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WTO rules allow "compulsory licensing" but with conditions.
If the govt considers that the patent-owner is selling too expensively, or is failing to supply the medicine at all. What it can do is to force the patent-owner to license someone else to produce generic versions.
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If the govt considers that the patent-owner is selling too expensively, or is failing to supply the medicine at all. What it can do is to force the patent-owner to license someone else to produce generic versions.
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But under WTO rules, compulsory licensing requires certain conditions.
1. Normally the government has to have negotiated a voluntary licence first. If that fails a compulsory licence is possible.
2. In an emergency, negotiating a voluntary licence can be skipped.
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1. Normally the government has to have negotiated a voluntary licence first. If that fails a compulsory licence is possible.
2. In an emergency, negotiating a voluntary licence can be skipped.
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3. In any case the company owning the patent has to be paid for the licence, it has to receive adequate remuneration. The WTO's rules don't say how much. It's left up to the country's (UK's) law.
WTO rules = the Trade-Related Intellectual Property Rights (TRIPS) Agreement
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WTO rules = the Trade-Related Intellectual Property Rights (TRIPS) Agreement
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In theory a challenge in the WTO might be possible. For example if Swiss company Novartis feels the UK government is not giving adequate remuneration for a compulsory licence, Switzerland could challenge the UK in the WTO. I don't think that's ever happened.
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Compulsory licensing is more common in developing countries, for example Brazil and Thailand. Often it is used as a threat. As a result, the patent owner cuts its own prices. No compulsory licence is actually issued. Brazil is been effective in doing this.
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Canada is a developed country that has favoured compulsory licensing in the past, but I believe pressure from the US has tightened the leeway in Canada (someone will know).
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Which means, that heavier use of compulsory licensing in the UK will make a free trade agreement with the US more difficult (surprise, surprise).
@jamie_love has often pointed out instances when the US has used compulsory licensing itself, but for other products not drugs.
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@jamie_love has often pointed out instances when the US has used compulsory licensing itself, but for other products not drugs.
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Compulsory licensing is more difficult with modern drugs known as biologics. Creating copies (bioequivalent versions) is not nearly as straightfoward as simply reproducing more traditional medicines in the form of chemical compounds
nhs.uk/conditions/bio…
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nhs.uk/conditions/bio…
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More on patents, medicines, access, public health on the WTO website here, including links to joint work with the World Health Organization and World Intellectual Property Organization
wto.org/english/tratop…
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wto.org/english/tratop…
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P.S.
