Article Text

Elusive quality: the challenges and ethical dilemmas faced by international non-governmental organisations in sourcing quality assured medical products
1. Katherine Enright
1. Nuffield Department of Population Health, University of Oxford, London, UK
1. Correspondence to Katherine Enright; katherine.enright{at}stx.ox.ac.uk

## Abstract

Although medical products that are of sound quality are fundamental to the delivery of healthcare, so too is their availability, affordability, accessibility and acceptability. However, achieving all of these aims consistently and simultaneously may be unfeasible due to a host of barriers—no matter the country. If uncertainty, constraints and conflicting priorities also threaten their delivery, not only does the situation becomes yet more challenging, the morally just course of action becomes yet more opaque. While global health organisations, supply chains and projects are heterogenous, international non-governmental organisations (iNGOs) responding to humanitarian crises or delivering development assistance in low-income and middle-income countries are undoubtedly prone to this issue. In a novel framing of the problem of substandard and falsified medicines, this article explores some ethical dilemmas that, directly or indirectly, could result in the quality of medical products in iNGO health projects to be compromised. Drawing on a broad literature base and years of experience as a senior humanitarian pharmacist, the author reflects on the barriers, culture and system that contributes to the existence and persistence of substandard and falsified medical products in global assistance projects. The paper offers an in-depth examination of pressures that may arise in four key areas (capacity, supply chain, bureaucracy and quality assurance) and postulates on the myriad ways in which this may alter the attitudes, behaviours and decision-making of iNGOs in a manner that disincentivises the prioritisation of medical product quality. This paper does not seek to excoriate the aid sector, but rather to lend a new perspective: that such predicaments are overlooked, real-world ethical dilemmas in urgent need of greater openness, research, debate and guidance, for the benefit of moral decision-making and patient care.

• health policy
• health systems
• public health

## Data availability statement

There are no data in this work

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### Summary box

• Extreme but conflicting pressures in iNGO-led health programmes may mean that it is unfeasible to consistently ensure medical product availability, affordability, acceptability and accessibility, in addition to assuring quality–therefore leading to hopeless choices and ethical dilemmas.

• The context in which iNGOs operate (in terms of culture, risk, opportunity and stakeholder expectation) may disincentivise the prioritisation of medical product quality (in favour of cost or speed, for example).

• Weak capacity places a heavy toll on the sourcing of quality assured medical products due to weak regulation, underqualified staff, insufficient human resources, under-funding and scant local commodities or services.

• Supply chain complexity makes ascertaining a medical product’s provenance highly problematic and creates a landscape of ambiguous accountability.

• Excessive or ill-considered bureaucracy, in a bid to enforce accountability, may make donors (rather than beneficiaries) the most important stakeholder: thus, shifting iNGO priorities from health outcomes to grant targets.

• In-country quality assurance and control measures may be resource-heavy but inadequate; not only does this raise the issue of resource allocation, the combination of uncertainty, excessive effort and pressure to deliver, may incentivise procurement from unproven national sources.

## Introduction

#### Challenges of bureaucracy

##### The accountability dilemma: should the piper serve the pauper or the payer?

Fiscal responsibility and accountability are exceptionally important in the aid sector, where tracking and justifying spend to donors and governments is a legal requirement and a moral obligation.38 However, the policies, procedures and culture that exist in order to achieve this level of scrutiny are not always the most advantageous for beneficiaries.26 29

First, funds are often earmarked to specific activities and spend categories by donors (the impact of which has received attention in the scientific community).29 39 40 This can create confusion, inefficiencies and undermine an iNGOs ability to autonomously adapt to the unpredictable context in which they work.29 Second, funds may be released on the day that a project goes live,26 even though activities such as recruitment and pharmaceutical procurement can have a very long lead time. It could take many months to prepare, adjust, ship and import a consignment of medical products to a programme in Myanmar or Afghanistan, for example. Therefore, for new programmes, the iNGO may face the dilemma of whether to scale back targets based on the new timeframe (which may bring about financial penalty from the donor), or to purchase medical products from a more accessible location (though one that is unlikely to comply with donor quality assurance policy).

Third, harsh penalties for overspend or underspend (such as disallowances and reputational damage) can have a significant and long-lasting detrimental impact to the project, staff and organisation. This encourages an iNGO to prioritise adherence to a budget that, because it is fixed (or difficult to modify), offers little reward for optimising value for money and the responsible use of resources. As drugs and medical devices often consume a large percentage of a health budget, it is an attractive area to make savings or to absorb increased spending. This can have a particularly pronounced effect on medical product quality. For example, in the case of overspend, slashing the drugs budget without altering project targets will often make international procurement unfeasible. This may force sourcing from the national market where, in humanitarian or development settings, the risk of substandard and falsified items is high.8 41 42 Underspend on the other hand may motivate an iNGO to purchase surplus medical supplies at the close of the project to balance accounts and secure a favourable donor assessment. As speed of delivery and accessibility are the primary concern in this instance, national vendors would be preferable to a time-consuming international order (which may also attract the support and attention of head office procurement teams).

Fourth, stringent policies and key performance indicators may be designated by donors to safeguard and monitor project quality, but instead can detract from it.10 Policies demanding that iNGOs consistently meet the standards of HICs may be attractive, as they are comparatively straightforward to write and understand, are familiar (being akin to the donor’s national legislature) and, reassuringly, do not permit quality to be compromised. However, if unachievable, actors may find that loopholes and waivers are easier to realise than quality assurance risk mitigation measures. Likewise, indicators that use easy-to-interpret quantitative measures (eg, stock levels) may unintentionally encourage product quality to be compromised, if not balanced with reasonable proxies for it. The latter, however, are more difficult to obtain, harder to understand and are not as directly relatable.

Therefore, for humanitarian and development contexts as a collective, an inflexible approach is not realistic —nor is it evidence-based. Although simple, standardised procedures and indicators may be suitable for some commodities, the complexity of sourcing medical products for use in LMIC contexts demands a more detailed, resourced and discerning method of oversight. Systems that fail to legislate for circumstances in which international procurement is unfeasible (eg, emergencies and supply chain failures), or who make excessive concessions through the use of waivers, will leave the iNGO without guidance for navigating procurement dilemmas and will encourage an all or nothing approach to medical product quality. Furthermore, in practice it may reinforce an unhelpful ‘us and them’ mentality in which ‘local procurement’ is synonymous with high-risk, poor-quality medical products. This can diminish respect for national regulatory systems, create markets that are excessively ‘Western’ focused (as exemplified by price hikes for EU Good Manufacturing Practice compliance10 or the imitation of CE marks43), and create protocols that are in contention with national importation requirements.

Strict protocols, basic indicators, written reports and the threat of sanctions are commonly used by institutional donors as tools for evaluating performance and creating accountability. This approach may be because, like iNGOs, donors may lack the resources required to create sufficiently nuanced policies and indicators, or the sophistication to effectively implement them. While a simplistic cookie-cutter approach may be advantageous for donor resources, it can undermine collaboration with iNGOs and disincentivise a commitment to quality.44 When this power imbalance is entrenched by harsh reprisals for deviation from procedures or expected targets, it can further discourage candid dialogue and disempower iNGO adaptability.44 As a result, there is a risk of establishing a tick-box culture that focuses on donor compliance, rather than health outcomes. Further research to appraise the impact of donor rules on organisational decision-making, medical product quality and, ultimately, health outcomes is strongly recommended.

#### Challenges of quality assurance

##### The uncertainty dilemma: when quality is a lottery

Unfortunately, the quality of a medical product cannot be determined by its appearance.15 Nor can it be reliably and routinely guaranteed, at scale, solely via chemical analysis.9 13 Though not without limitations, a procurer’s confidence in product quality is either based on trust in the NDRA,45 or based on knowledge and evaluation of the manufacturer’s, distributor’s and supply chain’s system and quality assurance measures.46 If these are robust and complete then, logically, the quality of the product can be consistently guaranteed.47 However, substantial money, skill and experience (both technical and people related) are required in order to visit and inspect infrastructure, equipment, materials, staff, procedures, permissions and records of the company.10 12 46 This is evidenced by the fact that only the results of specific regulators (either individuals or organisations) will be acknowledged as credible by global regulatory institutions (eg, the Pharmaceutical Inspection and Co-operation Scheme) and most NDRAs.

The issue of quality variance is clouded by the fact that its classification is somewhat subjective.41 48 This is not necessarily due to a deviation of standards between countries, organisations or individuals (although this may be the case), it can be influenced by circumstances during evaluation.7 Differences in capacity, competence and ability to access key locations may alter how thoroughly an assessor (eg, a regulatory authority or iNGO health provider) is able to scrutinise a manufacturer, distributor or product.12 49 In addition, the experience and risk appetite of the assessor (or their organisation) may impact their evaluation of what is deemed to be acceptable. As a result, an item that is quality assured by one country, donor, charity or healthcare professional may not be approved by another, even though all parties are referencing the same standards.

If the quality assurance of medical products is an institutional responsibility that yields differing conclusions, this begs the question: who should determine what is acceptable? This moral dilemma is faced by iNGOs involved with health provision in LMICs, if a medical product that is legally approved by the host nation would be rejected by the benefactor’s one. In 2010 a WHO assessment of regulatory systems in Sub-Saharan Africa concluded that ‘on the whole, [the assessed] countries did not have the capacity to control the quality, safety and efficacy of the medicines circulating on their markets or passing through their territories’.50 Today the global differential is still alarming: it is estimated that nearly three quarters of NDRAs are benchmarked at Maturity Level 1 or 2, and are therefore not considered to have a ‘stable, well-functioning and integrated regulatory system’.51 Currently there is a lack of consensus (and a paucity of dialogue) regarding whose medical products, in a generalised sense, should be sourced: those legally approved by the host nation (but whose quality may be questionable), or those equivalent to the standards of the benefactor’s nation (where, in this paper, it is assumed that the latter is a WHO-listed authority benchmarked at Maturity Level 3 or 4).

##### The unspeakable dilemma: choosing quality or availability

For a health iNGO, there are several options regarding a quality assurance audit of suppliers in LMIC settings, including perform them in-house, collaborate with other organisations, rely on publicly available reports, outsource them to a third-party procurement agent or do not conduct them. (These choices are discussed briefly below.) However, it is feasible that none of these options will be ideal, even in combination, particularly for programmes with a broad medical product list.

In-house quality assurance is prohibitively expensive for many iNGOs, given the plethora of medical products, suppliers and destinations involved. However, larger agencies may consider this worth the effort for key countries, programmes or where collaborative opportunities exist. Invariably however, the audits do not deliver a holistic package of knowledge on which to base all sourcing decisions for the project. This is because they may only give an ad hoc snapshot, be insufficiently in-depth, fail to cover all required products or provide technical information that the organisation is unable to interpret or action.

Although a staple method for NDRAs (and one that is encouraged by the WHO),45 a ‘reliance’ approach to quality assurance is unfeasible for many iNGOs. This technique involves establishing equivalence of each batch of a medical product with one that is approved by a ‘trusted’ NDRA, or auditor. This desk-based assessment may be advantageous in terms of cost and personnel security but, as it involves a review of dossiers and documentation for each individual product, it is dependent on access to commercially sensitive information (and staff with the skill to interpret it). Ideally, this is achieved via cross-organisational information-sharing agreements, but iNGOs may lack the negotiating power (that NDRAs enjoy) to broker such an exchange. Instead therefore, they may need to piece together data from public domains (eg, the list of European Medicines Agency-approved manufacturers), the host government, partner organisations and the manufacturer themselves. Not only is this time-consuming, it is unlikely to yield the sufficiently detailed or validated information that is necessary for evidence-based decision-making.

Furthermore, iNGOs that require a range of commodities may prefer wholesalers who are a ‘one-stop-shop’ and may, therefore, deem the evaluation of individual production lines of a manufacturer to be unworkable (or pointless, if the minimum order quantities are greater than their needs). Thus, based on the same concept of trust and reliance, charities with the risk appetite to do so may conduct remote assessments of vendors (not individual products) using shared or publicly obtainable information. As the procurement habits of a humanitarian organisation are unlikely to overlap with that of an HIC, data from a stringent and reliable NDRA (ie, benchmarked at Level 1 or 2) are in short supply. Reports of a trusted auditor (eg, QUAMED) may be available but are unlikely to yield positive results,42 or it may only be possible to gather several pieces of vague and decontextualised data—a list of the vendor’s customers, for example. This practice, and the uncertainty it creates, may increase the risk of sourcing poor-quality medical products and may even invite exploitation.9 10 Given the risks, this area would benefit from scrutiny to understand the extent of (and drivers for) remote assessments and whether poor-quality data have an influence on iNGO decision-making.

For many organisations, purchasing will either be outsourced to an international procurement agent or conducted nationally (either by internal personnel, or integrated with a partner’s supply chain). In the case of the latter (national procurement), the iNGO may purely consider their role to be programme implementation and argue that product quality is a government responsibility. Whereas in the former circumstance, a supplier is relied on to ensure quality standards are met. Anecdotal evidence suggests that organisational culture, risk appetite, capacity, multinational status and operational constraints are all influential in determining whether an NGO considers product quality to fall under its responsibility. Further research would be beneficial to qualify this, comprehend the role of donors and to unravel key aspects of organisational decision-making.

Given the significant level of effort required to conduct quality assurance activities, an ethical issue that is common in healthcare comes to the fore: that of resource allocation. In the event of supply chain delays or failures, iNGO actors in humanitarian and development settings may be unable to source goods in both the quality and quantity required (with the time and funds available). This may cause considerable internal conflict regarding budgets and resource allocation. This tension is, frequently, a matter of quality versus availability.52 Broadly, for an iNGO to guarantee medical product quality in a low-income country, expensive and time-consuming international procurement (which depletes significant funds, time and effort from a limited pool of resources) is required. Not only does this divert capital and people from other needs and initiatives, it may be impracticable for emergencies and short-lived grants or contracts. On the other hand, availability can often be comfortably achieved through the indiscriminate purchase of goods from a market according to cost, ease and speed. While this may be a highly attractive course of action, it bypasses quality assurance and therefore threatens medical product safety and efficacy (and, by extension, patient well-being).

This is an ethical challenge that, as yet, has been largely unexplored. This may be because, culturally, only one course of action in this dilemma is considered acceptable. The idea of compromising a medical product’s quality, safety and efficacy, and distributing it to a vulnerable (perhaps paediatric) beneficiary, seems unconscionable. (Indeed, arguments that this runs contrary to the tenets of beneficence, non-maleficence and justice have been presented53). Therefore, discussion of this issue tends to focus on the need for quality: how it should be nurtured, methods for monitoring it and ways to enforce it. While this line of enquiry is important, it alienates those facing current and real-world challenges. It fails to acknowledge the competing pressures that urgency and budgets create, instead establishing a paradigm where deviation from a stringent quality standard becomes an unreasonable and unspeakable action.

This, of course, does not solve the issue—rather, it compounds it. If an iNGO chooses to derogate a procedure that could impact medical product quality, it forces the decision to be made internally (and the donor or State may not even be involved). Away from the public domain, the global health community is unable to compare, scrutinise and debate purchases (or the consequences of them), and thus cannot learn from them. Not only is this conducive to repeated errors of judgement (and therefore potential beneficiary harm), it impedes collective work towards an evidence-based framework for handling these tough decisions. Therefore decision-makers and influencers of iNGO health programmes urgently need to concede that this is a problem, and to create an environment that facilitates open and honest dialogue.

## Conclusion

The complexity of medical products (as well as the systems in which they exist) and the limits of technology, combined with a dearth of capacity in a context that demands increased resources (due to natural and man-made disruptions), creates a colossal barrier to sourcing quality assured medical products. For iNGO procurers, these challenges are compounded by the numerous additional (and oftentimes) competing donor, host and user expectations. When these pressures are nested in a culture of weak accountability and unsympathetic reprisals, the reward for compromising medical product quality and achieving competing priorities may outweigh the risks, costs and challenges associated with adhering to legal and moral quality assurance requirements.

Despite the challenges discussed in this paper, it is vital that the global health community is undeterred in its mission to eradicate the scourge of falsified and substandard medical products that threaten patient health. However, because of these challenges, it is also vital that the global health community openly explores justifications and risk-managed methods for compromising medical product quality. Greater research is required to gather and analyse the normative values of actors involved in the provision and consumption of medical products, and to understand and categorise the influences and influencers at play. This initial step should facilitate conversation regarding the circumstances that would willingly lead to, through action or inaction, the failure to assure that medical products distributed within the supply chain meet minimum quality standards. Accepting and understanding these decisions is a prerequisite to designing solutions that will help to avoid them in the future but, more than this, is also key to establishing the sector-wide professional empathy that is necessary for acknowledging difficulties, encouraging honest dialogue and improving standards.

## Data availability statement

There are no data in this work

## Acknowledgments

The author wishes to thank Dr Patricia Kingori for their formative discussions regarding uncertainty, as well as for her encouragement and support in submitting this article. The author is very grateful to Joseph Bamborough, Raffaella Ravinetto, Christopher Enright and the unknown peer reviewer for their helpful comments on drafts of the manuscript, which undoubtedly helped to improve the quality of the article. Finally, the author extends her thanks to her donor, the Wellcome Trust.

## Footnotes

• Handling editor Seye Abimbola