Medicines for Africa I Challenges and Opportunities in the African Market I Utano Newsletter I April 2024

Medicines for Africa I Meet the Inaugural Board of Directors of the African Medicines Agency Now Poised to Elect the Agency's Director General

The appointment of the African Medicines Agency's Board of Directors on Monday, April 22, 2024 takes the African continent closer to the realization of this ambitious project. Countries represented on the Board include Benin, Egypt, the Kingdom of Lesotho and Rwanda. The Board of Directors will be chaired by Benin's Dr Yossounon CHABI , the Directeur Général de l'@Agence Béninoise du Médicament et des autres produits de santé (ABRP) below for the next three years. Other notable board members are Egypt's assistant Minister of Health for Public Health Projects and Initiatives Mohamed Hassani, Germina Mphoso , a Senior Pharmacist (Director Pharmaceuticals) at the Ministry of Health Lesotho and Emile Bienvenue, The Director General of Rwanda FDA .

The nomination of the AMA board is a big opportunity to further Africa's goals of strengthening its regulatory environment for medicines, for the development of its medicines and vaccine manufacturing industry and keeping African patients safe from counterfeited substandard medicines. Know more about the AMA here: https://pharmaboardroom.com/interviews/lenias-hwenda-founder-ceo-medicines-for-africa/

Dr Yossounon CHABI: Directeur Général of Agence Béninoise du Médicament et des autres produits de santé

Medicines for Africa (mfa) for Africa congratulates the Chairperson and the inaugural governing board of the African Medicines Agency on their nomination to serve for the next three years. We wish them all the success and we look forward to supporting them succeed at to ensuring the quality, safety, and efficacy of healthcare products in Africa at this great ambitious project.

One of the most important tasks that the board needs to now perform is to find the most capable individual who is well-equipped to lead the African Medicines Agency as the Director General capable of addressing complex challenges in a complex legal and policy environment including the scourge of counterfeit and substandard medical products.

Know more here https://www.dhirubhai.net/pulse/medicines-africa-i-merit-over-politics-african-agency-buite/

Medicines for Africa I Why are Big Pharma Companies Exiting the African Market and What does this Mean for the Continent?

There is not doubt that the retreat of major pharmaceutical corporations like GSK, Sanofi, and Moderna from the African market is reshaping the pharmaceutical landscape of the continent. Whether it shapes it for better or worse depends on how domestic manufacturers, investors, governments and international organizations respond to this what tangible support is made available to support Africa’s nascent pharma manufacturing sector. ?While their departure is seen as an opportunity for domestic manufacturers to fill the void, several challenges undermine this potential transition.

Big pharma companies scaling back their operations in Africa are doing so due to various challenges, including regulatory hurdles, financial constraints, and the high cost of business operations. These business decisions have far-reaching implications on access to essential medications and vaccines on the African continent.

Know More here: https://www.businesslive.co.za/bd/opinion/2024-04-30-lenias-hwenda-big-pharmas-exit-from-africa-a-blow-for-access-to-medicines/#google_vignette

Medicines for Africa I Big Shoes to Fill: The Challenges and Opportunities for Domestic Manufacturers in the African Market

Like most things in life, the withdrawal of major pharmaceutical companies like GSK, Sanofi, Bayer, and Moderna from the African market has both upsides and downsides. On the one hand, it creates significant challenges for local healthcare systems but on the other hand, it creates opportunities for domestic manufacturers.

Pharma giants have cited myriad operational difficulties, from regulatory hurdles and financial constraints to infrastructural deficiencies, as reasons for their retreat. For example, Moderna’s recent decision to halt the establishment of a USD200 million vaccine production facility in Kenya was due to financial and strategic recalibrations, the kind that other big pharma companies are also making, and a result, choosing to abandon direct involvement in African markets.

The retreat of major pharmaceutical corporations from the African market is likely to reshape the pharmaceutical landscape of the continent. Whether it is for better or worse remains to be seen. The outcome will largely depend on whether domestic manufacturers can effectively step into the gap left behind by big pharma and navigate the complexities and challenges presented by the African pharmaceutical market, including securing support from governments and international organizations.

Here are some the challenges that domestic produces will face.

Challenge 1- African manufacturers face stiff competition from Indian companies, who dominate the African market. Indian companies have the advantage of low-cost production manufacturing businesses that are vertically integrated, which gives them access to low-cost raw materials and allows them to produce generic medications cheaply. Most domestic manufacturers, however, are not vertically integrated and do not have ready access to raw materials at low cost. Since active pharmaceutical ingredients (APIs) constitute a major cost component in pharmaceutical manufacturing, it is difficult for domestic manufacturers to lower production cost. A handful of domestic African companies have scope to manufacture APIs but not at sufficient scale to have significant impact on price. ?As a result, international procurement markets are reluctant to buy African-made medicines because they feel that they can get more bang for their buck from cheap Indian generics. There is also the perception that African-made medicines are of poor quality, even though they are likely to of better quality than imported ones.

Challenge 2 – Domestic manufacturers in African countries face stiff competition from illicit counterfeited medicines which have a high prevalence in the African market where they kill almost a million people annually compounded by the weak regulatory environment. Counterfeits containing no active ingredients literally cost pennies to make and are therefore always going to be the cost-leader in vulnerable markets.

Challenge 3- The already difficult and competitive landscape is further exacerbated by the lack of substantive governmental support to promote local pharmaceutical sectors. More on this later.

Challenge 4 - A major impediment to domestic manufacturers scaling up their operations is the inability of African pharma businesses to attract significant investment necessary for expanding and upgrading manufacturing facilities to improve quality and widen their therapeutic product portfolios for the multitude of unmet medical needs. Investing in WHO prequalification to be able to access international procurement markets requires significant funding without which domestic companies continue to be locked out of international markets such as GAVI and the Global Fund. Despite saying that they realize there is a need to support domestic manufacturing in Africa, international donors do not offer genuine investment support to that moves the needle. Often times funds are even pledged with conditions that make it virtually impossible for beneficiaries to access them.

Missed opportunities

Domestic companies lucky enough to attract investment still face the same challenges that are driving the exit of big pharma. Ultimately, the fundamental issues that are deterring big pharma from maintaining their operations in Africa, such as unpredictable market conditions, infrastructural weaknesses and bureaucratic inefficiencies, also plague local manufacturers. When Moderna retreated from Kenya where it planned to invest $200 million into a vaccine manufacturing facility, it cited unpredictable demand and financial losses as primary reasons for its decision. Unlike big pharma who can pull back and choose to manage their operations through third-party distributors instead, domestic manufacturers cannot escape the harsh realities of the African market. Adjusting their business strategy to limit the rising operational costs and complex demands of the African market is simply not an option.

Moderna’s exit scenario highlights a broader question - can manufacturing expensive, high-tech products like mRNA and vectored vaccines in a market that is currently unable to sustain such ventures without substantial external support be economically feasible? The partnership between Aspen Pharmacare and Johnson & Johnson, which was heralded as a cornerstone of Africa’s COVID-19 response, set a bad precedent by stumbling at the first hurdle to access the market when Aspen failed to secure orders for its Aspenovax. Despite the local packaging and intended distribution within Africa, the vaccines saw little uptake due to the influx of cheaper, donated vaccines from Western countries and pervasive vaccine hesitancy among the African population. Aspen Pharmacare made a big investment and delivered but did not receive the collective support it needed to make the investment viable. This led Aspen to consider closing the production line before a fortuitus rescue by it entering another partnership with the Serum Institute of India, a well-established player in the African market.

The contrasting fortunes of Aspen Pharmacare and the Serum Institute of India illustrate the challenges and opportunities in the African pharmaceutical manufacturing landscape. While Aspen struggled to access market for its locally produced vaccines due to lack of orders and competition from donated vaccines, the Serum Institute has successfully captured a significant share of the vaccine market in Africa and thrives and enjoys the support of donors. Their success can be attributed to established demand through international initiatives and competitive pricing, which Aspen could not match despite its local presence. Bottom line is that to compete, you have to offer competitive pricing. Another factor that played out against Aspen is that African consumers have been conditioned to reject African-made products just because they are made in Africa.

Governmental inaction

Governments across the continent have been slow to implement the necessary policies needed to support local pharmaceutical production businesses to succeed. Despite the urgent need for a stronger manufacturing sector, there has been minimal progress in providing financial and policy incentives, or infrastructural investments that would facilitate a more supportive environment for local pharmaceutical companies. The lion’s share of the funding driving progress with improving the regulatory environment through the African Medicines Agency (AMA) which is critical for domestic manufacturing appears to be coming from external sources in European capitals. The appearance is that African governments are giving little if anything, towards the AMA. Furthermore, besides Egypt, two of Africa’s top three economies, South Africa and Nigeria, are not even in the picture to help ensure that the AMA is well-funded.

So, in theory, the retreat of big pharmaceutical giants should present an opportunity for local businesses to thrive, but their scale, limited funding, market constraints, and uneven playing field makes fulfilling that potential mission nearly impossible. For local manufacturers to truly capitalize on the departure of big pharma, African governments need to undertake several well-coordinated strategic actions. Besides the ongoing regulatory reforms to streamline regulatory processes to reduce the time and cost of bringing pharmaceutical products to the market, the market needs to provide financial incentives through subsidies, tax breaks, and funding opportunities to reduce the operational costs for local manufacturers. Governments need to attract investment in infrastructure to enhance power supply, transportation networks, and technological capabilities needed for pharmaceutical manufacturing to thrive. Most importantly, policy interventions that prioritize the procurement of locally manufactured medicines are needed to even out the playing field for domestic industries. Otherwise, domestic manufacturers will continue to be overrun by low-cost Indian manufacturers and illicit counterfeit traders.

Without a significant shift in policy and investment by governments, we can expect the local pharmaceutical industry to continue to struggle, leaving the healthcare systems vulnerable to continued reliance on imports, poor security of access, medicine shortages, and vulnerability to counterfeit medicines. The case of Aspen and the aborted Moderna facility serve as potent reminders of the complex, multifaceted challenges that must be surmounted before domestic manufacturing can step into the gap and develop a resilient, independent pharmaceutical sector in Africa.

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The Leading Women in EU-AU Partnership to Invest in Production in African Countries

The European Union-African Union High Level Ministerial Event on Global Health Partnership and Equitable Access can be considered a total success if all the promises that were made come to pass. Not to be a sceptic or anything, but in international affairs, many a promise are made that never materialize, so it is always good to be cautiously optimistic. Anyway, the purpose of the EU-AU meeting was to build bridges, sharing knowledge whilst emphasizing African sovereignty in order to set the stage for a stronger, respectful partnership between the European Union and the African Union .

The meeting was considered by some as an attempt to heal past wounds notably from the Covid-19 pandemic access to medical supplies farce that showed that claims of solidarity are oftentimes just propaganda and nothing more which dented confidence in the partnership between Europe and Africa. Many will now hope that the two continents are now on a path to crafting the kind of partnership that Africa has always hoped for but one that Europe has always resisted.

Doing so will help to make healthcare access more equitable for everyone, everywhere. The meeting was notable for the number of female leaders leading the proceedings. The two leading commissioners on the Africa and European side were both women and the Minister of Development Cooperation on the Belgian Presidency side was also a woman. The CEO of the African Union Development Agency spearheading the creation of the African Medicines Agency as well as the CEO of the European Medicines Agency were all women.

European Support for manufacturing and access to vaccines, medicines and health technologies in Africa

As part of the Team Europe initiative on manufacturing and access to vaccines, medicines and health technologies in Africa Commissioner Jutta Urpilainen signed a letter of intent with the African Union Development Agency-NEPAD – NEPAD and announced Team Europe support to contribute to the two main African institutions for public health, the Africa Centres for Disease Control and Prevention (Africa CDC), and the African Medicines Agency (AMA).

Five million euros will be granted to AUDA-NEPAD in order to advance the African Medicines Regulatory Harmonisation (AMRH) program and the operationalisation of the African Medicines Agency (AMA). This project will support four specific workstreams: policy and legal frameworks, regulatory capacity development, regulatory information management systems and overall project coordination. The African Union Development Agency?(AUDA-NEPAD) will work closely with Regional Economic Communities (RECs) and African Union Member States. Read more here: https://international-partnerships.ec.europa.eu/news-and-events/news/team-europe-invests-over-20-million-boost-african-vaccine-manufacturing-2022-11-28_en

“We have consistently supported the African Union’s goal to boost vaccine and medicine production in Africa, as part of our commitments jointly agreed at the Summit in February. Today’s new partnerships are another steppingstone in our joint endeavour for a safe and healthy African continent.” Commissioner for International Partnerships, Jutta?Urpilainen

Spotlight: Senegal on the Verge of Achieving Maturity Level 3 for the Regulation of Medicines

?? ?? ??The continent of Africa has achieved a significant milestone in its healthcare regulatory landscape, with five of its regulatory agencies—South Africa, Ghana, Nigeria, Tanzania, and Egypt—operating at the World Health Organization's (WHO) Maturity Level 3 (ML3). Now, the Agence sénégalaise de Réglementation Pharmaceutique (ARP) is on the verge of reaching maturity level 3 as well and this could happen in a matter of weeks.

When it succeeds, Senegal will become the first French-speaking African country to reach high level of maturity to join Ghana, South Africa, Nigeria, Egypt and Tanzania to become the 6th country on the continent to have a level 3 maturity regulatory agency for medicines.

The Significance of Maturity Level 3 for Senegal and Africa

To put this into perspective, India's medicines regulator, CDSCO is not a level 3 authority for medicines and Senegal is likely to surpass India as a stable well functioning regulatory authority. That is no small feat for the relatively smaller nation which is also home to one of the world's few yellow fever vaccine manufacturing facilities and is also investing into pharmaceutical production with recent major investment into one of its domestic manufacturers Duopharm Senegal by the IFC - International Finance Corporation .

The IFC will support Duopharm Senegal develop the skills and expertise it needs in different areas to become successful. These include market research, factory design, and global visibility on good drug manufacturing practices.??The maturation of Agence sénégalaise de Réglementation Pharmaceutique to level 3 maturity will be a major step towards the oversight of manufacturing facilities like this to produce medicines that the continent of Africa can have confidence in.

This significance of level 3 maturity is that it signifies a regulatory system that is well-functioning and capable of effectively overseing the quality, safety, and efficacy of medical products . The significance of African countries achieving ML3 status cannot be overstated. It marks a crucial advancement in the continent's ability to control substandard and falsified medicines, which pose a grave threat to public health. Substandard and falsified medicines not only undermine patient trust in healthcare systems but can also lead to treatment failure, drug resistance, and even death. By achieving ML3, regulatory agencies in Africa demonstrate their commitment to upholding high standards in medicine regulation, thereby ensuring that the medicines available to the population are safe, effective, and of good quality.

A Maturing Regulatory Environment: Ket to Patient Safety in Africa

The attainment of ML3 status by additional African countries will enhance the continent's collective capability to combat the proliferation of substandard and falsified medicines. It enables regulatory agencies to implement more rigorous inspection procedures, enhance surveillance and monitoring activities, and foster greater collaboration both within the continent and internationally. This level of regulatory maturity also facilitates faster and more efficient market access for new and essential medicines, thereby improving healthcare outcomes.

Furthermore, more countries achieving ML3 status enhances the ability of African countries to participate in global health governance, contributing to international standards and practices. It signals to international partners and investors the reliability and effectiveness of the continent's regulatory systems, potentially attracting more investments in healthcare infrastructure and pharmaceutical manufacturing. This, in turn, can lead to increased local production of medicines, reduced reliance on imports, and ultimately, greater healthcare sovereignty.

How the UK Government Decision not to Invest in Training More Doctors will Impact Africa

The UK government has paused its plan to double the number of doctors trained in England by 2031, a decision that has caused widespread dismay across the NHS, medical schools, and universities. Despite initial promises to increase medical school places from 7,500 to 15,000 to address workforce shortages and geographic inequities, a leaked letter reveals only 350 additional places will be funded in 2025-26, much less than expected. This delay contrasts sharply with the urgent need for more doctors, evidenced by 8,858 current vacancies and a strikingly low doctor-to-population ratio in England compared to other countries.

Labour criticizes the government's slow progress, emphasizing the NHS crisis and the high cost of agency staff due to staffing shortages. For African countries, this development has multifaceted implications. Many African nations already face significant healthcare worker shortages, exacerbated by the migration of health professionals to Western countries in search of better opportunities. The UK's decision to stall the increase in trained doctors could potentially worsen this "brain drain" effect if it leads to increased recruitment from countries with already strained healthcare systems which it will inevitably do to plug the gap.

This could further deplete Africa's healthcare resources, impacting the delivery of essential health services and the overall health outcomes of the population. Moreover, the delay in expanding the UK's medical workforce might encourage other Western countries to fill their gaps by attracting more health workers from abroad, including Africa, thereby intensifying the challenges these countries face in retaining their healthcare professionals. The UK government backtrack has particularly affected areas with severe doctor shortages, like Yorkshire and the north-east of England, which will receive just 52 extra places.

University leaders express disappointment, highlighting the impact on local medical workforce expansion and efforts to address regional inequalities. The government suggests a "larger scale expansion" from 2026-27 but offers no funding guarantees for future intakes.

Behind the Scenes at the EU-AU Summit

African Nations Take Action Against Johnson & Johnson's Talcum Powder Over Safety Concerns

The African Center for Corrective and Preventive Action (ACCPA) initiated legal proceedings at the High Court of Kenya, seeking a judicial order to halt 强生公司 Services INC and its local subsidiary, 强生公司 Ltd, from continuing the production, sale, and distribution of 强生公司 Baby Powder within Kenya. This legal move underscores growing safety concerns surrounding the product.

Simultaneously, the Rwanda FDA (Rwanda Food and Drug Authority) also issued a comprehensive recall of all talcum-based Johnson’s baby powder products. This decision was influenced by similar recalls in various countries, reflecting a global reassessment of the product's safety. The Rwanda FDA action came after a notification from the manufacturer stating a strategic shift at the global level to discontinue talcum-based baby powders in favor of a cornstarch-based product line, marking a significant pivot in their product strategy.

Further emphasizing the seriousness of the issue, the Rwanda FDA mandated all importers, distributors, and retailers dealing in cosmetic products to immediately cease the importation and distribution of the talcum-based product. Importers were required to report detailed inventory information, including quantities imported, distributed, returned, and remaining stock of talcum-based Johnson's baby powder within ten days following the recall announcement. This directive aimed to ensure comprehensive compliance and safeguard public health, with the Rwanda FDA also advising the public to discontinue the use of the talcum-based product.

This series of measures highlights the growing concerns across African countries regarding the safety of talcum powder. The product, which has been the focus of numerous lawsuits in the United States due to allegations of harm to consumer health, is now facing increased scrutiny and regulatory action on the African continent.

Enhancing Medicines Manufacturing Oversight: Insights from South Africa and Zimbabwe

According to Wayne Muller, "We do not have systems in place to control the quality of ingredients used in making medicines. We focus a lot on the active ingredients but less on the excipients." Wayne Muller, a leading African regulatory expert for medicines.

Key Points:

1. Regulatory Gaps in Medicine Quality Control: Wayne Muller highlights a significant oversight in the regulatory framework for drug manufacturing, emphasizing the need for a holistic approach that includes both active ingredients and excipients to ensure comprehensive quality control.
2. Global Call for Regulatory Improvement: There is a pressing need for countries, especially those in the medicine production forefront like India and China, to enhance their regulatory understanding and practices, with a focus on preventing contamination and ensuring the integrity of all medicine components during manufactuering.
3. The Critical Role of Training and Inspection: The podcast underscores the importance of training inspectorates to conduct more effective inspections of medicine manufacturing facilities. This involves a shift towards a more risk-based assessment that accounts for potential adulteration of both active ingredients and excipients, and aligns site production realities with regulatory dossier expectations.

Tackling Counterfeit Medicines in Africa: Insights from Farai Masekela

Farai Masekela, the Chairperson of the African Medicines Regulatory Harmonization (AMRH) Initiative's Technical Committee for Essential Medical Product Evaluation speaking with Wayne Muller and Lenias Hwenda on Utano Podcast: Let's Talk about Health in Africa.

Key Takeaways:

1. Systemic Challenges with Counterfeits: Farai Masekela emphasizes the widespread issue of counterfeit medical products across Africa, underscoring the urgent need for robust systems to ensure that approved medicines meet quality standards, starting from the manufacturing process.
2. Vulnerability of Markets with Weak Controls: Markets with less stringent measures for detecting and preventing counterfeit medicines are more susceptible to these threats, highlighting the need for stronger regulatory frameworks.
3. Enhanced Import/Export Controls: There's a call for rigorous testing of medical products at African entry points to better detect adulterated items, suggesting a continent-wide strategy to safeguard public health.
4. Collaborative Efforts for Quality Assurance: Under initiatives like the AMRH and the African Medicines Agency, African nations are encouraged to collaborate in ensuring that medicines entering any national market are of high quality and safe for consumption.

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