Info Service on Health Issues (Jan12/05)
WHO: New compromised medicines mechanism agreed, some concerns remain
Heba Wanis* (Geneva): In its 130th session which ended this week the WHO Executive Board agreed to the establishment of a intergovernmental mechanism on substandard/spurious/falsely-labelled/falsified/counterfeit medical products”, though concerns over WHO’s relationship with IMPACT as well as modalities of the mechanism remain unresolved.
Decision to establish a new Member State (MS) mechanism was taken by the Open Ended Working Group (OEWG) in its meeting in October 2011 as a compromise over continuing differences on WHO's operations in dealing with compromised medical products. The MS mechanism will have a broad mandate on the prevention and control of compromised medical products that includes addressing access to affordable medical products, including the supply and use of generic medical products. [For information on the outcomes of the OEWG see http://www.twnside.org.sg/title2/intellectual_property/info.service/2011/ipr.info.111103.htm].
With some amendment, the EB approved the outcomes achieved by the OEWG. These outcomes (i.e. the draft resolution, an annex containing the agreed goals, objectives and terms of reference of the MS mechanism and a report on the outcome of the OEWG) will now be transmitted to the 2012 World Health Assembly (WHA) for adoption.
While the establishment of a MS mechanism was agreed to by the OEWG, the Report of the OEWG noted that divergent views were expressed with regard to WHO's involvement with International Medical Products Anti-Counterfeiting Taskforce (IMPACT). [WHO’s relationship with IMPACT has been a sticking point in OEWG discussions. Many member states and civil society have called for WHO to disengage from IMPACT on the basis it is an IP enforcement initiative, lacks credibility and legitimacy. But a handful of countries continue to support the initiative.]
No resolution was reach on this matter at the EB although some countries called for a decision to be taken on the matter at the WHA.
Member states’ intervention at the EB also highlighted some concerns over modalities on the convening of the member state mechanism.
China in its intervention proposed addition of a clause “in a voluntary manner” to operational paragraph 6 of the draft resolution, saying that MS must be allowed to work in a voluntary manner and build up progressively.
The agreed text of paragraph 6 of the draft resolution now reads “6. URGES Members States to: (1) on a voluntary basis, participate in and collaborate with the Member State mechanism referred to in operative paragraph 4; (2) provide sufficient financial resources to strengthen the work of the Secretariat in this area”.
Estonia, on behalf of the EU, supported by Norway initially did not favour reopening the text agreed by the OEWG, however the legal counsel clarified that participation in the OEWG was indeed voluntary.
On modalities of the MS mechanism, Chile, on behalf of UNASUR announced that Argentina will host the first conference on SSFFC. Following this, Argentina invited all Member States to the meeting in Buenos Aires in October.
However this proposal met with some reluctance with several countries suggesting that a preparatory meeting be held in Geneva prior to Buenos Aires meeting. This proposal is likely to be finalised at the WHA in May 2012.
Disassociation from IMPACT stressed
Interventions on the topic also revealed clear positions on the MS mechanism and on IMPACT.
India said that IP enforcement should remain outside discussions on quality, safety and efficacy (QSE) at the WHO, and called for severing any links with IMPACT.
India attributed the problem of compromised medicines to weak drug regulatory structures adding that WHO’s focus should be on strengthening of drug regulatory authorities (DRA) to ensure QSE of medicines including pharmacovigilance processes; and promotion of generics.
Nigeria, on behalf of the members of the African regional office (AFRO) noted that SSFFC medicines was a major public health challenge to the region and encouraged WHO’s work on medicines supply chain, local production, capacity building, and multisectoral collaboration to ensure access to QSE medicines. It proposed creating a sub-committee to work on the definitions of SSFFC.
Barbados called on WHO to strengthen DRAs, including drug inspection, pharmacovigilance and pre-qualification programmes.
Brazil said that “activities carried out by IMPACT and the attempts to redefine the term “counterfeit”, already defined in the TRIPS Agreement, were examples of the lack of clarity between intellectual property aspects and public health collective interests within WHO”.
Brazil also mentioned the emergence of anti-counterfeiting measures linked to TRIPS-plus standards and IP enforcement, giving the example of the Anti-Counterfeiting Trade Agreement (ACTA), and the 19 detentions by customs authorities of medicines in transit through the EU. Brazil said that these confirmed their concerns.
On the issue of SSFFC definitions, Brazil said that it was more relevant to focus discussions on characterising the actions or behaviours, which should be prevented.
On IMPACT, Brazil noted that it was an issue that cannot be left unresolved in the proposed mechanism. “We must be strive to find a solution to this one issue that still set us apart”, Brazil said, adding that it trusts that MS will be able to decide on this matter during the WHA in May.
Bangladesh noted that the OEWG had not been in a position to come with specific recommendations on the WHO’s relationship with IMPACT, and called for bridging the divergent views of MS by the WHA in May adding that there is legitimate grounds for WHO to dissociate from IMPACT.
Thailand aligned itself with India and Bangladesh regarding IMPACT.
USA noted the sensitivity around IMPACT, and mentioned that once the MS mechanism is in place, the USA will transfer their support from IMPACT to the mechanism. The intervention also focused on securing global supply chains of medicines, DRA strengthening and implementation of border measures.
Iran expressed its “deep concern” regarding the lack of finances in the area of QSE at WHO, drawing the attention of EB Members to the fact that in spite of this, MS still expect the WHO to play an active role in this regard. Iran expected collaboration between MS and the Secretariat to secure the necessary funds.
The necessity of allocating resources to the work of QSE at the WHO Secretariat was also highlighted by Switzerland.
Canada highlighted its support for the new MS-driven mechanism and noted that all relevant stakeholders should be involved.
Japan mentioned their concerns are not only on QSE of medicines, but also the violation of trademark and design rights. Japan called for cooperation with all relevant stakeholders such as the private sector, and expressed its willingness to support activities of countries in need.
The WHO Secretariat responded to queries and concerns by MS, particularly on limited finances directed to QSE work, saying that it would be difficult to mobilise extrabudgetary resources for what is considered core work of the WHO. The Secretariat requested “greater clarity” from MS on the exact nature of the MS mechanism in order to assess the costs.