Medicines for Africa | Utano Newsletter | December 2023

Spotlight: Leader Profile

Meet the Leader Overseeing the Precursor of the African Medicines Agency | Utano Newsletter | Medicines for Africa

"If Africa sneezes. The world shakes." Chimwemwe Chamdimba

Chimwemwe Chamdimba is a graduate of the University of Malawi. She is a scientist with a background in government where she worked for the Budget and Finance Committee of the Malawi National Assembly focusing on the heath and agriculture sectors. She has spent fifteen years at Linda Yobo and recently took over the leadership of the precursor of the African Medicines Agency, the African Medicines Regulatory Harmonisation from Dr Margareth Ndomondo Sigonda on her retirement. Chimwemwe is in charge of overseeing efforts to put in place the remaining structures of the African Medicines Agency as an institution. Thought the agency has been operational under its precursor name since 2009 when the African Medicines Harmonisation initiative started, the agency is expected to begin operating under its legal name, the African Medicines Agency in 2024 in Kigali, Rwanda. Below Chimwemwe answers your questions on the African Medicines Agency.

Spotlight | Chimwemwe answers your questions | Utano Newsletter | Medicines for Africa

1. When will the African Medicines Agency begin its work? "The African Medicines Agency has been up and running since 2009 when we started the African Medicines Regulatory Harmonisation Initiative."
2. What is the significance of the African Medicines Agency for trade in Africa? "For us to unlock continental trade and investment in pharmaceuticals, we have to take care of the regulatory systems and standards. The work that we are doing is pivotal to that."
3. How will the African Medicines Agency work? "The African Medicines Agency will operate through continental technical committees and the experts for these commitees will come from national medicines agencies. That is the same model that the European Medicines Agency uses."
4. Can the African Medicines Agency work if national capacity is weak? "We need to have capacity at the national level to be able to provide capacity at the continental level. This is the same model that the European Medicines Agency uses. They use technical group that do the work at the continental level. Decisions made by AMA will depend on national medicines agencies to implement its decisions."
5. Will the African Medicines Agency support all countries reach high maturity? "The goal is not to have all countries operating at high level maturity across the continent. We expect to have a mix of capacities. What we want is for African countries to have the basic capacity to regulate medical products within their economies. We are moving countries towards that to ensure that every country has the minimum level of capacity to be able to regulate medical products effectively within their jurisdiction."
6. When will the African Medicines Agency's board of Directors be in place? "The board is currently being nominated. We already have nominations according to the s of the AMA Treaty because the Treaty specifies the composition of the board. We expect to have the board in pace by end of 2023, or early 2024."
7. Does the African Medicines Agency have a Director General? "Once we conclude the process of nominating the board by the end of 2023 or early 2024, the board will begin the process of nominating the Director General in Q1 2024. Once the board is in place, we expect them to advertise for the recruitment of the Director General. As we sit today, the terms of reference are finalised. They are already in place. The board will conduct interviews and make a recommendation of the who should be nominated Director General. We expect the Director General to be in place by the middle of 2024."
8. Does the African Medicines Agency have offices yet? "Yes. The government of Rwanda has already signed the hosting agreement. I want to thank the government of Rwanda bacuse they have already allocated a big beautiful building. So we already have the office space for AMA. It's just waiting for the staff to go and occupy the building."
9. When will the agency start operating under its legal name,The African Medicines Agency instead of its precursor name, the African Medicines Regulatory Agency? "Very soon.
10. What are you most excited about in 2024?

Spotlight | Chimwemwe′s Message at the Recently concluded Scientific Conference on Medical Products Regulation in Africa | Medicines for Africa

"As I reflect on #SCOMRA2023, The discussions into the vital connections between regulatory systems and local production support probed actionable strategies to not only harmonize regulatory processes but also ignite local manufacturing capabilities. The synergy in these discussions highlights our shared commitment to transforming the vision of access to quality medical products into a tangible reality. As we bid farewell to this enriching experience, let's carry forward the spirit of collaboration, innovation, and shared dedication that defined our time together. The connections made and insights gained will be guiding beacons in our ongoing efforts to strengthen regulatory landscapes across the continent. A heartfelt thank you to all participants and our incredible partners who played a pivotal role in making this conference a resounding success! Your contributions have truly made a difference."

When Communities Lead | Utano Newsletter | Medicines for Africa

"Communities are not in the way, they light the way to the end of AIDS. Community leadership builds stronger and healthier societies." Winnie Byanyima , Executive Director, UNAIDS

The existential challenge facing the wellbeing of African people

"We face an existential challenge for the wellbeing of our people. As regulators, we play a key role in enabling and supporting the availability of medicines of assured quality and facilitating local production. Many of our medicines regulatory agencies are struggling with backlogs. Reliance and digitisation is going to help us ensure timely access to safe and quality-assured medical products on the continent. Reliance is important but the questions is how do we begin to rely on ourselves, that the excellent capacity on the continent is fully utilised. We have five regulatory authorities operating at a high maturity level on the African continent. When a product has received authorisation by one of our high maturity agencies like the Egyptian Drug Authority (EDA), Food and Drugs Authority,Ghana , South African Health Products Regulatory Authority (SAHPRA), National Agency for Food and Drug Administration and Control (NAFDAC) or Tanzania Food and Drugs Authority (TFDA), others on the continent, in Europe and around the world should have confidence in the products that are approved by high maturity African agencies and in products manufactured with their oversight on the African continent."?Dr Boitumelo Semete-Makokotlela

Sustainable development happens when communities participate in a meaningful way | Utano Newsletter | Medicines for Africa

Truly sustainable development happens when communities lead. This is true for any community including African communities. What was different about the scientific conference on medical products regulation in African recently held by the African Medicines Harmonisation Initiative in Egypt Cairo hosted by the Egyptian Drug Authority is that this meeting looked and felt like a meeting led by African communities. Most meetings that are held in Africa are often lacking in the participation of Africans. Inclusion of Africans on panels and speakers is often tokenistic. This practice makes a great disservice to the goal of developing initiatives. Representation matters. True representation, that is, when people who represent those communities are included, beyond the token one or two individuals better serves international initiatives. Medicines for Africa congratulates the organisers of this meeting and their partners for having a meeting about Africa in which there is genuine meaningful participation by Africans.

World AIDS Day 2023 | Utano Newsletter | Medicines for Africa

On #WorldAIDSDay, we commemorate more than 40 million lives that we have lost to HIV/AIDS. We have lost friends, family members, and millions of loved ones. HIV/AIDS is still raging in communities. Its transmission is not showing signs of slowing down. More than 39 million people are living with HIV today. They must depend on medications to stay healthy. It is important that quality-assured medicines remain accessible to those who need them.

After Four Decades of Battling to Save Lives from HIV/AIDS, Where Are We? | Utano Newsletter | Medicines for Africa

Earlier this year Lenias Hwenda of Medicines for Africa | mfa wrote a 3 part series published in PharmaBoardroom . Read part one here and part two here. In the third and final piece Lenias Hwenda′s series looks back at the challenges and successes of HIV/AIDS treatments over the past 40 years and potential medical breakthroughs to come She examines the persistent challenge of HIV/AIDS survivors losing their lives to noncommunicable diseases (NCDs), calls for a new public health approach in what is now the fifth decade of battling HIV/AIDS, and finishes with her optimism about the breakthrough that a safe and effective HIV vaccine would represent. Read part 3 here.

The persistent challenge of HIV/AIDS survivors | Utano Newsletter | Medicines for Africa

Noncommunicable diseases Billions of dollars have been invested in saving millions of lives from HIV/AIDS. The success is however clouded by the fact that long-term HIV/AIDS survivors are increasingly losing their lives to unmanaged non-communicable diseases like cancer, diabetes, and cardiovascular diseases (CVD). Few health systems in low- and middle-income countries (LMICs) have adequate programs and infrastructure for non-communicable disease management for national populations.

HIV/AIDS has had a disproportionate impact on the young economically productive demographic. Those affected individuals carry it for life and they have a heightened vulnerability to other chronic conditions affecting the general population. And so whilst AIDS has become a medically manageable chronic condition that is no longer among the 10 leading causes of death globally, at a population level, HIV gains are not being fully realised because health systems neglect NCDs which subsequently take the lives saved by HIV/AIDS programs.

Read the article here

Community leadership is key to limiting HIV transmission | Utano Newsletter | Medicines for Africa

This is critically important for controlling transmission from person to person. We know that effective treatment that leads to the virus being undetectable in the blood of infected individuals means that theat individual cannot transmit to others. Undetectable is untransmitable. However besides the biomedical controls for limiting transmission, ultimately the best interventions for reducing transmission are those in which communities lead.

We need community leadership to protect girls and young women who are the most disproportionately affected by new infections. The leadership of Prince Nhlanganiso Zulu, an enthusiastic spokesman on behalf of the male circumcision campaign in KwaZulu Natal has shown just how much can be achieved when communities lead. KwaZulu Natal reached 1 million male circumcisions in 2018 and have by now surpassed that. That is a critical milestone for Kwazulu Natal, a province with the highest prevalence of HIV infection in South Africa .

That is why on #WorldAIDSDay2023, we should not only honour the leadership of communities. We should call of governments to concretely support communities lead efforts to ensure that people receive treatment, they stay on it and above all, we prevent new transmission by protecting young women and girls. Winnie Byayima says that communities are often seen as being in the way of those who wish to intervene. But she is right when she says "Communities are not in the way, they light the way to the end of AIDS. Community leadership builds stronger and healthier societies."

In KwaZulu-Natal, the province I live, young women 15 to 19 years had six times more infection compared to men. At age 20 to 24 years, 12 percent of women are already infected with HIV.” · Men get infected 5-7 years later than women do.“ I was hearing from the women themselves that they understand the risk but everything we had available depended on male cooperation. If you are 20 years old and your partner is 25 or 26 or 27, you likely would have had a child and dropped out of school. So you get caught up in vicious cycles of poverty and dependency.

Listen to the Prof. Quarraisha Abdool Karim′s podcast here | Utano Newsletter | Medicines for Africa

Click on the photo to listen to Prof. Quarraisha Abdool Karim speak to Lenias Hwenda a on Utano Podcast .

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