Africa moves to curtail counterfeit medicines
By Lovemore Ranga Mataire
Recently in Victoria Falls The African Union in coordination with the World Health Organisation and the New Partnership for Africa’s Development (Nepad) is setting up an African Medicine Agency (AMA), a super regulatory body that will ensure the prevention of the circulation and administering of counterfeit drugs.
In an interview on the sidelines of the67th WHO Regional Committee for Africa Summit in Victoria Falls last week, African Union Divisional Head for Health, Nutrition and Population in the Department of Social Affairs, Dr Margaret Agma-Anyetei said the regulatory body would be operational next year. “The African Region Commission in partnership with Nepad agency and WHO have been tasked by a taskforce which was established by the Ministers of Health following their endorsement to set up an African Medicines Agency by 2018 on the continent,” said Dr Agma-Anyetei.
She said the idea behind the setting of the agency was to ensure that the continent no longer has substandard or fake drugs in circulation. Dr Agama-Anyetei said it would be a super regulatory body which would be formed by natural regulators from all member states. At least 15 member countries have to ratify the treaty for its establishment to ensure that the body becomes operational by 2018.
“We have counterfeit and fake medicines which are produced on the continent and which are also imported into the continent. And you can imagine the health implications for our people who think that the medicine is genuine yet it compromises their health,” Dr Agama-Anyetei. She said most countries already had local regulatory bodies which must be supported by the new super regulatory body Dr Agama-Anyetei said the continental body would tap much from Zimbabwe’s experience which already has an operational medicines control body.
An African Medicines Agency, the continent’s first super-regulator, could be approved as soon as next year The African Medicines Agency (AMA)’s remit would be to speed up the availability of affordable medicines that are needed on the continent and reduce dangerous, spurious, substandard and falsified medicines. It is modelled on the workings of the European medicines agency (EMA), which carries out scientific evaluations and monitors the safety of medicines within 28 EU countries plus nations of the European Economic Area. But while the EMA serves a market of over 500 million people living in the EU, the AMA will work on behalf of 54 member states, serving 1.13 billion people. Like EMA, AMA will not replace national regulators, which would continue their work to register drugs that are safe and efficacious for their own populations.
AMA will instead provide regulatory guidance and scientific opinions on complex molecules, traditional medicines and emerging issues, such as pandemics. It will monitor adverse effects of medicines and vaccines once they reach the market. The super-regulatory body would also conduct inspections of manufacturing facilities to check that drugs are being manufactured at good international manufacturing quality standards. It would also help to evaluate and coordinate products for public health emergencies, such as Ebola. The new super-regulatory body will contribute to establishing an enabling environment for the development of the pharmaceutical industry and lead to better coordination of different partners and stakeholders