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Should the makers of Tamiflu be forced to share their knowledge? Breaking the patent will only discourage the development of other needed antiviral drugs, says ALEC VAN GELDER

Breaking the patent will only discourage the development of other needed antiviral drugs, says ALEC VAN GELDER

With all the hysteria surrounding the possible mutation of the avian flu virus into a form that puts humans at risk, policy-makers have subjected us to everything, apart from common sense. There are no easy solutions to the predicted outbreak. Misleading the public and ignoring the outcome of myopic actions are simply not acceptable with millions of lives at stake.

At least 65 people have already died from a strain of avian flu called H5N1, contracted from close contact with poultry. A further 100 are believed to be infected. Those most at risk are people who work closely with poultry in relatively unsanitary, cramped conditions: By definition, these people are poor. So far, there is no proof that a strand of H5N1 can spread between humans -- nor that it will.

Yet, the hysteria surrounding avian flu far surpasses that which accompanies the yearly arrival of a new flu strand, which regularly kill hundreds of people. And it surpasses, by several orders of magnitude, the attention given to other diseases, such as diarrhea, that claim at least three million lives a year in poor countries. The reason for this hysteria is the prediction that, if this virus mutates into a form transmissible between humans, tens of millions will be at risk, as in the 1918 pandemic that killed 50 million to 100 million people. But what is the rational response to such predictions?

We know that viruses mutate, and strike in unpredictable ways. It is plausible that this virus might mutate and that an epidemic -- or even a pandemic -- might result. Since we cannot predict exactly how the virus might mutate, or where or when, we need a response that is both preventive and adaptive.

Preventive measures might include vaccinating those likely to become infected with both H5N1 and conventional influenza viruses. This would reduce the chances that H5N1 could acquire genes that would enable it to be transmitted between humans. Adaptive measures might include identifying potential vaccines and treatments for H5N1 and ensuring that these are available for use when necessary. So far, only one medicine has proved effective in treating human cases of H5N1. That medicine, Tamiflu, was developed by the pharmaceutical company Roche, which owns the patent. Because of the pressure to "do something," politicians are considering breaking Roche's patent on the populist premise that this will increase the availability of Tamiflu.

While it makes sense to build government stockpiles of Tamiflu, in preparation for a possible outbreak of H5N1, it is far from clear that breaking the patent would be helpful. Indeed, the opposite is more likely to be the case. First, the raw ingredients for Tamiflu come from a Chinese herb that is in short supply. Unless production of the herb is increased, it will be impossible to increase production of Tamiflu. In this case, breaking the patent would have no impact on availability of the drug.

Second, Tamiflu is difficult to manufacture. Since Roche has developed the manufacturing expertise, it seems sensible to encourage Roche to increase production and/or to help other companies produce the drug under a voluntary licence. Breaking the patent through compulsory licensing would actively discourage Roche from either producing the drug or lending its expertise, and that would be directly counterproductive.

Third, given that scientists have only a vague idea of what a human strain of H5N1 might look like, there is no certainty that Tamiflu will be effective. And even if Tamiflu does work on some people, widespread use would inevitably result in the development of resistant strains. So, either way, other options are needed.

Yet, if governments break the patent on Tamiflu, no pharmaceutical company is going to want to develop a new antiviral for fear that its expensively developed innovative medicine will simply be stolen without adequate compensation for the tens or hundreds of millions of dollars invested.

In light of the potential threat posed by a human strain of H5N1 or other similarly deadly viruses, there are constructive things that governments could do. First, they could offer to buy large quantities of vaccines or antivirals that meet clearly defined criteria. Second, they might offer tax breaks to companies that choose to invest in the development of relevant vaccines and antivirals.

But the most important role for government is to uphold private property rights and ensure that the rule of law applies -- which means protecting rather than breaking patents. The alternative -- the rule of the mob -- would truly be devastating.

Alec van Gelder is a research fellow specializing in technology issues at International Policy Network, a London-based charity that promotes free-market institutions.

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