WHO Director-General’s opening remarks at the Regional Committee side event on Fighting Substandard and Falsified Medicines in Africa: A Collaborative and Integrative Approach – 23 August 2022

Your Excellency, Minister Mijiyawa,

Your Excellency, Minister Mainassara,

Your Excellency, Minister Ngamije,

Directeur-General Amalvy,

Excellencies, dear colleagues and friends,

Bonsoir, cher collègues et amis,

I thank the Government of Togo for hosting this important event, and for your leadership in addressing the threat of substandard and falsified medicines.

The magnitude of this problem, and its damage to both lives and to economies, is immense.

At best, these medicines fail to treat or prevent disease, wasting precious resources and exploiting the hopes and fears of vulnerable people.

At worst, they kill, and fan the flames of drug resistance, putting all of us at risk.

WHO estimates that more than one in ten medicines in low- and middle-income countries is either substandard or falsified.

We estimate that substandard or falsified antibiotics to treat pneumonia in children under five-years-old result in anywhere from 72,000 to 169,00 deaths each year.

Similarly, bad antimalarials are estimated to lead to anywhere from 31,000 to 116,000 deaths in sub-Saharan Africa each year.

Other examples include falsified cholera vaccines, leukaemia drugs that contain simply paracetamol, and faulty diabetes medicines that cause patients to suffer hypoglycaemia.

At the same time, low- and middle-income countries are estimated to spend more than 30 billion US dollars annually on substandard and falsified medicines.

This is not only public money that is being thrown away, it is being used on products that cause harm to the populations they are supposed to help.

Substandard and falsified medical products can be found in illegal street markets, via unregulated websites, and even in pharmacies, clinics and hospitals.

The WHO Global surveillance and monitoring system, which has been in place since 2013, has issued more than 70 global alerts to date.

Many of these alerts have been issued in Africa.

Last year alone, we issued eleven alerts, including five for COVID-19 products.

How can countries prevent, prepare for, and respond to public health emergencies if they cannot trust their own medicines and medical supplies?

There are several reasons for the proliferation of substandard and falsified medicines.

First, a lack of access to affordable efficacious and safe medicines forces desperate people to buy medicines from unreliable sources.

Second, a lack of good governance allows corruption to penetrate health systems and leaves loopholes for criminal groups to exploit.

Third, a lack of technical capacity undermines the integrity of supply chains and limits the ability of countries to safeguard the health of their people.

Stopping the scourge of falsified and substandard medical products requires working across sectors locally, nationally and internationally, and working closely with the private sector.

Law enforcement, through regulatory oversight by mature national regulatory authorities, and international cooperation are indispensable to stopping the flow of these faulty products, which undermine public health.

The COVID-19 pandemic highlights the importance of sharing information and collaboration within global supply chains, including the false information spread by criminal organizations.

WHO has been working to combat substandard and falsified medicines for many years.

Together with our Member States, WHO has developed a comprehensive strategy to prevent, detect and respond to substandard and falsified medical products.

This strategy includes 12 actions, from education to border control, from supply chain integrity to transparent legal processes.

This is complimented by the Lomé Initiative, in which African leaders committed to put falsified and substandard medicines on the highest political agenda.

WHO works closely with countries in Africa to strengthen national regulatory authorities and support local production of quality medical products, to prevent the use of falsified and substandard medicines.

The sharing of data from national regulatory authorities is critical to our joint efforts to stop the trade in these illicit, dangerous products.

We must change the common mindset that reporting on these bad medical products reflects negatively on countries.

We cannot stop this problem if we hide it, or pretend it’s not there.

WHO supports our Member States to shift this paradigm, so that high-levels of reporting are seen not as a failing, but as an indicator of an efficient response to the problem.

The Brazzaville Foundation is making an important contribution to this effort by auditing existing legislation related to substandard and falsified medical products.

Such strategic intelligence will inform our work in promoting appropriate legal tools and public health interventions.

As you know, WHO does not have a mandate to enforce criminal penalties, but we welcome collaboration with national institutions that can bring legal action against the producers and distributors of these damaging products.

With the Lomé Declaration and our continued work today, African leaders have sent a clear message that they will fight falsified and substandard medicines aggressively and urgently.

But remember, our biggest challenge is ensuring people have access to high-quality, affordable medicines.

After all, substandard and falsified medical products only exist because access to quality and affordable medicines does not.

By taking focused, concerted action, we can remove the market opportunity for substandard and falsified medicines. The new African Medicines Agency, which will be hosted in Rwanda, will play a critical role in this effort.

Thank you all once again for your attention and commitment to this serious public health threat.

Our sisters and brothers on this continent deserve nothing less than the highest quality medical products, and that is what we must work towards.

Working together, we can build a healthier, safer, and more prosperous Africa for all.

I thank you. Merci beaucoup.

Source: World Health Organization

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