magine being a patient with a chronic non-communicable disease (such as diabetes or hypertension) in Africa. You must constantly visit local health centers for follow-up, and most of the time you go home without the medications required to manage your blood sugar and blood pressure. Over time, as you age and with little money to spare (especially with so many dependents in the family), your health deteriorates, as the above conditions start to dim your eyesight and harm your kidneys. Before long, you find yourself requiring more expensive interventions, potentially including a kidney transplant. If you are very lucky, you can survive a few more years. But your poor quality of life requires more and more care from your family members, who must now stop caring for themselves, by being economically productive, to take care of you.

This unfortunately is the story of many people here in Africa and is replicated across most disease areas. Despite the advances we see in technology, access to quality healthcare has remained a pipe dream to many in Africa. Lack of timely access to good-quality medication has been a leading contributor to such bad health outcomes. Poor healthcare infrastructure, lack of reimbursement systems for healthcare costs, and inadequate funding of healthcare are other factors that continue to worsen this situation.

One other negative factor, like a silent pandemic in Africa, has been weak regulatory systems for health products, and diverse regulatory systems at different levels of maturity which prove too fragmented and inefficient to do patients in their jurisdictions any good. Poor-quality medicines cause harm to patients in countries with weak or even nonexistent regulatory systems, while unnecessary administrative complications delay regulatory approval and patient access to quality products in others.

We have seen, for example, a new medication for management of cardiovascular disease complications launched in the EU and US only available to patients in select African countries more than five (5) and in some cases as many as nine (9) years later. While this and other delays are mostly attributable to slow regulatory processes, other factors include a lack of business appetite to launch new medicines in Africa due at times to its unpredictable regulatory environment.

Fortunately, this situation in Africa has greatly improved over the past five-plus years, driven perhaps by recent public health occurrences which forced various stakeholders to think and act differently, including but not limited to the pandemic. We have seen various initiatives to bridge the gaps and strengthen the medicines regulatory systems in the continent, bringing welcome relief to patients in Africa.

One example has been the acceleration of the African Medicines Regulatory Harmonization (AMRH) initiative outcomes. In East Africa, this initiative has led to a significant reduction in regulatory timelines for new drug application authorizations from a high of up to 36 months to a low of 6-9 months, drastically accelerating patient access to lifesaving medications.

Through various trade associations including the Kenya Association of Pharmaceutical Industry (KAPI) and the Africa Regulatory Network (ARN) under IFPMA, the pharmaceutical industry in Africa has been an active participant in not only reshaping this regulatory environment but also utilizing it to accelerate patient access to new products from association member companies. We have witnessed the recent success of product approvals spread across different therapeutic categories including but not limited to cancer therapies and cardiovascular drugs. These approvals position industry for future success in not only making lifesaving medications available to patients but for the promise of a thriving and sustainable pharmaceutical business environment in East Africa.

All stakeholders understand that this is not the only piece of work required to unleash the full potential of Africa healthcare. Much work will still be required of industry and all other stakeholders. We are eagerly following the establishment of the African Medicines Agency, which will intersect with other continental bodies (i.e., the African Continental Free Trade Area [AfCFTA] and Africa Centres for Disease Control and Prevention [CDC]) to shape the healthcare environment in Africa by supporting emerging trends in pooled procurement, local manufacturing, and overcoming the hurdles encountered so far during cross-border movement of pharmaceutical products.

But for now, industry can find satisfaction in knowing that we have offered our vital contribution to this evolutionary story of medicine regulatory systems and advancing access for patients in Africa.

Learn more about this topic at DIA’s Middle East and North Africa Conference (MENA), November 2024 in Cairo, Egypt.