13.13 Substandard/spurious/falsely-labelled/falsified/counterfeit medical products: report of the Working Group of Member States

Documents

See Decision from WHA63
WHO documents A65/23 and EB130/2012/REC/1, resolution EB130.R13
See Watchers' Notes of Discussion at EB130
See also WHO Watch topic pages on access to medicinces and IPRs 
See WHO Watch report of debate at WHA below
See WHO Watch comment below
See statement by WCC, TWN and PHM read to the 65th WHA on SSFFC

The issues before the Assembly

From the 1980s Big Pharma has been concerned regarding calls for WHO to provide more support for the rational use of medicines.  From the early 1990s Big Pharma has been looking for ways to harness the authority of the WHO in the defense of intellectual property ‘rights’ (as defined within increasingly restrictive IP regimes).  From the late 1990s Big Pharma has been increasingly apprehensive about the delegitimation of the patent regime upon which it depends for its profits.

One strategy adopted by Big Pharma was the International Medical Product Anti-Counterfeit Taskforce (IMPACT) which was established as a collaboration between the International Federation of Pharmaceutical Manufacturers (IFPMA) and WHO. This was a ‘partnership’ which was never authorised by the Assembly. IMPACT was designed to take advantage of ambiguities around the meaning of ‘counterfeit’ and deliberately conflated the policing of QSE compromised medicines (compromised with respect to quality, safety and efficacy) with the policing of (claimed) intellectual property rights.

From the mid 2000s WHO has been subject to increasing criticism from civil society for its association with IMPACT (including organisational and internet hosting) because of the use of WHO resources and authority to police often contentious IP claims.

There have been strong calls to dissociate WHO from IMPACT and to clearly demarcate the WHO’s public health mandate, concerning QSE compromised medicines, from the policiing of various IP regimes.

An Open Ended Working Group of Member States was established by WHA63 and met in February and October 2011 with the aim of finding ways of ensuring the QSE and affordability of medicines. The Working Group prepared a report (Document A65/23) which includes the proposed member state mechanism.

The report reaffirmed WHO’s role in ensuring the availability and affordability of quality, safe and efficacious medical products and highlighted the lack of finances for work needed in this important area.

The report outlines the goal, objectives, structure, meetings, relations with other stakeholders and experts, reporting and review and transparency and conflict of interest provisions associated with the proposed MS Mechanism on SSFFC medical products.

PHM Comment

WHO should withdraw its support for IMPACT.  The IPRs that IMPACT seeks to police are often contentious and the role of high levels of IP protection in denying many people access to medications is also contentious.

The problem of QSE compromised medicines is very real and must be addressed. WHO has a critical mandate with respect to the regulation of medicines to ensure quality, safety, efficacy, rational use and affordability. The effective regulation of QSE depends on adequately resourced and well functioning drug regulatory agencies at the country level,  WHO has a critical mandate to support the development of drug regulatory capacity at the country level and to support regional collaboration in drug regulation.

The market for QSE compromised medicines is created by high prices of quality medicines. High prevalence of compromised medicines reflects the failure of some member states to invest in drug regulation, and the failure of donors to support such regulation.

It reflects the lack of capacity within the WHO Secretariat to provide proper support to capacity building for drug regulation both at the country level and through regional collaboration.

The lack of capacity within WHO to properly support capacity building in this critically important area reflects the deliberate choice of member states to restrict the untied assessed contributions to WHO and to make it dependent on tied donor funds. Clearly the donors have chosen to choke WHO’s role in drug regulation while supporting IP policing through IMPACT.

This reflects a massive conflict of interest.  The large member states who provide the bulk of the earmarked funding to WHO are also home to large originator pharmaceutical manufacturers and represent significant portions of national export earnings and tax revenues.  

In this context, IP policing (in association with increasing levels of IP protection) is a necessary part of maintaining export earnings. Big Pharma would have no objection to WHO promoting capacity building with respect to QSE compromised medicines but they are determined to prevent action on the rational use of drugs, essential drug lists and single payer reimbursement schemes based on cost effectiveness.

The WG on SSFFC has clearly reached a stalemate.  The proposed ‘member state mechanism’ will keep the dialogue alive and will keep the focus on WHO’s role in capacity building for drug regulation. This is good. However, under this compromise WHO will continue as a member of IMPACT and will continue to bestow its legitimacy on the use of the ‘health objective’ as a cover for policing IPRs.  

PHM calls on MS to dissociate WHO from IMPACT; to properly fund the drug regulatory capacity building role of WHO at global, regional and country levels; and to resolve the financial crisis of WHO by increasing assessed contributions and converting tied donor funding to untied donations.  

WHO Watch Report on Discussion at WHA65

The 65th WHA approved a new Member State Mechanism to address substandard/spurious/falsely-labelled/falsified/counterfeit (SSFFC) medical products.

There was a general positive feeling among delegations as they welcomed the establishment of the mechanism, which aims at looking into the problem of SSFFC medicines from a public health perspective excluding all trade and intellectual property considerations.

The EU asked the WHO to secure the necessary financial means for the MS mechanism in the next programme of work.

At the same time, there were also calls for transparency and comprehensiveness in the implementation of the mechanism.

Members emphasised the important role the WHO has to play in ensuring quality, safety and efficacy (QSE) of medical products, given the organisation’s mandate. Members further requested that drug regulatory capacity, including market surveillance and pharmacovigilance, be developed in countries where it is inadequate or non-existent. Brazil highlighted addressing root causes of the problem of compromised as necessary to efficiently prevent SSFFC from further penetrating markets. That said, they called for making medicines accessible for the poor.

Some countries also raised the problem of medicines sold over the internet.

On a different note, some interventions stood on a different ground. For example, Nigeria called for an international convention on counterfeiting, saying that medical counterfeiting requires international efforts.

Bahamas, surprisingly, attributed the prevalence of SSFFC medical products to parallel importation, one of the flexibilities in the TRIPS Agreement which provides means for accessing medicines.

Indonesia pinpointed an important point by raising the question of how the mechanism will be translated into an action plan. The 65th WHA did not answer this question last week. There is no clarity on this matter at this point in time.

The first conference on SSFFC medical products will be held in Buenos Aires, Argentina in October. The Union of South American Nations (UNASUR) expressed their wish to hold the first meeting of the MS mechanism during this conference; however, there were reservations from several countries such as the EU and Mexico.

See statement by WCC, TWN and PHM to the 65th WHA on SSFFC