The Prime Minister’s Office enters the ‘Pharma-IPR’ debate

The Economic Times, the Financial Express and the Business Standard have all carried reports on the fact that the Prime Minister’s Office (PMO) has entered the debate on India’s IPR policy after having a high-powered meeting with the top level management of innovation-led multi-national pharmaceutical companies and lobby groups such as OPPI, Eli Lilly, Novartis, BMS & Pfizer. Apparently the PMO has circulated a note, based on the submissions of OPPI, amongst the Ministry of Commerce, Ministry of Health & Family Welfare & Department of Legal Affairs seeking their views on a number of policy suggestions related to the pharma-IPR debate. As per the Business Standard report the PMO has asked the Department of Pharmaceuticals, Ministry of Chemicals and Fertilizers to take the lead in co-ordinating the efforts of various ministries and department. This is quite surprising since the IPR policy usually falls within the purview of the Department of Commerce & Department of Industrial Policy and Promotion (DIPP) both of which function under the Ministry of Commerce.

The main proposal includes a ‘legislative review’ of Section 3(d) and possibly defining the term ‘efficacy’. This proposal of the PMO is not as problematic as is being made out in the media since the 88th Report of the Department Related Parliamentary Standing Committee on Commerce in the year 2008 on the ‘Patents & Trademarks System in India’ contained the very same proposal. In para 5.35 the Committee clearly urges the Government to clarify the confusion on Section 3(d). I reproduce the pertinent portion of the Report below:

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.

It is surprising that the PMO has sought to intervene at this stage when the question of Section 3(d) and its possible interpretation is pending before the Supreme Court in the Novartis-Glivec case.

The most controversial and mis-guided proposal in the PMO note is the question of ‘linkage’ between the patent office and the drug regulatory authorities. This again is a question pending before the Supreme Court in the Bayer-Cipla case. Bayer failed in its attempt before the Delhi High Court to establish this ‘linkage’ between the Patent Office and the DCGI. However of all the proposals, this is the easiest for the government to execute since all it requires is an amendment to the Drugs and Cosmetics Rules and not a positive legislation through Parliament. Such an amendment does not require to be voted on by Parliament since the rules are only required to be placed before the House for a few months after which they are deemed to be passed unless a MP objects to the same.

It would appear to me that the OPPI and MNC pharma companies are getting pretty nervous about the Supreme Court deciding these cases.

The PMO has also requested a consultation on the question of data exclusivity. It is surprising that the PMO has asked the Ministries to debate this proposal since the Department of Commerce has been emphatic in its rejection of such a demand in the FTAs that are being negotiated with the E.U.