Africa: Regulation of Medicines in Africa

Kampala, Uganda — Africa’s limited pharmaceutical industry, high costs of raw materials, and dependence on imported medicines have long hampered citizens’ access to the medicines they need.

The challenges the continent faces are daunting. They include poor supply chain systems, lack of government investment in the pharmaceutical sector, unfavourable manufacturing conditions, limited health workforce, lack of sustainable health financing mechanisms or infrastructure and technical know-how, low investment in research and development, and circulation of fake medicines.

Rectifying these problems is where the African Medicines Regulatory Harmonisation (AMRH) programme comes in. Five years after the inaugural AMRH Week in Kigali, Rwanda in 2018, experts gathered in Ghana this month to discuss the AMRH’s potential to address these gaps, drive change for the African continent, achieve Universal Health Coverage, and galvanize resources to meet the continent’s health needs.

The week-long conference brought together African leaders and policymakers, members of the AMRH steering committee and technical committees, regional economic communities, the AMRH Partnership Platform and other partners and stakeholders.

Safe medicine

“At its core, the mission of the AMRH is to facilitate the harmonisation of medicine regulation and to create the desired outcome of access to quality, safe, efficacious and affordable medicine for the African continent,” said Mimi Darko, CEO of Ghana’s Food and Drugs Authority. “There are many reasons this is critical but in recent times nothing has brought this home but the ravages of the COVID-19 pandemic.”

COVID-19, she said, helped to shift the attention of many African countries from the short-term, urgent needs of their populations to building long-term resilience for the continent.

“It is no surprise that vaccine production is at the centre of initiatives culminating in the partnership for the African Vaccine Manufacturing, the first ever kind of collaboration for Africa,” added Darko.

This year’s focus was on regulatory processes, harmonisation and strengthening National Regulatory Authorities (NRAs) across Africa and other low- and middle-income countries facing challenges in ensuring access to quality-assured medical devices, in-vitro diagnostics, personal protective equipment (PPEs) and other health products.

Emer Cooke, executive director of the European Medicines Agency (EMA), said it was critical for Africa to develop its medicines agency to gain control over regulatory and price mechanisms for the continent.

“The EMA’s support for the region during the pandemic was enormous through the EU-AU partnerships and the Africa CDC. But what is critical now is the efforts to establish the African medicine agency initiative,” Cooke said. “This will help coordinate, facilitate and harmonise access to medicine for disease cohorts in the region.”

The EMA pledged to give the AMRH steering committee technical support to address some of the challenges highlighted.

Slow pace of ratifying AMA

Dr David Mukanga, deputy director of African regulatory systems at the Gates Foundation and chairperson of the AMRH Partnership Platform, said member states’ delays in ratifying the AMA treaty was the main challenge so far.

“The rate at which we’re moving as a continent in signing and ratifying the AMA treaty is of great concern. This is because ensuring that medicine and medical products are available for everyone is a huge task and we need to move faster in professing solutions by turning our ideas into products for our people and the delays are not helping” he stressed.

In the long term, Mukanga said leveraging the scarce resources of the continent to create the AMA would help to will deliver universal health coverage.

Dr Matshidiso Moeti, the World Health Organisations’ (WHO) Africa regional director, said in a statement to the meeting that substantive strides have been made by the AMRH to develop the regulatory framework to oversee pharmaceutical products, capacity building and technical support for member countries.

The AMRH strategy, which is operating in five regional and economic committees, has been able to deliver positive results by helping countries to access a robust legal framework and to harmonise regulatory requirements, standards, processes and capacity building.

However, she urged the extension of regulation from generic medicine to cover new chemical-entity vaccines, medical devices and in-vitro diagnosis, hinting that $1 million has been allocated for the AU-WHO joint work plan to establish and operationalise the AMA.

Pledging the WHO’s support for the AMA, she called for local investments in the regulatory systems and its processes to safeguard it.

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