Dear colleagues and friends,
Good morning, good afternoon, good evening, and a warm welcome to all of you joining us from around the world.
As you know, two weeks ago the WHO Secretariat issued a medical product alert for four contaminated medicines identified in The Gambia that have been potentially linked with acute kidney injuries and 69 deaths among children.
The investigation is continuing into how these products were contaminated, how they entered the supply chain, and whether contaminated medicines have been shipped to any other countries.
For the families who have lost children, this is beyond heartbreaking.
Simply by trying to care for their children's health, they have lost them forever.
This alert is one of six the Secretariat has issued this year, and underscores what is at stake in the issue you are here to discuss.
Access to safe, effective, quality and affordable medicines is a cornerstone of universal health coverage.
Substandard and falsified medicines undermine the entire health system and jeopardise progress towards UHC.
At best, they fail to treat or prevent disease, wasting precious resources, exploiting the hopes and fears of vulnerable people, and eroding trust.
At worst, they kill, and fan the flames of drug resistance, putting all of us at risk.
It has now been 10 years since the establishment of the Member State mechanism on substandard and falsified medical products.
Unfortunately, the prevalence of these products remains high.
Even understanding the true scope of the problem continues to be a challenge. The lack of information sharing between countries is evident in the under-reporting of our global surveillance and monitoring system.
In a world of globalized supply chains, we are all vulnerable to substandard and falsified medical products.
The COVID-19 pandemic has highlighted the scientific and policy challenges in making high-quality diagnostics, therapeutics and vaccines accessible around the world, particularly in lower-income countries.
I commend the Steering Committee's recent proposals on the need to review the impact and effectiveness of the mechanism in its goal of promoting access to safe, efficacious, quality and affordable medical products.
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It is important that countries have full ownership of the workplan, by leading the process, and setting practical outcomes focused on impact.
I therefore urge Member States to voice their issues and make pragmatic proposals for the longer term.
The workplan also covers activities on support to improve competency and governance within national regulatory authorities.
I am glad to note that our program on benchmarking of national regulatory authorities, followed by development of institutional plans, is already showing improvements in market surveillance and control activities in several Member States.
The Secretariat will conduct studies on return on investments for market surveillance that will be reported to you during the next year, to assist you in making evidence-based interventions.
Thank you all for your engagement in this critical issue.
I look forward to hearing about the results of your deliberations.
I thank you.
