Publications
South Africa Dares the TRIPS Conditionalities for AIDS Drugs ?
Dr. A.D.Damodaran

1.       IP Wire Newsletter Issue 25 has highlighted the " South African  controversy on AIDS drugs and gene patents ", according to which, " The worlds most powerful drug firms go head-to-head with the South  African government in a landmark case that could decide the developing  worlds access to affordable medicines, including AIDS drugs". The drug industry      ( GlaxoSmithKline and 41 others together) goes to the Pretoria High Court in a bid to strike down legislation that would allow the state to import and manufacture generic versions of patent medicines, especially antiretroviral anti-AIDS drugs.The hearing is supposed to last for week and the ruling might not come before the year end.

2.       About three years ago the SA government amended its Medicines and  RelatedSubstances Control Act 1965 to enable it to import  anti-retroviral drugs at the best price to treat its growing number of AIDS patients.The amendment , especially its section 15C , was interpreted by the powerful drugs industry as a challenge to the TRIPS related IPR issues , since the amended act allowed the government to " prescribe conditions on which any medicine which is identical in composition , meets the same quality standard, is intended to have the same proprietary name as that of another medicine already registered with the Republic " to be imported from anywhere, " notwithstanding anything to the contrary contained in the Patents Act,1978" , leaving the provisions on compulsory licensing as such without any change. Such an action was resorted by the SA government since the number of HIV infested people were increasing very rapidly in the country ( late 1999 figures put the number at five million with a growing AIDS death toll of 700 to 800 per day . According to another source , more than 25 million of the 36 million people infected with HIV live in sub-Saharan Africa!).  The SA officials reportedly have emphasized that the government will respect its international trade agreements offering protection for patents and allow exceptions only in emergencies . According to Economic & Political Weekly , the Indian company CIPLA in turn offered to supply at an incredibly low price of $300 per patient per year ( the Indian Act 1970 allows patented drugs to be manufactured by new processes ) and this led to the salutary effect of 80-90 per cent cost reduction by the drug MNC92s in countries such as Ivory Coast. Obviously such developments have churned up the whole matter into much wider issues.

3.       Importantly enough, a number of voluntary agencies have accused the  global pharmaceutical industry and the western governments of waging  what they call " an undeclared drugs war against the worlds poor countries", to quote BBC News. OXFAM has called on the WTO " to change its patent rules which, it says, result in restricted access to life-saving drugs " to quote again BBC News. It wants the largest drug firm GlaxoSmithKline to drop legal action against countries which are producing cheaper drugs.

4.       Apart from SA , countries such as Brazil , Thailand , etc are also  attracting the wrath of the drug industry for such " TRIPS violations" , with WTO setting up even a dispute panel to examine a US complaint over the Brazilian law , which allows local companies to produce patented drugs in certain cases. No wonder that the OXFAM policy director Justin Forsyth has even said " This is the shadowy side of globalization. We know that making life-saving drugs more affordable isn't the whole answer. However the balance has skewed too far toward corporate wealth rather than public health".

5.       The reaction from the industry is on expected line. The non-executive  chairman of GSK , Sir Richard Sykes , has charged those such as the Indian producers of cheaper generic drugs with " piracy" 85." exporting to countries where IPR is not protected , like Latin America, for example".

6.       The crucial issue of conflict is the following : whereas the compulsory licensing powers may give powers to the government to force the patent holders to accept local manufacture / supply at negotiated prices , developing countries would always be at a vulnerable position in actual practice all through the negotiation process and invariably the legal processes would be also time-consuming. Hence the need for special legal provisions to meet special requirements.

7.       Importantly enough, the Indian Patents Act 1970 retained the provisions of " licenses of rights" for food and drug articles only to meet such special requirements (The UK law even in its latest version retains special provisions " for the supply of specified drugs through the national health scheme). These clauses are now being deleted as per Second Amendment 1999 Bill currently before the parliament. In line with the existing law , an EMR (Exclusive Marketing Rights) application has already been filed in India by GSK for an AIDS drug.With a growing number of HIV cases in India, the implications could be serious if the parliament does not critically plan for a re-look of the Bill under discussion.