From: <b class="gmail_sendername">Alice Fabbri</b> <span dir="ltr"><<a href="mailto:alealifab@gmail.com">alealifab@gmail.com</a>></span><br><div class="gmail_quote"><br><div text="#000000" bgcolor="#ffffff">
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<span style="vertical-align:baseline;font-variant:normal;font-style:normal;font-size:15px;background-color:transparent;text-decoration:none;font-family:Arial;font-weight:normal">The problem of QSE compromised
medicines</span><span style="vertical-align:baseline;font-variant:normal;font-style:normal;font-size:15px;background-color:transparent;text-decoration:none;font-family:Arial;font-weight:normal"> (compromised with respect to
quality, safety and efficacy) </span><span style="vertical-align:baseline;font-variant:normal;font-style:normal;font-size:15px;background-color:transparent;text-decoration:none;font-family:Arial;font-weight:normal"> is very real and must be addressed.</span><span style="vertical-align:baseline;font-variant:normal;font-style:normal;font-size:15px;background-color:transparent;text-decoration:none;font-family:Arial;font-weight:normal"> <br>
PHM calls on Member States to dissociate WHO from IMPACT</span><span style="vertical-align:baseline;font-variant:normal;font-style:normal;font-size:15px;background-color:transparent;text-decoration:none;font-family:Arial;font-weight:normal"> and to clearly demarcate the WHO’s
public health mandate, concerning QSE compromised medicines, from
the policing of various IP regimes.<br>
See below the comments the WHO watchers prepared for WHA65</span>!<br>
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<h2 dir="ltr"><span style="vertical-align:baseline;font-variant:normal;font-style:normal;font-size:19px;background-color:transparent;text-decoration:none;font-family:Arial;font-weight:bold">SSFFC:
Substandard/spurious/falsely-labelled/falsified/counterfeit
medical products: report of the Working Group of Member States
(Document </span><a href="http://apps.who.int/gb/ebwha/pdf_files/WHA65/A65_23-en.pdf" target="_blank"><span style="font-size:19px;font-family:Arial;color:rgb(17,85,204);background-color:transparent;font-weight:bold;font-style:normal;font-variant:normal;text-decoration:underline;vertical-align:baseline">A65/23</span></a><span style="vertical-align:baseline;font-variant:normal;font-style:normal;font-size:19px;background-color:transparent;text-decoration:none;font-family:Arial;font-weight:bold">)</span></h2>
<span style="vertical-align:baseline;font-variant:normal;font-style:normal;font-size:15px;background-color:transparent;text-decoration:none;font-family:Arial;font-weight:bold"></span><span style="font-size:16px;font-family:Arial;color:rgb(102,102,102);background-color:transparent;font-weight:bold;font-style:normal;font-variant:normal;text-decoration:none;vertical-align:baseline">The
issues before the Assembly </span><span style="vertical-align:baseline;font-variant:normal;font-style:normal;font-size:15px;background-color:transparent;text-decoration:none;font-family:Arial;font-weight:normal"><br>
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. </span><br>
<span style="vertical-align:baseline;font-variant:normal;font-style:normal;font-size:15px;background-color:transparent;text-decoration:none;font-family:Arial;font-weight:normal"></span><br>
<span style="vertical-align:baseline;font-variant:normal;font-style:normal;font-size:15px;background-color:transparent;text-decoration:none;font-family:Arial;font-weight:normal">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. </span><br>
<span style="vertical-align:baseline;font-variant:normal;font-style:normal;font-size:15px;background-color:transparent;text-decoration:none;font-family:Arial;font-weight:normal"></span><br>
<span style="vertical-align:baseline;font-variant:normal;font-style:normal;font-size:15px;background-color:transparent;text-decoration:none;font-family:Arial;font-weight:normal">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.</span><br>
<span style="vertical-align:baseline;font-variant:normal;font-style:normal;font-size:15px;background-color:transparent;text-decoration:none;font-family:Arial;font-weight:normal"> </span><br>
<span style="vertical-align:baseline;font-variant:normal;font-style:normal;font-size:15px;background-color:transparent;text-decoration:none;font-family:Arial;font-weight:normal">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.</span><br>
<span style="vertical-align:baseline;font-variant:normal;font-style:normal;font-size:15px;background-color:transparent;text-decoration:none;font-family:Arial;font-weight:normal"> </span><br>
<span style="vertical-align:baseline;font-variant:normal;font-style:normal;font-size:15px;background-color:transparent;text-decoration:none;font-family:Arial;font-weight:normal">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 (</span><a href="http://apps.who.int/gb/ebwha/pdf_files/WHA65/A65_23-en.pdf" target="_blank"><span style="font-size:15px;font-family:Arial;color:rgb(17,85,204);background-color:transparent;font-weight:normal;font-style:normal;font-variant:normal;text-decoration:underline;vertical-align:baseline">Document A65/23</span></a><span style="vertical-align:baseline;font-variant:normal;font-style:normal;font-size:15px;background-color:transparent;text-decoration:none;font-family:Arial;font-weight:normal">) which includes the proposed member
state mechanism. </span><br>
<span style="vertical-align:baseline;font-variant:normal;font-style:normal;font-size:15px;background-color:transparent;text-decoration:none;font-family:Arial;font-weight:normal"> </span><br>
<span style="vertical-align:baseline;font-variant:normal;font-style:normal;font-size:15px;background-color:transparent;text-decoration:none;font-family:Arial;font-weight:normal">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.</span><br>
<span style="vertical-align:baseline;font-variant:normal;font-style:normal;font-size:15px;background-color:transparent;text-decoration:none;font-family:Arial;font-weight:normal"> </span><br>
<span style="vertical-align:baseline;font-variant:normal;font-style:normal;font-size:15px;background-color:transparent;text-decoration:none;font-family:Arial;font-weight:normal">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. </span><br>
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<h3 dir="ltr"><span style="font-size:16px;font-family:Arial;color:rgb(102,102,102);background-color:transparent;font-weight:bold;font-style:normal;font-variant:normal;text-decoration:none;vertical-align:baseline">PHM Comment</span></h3>
<span style="vertical-align:baseline;font-variant:normal;font-style:normal;font-size:15px;background-color:transparent;text-decoration:none;font-family:Arial;font-weight:normal"> </span><span style="vertical-align:baseline;font-variant:normal;font-style:normal;font-size:15px;background-color:transparent;text-decoration:none;font-family:Arial;font-weight:normal">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. </span><br>
<span style="vertical-align:baseline;font-variant:normal;font-style:normal;font-size:15px;background-color:transparent;text-decoration:none;font-family:Arial;font-weight:normal"></span><br>
<span style="vertical-align:baseline;font-variant:normal;font-style:normal;font-size:15px;background-color:transparent;text-decoration:none;font-family:Arial;font-weight:normal">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. </span><br>
<span style="vertical-align:baseline;font-variant:normal;font-style:normal;font-size:15px;background-color:transparent;text-decoration:none;font-family:Arial;font-weight:normal"></span><br>
<span style="vertical-align:baseline;font-variant:normal;font-style:normal;font-size:15px;background-color:transparent;text-decoration:none;font-family:Arial;font-weight:normal">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.</span><br>
<span style="vertical-align:baseline;font-variant:normal;font-style:normal;font-size:15px;background-color:transparent;text-decoration:none;font-family:Arial;font-weight:normal"></span><br>
<span style="vertical-align:baseline;font-variant:normal;font-style:normal;font-size:15px;background-color:transparent;text-decoration:none;font-family:Arial;font-weight:normal">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. </span><br>
<span style="vertical-align:baseline;font-variant:normal;font-style:normal;font-size:15px;background-color:transparent;text-decoration:none;font-family:Arial;font-weight:normal"></span><br>
<span style="vertical-align:baseline;font-variant:normal;font-style:normal;font-size:15px;background-color:transparent;text-decoration:none;font-family:Arial;font-weight:normal">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.</span><br>
<span style="vertical-align:baseline;font-variant:normal;font-style:normal;font-size:15px;background-color:transparent;text-decoration:none;font-family:Arial;font-weight:normal"></span><br>
<span style="vertical-align:baseline;font-variant:normal;font-style:normal;font-size:15px;background-color:transparent;text-decoration:none;font-family:Arial;font-weight:normal">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. </span><br>
<span style="vertical-align:baseline;font-variant:normal;font-style:normal;font-size:15px;background-color:transparent;text-decoration:none;font-family:Arial;font-weight:normal"></span><br>
<span style="vertical-align:baseline;font-variant:normal;font-style:normal;font-size:15px;background-color:transparent;text-decoration:none;font-family:Arial;font-weight:normal">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. </span><br>
<span style="vertical-align:baseline;font-variant:normal;font-style:normal;font-size:15px;background-color:transparent;text-decoration:none;font-family:Arial;font-weight:normal"></span><br>
<span style="vertical-align:baseline;font-variant:normal;font-style:normal;font-size:15px;background-color:transparent;text-decoration:none;font-family:Arial;font-weight:normal">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. </span><br>
<span style="vertical-align:baseline;font-variant:normal;font-style:normal;font-size:15px;background-color:transparent;text-decoration:none;font-family:Arial;font-weight:normal"></span><br>
<span style="vertical-align:baseline;font-variant:normal;font-style:normal;font-size:15px;background-color:transparent;text-decoration:none;font-family:Arial;font-weight:normal">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. </span><br>
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