INDIA BUSINESS WORLD - APRIL 2007
The Month that was ...

DEMOCRATS DEMAND US ADHERE TO WTO OBLIGATIONS ON TRIPS

THE Doha Declaration on Trips and Public Health Agreement has become contentious with Swiss pharma major Novartis challenging the Indian Patents Act (Amendment 2005) - that was amended in conformity with India's WTO obligations - in Chennai High Court on March 26 and the US pharma company Abbot Laboratories refusing to market its latest developing country-specific anti HIV/AIDS medicine in Thailand. The Thai government has introduced compulsory licensing in the interest of public health.

Meanwhile, the South North Development Monitor (SUNS) has reported that 12 influential US Democrat congressmen (including Henry Waxman, the chairman of the committee of the House of Representatives on oversight and government reform) have written to US trade representative Susan Schwab on March 12 to stick to the Doha Declaration, Trips and Public Health in US trade negotiations, and not insist on FTAs with Thailand, Malaysia or others on harsher conditions. The Democrats have flayed the USTR's tendency to exceed the provisions of the WTO Trips agreement in its provisions of FTAs. They have said that the Trade Promotion Authority (TPA) of 2002 giving the US president fast track authority in trade agreements (including the current Doha Development Round) until June end, has directed the US government to "adhere to the Doha Declaration as a principle negotiating objective in US trade negotiations." However, the current FTAs have provisions that "strip away flexibilities to which countries are entitled under Trips."

The letter by the Democrats states that the "world's consensus at Doha was that all nations have the right to use the flexibilities available under Trips" and as a signatory to the Doha Declaration on Trips and Public Health, harsher conditions should not be imposed by the US in FTAs.

The issues taken up in the letter talks of issues like the Bolar provision, which allows for early registration of generics so that that they can enter the market rapidly when the original patent expires; a requirement that patent applicants should describe the best method to reproduce an invention; protections to address attempts to gain repeated and unjustified patents on a product.

The Congressmen have pointed out that under FTAs, the USTR insists that the normal patent term of 20 years under Trips be extended when there are delays in either the review of the patent or marketing approval period for potentially unlimited patent extensions. Developing countries have limited resources for patent review and marketing approval activities, therefore, this is taking unfair advantage of their handicap, said the letter.

The Congressmen expressed their concern about data exclusivity, or the exclusive rights over use of clinical test data submitted for a drug's first approval, for the FTAs do not require caps whereas the US law places strict caps on the periods available. The letter opposed the linkage between drug approval and patent authorities, where a drug regulatory authority is required to withhold approval of a generic drug until it can certify that no patent would be violated. The letter also referred to clinical test data to be submitted to regulatory authorities for approval and marketing of a drug within a specific period. According to the letter, the data exclusivity creates potential for serious harm for developing countries in the case of generics.