TWN Info Service on WTO and Trade Issues (Aug08/09)
Geneva, 11 Aug (Sangeeta Shashikant and Riaz K. Tayob) -- The jurisdiction of international organisations over the enforcement of intellectual property violations has also become a controversial issue in the World Health Organisation, as it has in other agencies recently.
In the World Customs Organisation, attempts to push through a new uniform set of standards on intellectual property (IP) enforcement by customs authorities has resulted in developing countries asking for a review of a misleading Secretariat report alleging consensus for adopting the standards (see SUNS #6534 dated 8 August 2008).
The Universal Postal Union,
which is holding its Congress in
Developed countries have also attempted in the past two years to place enforcement of IPRs as an item on the agenda of the Council for TRIPS at the WTO, but this has faced objections by developing countries which argue that enforcement comes under the jurisdiction of national authorities, and parties that are dissatisfied can have recourse to the dispute settlement system of the WTO.
A similar debate on the content and mandate of IP enforcement also took place at the World Health Assembly, which is the annual forum for member states of the WHO to discuss health policies.
A draft resolution on counterfeit of medical products presented at the 61st World Health Assembly in May 2008 was the subject of intense discussion, as was a WHO Secretariat report (A61/16) on this issue.
After many member states raised concerns about the implications of the draft, it was decided to defer a decision on it. Instead, the next meeting of the WHO Executive Board in January 2009 will discuss the draft, and another discussion will be held at the next WHA in May 2009.
Both the draft Resolution and the Secretariat's report essentially sought to legitimize an initiative known as "International Medical Products Anti-Counterfeiting Taskforce" (IMPACT), its activities and documents.
The draft resolution (A61/A/Conf.
Paper No. 1) was initially sponsored by
During the debate at the WHA (23rd May), several developing countries raised several concerns, including:
-- The composition of IMPACT, whose members comprise industry representatives as well as law enforcement organisations;
-- The hasty push to endorse IMPACT initiative; and
-- The definition of counterfeiting proposed by IMPACT and the principles and recommendations developed by IMPACT without any prior deliberations of member states, while sidelining previous WHO guidelines on counterfeiting, without adequate explanation.
Countries also objected to the Secretariat's report for endorsing IMPACT and its activities and for addressing counterfeiting as an end in itself rather than as a public health issue.
A major underlying concern
of the countries is that legitimate generic medicines may get caught
up in the web of definitions and enforcement of "counterfeit products",
with adverse consequences for access to medicine as well as legitimate
After a lengthy discussion on the subject, the WHA in May agreed that the Secretariat's report and the draft resolution will be considered further by the 124th session of the Executive Board (in January 2009), for a decision on how to refer the matter (including the draft resolution) to the 62nd World Health Assembly in May 2009.
According to the Secretariat
report, the WHO launched IMPACT in 2006 following a conference in
According to the report, there are five working groups under IMPACT, on (1) Legislative and Regulatory Infrastructure; (2) Regulatory Implementation; (3) Enforcement; (4) Anti-Counterfeiting Technologies; and (5) Communication.
The report states that IMPACT has developed: "Principles and elements for national legislation against counterfeit medical products", recommendations for strengthening WHO's Good Distribution Practices (and submitted them for consideration and appropriate action to WHO's Expert Committee on Specifications for Pharmaceutical Preparations); a guide to investigating counterfeiting of medical products and other pharmaceutical crimes (for training regulatory and enforcement officers); drawn up a communication strategy for creating awareness of the risks created by counterfeit medical products in the supply systems; and has published a summary assessment of existing technologies.
The draft resolution, inter alia, urges member states to: (1) establish and enforce legislation and regulations that prevent counterfeit medical products to be manufactured, exported, imported or traded in international transactions and the regulated distribution system, taking into account the principles and recommendations developed by IMPACT; (2) establish effective mechanisms of coordination and collaboration amongst health enforcement and other authorities as well as appropriate mechanisms enabling international cooperation; (3) promote awareness among health professionals and consumers of the risks posed by counterfeit medical products.
The draft resolution also requests the DG, inter alia, to: (1) support member states to develop and implement policies aimed at combating counterfeit medical products including facilitating and exchanging information at the international level, developing tools, guidelines, training and awareness initiative, and methodology for evaluation and monitoring; (2) strengthen the Secretariat of IMPACT; (3) seek extra budgetary resources in addition to those in the regular budget to this end; and (4) continue the development and dissemination of independent information on instances of counterfeits.
Essentially, the draft Resolution and the Secretariat's report sought to legitimize IMPACT, its activities and documents.
Some delegates as well as several independent experts following the issue say that member states should critically analyse IMPACT and its activities, including conflicts of interests as well as implications of the definition and measures proposed by IMPACT on developing countries before deciding on the endorsement of the initiative, its activities and the two documents.
According to experts, several
of the measures proposed by IMPACT appear to be burdensome, financially
and otherwise on governments, impinge on sovereignty, go beyond requirements
of the TRIPS Agreement, promote purchase of IPR protected technologies
(to combat counterfeiting) and has the potential of hampering legitimate
The delegate added that he had participated in the IMPACT meetings, but representatives of big pharmaceutical companies prepared all the documents in advance. There was hardly any deliberation during the meetings on the documents, which were then just presented for quick endorsement by participants at the meeting.
Another concern of experts is the definition of "counterfeiting", and the related mixing up of two separate issues - the counterfeiting of products and the quality of drugs.
These issues were captured well in an article of the Delhi-based Times of India, which said that: "WHO defines counterfeit medicines as those which are deliberately and fraudulently mislabeled with respect to identity or source. At the same time, products with correct ingredients but fake packaging bring trademark infringement within the scope of the definition. Thus, the definition mixes issues of spurious drugs and substandard drugs with intellectual property infringement."
IMPACT provides another definition, i. e. that ''a medical product is counterfeit when there is a false representation in relation to its identity, history, or source" and this applies "to the product, its container, packaging or other labeling information". According to the definition, it applies to "both branded and generic products.''
According to the Times article, although "the term counterfeiting has different definitions around the world, it is often defined as a trademark infringement". It quotes an expert from the Delhi-based Centre for Trade and Development (CENTAD) as saying: "The adoption of the IMPACT definition will have adverse impact on the access to drugs by branding legally produced generic drugs as counterfeit drugs''. The article also reported on fears that "with such regulations, customs authorities across the world will seize or delay the transit of legitimate generic medicines on suspicion of their being counterfeit".
Several of the concerns above were also voiced by some member states during the debate on the draft resolution and the Secretariat's report during the WHA last May, while some other member states supported the draft resolution and the report.
The guidelines provide that
member states take their own measures to combat counterfeits, said
It also said that it was
important to state up front that the aim was to protect public health
and not trade interests. It emphasised that generic and branded medicines
that are not registered but that are available are not counterfeits.
Cuba said that not adopting the resolution does not mean that a country will not act against counterfeit goods as Cuba was doing a great deal in this regard.
A drug that had not received
regulatory approval is not necessarily harmful. The manufacture of counterfeits
is not limited to developing countries but also includes