenza pandemic; and (c) PIP Secretariat for the management and implementation of the Framework.
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The new treatment recommendations that extend the 2018 treat all recommendation for adults with chronic HCV infection to include adolescents and children down to 3 years, and to align the existing recommended pangenotypic direct-acting antiviral (DAA) regimens (SOF/DCV, SOF/VEL and G/P) for adults, ...to those for adolescents and children. This alignment is expected to simplify procurement, promote access to treatment among children in low- and middle-income countries and contribute to global efforts to eliminate the disease
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PHARMA’S RESPONSE TO THE COVID-19 VACCINES CRISIS. Update Feb., 14, 2022. In September 2021, Amnesty International published A Double Dose of Inequality, which assessed the extent to which the pharmaceutical industry was restricting access to Covid-19 vaccines. This report updates that assessment ...of five leading vaccine manufacturers, AstraZeneca plc, BioNTech SE, Johnson & Johnson, Moderna Inc., and Pfizer Inc. It also includes for the first time an assessment of the two largest Chinese vaccine producers, China National Pharmaceutical Group Co., Ltd. (Sinopharm) and Sinovac Biotech Ltd. (Sinovac).
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Accessed: 02.05.2020
These interim IPC recommendations for health settings have been developed through the contributions of many individuals and institutions, such as the Centers for Disease Control-Kenya; ITECH; US Agency for International Development (USAID) Medicines, Technologies, and Pharmaceu...tical Services (MTaPS) Program; and WHO that are committed to ensuring that the transmission of COVID-19 to HCWs and the public within the health care setting is limited. The Ministry of Health (MOH) through the Directorate of Health Standards Quality Assurance and Regulations wishes to thank all the contributing authors led by the sub-committee on case management and IPC for the COVID-19 response for their expertise and time given to writing these guidelines.
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August 2020.
Essential diagnostic products areconsidered an integral part of UHC, they are an indispensable element for delivery ofservices andare also a requirement for qualitycare. Despite this realization, a review of the UHC pilot in September 2019 es...tablished that whereas the Kenya Medical Supplies Authority (KEMSA) was able to fill up to 80% of pharmaceutical items, the order fill rate for diagnostic products was less than 50 percent for level 2 and 3 facilities and as low as 30 percent for level 4 and 5 facilities.
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This report, published in conjunction with a summary overview of results of rounds 1–8, is the eighth and final report in a series of laboratory-based evaluations of rapid diagnostic tests (RDTs) for malaria. It provides a comparative measure of their performance in a standardized way to distingu...ish between well and poorly performing tests.
These results constitute the laboratory evaluation component of the WHO prequalification process for malaria RDTs and inform the current WHO procurement recommendations. In round 8, 35 RDTs from 17 manufacturers were assessed. For the first time the evaluation included an assessment of product performance against a panel of P. falciparum parasites with pfhrp2/3 gene deletions and therefore not expressing HRP2.
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The guidelines reiterate that the general principles of ethics for biomedical research involving human participants shall also be applicable. In addition, the guidelines specify unique provisions for stem cells, because of their inherent property for unlimited proliferation, differentiation to cells... of the germ layers, oncogenic potential, unrecognised toxicities and possible involvement in pre-implantation stages of human development. The guideline therefore focuses on: 1. Monitoring mechanism and regulatory pathway for basic, clinical research and product development based on categories of research and level of manipulation. 2. Procurement of gametes, embryos and somatic cells for derivation and propagation of any stem cell lines, their banking and distribution. 3. Other important areas like international collaboration, exchange of cell/lines and education for stakeholders and advertisement.
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PQM conducted an assessment of the medicine quality assurance and quality control systems in Rwanda during November 9-13, 2009. Medicine quality assurance remains to be developed in Rwanda: the country has neither a medicine regulatory authority (MRA) nor a national medicine quality control laborato...ry – the two key institutions to ensure the quality, safety, and efficacy of medicines. The MOH Pharmacy Taskforce (PTF) is to be commended however for successfully controlling the pharmaceutical market to the extent that there is no informal medicines market in Rwanda. Based on its findings, the assessment team expects Rwanda to be able to make great strides in evidence-based medicines quality assurance in the short to medium term, provided it receives adequate technical assistance and financial support.
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