[Ip-health] IGWG: More on scope of disease - Prof. Kevin Outterson submission

[Judit Rius Sanjuan]

Prof. Kevin Outterson, Associate Professor of Law at Boston University,
submitted a contribution to the Second Public Hearing on scope of
diseases and specifically on the phrase =93diseases which
disproportionately affect developing countries=94 that I believe can be
useful to delegates.

His whole submission is available at:
http://www.who.int/phi/public_hearings/second/contributions_section1/Sectio=
n1_Kevin_Outterson_Boston_Uni_Full_Contribution.pdf

Below some fragments:

" The phrase is best understood when limited to a particular innovation
market failure: the lack of commercial research into neglected (Type II)
and very neglected (Type III) diseases. No substantial market in
high-income countries exists for these diseases, necessitating various
non-market mechanisms such as product development publicprivate
partnerships and advance purchase commitments in order to facilitate
innovation.

But the innovation gap is not the only problem facing this IGWG. Your
terms of reference also include ensuring equitable access to patented
innovations treating all diseases, including Type I, II and III
diseases. WHA 59.24 urges member states: to work to ensure that progress
in basic science and biomedicine is translated into improved, safe and
affordable health products =96 drugs, vaccines and diagnostics =96 to
respond to all patients=92 and clients=92 needs, especially those living in
poverty, taking into account the critical role of gender, and to ensure
that capacity is strengthened to support rapid delivery of essential
medicines to people;=94 WHA 59.24 par. 2(3).

The WHO Commission Report (2006) clearly identified the needs in this
area, giving the example of cervical cancer as a Type I disease of great
importance in low- and middle income countries (at 12-15). Focusing more
resources on neglected diseases is entirely appropriate; but we cannot
overlook the fact that chronic conditions in the high-income and
low-income worlds are converging. Non-communicable disease accounted for 47=
%
of the global burden of disease in 2001 (WHO 2004a) and about 49% of the
global DALYs in 2001. (Mathers, Lopez & Murray 2006, Annex 3C). The
global disease list includes many of the major chronic conditions
associated with wealthy countries =97 including cardiovascular disease,
stroke, mental illness, diabetes, and arthritis. These =93wealthy country=
=94
diseases are also the leading causes of adult disease burdens throughout
the world. (WHO Commission Report 2006; WHO 2004b; Outterson 2005, at
244-46)

The concern that prompts this submission is certain language and actions
by the United States government that might lead to an inappropriate
extension of the phrase =93disproportionately affecting developing
countries=94 from the innovation gap to other issues, including the access
gap. For example, in its comments to the Draft Global Strategy, the
United States claims that the phase necessarily limits the scope of the
IGWG=92s mandate to Type II and III diseases: =93The IGWG should not
consider Recommendation 2.4 as the focus of its work should be on
diseases that disproportionately affect developing countries, more
commonly referred to as Type II and Type III diseases.=94 (US Comments 2007=
)

(the recommendation 2.4) language does not specifically limit access
initiatives to Type II and III diseases. But the US Comments routinely
use the phrase =93disproportionately affecting developing countries=94
without explicitly stating that this language only relates to the
innovation gap. A clarification here could alleviate my apprehension

Other actions by the US Government may lead to some confusion on this
point. For example, while the WHO Commission Report (at p. 22) and WHA
59.24 (at par. 2(4)) supported the use of TRIPS flexibilities by
developing countries, the United States Trade Representative=92s Office
elevated Thailand to the Special 301 Priority Watch List when Thailand
issued compulsory licenses on clopidogrel (Plavix), a patented drug
which treats
heart disease, in addition to two AIDS drugs, efavirenz and
lopinavir/ritonavir. (USTR 2007).

Some observers might think that the US Government hopes to restrict
compulsory licenses to Type II and III conditions. This idea is not
without foundation, as the USTR reacted with particular swiftness
against Thailand=92s use of a compulsory license on a drug for a Type I
condition, heart disease. Nothing in TRIPS or Doha limits compulsory
licenses to Type II and III diseases. Again, a clarification to that
effect, by the IGWG or the US Government, would be helpful."


--
Judit Rius Sanjuan
Attorney
judit.rius@keionline.org

Knowledge Ecology International (KEI)
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