Hans V. Hogerzeil

Is access to essential medicines as part of the fulfilment of the right to health enforceable through the courts

BACKGROUNDnMost countries in the world have become States parties to one or more international human rights treaties, thus creating an obligation by the State to its people towards the realisation of the right to health, which includes access to essential medicines. But whether such access is enforceable in practice is unknown.nnnMETHODSnWe did a systematic search to identify completed court cases in low-income and middle-income countries in which individuals or groups had claimed access to essential medicines with reference to the right to health in general, or to specific human rights treaties ratified by the government. We identified and analysed 71 court cases from 12 countries in which access to essential medicines was claimed with reference to the right to health.nnnFINDINGSnIn 59 cases, access to essential medicines as part of the fulfilment of the right to health could indeed be enforced through the courts, with most coming from Central and Latin America. Success was mainly linked to constitutional provisions on the right to health, supported by the human rights treaties. Other success factors were a link between the right to health and the right to life, and support by public-interest non-government organisations. Individual cases have generated entitlements across a population group, the right to health was not restricted by limitations in social security coverage, and government policies have successfully been challenged in court.nnnINTERPRETATIONnSkilful litigation can help to ensure that governments fulfil their constitutional and international treaty obligations. Such assurances are especially valuable in countries in which social security systems are still being developed. However, redress mechanisms through the courts should be used as a last resort. Rather, policymakers should ensure that human rights standards guide their health policies and programmes from the outset.

Twenty-five years of essential medicines.

The twentieth century opened with only one widely available modern medicine: acetylsalicylic acid (aspirin). In the 1940s the first antibiotic, the first mass produced antimalarial, and the first antitubercular were introduced. The 1950s and 1960s saw the rapid introduction of oral contraceptives, medicines for diabetes, and then medicines for mental illness, many infectious diseases, cardiovascular diseases, and cancer. By the 1970s effective medicines--though not always ideal--existed for nearly every major illness. Yet for half the worlds population, it was as if they were still living in the nineteenth century. For them, modern medicines were unavailable, unaffordable, of poor quality, or ineffective because not properly used. In 1975 the World Health Assembly introduced the concepts of essential drugs and national drug policy, and they quickly became part of the global public health vocabulary. The Health Assembly was building on precedents set in Scandinavia, North America and some pioneering developing countries, such as Papua New Guinea, Peru, Sri Lanka, and the United Republic of Tanzania, in the hope that they would provide a way to begin closing the huge gap between those who were benefiing from the pharmaceutical harvest of the mid-1900s and those who were not. In October 1977, WHO produced the first Model List of Essential Drugs and in 1978 the Declaration of Alma-Ata identified provision of essential drugs as one of the eight elements of primary health care. According to the current WHO Expert Committee on the Selection and Use of Essential Medicines, Essential medicines are those that satisfy the priority health needs of the population. They are selected with due regard to disease prevalence, evidence of efficacy and safety, and comparative cost-effectiveness. Essential medicines are intended to be available within the context of functioning health systems at all times in adequate amounts, in the appropriate dosage forms with assured quality, and at a price the individual and the community can afford. The implementation of the concept of essential medicines is intended to be flexible and adaptable to many different situations; exactly which medicines are regarded as essential remains a national responsibility. Thanks partly to the recognition and application of these principles, the situation has changed enormously since 1977. The following examples give some idea of the contrast. In 1977, perhaps a dozen countries had what would now be considered an essential medicines list or an essential drugs programme. Today, four out of five countries--at least 156 countries in total--have adopted national essential medicines lists. National lists are widely used for public procurement systems, reimbursement schemes, training, public education, and other national health activities. Most countries have recently updated their lists, and WHO has updated its own model list of essential medicines on average every two years for the 25 years. In 1977, the concept of a national drug policy was unknown to almost everyone. Today, over 100 countries have national drug policies in place or under development. These policies are being introduced at increasing speed in every region. More importantly, a growing number of countries are moving directly from policy to action. The national drug policy is increasingly serving as a framework within which interested parties can work for pharmaceutical sector reform within countries. In 1977, objective information on rational use of drugs was extremely limited, especially in developing countries. Today, at least 135 countries have their own therapeutic manuals and formularies, which provide health professionals with current, accurate and unbiased advice on the rational use of drugs. In addition, this year the WHO Model Formulary was launched. In 1977, medical training was often based on brand names, and little attention was given to systematic teaching about rational drug use. …

Essential medicines and human rights: what can they learn from each other?

Most countries have acceded to at least one global or regional covenant or treaty confirming the right to health. After years of international discussions on human rights, many governments are now moving towards practical implementation of their commitments. A practical example may be of help to those governments who aim to translate their international treaty obligations into practice. WHOs Essential Medicines Programme is an example of how this transition from legal principles to practical implementation may be achieved. This programme has been consistent with human rights principles since its inception in the early 1980s, through its focus on equitable access to essential medicines. This paper provides a brief overview of what the international human rights instruments mention about access to essential medicines, and proposes five assessment questions and practical recommendations for governments. These recommendations cover the selection of essential medicines, participation in programme development, mechanisms for transparency and accountability, equitable access by vulnerable groups, and redress mechanisms.

Instability of (methyl)ergometrine in tropical climates: an overview

Parenteral ergometrine is widely used for the prevention and treatment of excessive uterine bleeding following birth. Unfortunately, in tropical climates it is often found to contain very little active ingredient: only 32 of 100 field samples from Bangladesh, Gambia, Malawi, Yemen and Zimbabwe contained 90-110% of the amount of active ingredient stated on the label, and 34 contained less than 60%. In this paper the results of nine studies, of which eight were initiated and coordinated by WHO, are reviewed to formulate answers to the following questions: (1) what is the extent of the problem of low potency of ergometrine in tropical climates; (2) is the problem due to instability or low initial quality, or both; (3) which practical measures can assure the quality of injectable ergometrine; and (4) are there any alternative drugs which are more stable? Injectable ergometrine is very unstable under tropical conditions and particularly if stored unrefrigerated and exposed to light, when it may loose up to 20% of its potency per month. However, there are differences between brands. Practical measures to assure the quality of injectable ergometrine therefore include a careful supplier selection and refrigerated storage. Ergometrine injection should always be protected from light until given to the patient. Loss of active ingredient can easily be detected by regular visual checks of the colour of the solution. Any discoloration implies that the solution contains less than 90% of the stated amount of active ingredient, and should not be used. Methylergometrine is no more stable than ergometrine. Parenteral oxytocin is more stable than both ergometrine and methylergometrine injection. Oral and buccal dosage forms are less stable than injections. In view of the better stability in tropical climates, similar cost, fewer side effects and comparative efficacy, parenteral oxytocin, rather than parenteral ergometrine, is the drug of choice in the prevention and treatment of postpartum haemorrhage.

Evaluation of rational drug prescribing in democratic yemen

The government of Democratic Yemen started an essential drugs programme in 1984. Every month quantities of 30 drugs are delivered in prepacked kits to health units and standard treatment schedules have been agreed. The quantities of each drug were estimated by applying the standard treatment schedules to the typical morbidity patterns seen at these facilities. Most health workers attended a training course on the correct use of the standard treatment schedules. Hospital and health centres have been included in the programme to a more limited extent. In March 1988 an evaluation of the programme was carried out. Comparisons were made between random samples of health units included in the programme and those where it had not yet been implemented. The adequacy of knowledge necessary for reasonable use of drugs was assessed by interviewing health workers. Actual drug prescription was studied by means of quantitative indicators. A more qualitative insight was obtained by reviewing drug prescriptions for four tracer diseases at a sample of health centre and hospital out-patient departments. Health workers at units included in the programme had significantly (P less than 0.05) higher levels of rational drug knowledge and better actual drug prescription in terms of proportions of patients receiving injections (25% vs 58%), antibiotics (45% vs 67%) and the average number of drugs per patient (1.5 vs 2.4)--all P less than 0.001. Many patients treated at health centres and hospitals were receiving irrational drug treatment for the tracer conditions. It is suggested that the methods used in this evaluation to measure rational drug prescription could be appropriate in the assessment of other essential drugs programmes.

Access to essential medicines in national constitutions

Access to essential medicines is well founded in international law as part of the right to the highest attainable standard of health (“the right to health”). The International Covenant on Economic, Social and Cultural Rights adopted in 1966 calls for States Parties to take steps to ensure access to medical services for all. General Comment 14, added in the year 2000, applies the principles of accessibility, availability, appropriateness and assured quality to goods and services, including essential medicines as defined by the World Health Organization’s (WHO’s) Action Programme on Essential Drugs. n nOne important success factor for the legal enforcement of access to essential medicines is the incorporation of right-to-health principles into national constitutions. In one study, in 11 out of 12 middle-income countries in which successful court cases in support of access took place there was supportive constitutional language and, in the twelfth country, international treaties ratified by the State acquire the status of national law.1 Constitutional recognition of the right to access to medical products and technologies has therefore become a country progress indicator in WHOs Medium-term strategic plan for 2008–2013.2 WHO recently published a first baseline study for this indicator, including a database and analysis of all health-related texts in national constitutions.3 n nThe study reports that 135 (73%) of 186 national constitutions include provisions on health or the right to health. Of these, 95 (51%) constitutions mention the right to access health facilities, goods and services, 62 (45%) include in-text reference to equity and non-discrimination and 111 (82%) include one or more article(s) mandating the right to be treated equally or freedom from discrimination. n nFour national constitutions (2%) specifically mention universal access to medicines. In Mexico, “(women) are entitled to medical and obstetrical attention, medicines, nursing aid and infant care services. Members of a workers family shall be entitled to medical attention and medicines, in those cases and in the proportions specified by law”. In Panama, “the State is primarily obligated to (…) supply medicines to all the people”. In the Philippines, “the State shall (…) endeavour to make essential goods, health and other social services available to all people at affordable cost”. In the Syrian Arab Republic, “the State protects the citizens’ health and provides them with the means of protection, treatment and medication”. n nSome constitutions, such as those of Cuba, Nicaragua and South Africa, use very clear text to describe access to health care, goods and services in more general terms, using words like “without exclusions”, “everyone” and “all citizens regardless of …”. Some texts focus on poor and disadvantaged groups, e.g. those of Nicaragua, the Philippines and Viet Nam. The constitutions of Ecuador and Panama specify that national medicine policies shall be established and implemented to achieve the constitutional obligations. n nThere are at least three different routes through which the right to health can be recognized in national legal frameworks. The strongest government commitment is created by including the right to essential goods and services in the national constitution. The second approach is constitutional recognition that international treaties ratified by the State override or acquire the status of national law. This option is available to 31 countries and was already used in a landmark court decision in Argentina.4 The third option, inclusion of health rights in other national legislation, is easier to create but also easier to change or cancel. This is the subject of another study currently under way. n nThe full range of strategies to promote universal access to essential medicines through rational selection, affordable prices, sustainable financing and reliable health systems is described in many other documents.5,6 Constitutional recognition of the right to access essential medicines is an important sign of national values and commitment, but is neither a guarantee nor an essential step – as shown by those countries that have failing health systems despite good constitutional language, and those that have good access without it. Yet the many court cases in the Americas have shown that constitutional recognition creates an important supportive environment, especially in middle-income countries where health insurance systems are being created and patients are becoming more aware of their rights and are more vocal in demanding them.1 More recent constitutional texts seem to include stronger commitments, possibly reflecting the positive influence of the global development of the right to health in the past 50 years. n nPolitical opportunities to update a country’s constitution present a chance to align national values and aspirations with international human rights standards. The new constitutional texts should then consider key human rights principles, and specifically the right to health and equitable access to essential medical goods and services. Constitutional frameworks can thus become valuable aspirational statements on which to base other legislation and policies. The examples identified in the recent WHO study could serve as a model.

Could the WHO Model List of Essential Medicines Do More for the Safe and Appropriate Use of Injections

A national drug policy addressing the safe and appropriate use of injections is an important element to prevent overuse and unsafe use of injections. Because the World Health Organization World Health Organization Model List of Essential Medicines is a keystone of national drug policies, the authors examined the way it addresses injection practices. They reviewed the 11th World Health Organization Model List of Essential Medicines to collect information on (1) injectable medicines, (2) diluents, and (3) the recommendations regarding the procurement of injection devices. Of 306 active ingredients on the list, 135 (44%) are mentioned in injectable form. Of these, 41 (30%) need diluents for reconstitution. The list does not mention the need to procure appropriate diluents, injection devices, and safety boxes in quantities that match the quantities of injectable medicines. In addition, the list provides limited information that can be used to forecast the needs of injection devices to administer the injectable medicines that are included in the list. Future revisions of the World Health Organization Model List of Essential Medicines should attempt to reduce the number of injectable formulations on the basis of evidence. In addition, the list should specify that when injectable medicines are being supplied, diluents, single‐use syringes, and safety boxes should be supplied. The volume of syringes needed for administration should be specified for each injectable medication on the list to facilitate the forecasting of the needs of injection devices.

Global Aspects of Drug Development

About nine million children die every year before they reach the age of 5 years, of conditions largely amendable with existing medicines. Lack of medicines is not the single most important health problem of children, but work to provide children with better access to appropriate medicines is essential for achievement of the child health goals set. Taking into consideration the global aspect in the development of paediatric medicines the benefits of the regional paediatric initiatives can be spread worldwide. This chapter provides insights in the challenges and opportunities of developing paediatric medicines for health needs of children in the developing world. The Essential Medicines List for children first made available in 2008 serves as an example of the many tools available from WHO to improve childrens access to the medicines they need.

Rare Diseases and Essential Medicines

This article addresses the question ‘to what extent medicines for rare diseases can be considered as essential’. Essential medicines are those that satisfy the priority healthcare needs of the population; they should be available at all times to all who need them. Rare diseases can be orphan diseases, which are universally rare, or neglected diseases, which are rare in industrialised countries but common in certain low- and middle-income countries. In both cases there is no profitable market for drug development.In low- and middle-income countries, medicines for neglected diseases can be classified as essential if the disease is common and the treatment is cost effective. If the treatment is costly, efforts should be made to reduce the price and ration its use. Medicines for orphan diseases do not address the priority healthcare needs of the population and should therefore not be listed as essential. Yet they could be supplied through special centres, provided the treatment is no less cost effective than treatments for common diseases which are not universally available. Orphan drugs that are less cost effective can only be supplied through the private sector or special programmes. In richer countries the same approach could be applied, but with a higher cut-off level of relative cost effectiveness.For the World Health Organization (WHO) Model List of Essential Medicines, a disease should be ‘non-rare’ somewhere in the world for a safe and effective treatment to be included. For true orphan diseases, which do not constitute a global public health priority, there is no justification for the WHO to list the treatment as essential.