Even as the committee on data protection of the Chemicals Ministry is to hold another round of meeting on September 6, MSF, the international health NGO has, written to the Health Ministry opposing any move to recommend compensatory model of data protection for pharmaceuticals.

The NGO has asked the government to view compensatory model cautiously as it implies an agreement to the data exclusivity model. "The compensatory model is based on the Data Exclusivity regime i.e. of providing exclusive rights on pharmaceutical data and preventing generic manufacture. It provides for generic manufacture on payment to the originator pharmaceutical company. It should be viewed cautiously as it implies an agreement to the Data Exclusivity Model" Leena Menghaney, Project Manager-India, Campaign for Access to Essential Medicines, MSF said.

According to MSF, the compensatory model of Data Exclusivity makes marketing approval for generic drugs the exception and not the norm, making generic manufacture difficult.

"Compensatory liability models are likely to be cumbersome and impose unnecessary costs and delays and could discourage competition. Disputes inevitably arise over the proper calculation of the compensation payment based on the costs of the clinical trials. For medicines that that are lifesaving for developing country populations but not particularly lucrative, a compensatory model may serve as a disincentive for generic manufacturers to apply for marketing approval if they have to increase costs by compensating another pharmaceutical company for the use of the data by the drug regulatory authority. Current debates about compensatory liability should also focus on the issue of whether the compensatory liability is required under TRIPS. As India correctly maintained in 2001, there is no obligation under TRIPS to introduce a compensatory scheme" It has stated.

MSF also urged the Health Ministry to initiate a serious debate on the associated problems with the Data Exclusivity Compensatory Model.