The WHO has delayed its controversial EB 124/14 amendment that would, according to some groups, broaden the organisation’s definition of “counterfeit” from its current focus on patient health to include infringements of intellectual property.
When issued last year the World Health Organization’s (WHO) proposal stressed that: “disputes about, or violation of intellectual property rights [IPR} are not to be confused with counterfeiting.” However, a subsequent correction to the document replaced “intellectual property rights” with the term “patents.”
This revision raised fears that the rules could be used by multinational drugmakers as a way of maintaining competitiveness enforcing IP rights against generics producers in countries where patent laws are not in place.
Delaying the proposed redefinition, a move decided at the WHO’s meeting in Geneva, Switzerland this week, follows considerable opposition from developing countries such as Brazil and India, where generic drugs dominate the market.
Specialist legal information website Intellectual Property Watch said that WHO members agreed to do further reporting in order to address the public health dimensions of counterfeit medicines, specifically the redefinition of the term, in time for the WHO's next meeting in May.
Reaction to the WHO’s move have been consistent with most observers agreeing that the decision is a victory for generics firm’s and a boon for those seeking to expand access to pharmaceuticals.
India’s Economic Times for example reports that the revised definition could have been used to label genuine generic products as fake based on minor variations in packaging and labelling.
In the same vein, The Daily Star in Bangladesh quotes an advisor to the country’s prime minister as saying: “it would be unacceptable to Bangladesh to introduce issues relating to intellectual property infringements or trademark violations under the pretext of combating ‘counterfeit’ medical products.”
These thoughts echo the conclusions of a January 15 report by non-governmental organisation the Third World Network. The document, entitled “WHO: Approach to "counterfeit" drugs may affect access to medicines” suggests that: “bundling legitimate health concerns under the rubric of "counterfeit", a term used in connection with IPRs [is] …oriented towards protecting and enforcing the rights of the IP holders.”
OPPI vs IDMA
In India, where exports from the generic drug industry generate INR 300bn ($6.1bn) a year, the reactions of industry organisations to the WHO’s decision are likely to differ significantly.
For example, The Organisation of Pharmaceutical Producers of India (OPPI) may will be disappointed by the climb-down given its announcement earlier this month that the proposed redefinition was “a step in the right direction.”
In contrast, rival body the Indian Drug Manufacturer’s Association (IDMA) will be pleased by the news having opposed the WHO definition as being “against developing countries and the generic drug industry.”
The WHO did not respond to in-PharmaTechnologist’s requests for comment and further information ahead of publication time.
What impact for IMPACT?
News of the WHO’s decision was accompanied by reports questioning the future of the unit that originally proposed the redefinition, the International Medicinal Products Anti-counterfeiting Taskforce (IMPACT).
India’s Economic Times said that some of the critics of the redefinition had also criticised the role of IMPACT, alleging that the body was shifting the focus of the WHO from patient health and safety to matters of intellectual property.