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[e-drug] Patented drugs on WHO/EML? (3)

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

dear E-druggers,

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

Nathan Ford



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)


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).

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