Hans V Hogerzeil

The concept of essential medicines: lessons for rich countries

Rich countries should follow the lead of poor countries and adopt a more systematic way of controlling the cost of drugs

Promotion of access to essential medicines for non-communicable diseases: practical implications of the UN political declaration

Access to medicines and vaccines to prevent and treat non-communicable diseases (NCDs) is unacceptably low worldwide. In the 2011 UN political declaration on the prevention and control of NCDs, heads of government made several commitments related to access to essential medicines, technologies, and vaccines for such diseases. 30 years of experience with policies for essential medicines and 10 years of scaling up of HIV treatment have provided the knowledge needed to address barriers to long-term effective treatment and prevention of NCDs. More medicines can be acquired within existing budgets with efficient selection, procurement, and use of generic medicines. Furthermore, low-income and middle-income countries need to increase mobilisation of domestic resources to cater for the many patients with NCDs who do not have access to treatment. Existing initiatives for HIV treatment offer useful lessons that can enhance access to pharmaceutical management of NCDs and improve adherence to long-term treatment of chronic illness; policy makers should also address unacceptable inequities in access to controlled opioid analgesics. In addition to off-patent medicines, governments can promote access to new and future on-patent medicinal products through coherent and equitable health and trade policies, particularly those for intellectual property. Frequent conflicts of interest need to be identified and managed, and indicators and targets for access to NCD medicines should be used to monitor progress. Only with these approaches can a difference be made to the lives of hundreds of millions of current and future patients with NCDs.

Guidelines for drug donations

Abstract Drug donations are usually given in response to acute emergencies, but they can also be part of development aid. Donations may be given directly by governments, by non-governmental organisations, as corporate donations (direct or through private voluntary organisations), or as private donations to single health facilities. Although there are legitimate differences between these donations, basic rules should apply to them all. This common core of “good donation practice” is the basis for new guidelines which have recently been issued by the World Health Organisation after consultation with all relevant United Nations agencies, the Red Cross, and other major international agencies active in humanitarian emergency relief. This article summarises the need for such guidelines, the development process, the core principles, and the guidelines themselves and gives practical advice to recipients and donor agencies.

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.

The quality and stability of essential drugs in rural Zimbabwe: controlled longitudinal study

In 1988 an alarming WHO report of substandard ergometrine injection in three developing countries1 led to field studies on the stability of essential drugs during international transport to the tropics and to specific stability studies on oxytocic drugs.2 We performed a controlled longitudinal study to measure the quality of essential drugs within rural Zimbabwe and to determine whether any failure was due to poor initial quality or to instability of the drugs during inland distribution and storage. During a two year period (January 1991 to December 1992), samples of drugs arriving at central medical stores in Harare and Bulawayo were retained as controls, and samples of the same batches were later retrieved from hospitals and health centres in five remote, hot, rural districts. We studied 789 …

Big Pharma and Social Responsibility — The Access to Medicine Index

The Access to Medicine Index, an independent initiative, ranks the worlds 20 largest research-based pharmaceutical companies according to their efforts to make their products more available, affordable, and accessible in developing countries.

Essential medicines are still essential

On Oct 21, WHO published the full report of the 20th Expert Committee on the Selection and Use of Essential Medicines, with its new WHO Model List of Essential Medicines (EML). The new list includes recently developed medicines for drug-resistant tuberculosis (bedaquiline and delamanid), a number of new cancer treatments (such as imatinib, rituximab, and trastuzumab), and, perhaps most controversially, new direct-acting antiviral drugs (DAA) for the treatment of hepatitis C (sofosbuvir, simeprevir, daclatasvir, ledipasvir, and ombitasvir). Several of these medicines are very expensive. For example, the new medicines to treat hepatitis C are priced up to US

Ensuring ethical drug promotion—whose responsibility?

95 000 per 12-week course of treatment, and their primary patents will only expire in 2024–30. Despite the ability of some payers and intermediaries to negotiate large discounts, even high-income countries are struggling to pay for broad access to these treatments. It is not the fi rst time that WHO has added expensive medicines to the Model List. In 2002, the agency included 12 antiretroviral medicines for HIV/AIDS that were patented in many countries, to focus global attention on a major global public health need and to stimulate interventions to expand access to these lifesaving medicines. These products were unaff ordable for almost all countries at that time. The new Model List now expands further into other therapeutic areas. The recent inclusion of new expensive medicines has raised many questions. Has the original concept of essential medicines lost its original relevance as a list of basic medicines for resource-constrained settings? Should the list include medicines not yet authorised by stringent regulatory authorities or not easily available? Should the list include medicines for off -label indications? Should the list automatically include any medicine mentioned in a WHO treatment guideline? Previous expert committees’ reports have provided some answers to these questions. For instance, in 2013 bevacizumab was included for the treatment of macular degeneration, on the basis of available evidence but in the absence of regulatory approval for that specifi c indication. In 2005, child-friendly formulations of zinc sulfate tablets were added, even though such dispersible dosage forms were not widely available at the time. For many years, the WHO Model List has been viewed by some as applicable only to resource-constrained settings, and was assumed to include only the most basic medicines. This is a profound misunderstanding. The same principle of a limited list of cost-eff ective services underpins the logic of managed care institutions, hospital formularies, and reimbursement lists. The idea of selecting a limited list of essential medicines applies in all countries and in a variety of settings. We therefore believe that the inclusion of the newly listed cancer treatments, as well as the much-needed options for drug-resistant tuberculosis, is consistent with the defi nition of essential medicines. In 2002, WHO decided that cost alone would not prevent a medicine from being listed, if other criteria of safety, effi cacy, and comparative cost-eff ectiveness were fulfi lled. Yet the 2015 decision to include a range of DAAs for hepatitis C introduces a new approach of listing several very eff ective medicines, rather than selecting a single regimen. According to the Expert Committee, “Inclusion on the EML of all DAAs proposed in the applications aims at promoting competition among available alternatives and allowing for the selection of optimal combination treatment regimens, which may or may not be existing fi xed-dose combinations”. The Committee also noted that WHO is working to promote the rapid

Health-sector reform in China and access to essential medicines

1 Chin-Dusting JPF, Dart AM. Age and the treatment gap in the use of statins. Lancet 2003; 361: 1925–26. 2 DeWilde S, Carey IM, Bremner SA, Richards N, Hilton SR, Cook DG. Evolution of statin prescribing 1994–2001: a case of ageism but not of sexism. Heart 2003; 89: 417–21. 3 Whincup PH, Emberson JR, Lennon L, Walker M, Papacosta O, Thompson A. Low prevalence of lipid lowering drug use in older men with established coronary heart disease. Heart 2002; 88: 25–29. 4 Reid FDA, Cook DG, Whincup PH. Use of statins in the secondary prevention of CHD: is treatment equitable? Heart 2002; 88: 15–19. 5 Wagner EH. Meeting the needs of chronically ill people. BMJ 2001; 323: 945–46. concentrations need to be. To us, the implication is that smokers, obese individuals, or those who live a sedentary lifestyle can safely continue to smoke, remain overweight, or take little exercise, provided they take medication to reduce their cholesterol values. Of all the major factors accepted as cardiovascular disease risks, only cholesterol is addressed—the campaign’s stated aim is not pursued. No mention is made of an actual medical product, but the campaign coincided with publication, in The Lancet, of the AngloScandinavian Cardiac Outcomes TrialLipid Lowering Arm study, showing reductions in major cardiovascular events after use of atorvastatin. We believe the campaign could have worried patients, encouraging them to request a prescription for statins. If so, we suggest that the campaign meets the definition of promotion noted in the WHO Ethical Criteria for Medicinal Drug Promotion: “. . . all informational and persuasive activities by manufacturers and distributors, the effect of which is to induce the prescription, supply, purchase and/or use of medicinal drugs”. Moreover, we believe the campaign did not respect several of WHO’s ethical criteria, in that it is neither accurate, informative, or balanced. Finally, we think the information used contained misleading statements and omissions likely to induce medically unjustifiable drug use or to give rise to undue risks. We conclude that this experience underscores the need for health authorities and those charged with reimbursing or for paying for medicines to urgently increase their vigilance with respect to drug promotion. In our opinion, they must also decide how they can play an active and effective part in regulation of promotional activities, and ensure that balanced health information is readily available to the public, so that prescribing is not unduly affected by drug promotion activities.

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

In 2009 the Chinese Government embarked on the most comprehensive health-sector reform since the economic reform of the 1970s, with a systematic plan to achieve universal health care by 2020. One of the key pillars of the reform is the establishment and implementation of a national essential medicines policy to ensure the safety, quality, supply, and aff ordability of medicines. In this issue of The Lancet Global Health, Yu Fang and colleagues report the eff ect of the reform on access to aff ordable essential medicines in Shaanxi Province in western China. Their main observation is that the availability of a standard basket of generic essential medicines in the public sector, which was already low in 2009 at 25·5%, further decreased to 20·5% in 2011. A similar decrease from 42·0% to 35·3% was seen with generic medicines in private pharmacies. At the same time the median price of 29 generic medicines fell, by 5·2% in the public sector and 4·7% in private pharmacies; the prices of 16 originator brand products reduced by around 8–11% in both sectors. This is the fi rst longitudinal price and availability survey since 2009 to follow the standard WHO/Health Action International (HAI) protocol. It presents valuable information to national programme managers and health policy makers about the eff ect of the healthcare reform. Yet the study has two limitations. First, the standard WHO/HAI basket of essential medicines might not be fully representative of usual prescribing practices in China. This point could underestimate availability because alternative medicines might be in stock. For example, amoxicillin tablets are produced by hundreds of local manufacturers in China. The survey only targeted the 500 mg strength, yet the 2012 Chinese Essential Medicines List recommends 125 mg and 250 mg. Low availability of the 500 mg strength might be misleading, since other strengths were probably available instead. The researchers mitigated this problem by adding 17 locally preferred essential medicines to the study. Unfortunately, the availability of these proved as poor as the standard basket. The second limitation is that the researchers present very few data on aff ordability beyond reporting a price decrease corrected for infl ation. Many other papers on the eff ect of the health reform claim a positive eff ect on access to medicines on the basis of price reduction. The paper by Fang and colleagues shows that such price reductions can come with signifi cant decreases in availability. Price reductions mean little if the cheaper medicines are not available. The study therefore gives additional evidence that classic pricing policies often do not work for generic medicines. If maximum prices for generic medicines are imposed, local manufacturers might simply move production capacity towards products for which the prices are not controlled, such as non-essential medicines or unnecessary combination products; or focus on products for exportation. For price reductions to have a real eff ect on aff ordability, more is therefore needed. A 5–10% price reduction, as shown in this study, does not mean much if the product was excessively expensive in the fi rst place. The link between price and aff ordability also depends very much on income level. Shaanxi is a province in western China with a large proportion of rural inhabitants and large disparities in social and economic development between rural and urban areas. Within the three income levels studied in the province, the price of a medicine might be aff ordable in one area and not in another. More detailed aff ordability studies are therefore needed, linking the catastrophic expenditure potential of a medicine to various income percentiles, as done by Niëns and colleagues. For example, in the Philippines, originator-brand atenolol would push an additional 22% of the population below the lowest poverty line of US