Authorisation of generic medicines at WTO level
Delivered in Plenary - February 10th 2003
I will not bash America because the whole set of international trading regulations on medicines is in a mess. Unfortunately, once drug companies - even with the best intention to alleviate suffering - allowed their products and intellectual property rights to be semi-confiscated under the guise of becoming available on affordable terms in developing countries, it was inevitable that all sorts of complications would arise.
These include definitions of what constitutes a measure to protect public health and is, therefore, subject to the compulsory licensing requirements allowed under TRIPS. Initially, the communicable diseases of HIV-AIDS, malaria and TB were included, but now there are plans to extend this list if the WHO thinks it appropriate. As these countries become more developed, more western diseases will become endemic, and a case will be made to extend the categories even further.
Also, as more migrants come to Europe, diseases such as the three above will become more common. This will create markets for these drugs and lead to enormous market- driven pressures for parallel re-importation by unscrupulous middlemen from LDCs, which produce them cheaply as generics. This will undercut the profits of legitimate pharmaceutical industries.
It also appears that the exemptions discriminate against smaller countries which lack the manufacturing base to produce the required life-saving drugs under compulsory licences. How much simpler it would have been if we had been more robust in defending the rights of drug companies to maintain their patent rights all over the world and then negotiated some differences in pricing, according to what the markets could actually bear and, at the same time, insisted that the burden of the drugs bill be picked up by and large by aid packages rather than by raiding the shareholder capital of the major pharmaceuticals. If there are to be reduced profits for the pharmaceuticals, my country, the UK, will suffer disproportionately, as it is a major employer and export-earner, and many of our pension funds are heavily invested in this sector. After all, many developing countries - even if the drugs were free - do not have the infrastructures to administer the treatments. Besides, profits are essential to fund further innovative research and development in the future, even into orphan drugs for rare tropical illnesses, which are of little interest in the West at present. At the very least, I call for a three-yearly review in future to see how this TRIPS agreement works out in practice.