[Ip-health] Lancet: WHO and Abbott in Thailand

Fri Mar 23 05:57:35 2007

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Lancet, 24 March 2007

Comment

WHO must defend patients' interests, not industry

Paul Cawthorne  a,   Nathan Ford a,   Jiraporn
Limpananont b,

Nimit Tienudom c   and   Wirat Purahong d

Is WHO's Director-General, Margaret Chan, more
concerned about the needs of patients or the interests
of industry? Addressing an audience in Bangkok in
February, she stressed the need to negotiate with drug
companies over access to medicines, and that the use
of compulsory licensing to import and manufacture
generic versions of patented drugs must be
=B3balanced=B2.1

Her statement was in reference to the Thai
government's recent issuing of compulsory licences for
efavirenz, lopinavir/ritonavir, and clopidogrel.
Thailand is one of the few developing countries that
have achieved universal access to antiretrovirals, but
access to efavirenz (needed by around 15% of
people on treatment) and lopinavir/ritonavir (for the
increasing number of people who need second-line) are
limited because of high price.

There are several reasons why Chan's comments are
misplaced. First, the Thai Government does not need to
be advised to negotiate: it has been in regular
contact with the industry over high prices of its
drugs in Thailand, but these negotiations have led
nowhere. The best price for originator's efavirenz is
still twice the price available from Indian generic
sources (US$500 per patient a year vs $224). The best
offer for originator's
lopinavir/ritonavir is $2000 per patient a year, five
times more than WHO's estimate of manufacturing
costs.2 The Thai Ministry of Health estimates that
the price of clopidogrel would fall by over 90% if
made generically.

These are substantial price differences in a country
where the average annual wage is $1400 a year.

Second, direct negotiations with companies are not as
successful as Chan thinks. She cited Brazil as a
positive example where negotiations with drug
companies have led to price reductions. However, the
prices negotiated
by Brazil for antiretrovirals are up to four times
more expensive than prices available on the
international market, and treatment costs are rising.
In
2003, three patented drugs=8Blopinavir/ritonavir,
nelfinavir, and efavirenz=8Btook up 63% of the total
antiretrovirals budget. In 2005, imports
accounted for 80% of Government expenditures on
antiretroviral drugs.3

Company deals have also stunted the development of
local generic manufacturing capacity, which is
reflected by the fact that no new generic AIDS drug
has been produced in Brazil since 2002.

Third, it is up to a government to decide when to
issue a compulsory licence. World Trade Organization
agreements nowhere state that negotiations
are a precondition to use of a compulsory licence by a
government,4 and even the US Government is not
questioning the legality of the Thai compulsory
licence.5

The need for =B3balance=B2 presumably refers to industry's
claim that patents are required to reimburse the costs
of innovation. We cannot say precisely
how much it costs to research and develop these drugs,
but we do know that they have already made billions of
dollars: last year alone sales of efavirenz, were $791
million,6 while sales for lopinavir/ritonavir were
over $1.1 billion.7

The US Government and the multinational drug industry
have put pressure on the Thai Government over its
intellectual property laws since 1985, and
as a result Thailand has implemented patent protection
sooner and stronger than required by the World Trade
Agreements.8 During this time, past WHO
Director-Generals were silent over the need to find a
balance to protect public health. We do not believe it
is the role of the Director-General of WHO to be
protecting the interests of industry the moment there
is a
challenge=8Ba legitimate and legal challenge=8Bto their
drug monopolies.

WHO is well aware of the high cost of new drugs for
Thailand. A recent WHO evaluation9 projected that
second-line therapy for a quarter of all HIV-infected
patients will be absorbing three-quarters of the
treatment budget by 2020, and the cost of antivirals
with second-line regimens could reach $500 million a
year if current prices remain. In response to these
rising drug costs, the World Bank has recommended that
Thailand should use compulsory licensing.10

Improving access to expensive medicines is not just an
issue for people with HIV/AIDS. The Thai Minister of
Public Health recently announced that he is
considering issuing compulsory licences for up to 11
more AIDS, cancer, heart and cardiovascular, and
neuropathic drugs and antibiotics.11

Not surprisingly, the drug industry is pressuring the
Thai Government to reverse its position. Abbott
Laboratories, which resisted all efforts by Government
and health groups to negotiate an affordable price for
lopinavir/ritonavir, has taken steps that show little
regard for public health in Thailand. The company
withdrew all pending drug-registration dossiers and
announced that it will not register any new drugs in
Thailand until the Government reverse its decision to
issue compulsory licences.12

Thailand, indeed all developing countries, need WHO to
put patients first, and encourage and support member
states to use flexibilities in patent  laws to improve
access to drugs. In a recent letter to the Minister,
Chan
clarified that WHO unequivocally supports the use of
compulsory licensing.13

This is a welcome clarification that should be
followed up by WHO's active technical and political
support for Thailand's efforts. In particular, WHO
should denounce the actions of Abbott. Protecting the
high price of one
new drug by withholding access to all others is an
unacceptable and unethical practice that no-one
concerned about public health should stay silent
about.

We declare that we have no conflict of interest.

References
1. Treerutkuarkul A. WHO raps compulsory licensing
plan: Govt urged
to seek
talks with drug firms. Bangkok Post. Feb 2, 2007:
http://www.bangkokpost.com/020207_News/02Feb2007_news15...
(accessed Feb 14, 2007)..
2. Pinheiro E, Vasan A, Kim JY, Leed E, Guimier J-M,
Perriens J. Examining
the production costs of antiretroviral
drugs. AIDS 2006; 20: 1745-1752.
MEDLINE
3. Okie S. Fighting HIV=8Blessons from Brazil. N Engl J
Med 2006; 354: 1977-1981.
4. World Trade Organization. Declaration on the TRIPS
agreement and
public
health. Nov 20, 2001:
http://www.wto.org/english/thewto_e/minist_e/min01_e/mi...
(accessed Feb 14, 2007)..
5. Letter from Ambassador Susan Schwab. United States
Trade
Representative,
to Congressman Allen. Jan 17, 2007:
http://www.cptech.org/ip/health/c/thailand/letter.pdf
(accessed Feb 14, 2007)..
6. Bristol-Myers Squibb. Bristol-Myers Squibb company
reports
financial
results for the fourth quarter and twelve months of
2006 and announces
EPS
guidance for 2007
http://newsroom.bms.com/index.php?s=3Dpress_releases&item...
(accessed Feb 14, 2007)..
7. Abbott. Abbott reports strong fourth-quarter
results and record
operating
cash flow in 2006. 2006:
http://www.abbott.com/global/url/pressRelease/en_US/60....
(accessed Feb 14, 2007)..
8. Wilson D, Cawthorne P, Ford N, Aongsonwang S.
Global trade and
access to
medicines: AIDS treatments in
Thailand. Lancet 1999; 354: 1893-1895. Full
Text | Full-Text PDF (58 KB) | MEDLINE | CrossRef
9. World Health Organization. External review of the
health sector
response
to HIV/AIDS in Thailand. August, 2005:
http://searo.who.int/LinkFiles/News_and_Events_Thailand...
(accessed Feb 14, 2007)..
10. Revenga A, Over M, Masaki E, et al. The economics
of
effective AIDS
treatment: evaluating policy options for Thailand. Jan
1, 2006:
http://www-wds.worldbank.org/external/default/main?page...
(accessed Feb 14, 2007)..
11. Treerutkuarkul A. Ministry pushes ahead with
patent breaking.
Bangkok
Post. Feb 13, 2007:
http://www.bangkokpost.com/130207_News/13Feb2007_news16...
(accessed Feb 14, 2007)..
12. Zamiska N. Abbott escalates Thai patent rift: firm
pulls plans
to offer
new drugs in spat with regime. Wall Street J March 14
2007;.
13. Letter from Dr Margaret Chan to Dr Mongkoi Na
Songkhla. . Feb
12, 2007:
http://www.cptech.org/blogs/ipdisputesinmedicine/index....
(accessed Feb 14, 2007)..
Back to top

Affiliations

a. M=E9decins Sans Fronti=E8res, Bangkok 10240, Thailand
b. Faculty of Pharmaceutical Sciences, Chulalongkorn
University,
Bangkok,
Thailand
c. AIDS Access Foundation, Bangkok, Thailand
d. Thai Network of People Living with HIV/AIDS,
Bangkok, Thailand

Kannikar KIJTIWATCHAKUL (Kar)
Mobile 66-85-0708954
kakablue@yahoo.com

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