Decision criteria for selecting essential medicines and their connection to guidelines: an interpretive descriptive qualitative interview study.

BACKGROUND AND OBJECTIVES: The World Health Organization Model List of Essential Medicines has led to at least 137 national lists. Essential medicines should be grounded in evidence-based guideline recommendations and explicit decision criteria. Essential medicines should be available, accessible, affordable, and the supporting evidence should be accompanied by a rating of the certainty one can place in it. Our objectives were to identify criteria and considerations that should be addressed in moving from a guideline recommendation regarding a medicine to the decision of whether to add, maintain, or remove a medicine from an essential medicines list. We also seek to explore opportunities to improve organizational processes to support evidence-based health decision-making more broadly. METHODS: We conducted a qualitative study with semistructured interviews of key informant stakeholders in the development and use of guidelines and essential medicine lists (EMLs). We used an interpretive descriptive analysis approach and thematic analysis of interview transcripts in NVIVO v12. RESULTS: We interviewed 16 key informants working at national and global levels across all WHO regions. We identified five themes: three descriptive/explanatory themes 1) EMLs and guidelines, the same, but different; 2) EMLs can drive price reductions and improve affordability and access; 3) Time lag and disconnect between guidelines and EMLs; and two prescriptive themes 4) An "evidence pipeline" could improve coordination between guidelines and EMLs; 5) Facilitating the link between the WHO Model List of Essential Medicines (WHO EML) and national EMLs could increase alignment. CONCLUSION: We found significant overlap and opportunities for alignment between guideline and essential medicine decision processes. This finding presents opportunities for guideline and EML developers to enhance strategies for collaboration. Future research should assess and evaluate these strategies in practice to support the shared goal of guidelines and EMLs: improvements in health.

Availability, prices, and affordability of selected essential cancer medicines in a middle-income country - the case of Mexico.

BACKGROUND: More alternatives have become available for the diagnosis and treatment of cancer in low- and middle-income countries. Because of increasing demands, governments are now facing a problem of limited affordability and availability of essential cancer medicines. Yet, precise information about the access to these medicines is limited, and the methodology is not very well developed. We assessed the availability and affordability of essential cancer medicines in Mexico, and compared their prices against those in other countries of the region. METHODS: We surveyed 21 public hospitals and 19 private pharmacies in 8 states of Mexico. Data were collected on the availability and prices of 49 essential cancer medicines. Prices were compared against those in Chile, Peru, Brazil, Colombia and PAHO's Strategic Fund. RESULTS: Of the various medicines, mean availability in public and private sector outlets was 61.2 and 67.5%, respectively. In the public sector, medicines covered by the public health insurance "People's Health Insurance" were more available. Only seven (public sector) and five (private sector) out of the 49 medicines were considered affordable. Public sector procurement prices were 41% lower than in other countries of the region. CONCLUSIONS: The availability of essential cancer medicines, in the public and private sector, falls below World Health Organization's 80% target. The affordability remains suboptimal as well. A national health insurance scheme could serve as a mechanism to improve access to cancer medicines in the public sector. Comprehensive pricing policies are warranted to improve the affordability of cancer medicines in the private sector.

Access to cancer medication in public hospitals in a middle-income country: The view of stakeholder.

BACKGROUND: Access to cancer medicines is a core component of comprehensive cancer care; as such, it is included in Mexico's public health insurance: Seguro Popular de Salud (SPS). Learning about stakeholders' experiences on processes and barriers influencing access to essential cancer medicines within healthcare facilities allows identifying needed policies to improve access to cancer care. OBJECTIVE: The aim of this study was to obtain the insights of health professionals in public hospitals in Mexico on how SPS influences access to cancer medicines regarding medicine selection, financing, and procurement and supply systems. The purpose is to identify policy areas that need strengthening to improve access to cancer medicines. METHODS: Semi-structured interviews were conducted with 67 health professionals from 21 public hospitals accredited by SPS across Mexico. A framework analysis was used with categories of analysis derived from the World Health Organization's Access framework. RESULTS: Most stakeholders reported that the availability of listed cancer medicines was sufficient. However, cancer specialists reported that medicines coverage by SPS was restrictive covering only basic cancer care. Public hospitals followed SPS treatment protocols in selecting and prescribing cancer medicines but used different procurement procedures. When essential cancer medicines were unavailable (not listed or stocked-out), hospitals reported several strategies such as prescribing alternative therapies, resorting to direct purchases, and assisting patients in obtaining medicines elsewhere. Other reported barriers to access to treatment were: distance to health facilities, poor insurance coverage, and financial restrictions. CONCLUSIONS: Health professionals have encountered benefits and challenges from the implementation of SPS influencing access to cancer medicines and care in Mexico, pointing to areas in which action is necessary. Finding the right balance between expanding the range and cost of cancer treatments covered by insurance and making basic cancer care available to all is a challenge faced by Mexico and other middle-income countries.

Legislating for universal access to medicines: a rights-based cross-national comparison of UHC laws in 16 countries.

Universal health coverage (UHC) aims to ensure that all people have access to health services including essential medicines without risking financial hardship. Yet, in many low- and middle-income countries (LMICs) inadequate UHC fails to ensure universal access to medicines and protect the poor and vulnerable against catastrophic spending in the event of illness. A human rights approach to essential medicines in national UHC legislation could remedy these inequities. This study identifies and compares legal texts from national UHC legislation that promote universal access to medicines in the legislation of 16 mostly LMICs: Algeria, Chile, Colombia, Ghana, Indonesia, Jordan, Mexico, Morocco, Nigeria, Philippines, Rwanda, South Africa, Tanzania, Turkey, Tunisia and Uruguay. The assessment tool was developed based on WHO's policy guidelines for essential medicines and international human rights law; it consists of 12 principles in three domains: legal rights and obligations, good governance, and technical implementation. Relevant legislation was identified, mapped, collected and independently assessed by multi-disciplinary, multi-lingual teams. Legal rights and State obligations toward medicines are frequently codified in UHC law, while most good governance principles are less common. Some technical implementation principles are frequently embedded in national UHC law (i.e. pooled user contributions and financial coverage for the vulnerable), while others are infrequent (i.e. sufficient government financing) to almost absent (i.e. seeking international assistance and cooperation). Generally, upper-middle and high-income countries tended to embed explicit rights and obligations with clear boundaries, and universal mechanisms for accountability and redress in domestic law while less affluent countries took different approaches. This research presents national law makers with both a checklist and a wish list for legal reform for access to medicines, as well as examples of legal texts. It may support goal 7 of the WHO Medicines & Health Products Strategic Programme 2016-30 to develop model legislation for medicines reimbursement.

The Impact of Price Negotiations on Public Procurement Prices and Access to 8 Innovative Cancer Medicines in a Middle-Income Country: The Case of Mexico.

BACKGROUND: To mitigate the effect of high prices, in 2008 Mexico established a commission that negotiates single procurement prices for patented medicines in the public sector. OBJECTIVES: We assessed the possible effect of price negotiations on the prices of new essential cancer medicines in Mexico between 2010 and 2016 and on access to these new cancer medicines. METHODS: We retrieved the public procurement prices and volume of 8 selected innovative cancer medicines in Mexico in addition to their maximum retail prices in the private sector. We calculated the median, interquartile (25%-75%) range, and maximum and minimum public procurement prices to analyze price changes and trends. We assessed changes between the maximum retail prices and the public procurement prices and changes in the volume procured from 2010 to 2016. RESULTS: Between 2010 and 2016, the prices of selected patented cancer medicines in the public sector decreased by 40% to 85%, expressed in US dollars. When expressed in Mexican pesos, public prices for 5 medicines reduced and others remained stable, whereas prices increased in the private sector over the same period. Procurement prices were not uniform between and within public institutions. The volumes of selected cancer medicines supplied in the public sector increased over the years, suggesting better access. CONCLUSION: Although direct causality is difficult to prove, the establishment of the negotiating commission seems to have led to reduced prices and possibly better access in the public sector. Medicine procurement by public hospitals should be monitored to ensure that negotiated prices benefit all institutions.

The right to health as the basis for universal health coverage: A cross-national analysis of national medicines policies of 71 countries.

Persistent barriers to universal access to medicines are limited social protection in the event of illness, inadequate financing for essential medicines, frequent stock-outs in the public sector, and high prices in the private sector. We argue that greater coherence between human rights law, national medicines policies, and universal health coverage schemes can address these barriers. We present a cross-national content analysis of national medicines policies from 71 countries published between 1990-2016. The World Health Organization's (WHO) 2001 guidelines for developing and implementing a national medicines policy and all 71 national medicines policies were assessed on 12 principles, linking a health systems approach to essential medicines with international human rights law for medicines affordability and financing for vulnerable groups. National medicines policies most frequently contain measures for medicines selection and efficient spending/cost-effectiveness. Four principles (legal right to health; government financing; efficient spending; and financial protection of vulnerable populations) are significantly stronger in national medicines policies published after 2004 than before. Six principles have remained weak or absent: pooling user contributions, international cooperation, and four principles for good governance. Overall, South Africa (1996), Indonesia and South Sudan (2006), Philippines (2011-2016), Malaysia (2012), Somalia (2013), Afghanistan (2014), and Uganda (2015) include the most relevant texts and can be used as models for other settings. We conclude that WHO's 2001 guidelines have guided the content and language of many subsequent national medicines policies. WHO and national policy makers can use these principles and the practical examples identified in our study to further align national medicines policies with human rights law and with Target 3.8 for universal access to essential medicines in the Sustainable Development Goals.

The importance of insulin donations for children in 43 low- and middle-income countries.

Diabetes mellitus is rapidly becoming one of the major diseases affecting people's health globally. Over half of 100 million diabetes patients who need insulin to survive, especially in low- and middle-income countries (LMIC), are not able to get this medicine and die prematurely. Since 2000, insulin-producing companies have started support programmes with a component of insulin donations to children and youth with type 1 diabetes in 43 LMIC. Based on their experiences we conclude, contrary to common belief, that the diagnosis, treatment, and prevention of fatal complications in children with type 1 diabetes in LMIC are very possible in practice, with large improvements in survival, mean body weight, mean glucose levels, and frequency of complications. Medicine donations can never offer a sustainable solution and we now propose a ten-step transition process towards a fully sustainable national diabetes care and prevention programme for children and youth with diabetes type 1.

Access to essential medicines in 195 countries: A human rights approach to sustainable development.

In 2008 the UN Special Rapporteur on the Right to Health published 72 right to health indicators in 194 health systems. We present a follow-up report of eight indicators for access to medicines to serve as a reference point for progress towards SDG Target 3.8 on essential medicines. Data for these eight indicators in 2015 were collected and compared with the 2008 report. Between 2008 and 2015 we observed increased numbers of constitutions recognising access to medicines (7-13 countries), countries with a national medicine policy (118-122) and with a national list of essential medicines (78-107). Public spending on pharmaceuticals decreased or rose modestly in most of the 44 countries. Median availability of a basket of lowest-priced generics increased in the public (63%-70% n = 9 countries) and private (84%-92% n = 10) sectors. Median child immunisation rates remained constant for measles (around 90%) and improved for three doses of diphtheria-tetanus-pertussis (79%-86%). These eight indicators are useful and feasible, but should be further strengthened and expanded. Future monitoring exercises should use these indicators to screen progress and guide national governments' action to ensure universal access to essential medicines as part of the right to health.

Access to innovative cancer medicines in a middle-income country - the case of Mexico.

BACKGROUND: Cancer has become the third cause of death in Mexico. Treatment for cancer is often complex and lengthy. New and better medicines enter the market at high prices, which may limit access. Like most Latin American countries, Mexico has an essential cancer medicines list that includes innovative medicines. Their accessibility and use in the public sector remains unknown. Therefore, we describe the use, as a proxy of access, of innovative and essential cancer medicines in the public sector in Mexico, by insurance institution, and by five regions between 2010 to 2016. METHODS: We used drug utilization research methods to assess the use of eight patented cancer medicines. Through the national transparency platform, we obtained data on the quantities of these medicines used in all public health facilities and social health insurance institutions and recalculated those figures into defined daily dose (DDD) per 1000 population per year. RESULTS: Overall, the use of all medicines increased over the years, especially for trastuzumab, rituximab and imatinib. The use of innovative medicines was higher per population covered in social health insurance institutions than in governmental facilities. Throughout the study period, the Central region (including Mexico City) has used more medicines per population than the other regions. CONCLUSIONS: The use and access of some essential innovative cancer medicines has increased over the years, but remains unequal across insurance schemes and regions. Particularly, the Ministry of Health Insurance scheme and Northern and Western regions in the country would benefit from additional efforts to increase access to essential cancer medicines.

Medicine procurement and the use of flexibilities in the Agreement on Trade-Related Aspects of Intellectual Property Rights, 2001-2016.

Millions of people, particularly in low- and middle-income countries, lack access to effective pharmaceuticals, often because they are unaffordable. The 2001 Ministerial Conference of the World Trade Organization (WTO) adopted the Doha Declaration on the TRIPS (Trade-Related Aspects of Intellectual Property Rights) Agreement and Public Health. The declaration recognized the implications of intellectual property rights for both new medicine development and the price of medicines. The declaration outlined measures, known as TRIPS flexibilities, that WTO Members can take to ensure access to medicines for all. These measures include compulsory licensing of medicines patents and the least-developed countries pharmaceutical transition measure. The aim of this study was to document the use of TRIPS flexibilities to access lower-priced generic medicines between 2001 and 2016. Overall, 176 instances of the possible use of TRIPS flexibilities by 89 countries were identified: 100 (56.8%) involved compulsory licences or public noncommercial use licences and 40 (22.7%) involved the least-developed countries pharmaceutical transition measure. The remainder were: 1 case of parallel importation; 3 research exceptions; and 32 non-patent-related measures. Of the 176 instances, 152 (86.4%) were implemented. They covered products for treating 14 different diseases. However, 137 (77.8%) concerned medicines for human immunodeficiency virus infection and acquired immune deficiency syndrome or related diseases. The use of TRIPS flexibilities was found to be more frequent than is commonly assumed. Given the problems faced by countries today in procuring high-priced, patented medicines, the practical, legal pathway provided by TRIPS flexibilities for accessing lower-cost generic equivalents is increasingly important.

Des millions de personnes, en particulier dans les pays à revenu faible et intermédiaire, ne peuvent accéder à des produits pharmaceutiques efficaces, souvent en raison de leur prix trop élevé. La Conférence ministérielle de 2001 de l'Organisation mondiale du commerce (OMC) a adopté la Déclaration de Doha sur l'Accord sur les ADPIC (aspects des droits de propriété intellectuelle qui touchent au commerce) et la santé publique. Cette déclaration a reconnu les implications des droits de propriété intellectuelle, aussi bien pour le développement de nouveaux médicaments que pour le prix des médicaments. Elle a détaillé des mesures, appelées flexibilités des ADPIC, que peuvent prendre les Membres de l'OMC pour assurer l'accès de tous aux médicaments, comme l'octroi de licences obligatoires aux brevets de médicaments et la mesure de transition pharmaceutique des pays les moins avancés. Le but de cette étude était d'examiner le recours aux flexibilités des ADPIC pour accéder à des médicaments génériques moins coûteux entre 2001 et 2016. Dans l'ensemble, 176 cas de recours possible aux flexibilités des ADPIC par 89 pays ont été relevés: 100 (56,8%) concernaient des licences obligatoires ou des licences d'utilisation publique à des fins non commerciales et 40 (22,7%) concernaient la mesure de transition pharmaceutique des pays les moins avancés. Quant aux autres, il s'agissait d'un cas d'importation parallèle, de 3 exceptions de recherche et de 32 mesures sans lien avec des brevets. Sur ces 176 cas, 152 (86,4%) ont été mis en œuvre. Ils portaient sur des produits destinés à traiter 14 maladies différentes. Cependant, 137 (77,8%) concernaient des médicaments contre le virus de l'immunodéficience humaine et le syndrome d'immunodéficience acquise ou des maladies apparentées. Le recours aux flexibilités des ADPIC s'est révélé plus fréquent que ce que l'on supposait. Étant donné les problèmes que rencontrent actuellement certains pays pour se procurer des médicaments brevetés à prix élevé, le cadre pratique et juridique offert par les flexibilités des ADPIC pour accéder à des équivalents génériques moins coûteux revêt une importance de plus en plus capitale.

Millones de personas, particularmente en países de ingresos bajos y medios, carecen de acceso a medicamentos efectivos, habitualmente porque no pueden pagarlos. La Conferencia Ministerial de 2001 de la Organización Mundial del Comercio (OMC) adoptó la Declaración de Doha relativa al Acuerdo sobre los ADPIC (Aspectos de los Derechos de Propiedad Intelectual relacionados con el Comercio) y la Salud Pública. La declaración reconoció las implicaciones de los derechos de propiedad intelectual para el desarrollo de nuevos medicamentos y el precio de los mismos. La declaración describió medidas, conocidas como flexibilidades de los ADPIC, que los Miembros de la OMC pueden tomar con el objetivo de asegurar el acceso a los medicamentos para todos. Estas medidas incluyen concesión obligatoria de licencias de patentes de medicamentos y la medida de transición farmacéutica de países menos desarrollados. El objetivo de este estudio fue documentar el uso de las flexibilidades de los ADPIC para acceder a medicamentos genéricos de precio inferior entre el 2001 y el 2016. En general, se identificaron 176 casos de posibles usos de las flexibilidades de los ADPIC: 100 (56.8%) implicaron licencias obligatorias o licencias de uso público no comercial y 40 (22.7%) apelaron a la medida de transición farmacéutica de países menos desarrollados. El resto fue: 1 caso de importación paralela; 3 excepciones de investigación; y 32 medidas no relacionadas con patentes. De los 176 casos, 152 (86.4%) se implementaron. Cubrieron productos para tratar 14 enfermedades diferentes. Sin embargo, 137 (77.8%) implicaron medicamentos para la infección del virus de inmunodeficiencia humana y el síndrome de inmunodeficiencia adquirida o enfermedades relacionadas. Resultó que el uso de las flexibilidades de los ADPIC fue más frecuente de lo que comúnmente se espera. Dados los problemas que enfrentan hoy los países en la adquisición de medicamentos de alto precio y patentados, el camino práctico y legal que ofrecen las flexibilidades de los ADPIC para acceder a equivalentes genéricos de costo inferior es cada vez más importante.

Policy approaches to improve availability and affordability of medicines in Mexico - an example of a middle income country.

BACKGROUND: The World Health Organization recommends establishing and implementing a national pharmaceutical policy (NPP) to guarantee effective and equitable access to medicines. Mexico has implemented several policy approaches to regulate the pharmaceutical sector, but it has no formal NPP. This article describes the approach that the Mexican government has taken to improve availability and affordability of essential medicines. METHODS: Descriptive policy analysis of public pharmaceutical policy proposals and health action plans on the basis of publicly available data and health progress reports, with a focus on availability and affordability of medicines. RESULTS: The government has implemented pooled procurement, price negotiations, and an information platform in the public sector to improve affordability and availability. The government mainly reports on the savings that these strategies have generated in the public expenditure but their full impact on availability and affordability has not been assessed. CONCLUSIONS: To increase availability and affordability of medicines in the public sector, the Mexican government has resorted on isolated strategies. In addition to efficient procurement, price negotiations and price information, other policy components and pricing interventions are needed. All these strategies should be included in a comprehensive NPP.

Impacts of a new insurance benefit with capitated provider payment on healthcare utilization, expenditure and quality of medication prescribing in China.

OBJECTIVES: To assess a new Chinese insurance benefit with capitated provider payment for common diseases in outpatients. METHODS: Longitudinal health insurance claims data, health administrative data and primary care facility data were used to assess trajectories in outpatient visits, inpatient admissions, expenditure per common disease outpatient (CD/OP) visit and prescribing indicators over time. We conducted segmented regression analyses of interrupted time series data to measure changes in level and trend overtime, and cross-sectional comparisons against external standards. RESULTS: The number of total outpatient visits at 46 primary care facilities (on the CD/OP benefit as of July 2012) increased by 46 895 visits/month (P = 0.004, 95% CI: 15 795-77 994); the average number of CD/OP visits reached 1.84/year/enrollee in 2012; monthly inpatient admissions dropped from 6.4 (2009) to 4.3 (2012) per 1000 enrollees; the median total expenditure per CD/OP visit dropped by CNY 15.40 (P = 0.16, 95% CI: -36.95~6.15); injectable use dropped by 7.38% (P = 0.03, 95% CI: -14.08%~-0.68%); antibiotic use was not improved. CONCLUSIONS: Zhuhai's new CD/OP benefit with capitated provider payment has expanded access to primary care, which may have led to a reduction in expensive specialist inpatient services for CD/OP benefit enrollees. Cost awareness was likely raised, and rapidly growing expenditures were contained. Although having been partially improved, inappropriate prescribing of antibiotics and injectables was still prevalent. More explicit incentives and specific quality of care targets must be incorporated into the capitated provider payment to promote scientifically sound and cost-effective care and treatment.

Achieving universal health coverage-the case of Zhuhai city.

OBJECTIVE: Universal health coverage cannot be achieved without evidence from research, which requires national and international support. We hope that our careful documentation of one of China's local experience in designing and implementing the basic health insurance coverage, and our analysis of how it helped to achieve universal health coverage, will inform other systems in China as well as other relevant countries on their way to universal coverage. METHODS: The paper first presents the development of Zhuhai's basic health insurance system chronologically; then comprehensively describes the background and the key components of the common disease outpatient benefit package; followed by a comparison with the common practices of outpatient benefit package of other areas of China and four neighboring countries. It also summarizes the strengths and weakness of the package, and lists the remaining research questions for future studies. RESULTS: The common disease outpatient benefit package of Zhuhai has helped to improve the universal health coverage of Zhuhai in the following aspects: securing all citizens' access to the common disease outpatient services under the basic health insurance coverage; containing the rapid growth of health expenditures; enhancing provider awareness of expenditure and encouraging cost-effective interventions through appropriate financial incentives; and shifting the focus from treatment to prevention and preventing the development of common diseases into serious conditions with high cost specialist services. The common disease outpatient benefit package greatly improved and strengthened the basic health insurance system through secured equal access to affordable outpatient care for common conditions. CONCLUSION: Limited health resources are used more efficiently by pooling the risks and by implementing capitated provider payment, which enhances the cost awareness by health care providers, to improves efficiency and creates positive incentives for health professionals for using the most cost-effective health interventions.

A quiet revolution in global public health: The World Health Organization's Prequalification of Medicines Programme.

Problems with the quality of medicines abound in countries where regulatory and legal oversight are weak, where medicines are unaffordable to most, and where the official supply often fails to reach patients. Quality is important to ensure effective treatment, to maintain patient and health-care worker confidence in treatment, and to prevent the development of resistance. In 2001, the WHO established the Prequalification of Medicines Programme in response to the need to select good-quality medicines for UN procurement. Member States of the WHO had requested its assistance in assessing the quality of low-cost generic medicines that were becoming increasingly available especially in treatments for HIV/AIDS. From a public health perspective, WHO PQP's greatest achievement is improved quality of life-saving medicines used today by millions of people in developing countries. Prequalification has made it possible to believe that everyone in the world will have access to safe, effective, and affordable medicines. Yet despite its track record and recognized importance to health, funding for the programme remains uncertain.