TWN Info Service on Health Issues (Nov15/05)
19 November 2015
Third World Network

WHO proposes to join Global Fund's IP enforcement initiative

Geneva, 19 Nov (K M Gopakumar) – The World Health Organization has proposed to join the intellectual property enforcement initiative of the Global Fund to Fight AIDS, Tuberculosis and Malaria (Global Fund).

This intellectual property (IP) enforcement initiative, known as the Global Steering Committee (GSC) for the quality of medical products, raises concerns over the health body's role in IP enforcement.  The Global Fund established the GSC as a multi-stakeholder platform.

According to a press release issued by the Global Fund on 23 March 2015, "The Global Steering Committee is harnessing the collective capabilities and innovations of major health development institutions to combat falsified, substandard, stolen and diverted medicines and other health products".

Norbert Hauser, former Inspector-General of the Global Fund, currently heads the GSC. According to the press release, "Representatives from regulatory and law enforcement agencies, non-governmental organizations and the pharmaceutical industry, including innovators and generic manufacturers, will be invited to join the GSC to contribute to an enhanced drug quality assurance framework, supply chain integrity, and expanded public awareness".

The fourth meeting of WHO's Member State Mechanism (MSM) on Substandard/Spurious/Falsely Labelled/ Falsified/Counterfeit Medical Products (SSFFC) is to take a decision on WHO's participation in the GSC.

The MSM Steering Committee in March allowed WHO to participate as an observer in the GSC. The MSM meeting is taking place at the WHO headquarters in Geneva on 19-20 November.

[The MSM was established through a World Health Assembly resolution to guide WHO's activities on quality, safety and efficacy of medicines without conflating it with intellectual property enforcement.]

The MSM Steering Committee, in its September meeting, asked the WHO Secretariat to critically review the potential benefits of their participation in the GSC, as well as any potential risks/obligations.

The Secretariat has come out with a report titled "WHO's participation in the global steering committee for quality assurance of health products".

In this report, the Secretariat states: "The risk of failing to collaborate in these areas of overlap may lead to the wastage of resources and the overburdening of Member States with a growing number of initiatives that may also be in competition with one another - generating confusion rather than clarity".

Further, it states that there may be merit in certain well-targeted and aligned initiatives. Three examples are listed covering each of the overlapping areas: regulatory strengthening, communication education and awareness- raising, and surveillance and monitoring of SSFFC medical products.

Astonishingly, the report is silent on the risk of participation in the GSC.

According to the Secretariat's paper, the current core members are the World Bank, the GAVI Alliance, United Nations Development Programme (UNDP), United States President's Malaria Initiative, USAID, United States Food and Drug Administration, UNITAID, The New Partnership for Africa's Development and INTERPOL.

The Secretariat's paper is silent on the non-core members which concerned observers suspect to be private sector actors, especially the pharmaceutical industry.

In an article in the America Journal of Tropical Medicine, authors Martin Cinnamond and Tom Woods, working with the Global Funds Inter Agency Task Force, wrote: "The GSC for quality assurance of health products will harness the collective efforts of multilateral and bilateral organizations, regional authorities, NGOs, manufacturers, and technical partners to facilitate an enhanced framework for both quality and supply chain integrity of medicines and health products" (http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4455089/).

However, the Secretariat's paper does not name any private sector participation. It carefully names only core members. Nevertheless, the Global Fund has a Memorandum of Association with the International Federation of Pharmaceutical Manufacturers & Associations (IFPMA) "to fight fake medicines" (http://www.theglobalfund.org/en/news/2013-12-02_Private_Sector_Engages_i n_Global_Fund_Replenishment/).

[The abovementioned article states that the Joint Interagency Task Force (JIATF) "is an initiative that offers a new, proactive, and intelligence-led approach to safeguarding the delivery of quality medicines for major donor organizations and protecting public health by identifying falsified medicines in countries where they appear. By also focusing on the issue of stolen and diverted medicines, JIATF provides an important assurance mechanism".]

The GSC initiative is another instance of intellectual property (IP) enforcement initiatives that conflate quality, safety and efficacy of medicines with IP enforcement. Neither GSC nor the Global Fund provide any definition of the term "falsified" medical products.

The available definition is from the European Union Directive on Falsified Medicines that defines 'falsified' as: "Any medicinal product with a false representation of: (a) its identity, including its packaging and labelling, its name or its composition as regards any of the ingredients including excipients and the strength of those ingredients; (b) its source, including its manufacturer, its country of manufacturing, its country of origin or its marketing authorisation holder; or (c) its history, including the records and documents relating to the distribution channels used. This definition does not include unintentional quality defects and is without prejudice to infringements of intellectual property rights."

Thus, the false representation of packaging and labelling provides amble scope for converting a trademark infringement or alleged infringement into a case of a falsified medicine.

According to the March press release, GSC is also harnessing the collective capabilities and innovations of major health development institutions to combat stolen and diverted medicines and other health products.

Observers point out that combating the diversion of medicines is in effect a combat on parallel importation, one of the flexibilities guaranteed under the TRIPS Agreement.

(Parallel importation allows the legal importation of medicines from a country, where the product is legally introduced and available at a lower price to another country where the originator's product is available at a higher price, without the permission of the IP owner.)

Further, stealing of medicines does not necessarily compromise the quality of medicines. Often the quality link of stolen medicines is established through a farfetched way that these medicines can be repackaged as some other medicine and pushed into the supply chain, which poses a threat to the safety of the patient.

The IP enforcement orientation of GSC is very clear from the involvement of Tom Woods, who co-authored the above-mentioned article in the American Journal of Tropical Medicine. Tom Woods is a Senior Advisor to the Global Fund and represents the Global Fund in the GSC. Tom Woods is also instrumental in the setting up of the JIATF.

However, neither the Global Fund nor the WHO Secretariat have disclosed the fact that Tom Woods is the President of Woods International LLC, a Washington-based private sector consulting firm.

According to the website of Woods International, both the firm and Tom Woods are involved in many activities related to anti-counterfeit medicines. The website discloses that one of their projects is to "provide advisory and representational services for one of the largest multilateral aid agencies focused on safe medicines in the developing world". This representation project makes him represent the Global Fund in the GSC and JIATF.

According to the firm's website, "Woods International raises public awareness through policy dialogue and advocacy. We also create partnerships for the deployment of programs and technology aimed at eradicating harmful fake drugs".

Further, Woods International claims that: "These public and private collaborations help equip and train regulatory and enforcement bodies with the tools and know-how they need. Woods International is building a global coalition made up of Leading Policy Institutions, International donor agencies and governments, Health, regulatory, and enforcement bodies within the developing world, private sector providers of technology, the pharmaceutical industry, public policy institutions and non-governmental organizations". (http://www.woodsinternationalllc.com/--fighting_falsified_and_substandard_medicines).

Further, the website clearly claims that Woods International is responsible for setting up of JIATF and the GSC. It states: "Building international coalition of multilateral development agencies to tackle the challenge of falsified, substandard, diverted and stolen medicines known as the Global Steering Committee for Quality Assurance of Health Products."

In other words, Woods International appears to use the Global Fund as a camouflage to host the JIATF and the GSC to serve its commercial interest of IP enforcement.  The Woods International website provides a number of events including on counterfeit medicines either organised or participated by Tom Woods. Some of these events are:

* June 24-25, 2015 - Global Steering Committee, Global Fund, and KPMG host workshop on access to safe medicines in developing countries. London, UK. Tom Woods to Chair.

* June 22, 2015 - Global Steering Committee on Quality Assurance of Medicines, Geneva, Switzerland.

* September 18, 2014 - Innovations at the Global Fund, PMI, and PEPFAR, Washington, DC Capitol Hill. Tom Woods chairs discussion.

* In June 2013, Tom Woods directed the senior policy conference on Access to Safe Medicines at the prestigious Wilton Park conference facility in Sussex, England. The meeting was broadly described as the most diverse gathering of regulators, manufacturers, technology providers, non-governmental organizations, and academics ever assembled on the topic.

* May 2013, Tom Woods visits China to meet with SFDA officials in Beijing as well as provincial level regulators in southern China.

* February 14, 2013 in Washington, DC, Woods International participates in the Institute of Medicine Workshop on International Regulatory Harmonization.

* February 4, 2013, Woods International supports US Pharmacopeia's Spectral Library Consortium meeting at the USP Headquarters in Rockville, MD.

* November 28-29, 2012 in Washington, DC, Woods International co-convened the 7th Global Forum on Pharmaceutical Anti-counterfeiting in partnership with UK-based Reconnaissance International. Tom Woods chaired the opening session.

It is really surprising that the WHO Secretariat, currently engaging in the process of enhanced safeguards through due diligence and risk assessment prior to taking decisions on engagement, did not put out this information related to the GSC and JIATF in the public domain.

The participation of INTERPOL is clear evidence of the IP enforcement agenda by conflating quality issues of medicines with IP issues.

INTERPOL has taken USD 4.5 million for the creation of INTERPOL's Pharmaceutical Crime Programme to further build on the work of its pharmaceutical Medical Product Counterfeiting and Pharmaceutical Crime unit (http://www.interpol.int/News-and-media/News/2013/PR031).

The close association of INTERPOL with pharmaceutical companies including the acceptance of financial resources raises serious issues of conflict of interest in the GSC process.

The cooperation between INTERPOL and the Global Fund already resulted in the conflation of quality issues with IP.

The Global Fund website carries a photograph of INTERPOL operations on counterfeit medicines as an activity of seizure of diverted medicines or counterfeit involvement with INTERPOL.

The Global Fund claims that "As part of Interpol's coordinated effort known as Operation Porcupine, 2,000 police and officials took part in raids across West Africa at the end of May, seizing almost 200 tons of fake or illicit medicines. In partnership with the Global Fund, The UN Operation Cote d'Ivoire (UNOCI) and the World Health Organization, the raids targeted markets, shops, storage facilities, pharmacies and private homes in order to seize diverted, stolen, or counterfeit medicines. During the raid in Lome, police discovered malaria drugs (ACTs) which had been diverted from their intended markets as well as counterfeit ACTs" (http://www.theglobalfund.org/en/blog/2014-06-26_Combatting_Theft_and_Counterfeiting_of_Medicines_in_West_Africa/).

This clearly shows that the Global Fund engagement is not confined to quality of medicines but even includes prevention of parallel importation, an important flexibility in the TRIPS Agreement.

The WHO Secretariat's paper mentions five Working Groups without naming the members of the working groups.

These Working Groups are: (1) supporting NMRA (national medical regulatory agencies), drug quality and supply chain authority; (2) data gathering, reporting, sharing, and analysis; (3) information dissemination and public awareness; (4) enforcement; and (5) public-private financing.

Some of the working groups are similar to the International Medical Product Anti-Counterfeit Taskforce (IMPACT), a multi-stakeholder platform for IP enforcement hosted by WHO till 2011.

The IMPACT secretariat was shifted out of WHO due to opposition from many Member States. IMPACT also worked in the same format of working groups.

These working groups are: Communications Working Group, Legislative and Regulatory Infrastructure Working Group, Regulatory Implementation Working Group, Enforcement Working Group and Technology Working Group.

It is not very clear if the IMPACT working groups are still functioning.

However, even though the Secretariat of IMPACT was shifted out of WHO, the latter continues to host IMPACT website (http://www.who.int/impact/en/).

One developing country delegate told Third World Network (TWN) that the Secretariat is trying to avoid the mistake they committed in the case of IMPACT where an initiative was launched without obtaining the permission of Member States.

Many Member States objected to hosting the IMPACT Secretariat in WHO as well as WHO's participation in IMPACT without the approval of governing bodies.

The same delegate also said that the Secretariat is trying to obtain Member State consent with "half-cooked information" and not disclosing vital information necessary to make an informed decision.

Several observers point to the lack of transparency in the activities of GSC. The Global Fund website provides little information.

There is little information regarding the composition of the working groups, and the financing mechanism of the GSC is not available on the website.

The MSM is expected to consider the participation of WHO in the GSC on 20 November.