Pre-COVID-19 context

Participants described a pre-COVID-19 pandemic context in which the national medicines regulator was perceived to have succeeded in enforcing stringent quality assurance measures on the market (table 2). However, the national medicines regulator’s lack of policing powers over the informal medical product sector was a significant limitation where poor-quality medical products could be sold in the unregulated informal sector:

Generally, the formal channels and the formal market is well regulated. The informal sector, that’s where we have a big challenge in the sense that our borders are too porous, and we do not have a presence at the ports of entry. So, a lot of unregistered medicines get smuggled into the country from neighboring countries, mostly places like Zambia for example, and they would have come as far as DRC [Democratic Republic of Congo], Tanzania and they just come through these ports of entry. That’s where our biggest challenge is [informal sector], because our enforcement activities are limited. —[Regulatory authority/Technical agency]

Disruptions to quality assurance and regulatory activities

COVID-19-related disruptions led to a reduction in some medical product quality assurance activities. Participants also described an overall shift of regulatory focus to COVID-19-related issues, in lieu of regular enforcement activities. Participants affiliated with the national medicines regulator described a reduction in the number of routine local premise inspections and an inability to conduct good manufacturing practice (GMP) inspections of manufacturers abroad, due to COVID-19-related travel restrictions. GMP inspections are an important quality assurance mechanism, where the regulator’s representatives verify compliance with GMP standards in the manufacturing of medical products that are registered for in-country use. GMP inspections are traditionally conducted in person at the manufacturing sites, and thus the inability to conduct inspections during the COVID-19 pandemic limited the regulator’s ability to verify GMP compliance. Further, GMP inspection fees are an important revenue source for the regulator and the reduction in number of inspections affected revenue flows, which could impact the NMRA’s other regulatory activities dependent on the fee revenue:

If a manufacturer wants to register their medicines, they invite us for an inspection, and we charge for those services. Because of COVID-19, unfortunately, we haven’t been able to conduct as many GMP inspections, as we would have done pre-COVID-19. So that’s one of the ways that I feel as an organization we have been affected, in terms of resource mobilization through those GMP inspections. We then actually moved to virtual GMP desk audit inspections, whereby we look at the paperwork and we speak to them via Zoom, and they take us through the facility. We have realized some revenue through that [virtual inspections], but it’s not as much as we used to get pre-COVID. —[Regulatory authority/Technical agency]

Participants affiliated with the national medicines regulator also described how movement restrictions and global logistical disruptions had caused delays to renovate the regulator’s national microbiology laboratory for certification by the WHO. Other participants cited potential disruptions to the regulator’s autonomy through political pressure to waive regulatory processes for medical products procured through government-to-government channels in response to COVID-19:

We had then seen some commodities from non-traditional suppliers, including pharmaceuticals from China coming to government, through government-to-government deals. So, for those types of products, definitely, you cannot vouch for their quality because they would not have gone through the necessary quality assurance process…however, because we were in the pandemic it was a balancing act. —[Donor]

Reports of poor-quality medical products

Most reports of poor-quality medical products among participants were for PPE such as masks, gowns and infrared thermometers used for the COVID-19 response (table 2). Participants stated that most of the poor-quality PPE products came from new suppliers who took advantage of the acute shortage to enter the market without following regulatory processes, including GMP compliance. Further, participants noted that PPE and other consumables were less regulated, making them an easy target for falsification and substandard products, compared with medicines that are stringently regulated:

Although the country is working towards regulating consumables, we still get substandard products…From where I sit here, I do not have the capacity to check whether that mask you are wearing is of good quality. So, if somebody comes with something that looks like an N-95 mask, you may not be able to assess if it is of good quality. The country actually lacks such a regulator [for testing consumables and PPE], but on the medicines side that’s taken care of. —[Government ministry]

In addition to COVID-19-related products, such as PPE, quality concerns were raised for paediatric oncology medicines, based on clinician observations of treatment failures. Cases of treatment failure were observed for a tumour that is considered easily treatable and were not previously observed before the COVID-19 pandemic. Clinician informants attributed these treatment failures to possible poor-quality medicines. The paediatric oncology medicines are not among the essential medicines that are procured by the central medical store for use in public sector facilities, but are procured through a non-governmental organisation:

On the issue of quality, we have no control over that. We were referred to the manufacturer because another foundation is buying from them. So, we buy from them and just give the drugs to the hospital. I know there has been a couple of cases at the hospital involving methotrexate [oncology drug]…we lost three patients. So, we don’t know whether it was a particular batch where the drug came from, what was wrong [whether the unexpected treatment failures were a result of a particular batch of poor-quality medicines]. There has been an incident [of suspected poor-quality medicines], but our drugs are never examined or taken to any lab or tested for anything [therefore the treatment failure cannot be conclusively attributed to quality issues]. As long they have been approved by the regulator, that’s it. —[Non-governmental/Multilateral organization]

Increased risks to quality

COVID-19-related supply chain disruptions led to increased risks to the quality of medical products. For example, participants stated that in response to shortages and supply bottlenecks associated with COVID-19, as well as increased demand for medical products used for COVID-19 management, there was a significant increase in medical products procured under special provisions that waived registration requirements. The special provisions, colloquially referred to as ‘Section 75’ (in reference to the section of the legislative act governing medical products), allows entities to import unregistered medicines for clinical use when the products are not available in the country.34 Some participants perceived that medicines imported under the Section 75 special provision had an increased risk of being of poor quality, since they were not subjected to the same quality assurance process that medicines registered by the country NMRA undergo:

For quality, we bring in products that are registered with [the regulator], and when products come, we get import permits and when they come here [arrive in the country], we still submit samples to the regulator [for quality testing]. So, the issues of poor quality only come with these section 75 products, that [is] where there have been quality issues…I remember there were even reports in South Africa that they tested some of the Ivermectin [which was being imported into Zimbabwe under section 75 waivers] and some of it were non-efficacious [i.e., with low/no active pharmaceutical ingredient content].—[Medical product wholesaler/distributor/retailer]

Supply chain delays and logistical disruptions associated with the COVID-19 pandemic resulted in increased risks to the quality of medical products from expirations and degradation due to prolonged and uncertain storage conditions during new logistical routes, necessitated by unavailability or delays on regular routes. At the health facility level, participants reported that during the pandemic, they often received products that had shorter than usual shelf life, due to initial delays in delivery, thus increasing the risk of using degraded or expired products. Social distancing and movement restrictions, in response to COVID-19, led to decreased incidence of some illnesses spread by close social contact, such as influenza and colds; the consequent reduced demand for medicines for those conditions also led to an increase in the number of expired medicines. Imported products were subjected to longer than usual transportation routes, which may have increased their risk of exposure to uncertain storage conditions. Meanwhile, increased demand for PPE and other medical products for COVID-19 necessitated storage of larger than normal volumes of products at health facilities, which strained storage capacity and may have resulted in some products being stored outside optimal conditions when storage capacity was exceeded:

A problem that came with COVID-19 was storage. We suddenly received lots of products [PPE and other medical products for COVID-19], we had to prepare for an outbreak…the amount of commodities that we were supposed to hold increased by a huge margin. So, you would find that ordinarily you are supposed to keep some things on pellets [in the medical product storage room], but sometimes the stocks would be too much. So, it could have compromised somehow the way we would store the things.—[Government ministry]

The larger number of agents in the supply chain, alongside the entry of non-traditional suppliers in the market during the COVID-19 period, also increased potential risks to product quality. Shortages of active pharmaceutical ingredients (APIs) raw materials and reduced business operations and logistical challenges due to COVID-19-related restrictions led international and other traditional local suppliers of medical products to withdraw from bidding for supply tenders. Consequently, there was an increase in third party agents and non-traditional suppliers who entered the medical product procurement and supply business, filling the gap vacated by traditional suppliers. The new market players took advantage of the COVID-19 emergency and the limited supply options to charge higher prices. The third party and non-traditional suppliers’ limited experience in supply chain management may also have increased risks to product quality.

Normally, it’s actually better to deal with the manufacturer of a product than to deal with an agent who will charge agent fees or to deal with a third party or fourth party. So, you will find that this chain of first, second, third, or fourth parties has got an implication on the price, and possibly sometimes on the quality of the product that you will get.—[Regulatory authority/Technical agency]

Finally, participants also perceived increased risks to quality from illicit/informal market access and the use of unregistered medicines. Movement restrictions to contain COVID-19, such as lockdowns, also had the unintended consequence of restricting access to licensed medicine outlets that sell quality-assured medicines, which may have increased the utilisation of medicines from unregulated informal markets. Some participants also described increased smuggling and sale of unregistered medicines from neighbouring countries on the informal market, including the smuggling of medicines intended for unapproved use for COVID-19 treatment such as ivermectin and azithromycin:

The system [regulatory system] continued to be there for monitoring the country [for medical product quality] but let’s not forget that we have neighboring countries, so obviously grey imports started to surface. I remember the [regulators] were going to [an informal market], there were antibiotics being sold [there] during that [COVID-19 pandemic] period. During that period when somebody was sick, they would do everything [to access medicines, when access to formal retail outlets was restricted].—[Academic/Independent consultant]

Quality perceived to be maintained

Despite the aforementioned reports of disruptions to quality assurance and regulatory activities, some participants stated that the quality of medical products had largely been maintained during the COVID-19 pandemic period. The maintenance of quality, in spite of COVID-19-related impacts, was attributed to the pre-COVID-19 regime of strict quality assurance processes implemented by the national medicines regulator, especially in the formal sector and for essential medicines. Participants also cited continuity in some quality assurance activities, such as predistribution and postdistribution quality testing, as a factor in maintaining product quality during the pandemic. Participants also stated that the quality of medical products was maintained during the COVID-19 pandemic through additional stringent quality assurance systems and regulations of donors and international organisations that support the procurement of medical products in Zimbabwe:

I think it [absence of quality issues among donor supported products] is because of the quality issues which were being well regulated. I don’t think there would be any manufacturer who would want to take advantage of the situation…there are strong and resilient systems which are able to provide checks and balances.—[Donor]

Mitigatory factors

Participants described mitigatory factors and/or adaptations that moderated the impact of COVID-19 on the quality and regulation of medical products in Zimbabwe. Among suppliers for large donor-funded contracts or for multilateral organisations, such as the United Nations Children’s Fund (UNICEF), there were strong financial incentives for suppliers to maintain the quality of medical products and continue adhering to quality assurance measures, despite challenges from COVID-19, in order to maintain the large contracts. Quality is one of the performance criteria for these contracts, and failing to maintain medical product quality would result in financial loss for the suppliers by losing large contracts and being precluded from bidding for future supply contracts. Further, the procurement of donor-funded products was often pooled at the global level through global supply divisions that had their own quality assurance mechanisms, in addition to the local quality assurance processes through the NMRA. Thus, the multilevel nature of quality assurance processes for medical products procured at the global level served as an extra safeguard against threats to quality during the COVID-19 pandemic:

Looking at the commodities that the [name of bilateral donor] supports, we have such rigorous quality assurance programs in place before commodities even get into the country [where they are subjected to further quality checks by the national regulator]. That’s part of what we pay [name of international implementing organization contracted by donor to provide supply chain and quality assurance services] to do. So, the quality of the items that were coming into the country that we procure were still at the same standards.—[Donor]

Another example of external mitigatory factors is that local medical product wholesalers and distributors, who had distribution agreements with global manufacturers of brand-name medical products, still had to comply with Good Storage Practices and Good Distribution Practices, where compliance was verified by the global manufacturers’ compliance departments:

There are standard operating procedures that exist in any distribution agreement. The bigger European companies, they have got quite big departments that deal with compliance to ensure that your operation [as a distributor] is in line with their standards. They work on the principle that a warehouse and drug distribution in Harare must be the same as drug distribution in the UK or US, etc.—[Medical product wholesaler/distributor/retailer]

Adaptations to COVID-19

An example of the adaptation of operational processes in response to COVID-19 disruptions is that the regulator quickly adopted virtual GMP inspections when it was challenging to conduct traditional in-person inspections. The virtual inspection approach provided assurance and some confidence in the application of GMP principles by manufacturers. Though not ideal, the adoption of the virtual inspection protocol demonstrated the regulatory agency’s resilience in trying to assure the quality of medical products even during a pandemic:

We have had to adjust to what are called virtual inspections…we connect with the manufacturer, and they provide their documentation…we even go into the facility, and they use videos and things like Zoom and other platforms…that’s how we have been operating since last year, virtually, mostly with the international players [manufacturers].—[Regulatory authority/Technical agency]

Another procurement organisation introduced flexibility in the timing of preshipment quality testing, as an adaptation to accommodate shipping delays caused by logistical disruptions from COVID-19. Instead of waiting for quality testing results before shipping, as was the policy prior to the COVID-19 pandemic, they would collect samples for testing and allow shipment while results were pending, and any follow-up actions based on testing results were conducted when products arrived in the country.

Previously before a product shipped, [name of contracted technical partner responsible for quality assurance] would go in and do the quality assurance testing and if a product passes it ships…but during this COVID-19 period, they would collect product samples and go ahead and ship it [shipment of medical products] and do the quality assurance testing while the products are sailing and before it’s [shipment] received in-country they would let us know [results of the pre-shipment quality assurance testing]…—[Non-governmental/Multilateral organization]

Finally, participants stated that COVID-19-related disruptions allowed the regulatory authority to accelerate efforts to automate and streamline regulatory processes:

It [COVID-19] actually helped us to quickly adapt our IT [information technology] infrastructure…Before COVID-19, there were a lot of suggestions on how the regulator should move towards automation of their systems, to be able to respond quickly to the needs of the customers. So, when COVID-19 came, we then realized that we were not moving quick enough. So, we had to move quickly enough to sort out our automation and automate most of our key business processes.—[Regulatory authority/Technical agency]