Saturday, October 1 2022

While safe and effective Covid-19 vaccines and treatments have been developed at record speed and unprecedented volumes, they have still not reached the vast majority of Africans who need them. After two years of this pandemic, African families are rightly angry and frustrated to be at the bottom of the global pack for these life-saving products.

Covid-19 has made it clear that African nations must work together to build national capacity to manufacture medical products and medical supplies.

How to achieve this goal

To do this, Africa needs a strong regulatory framework that encourages the expansion of domestic development of medical products, ensures the quality of medicines manufactured and sold here, builds public and industry confidence in our systems pharmaceutical and healthcare industries and contributes to the economic health of the continent by supporting manufacturing jobs and eventually creating export markets for these quality products.

The AU recently took a big step forward in this regard after at least 15 Member States ratified the treaty establishing the African Medicines Agency (AMA), a new continent-wide regulator that will complement national and regional efforts to protect and promote public health in Africa. Africa.

Of course, the need for strict regulation of medical products did not start with Covid-19. Insufficient access to quality, safe, effective and affordable medical products in Africa has posed public health challenges for decades. A 2017 WHO analysis found that 42% of all reports of fake medicines in the previous four years came from Africa, and other studies suggest that up to 70% of medicines in some African countries are fake.

These substandard and falsified products are a threat to Africa. Research estimates that more than 100,000 children in sub-Saharan Africa die each year from poor quality antimalarial drugs, and that 79,000 to 116,000 more children die of pneumonia each year for the same reason – a terrible loss to understand.

Several case studies have reported that hospitalized children died unnecessarily from infectious diseases because the drugs contained a small fraction of the claimed active ingredient. Effective market regulation is essential here: poorly regulated markets prevent access to quality medicines because producers are unwilling and unable to compete with substandard and falsified alternatives.

Even when medical products are of high quality, the lack of an effective regulatory ecosystem often delays their introduction into African communities. Historically, registration requirements for new drugs can vary widely from country to country, increasing the time, money, and effort required to register the same drug in different countries. A 2012 study found that it took an average of four to seven years to register a new product in sub-Saharan Africa, compared to just 6 to 12 months in high-income regions.

As a result, many Africans have access to fewer quality medicines and medical tools than those in wealthier countries, yet must pay higher prices due to shortages and lack of competition. The lack of clear, effective, science-based regulatory pathways also discourages pharmaceutical companies from seeking approvals, even though their innovations are often the most needed here. This has had considerable human and economic costs for African communities.

That said, things have changed for the better. Over the past ten years, under the leadership of the African Medicines Regulatory Harmonization Initiative of the AU Development Agency, much has been achieved at regional and national levels to harmonize technical standards and optimize regulatory processes on the continent. According to a PLOS Medicine report on the East African Community, registration times fell from 24-36 months in 2012 to 8-14 months in 2017.

The AMA was created to build on these advances and complement national and regional efforts to develop a strong, predictable, accountable and effective regulatory system for health products. Rather than having to negotiate 55 times, drug and medical device companies would be able to manage an evaluation process and obtain a recommendation, which could be used by all African countries to authorize the product at the level national.

By working with WADA to align healthcare procedures, African governments will speed up the delivery of drugs and medicines, ensure their high quality and reduce costs by reducing redundancies and increasing competition. Equally important, a strong African regulatory regime will build public confidence in medicines made on the continent, eliminate counterfeit and counterfeit products, and create the conditions for strengthening the domestic medical manufacturing sector necessary for future pandemics and epidemics.

At the end of the line

That is why, as part of the EU-AU summit this week, a group of international donors, including the Bill & Melinda Gates Foundation and the European Commission, responded to the AU’s call by announcing funding for more than 100 million euros. This will support WADA and other African regulatory initiatives, strengthen Africa’s regulatory capacity, and improve access to affordable, quality medicines and vaccines across the continent.

This financial assistance is vital. But to succeed in their essential mission of improving Africa’s regulatory framework, WADA and its sister regulators will also need the support and collaboration of African governments and industries. When Africa can ensure that all medical products here, whether produced locally or imported, meet international standards for safety, quality and efficacy, our domestic health and manufacturing sectors will thrive and more African citizens will be able to obtain life-saving vaccines, medicines and medicines. medical supplies when they need them.

Dr Ibrahim Assane Mayaki is the Director General of the African Union Development Agency (AUDA-NEPAD) and Cheikh Oumar Seydi is the Africa Director of the Bill & Melinda Gates Foundation


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