COVID-19: USP offers guidance on strategic response model to African Regulatory Authorities 

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The world faces an existential threat owing to the outbreak of the COVID-19 pandemic that has now shut down major economies and caused significant global disruption. The World Health Organization estimates that about 44 million people could get infected by the Virus in the continent, and a projected 200 thousand deaths. A recent survey by the African Union shows that about 20 million jobs are at risk in the continent, as economies are fast shrinking in response to COVID-19-induced disruptions. In this exclusive interview with African Leadership Magazine, Dr Lawrence Evans, Senior Technical Director, USP’s Global Public Health team, talks about the impact of the pandemic on the continent’s public system; the agency’s time-tested guide for a response during an outbreak like COVID-19; the dangers of substandard medicine as the continent battles the pandemic, among other issues. Excerpt.    

According to data by the United Nations Economic Commission for Africa, UNECA, under the worst-case scenario, with no interventions against COVID-19, Africa could see 3.3 million deaths and 1.2 billion infections, due largely in part to the continent’s fragile health systems. What in your view can be done to limit the projected disruptions?

COVID-19 is bringing to light additional vulnerabilities across African health systems that can disrupt an already fragile system. One of the most critical disruptions the COVID-19 pandemic is causing is to the supply of quality essential medical products. We are seeing shortages of some medical products needed for the COVID-19 response as well as shortages of those for non-COVID-19 related treatments. As a result, it’s leaving a vacuum for poor-quality medical products to enter, and is the reason for the uptick in falsified medical products which may compromise efforts against both COVID-19 and other diseases.

This pandemic requires us to go beyond business as usual. Based on decades of experience, USP has offered guidance to regulatory authorities on how to respond to medical product shortages and protect patients from poor-quality medical products during the crisis. Regulators must take steps to stem the proliferation of substandard and falsified medical products during this pandemic, which is particularly challenging given travel restrictions. Our guidance recommends strategies to remotely monitor product quality using various types of information including patient reporting and product serialization.  

Local manufacturers must also be part of the solution. The guidance includes ways that governments can help incentivize the production of quality-assured medical products locally. In some African countries, local pharmaceutical manufacturers are ripe to rapidly scale up their production capacity to support COVID-19 efforts.

USP is also continuing to provide quality standards for medical products, which are disseminated to over 150 countries, while also supporting vaccine developers and manufacturers of COVID-19 therapies during this crisis.

According to the World Health Organization, WHO, Africa accounts for around 42% of the world’s cases of fake and counterfeit drugs. How is USP helping towards solving this obvious challenge, especially in line with its vision of a world in which all have access to high quality, safe and beneficial medicine and foods?

In Africa, USP works at the country, regional, and continental levels to help regulators protect patients from substandard and falsified medical products.

At the country level, we work with individual regulatory authorities to help them strengthen their medical product quality assurance systems, including building the capacity to find and remove poor quality medical products from the market. Our guidance on Pandemic Preparedness for Regulators in Low- and Middle-Income Countries recommends strategies to prioritize quality surveillance using a risk-based approach and applying technology to remotely monitor product quality. 

USP also works with the eight regional economic communities to support specific initiatives such as the West Africa Medicines Regulatory Harmonization Program. These initiatives are harmonizing medical product regulation and increasing collaboration to detect and remove poor-quality medical products in vulnerable cross-border areas.

At the continental level, we work with the African Medicines Regulatory Harmonization Initiative (AMRH) to encourage collaboration and establish policies that each individual country can adopt with the goal of improving the health of their citizens. AMRH focuses on policy alignment, regional integration and harmonization, and human and institutional capacity development – and we will be expanding our assistance across the board.

In addition, USP has a continent-wide training hub in Ghana that has trained more than 1300 regulatory professionals from 45 African countries. Through our training, we are helping to build the workforce that is protecting patients from substandard and falsified medical products.

USP has over the past 200 years created unique Standards for different ranges of medicines through it’s chain of production for over 140 countries. What are the peculiar challenges USP continues to face when dealing with Manufacturers in African Countries?

A major challenge for African pharmaceutical manufacturers is that they don’t have easy access to raw materials. They must source active pharmaceutical ingredients – an essential component in medical products – primarily from Asia. There are very few manufacturers of active ingredients on the continent. Other components such as inactive ingredients and packaging are also imported and are heavily taxed. The taxation combined with local currency devaluation make it difficult for African manufacturers to remain cost-competitive with imported medical products. In 2019, USP developed a thought leadership piece on local pharmaceutical production that also describes the situation in Africa. 

Another challenge is limited access to the broader ecosystem of services that are needed to produce medical products. For instance, manufacturers of generic drugs need to show they are equivalent to the brand name products. But in Africa, there are few facilities that can do such bioequivalence studies. There is also very limited capacity to support manufacturers in properly maintaining and qualifying their equipment, so they often rely on experts from Europe and the US to provide these services – and this can be expensive and lead to delays.

As the impact of the deadly virus unfolds, we see the weaknesses and vulnerabilities in global supply chain of medicines globally. How has USP ensured that quality of medicines manufactured and distributed are not compromised?

USP sets public standards for the quality of medical products to facilitate the supply of quality-assured medical products. Our standards are used in more than 150 countries and required by law in 40 countries. Ultimately it is up to national regulators to ensure that medical products are quality-assured, safe, and effective. Over the years, USP has collaborated with regulators in many African countries to strengthen their quality assurance systems, and this work continues. We have also widely distributed guidance for regulators specific to the COVID-19 pandemic.

Substandard medical products can result from poor manufacturing practices and improper storage. USP supports manufacturers to produce quality-assured products locally, which shortens the supply chain thereby minimizing vulnerabilities– particularly for products that are sensitive to temperature conditions. We also provide insight on proper storage of products throughout the supply chain in keeping with good storage and distribution practices to help ensure that they maintain their quality. USP’s efforts to support local manufacturing of priority essential medical products in Africa and to strengthen regulatory quality assurance systems has been in collaboration with USAID.

We understand that one of the major challenges in quality medicine is Antimicrobial resistance and according to statistics, it is responsible for over 700,000 deaths annually. How has USP taken up this challenge especially in Developing countries where quality may easily be traded for gains?

Increasingly, the use of poor-quality medical products—which can result in sub-optimal dosing and

lead to treatment failure—is considered a contributing factor in the development of antimicrobial resistance. When poor-quality medical products are used, they can allow drug-resistant bacteria to survive and multiply, which can ultimately harm other patients. 

USP develops quality standards for antimicrobial medical products that can help regulators and industry ensure quality. We also help build regulators’ capacity to ensure antimicrobial medical products are produced, procured, distributed, stored, dispensed, and used appropriately; and raise awareness of how poor-quality medical products contribute to antimicrobial resistance. A major part of our work includes strengthening laboratory networks to detect and remove poor-quality antimicrobials and improving local capacity to test for and monitor the emergence of antimicrobial resistance. In addition, research conducted by USP and our partners through our Quality Institute and other programs is continuing to shed light on the links between poor-quality medical products and antimicrobial resistance and helping identify solutions to inform policies.

According to official statement by USP from the website, USP is currently helping to accelerate the work in developing vaccines and treatment and helping to build a more resilient global medicine supply chain. With regards to the current global pandemic, An African Country, Madagascar has openly claimed to have locally manufactured organic cure for the COVID-19 and we see African government making plans for huge patronage. One may begin to wonder why this “Cure” has not received the desired attention it should have. The country having recorded about 183 cases and 105 recoveries with no death recorded. This should be good enough to attract attention to put the substance to clinical testing. Has USP considered this a possible cure for the Virus? If not,what advise would you give to consumers of this substance?

USP’s role is to ensure that quality is built into the equation as soon as possible so that any treatment or vaccine that may be successful is quality-assured and meets regulatory requirements. We help facilitate development of COVID-19 treatments and vaccines through the implementation of our quality standards, which are available to developers and manufacturers worldwide. This accelerates regulatory acceptance worldwide. We do not make recommendations regarding specific products. We are also working on creating additional training opportunities to help manufacturers use new techniques to evaluate therapeutics and vaccines.

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