Malabo (Equatorial Guinea), 2 September 2010 — The use of counterfeit medical products is a global public health problem. Illegitimate distribution and rampant use of substandard, spurious, falsely labelled, falsified and/or counterfeit medical products lead to loss of confidence in health systems, health professionals, pharmaceutical manufacturers and distributors. In order to find a lasting solution to this problem, WHO established a taskforce which prepared a report which has been submitted for consideration during the Sixtieth session of the Regional Committee whose deliberations started on 30 August 2010 in Malabo.

The report of the Regional Taskforce reviews the current status, issues and challenges concerning substandard, spurious, falsely labelled, falsified and/or counterfeit medical products and proposes actions to prevent and control the manufacture, distribution and use of such products in the WHO African Region.

The Regional Taskforce therefore proposes to Member States and WHO to implement a wide range of interventions to address this problem.

The Taskforce recommends to Member States:

• to reaffirm their commitments to fight against substandard, spurious, falsely labelled, falsified and/or counterfeit medical products and engage in updating, developing, implementing and monitoring national medicines policies;
• to establish National Medicines Regulatory Authorities (NMRAs) that have adequate legal mandate, independence and institutional capacity to ensure and strictly enforce compliance of medical products with standards of quality, safety and efficiency; and to effectively control the manufacture, export, import and distribution of substandard, spurious, falsely labelled, falsified and/or counterfeit medical products;
• to develop and implement a sustainable human resource strategy for the pharmaceutical sector;
• to put in place reliable supply systems and the requisite financial resources to ensure the availability of quality and affordable essential medical products in public health facilities;
• to establish effective systems to carry out specific studies and routine market surveillance to quantify the magnitude of the problem of substandard, spurious, falsely labelled, falsified and/or counterfeit medical products to inform the development and implementation of appropriate policies and regulations; and
• to establish effective national, regional and international cooperation and collaboration mechanisms including reinforcing regulatory networks and exchange of information among public health and law enforcement authorities, professional associations, NGOs and other relevant authorities to improve the prevention, detection, investigation and prosecution of cases related to substandard, spurious, falsely labelled, falsified and/or counterfeit medical products.

The Taskforce recommends to WHO:

• to further develop tools and guidelines enabling Member States to adapt and implement policies and strategies;
• to continue to assess and strengthen NMRAs in order to ensure the quality, efficacy and safety of medical products;
• to support Member States to mobilize more resources for developing human resource capacity for the pharmaceutical sector;
• to continue to facilitate the exchange of objective and independent regulatory information among Member States;
• to intensify the promotion and implementation of good governance, accountability and transparency in Member States;
• to strengthen the conduct and dissemination of operational research on substandard, spurious, falsely labelled, falsified and/or counterfeit medical products and encourage Member States to use evidence for policy actions; and
• to strengthen the monitoring and evaluation of programmes dedicated to combating the manufacture, distribution and use of substandard, spurious, falsely labelled, falsified and/or counterfeit medical products.

Intervenciones de Prevención y Control de los Productos Médicos de Calidad Subestándar, Espurios, de Etiquetado Engañoso, Falsificados o de Imitación en la Región de África de la OMS

For more information, please contact

Technical contact

Dr Jean-Marie Trapsida, WHO/AFRO, Brazzaville; Tel.: +47 241 39 258; E-mail: trapsidaj [at] afro.who.int (trapsidaj[at]afro[dot]who[dot]int)

Media contact

Samuel T Ajibola, WHO/AFRO, Brazzaville; Tel.: +242 7700202; +41 241 39378; E-mail: ajibolas [at] afro.who.int (ajibolas[at]afro[dot]who[dot]int)

Barbara Etoa, WHO/AFRO, Tel: (+240) 222716100 E-mail: etoab [at] cm.afro.who.int (etoab[at]cm[dot]afro[dot]who[dot]int)

Souleymane Koné, WHO/AFRO Tel: (+240) 222716100 E-mail: kones [at] ci.afro.who.int (kones[at]ci[dot]afro[dot]who[dot]int)