Protecting patients from substandard and counterfeit medicines
MANILA, 24 October 2013 - Member States must do more to combat substandard/spurious/falsely-labelled/falsified/counterfeit medical products. This was the recommendation made by the World Health Organization (WHO) during the sixty-fourth session of the Regional Committee for the Western Pacific on 21–25 October in Manila.
“Citizens of Member States put a great deal of trust in their governments and in WHO, so we must do our utmost to protect their rights and safety,” said Dr Shin Young-soo, WHO Regional Director for the Western Pacific. “Combating medicines that are substandard, spurious, falsely-labelled or counterfeit is part of preserving that trust. Patients must be assured that they are receiving genuine medicines that will help them.”
The discussion followed from a resolution from the Sixty-fifth World Health Assembly (2012), where Member States and WHO established a mechanism to combat substandard and counterfeit products. This mechanism takes the form of a specialized committee focusing on devising workplans and implementation strategies to help Member States protect patients from spurious and substandard medicines.
A major challenge for this mechanism will be to define clearly the different terms relating to the quality of medicines, taking special care to delineate them from the issues of intellectual property and trademark infringement. Member States themselves have divergent views about how best to address these issues.
Substandard and counterfeit medicines pose a great threat in the Western Pacific Region, where they are often found in circulation in several countries. In addition to harming individual patients, these products may significantly contribute to the emergence of antimicrobial resistance, such as artemisinin-resistant malaria in the Greater Mekong Subregion and the spread of multidrug-resistant tuberculosis. WHO’s recent review of health systems strategies (2013) identified this as a major area for WHO to assist Member States.
WHO has already set up a rapid alert system for combating counterfeit medicines to help Member States coordinate with WHO and other partner agencies. In this system, Member States report counterfeit cases to WHO, which then disseminates the information to all Member States and adds the spurious product to the regional database for ministries of health and law enforcement agencies to consult. In 2011, WHO and Interpol conducted a joint operation (STORM) to combat counterfeit medicines in several Member States.
According to Dr Shin, “The new mechanism on substandard and counterfeit medicines will further our efforts to protect patients and reduce the likelihood of developing antimicrobial resistance.”
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Mr Ruel E. Serrano
Assistant, Public Information Office
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