E-DRUG: Lancet: WHO must defend patients' interests, not industry
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Lancet, 24 March 2007
[copied as fair use]
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 'balanced'.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 drugslopinavir/ritonavir, nelfinavir, and
efavirenztook 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 'balance' 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
challengea legitimate and legal challengeto 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 HIVlessons 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=press_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)..
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Authors Affiliations
a. Médecins Sans Frontières, 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
nathan ford <nathan.ford@london.msf.org>