Abdelmonem Fawzi
Asaying by Scottish essayist, historian and philosopher, Thomas Carlyle, goes as “He who has health has hope, and he who has hope, has everything”.
This is why most people say a man who is in good physical and mental health has to appreciate the world to the fullest. The same person can solve all problems with ease.
As a field, health encapsulates Africa’s development challenges.
Every year, the lack of access to basic healthcare, mostly caused by low funding, contributes to millions of deaths, untold suffering and harrowing health tragedies on the continent.
According to the World Health Organisation (WHO), Africa carries 25% of the world’s disease burden, even as the continent’s share of global health expenditure is less than 1%.
Worse still, Africa manufactures only a fraction — less than 2%— of the medicines consumed in it, the WHO says.
In 2001, African countries agreed to allocate at least 15% of their budgets to healthcare. Yet most of these countries have not met this commitment.
It takes a lot of ingenuity to turn the ship around. For example, Rwanda has managed to set up a national health insurance scheme which now covers 91% of all Rwandans (Rwanda is Africa’s miracle, one that I will write about soon).
This stands in sharp contrast with other African countries where medical insurance schemes cover, on average, less than 8% of the population, according to the WHO.
Africa’s key challenge, however, lies in the need for confronting counterfeit medicines. Tens of thousands of people die on the continent annually from these medicines.
Selling fake medicines is the world’s most lucrative trade, with a global market worth roughly $200 billion, according to the WHO.
Africa accounts for around 42% of this market due in part to the continent’s porous borders, weak legislation and poor healthcare.
Nevertheless, we have good news: the African Union Development Agency (AUDA-NEPAD) has developed, along with key stakeholders, the AU Model Law on Medical Products Regulation (AU Model Law) to ensure the promotion of innovation and access to new health technologies.
The goal of this non-prescriptive model legislation is to streamline regulatory systems and facilitate the overall regional harmonisation process.
The history of the AU Model Law was developed through the AMRH initiative platform and endorsed by the Pan African Parliament Committee on Health, Labour and Social Affairs.
In November 2015, the AU Technical Committee on Justice and Legal Affairs approved the AU Model Law which is available for use as a starting point for the establishment of regulatory bodies and providing support for legislation in AU Member States.
In January 2016, the AU Model Law was then endorsed at the AU Summit by the AU Heads of State and Government.
Following endorsement, the following steps taken were to engage with regional economic communities, regional organizations and member states to update and enact regional legal frameworks and national laws on the regulation of medical products.
The objective of the AU Model Law is to increase collaboration across countries and ensure that medical products that hold promise are developed, tested, and scaled up for the improvement of health impacts.
The AU Model Law also supports the AU’s desire to promote local pharmaceutical production, with the goal of protecting public health and pushing economic growth forward, as well as supporting continental efforts to advocate for, and catalyse access to novel medical products for patients in need.
Through the AU Model Law domestication process, a country can adapt the law so that it is consistent with its constitutional principles and legal system, as well as amend or repeal any inconsistent national laws in force.
The AU Model Law is intended to serve as a template for AU Member States to adopt best practices in medical products regulation into their national laws.
The African Medicines Agency (AMA) Treaty, adopted in 2019, was mandated to enhance the approval process for safe and high-quality medical products by facilitating collaboration and reliance mechanisms.
It provides regulatory and scientific guidance for priority diseases, emerging diseases, and traditional medicines.
The AMA aims to harmonise regulatory frameworks across Africa, promote local production, stimulate innovation, and ensure the efficient introduction of innovations to the African market.
It builds upon the African Medicines Regulatory Harmonisation initiative and is the second specialised health agency of the African Union, after the Africa Centres for Disease Control and Prevention.
“The AMA will ensure regulatory convergence and reliance, which promotes faster introduction of new and advanced medical products into the market, hence quicker access by patients at a lower cost,” Johnpaul Omollo, the regional representative of global health organisation, PATH, said.
The problem is that only 29 out of 55 African countries have ratified the treaty and deposited their written instruments of ratification, which provide formal evidence of consent to be bound by the treaty and may include reservations and declarations, as of March 2024.
This slow process delays the intention to harmonise and strengthen regulatory systems at a continental level.
Besides, providing technical support to countries, PATH has also worked with AUDA-NEPAD to develop a training manual in the legal steps for the AMA Treaty ratification and the AU Model Law, as well as communication packets with information defining the role of the AMA and its relationship with the NRAs.
PATH also supported civil society groups, the AMA advocates, and NRAs, among other stakeholders, in engagements to understand the process of treaty ratification.
It remains to be said that we should ratify the treaty. This will help us build a sustainable healthcare system on our continent.
