Changing global essential medicines norms to improve access to AIDS treatment: Lessons from Brazil

Abstract

Brazil's large-scale, successful HIV/AIDS treatment programme is considered by many to be a model for other developing countries aiming to improve access to AIDS treatment. Far less is known about Brazil's important role in changing global norms related to international pharmaceutical policy, particularly international human rights, health and trade policies governing access to essential medicines. Prompted by Brazil's interest in preserving its national AIDS treatment policies during World Trade Organisation trade disputes with the USA, these efforts to change global essential medicines norms have had important implications for other countries, particularly those scaling up AIDS treatment. This paper analyses Brazil's contributions to global essential medicines policy and explains the relevance of Brazil's contributions to global health policy today.     

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

ABSTRACT

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 essential drugs in developing countries

Every year infectious diseases kill about 13 million people, about 30.000 deaths a day. Almost half of the victims are children younger than 5 years old, most of them belong to developing countries. Most of the premature deaths and the incapacity cases associated to infectious diseases could be avoided if the poor had access to medicines. In the developing world, the poverty of the families, the inappropried public expense and the lack of sanitary infrastructures get together to leave out of the reach of the poor the possibility of an adequate medical treatment. According to World Health Organization (WHO) in the developing countries about 2,000 million people lack access to essential medicines.The new patent rules of the World Trade Organization (WTO) will reduce even more access to essential medicines to the poor. Granting trade exclusivity rights to the owners of the patents for a period of at least 20 years limits the right of the governments to allow production, trade and importation of low cost copies (generics) of patented drugs. It is not a theoretical or far away menace. The application of these more strict rules has all ready caused serious problems to developing countries producers of generics as India or Brazil or to importers of these as South Africa or Kenya. They have been press, taken to court and threaten of sanctions by the pharmaceutical industry and some developed countries governments.The decision of some developing countries to fight for their most needed people's health added to the international campaign for the access to essential medicines defended by some non governmental organizations like Act Up, Treatment Action Campaign, Doctors Without Borders and Intermon Oxfam have implied small victories on behalf of the poor countries access to medicines. But deeper changes in the patent rules and the investigation of the diseases of the developing world are needed to improve health in the developing countries.     

Providing affordable essential medicines to African households: the missing policies and institutions for price containment

Medicines are integral of any healthcare system, and limited access to medicines undermines health systems' objectives of equity, efficiency and health development. In African countries, where it is estimated that 50-60% of the populace lack "access" to essential medicines, health problems associated with limited drug benefits are more damaging. However, there is no single solution to medicine access problem given its multiple dimensions: availability, acceptability, affordability and accessibility. This paper explores affordability dimension of medicine access and concentrates solely on price regulatory policies and institutional structures that national and international policy makers may consider in making prices of essential drugs compatible to the purchasing power of African households. The main theme is the application of the concept of bilateral dependence in creating price-sensitive purchasers to exert countervailing market power on drug price setting in African healthcare systems.     

Missing data on accessibility of children’s medicines

Child-appropriate medicines are essential for the safe and effective treatment of children, yet we have observed a large gap in the data required to adequately monitor access to these medicines. We have examined data on the availability and pricing of child-appropriate medicines across 50 surveys. Child-appropriate medicines for nine out of 12 priority diseases in children were infrequently surveyed or not at all. A similar data deficit on age-appropriate medicines is detectable in the broader scientific literature. We also note that existing instruments for collecting data on the availability or prices of medicines are limited in their ability to generate the required data for children. We have identified four priorities as key for improved monitoring of access to medicines for children: (i) dedicated child medicine surveys are needed on availability and prices of child-appropriate medicines; (ii) standardized survey instruments should include age-appropriate medicines and dosages; (iii) health facility service readiness survey tools should include the collection of data on the price of child-appropriate medicines in addition to the availability of medicines; and (iv) sustainable development goal indicator 3.b.3 should be modified to enable the monitoring of access to medicines for children. These deficiencies need to be addressed to ensure the monitoring of access to child medicines as part of the sustainable development goal agenda for 2030 and to implement appropriate interventions for improving access for this vulnerable population.     

Supply-chain strategies for essential medicines in rural western Kenya during COVID-19

ProblemThe coronavirus disease 2019 (COVID-19) pandemic has disrupted health systems worldwide and threatened the supply of essential medicines. Especially affected are vulnerable patients in low- and middle-income countries who can only afford access to public health systems.ApproachSoon after physical distancing and curfew orders began on 15 March 2020 in Kenya, we rapidly implemented three supply-chain strategies to ensure a continuous supply of essential medicines while minimizing patients’ COVID-19 exposure risks. We redistributed central stocks of medicines to peripheral health facilities to ensure local availability for several months. We equipped smaller, remote health facilities with medicine tackle boxes. We also made deliveries of medicines to patients with difficulty reaching facilities.Local settingΤo implement these strategies we leveraged our 30-year partnership with local health authorities in rural western Kenya and the existing revolving fund pharmacy scheme serving 85 peripheral health centres.Relevant changesIn April 2020, stocks of essential chronic and non-chronic disease medicines redistributed to peripheral health facilities increased to 835 140 units, as compared with 316 330 units in April 2019. We provided medicine tackle boxes to an additional 46 health facilities. Our team successfully delivered medications to 264 out of 311 patients (84.9%) with noncommunicable diseases whom we were able to reach.Lessons learntOur revolving fund pharmacy model has ensured that patients’ access to essential medicines has not been interrupted during the pandemic. Success was built on a community approach to extend pharmaceutical services, adapting our current supply-chain infrastructure and working quickly in partnership with local health authorities.     

制定并落实目标全面的国家药物政策：印度经验与教训

中国和印度同为经济崛起中的大国,在全球医药市场中起着举足轻重的作用。世界上绝大多数价格低廉的通用名药都是由这两个国家生产供应的,但这两个国家的国民却在不同程度上面临着获得有质量保证基本药物的挑战。药品的经济学和社会学属性,医药领域的健康目标和经济发展目标,如何平衡医药产业的发展对经济和社会作出的贡献等问题,在这两个国家都存在着热议。本文回顾印度国家药物政策的历史演变过程,剖析其产生的矛盾效果：培育了强大的民族医药产业,但本国多数民众基本用药仍得不到保障。文章还分析印度德里地区制定、贯彻和落实区域药物政策的成功经验,希望为中国制定目标全面的国家药物政策和建立国家基本药物制度提供有益的经验和教训。     

An examination of pharmaceutical systems in severely disrupted countries

This research assesses informal markets that dominate pharmaceutical systems in severely disrupted countries and identifies areas for further investigation. Findings are based on recent academic papers, policy and grey literature, and field studies in Somalia, Afghanistan, the Democratic Republic of Congo and Haiti. The public sector in the studied countries is characterized in part by weak Ministries of Health and low donor coordination. Informal markets, where medicines are regularly sold in market stalls and unregulated pharmacies, often accompanied by unqualified medical advice, have proliferated. Counterfeit and sub-standard medicines trade networks have also developed. To help increase medicine availability for citizens, informal markets should be integrated into existing access to medicines initiatives.     

A human rights approach to the WHO Model List of Essential Medicines

Since the first WHO Model List of Essential Medicines was adopted in 1977, it has become a popular tool among health professionals and Member States. WHO's joint effort with the United Nations Committee on Economic, Social and Cultural Rights has resulted in the inclusion of access to essential medicines in the core content of the right to health. The Committee states that the right to health contains a series of elements, such as availability, accessibility, acceptability and quality of health goods, services and programmes, which are in line with the WHO statement that essential medicines are intended to be available within the context of health systems in adequate amounts at all times, in the appropriate dosage forms, with assured quality and information, and at a price that the individual and the community can afford. The author considers another perspective by looking at the obligations to respect, protect and fulfil the right to health undertaken by the states adhering to the International Covenant of Economic, Social and Cultural Rights (ICESCR) and explores the relationship between access to medicines, the protection of intellectual property, and human rights.     

Gender and medicines: an international public health perspective

Despite outstanding progress in the area of medicines, their access and use have not been equitable throughout the world. Fifteen percent of the world's population consumes 91% of the world's production of pharmaceuticals. Only one third of the world population has access to essential medicines. Additionally, studies carried out in developing countries reveal that gender-related barriers in access to health services and medicines are greater for women than men because of social and cultural factors. In high-income settings, women are reported to use more medicines than men. Moreover, the current devastating human immunodeficiency virus (HIV) epidemic impacts women disproportionately. Women are more vulnerable to HIV infection than men biologically but also because of gender inequalities. More social and statistical data, in both developing and developed countries, are needed to fully understand the impact of gender on access to and use of medicines. Improving access to essential medicines will be possible only if countries introduce a gender perspective in their medicine policies.     

Legal and policy foundations for global generic competition: Promoting affordable drug pricing in developing societies

The so-called ‘TRIPS flexibilities’ restated in 2001 by the World Trade Organization's Doha Declaration on TRIPS and Public Health offer a variety of policy avenues for promoting global price-based competition for essential medicines, and thus for improving access to affordable medicines in the developing world. In recent years, developing countries and international organisations alike have begun to explore the potentialities of global generic markets and competition generally, and also of using compulsory licensing to remedy anti-competitive practices (e.g. excessive pricing) through TRIPS-compatible antitrust enforcement. These and other ‘pro-competitive’ TRIPS flexibilities currently available provide the critical leverage and policy space necessary to improve access to affordable medicines in the developing world.     

Access to medicines and domestic compulsory licensing: Learning from Canada and Thailand

Abstract

Within the array of measures for improving medicines access for the world's neediest populations, governments of many countries have turned to compulsory licensing, a statutory mechanism to enable third parties to manufacture a product or process still under patent. In this paper, we focus on a historic case example from Canada and the present example of Thailand's use of domestic compulsory licenses as a policy tool for ensuring public access to affordable medicines. The overarching objective is to draw out policy and legislative insights that may be of value for countries with pharmaceutical manufacturing capacity and which are considering better access to patented medicines for their populations under the current global intellectual property regime. From these cases, it is apparent that although compulsory licensing is not a novel remedy, even in a post-Trade Related Aspects of Intellectual Property Rights environment, it remains a powerful policy tool in improving access to medicines in a variety of domestic settings.     

The essential drugs concept is needed now more than ever

The debate on access to essential medicines, which was live in the late 1970s and 1980s when strong pressure from public health advocates led the pharmaceutical industry to accept the concept, is now back on the international health policy agenda. Currently, the Essential Drugs List (EDL) forms an integral part of national drug policies in 146 countries, guiding the selection of drugs on the basis of public health relevance, efficacy, safety and cost. The essential medicines debate is back on the agenda as part of the access to medicines debate. The Trade Related Aspects on Intellectual Property Rights agreement has caused concern among public health advocates in terms of its impact on access to essential medicines. This article reviews the concept of essential medicines in the light of the changing political context and recommends that the EDL is supported as a crucial public policy tool in all countries.     

中国基本药物改革：为实现最佳健康产出的选择

2009年4月,中国政府发布了《关于深化医药卫生体制改革的意见》,提出到2020年实现全民享有基本医疗卫生服务的目标。改革的重点任务之一是建立基本药物制度。在全球范围内,基本药物这一概念自1975年首次被世界卫生大会提出以来,一直具有非常重要盼意义。这一概念最初强调药物的可及性和基本药物目录。但随时间推移,这一概念的内涵逐渐演变。现在各国引入基本药物概念,主要是为了确保药物可及性与可支付性、合理用药以及药物的质量和安全性。瑞典、挪威以及经合组织国家的经验表明,基本药物的概念可灵活适用于多种情形。在中国,基本药物制度的改革已取得良好成果,在非常短的时间内使公众更多获益,继续贯彻基本药物制度将有利于在中国实现最佳健康产出。     

中国东部某省儿童基本药物可获得性、价格及可负担性调查分析

目的：分析儿童用药政策实施以来儿童基本药物可获得性、价格及可负担性的现状,为后续制定和完善相关政策提供实证依据。方法：利用中国东部某省基本药物采购平台数据库中2012、2016年数据,依据世界卫生组织（WHO）和国际健康行动组织（HAI）推荐的标准药物调查方法,对49种儿童基本药物的可获得性、价格及可负担性现状进行分析。结果：儿童基本药物可获得性、价格及可负担性整体较好。（1）可获得性方面,2016年较2012年总体出现下降;且2016年、2012年三级医疗机构均高于二级医疗机构和一级医疗机构;仿制药高于原研药。（2）价格方面,2016年较2012年8种原研药价格下降;26种仿制药价格下降,16种仿制药价格上升。（3）可负担性方面,2016年较2012年总体可负担性提高;仿制药总体可负担性优于原研药。结论：（1）三级医疗机构总体可获得性高于一、二级医疗机构。低年龄段儿童基本药物可获得性较差,缺少适宜品种、剂型和规格的药品。（2）儿童基本药物原研药的价格高于国际参考价格,仿制药的价格相对较低。（3）儿童基本药物可负担性较好,2016年较2012年总体可负担性提高,仿制药总体可负担性优于原研药。     

Can NGOs regulate medicines markets? Social enterprise in wholesaling,and access to essential medicines

Background  

Citizens of high income countries rely on highly regulated medicines markets. However low income countries' impoverished populations generally struggle for access to essential medicines through out-of-pocket purchase on poorly regulated markets; results include ill health, drug resistance and further impoverishment. While the role of health facilities owned by non-governmental organisations (NGOs) in low income countries is well documented, national and international wholesaling of essential medicines by NGOs is largely unstudied. This article describes and assesses the activity of NGOs and social enterprise in essential medicines wholesaling.     

Applying the essential medicines concept to US preferred drug lists

Objectives. We assessed whether state Medicaid preferred drug lists are concordant with the World Health Organization''s 2009 16th Essential Medicines List and with each other. We also characterized listed medicines by generic availability and appearance on treatment guidelines.Methods. We derived generic availability and first-line treatment status from the US Food and Drug Administration''s Orange Book and the 2004–2009 National Health Service National Institute for Clinical Excellence guidelines. We report characteristics of Essential Medicines List and preferred drug list (PDL)-only medicines and describe differences between medicines that are frequently and infrequently listed on PDLs.Results. Only 6 of 120 Essential Medicines List medicines appeared on fewer than 50% of PDLs. PDL-only medicines (n = 249) were less likely than were Essential Medicines List medicines (n = 120) to have generic versions available (56% vs 76%) and to be first-line treatments (21% vs 41%). The content of PDLs was variable: 33% of medicines appeared on 80% to 100% of PDLs.Conclusions. Application of the essential medicines concept to Medicaid PDLs could reduce costs and provide more equitable and evidence-based health care to low-income patients in the United States.The essential medicines concept is designed to promote the availability, accessibility, affordability, quality, and rational use of medicines that meet public health needs.¹ A key element of the concept is the World Health Organization (WHO) Essential Medicines List, which serves as a model for public supply and reimbursement. The first WHO Essential Medicines List was drafted in 1977 to address the gap in medication access between citizens of high- and low-income countries. The list aimed to highlight the most critical medicines for the needs of the national population.¹ Since 2002, biannual revisions of the list have adhered to rigorous standards of evidence and consider disease prevalence and the safety and efficacy of medicines.² Relative cost may be evaluated as well, but no medicine is excluded from consideration because of high cost.³ Additional features of the essential medicines concept are the development of evidence-based clinical guidelines and a national medicines policy.WHO advises countries to adapt the Essential Medicines List according to their priority health care needs.¹ In 2007, WHO found that 131 of 151 countries surveyed (87%) had a national essential medicines list. However, discrepancies exist between the WHO Essential Medicines List and these national lists, for a variety of reasons. For example, an Essential Medicines List medicine may not be a recommended therapy on a national guideline, or a medicine deemed as essential by the WHO may not be licensed in a country. An essential medicines list can serve as a model for procurement, local licensing and manufacturing, and the rational use of high-quality essential medicines. It also helps in allocating limited resources effectively and can be used as an advocacy tool to ensure that essential medicines are available and affordable for the population. The United States does not officially consult the Essential Medicines List, nor does it have a national medicines list.¹In the United States, the Medicaid program was enacted in 1965 to provide health care services to eligible low-income individuals, including families with children, the elderly, and the disabled.⁴ Currently, about 20% of the US population—60 million people—are enrolled in Medicaid,⁴ a number expected to increase with recent health care reforms. Medicaid preferred drug lists (PDLs) enumerate medicines that are fully reimbursed by Medicaid without prior authorization.⁵ Each state''s Medicaid agency maintains a single PDL for its fee-for-service patients.No standardized method for PDL development across states currently exists.⁶ As of May 2010, 11 states make financial contributions to the Drug Effectiveness Review Project,⁷ which offers evidence-based drug class reviews. However, many states offer no information on their PDL development process. One review of 18 studies of restrictive Medicaid formularies noted that none of the studies provided details as to how the formularies were constructed.⁸ One small study suggests that PDLs vary widely, but neither a large-scale comparison of PDLs nor a characterization of the most variable or most consistent medicines currently exists.⁶Low-income countries use the WHO Essential Medicines List to target their scarce resources for the procurement of the most-needed medicines.³ Medicaid drug reimbursements are linked to PDLs that are developed by each state. Thus, Medicaid recipients, who are typically low-income people, are likely to receive medicines from these preferred drug lists.⁶Our objectives were (1) to determine whether Medicaid patients have access to all Essential Medicines List medicines, (2) to assess the concordance between the Essential Medicines List and PDLs, and (3) to evaluate the consistency of PDLs. To better understand sources of variability among PDLs and the Essential Medicines List, we describe whether listed medicines had generic versions available and whether they are recommended as first-line treatments in evidence-based clinical guidelines. We expected that PDLs would have more brand name–only medicines and fewer first-line treatments than would the Essential Medicines List.     

免费用药政策对促进中国药品公平可及的启示

促进药品公平可及是保障卫生公平性的重要内容。国际上通过免费用药政策保障药品公平可及是通行惯例,大部分国家免费用药政策覆盖人群包括无支付能力的患者、5岁以下儿童、孕妇和老年人,免费药品包括基本药物、慢性病用药、传染性疾病和疫苗等,免费用药筹资来源包括医疗保险、政府财政直接投入和国际援助,免费用药发放多依赖公立医疗机构。我国免费用药政策主要针对部分传染性疾病和疫苗,疾病覆盖面较窄。本文认为,我国经济发展已达到中等收入国家水平,应当扩大针对糖尿病、高血压等慢性病免费用药范围,并通过对基本药物免费进一步促进中国药品公平可及。     

Should COVID-19 Vaccines Authorized for Emergency Use Be Considered “Essential” Medicines?

A critical debate in the race to develop, market, and distribute COVID-19 vaccines could define the future of this pandemic: How much evidence demonstrating a vaccine’s safety and efficacy should be required before it is considered “essential”? If a COVID-19 vaccine were to be designated an essential medicine by the World Health Organization, this would invoke special “core” human rights duties for governments to provide the vaccine as a matter of priority irrespective of resource constraints. States would also have duties to make the vaccine available in adequate amounts, in the appropriate dosage forms, with assured quality and adequate information, and at an affordable price. This question is especially critical and unique given that COVID-19 vaccines have in many cases been authorized for use via national emergency use authorization processes—mechanisms that enable the public to gain access to promising medical products before they have received full regulatory approval and licensure. In this paper, we examine whether unlicensed COVID-19 vaccines authorized for emergency use should ever be considered essential medicines, thereby placing prioritized obligations on countries regarding their accessibility and affordability.