Mr Kwaku Agyeman-Manu, the Minister of Health, has called for stronger collaboration and networking among African countries, to sustain the momentum for the harmonisation of the processes for medicine registration and regulation to safeguard the health of the people.
This, he said, would save the continent of the challenges of having to deal with cross-border transfer of fake medicines and other substandard pharmaceutical products, which have huge negative impacts on health systems as well as on patients.
Speaking at the third Biennial Scientific Conference on Medical Products Regulations in Africa on Monday in Accra, Mr Agyemang-Manu said although significant strides had been made over the years to enhance and modernise the regulation of pharmaceutical manufacturing and product quality across the world, the drug registration system in Africa remained complex and varied.
The two-day conference being organised by international stakeholders with support from the Government of Ghana, the West African Health Organisation (WAHO) and the New Partnership for Africa’s Development (NEPAD) is on the theme: “Sustaining the Momentum for Regulatory Harmonisation in Africa”.
The delegates attending the conference include key stakeholders made up of regulators, policymakers, academia, the scientific community, private sector and civil society from across Africa.
The participants are discussing and contributing towards the future of medicine regulation and harmonisation in Africa, which affects both industrial and regulatory aspects, as well as the aspirations of civil society and its wish to benefit from best practice and best medicine.
While welcoming the delegates to the conference, Mr Agyemang-Manu noted that the African Medicines Regulatory Harmonization (AMRH) initiative, currently being run by the countries had some ongoing pilot projects aimed at improving national regulatory processes and that when that was completed, it would go a long way towards meeting the goal of regulatory harmonization and convergence.
The Minister, however said in the absence of that, each country was presently invoking their own separate audit and assessment processes, and many of them dealt with regulatory issues independently, which meant that manufacturers had to make formal registrations in every country, and each country’s regulatory agency would assess whether the drug was right for its market or not.
Mr Agyeman-Manu said this, almost guarantees the fact that Africans would be the last to benefit from new drugs launched onto the international market.
He said: “what is needed is a single agency, which could do all these work once, rather the current duplication, and then allow applicants and individual countries to benefit from it without having to reinvent the wheel”.
He emphasized that the harmonisation of the processes for medicine regulation had been on the drawing table for far too long and that time was overdue, for countries to unite their resources and strengthen their networking systems to make that dream a reality.
The Sector Minister said there was also the need to double efforts at building strong systems that would guarantee the quality and safety of all pharmaceutical products, while reducing duplication of functions, and also minimising the timing for registration processes.
Dr Margaret Agama-Anyetei, the Head Division, Health, Nutrition and Population at the African Union Commission, said the conference would serve as a platform for stakeholders to brainstorm on the role of ethical and regulatory approval of clinical trials of new medicines, as well as neglected tropical diseases.
She said African leaders and Heads of States have agreed to establish the proposed continental body known as the African Medicines Agency by 2018, to regulate medicines and strengthen systems along the value chain to protect the health of the people.
Mrs Delese Mimi Darko, Chief Executive Officer of the Food and Drugs Authority, said “we are working as individual countries to harmonise our systems, our procedures, our processes and we have already started”.
She explained that the member countries in the ECOWAS sub-region had already started working towards the harmonisation processes, citing Ghana, Nigeria, Sierra Leone, Liberia and The Gambia, as among the countries to harmonise the way things were done.