WHO Executive Board Grapples with IP Issues
Intellectual property was one of the contentious issues debated at the recent World Health Organisation Executive Board (EB) meeting, which concluded on Tuesday after just over a week of talks. Discussions centered on the WHO report and draft resolution on counterfeit medicines and on the Global Strategy and Plan of Action on Public Health, Innovation and Intellectual Property.
Controversy over Counterfeit Medicines
The recent seizure of a shipment of generic medicines, headed to Brazil, by the Dutch customs officials energized debate on the issue of counterfeit medical products. Brazil expressed “great concern” over the action by the Dutch authorities and indicated that it would consider further action in response, including at the WTO, as the problem evolved (see related story, this issue).
This debate also sparked questions regarding the definition of the term ‘counterfeit’, especially as it relates to the WHO mandate. Some developing countries, as well as an NGO, pointed out that as it stands the term ‘counterfeit’ is associated with trademark violations as defined in the WTO’s Trade-related Aspects of Intellectual Property Agreement (TRIPS). The Swiss delegate suggested that perhaps given the mandate for WHO in the protection of public health, the term ‘counterfeit medical products’ is more appropriate.
At the same time, however, some members questioned why the WHO is focusing on the definition of ‘counterfeit’ rather than directly addressing health issues associated with spurious and substandard drugs. Furthermore, a source present at the meeting suggested that some delegates were apprehensive to use the term ‘counterfeit’ as it can be used to facilitate and expedite the IP enforcement measures under the guise of working to combat the falsification of medical products and other such practices that are a risk to public health.
Concerns about IMPACT
Some members, primarily developing countries, expressed some concerns over the role and working methods of the IMPACT, which was launched in 2006 following a WHO conference in Rome. Included in the mandate of IMPACT, as outlined in the Rome Declaration, is the task of raising awareness among national authorities and decision-makers about counterfeit medicines, and calling for effective legislative measures to combat the spread of the spurious drugs. The taskforce is also charged with promoting coordination among different anti-counterfeiting initiatives.
Members’ concerns focused on the fact that the chair of IMPACT’s working group on technology is also the Director General of the International Federation of Pharmaceutical Manufacturers and Associations (IFPMA), an association of multinational companies.
Developing countries and several NGOs were also uneasy about the fact that the WHO Secretariat’s report and draft resolution for the Executive Board meeting were propelled largely by the work of its partnership with IMPACT. One non-governmental source expressed concern that such endorsement could establish a significant precedent of private sector involvement in WHO activities.
Given these issues, many members were not keen to adopt the proposed resolution. Paraguay on behalf of the group of Latin American and Caribbean Countries (GRULAC) stated that its members were not ready to support the draft in its current form. Ultimately, members agreed that the WHO Secretariat should prepare further reports on the impact of counterfeit medicines on public health, as well as a new document, without resolution, on the way forward to the World Health Assembly in May of this year.
Public Health, Innovation and Intellectual Property
While the issue of counterfeit medicines gave rise to extensive discussions, the agenda item on the Global Strategy and Plan of Action on Public Health, Innovation and Intellectual Property was dealt with more swiftly.
The WHO revealed the costing estimates for the implementation of the WHO strategy on global public health and intellection property, giving a detailed breakdown of the funding required from 2009 to 2015 to “carry out the activities associated with each specific actions at two levels: national and international.” The activities include building and improving innovative capacity, promoting the transfer of technology, and improving the application and management of IP. The total cost of the estimated needs (excluding research and development) exceeds US $2 billion; national-level activities constitute approximately 60 percent of this total figure.
On research and development the funding is expected to be as much US $147 billion. Those funds will cover R&D, the education of R&D workers, R&D infrastructure, and support units. Taken together, the implementation of the strategy and action plan is budgeted at US $149 billion, or US $20 billion per year.
These estimated funding needs were one of the outstanding components of the plan of action that the member states had requested the Director General to finalise during this meeting of the EB.
The Medecin Sans Frontieres’ Campaign for Access to Essential Medicines contended that “further work is needed” by the WHO Executive Board on this issue. James Arkinstall, an MSF spokesman, called for specific actions on this front, and urged the EB to adopt qualitative indicators as part of Global Plan of Action. “It’s not just the number or the process that needs to be measured, it is the effect and the impact,” the spokesman said.
Barbados and Bolivia presented a proposal on ways to use the ‘prize fund model’ to encourage research with respect to diseases that disproportionately affect developing countries. Both countries requested confirmation from the Secretariat that the proposals would be examined by the expert working group the Director General had established. The Secretariat indicated that the proposals would be examined at the second meeting of the working group later this year. The WHO has also encouraged other member states to submit proposals on ways to encourage research into diseases that disproportionately affect developing countries.
Discussions on counterfeit medical products and on the implementation of Global Strategy and Plan of Action on Public Health, Innovation and Intellectual Property are likely to receive significant attention at the next meeting of the World Health Assembly (18-27 May 2008).
ICTSD reporting; “India may drag EU to WTO on Seizure of Drugs,” HINDUSTAN TIMES, 18 January 2009; “Brazil to object to Dutch Seizure of generic drug,” REUTERS, 23 January 2009; “Dr Reddy’s Consignment of Drugs to Brazil Seized,” THE MINT, 15 January 2009; “WHO Puts nearly $150 Billion Proce Tag on Global R & D Strategy for Neglected Diseases,” IP-WATCH, 22 January 2009; “Hope for Consensus on WHO and Counterfeits Moves to May assembly,” IP-WATCH, 27 January 2009.