PHM-Exch> News on Substandard/spurious/falsely-labelled/falsified/counterfeit medical products from WHA65

[Claudio Schuftan]

From: Alice Fabbri <alealifab at gmail.com>


The problem of QSE compromised medicines (compromised with respect to
quality, safety and efficacy) is very real and must be addressed.
PHM calls on Member States to dissociate WHO from IMPACT and to clearly
demarcate the WHO’s public health mandate, concerning QSE compromised
medicines, from the policing of various IP regimes.
See below the comments the WHO watchers prepared for WHA65!

SSFFC: Substandard/spurious/falsely-labelled/falsified/counterfeit medical
products: report of the Working Group of Member States (Document
A65/23<http://apps.who.int/gb/ebwha/pdf_files/WHA65/A65_23-en.pdf>
) 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 policing 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<http://apps.who.int/gb/ebwha/pdf_files/WHA65/A65_23-en.pdf>)
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.
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