Weak meds regulation prompts new WHO strategy for Africa

Failures by national medicine regulatory authorities (NMRAs) are making Africa a fertile ground for poor quality and fake drugs, says the World Health Organization.

The situation has prompted the proposal of a new 10-year strategy by the WHO's Africa regional head - Dr Matshidiso Moeti - aimed at strengthening the ability of NMRAs to ensure that only "safe, good quality and effective medical products" are available in the supply chain.

Despite WHO assistance, "the majority of NMRAs do not have the full capacity to regulate medical products due to persistent shortage of human, technical, logistical and financial resources," it says.

The weak performance of NMRAs means there is "increasing circulation" of what the WHO calls substandard/spurious/falsely-labelled/falsified/counterfeit (SSFFC) medical products in the African Region, such that incidents involving these drugs are top of the leaderboard in reporting to the WHO rapid alert system.

"Surveys to date show quality failure rates of up to 28 per cent in some cases," says the strategy document.

The WHO's solution is to try to improve the governance of regulatory systems for medicinal products, bolster NMRA capacity and increase harmonization of regulations in the region.

Specifically, it wants all member states to have access to certified or prequalified quality control laboratories by 2018 - 72 per cent have this at present - and have pharmacovigilance systems in place by 2025. It is also asking all member states to regularly report individual case safety reports on medicines to its centralised drug monitoring unit.

The document also highlights several actions that member states should be engaged in:

- Taking appropriate measures to address the high cost of medicines that limits access, and the illicit entry of medicaments due to porous borders, while maintaining the integrity of the supply chain.

- Monitoring of alerts on SSFFC medical products to improve risk management for informed decision-making to strengthen market surveillance and protect public health.

- Joint prequalification of suppliers of medical products within the framework of harmonization projects of the regional economic communities (RECs).

- Reliance on certified or prequalified quality control laboratories for systematic control of authorized medical products.

- Active investigation, prosecution and confiscation of the assets of those responsible for the manufacture and distribution of SSFFC medical products.

"Functional regulatory systems ensure that medical products consistently meet international standards and are monitored from clinical evaluation to licensure and use," said Dr Moeti.

"They play a critical role in protecting people's health and strengthening health systems to contribute to universal health coverage."

The strategy was presented at the annual meeting of Health Ministers from the WHO African region which was held in Addis Ababa this week. Every two years, there will be an assessment of how countries are implementing the strategy based on a set of agreed indicators.