The World Health Organisation (WHO) announced that it will develop the necessary technical definitions, global norms and standards for assessment methods, technologies, and legal and regulatory measures for combating substandard/spurious/falsely-labelled/falsified/counterfeit medicines, using the Organization’s well-established procedures for the independent development of global standards and policy guidance.
The WHO has made it clear ahead of the proposed meeting to set up the working group to address the problems of counterfeit from February 28 to March 2, after many countries led by India raised apprehensions on the delay in setting up the working group instead of leaving the task with controversial International Medical Products Anti-Counterfeiting Taskforce (IMPACT).
“Globally, substandard medicines constitute the most common type of quality problem, and the one that has the largest negative impact on health. WHO will therefore continue to strengthen its global and country-level activities in promoting the availability of efficacious, safe and affordable medicines of good quality. Strengthening national regulatory systems will also, indirectly, reduce the possibilities for substandard/spurious/falsely-labelled/falsified/counterfeit medicines to enter the market. Since regulatory approaches on their own are not sufficient, as discussed, specific additional actions will be needed to combat the negative public health impact of “counterfeit” medicines,” according to the documents released by the agency.
In terms of the problem of counterfeit medicines, the promotion of awareness on things including the extent and dangers, and the necessary actions against it will be central activities of WHO, together with all relevant stakeholders. The campaign will target governments, health policy-makers, health professionals and the public, the agency said.
“In order to foster such awareness and to give meaningful technical support to Member States and other stakeholders, the Secretariat must first be clear and consistent in several areas: the definitions, the recommended actions and the public messages. To this end, WHO will develop the necessary technical definitions,” it said.
“In this regard, many experts recognize that the term “counterfeit medicine”, while fully appropriate and generally accepted at the time of its first use in 1988, has been overtaken by international developments and is now increasingly perceived as associated with intellectual property rights rather than public health. In order to stress the public health aspect of the problem while developing the global norms and standards, it is proposed that “counterfeit” in WHO’s definition be modified to “falsified”, and that the term “counterfeit medicine” be reserved for a falsified medicine with a counterfeit trademark, in accordance with existing WIPO definitions,” the documents said.
In 2009, following discussions at the Sixty-first World Health Assembly and the 124th session of the Executive Board, and the questions raised about WHO’s involvement in the Taskforce, WHO formally re-established its own programme to combat “counterfeit” medicines within the Essential Medicines and Pharmaceutical Policies Department, in addition to its continuing involvement in the Taskforce. WHO also introduced a clear distinction between the Secretariat’s activities and those of the Taskforce; for example, two different web sites were established and a new WHO fact sheet was issued, it said on the works so far on the front.
“Since July 2010, WHO’s work in this area has continued, but on a sharply reduced scale, owing to limited resources. Its focus is on developing global normative guidance and expansion of the Rapid Alert System in some regions,” the documents said.