TWN Info Service on Health Issues (May10/05)
25 May 2010
Third World Network

Clash over WHO's role in "counterfeits", IMPACT
Published in SUNS #6929 dated 25 May 2010

Geneva, 21 May (Sangeeta Shashikant) -- The ongoing concerns over the role of the World Health Organization (WHO) on the issue of counterfeit medicines and its involvement in the International Medical Product Anti-Counterfeit Task-force (IMPACT) since the 2008 World Health Assembly (WHA) culminated in a clash at the Health Assembly on Wednesday afternoon.

These concerns surfaced during the discussions on the agenda item on "Counterfeit Medical Products" at the week-long session (17-21 May) of the World Health Assembly, an annual gathering of 193 WHO Member States.

The clash among WHO Member States and between WHO Member States and the WHO Secretariat was over whether the WHO should use the term "counterfeit" -- which is defined in the TRIPS Agreement as referring to a specific category of trademark violation -- to also refer to medical products of compromised quality, safety and efficacy (QSE), as well as over WHO's continued involvement in IMPACT.

Frustration with the WHO Secretariat's lack of understanding of the problems surrounding the use of the term "counterfeit" as a public health term, as well as its persistence in promoting IMPACT despite repeated objections raised by WHO Member States since the 2008 WHA was clearly visible in the interventions made by developing countries.

Brazil said that it was important to call "a spade a spade" (referring to the problem of the dual meaning of "counterfeit"), adding that "counterfeit" was a matter for the World Trade Organization (WTO) and World Intellectual Property Organization (WIPO) and not WHO, which should be focused on "falsified" medicines. It also questioned the mandate of WHO.

"Is it a police organisation that looks after importers and exporters of medicines," asked Brazil, adding that it did not favour changing the mandate of the organisation into a police organisation. It further said that it had a problem with a group of private interests waging a war in WHO against generic medicines.

[Since 2008, many concerns have been raised over IMPACT, i. e. relating to participation, transparency, accountability, conflicts of interest, involvement of entities with an interest in promoting the Intellectual Property (IP) enforcement agenda under the banner of "anti-counterfeiting", the extensive involvement of Big Pharma and International Criminal Police Organization (Interpol) etc. For information on concerns over IMPACT, see briefing paper titled "WHO's Counterfeit Programme: Legitimises IP Enforcement Agenda, Undermines Public Health", available at www. twnside. org. sg]

India pointed out that an over-broad definition of counterfeit medicines that went beyond the TRIPS Agreement had the potential to handcuff countries from utilizing TRIPS flexibilities, adding that having a dual meaning to the term "counterfeit" creates confusion between QSE and IPR issues and results in viewing the issue of QSE through the prism of IPRs.

On the issue of IMPACT, India pointed out that the G-8 Summit Declaration at Heilligendam in 2007 endorsed the work of IMPACT in the context of IPR infringement and the economic losses due to counterfeiting and piracy. Thus, "Clearly, IMPACT is ... an instrument of IPR policy and market access by some of the largest economies of the world" and it is "one of the prongs of the multi-pronged TRIPS+ enforcement drive of some developed countries and originator pharmaceutical companies".

Concerns raised by India and Brazil were echoed by many other countries including Venezuela, Bolivia, Ecuador, Bangladesh, Egypt, Iran and Pakistan, which also pointed amongst others to the lack of accountability of IMPACT, as it operates outside the purview of WHO Member States.

A few developing countries such as Nigeria insisted on using the "counterfeit" terminology, saying that there was mounting evidence that national measures were insufficient and that there was a need for more sophisticated expertise. It said that the matter was about "life and not about technology, politics".

The developed countries defended the WHO's work on "counterfeits" as well as the work of IMPACT. IMPACT was established "to enable its broad range of partners to work towards common goals under WHO leadership," said Spain, on behalf of the European Union. The US emphasised that "WHO is the forum to address the public health issues related to counterfeit, falsified or substandard medical products," and that other issues could be addressed in other forums.

The various interventions triggered a response from WHO Director-General Dr. Margaret Chan, who said that WHO would focus on the public health problems, and confirmed that the WHO had no role to play in IPR enforcement. She spoke of the need to take a multi-disciplinary and multi-faceted approach but only on the public health aspect and not on law enforcement or IP enforcement.

Dr. Chan also said that the perception that WHO was waging a war on generic medicines was not good, and if there is anything that WHO is doing to attack genuine, quality, generic medicines, "I will punish those staff".

She stressed that as a public health organization, the WHO did not want to create any perception that it was supporting or enforcing IP law. Dr. Chan said that the challenge is how to collaborate with other agencies without necessarily being part of their agenda. She added that she would like to minimize the perception about working for Interpol (a member of IMPACT). "WHO is not a police department. We must maintain our independence," she said.

She asked to be allowed to continue addressing public health dimensions using the term substandard/falsified/spurious/counterfeit medical products until there was agreement on the matter.

Brazil said that it was not comfortable with the intimate relationship between WHO and IMPACT, since Member States never gave a mandate to WHO to be the Secretariat of IMPACT. It added that IMPACT was not the right body for dealing with QSE issues.

Dr. Chan however continued to defend IMPACT, saying that IMPACT was formed before she took office. The WHO is heavily involved in partnerships, she added, giving the example of UNITAID (a partnership which was never approved by the WHA).

Dr. Chan's response provoked the ire of some countries.

India said that it was not fair to compare UNITAID with IMPACT, as the former was about access (to treatment for HIV/AIDS, malaria and tuberculosis) for the benefit of developing countries, while the latter was controversial. Venezuela appealed to Dr. Chan to help developing countries abolish IMPACT, stressing the need for the WHO's support to contribute to developing countries' interests.

Kenya said that if the Director-General is not happy with the marriage, then get a divorce. It called for an end to the marriage between WHO and IMPACT. It said that IMPACT was helping developing countries to come up with anti-counterfeiting legislation, which has been problematic for health and access to medicines. It further said that IMPACT has been acting as though it represents WHO expertise in Africa, adding that Kenya's law on counterfeit products resulted from advice given by IMPACT, which has also been approaching other countries in Africa, such as South Africa.

Brazil supported Kenya's call for a divorce, adding that if IMPACT wants to have a life of its own, "find another spouse" that's fine - but no marriage with the WHO.

Concerns raised by developing countries are also reflected respectively in three separate draft resolutions presented during the WHA: Draft resolution by the Union of South American Nations (UNASUR) (A63/A/Conf. Paper No. 4); Draft resolution by the South East Asian countries (SEARO) (A63/A/Conf. Paper No. 5); and draft resolution by the Africa Group (AFRO) (A63/A/Conf. Paper No. 6).

Following the opening statements on the agenda item, there was recognition by India and Brazil, and others that it may be premature to attempt to negotiate these resolutions, and they proposed the formation of an intergovernmental working group to find some resolution to the matter, including effects of using different terms, the relationship between WHO and IMPACT, and an examination of the three draft resolutions that have been submitted to the WHO, before the next WHA.

India said that it attaches the highest importance to access to affordable, safe, high quality and efficacious medicines and that its delegation believed in the importance of promoting universal access to medicines and health for all as part of the commitment to the Right to Health, as an integral part of Economic, Social and Cultural Rights. It added that it supported international cooperation to promote these objectives as well as international efforts to fight against products that do not meet QSE standards. It further said that it upholds the primacy of health over IPR issues as agreed in the Doha Declaration on TRIPS and Public Health.

Referring to the Secretariat's report on "Counterfeit medical products" (A63/23), India said that it has several concerns regarding the use of the term "counterfeit" in the work of WHO, i. e. it may be counterproductive to define a "counterfeit medicine" as encompassing anything more than the narrow class of trademark infringement contemplated in the TRIPS Agreement. It further said that adopting an over-broad definition of counterfeit medicines has the potential to handcuff countries from utilizing flexibilities in the TRIPS Agreement.

India also said that any issue regarding the definition of "counterfeits" can be dealt with only in the WTO, which is the custodian of the TRIPS Agreement, and that the WHO, with its public health mandate, should remain focused on QSE issues. It recalled the Director-General's suggestion at the 62nd WHA to replace the use of the term "counterfeit" with an appropriate term to describe medical products of compromised QSE, and said that "It is time to work on that suggestion".

India pointed out that the Secretariat's own report (A63/23) acknowledges that "no accurate data on the extent of the problem exists" and that there are difficulties in compiling data pertaining to counterfeits. It further said that "projected data has often conflated different terms (counterfeits, substandard etc.) and given misleading proportions of the problem" and that "In the absence of a clear understanding of the term, any statistical analysis is devoid of value".

India also said that it was obvious from WHO's preliminary summary presented to Member States on use of the term "counterfeit medicines and/or equivalent in national legislation" that there was no consensus on the use of the term "counterfeit" and that different terminologies were used including "counterfeits", "falsified", "illicit", "illegal, "unregistered", "unauthorized", "adulterated" etc. It added that pursuing the issue of "counterfeits" without a consensus on its use is a non-starter and that Members need to explore other alternatives to describe medical products that compromise QSE.

Another concern expressed by India is viewing the issue of QSE through the prism of IPRs. It said that this creates a confusion between QSE and IPR issues, adding that the work of IMPACT is premised on this duplicity and it only furthers the work of the proponents of TRIPS-plus IP enforcement norms.

India said that the world needs to draw lessons from the fallout of this deliberate confusion in the form of numerous drug seizures of generic drug consignments at EU ports. It said that the EU has justified the drug seizures on the grounds of tackling substandard/fake/spurious medicines but the actual impact has been denial of generic drug supplies to several developing countries, including Least Developed Countries (e. g., Brazil, Peru, Colombia, Ecuador, Mexico, Nigeria, Venezuela and Vanuatu).

On IMPACT, India said that it was well established that IMPACT had not been created on the basis of a decision by Member States nor have Member States approved its Terms of Reference. It added that there is no intergovernmental oversight by any organ of IMPACT's operations and work. It expressed concern over its non-representative nature, lack of transparency and conflicts of interest arising out of the involvement of Big Pharma, and the considerable opacity regarding the source of funding and decision-making processes of IMPACT. India also referred to the FAQ posted on IMPACT's website, which acknowledged that "to date, participation in task force meetings has not required any declaration of interests".

India recalled that it is for these reasons that a proposal to endorse the recommendations of IMPACT was rejected in the 124th Executive Board meeting in January 2009. Noting this, India said "we do not understand how IMPACT has become the main conduit for WHO's work on counterfeit medicines" mentioned in paragraph 16 of the Secretariat's report A63/23.

India stressed that it "cannot accept any IMPACT document becoming a WHO document without express consideration and approval in WHO governing bodies". It said that in its view IMPACT served less the purpose of public health and more the purpose of IPR enforcement and market access for developed countries and the big pharmaceutical companies.

India added: "It is not surprising that the G-8 Summit Declaration at Heiligendam in 2007 endorsed the work of IMPACT in the context of IPR infringement and the economic losses due to counterfeiting and piracy".

"Clearly, IMPACT is ... an instrument of IPR policy and market access by some of the largest economies of the world" and it is "one of the prongs of the multi-pronged TRIPS+ enforcement drive of some developed countries and originator pharmaceutical companies," it further said.

India recommended that WHO continue its focus on its mandate on public health and play its role in strengthening national health surveillance systems and promoting access to medicines, saying that a diversion into issues of IP enforcement will dilute WHO's work in its mandated areas.

Brazil said that in any negotiation it is important to call "a spade a spade", adding that there are two meanings for "counterfeit" around the room; one meaning IP infringement and the other meaning falsified medicines.

Brazil also questioned the mandate of WHO. "Is it a police organisation that looks after importers and exporters of medicines," Brazil asked, adding that it did not favour changing the mandate of this organisation into a police organisation. It added that some countries seem to disguise trade and commercial interests under public health. It said that while it was in favour of discussing falsified medicine in WHO, the issue of counterfeit medicine is a subject for WIPO and WTO.

It also said that it had a problem with a group of private interests waging a war in the organisation against generic medicines. It stressed the importance of intergovernmental processes in dealing with the matter, adding that the matter was not an exercise for the industry, which has a conflict of interest. It called for a halt to IMPACT.

Bangladesh also reiterated that the issue of counterfeit (medical products) tends to conflate an issue of general public health concern with IP issues, adding that any notion of counterfeit that goes beyond the TRIPS Agreement is "TRIPS-plus". It also said that there is a deliberate attempt to confuse IP and health matters, which raises concern about legitimate access to medicines in developing countries. It added that WHO had said that it would reconsider the use of the term "counterfeit" but there has been no progress on the matter.

Egypt pointed to the need for a clear distinction between ensuring the QSE of medicines, which is a public health issue directly within the remit of WHO, and the issue of "counterfeiting", which is a term pertaining to the field of IP, and specifically a problem of trademark violation - as referred to in the TRIPS Agreement. It added that the latter issue should be dealt with under relevant national IP legislation and by more competent Geneva-based organizations, chiefly the WTO and WIPO.

Attention should be paid at the WHO, and solutions must be urgently found from a public health perspective, and not through the lens of IPRs. It also pointed to the need to not confuse the issue of substandard medicines (which is lacking in QSE) and represents a far larger risk to public health than counterfeit medicines.

It also pointed to its own legislation, i. e. Law No. 281 of 1994 that addresses issues of QSE of drugs, medical products and medicinal herbs, and Law No. 82 of 2002 on IP protection that addresses the issue of counterfeiting. It said that only through a clarification of these two issues can national legislation address effectively and efficiently the serious public health problem of substandard medicines pertaining to their QSE and not confuse issues of IP protection that relate to standards of protection that vary from one jurisdiction to the next, and particularly so between developing and developed countries.

On the issue of IMPACT, Egypt noted that it is an initiative that does not enjoy any mandate from WHO's governing bodies and that there are questions arising with regard to issues of representation in IMPACT, conflict of interest, questions on the quality and accuracy of data, including statistics used - all of which pertain to objectivity issues.

Iran also stressed the need to remain focused on the issue of falsely labeled, spurious and substandard drugs and avoid issues pertaining to IPRs, which are better handled by other agencies where private rights-holders play an important role. It pointed to the need to avoid advancing the IP enforcement agenda through a public health framework, and stressed on the need for an effective programme to address QSE issues.

Pakistan said that although healers of the world have gathered, the focus was on IP matters instead. It stressed that "counterfeit" should not be mixed up with QSE issues, adding that public health takes a backseat when it comes to IP issues. It also expressed concern over IMPACT's role.

Spain, on behalf of the EU, said that it was not yet time for a divorce (between WHO and IMPACT), adding that the umbrella of WHO was essential in the fight against counterfeit (medical products). In this regard, it supported IMPACT and said that it was time to further think about the relationship between WHO and IMPACT.

The US said that counterfeit, falsified and/or substandard medicines severely impacts populations, adding that it was a global threat. It further said that the lack of reliable data prevents public health policymakers from comprehensively addressing the issues surrounding the problem in a systematic, sustainable way.

It recognized WHO and IMPACT for their work to address the public health aspects of counterfeiting of medical products. It also spoke of the need for outreach and coordination with international regulators and law enforcement.

Switzerland acknowledged that IMPACT's mandate needed clarifying but said it appreciated its technical work. +