TWN Info Service on Health Issues (May10/04)
17 May 2010
Third World Network

NGOs concerned over WHO's role in "counterfeit" drugs, IMPACT
Published in SUNS #6924 dated 17 May 2010

Geneva, 12 May (Kanaga Raja) -- More than forty-five non-governmental organizations (NGOs) have voiced concern over the involvement of the World Health Organization (WHO) in the issue of "counterfeit" medical products, which they said will have adverse consequences for access to affordable medicines while also failing to address the very real problem of proliferation of pharmaceuticals with compromised quality, safety and  efficacy.

The Open Letter is available at:

In an open letter to WHO Director-General Dr Margaret Chan, the civil society organizations were also troubled by WHO's engagement in the International Medical Product Anti-Counterfeit Taskforce (IMPACT).

Among the concerns raised by the NGOs over WHO's role in IMPACT include its links to entities that are engaged in matters pertaining to Intellectual Property (IP) enforcement, the central role played by the International Federation of Pharmaceutical Manufacturers' Associations (IFPMA) in IMPACT's activities, the lack of transparency surrounding IMPACT's activities and the lack of accountability, as IMPACT has operated outside the purview of WHO Member States.

(IMPACT was launched by the WHO in 2006, and according to the health agency, it is aimed at building "coordinated networks across and between countries in order to halt the production, trading and selling of fake medicines around the globe.")

(According to the WHO, IMPACT is "a partnership comprised of all the major anti-counterfeiting players" including international organizations and enforcement agencies such as Interpol, Organization for Economic Cooperation and Development, World Customs Organization, World Intellectual Property Organization, World Trade Organization, pharmaceutical manufacturers' associations such as IFPMA, as well as NGOs and drug and regulatory authorities.)

The open letter by the civil society groups comes just as the World Health Assembly (WHA) of the World Health Organization begins its annual week-long session on 17 May. The issue of "Counterfeit Medical Products" is on the agenda of the Assembly.

The open letter was signed by amongst others the Berne Declaration (Switzerland), Centre for Trade and Development (CENTAD, India), the Delhi Network of Positive People (DNP+, India), Edmonds Institute (US), Health Action International (HAI, global as well as regional branches), Health GAP (US), Oxfam International, Peoples Health Movement - Global, Research Foundation for Science Technology and Ecology (India), SEATINI (Uganda) and Third World Network.

The open letter was also accompanied by a separate joint NGO statement by Third World Network and Health Action International - Global, voicing serious concern over WHO's participation in, and endorsement of, IMPACT. (See details of the joint statement below.)

In the open letter to Director-General Dr Chan, the civil society groups said that the term "Counterfeit" is defined by the WTO-TRIPS Agreement as referring to a specific category of trademark violation and in some legislation to all other intellectual property (IP) violations as well.

Today, they said, it is widely known that business interests and governments in OECD countries that represent them are making use of trade agreements, plurilateral government initiatives (e.g. the Anti-Counterfeit Trade Agreement) and programmes in international agencies to set and enforce higher IP standards under the heading of "Counterfeiting".

It is against this background that WHO's use of the term "Counterfeit" to refer to a range of pharmaceutical quality and safety problems is of most concern, said the groups. They note that not only has this resulted in confusion but also offered a convenient route for proponents of an extended IP agenda to press for inappropriate IP enforcement standards in developing countries under the false premise that such standards will deliver quality assured pharmaceuticals to the people.

In this context, the letter cited as an example, the East African region where several anti-counterfeiting legislation have been enacted or are in the process of being enacted. "Whilst the proclaimed rationale for such legislation is to protect the public from unsafe products, these legislations are in actual fact only about protecting the rights of IP holders to the detriment of access to affordable generic pharmaceuticals."

Most of these legislations define "Counterfeit" products as being substantially similar or identical to IP protected products, which effectively makes every generic pharmaceutical a counterfeit. In Kenya, enactment of the Anti-Counterfeit Act 2008 has been challenged by people living with HIV/AIDS on the grounds that enforcement and application of the Act will deny them access to affordable essential medicines and thus deny their Right to Life.

The open letter said: "Equating 'Counterfeit' (a term defined in the TRIPS Agreement) to spurious  (i.e. products with no or insufficient or toxic active ingredients) and falsely labelled pharmaceutical products not only undermines confidence in much-needed affordable quality generic products but also results in public health problems being addressed through an IP enforcement lens. Such an approach will not deliver the solutions needed to address the proliferation of spurious and falsely labelled pharmaceuticals, which arise irrespective of whether there is an IP violation."

Moreover, said the groups, confusion over the use of the term "Counterfeit" makes it impossible to obtain data on the true extent of the proliferation of medicines which do not meet quality, safety and efficacy standards because the data on "Counterfeit" would also refer to situations involving IP infringements.

"We would also point out that empirical, reliable and transparent statistics about 'counterfeit drugs' is non-existent and that the only comprehensive global collection of data on drug counterfeiting is held by the Pharmaceutical Security Institute (PSI), an industry body that fails to make information available for public scrutiny."

In addition, the civil society groups said that they are troubled by WHO's engagement in IMPACT and share the concerns of the many Member States that have questioned the legitimacy of IMPACT. In particular, concerns have been raised about participation in IMPACT's activities especially the central role played by IFPMA in IMPACT's activities, lack of transparency surrounding IMPACT's activities, and lack of accountability, as IMPACT has operated outside the purview of WHO Member States.

Concerns have also been raised by the groups about IMPACT's link to entities which are very much engaged on matters pertaining to IP enforcement under the banner of "anti-counterfeiting activities", such as the Interpol, OECD, the World Customs Organisation (WCO), the World Intellectual Property Organization (WIPO), the European Commission and the multinational pharmaceutical industry.

"This further raises concern about conflicts of interests, about which WHO by its own admission, has taken no measures to address. It is also particularly noteworthy that IMPACT has been identified as an initiative involved in IP enforcement."

The groups cited another key concern in respect of IMPACT's Principles & Elements for National Legislation Against Counterfeit Medical Products, which they said are not only problematic because they emerge from an initiative whose legitimacy is in question but also because it includes a call for addressing counterfeit medical products inter alia by establishing or enhancing intellectual property legislation, contains provisions that could result in TRIPS-plus implementation as well as non-tariff barriers for trade in medical products which could undermine access to affordable medicines, become entry barriers for generic industries, particularly of developing countries, and affect use of flexibilities such as parallel importation of good quality medicines.

According to the open letter, these elements also promote measures that have led to seizures/detainment of good quality pharmaceuticals in transit at European ports on request of MNCs (multinational corporations) on suspicion of IP violations, which resulted in delayed treatment for developing country patients.

"Moreover, the approach adopted by IMPACT is faulty as it fails to address the root causes for the proliferation of pharmaceuticals with compromised quality and safety, in particular the high price of pharmaceutical products which results in inequitable access and the problem of weak regulatory capacity in developing countries in terms of facilities, financial and human resources.

"The above-mentioned concerns raised by Member States have been largely ignored, with the WHO continuing to promote use of the term 'Counterfeit', and to endorse IMPACT including by allowing IMPACT to use WHO's logo on its documents, even where such documents are prepared by the pharmaceutical industry. Moreover, despite repeated objections to IMPACT and its Principles & Elements, WHO also appears to be pushing for the adoption of such elements as a WHO document bypassing scrutiny of the World Health Assembly," says the open letter to Dr Chan.

"We are of the view that WHO's continued involvement in IMPACT threatens to undermine WHO's credibility as an organisation that is impartial and that upholds the interests of public health," the groups stressed.

In view of the above, the civil society groups urged the WHO Secretariat:

-- to explore use of other terminologies through Member-driven process to capture the problem of pharmaceuticals with compromised quality, safety and efficacy, substituting the term "Counterfeit" which is already defined in the TRIPS Agreement;

-- to distance itself from IMPACT, its activities and its Draft Principles & Elements and to stop functioning as the Secretariat of IMPACT;

-- to withdraw WHO's logo from all IMPACT documents and to ensure that WHO does not endorse any other activities that promotes the IP enforcement agenda; and

-- to reorient its programme towards addressing the real causes and solutions to pharmaceuticals with compromised quality, safety and efficacy, in particular focus its attention to dealing with high prices of pharmaceuticals, ensuring timely availability of affordable pharmaceuticals, as well as strengthening the capacity of drug regulatory authorities.

In a separate joint statement voicing concerns on WHO's participation and endorsement of IMPACT, Third World Network and Health Action International said that IMPACT has been identified as an intellectual property (IP) enforcement initiative, operating outside the purview of WHO Member States and it fails to address the root causes of the proliferation of medicines with compromised quality and safety, such as high medicines prices.

"WHO's involvement in IMPACT legitimises the TRIPS-plus-plus IP enforcement agenda pushed by OECD governments and businesses and undermines public health. It threatens WHO's credibility as an institution charged with protecting the Right to Health," said Sangeeta Shashikant, from Third World Network.

Sophie Bloemen from Health Action International commented: "governments and intergovernmental bodies should not spend time advancing and strengthening the IP rights of pharmaceutical companies, who are free to protect their private rights at their own expense, and instead should focus on tackling the key issues that affect public health."

"At a time when millions of people still go without the medicines they need due to high prices, ongoing WHO participation in IMPACT is a major step in the wrong direction. Enabling the pharmaceutical industry to aggressively enforce intellectual property rights in developing countries does nothing to lower medicine prices or improve the quality of medicines" added Rohit Malpani of Oxfam.

According to the joint TWN-HAI statement, despite the many pressing issues of quality, safety, and efficacy of medicines, there is still a narrow focus on intellectual property in relation to medicines and the focus on so-called "counterfeit" medicines means that even fewer resources are available to address real public health threats from compromised quality and safety.

Dr. Gopal Debade, Co-Convener of the All India Drug Action Network (AIDAN), said that "high prices and unethical promotion of drugs are the basic factors responsible for the circulation of medicines with compromised quality. WHO should focus on these fundamental issues and not on the enforcement of IP rights."

Kevin Outterson, Associate Professor and Director of the Health Law Program at Boston University, reinforced this point by stating that "counterfeiting is the intentional violation of trademark law - and nothing more. The patent-based drug industry has tried for years to confuse the issue, tricking policy makers into distrusting and blocking genuine generic drugs through patent laws and border enforcement. Generic drugs save lives and should be promoted."

Loon Gangte of the Delhi Network of Positive People (DNP+) in India said: "WHO's primary concern should be public health and not the enforcement of intellectual property rights. As a public health organisation, it should not pursue an agenda that puts patients' lives in danger".

According to the TWN-HAI statement, the WHO should refocus its efforts on addressing the wider public health threats by: promoting intergovernmental discourse on medicines quality, safety and efficacy; strengthening the capacity of drug regulatory authorities; addressing high medicine prices and other barriers to access; and preventing the unethical promotion and marketing of medicines that divert already limited health resources toward high-priced medicines instead of affordable essential medicines.

Meanwhile, according to some sources, seventeen NGOs have also written to Mr Anand Grover, the UN Special Rapporteur on the right of everyone to the enjoyment of the highest attainable standard of physical and mental health, requesting his intervention on anti-counterfeiting initiatives in WHO to safeguard the Right to Health. +