TWN Info Service on Health Issues (Feb09/01)
Please find below a news report on the outcome of discussion in WHO on "Counterfeit Medical Products".
WHO Secretariat is to come up with a new report to be sent to the World Health Assembly in May 2009. EB 124/14 which contained the Secretariat's report and draft resolution has been dropped due to significant opposition from several developing countries.
Concerns voiced over IMPACT, Secretariat's role on "counterfeits"
Geneva, 27 Jan (Sangeeta Shashikant) -- Many developing countries voiced concerns at a meeting of the Executive Board of the World Health Organization (WHO) over the Secretariat using the term "counterfeit" to describe problems relating to the quality, safety and efficacy of medical products, and addressing such problems through the International Medical Products Anti-Counterfeit Taskforce (IMPACT).
At a meeting of the Executive Board on 23 January, Latin American (grouped under GRULAC) and Southeast Asian countries (called SEARO) as well as Iran and Egypt were concerned that the term "counterfeit", used in connection with IP violations particularly trademark infringements, would result in the WHO addressing health concerns through IP enforcement measures.
Concerns were also raised over the WHO's anti-counterfeit taskforce IMPACT, which many countries felt was unsuited to address the issue of quality, safety and efficacy (QSE) of medical products because its establishment lacked a mandate from the WHO's governing bodies; its emphasis on "counterfeits"; the involvement of the private sector in its activities thus raising issues of conflicts of interest; and lack of transparency.
The Africa Group, recognizing alarm among some countries over the use of the term "counterfeit", recommended improving its definition.
The documents presented by the Secretariat featured counterfeit as a severe health problem distinct from IP issues and sought endorsement for IMPACT and its activities.
Analysis of the Secretariat's report and attached draft resolution suggests that the documents may potentially become a problem for the prompt availability of affordable generic medicines (See SUNS #6623 dated 22 January 2009 and SUNS #6618 dated 15 January 2009.)
The debate at the Executive Board resulted in significant convergence among most developing countries present that more efforts need to be made to strengthen the drug regulatory authorities - which tend to be weak in developing countries to address QSE through WHO with guidance from member states.
Noting the unease and dissatisfaction with the approach taken by the report and draft resolution, on the suggestion of WHO Director-General Dr. Margaret Chan, it was agreed that WHO would prepare a new report (without a resolution) for member states' consideration at the World Health Assembly (WHA), which would address the public health dimension of the issues and what WHO is doing to strengthen the DRA (Drug Regulatory Authorities). In this regard, it would also look at the Global Strategy and Plan of Action (GSPOA) on Public Health, Innovation and Intellectual Property.
the request of
However, the agreement was preceded by a push from the Chair of the meeting (Sir Liam Donaldson of the UK), the EU and the Swiss delegation for either an informal working group or some outcome on the issue of counterfeits, despite the apparent dissatisfaction among Executive Board and non-Executive Board members with document EB124/14 prepared by the Secretariat.
Sir Liam, on one occasion drew parallels with the draft resolution on "The grave health situation caused by Israeli military operations in the occupied Palestinian territory, particularly in the occupied Gaza Strip", and said that sometimes content did not matter and that agreement was needed more as a symbolism so as not to give comfort to counterfeiters. He argued that it might be possible to agree to a shorter resolution.
However, such a push was resisted, and resulted in sharp responses from many of the developing countries participating in the meeting as Executive Board members and observers.
However, it stressed that WHO is not the appropriate forum for observance of IPRs and that "counterfeit" pertains to infringement of IP rights, particularly trademarks and has nothing to do with health concerns. WHO should guide discussions on health issues and not deal with issues that are the purview of other fora. It further stated that actions should be adopted after a process of negotiations among Member States that includes the strengthening of the health authorities responsible for regulation of medicines.
In relation to this case, Brazil also read a joint statement by its Minister of Foreign Relations Celso Amorim and the Minister of Health, Dr. Jose Gomes Temporao, which states: "The decision to retain the shipment - which was not, at any moment, brought onto Dutch territory - was undertaken as a result of an administrative request from a third company (therefore, without the official endorsement of the local judiciary system) which allegedly owns intellectual property rights over LOSARTAN in the Netherlands" and that this "process imposes on the supplier, and not on the company which requested the intervention, the responsibility to prove the legality of the transaction, essentially an inversion of the universally accepted juridical concept that the accusatory party must present the evidence."
The statement said that "Irrespective of the value or volume involved, or of the fact that the shipment was returned to the country of origin (India), the Brazilian Government considers that the decision by the Dutch authorities to detain an input which is strategic to public health in a developing country, and exported in conformity with the existing international norms, represents a grave drawback in the treatment of the issue of the universal access to medicines" and "represents a distorted use of the international intellectual property system, supposedly upheld by European Union legislation, and contrary to the spirit and provisions of the Doha Declaration on TRIPS and Public Health." The statement added that "this is the sort of procedure that this Organization should oppose firmly".
Brazil said that the case must be seen in light of the direction which the IMPACT initiative has taken, i.e. under the pretext of a fight against counterfeit medicines, it attempts to impose a revision of WHO's position on the issue, with a view to inhibit the legitimate commerce of high quality, competitively priced generic drugs. Brazil stressed its dissatisfaction with the action undertaken in the port of Rotterdam, which it said raised doubts with respect to the commitment of European countries to the issue of access to medicines by developing countries. It added that the action may also be taken up in the WTO.
Indonesia said that SEARO countries "do not accept" particularly the Principles and Elements for National Legislation (Model Elements) produced by IMPACT, since the process has not been inclusive, and it is the "sovereign" right of countries. It also stressed that the focus should be on the strengthening of the DRA and any discussion on this should be intergovernmental in nature.
It further stated that any definition should exclude all IP infringements. It referred to Secretariat’s report which states that the proposed definition “will serve as a model text for national legislation”, adding that if so it has to be a definition by member states and not by IMPACT since an inaccurate or misleading definition could have impact on developing countries and its industries.
It stressed the importance for developing countries to retain as much policy space as possible, and concluded stating that it could not support WHO's report and the draft resolution as it focuses on combating counterfeits as an end in itself rather than as a public health effort.
[Several African country delegates participating in the Executive Board meetings have privately pointed out that in using the term "counterfeit", they intend to protect against medicines with no or wrong active ingredients (spurious medicines) and medicines of low quality (substandard medicines) and that their intention on this issue is not to protect or enforce IP rights - see SUNS #6623 dated 22 January 2009].
Hungary, on behalf of the EU, said that this issue was a "priority" for the EU, adding that the new EU draft legislation is based on IMPACT's Model Elements and that the fight against counterfeit required international action based on clear principles and cooperation between the police, banks and customs. In this regard, WHO has the coordinating role.
spoke in favor of the Report and draft resolution while
Sir Liam, the chair of the Executive Board, picked up the possibility of a small informal drafting group and sought to push it forward. However, the Chair's push for a small drafting group and a short resolution was resisted, and in fact resulted in sharp responses from many of the developing countries participating in the meeting as Executive Board members and observers.
It also reiterated that “counterfeit” which pertains IP violations are not per se quality problems and not an issue for WHO. It stressed on the need to focus on the issues of false labeling, substandard and spurious medicines and avoid issues of IP enforcement.
Egypt said that recently there has been a lack of clarity as to what WHO's activities have been and should be in relation to QSE of medical products, adding that there is a growing sense of unease about IMPACT, an initiative not enjoying a mandate from WHO's governing bodies.
It asked Executive Board members: "Are we discussing public health problems, or are we, as has recently been witnessed in other intergovernmental fora in specialized agencies of the United Nations and other IGOs, witnessing an importation of a specific IP enforcement agenda into the WHO?"
Ensuring quality of drugs requires utmost attention and should be handled through DRA and WHO has a role to play in supporting DRA, but on the other hand, counterfeit is a trademark violation, which should be dealt with under relevant IP laws, it added. It further stated that WHO should pay attention to finding solutions, not through the lens of IP, but health.
It also said that substandard products represent a far larger risk and these classes (i.e. counterfeit and substandard) must not be confused particularly at the WHO.
As to form, it alluded to the problem of transparency, insufficient documents, and unclear funding as well as IMPACT meetings held everywhere except in Geneva, adding that to give legitimacy to the issue it has to be dealt with in WHO or at least a group established by EB or WHA.
It referred to a definition that emerged in 1992 but not adopted by member states and spoke of the need for a definition which would be to everyone’s satisfaction, recognize the problem, adding that this issue cannot be resolved in a working group in an EB session.
Dr. Carissa F. Etienne, Assistant Director General of Health System and Services attempted to reiterate the same old arguments of WHO found in the Secretariat’s report in response to many of the interventions made i.e. that counterfeiting is a public health problem and that there were statistics on it, adding that counterfeit in WHO referred to patients that were the victims.
Dr. Etienne also said that IMPACT’s secretariat lies in WHO and attempts to bring stakeholders together and that the Secretariat will make IMPACT more transparent.
However countries simply could not accept Dr. Etienne’s explanation.
It also said that the Secretariat’s report builds on the technical work done by a group which is not a member driven group and that member states don’t know whether IMPACT when it deliberates takes into consideration the relevant guidelines and issue such as high prices, and its impact on counterfeits.
It also cautioned the Secretariat that it would not like too see WHO being taken over by the Interpol or the police.