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Health Affairs, 23, no. 5 (2004): 279-280
doi: 10.1377/hlthaff.23.5.279-a
© 2004 by Project HOPE
 
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Letters

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 Goemaere1, Michel Lotrofska2, Yves Marchandy3 and Ellen’t Hoen4

Editor's Notes

1 (South Africa) Back

2 (Brazil) Back

3 (China) Back

4 (Paris) Back

NOTES

  1. 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.
  2. 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.
  3. P. Boulet, C. Garrison, and E. ’t Hoen, Drug Patents under the Spotlight: Sharing Practical Knowledge about Pharmaceutical Patents, Médecins sans Frontières, May 2003, www.accessmed-msf.org/documents/patents_2003.pdf (14 July 2004).
  4. 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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