Experts discuss medical products regulations in Africa
A meeting to harmonise policies and standards to weed out fake medicine manufacturers and medical product suppliers out of the healthcare sector on the African continent has begun in Accra.
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The two-day ‘Third Biennial Scientific Conference on Medical Products Regulation in Africa’ is also meant to review progress in regulatory systems strengthening and harmonisation in Africa for improved access to medical products and health technologies.
The conference, which brings together stakeholders, including regulators, policy makers, academia, the scientific community, private sector and civil society, is also to identify actions towards sustaining the momentum of regulatory harmonisation in Africa and facilitate a platform to share lessons and best practices in regulatory systems strengthening.
At the opening ceremony, the Minister of Health, Mr Kwaku Agyemang-Manu, observed that medical products regulation harmonisation had been on the drawing board for quite some time and the initial assessments pointed out that it took as long as four years or more to get access to global health medicinal products in certain African countries.
Capacity
Mr Agyemang-Manu blamed that situation on the absence of adequate technical capacity, adding that other factors had been resource constraints, different technical and administrative requirements between countries and failure to leverage regulatory review activities already performed by trusted and better resourced regulatory authorities.
“The idea of harmonisation was birthed out of a need to address these obstacles to access medicines in the region, to ensure quality and safety of medical products in the African region while preventing duplication of efforts by member states,” he said.
In view of this, the African Medicine Regulatory Harmonisation (AMRH) initiative was set up with a vision to reduce the overall timelines for regulatory processes throughout the life cycle of a product without compromising product safety, efficacy, good performance and quality.
Remedies
According to the Health Minister, there were some initiatives to put fake medicines and medical products producers out of business.
“Within the ECOWAS, a committee comprising representatives of all the 16 member states on Substandard and Falsified (SF) medicines and illicit trade on medicines in the sub-region has been set up and is active.
“There has also been an agreement on a Common Technical Document (CTD) for medicine registration with technical support from WHO which is in the process of being validated this year,” he said.
He rallied countries across the continent to open up a little bit more to the agenda of providing safer medicines for the citizenry while consolidating efforts at leveraging on all fronts, including language differences and differences in organisational structures and guidelines.
Clinical quality
The World Health Organisation (WHO) Representative in Ghana, Dr Owen Laws Kaluwa, observed that clinical quality care required access to quality assured medical products, including vaccines, medicines, blood and blood products.
He observed that it was efficient regulatory systems that would ensure access to quality medicines and medical devices.
Africa Medicines Agency
For her part, the Head of Social Health Affairs of the African Union Commission said the commission was on the verge of establishing the Africa Medicines Agency (AMA) to ensure regulations of medicines and medical products across the continent with the endorsement of all 54 heads of states and governments.
“A lot of medicines and medical products on the continent are fake and falsified or counterfeits. This means our citizens are using these products for health and are not getting better.
“Their diseases go on and on. They are spending a lot of money because they keep going back for the same type of medicines which are not resulting in a cure for them. This is why it is important that regulations of medical products and medicines across the continent take place,” she said.
