In what seems to be a corrective move after dropping the controversial draft resolution on counterfeit drugs and IMPACT fiasco, the World Health Organisation will now prepare a new report for member states' consideration at the World Health Assembly to address the public health dimension of issues and on what WHO is doing to strengthen the drug regulatory authorities.
After `mishandling' the whole issue through its task force-IMPACT-and earning the wrath of most of the member states, the world body will also come out with a report after investigating the issues of conflicts of interests among members of IMPACT. The WHO would now look at the global strategy and plan of action on public health, innovation and intellectual property, it is learnt. Importantly, the IMPACT will not have any more roles to play as the WHO plans to prepare the report, not a resolution, by refocusing itself on the right approach and goals.
This comes in the wake of rejection of the draft resolution by its Secretariat at the recent Executive Board meeting which witnessed convergence of Latin American, Southeast Asian countries along with Iran and Egypt to defeat the designs of IMPACT which wanted to redraft definition of counterfeit medical products. The WHO secretariat had come under fire for using term of `counterfeit' to describe the problems relating to the quality, safety and efficacy (QSE). Concerns were also raised on using this term in connection with IP violations particularly trademark infringements.
As pointed out by many industry associations and public interest groups in India, IMPACT was criticised by most of the countries as it lacked mandate from the WHO governing bodies, for its emphasis on counterfeits, involvement of private sector and for lack of transparency. The member states rather asked the WHO to refocus itself on the right issues and called for efforts to strengthen the drug regulatory authorities to address the quality issues under WHO guidance. Though the EU and Swiss delegations pressed for either an informal working group or some outcome on the issues of counterfeits, the executive board meeting rejected it.
Brazil in particular led the attack on the draft resolution. It emphasized that WHO is the forum for debate of methodologies focused on QSE of medical products and should help Member States to strengthen their DRA. It added that WHO is not a "forum for discussions on enforcement of intellectual property rights". It said that any norms or definitions set to deal with QSE of medical products have to be inclusive, evidence-based and done through a Member State-driven process.