[e-drug] Patented drugs on WHO/EML? (2)

e-drug
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E-DRUG: Patented drugs on WHO/EML? (2)
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Hi all

Wilbert has already responded on Dr Mohanta's question about the patent
status of medicines on the WHO EML. There is one paper that has
attempted to address this question - Amir Attaran. How Do Patents And
Economic Policies Affect Access To Essential Medicines In Developing
Countries? Health Affairs 2004; 23 (3): 155-166 (see
http://content.healthaffairs.org/cgi/content/abstract/23/3/155) - the
gist of the argument is this: "This paper studies the relationship
between patents and access to essential medicines. It finds that in
sixty-five low- and middle-income countries, where four billion people
live, patenting is rare for 319 products on the World Health
Organization's Model List of Essential Medicines. Only seventeen
essential medicines are patentable, although usually not actually
patented, so that overall patent incidence is low (1.4 percent) and
concentrated in larger markets. "

Here's an electronic response posted to the same journal by Connie Liu,

Global Health Chair, American Medical Student Association, and
Sanjay Basu, AIDS Program, Yale University School of Medicine
(http://content.healthaffairs.org/cgi/eletters/23/3/155) - "Amir
Attaran concludes that patents only infrequently constrain access to
WHO-classified "essential medicines" in poor countries. We find his
study claims and methodology problematic. Attaran finds that key
patented drugs, which are out of reach from over 40 million persons, are
the exception to his conclusion; yet 40 million persons are a
substantial exception by any reasonable standard.(1) He tries to argue
that patents are insignificant by showing that small numbers of them are
in poor countries; yet those patents that do exist happen to often
correlate to the conditions of highest morbidity and mortality, and
therefore constrain access for large numbers of persons. A more
reasonable test of the influence of patenting on access would be to
compare how many persons in need of particular drugs would gain or lose
access or would have their access to drugs be unaffected if patents that
did exist in their country were removed or modified. In fact, other
assessments of the impact of patents on access have found profoundly
different results from that published by Attaran, using existing
empirical data.(2) Attaran also argues that the WHO essential medicines
list that he uses as the basis for his evaluation does not use patent
status as an explicit criterion for exclusion, and therefore does not
unfairly bias his study's methodology. Yet "cost-effectiveness"--of
which drug price is a key component--is used as a primary basis for
including or excluding medicines from the WHO list. Local or regional
variabilities in medicine needs are therefore unaccounted for through
this approach, as are key second-line regimens needed for physicians to
maximize their flexibility in treating difficult diseases. Attaran
should be reminded that the very organizations and activists he
criticizes were the main reason that key AIDS drugs and second-line
therapies for drug-resistant tuberculosis are now included on the WHO
list.(3) Attaran has failed to account for the full impact patents have
on access to generic medications. Even when no patents exist within a
small country, generic drugs can still effectively supply the market.
Patents within larger markets, particularly in those countries with
production capacity, are of primary concern because generics need to be
able to sustain their production in these markets in order to export to
the smaller and poorer locales that usually have little domestic
manufacturing capacity. Finally, Attaran appears to have created a false
dichotomy between patents and poverty. We are all well aware that
numerous factors constrain access to medicines and hinder their
appropriate delivery, with poverty being a central factor. But to
acknowledge that there are several blockages in the pipeline between
better research and better patient outcomes does not logically render
one important blockage less obstructive. 1. United Nations. December
2003. AIDS epidemic update. [United Nations Program on HIV/AIDS].
Accessed May 11, 2004. Available at http://www.unaids.org/en/default.asp
2. J. Borrell and J. Watal. May 2002. Impact of Patents on Access to
HIV/AIDS Drugs in Developing Countries. [Harvard University Center for
International Development Working Paper]. Cambridge: Harvard CID.
Accessed May 11, 2004. Available at www2.cid.harvard.edu/cidwp/092.pdf
3. World Health Organization. April 2, 2004. WHO takes major steps to
make HIV treatment accessible. [World Health Organization Press
Release]. Accessed May 11, 2004. Available at
www.who.int/mediacentre/releases/release28/en/"

There are of course those who find Attaran's analysis compelling - see
for example Roger Bate's article at
http://www.nationalreview.com/comment/bate200405171342.asp - "Dr.
Attaran's argument should squash once and for all demands for compulsory
licensing of patented medicines in most poor countries."

What Attaran did find is that patents on essential medicines are more
common " in developing countries having larger populations, richer per
capita national income, or a higher Gini coefficient" - these are likely
to be countries with some pharmaceutical manufacturing capacity, such as
India, China, Brazil or South Africa.

A more pertinent question perhaps would be: what is happening in India
now with the 1995-2005 "mailbox" drugs?

Those interested in the issue of patents and access can find many
pointers at http://www.iprsonline.org/resources/health.htm. A good
overview can be found in the DFID document "Access to Medicines in
Under-served Markets: What are the implications of changes in
intellectual property rights, trade and drug registration policy?" (see
http://www.dfidhealthrc.org/shared/publications/Issues_papers/ATM/DFID_synthesis_aw.pdf)

regards
Andy

2

E-DRUG: Patented drugs on WHO/EML? (3)
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dear E-druggers,

MSF also published a response to the Health Affairs article - see below.

Nathan Ford
MSF UK
nathan.ford@london.msf.org

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http://content.healthaffairs.org/cgi/content/full/23/5/279-a

Health Affairs, Vol 23, Issue 5, 279-280

Patent Status Matters

Attaran argues that because few drugs on the EML are patented, patent status
has no impact on access to medicines in poor countries. This contention is
flawed in many respects. First, all countries are not equal. Drug companies
tend not to patent in countries that lack market potential or manufacturing
capacity. Not surprisingly, in South Africa, which has manufacturing
potential for domestic use and regional export, more than 95 percent of
antiretrovirals (ARVs) are patented.1 It only takes patents in a few key
markets for patents to be a problem everywhere. Second, all medicines are
not equal. Just a few expensive patented medicines can skew entire treatment
budgets. Of the fourteen ARV drugs in the Brazilian National AIDS Program,
three new single-source products accounted for 63 percent of total program
costs in 2003.

Third, patented drugs have been excluded from the EML because of cost. While
Attaran argues that cost is not an EML exclusion criterion, his own
bibliography indicates that rules were only changed in 2001: For 95 percent
of the EML's life, cost was a concern.2 As such, the proportion of patented
drugs on the EML can be expected to increase in the future. Fourth, patent
coverage will increase generally. Under WTO rules, developing countries must
have patent systems in place by 1 January 2005, while least-developed
countries have until 2016. It is not surprising that essential drugs are not
patented in many developing countries, because for most of the past twenty
years there was no requirement to do so.3

In our experience providing medical aid in more than eighty countries,
patents and other exclusive rights remain a major factor in increasing drug
prices or in blocking availability altogether. In China, for example,
GlaxoSmith-Kline's patent on the ARV drug 3TC blocks the availability of the
simplest and most affordable AIDS treatment available worldwide-the
WHO-recommended fixed-dose combination of d4T/3TC/NVP. Doctors are forced to
use brand-name medicines that are five times more expensive and prescribe
individual drugs rather than the combined pill; this complicates the
treatment regimen. Had there been no patent barrier, Chinese producers would
have been able to manufacture and export generic versions of the recommended
fixed-dose combination. Governments must ensure that drug prices are
affordable to their populations by freely making use of their WTO rights to
issue compulsory licenses to overcome patents whenever needed. These rights
are openly being undermined through U.S. pressure to limit the use of
compulsory licensing in regional and bilateral trade agreements in the
developing world.4

We must do all that we can to alleviate poverty, but this is not the only
answer to the immediate health crisis. Getting one billion people out of
abject poverty is not going to happen overnight; doctors need to save lives
now. Unless the exclusive power of patent holders to set prices is
restrained, access to essential medicines will become an increasing concern
for the world's most vulnerable patients.

Eric Goemaere (MSF South Africa), Michel Lotrofska (MSF Brazil), Yves
Marchandy (MSF China) and Ellen't Hoen (MSF Paris)

NOTES

E. Goemaere et al., "Do Patents Prevent Access to Drugs for HIV in
Developing Countries?" Journal of the American Medical Association 287, no.
7 (2002): 841.[ISI][Medline]

World Health Organization, "Procedure to Update and Disseminate the WHO
Model List of Essential Medicines," WHO Doc. no. EB109/8 (Annex), 7 December
2001, www.who.int/medicines/organization/par/edl/procedures.shtml (15 July
2004); and P. Chirac and R. Laing, "Updating the WHO Essential Drugs List,"
Lancet 357, no. 9262 (2001): 1134.

P. Boulet, C. Garrison, and E. 't Hoen, Drug Patents under the Spotlight:
Sharing Practical Knowledge about Pharmaceutical Patents, Midecins sans
Frontihres, May 2003, www.accessmed-msf.org/documents/patents_2003.pdf (14
July 2004).

MSF, "Access to Medicines at Risk Across the Globe: What to Watch Out For in
the Free Trade Agreements with the United States," May 2004,
www.accessmed-msf.org/documents/ftabriefingenglish.pdf (14 July 2004).