Imagine being a chronic non-communicable disease (diabetes and hypertension) patient in Africa. Having to constantly visit local health centres for follow-up. Most of the times going 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 the many dependents in the family your health deteriorates, as the above conditions start to affect your eyesight and harm your kidneys. Before long you find yourself requiring more expensive interventions including potential kidney transplant. If very lucky you survive a few more years but with bad quality of life requiring more care from your family members who by now stop being economically productive to take care of you.
This unfortunately has been the story of many here in Africa. This picture is replicated in most disease areas. Despite the advances we see in technology, the topic of access to quality healthcare has remained a pipe dream to many. Lack of timely access to good quality medication has been a leading contributor to the above bad health outcomes.
Poor healthcare infrastructure, lack of reimbursement systems for healthcare costs, inadequate funding of healthcare are some of the factors that continue to worsen this situation.
Silent pandemic
However, one other factor that has been a silent pandemic in Africa has been the weak regulatory systems for health products which have led at times to poor quality products in the market causing harm to patients in countries that have very weak/non-existent regulatory systems or delayed access to medical products in the countries that tend to add unnecessary administrative burden to the medicines approval processes.
These diverse regulatory systems at different levels of maturity have over time proved too fragmented and inefficient for any good to the patients. It has been the case that once a new medication is launched in the developed countries, it only became available to African patients 4- 7 years later, a delay that is mostly attributable to slow regulatory processes among other factors like lack of appetite by companies to launch products in Africa – due at times to unpredictable regulatory environment.
Fortunately, the situation has greatly improved over the last five plus years, perhaps also driven by recent public health occurrences including the Covid-19 pandemic which forced stakeholders to think and act differently.
We have witnessed various initiatives to bridge the gaps and strengthen the medicines regulatory systems in the continent — a welcome relieve to patients in Africa. An example is the acceleration of the Africa Medicines Regulatory Harmonization initiative outcomes. In East Africa, the initiative has led to a significant reduction in regulatory timelines for new drug application authorisations from a high of up to 36 months to a low of 6-9 months. Drastically accelerating access of life-saving medications to patients.
We, the pharmaceutical industry in Africa, have been an active participant — through various trade associations — in not only shaping this regulatory environment but also utilising it for new products by our member companies. The success of which we have witnessed with recent approvals of products spread across different therapeutic categories including but not limited to cancer therapies, cardiovascular drugs among others.
Approvals which have set the industry up for future success in not only availing these life-saving medications to the patients but also promising a thriving and sustainable business here in East Africa. This is not the only piece of work that is required to unleash the full potential of Africa healthcare. A lot still will be required of stakeholders.
We are eagerly following up on the establishment of Africa Medicines Agency which will intersect with other continental bodies. For now, we can rest easy knowing that we have offered our vital contribution to this evolutionary story of Africa Medicines Regulatory Systems and advancing access agenda for Africa patients.
Dr Mwangi is a Pharmaceutical Industry Expert & Commentator
Source link : https://nation.africa/kenya/blogs-opinion/blogs/-weak-regulatory-systems-delay-access-to-medicines-in-africa-4784108
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Publish date : 2024-10-02 21:00:00
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