IT is easy to assume that since India has safeguarded intellectual property rights it is therefore bound to allow data exclusivity (DE). In fact, these are two separate issues that are being deliberately conflated by multinational companies in order to ensure that drug regulatory authorities protect their monopoly in the Indian market.
Multinational companies arguing in favour of DE are doing so under the World Trade Organisation TRIPS agreement, which seeks to balance the interests of the innovator with that of public health. Article 39.3 states: "Members, when requiring, as a condition of approving the marketing of pharmaceutical... products which utilise new chemical entities, the submission of undisclosed test or other data, the origination of which involves considerable effort, shall protect such data against unfair commercial use."
However DE and intellectual property patents are legally and conceptually distinct: patents reward invention, while DE rewards investment in clinical trials when drugs are registered for market approval. Dr. Amit Sengupta of the Delhi Science Forum, made it clear that while intellectual property is a private right protected by patent laws, the registration of drugs is moderated by the Drugs Controller General (India) (DCG-I).
"Unfair commercial use" would occur if the DCG(I) made public or shared the test data given to it, but since it examines data in the public interest such use cannot be classified as "commercial". Neither should it be termed "unfair"; generic companies have already produced the drug at a cheaper rate through their own creative process and without seeing the data in question. So it is entirely consistent with the language of the TRIPS agreement to require that data submitted to the DCG(I) are kept confidential and allow their use for generic applications.
The history of intellectual property negotiations is instructive. In 1995, when patent licensing was reviewed, multinational companies made the case for a six-year DE period on the basis that they needed to cover the costs of drug trials. Because of the complications involved, the negotiators simply gave a patent licence extension from 14 to 20 years. As D.G. Shah of the Indian Pharmaceutical Alliance put it, asking for additional DE when it is already included in patent provisions amounts to "encashing your million dollar note twice".
The drafting of the TRIPS document itself reveals that DE was not the intention of the drafters: they deliberately rejected the more explicit provisions of the earlier NAFTA (North American Free Trade Agreement) document. The Indian government played its part in rejecting such DE provisions and clearly stated in its 2001 submission to the WTO that such provisions were not in the interests of public health. It made a further argument to the same effect last December. India has every right to make use of the TRIPS flexibilities provided by the WTO agreement. As Article 1.1 states, "Members may, but shall not be obliged to, implement in their law more extensive protection than is required by this Agreement. Members shall be free to determine the appropriate method fo implementing the provisions of this Agreement within their own legal system and practice."
Sarah HiddlestonCOMMents
COMMents
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