Harmonisation for Patient Centered Universal Health Coverage

Monday, 7 August 2017

John Mwangi, Head Middle Africa, Regulatory Affairs & Cluster Quality, Bayer East Africa explores medicine regulation harmonisation by giving us an African perspective with insight on what is to come.

Access to medicines remains a big challenge in the African continent.  Among the factors that are attributable to this situation is the current medicines regulatory systems in Africa which tends to be as diverse in form and content as there are African countries. There has over time been general developments that are geared towards ensuring availability of safe and efficacious medicines by setting up regulatory systems by Africa countries. On one hand these regulatory systems have worked progressively to safeguard the public health of the populations. However, they could also become and have become to a certain extent a hindrance to the timely access to medicines by the same populations they are targeted to support. In particular, diverse requirements developed by individual countries, have increased complexity and decreased the speed of access to the medicines without a commensurate increase in oversight due to the fragmented approach to medicines regulation. It is against this background, that the African Medicines Regulatory Harmonisation (AMRH) initiative has envisioned the formation of Africa Medicines Agency (AMA) as the ultimate solution towards more harmonised regulations across the continent that not only safeguards the public health of the populations, but does so with elimination of the current barriers that often hinder timely access to the medicines by the populace in Africa.

Typically, the manufacturers of pharmaceutical products and other health technologies have to contend with satisfying regulatory requirements ranging from good manufacturing practices, documentation and content, post approval changes, labeling updates among others. Coupled with multiple country requirements, this greatly hampers access to health products. Through the AMRH initiative the African Union through NEPAD agency is spearheading a systematic relook at all existing regulations and establishing convergence and harmonisation of requirements with view of having one health authority for the continent. This is currently driven through the regional economic blocks (RECs) as the building blocks. The ultimate result is therefore to be able to have one standard product for the continent. The benefits abound not only to the patients, but also to the industry, health agencies among other stakeholders.

The underlining principle in setting up harmonised regulations includes the realization that doing so would ensure more efficient utilization of the often scarce resources required by individual countries. In addition, this is premised on the fact that medicines regulation should follow the scientific approach as opposed to the current more administrative process. This would allow for more utilization of scientific evidence generated elsewhere arriving at regulatory decisions by the individual countries.  It is expected that this shift to a more scientific approach would be driven through such approaches as work-sharing among health authorities, reliance practices and collaboration among health authorities as well as utilization of risk based approaches to arrive at faster,  yet scientifically sound regulatory decisions.

In the end the greatest of benefits abound to the patients. Harmonised regulations will not only ensure faster access to new and often innovative health products, but in the long run will safeguard reliable and  sustainable supply chain ensuring that there is good level of predictability of medicines supply. This is expected to happen with a good level of market control and therefore high quality and safe medicines being available to the patients. Additionally, the resulting pooling of markets would trigger local and regional investments in the manufacture of essential health products in the region.Above paints a picture of a well functioning system will emerge.

However for this to really work, a lot would be expected of all involved stakeholders:

  • A lot of learning from other jurisdictions would prove to be very helpful.

  • An early and all-inclusive approach bringing all stakeholders onboard will greatly add value to AMA.

  • There will be requirements to actively look for areas of synergy and collaboration among the existing health authorities in the continent.

  • Massive utilization of information technology as one of the pillars for work sharing among regulatory agencies will also be needed.

  • Last but not least, the above and all the benefits that would accrue will not happen in the absence of political goodwill. As such the leadership at the Africa Union as well as the RECs is called up on to keep up the support of the AMRH initiative.