COMPULSORY LICENSING: HAVE YOUR SAY

The UK Patent Office is inviting responses in its Consultation on the Proposed Regulation on Compulsory Licensing of Pharmaceutical Patents for Export to Countries with Public Health Problems. The consultation considers a proposed EU Regulation that would allow compulsory licenses to be granted in the EU where developing countries do not have the manufacturing capacity to produce pharamceuticals to meet urgent public health problems. Ordinarily, the TRIPs Agreement limits the grant to compulsory licences to situations where there is a need on the market in which the licence is being granted. However, following the Doha Declaration on Public Health in 2001, the WTO decided to make an exception to this rule by allowing WTO Members to grant compulsory licences for the production and sale of patented pharmaceutical products intended for export to third countries with insufficient or no manufacturing capacity in the pharmaceutical sector. The way that this is achieved is by waiving the TRIPs restriction on compulsory licences for export iN the relevant countries.

The EU Regulation is seeking to introduce this exception across the EU. It includes safeguards against trade diversion and rules to ensure transparency, and provides for future replacement of the WTO Decision by an amendment to the TRIPs Agreement.

Those who wish to take part in the consultation should email medicinesexport@patent.gov.uk by 23 May 2005 or follow the instructions on the Patent Office website.

The IPKat has a great deal of sympathy for the plight of those in need of pharmaceuticals in developing countries. However, he notes that the role of compulsory licences is usually to get the product in question on the market where the patent holder is failing to exploit the patent. This is not the case here, where there is no evidence that the patent holders wouldn’t used the patents for the payment of a feel. The IPKat is at least heartened by the fact that there will be measures to stop the resulting products getting back on to the EU market, though he wonders how effective they will be in practice.

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