RECENT deaths from the H5N1 flu have highlighted the question of access to drugs to combat the disease. Do patents, by giving pharmaceutical companies the monopoly that makes drug production viable, also put drugs beyond the reach of those for whom they are intended?
Health workers believe that the most effective way to contain the spread of avian flu is by rapid, localised treatment with antiviral drugs. One such drug that has achieved particular success in treating the H5N1 strain is Tamiflu. This, if taken within 36 hours of the illness starting, stops the virus from replicating. Tamiflu is prepared from star anise and was developed by Gilead Sciences in California.
Roche, the pharmaceutical company, now owns all the rights to the drug and has agreed to supply the World Health Organisation with enough Tamiflu to treat three million people. In order to improve availability, Roche has granted licences to produce the drug to two Asian manufacturers of generic pharmaceuticals — these drugs are not covered by a patent but contain the same active ingredient as the patented drug and therefore have the same therapeutic effect.
Should the antiviral response not be sufficient, or the virus develops a resistance to Tamiflu, there are also potential vaccines in the pipeline, although again there are issues with production capacity and it is anticipated that it will take some time to produce commercial levels of any vaccine.
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Because Roche owns the patent rights to Tamiflu, the company has a monopoly right to make, use and sell it. Governments that wish to stock supplies will be expected to pay the normal commercial price for the drug. This gives rise to a common dilemma. To be profitable and to enable further research, pharmaceutical companies maintain that they need to be paid in full for their products. This may make the products too expensive for poor countries or for countries that require a drug in large quantities because of a health crisis, whether current or imminent. Since generic drug companies also need to make profits, this problem cannot be wholly addressed by licensing out the rights, as Roche did.
Governments can address this issue in a number of ways rather than simply leave it to market forces. Recently, the Brazilian Government, which provides free antivirals to every patient who needs them, threatened to invoke a public-interest provision in Brazilian law that would have allowed it to disregard an existing patent on an HIV antiretroviral treatment and to start producing the drug itself.
Similarly, in 2001, the Canadian and US governments were prepared to manufacture the patented Bayer antibiotic, which was the most effective treatment against anthrax, although in the event the predicted anthrax threat did not develop.
This was especially ironic in the case of the US, where the Bush Administration had championed the pharmaceutical industry, voicing its opposition to the South African Government’s attempt to obtain cheap Aids drugs by taking similar measures.
In the UK, the Government has two options if it wishes to get around any UK patents standing in the way of the manufacture of necessary drugs or vaccines in response to a bird-flu pandemic.
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There are provisions for obtaining compulsory licence of patents (as did Brazil, the US and Canada) on the ground that the demand for the product in the UK is not being met on reasonable terms. However, the Government would need to show as a fact that this was the case.
The procedure for the grant of a compulsory licence is available for patents only from three years after grant, is onerous and rarely invoked. It also involves using third-party manufacturers that might not have the same expertise as the patent holders. Alternatively, there is a provision for Crown use, which allows any government department to use (as well as manufacture, import or store) any patented product on various grounds including emergency or war. This covers the supply of scheduled drugs to the NHS. These provisions are of wide potential application and seem the most likely mechanism to be adopted.
The US Government is considering legislation that would co-ordinate vaccine development by the private and public sectors. The proposed Bill could protect pharmaceutical companies from claims by patients who had been injured by the vaccines.
The World Trade Organisation has recently proposed a mechanism whereby less developed countries, such as those where H5N1 is currently rife, may be supplied with equivalents of patented drugs.
Manufacturers of generic pharmaceuticals will be able to obtain a compulsory licence of the patent in order to export the drug. If this proposal were to be effective for bird flu treatments, the draft European Community regulation that incorporates these proposals would need to be implemented so that generics manufacturers in Europe could begin production of those drugs.
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However, recent health crises suggest that the problem facing the developed world in tackling the bird flu threat will not be lack of resources or circumventing patent monopolies, but having the motivation and organisation to take co-ordinated and decisive action in time.
Simon Portman and Mark Elmslie are partners specialising in bioscience and intellectual property respectively at Hewitsons solicitors in Cambridge. Their book Intellectual Property: the Lifeblood of your Company, published by Chandos, will be published shortly