Talking point on Cipro patent dispute October 24, 2001 , version 1.0
James Love <love at cptech.org> cell 1.202.361.3040 http://www.cptech.org/ip/health/cl/cipro/
1. The need for generic ciprofloxacin depends upon three factors.
a. Can terrorists deliver anthrax to large numbers of people?
b. Do the terrorists have access to strains of anthrax that are resistance to other (cheaper and widely available) antibiotics?
c. Could an attack take place before Bayer could deliver large quantities of cirpo?
2. Based upon what we know, there is a non-zero chance that all of these things could happen. In fact, no one knows what the probability is, but it clearly not a trivial risk, given the consequences.
3. There is evidence that the Russians have developed strains of Anthrax that are resistant to ordinary antibiotics.
4. The Federation of American Scientists say that 100 kilos of Anthrax could kill 1 to 3 million persons. (http://www.fas.org/nuke/intro/bw/agent.htm#b02). Many have pointed out that this is difficult, but it is also not impossible. There is no evidence that the terrorists can do this, but there is also no evidence that they cannot do this.
5. Secretary Thompson says we need medications for 10 million persons. At the 120 pill recommended course of treatment for ciprofloxacin, this is 1.2 billion pills. Bayer says it can produce 2 million per day. At this rate it would take 600 days to supply 1.2 billion pills. The US is now saying it will only provide 10 doses of ciprofloxacin, and then switch to a cheaper antibiotic. The rationale for switching is not clear, particular if we face an attack with a disease resistant strain.
6. Apparently 5 generic companies have already received US FDA clearance for the quality of their ciprofloxacin, and could immediately be asked to manufacture the drug.
7. The US government already has the right to use patents without a license, under 28 US 1498. (http://www.cptech.org/ip/health/cl/us-1498.html), an authority which is often used for other patents. The US could also pass HR 1708, which would address the problems in 1498 regarding compensation.
8. The US can clearly address supply issues faster with six suppliers, than with one. (see http://www.cptech.org/ip/health/cl/cipro/)
9. The US is cutting corners on public health to protect its negotiating position in the Doha WTO meeting on November 9-13, where the issue of compulsory licensing of drugs, and imports under a compulsory license where a country does not have domestic capacity for production, is a central issue, with the US, Canada and the EU opposing the Africa group.
10. Americans are being put at risk in order to protect the pharmaceutical companies in Africa and other developing countries.
11. The entire dispute is about how much risk we are willing to undertake to protect the idea that patents are more important than public health. Thompson and others are rolling the dice, hoping we don't need ciprofloxacin. I hope they are right and we don't need ciprofloxacin, but I don't think we should take unncessary risks with the public health, and certainly not to make a polemical point over patent rights.
-- James Love Consumer Project on Technology P.O. Box 19367, Washington, DC 20036 http://www.cptech.org, mailto:love at cptech.org voice: 1.202.387.8030 fax 1.202.234.5176 mobile 1.202.361.3040 _______________________________________________ Info-policy-notes mailing list Info-policy-notes at lists.essential.org http://lists.essential.org/mailman/listinfo/info-policy-notes