LomÉ Initiative Signing

Fake drugs: Unharmonized legislation threatens the lives of African patients

By Vassia Barba contact

- Last updated on GMT

(Image: Getty/Delbars)
(Image: Getty/Delbars)

Related tags: Falsified medicine, Africa, Regulation, World health organization

Although control measures are applied, falsified medicines are present in the supply chain in Niger, with solutions requiring cross-country collaboration, says the country’s Ministry of Health.

The spotlight was put on the topic of falsified medicines earlier this month with the signing of the Lomé Initiative​, a political declaration under which the governments of seven African countries agreed to act to fight the issue, and improve access to quality medicines for African populations.

During the signing events that took place in Lomé, Togo, in-PharmaTechnologist spoke with Barira Dan Nouhou, the director of Pharmacy and Traditional Medicine in the Ministry of Health of Niger, about how falsified medicine are introduced into the country’s supply chain and what are the obstacles to tackling the problem.

According to Dan Nouhou, the smuggling of fake drugs occurring at the country’s borders is the main weak point in the supply chain, and that is exacerbated due to the fact that Niger imports ‘more than 99%’ of its needs in medicine, making the control processes difficult.

On top of that, Dan Nouhou referred to the existing situation as an ‘asymmetric warfare’, with “the authorities in charge, and the regulations they follow, [being] relatively new, whereas networks of traffickers and criminals have been in place for years and years.”

The executive noted that even figures documenting the situation are hard to generate, since the parties involved in the control process, such as the police or the ministry, do not collaborate sufficiently with each other, nor do they operate under a consistent procedure.

Call for harmonized legislation

Dan Nouhou described the current situation as determined by complex and non-efficient regulatory framework which can be very easily violated, and which is unharmonized not only at country, but also at regional level.

Therefore, harmonization of the legislation, according to Dan Nouhou, can and needs to be achieved with the establishment of the African Medicines Agency (AMA), which would be the African equivalent of the European Medicines Agency, in charge of the evaluation and supervision of medicinal products.

A treaty for the establishment of the AMA was adopted by the African Union Heads of State and Government during their 32nd Ordinary Session of the Assembly, in February 2019. However, the treaty still needs to be ratified by fifteen African Union Member States, which, to date, has not been realized.

Local manufacturing

With the representative of the Nigerien Ministry of Health stating that the country imports ‘more than 99%’ of its needs in medicine, questions were raised about the landscape of drug manufacturing in the country and the potential development of industry.

Dan Nouhou explained that there is one manufacturing plant in the country, which is ‘working slowly’, adding that the effort towards this direction could be done regionally, under a joint approach in between countries.

More specifically, the executive noted that countries such as Nigeria, which hold greater manufacturing capabilities compared to Niger, should be encouraged to ‘lead the way’, and subsequently the neighboring countries could benefit from each other’s production to cover demand.

Speaking to in-PharmaTechnologist​, the World Health Organization (WHO)’s director-general, Tedros Adhanom Ghebreyesus, also noted that local drug manufacturing is included in the strategies to tackle falsified medicine in Africa.

However, Pernette Bourdillon Esteve, head of the WHO’s team on falsified and substandard medicines, explained to us​ that a precondition to this is the establishment of a proficient regulatory framework, and to enforce it in order to secure the currently vulnerable supply chain.

Related topics: Markets & Regulations, QA/QC, Regulations

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