Dec 28, 2015 | News

NEPAD leads discussions on a critical law to regulate good quality and affordable medicine in Africa

One of the biggest policy decisions on health and medicine regulation in Africa is under discussion in Dar es Salaam, Tanzania, led by the NEPAD Agency.

NEPAD in collaboration with African Union Commission (AUC) and Pan-African Parliament (PAP) have spearheaded the development of the AU Model Law aimed at assisting RECs and African countries to enact or review their national laws and subsequently harmonize them with regional policies.

East African Community (EAC) stakeholders consultation meeting on the Model Law on Medical Products Regulation and Harmonization is a culmination of months of meetings, deliberations and drafting. The technical working group is composed of diverse experts from the African Union; UN Development Programme (UNDP); the World Bank; UNAIDs; World Health Organisation; the Bill and Melinda Gates Foundation.

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Mrs Margareth Ndomondo-Sigonda, Pharmaceutical Coordinator for the AMRH Programme with Dr Donald Mmbando, Chief Medical Officer at Tanzania’s Ministry of Health; Professor Aggrey Ambali Head of the NEPAD Science, Technology and Innovation Hub (NSTIH 

The rationale behind the Model Law was inspired by the lack of comprehensive medicines legislation in many African countries. A NEPAD analysis revealed numerous gaps in legal frameworks. While some countries have legislation in line with the core elements recommended by the World Health Organization (WHO), others do not have medicines regulatory laws in place. Today’s meeting has brought together experts from international organisations, funding partners as well as representatives from the pharmaceutical industry.

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                                                                  Meeting participants and NEPAD staff

The Model Law is envisioned to contribute to increased access to safe, quality and affordable medical products and technologies to people in Africa. Through its enforcement, effective medicines regulation will promote and protect public health by ensuring that drugs are of the required quality, safety and that they are properly manufactured, stored, distributed and dispensed. Better regulation will also ensure that health professionals and patients have the necessary information to enable them to use medicines rationally, as well as  detect illegal manufacturing and trade of drugs.

Given the need for a focused approach in regulation of medicines, the EAC region was selected as a single region to implement NEPAD’s African Medicines Regulatory Harmonization Programme ( AMRH) which has worked with the Government of Tanzanian to host today’s consultative meeting.

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Dr Bala Saratou-Boukari Sabo of the Pan African Parliament 

Dr Bala Saratou-Boukari Sabo Chair of the Committee on Health, Labour and Social Affairs at the Pan-African Parliament said that the continental legislative body will play an important role in ensuring that the Law is well understood among Africa’s various constituencies.

Professor Aggrey Ambali said “The purpose of this law is not for us to prescribe what member states should do. That is why we will go throughout the Continent to get input to ensure that this law is widely consultative and owned by Africans,” he said.

The meeting received a further boost from the World Bank’s Senior Operations Officer Mr Apollo Muhairwe (below)who pledged a commitment to mobilise resources to ensure the effective impact of the sensitisation and implementing of the Law.

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Mr Apollo Muhairwe of the World Bank

Several milestones have been achieved  in medicine regulations in the East African community including standard guidelines which are now being followed and institutional strengthening and capacity development in organisations and departments dealing with medicines and drugs.

The Law will be presented to ministries of health, justice and other stakeholders before submission to the African Union Commission. The purpose is to domesticate the Law so that African countries own and put it into practise. The vision of the AU is to create a single medicines regulatory authority in Africa.

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Delegates to the consultative meeting on Model Law on Medical Products Regulation and Harmonization