DANGER OF DATA EXCLUSIVITY - Pharmabiz Editorial of July 6th

DANGER OF DATA EXCLUSIVITY

Thursday, July 06, 2006 08:00 IST

P A Francis

After successfully forcing the government to change the Indian patent law last year, drug multinationals are at work again to make the government accept data exclusivity of drugs as a part of Indian drug laws. They are not finding it that easy as Indian drug sector and consumer bodies are strongly opposing this move of extending monopoly on drugs beyond the patent period. The research-based US and European pharma companies feel that India should guarantee to a period in which test and clinical data of a new drug filed with regulatory authorities should not be referred to by any other company for obtaining marketing authorisation to launch a similar product in the market. Currently, when manufacturers of generics apply for approval of their drug, they claim bioequivalence to the originator's product without conducting clinical trials by themselves. They just make a reference to the originator's submitted data for approval. Regulatory authorities can then rely on such data for determining the safety and efficacy of the drug before marketing approval is granted to subsequent applicants. Such a regulatory practice is justified considering the social and economic costs involved in the repetitive animal and human trials in the developing countries. MNCs fear that the generic companies may capture a major part of their market by using the inventor's clinical data once the drug goes off patent. This is quite possible with the entry of generics at very low prices. But on the other hand, data exclusivity provides a free hand to the originator company to continue with its monopoly pricing for an unjustifiably longer period.

Access to medicine is key a social guarantee all the responsible governments should ensure to their people. For this governments have to exercise their powers and need to frame suitable laws. The issue of allowing data exclusivity for drugs has to be seen in this background. The matter has been taken up with the Prime Minister by certain bodies like Affordable Medicines and treatment Campaign (ATMC) in the past. ATMC is right in saying that India is a party to International Covenant on Economic Social and Cultural Rights (ICESCR) and the country has an international obligation to protect people's right to health. Access to and availability of drugs at reasonable prices are recognized as important components of right to health under this covenant. WHO has also made it very clear that the demand for data exclusivity is a TRIPS Plus requirement and that goes against the principle of access to medicine. An interesting suggestion that has come up from the domestic industry in this regard is the provision for pre grant opposition in case government decides some form of data exclusivity. The department of chemicals has called an inter ministerial meeting on July 12 to take a final view on data exclusivity. It is important that all the concerned ministries handle the issue taking into consideration of the government obligation to the people.