Q&A: Towards medicines regulatory harmonization — lessons from Zimbabwe

As it stands, many countries across Africa operate with their own set of rules and regulations when it comes to review, approval, registration, and marketing authorization of medicines. The lack of synchronization not only delays patient access to medicines, but it can often mean that poor-quality, or even substandard and falsified medicines, make their way into the hands of patients, potentially causing serious damage.

According to the African Medicines Regulatory Harmonisation program, harmonization is the key to solving this predicament. Having African countries work together to align their regulatory practices, processes, and procedures could ensure that patients have access to the vital and potentially life-saving medicines they need. This is in line with the AMRH vision of ensuring that African people have access to essential medical products and technologies.

Zimbabwe, one of the pioneers in implementing its own effective medicines regulatory processes and systems, is very much a part of the harmonization processes, and is sharing its experiences to help other countries do the same.

“We think that we have a very effective regulatory process and system in Zimbabwe. It has been going on since 1969, and in 1997 we became an autonomous agency so we're not supported directly by the government, we are fully independent,” explained Gugu N. Mahlangu, director general of the Medicines Control Authority of Zimbabwe, or MCAZ, citing evaluations and registrations of medicines, pharmacovigilance, clinical trials, licensing and enforcement as key components of the system.

Sitting down with Devex in Accra, Ghana, at the 3rd Biennial Scientific Conference on Medical Products Regulation in Africa, she discussed how the country is participating in the harmonization efforts and sharing lessons learned and best practices, but also acknowledged there are still some challenges ahead in getting substandard and falsified medicines off the streets.

Below are highlights from the conversation, edited for length and clarity.

What are the current challenges around regulation in preventing poor-quality and substandard distribution of medicines in Zimbabwe?

Due to the economic challenges our country has faced since the mid-2000s, procurement of essential medicines has to a large extent been supported by various partners such as UNICEF, UNDP, and The Global Fund supporting many primary care products, HIV/AIDS, malaria, and tuberculosis drugs. Some of the products that are supported by the partners are World Health Organization prequalified or locally registered. The partners have supported the implementation of robust market surveillance processes to ensure the quality of the medicines in the public sector supply chain.

Having said that, because of the economy, we also now have an emerging, what I'll call, illicit market. There is an increasing number of people who are vending medicines on the streets. Our inspectors might be busy inspecting a pharmacy, but outside on the streets there is somebody that is selling uninspected, probably fake, medicines that have not gone through a rigorous quality assurance check. This year in particular it has severely affected our reputation as an effective regulator because the population says “but what is MCAZ doing about medicines on the street?” However, dealing with the current challenges in Zimbabwe is not really our sole responsibility. We should work with other law enforcement officers, because we don't have any powers over ordinary citizens as a regulator. All we can do is report them to the police and the police then have to take action, so there are societal issues involved and we have to work in a multisectoral approach. Those are the main challenges that we see right now.

As a leader in the region, when it comes to implementing regulation systems and leading efforts to harmonize these with other countries, what is Zimbabwe doing to advise or assist other countries?

Way back in the early nineties, we had a program with WHO where we were doing capacity development for English-speaking African countries. WHO was willing to support us to get the system at the time and we developed a training program for capacity development of regulators so they would come on a modular basis. We had three one-month modules, so the first month we treated these officers as if they were MCAZ staff members, we peer reviewed them, we gave them work to do, we did mock meetings and they participated in the review of actual dossiers. They learned how to structure an agenda and to write minutes: Those are the mundane things that actually make a regulatory system work, behind the scenes processes. We had a lot of people come through this training including the former head of the agency in Zambia; and we trained regulatory officers from Botswana, Namibia, Mozambique, Ghana, Kenya, and Tanzania.

How did the 3rd Biennial Scientific Conference on Medical Products Regulation in Africa energize the conversation around regulatory harmonization and improved systems and what were the main takeaways to come from that?

The main takeaway from the scientific conference gave us an opportunity to share what we were doing in our various regional economic communities. It was also an opportunity to consolidate some of the work the AMRH has been doing and get people to understand it. Hopefully, we were also able to get partners to see the value proposition in the work that is going on.

I note that sharing experiences makes people then reflect and think about how they should be approaching this whole harmonization effort. It gives us a chance to see what issues we should be focusing on as a continent to expand from regulation and harmonization of registration of medicines and vaccines to include pharmacovigilance, postmarketing surveillance, and other product streams such as medical devices. It is important to establish consolidating institutions in Africa, such as the proposed African Medicines Agency. AMA is intended to spearhead this work and hopefully coordinate all the partners and stakeholders involved to reduce duplication and lead to more efficient utilization of resources, both human and financial resources for the continent.

Finally, there is this issue of agencies working on their own. It is evident that we can no longer do everything on our own. We need to work together and we need to rely on the decisions that have been made by other parties that are doing similar work to us so that we reduce our own workload and improve access of medicines to our citizens. The approach of implementing programs such as the AMRH initiative from a regional perspective, by bringing together agencies at differing levels of development, is key in leveraging on the expertise of each other for mutual benefits. Evidence in the East African Community shows that the regional approach is the best option, and of course the Zazibona work-sharing initiative in the Southern African Development Community have both already proved the effectiveness of regional approaches for the registration of medicines and good manufacturing practice inspections. These regional approaches must be sustained and scaled up to other regions. Patients are waiting, the regional approach is vital in strengthening medicines regulation and harmonization efforts to overcome the challenge of fake medicines on the market collectively as it cuts across national boundaries and will ensure patients have timely access to high-quality, safe, and efficacious medical products and technologies.