TWN Info Service on Health Issues (Mar11/01)
4 March 2011
Third World Network

Members meet to shape role in QSE, examine IMPACT
Published in SUNS #7100 dated 3 March 2011

Geneva, 2 Mar (Sangeeta Shashikant*) -- The Working Group on Substandard /Spurious/Falsely-labelled/Falsified/Counterfeit Medical Products (SSFFC) of the World Health Organization (WHO) began discussions Monday on defining the role of WHO in matters pertaining to the quality, safety and efficacy (QSE) of medical products.

A particular focus of the Working Group, which is meeting for the first time, will be on WHO's role in the prevention and control of medical products of compromised QSE, as well as its relationship with the International Medical Products Anti-Counterfeiting Task-force (IMPACT).

The Working Group is meeting from 28 February to 2 March.

Since 2008, the WHO has been mired in controversy over its continued use of the term "counterfeit" to refer to QSE-compromised medical products, with a definition that is inconsistent with the WTO-TRIPS Agreement, as well as due to its involvement in IMPACT.

[The only multilaterally agreed definition of "counterfeit" is in the TRIPS Agreement wherein the term refers to a specific category of trademark infringements. WHO's use of the term "counterfeit" to refer to QSE-compromised medical products led to concerns that WHO was conflating the issue of QSE with Intellectual Property Rights (IPRs).

[WHO's involvement in IMPACT has been particularly tendentious. IMPACT is a multi-stakeholder initiative with a heavy private-sector presence that was initiated without a mandate from the World Health Assembly. WHO serves as the Secretariat for IMPACT. The G8 countries and the European Union have identified IMPACT as an important initiative in the context of the Intellectual Property (IP) enforcement agenda.]

At the 2010 World Health Assembly (WHA), a group of developing countries, concerned about WHO promoting an IP enforcement agenda under the guise of dealing with compromised medical products, sought to discontinue the use of the term "counterfeit" in the context of compromised medical products and to disengage WHO from IMPACT. Other countries, on the other hand, insisted on the status quo and even were for enhancing its work.

The divisive wrangle during the 2010 Assemblies led to the formation of the Working Group, with a mandate to examine "from a public health perspective, excluding trade and intellectual property considerations", WHO's role in measures to ensure the availability of affordable QSE medical products and in the prevention and control of medical products of compromised QSE, WHO's relationship with IMPACT, and other issues as raised in the various draft resolutions proposed by different groupings during the Assemblies.

The Assemblies also diffused the heated differences over terminologies by provisionally agreeing to substitute the term "counterfeit medical products" with substandard/spurious/falsified/falsely-labelled/counterfeit medical products.

Preliminary interventions made during the Working Group suggest that divergences remain, albeit perhaps with somewhat less intensity.

Unlike during the Assemblies, WHO Member States did not insist on using the terminology of "counterfeit medical products" to refer to compromised medical products. Some developing countries also pointed to the need to better understand the problem before agreeing on terminology.

However, some developed countries such as Canada and the European Union took up the Secretariat's suggestion of using the term "falsified products" and proposed definitions and principles on the terminology.

On the issue of IMPACT, Brazil and India pointed out that its establishment has been without a mandate from WHO Member States, and called for a moratorium on its work and relationship with the WHO. Furthermore, IMPACT's links to the IP enforcement agenda and the extensive participation of the private sector in IMPACT's activities were some of the issues raised.

The African Group also appeared to have moved from a position that unequivocally supported IMPACT and its relationship with WHO to one that called for the status of IMPACT to be reviewed.

Many developing countries also stressed on the need to remain focused on dealing with high prices of medicines and improving access to affordable generic products, underscoring that high prices led to the proliferation of compromised medical products. They also emphasized on the need to step up action to strengthen regulatory capacity, which is weak in many developing countries.

In the opening session of the Working Group on Monday, the WHO Director-General, Dr Margaret Chan, spoke of how "an area of work that affects the capacity of medicines to protect public health has become clouded with confusion and controversy".

"We need to clear the air," she said, pointing out that WHO's priority was to protect populations from the harm caused by poor-quality, unsafe medicines. She added that approaches, initiatives and definitions should support this public health priority, and not undermine it or divert the response to serve other purposes.

Dr Chan also said that the causes of compromised medical products are many and can be the result of unintended as well as deliberate actions.

Factors that compromise quality, safety and efficacy include substandard active and inactive ingredients, poor manufacturing practices, improper packaging, transport and storage, and product deterioration, she said, further stressing that "strengthening drug regulatory capacities is the best way to turn off the tap of bad medicines".

"The WHO approach to address the problem in developing countries is the same as that used successfully by wealthy nations to protect their populations. That is: strict regulatory control of medicines on the market, strict enforcement of quality standards, and diligent pharmacovigilance. Nothing suggests the need for a double-standard," Dr Chan added.

She emphasized that "WHO is not interested in expanding IP enforcement or in introducing stricter rules for doing so" and that it does not "favour any initiative that reduces competition from generic products", adding that "WHO not only supports generic products" but also "aggressively promotes them", as they "serve public health in multiple ways".

The Director-General's opening statement was followed by a presentation by Dr Hans V. Hogerzeil from the Secretariat on its work in combating SSFFC largely along the lines of the WHO documents prepared for the Working Group: A/SSFFC/WG/2; A/SSFFC/WG/3 Rev. 1; and A/SSFFC/WG/4.

The Secretariat highlighted three outstanding matters for discussion in its presentation to Member States.

The first was on "Definitions of SSFFC medicines" wherein it claimed that the issue was to separate public health from intellectual property aspects. In this regard, it asked: "Should IGWG (Intergovernmental Working Group) or WHO Expert Committee on Specifications for Pharmaceutical Preparations develop the definitions? Should the definition(s) be approved by EB (Executive Board)/WHA?"

The second matter raised by the Secretariat pertained to "Enforcement in the area of SSFFC medicines". On this, the Secretariat raised the issue of "To what extent should WHO support Member States in national and international law enforcement?".

The third outstanding matter raised by the Secretariat was on "Governance of international collaboration" and on this, it highlighted the issue of "With IMPACT, WHO is perceived to have gone beyond its mandate; should WHO step out of IMPACT? Should the pharmaceutical industry be part of an international task force?". It also said: "Give a clear mandate and governance structure to new international collaboration on combating SSFFC medicines".

Rwanda, on behalf of the African Region (AFRO), noted that the magnitude of the SSFFC problem is not exactly known. However, the existence of "even one case is unacceptable".

It was also of the view that SSFFC medical products are primarily motivated by the potentially huge profits and factors that facilitate the production or circulation of those products, including, amongst others, lack of a harmonized definition of counterfeiting; the high cost of medical products; and the lack of appropriate legislation.

It added that the "AFRO Group is convinced that strengthening the capacity of national authorities of regulation remains one of the key solutions to an effective fight against this scourge". It called on WHO "to make this a priority and give more resources to it".

On the issue of IMPACT, Rwanda said: "While acknowledging the support that IMPACT has made for some African countries, the Africa Group is recommending that IMPACT's status be reviewed and its mandate expanded by the World Health Assembly".

India commended the setting up of the Working Group and pointed out that it was a historic moment when the WHA decided to change the term "Counterfeit Medical Products" to a more accurate and acceptable provisional nomenclature of "Sub-standard/spurious/compromise/falsely-labelled/falsified/counterfeit medical products". It added that the general understanding is that the subject matter is medical products of questionable quality, safety and efficacy.

It expressed hope that the Working Group will focus its attention on strengthening national health authorities; strengthening the work of WHO through active participation of Member States in its norm-setting functions; and improving access to affordable medicines of good quality.

While India welcomed the Secretariat's preparation of documents for the meeting, it pointed out that its view on substance may differ from what is contained in the documents. It also underscored the "omission" by the Secretariat that sought to replace reference to "sub standard/spurious/falsely labelled/falsified/counterfeit medical products" with "counterfeit" in its document A/SSFFS/WG/3.

India said that the Secretariat's act was a violation of the WHA decision to do just the opposite, that is, to replace the term "counterfeit" with SSFFC. [The Secretariat was asked to rectify the problem by way of an official letter by the South East Asia Regional Office (SEARO) Group].

India also cautioned the Working Group against starting work by beginning with definitions, stressing the importance of the discussions reaching a certain level of maturity before venturing into definitions.

On the subject of terminologies, it said that "counterfeiting" had a specific connotation in relation to intellectual property law and thus was not suitable for defining the common objective of medicines with compromised QSE.

Efforts by certain interest groups to create deliberate confusion by conflating IPR concepts with issues concerned with the quality, safety and efficacy of medicines have led to the seizure of generic drug consignments at EU ports, India said, adding that it resulted in denial of access to efficacious and affordable generic medicines to several developing countries, including the Least Developed Countries.

India further said that despite efforts by the Indian government, the matter has not been resolved and EU Regulation 1323/2003 [that led to the seizures of generic medicines] continues to hang like the sword of Damocles.

It then proposed that before defining the terms, the problems must be defined and once there is conceptual clarity, the terms can then be defined. A consensus on concepts would certainly be much easier than terminologies, which could have linguistic or contextual specificities, India added.

On the issue of IMPACT, India questioned its legitimacy, since neither its creation nor its Terms of Reference have been approved by the WHO's Governing Bodies (the WHA and EB).

Pointing out that IMPACT often states that 160 participants at a Rome Conference approved its creation in the Declaration of Rome, it questioned when have the WHO Member States abdicated decision-making on such crucial issues to a meeting comprising industry and invitees participating in their individual capacities.

India further reprimanded IMPACT for unduly influencing the issues of the Working Group. It queried how IMPACT's Executive Secretary, in her capacity as Manager of the WHO Medicines Quality Assurance Programme and Medicines Anti-Counterfeiting Programme, issued invitations to hold a meeting in Berlin in July/August of 2010 to discuss issues mandated to the Working Group.

Highlighting that IMPACT has been praised in the Summit Declarations of the G8 (Heiligendamm, 7 June 2007) for its work on IPR enforcement, India argued that IMPACT does not belong to the WHO whose mandate is global public health.

It also emphasized that IMPACT was diverting WHO's attention away from its mandated role on global public health, and called for a moratorium on the work of IMPACT until the activities and objectives of the task-force are appropriately assessed and discussed by the Working Group. It further stressed that WHO cannot allow itself to become a platform for TRIPS-plus IP enforcement initiatives.

India further said that some countries are happy about the positive contribution of IMPACT, and if so, being a well-funded organisation, IMPACT could continue its work. But India strongly urged that the "relationship" with WHO, which is under question and examination, be suspended till a Member States' decision.

It proposed that the recently-concluded Anti-Counterfeiting Trade Agreement (ACTA) be a new home for IMPACT. Recalling that during the 2010 Health Assemblies, the Kenyan delegation had called for a "divorce" between the WHO and IMPACT, India said that it was calling for a "re-marriage" between IMPACT and ACTA.

Brazil acknowledged the gravity of the problem of compromised medical products, but stressed that discussion on such products cannot be dissociated from the underlying problem of unequal access of the world population to essential medicines.

It quoted WHO as saying that 30% of the world population have no access to medicines and most people in poor countries must pay for medicines out of their own pockets. It asked whether a market for compromised medical products would thrive if medicines were accessible and affordable to those in need.

Brazil further stressed that high prices constitute a barrier to access to medicines, adding that it would be useful to discuss the role that generics can play in reducing the prices of medical products. It also said that special emphasis must be placed on the strengthening of national regulatory agencies, as they have a central role to play in quality control.

Capacity-building, improvement of laboratory infrastructure and strengthening of regulatory agencies are pivotal to protect the rights of patients and consumers of medical products, Brazil added.

With respect to IMPACT, Brazil pointed out that it has never received a clear and specific mandate from WHO Member States to carry out its activities, nor has the WHO governing bodies approved the Terms of Reference of the task-force.

It also raised the problem of conflict of interests within IMPACT deriving from the participation of representatives of the private sector, as well as national and regional IPR enforcement agencies. These institutions can be consulted but that private vested interests should not influence processes, which must be guided by certain principles and goals that include the collective interest, the human right to health and social inclusion, added Brazil.

Brazil noted that since IMPACT's inception, there have been questions on the driving force behind IMPACT and uncertainties about its real intentions. It also expressed concern that in its present format without intergovernmental oversight, commercial goals could be easily pursued under a disguised public health lens. In addition, it raised the problems of undue WHO involvement, lack of transparency and lack of accountability.

Brazil called for a "moratorium on the work of IMPACT, until the activities and objectives of the task-force are appropriately assessed by the Working Group". It also cautioned that more equitable access to life-saving medical care, both at the national and international levels, must be the main objective of WHO, adding that it is "fundamental to ensure that international public health policies are not subordinated to trade priorities and concerns".

Sri Lanka noted that WHO's role in assisting developing countries to obtain the QSE drugs at affordable prices remains important and significant. To this end, Member States must retain their leadership and discuss the actual ground realities faced by many developing countries in accessing quality medicines at affordable prices.

It added that the focus of the dialogue should be on enhancing universal access to health care and building health services-related infrastructure in developing countries, and on developing national drug regulatory capacities, including strengthening national laboratory systems to ensure that substandard medicines will not enter the market.

With respect to IMPACT, Sri Lanka said that the solution to the problem of compromised medicines cannot be derived from IMPACT, which has not been established following the mandate and a decision taken by all Member States. "This simple logic therefore questions the mandate, the rules of procedure or any rule under which IMPACT is operating," it added.

Furthermore, it said, the focus of IMPACT is not purely on public health but on the trade aspect, which goes beyond the scope of this organization. It suggested that Member States organize an intergovernmental mechanism with a proper mandate and a clear focus to prevent compromised QSE medicines.

Indonesia suggested that WHO provide more technical assistance in improving the capacities of developing countries to enable them to be more self-reliant in ensuring QSE (of medicines).

It also suggested that WHO identify the needs of developing countries and determine strategic actions for them to become more self-reliant in QSE and affordable medicines. It further urged that discussion on QSE be separated from IP aspects. It also expressed reservation with regard to the WHO's relationship with IMPACT.

The Working Group spent most of Monday and Tuesday discussing the role of the WHO in QSE matters, as well as its role in the control and prevention of compromised medical products and its relationship with IMPACT.

According to some sources, a group of regulators met during lunch time on Tuesday to facilitate the preparation of a Secretariat paper on WHO's role in QSE matters.

On Wednesday, the Working Group is expected to discuss reporting to the World Health Assembly on its work, which will most likely entail a follow-up process to the Working Group.

(* With inputs from Heba Wanis and K. M. Gopakumar.) +