DIPP defers decision on issuance of compulsory licence for cancer drug Dasatinib

Source: Economic Times

The department of industrial policy and promotion, or DIPP, has delayed a decision on issuing a compulsory licence for cancer drug Dasatinib by seeking fresh clarification from the health ministry early this week.

Through compulsory licensing — provided under the Indian Patent Act — the government can allow someone else to produce Dasatinib without the consent of the patent owner,Bristol-Myers Squibb. If the DIPP had agreed to issue such a license on health ministry’s recommendation, it would have cheered the public health activists, but would have had adverse repercussions on Indo-US relations.

While the health ministry has repeatedly urged DIPP to issue the first government initiated compulsory license (CL) for Dasatinib after an expert panel made out a case for the same, the latter doesn’t seem convinced yet. “DIPP has sought further information to justify the issuance of a CL under Section 92 of Indian Patents Act,” said an official privy to the matter. In a 10-question letter to the health ministry, it has sought information on the total cost that government incurs on procurement of Dasatinib — used for treatment of chronic myeloid leukaemia — through its arms such as defence ministry, Central Government Health Scheme and Indian Railways.

The health ministry had earlier argued that many public institutions including Indian Railways, CGHS, Army Hospital Research and Referral are procuring the drug, but in small quantities partially because of its high price. It pointed out that a CL for ‘public non-commercial use’ will allow the government to source generic versions of Dasatinib at a fraction of the cost.

“In its letter, DIPP has pointed out that the probability of this type of cancer is just 0.001% and there is no visible incidence of an increase in the trend and sought the rationale for dubbing it a ‘national emergency’ or ‘extreme urgency’,” said the official quoted earlier. Under Indian laws, criteria for permitting a CL include cases of ‘extreme urgency’, ‘national emergency’ and ‘public non-commercial use’.

DIPP has also sought information on whether this drug serves as the first line of treatment and can be considered as a cure for the disease it is used to treat. The development comes at a time when the US Trade Representative’s office has just begun an out-of-cycle review (OCR) of India’s intellectual propertyregime. The OCR follows its annual Special 301 Report that came out in April, in which the USTR had placed India on the ‘Priority Watch List’ containing countries whose IP regimes are a serious concern. The next level of ‘priority foreign country’, which is USTR’s worst classification, can trigger trade sanctions.

In its release announcing the unilateral review this week the USTR, however, said, “The OCR will not revisit India’s designation on the 2014 Priority Watch List.”

This entry was posted in Compulsory Licensing, Indian Patent Law, Out of Cycle Review (OCR), Patents, US pressure on India, USTR 301 report and tagged , , , . Bookmark the permalink.

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