How moves towards universal health coverage could encourage poor quality drugs: an essay by Elizabeth Pisani

In her thoughtful essay, Elizabeth Pisani warns against some possible unwanted consequences of the (morally imperative) effort to achieve universal health coverage (1). In particular, she notes that an unconditional push toward the lowest possible prices of essential medicines would lead some manufacturers to apply cuts on quality assurance (QA) costs, for keeping profits as high as possible. Insufficient QA along the manufacturing and distribution cycle would in turn increase the risk that poor-quality medicines reach the patients (and/or could cause manufacturers’ withdrawal from a given market, as already reported for Romania (1)).

Poor-quality medicines prevalence is higher in countries where National Regulatory Authorities are under-resourced and cannot provide effective oversight (2-4). Risks are undoubtedly magnified if procurement officials put exclusive focus on minimizing medicines’ direct costs, without stringent pre-requisites for quality standards.

Organizations that purchase medicines based exclusively on pricing considerations, in absence of evidence of adequate QA, implicitly accept the risk of harming the patients they serve (5). An ill-informed pragmatism, by focusing on the short-term “cost” of the medicines, neglects the more important “value” of the medicine: a substandard cheaper medicine will eventually impose higher costs on the health system, because of the failure to cure (5).

However, we believe that quality and affordability can go together, as shown for instance by the experience of the WHO Prequalification Programme (PQP) (6) and of the Medicines Patent Pool (7); and that incentives to invest in pharmaceutical QA may even descend from the market. In fact, prices are not only linked to manufacturing costs, but also to manufacturing volumes and to market opportunities (5). In many cases, the WHO Prequalification Programme (PQP) has brought international procurement prices of quality-assured medicines down , because manufacturers which invested in WHO PQP were indirectly rewarded through access to a significant market and, in turn, they had the opportunity for economies of scale (5,6).

Therefore, to complement the important measures listed by Pisani (1), we call all major purchasers, including major funding agencies and their implementers, to create the demand for quality-assured essential medicines, by setting stringent QA criteria as a pre-requisite for purchase (8). By doing so, they would positively shape the market toward affordable, quality-assured products, and would contribute to the achievement of universal health coverage.

References

1. Pisani E. How moves towards universal health coverage could encourage poor quality drugs: an essay by Elizabeth Pisani. BMJ 2019; 366:l5327
2. World Health Organization. Improving the quality of medical products for universal access. WHO Essential Medicines and Health Products. www.who.int/medicines/regulation/fact-figures-qual-med/en
3. Caudron JM, Ford N, Henkens M et al. Substandard medicines in resource-poor settings: a problem that can no longer be ignored. TMIH 2008; 13(8): 1062–1072
4. Gaurvika M. L. Nayyar et al. Review Article Falsified and Substandard Drugs: Stopping the Pandemic. Am. J. Trop. Med. Hyg. 2019, 00(0): 1–8
5. Ravinetto R, Pinxten W, Rago L. Quality of medicines in resource-limited settings: need for ethical guidance. Global Bioethics 2018; 29:1, 81-94
6. 't Hoen EF, Hogerzeil HV, Quick JD, et al. A quiet revolution in global public health: the world health organization's prequalification of medicines programme. J Public Health Policy 2014;35:137–61.
7. Burrone E, Gotham D, Gray A et al. Patent pooling to increase access to essential medicines. Bull World Health Organ 2019; 97(8): 575-7
8. Assuring Medicines Quality in Medicines Procurement, a side event to the WHA 2019. https://www.itg.be/Files/docs/Assuring_Medicine_Quality_WHA_RT_7_2_519.pdf