PATH Report: Uniform Regulatory Review For New Medicines In Eastern, Southern Africa Could Save 23,000 Lives Annually

A new report released today by PATH, the international global health NGO, shows that some 23,000 lives a year could be saved through more harmonised regulatory processes for health products in southern and eastern Africa – and this just for two essential medications that were subjected to the review.

The new report, “Making the case: how regulatory harmonisation can save lives in Africa” aims to make real an otherwise abstract policy issue—regulatory harmonisation.

The report modeled the results of regulatory harmonisation for just two new emerging medicines, demonstrating that by accelerating the timeline for registration and scale-up by just two years, more than 23,000 lives could be saved in the six countries of the East Africa Community (Burundi, Kenya, Rwanda, South Sudan, Tanzania and Uganda), as well as the five “Zazibona” countries of southern Africa (Botswana, Namibia, South Africa, Zambia and Zimbabwe).

The PATH findings demonstrate the even wider potential impact—measured in lives saved—that efforts to harmonise regulatory approvals for health products across all countries in Africa could have potentially.

Currently, since regulatory processes differ from country to country, researchers and manufacturers must navigate multiple regulatory systems to register the same health product in more than one country. To address these challenges, a number of efforts are underway in sub-Saharan Africa to harmonise regulatory activities, but progress is slow. The report calls for political commitments to be paired with a commitment to providing resources.

In January 2016, the African Union Heads of State adopted the Model Law on Medical Products Regulation, meant to guide national governments and regional economic communities (RECs) to harmonise regulatory systems and increase collaboration across countries. However, progress on harmonisation remains incremental.

In the PATH analysis, two drugs relevant to maternal, newborn and child health, and in the late-stage clinical stage pipeline (Phase III or more) were reviewed, to see how accelerating the regulatory process might have lifesaving effects. The products selected were:

  • Heat-stable carbetocin, which can be used to stop severe bleeding after childbirth, potentially in the place of oxytocin, which is not regularly available to women in remote areas, due to the complex storage and handling conditions;
  • Amoxicillin dispersible tablets to treat pneumonia, which is the leading infectious cause of death in children under five globally, with nearly a million deaths a year. Dispersible tablets are the World Health Organization’s recommended treatment for childhood pneumonia and have several advantages over other formulations of amoxicillin, being less expensive and easier to deliver remotely.

The assessment of lives that could potentially be saved by more rapid scale up of access to the two drugs, was performed using the Lives Saved Tool (LiST), developed by the Johns Hopkins Bloomberg School of Public Health. The study estimated the potential health impact of accelerated access on lives saved through a harmonised regulatory approach, as compared to regulatory reviews conducted country by country. The modelling results demonstrate that accelerating approval and launch timing by one or two years due to regulatory harmonisation can have substantial impact on saving lives.


Image Credits: PATH.

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