The initial stumbling block of the process was fear that the workload and the implementation costs would be unbearable or not manageable. Therefore, the Commitment integrates pragmatic administrative and financial rules. Implementers are requested to integrate in their financing applications a specific section for pharmaceutical QA, with a justified corresponding budget. They are also invited to consider how costs “could be rationalized and mutualized by aligning the strengths of the various implementers”. Concerns might remain about the costs of building a QA system, especially for those who must start from zero. However, an exclusive focus on the “direct costs” (such as hiring a QA pharmacist, developing a QA policy, sub-contracting pharmaceutical audits to qualified experts, upgrading storage facilities, etc.) would ignore the long-term gains of investing in QA, as well as the losses caused by not doing it: (undetected) poor-quality medicines would impose higher costs on implementers’ programs and local health systems, cause avoidable morbidity and mortality, and erode trust in medical services.
A second stumbling block was the fear that the process would result in the (further) weakening of the local pharmaceutical supply systems. To mitigate it, the “Commitment” recommends considering local purchases (provided that quality risks are assessed and mitigated), and prioritizing existing local structures for storage and distribution. Such choices should be based on risk analysis and management, and accompanied by plans to strengthen the local capacities, i.e. through capacity building for pre-qualification, purchases, storage and distribution, depending on needs (e.g. of local procurement agencies). The implementers should integrate in their financing applications a specific section for such activities, and consider if/how costs could be rationalized and mutualized. Noteworthy, academic institutions may contribute to capacity-building, by means of education programs and collaborative operational research . This approach addresses the fears that the “Commitment” would overrule the power of the NMRAs, so contradicting the principle of state sovereignty, or indulging in paternalism. The NMRAs should be a privileged partner of DGD implementers to discuss any relevant issues, included but not limited to audits planned in-country, audits findings, medicines importation (that can only take place with the NMRA approval) and possible research collaborations.
When it comes to possible adoption of this “model policy” by other donors or implementers, a third stumbling block is the possibility that the potential gains of the policy are misunderstood. In particular, donors, implementers and also policy-makers may still be unaware of the potential detrimental effects of non-quality-assured products, which often go undetected. For instance, therapeutic failure caused by an under-dosed medicine can be attributed to other reasons, such as late referral, and even cases of toxicity due to a contaminated medicine may go unnoticed unless cases are clustered, e.g. at hospital level. But “treating” patients, i.e. administering a medicine the quality of which has not been adequately verified, is different from “curing” patients, i.e. administering a quality-assured medicine which has been proven to be effective and safe. We hope that more and more policy-makers, implementers and donors become aware that investing in quality assurance results in gains for health (improved quality of care), ethical behavior (no double standards between patients in affluent and poor countries) and even cost-effectiveness (better quality of care means less therapeutic failures, and decreased long-term health costs). In addition, if more donors and implementers joined forces in requiring quality-assured products, they would create a “market incentive” to quality that could in the long-term lead to broader availability and lower prices of such products (as shown by the experience of WHO pre-qualified antiretroviral and antimalarial). A risk of blockage would remain, in case local suppliers were unable to supply quality-assured products and it was impossible to import. To mitigate this risk, it is essential to involve the key-local counterparts and especially the NMRAs in the development of the strategic approach, with the ultimate aim of empowering local partners and maximizing patients’ protection.
Finally, acknowledging the complexity of this undertaking, the new policy will be implemented in a stepwise approach, by means of a flexible and constructive monitoring and evaluation, with ongoing “peer-reviews” (via Be-cause Health) and concerted corrections between implementers and the DGD. In the long term, the step-wise approach could lead to defining criteria for accreditation of implementers.