WHO Africa Region Addresses Strategies On Counterfeits, Malaria, Hepatitis

The 47 members of the World Health Organization African region this week adopted or considered a series of measures aimed at fighting substandard and counterfeit medical products, eliminating malaria and viral hepatitis, and setting a global strategy and plan of action on ageing and health that includes a focus on non-communicable diseases. They also adopted a plan for disease outbreaks and health emergencies.

The 66th session of the WHO Regional Committee for Africa is being held in Addis Ababa, Ethiopia from 19–23 August.

Regional Strategy on Medicines Regulation

WHO Regional Director for Africa, Dr Matshidiso Moeti, proposed a regional strategy aimed at “strengthening National Medicine Regulatory Authorities (NMRAs) in order to ensure that only safe, good quality and effective medical products are available in countries,” according to a press release, which includes the attached strategy. Poor quality or fake medicines are a significant problem in Africa.

“In a strategy aimed at ensuring that NMRAs are strengthened to effectively fulfil their regulatory functions, Dr Moeti highlights a range of actions to be taken by countries,” the release said.

Actions include: “By 2018, countries are expected to ensure that a regular surveillance of all medical products circulating on the market is carried out. During the same timeframe, it is recommended that countries have access to certified quality control laboratories, and embark on joint reviews of applications for clinical trials. The Regional Director urged countries to establish governing bodies and quality management systems for NMRAs by 2025. She also urged that by the same period, application for clinical trials or marketing authorization of medical products takes a maximum of six months.”

It also said, “It is expected that countries will provide adequate human, financial and technical resources for the NMRAs to be functional and harmonize their regulatory practices with international recognized standards and initiatives.”

Every two years, there will be “an assessment of how countries are implementing the strategy based on a set of agreed indicators,” said the release.

The strategy sets targets up to the year 2025.

The focus on national medical regulatory authorities in part arises from the 2012 World Health Assembly resolution 65.19 on “substandard/spurious/falsely-labelled/falsified/counterfeit” (SSFFC) medical products, the term of reference agreed in recent years by WHO member states.

This week’s strategy states: “regulatory personnel from countries have been trained to prevent and control substandard/spurious/falsely-labelled/falsified/counterfeit (SSFFC) medical products. Countries in the Region are now reporting incidents on SSFFC medical products to the Global Surveillance and Monitoring System to protect public health.”

It adds: “Due to weak performance of NMRAs, there is increasing circulation of SSFFC Medical
products in the African Region, which is currently leading in reporting to the WHO rapid alert
system.” So far, “Thirty four (72%) countries have quality control laboratories in place, at different stages of development and 21 (63%) of them are engaged in market surveillance.”

One of the stated goals of the strategy is to “strengthen regional regulatory harmonization and convergence.”

“Despite the progress made by countries in regulating medical products in the WHO African
Region, several challenges remain,” the strategy concludes. “It is expected that this strategy will ensure that Member States have legally-mandated and functional NMRAs to regulate and provide access to medicines which meet international standards of quality, safety and efficacy for all who need them, while promoting harmonization across the RECs and leading to operationalization of the AMA.”

Outbreaks and Emergencies

The conference also considered a $106.8M strategy for WHO to tackle disease outbreaks and other health emergencies in Africa, according to a press release. Health ministers adopted the regional strategy on health security and emergencies, according to a second press release [updated].

The region faces more than 100 public health emergencies every year, 80 percent of which arise from infectious diseases, it said.

Malaria

The members also adopted a new framework for ending malaria in the region, while noting the success of efforts in making malaria no longer the leading cause of death among children in sub-Saharan Africa. The new framework mentions the problem of substandard and counterfeit medicines, and foresees an end to malaria by 2030 with sufficient investment.

A press release (including the framework) stated: “Today, all forty-seven WHO Member States in the African Region adopted unanimously a new malaria framework for Africa. This framework aims to guide African countries on how to implement the Global Technical Strategy for malaria in the Region. It proposes specific priority interventions and actions to be implemented by Member States to reach ‘an African Region free of malaria’.”

Among the Issues and Challenges listed in the framework is (in paragraph 12): “The increasing circulation of products of non-assured quality as well as substandard and counterfeit medicines in countries raises the risk of resistance.” The framework also mentions the need to focus on innovation and research.

WHO said that based on a population of 830 million in the region, an estimated US$ 66 million will be needed to eradicate the disease by 2030.

Between 2000 and 2015, the number of malaria cases declined by 42 percent and deaths by 66 percent, which WHO said translates into about 6.2 million lives saved, most of them children.

Hepatitis

Meanwhile, a separate framework was agreed on viral hepatitis, for the period from 2016-2020. It aims to reduce chronic viral hepatitis B and C infections in the region by one-third. It also makes mention of medicines access and high prices.

“Despite availability of treatment for chronic hepatitis B and hepatitis C, it is inaccessible to most patients due to the high prices of medicines,” it states (para 13). “Patients with complications of chronic hepatitis infection, including end-stage cirrhosis and hepatocellular carcinoma, have limited access to basic care, and many of them have turned to traditional medicine.”

The hepatitis press release (with framework) is available here.

Global Strategy

And in addition, the African Ministers of Health endorsed an implementation framework for the Global Strategy and Plan of Action on Ageing and Health.

 

Image Credits: WHO