Meeting on substandard/spurious/falsely-labelled/falsified/counterfeit medical products
Dr Margaret Chan
Director-General of the World Health Organization
Excellencies, honourable ministers, distinguished delegates, ladies and gentlemen,
Let me thank the government of Argentina for so generously and graciously hosting this first meeting of the Member State mechanism on substandard/spurious/falsely-labelled/falsified/counterfeit medical products.
How we move forward on this issue is now firmly in the hands of Member States. The Member State mechanism will be responsible for any decisions, actions, consultations with expert groups, recommended tools and measures, or requests to the Secretariat needed to combat these harmful products.
Outcomes of the Member State mechanism will complement and strengthen WHO’s long-established measures to ensure the availability of good quality, safe, efficacious, and affordable medical products.
The goal, objectives, and terms of reference for this meeting were established in an annex to resolution WHA65.19, approved by the World Health Assembly in May.
The objectives recognize the need to strengthen regulatory capacity and quality control laboratories at national and regional levels. The need to ensure the integrity of the supply chain is clearly stated, as is the importance of cooperation and collaboration on surveillance and monitoring of these products.
The Member State mechanism may also further develop definitions of substandard/spurious/falsely-labelled/ falsified/counterfeit medical products. You seek ways to ensure that combatting these products does not result in hindering the availability of legitimate generic medicines.
The emphasis is firmly placed on looking at problems from a public health perspective. Trade and intellectual property considerations are explicitly excluded.
The work set out for you is challenging, but this is a job that must be done. Public health needs to be concerned about harmful products that can, in any way, compromise the health of consumers.
WHO and its Member States must be concerned whenever harmful products enter the supply chain, regardless of the motive or cause, and regardless of whether the cause reflects deliberate deception, negligence, or weak capacity for quality assurance and regulatory control.
The quest to keep harmful products out of the supply chain is a quest to protect the health of people. Patients receiving such products get, at best, bad treatment. At worst, they can, and do, die.
To underscore the importance of your work, I need only mention the scale of the problem caused by ineffective medicines for malaria. A study published in June of this year examined samples of malaria medicines from several countries in South-East Asia and sub-Saharan Africa. In both regions, 35% of the samples failed chemical analysis.
In South-East Asia, 46% failed packaging analysis and 36% were classified as falsified. In sub-Saharan Africa, 35% failed packaging analysis and 20% were classified as falsified.
We cannot let poor quality medicines undermine the huge progress being made against malaria and so many other diseases.
Patients in the developing world are at greatest risk from the proliferation of harmful medical products, but patients everywhere are vulnerable. It is our duty to protect them. And we must do so through collaborative action, using a multifaceted approach.
You have defined the goal, objectives, and terms of reference for this meeting very clearly and after much discussion.
The way forward is in your hands. I wish you a most productive meeting.