We had blogged about the PMO’s note over here. It also appears to me that I have made a mistake in this previous post of mine when I stated that linkage can be implemented through an amendment to the rules. ‘Linkage’ can be implemented only through a Parliamentary legislation. Data exclusivity however maybe implemented by an amendment to the rules but even that maybe a debatable proposition. I’ve appended a correction to the old post reflecting this error on my part.
The ToI report also quotes the President of the Indian Drug Manufacturer Association as stating that “We are certain there will be no further review of section 3(d) of the Indian Patents Act. If anybody even tries to bring it up, we will fight tooth and nail to oppose it. Changing this section will be tremendously detrimental to the health of India’s generic drug industry.” As reported in my earlier post the demand to review Section 3(d) has come even from the Parliamentary Standing Committee on Commerce. In pertinent part the report stated the following: “However, even Section 3(d) is not free from ambiguities. The Government should clarify the usage of terms ‘significantly’ and ‘efficacy’, which form part of Section 3(d), to clear the ambiguities involved in the interpretation of the said section. It needs to be ensured that the laws are not TRIPS-plus but just TRIPS compliant.”
However as rightly pointed out by Dr. Gopa Kumar Nair, in the ToI report, the circulation of the note by the PMO should not be seen as an endorsement of the same by the Prime Minister himself. The final call will be taken only after receiving Ministry inputs. Given that both the Ministry of Industry and Commerce and Ministry of Health are pretty much against any further concessions to the innovator companies it is unlikely that they will endorse the contents of the PMO’s notes.
