TWN Info Service on Intellectual Property Issues (June09/06)
3 June 2009
Third World Network

The issue of counterfeit although off the World Health Assembly agenda became  an issue at the recently concluded Assembly. Below is a news report on discussions on "counterfeit".

Regards
Sangeeta Shashikant
Third World Network
email: sangeeta@thirdworldnetwork.net

WHO's Director General willing to drop ‘counterfeit’, stresses on substandard

Sangeeta Shashikant (Geneva): WHO’s Director General, Dr. Margaret Chan offered to drop the term ‘counterfeit’ in favor of other terms such as substandard amidst concerns from several developing countries during the World Health Assembly that in using the term WHO was endorsing the G8 countries’ and Big Pharma’s agenda on IP enforcement.

Interventions by some developing countries during discussions on WHO’s Mid-Term Strategy plan 2008-2013 (MTSP) raising concerns over the use of the term ‘counterfeit’ prompted Dr. Chan to state that ‘If you don’t like the term, we can use another term’.

Dr. Chan also stressed on the need to address the public health dimension of sub-standard products.

WHO’s keen focus on the issue of ‘counterfeit’ medical products, as opposed to legitimate public health concerns of falsely labeled, substandard and spurious products was heavily questioned by many developing countries during the January Executive Board meeting.

The concern is using the term ‘counterfeit’(a  term used in connection with IP violations particularly trademark infringements) to describe problems relating to the quality, safety and efficacy of medical products would result in WHO addressing health concerns through IP enforcement measures.

During the January EB meeting, developing countries also questioned the legitimacy of the International Medical Products Anti-Counterfeiting Taskforce (IMPACT), particularly with regard to its composition and the issue of conflicts of interests. IMPACT is being pushed by the WHO Secretariat as the vehicle for implementing programmes to combat counterfeit medicines.

This controversial issue although initially on the agenda of the WHA was later postponed to next year for discussion as a result of the shortening of the WHA due to the swine flu outbreak.

Although off the agenda, the issue of counterfeits was raised on 2 occasions by several developing countries during discussion on WHO’s MTSP, at last week’s WHA.

The MTSP document contains 3 references to counterfeit medicines under Strategic Objective (SO) 11 that pertains to ‘ensure improved access, quality and use of medical products and technologies’.

The MTSP states that ‘Globalization allows for an unprecedented growth in counterfeit medical products’ and that ‘attention should focus on reliable procurement, combating counterfeit and substandard products, cost-effective clinical interventions, long-term adherence to treatment containing antimicrobial resistance’.

It further speaks of ‘providing support to countries for producing, using and exporting products of assured quality, safety and efficacy through strengthening of national regulatory authorities and an international programme to combat counterfeit medicines’.

Under SO 11.2 the Organization wide expectations relate to  ‘International norms, standards and guidelines for the quality, safety, efficacy and cost-effective use of medical products and technologies  developed and their national and/or regional implementation advocated and supported’.

References to international norm setting includes activities related to ‘combat counterfeit’ and IMPACT’s norms as WHO’s draft Medicines Strategy (2008-2013) which elaborates on SO 11.2 refers to ‘supporting countries in implementing the IMPACT strategy’.

The corresponding budget document shows projection of US 50 million for these activities.

On SO 11, Thailand said that since ‘IMPACT was questioned during the last EB meeting in January 2009 in terms of conflict of interest and its composition’ reference to IMPACT in the draft Medicines Strategy should be removed.

It added that this was in line with ‘WHO’s promotion of good governance and transparency".

It further added that WHO, by its constitutional mandate is required to disassociate and de-link itself on the issue of pharmaceutical quality which is health threat to the population from the issues of intellectual property rights violation, which are the explicit goals and ambitions of the IMPACT.

Thailand also said that the magnitude of the scale of counterfeit medicines is unclear as the results of studies are based on selection-biased samples in favour of showing a high problem of counterfeit medicines.

‘WHO should reference its work from reviewed published literature for which authors had clearly indicated no conflict of interests and free from sponsors from pharma industry’, it added.

Thailand also said that ‘limited public health resources should be allocated to the real prioritized problems’.

Brazil expressed great concern with the use of the expression ‘counterfeit medicines’.

Brazil said that it was deeply concerned about the quality, safety and efficacy of medicines and other medical products and that it was working to combat the practice of falsification of medicines and to hinder all forms of illegality related to those products, taking into consideration the protection of public health and the promotion of access to medicines.

Brazil recalled that during the January EB meeting, GRULAC members presented a statement expressing concerns on this issue.

It expressed concern with the idea of having WHO focus its work on ‘an international programme to combat counterfeit medicines’ mentioned in the MTSP.

It emphasized that counterfeit product was defined in the TRIPS Agreement and it related to ‘trademarks’.

Brazil also expressed concern with IMPACT, whose programme it said ‘attempts to impose a revision of WHO's position on the issue of counterfeiting, in order to inhibit the legitimate commerce of good-quality and affordable generic drugs’.

Brazil underlined the role of WHO in helping Member States to strengthen its regulatory capacities based on concerns of health surveillance and regulation and stressed that ‘WHO should not promote the enforcement of intellectual property rights, since it does not fall under the mandate of the Organization’.

Brazil defends the primacy of public health over trade, it added. It requested the Secretariat to revise the present version of the MTSP in order to incorporate a more precise picture on how the debate about the quality of medicines stands in this Organization and to delete all the references to counterfeiting in the text.

India said that since the EB had asked the WHO secretariat to prepare reports for consideration of the WHA and since these reports had not been considered by WHA, a line to the effect that members’ views on these issues should not be prejudged should be added to the MTSP.

Suriname also agreed to the removal of IMPACT as its strategy and composition had been questioned.

Ambassador Angelica Navarro of Bolivia also expressed concern about the inclusion of topics that were not discussed by members. It also said that it did not think there should be a reference to an international programme to combat counterfeit medicines.

To these concerns, Dr. Chan said that she was mindful that the term counterfeit had created concerns and reassured members that WHO will not implement anything related to IP enforcement.

Dr. Chan said that ‘If you don’t like the term, we can use another term’, adding that she would avoid using the term ‘counterfeit’ for substandard as the latter was a huge problem.

WHO will address the problem created by substandard medicines in developing countries with a weak drug regulatory authority, she added.

Substandard medicines can cause resistance and can compromise your authority and credibility of health agencies and thus the public health dimension of sub-standard would be addressed, Chan further added.

She reassured WHA participants that WHO’s role is to provide public health advise.

On another occasion during the WHA, last Friday, as the resolution endorsing MTSP came up for consideration Brazil  supported by Thailand sought clarity as to whether its amendments to the MTSP were included. The Secretariat responded to the query stating that amendments as requested would be made.

Removal of references of ‘counterfeit’ from the MTSP, should have the effect of ensuring that WHO’s resources are not used to fund activities to combat counterfeit medicines as well as the IMPACT initiative.

According to sources, few hours before the close of the WHA , US that had failed to raise any objections during interventions on the MTSP revealed its unhappiness with the outcome on the MTSP to the Secretariat and several delegations.

It is unclear how the Secretariat intends to manage the matter. Sources say as the US as well as the industry are likely to keep the pressure up on the Secretariat on this matter.

The exact text of the revised MTSP incorporating the amendments was not available during the WHA.