Damaging Editorial & Befitting Reply By Amit Sentgupta on Data Exclusivity

Elusive data exclusivity norms

India should learn from the competition BJP leader Murli Manohar Joshi’s letter to the Prime Minister cautioning against allowing for data exclusivity once again brings to the fore the reluctance to concede on intellectual property rights (IPR) issues, even after other countries have taken a clear stand long before. Data exclusivity provisions of the Trade Related Intellectual Property (TRIPS) agreement, requires WTO member-states to protect clinical data filed for securing marketing approval or for registration. It means that the clinical data filed by patent holders should not be used for ensuing applications on similar products. This is because clinical tests for generating data are very expensive—as much as $500 million or even more—and it would be only fair to the original innovators if competing products are not allowed to benefit from the data, at least for a specific period of time.
Opponents of data exclusivity provisions argue the TRIPS provisions speak only about the protection of test data against unfair use and nothing on data exclusivity. It is also pointed out that data exclusivity might restrict access to drugs, especially generics, which helps keep down prices. Other arguments focus on unwarranted extension of patent rights and obstacles to compulsory licensing, which helps poor countries to avert emergencies. The World Health Organisation (WHO) support to the views that IPRs and drug regulations are separate issues, also buttress the opposition claim. But almost all developed countries and most developing ones, including China, Brazil and South Africa, to name a few, have ruled in favour of data exclusivity. The extent of non-conformity across nations is mainly about the period of exclusivity: it is seven years in the United States and six years in China. The EU allows member-countries a six or 10-year period, depending on product characteristics. Even Israel, one of the most important producers of generic medicines, gave in to demands for data exclusivity around last year.
Countries have little choice, as the potential losses from not having data exclusivity are much higher. How will it be in India’s interest if the absence of these norms discourages companies from introducing new products? Strong IPRs remain a keystone to accelerated growth of the buoyant Indian pharmaceutical industry. And it certainly would not be in India’s interest if the R&D majors take fright and decide to pull out their investments. So, it is time we took the call and sent the right signals. Any further delay will only benefit the competition.


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Amit's Reply:

Erroneous exclusivity
- Amit Sen Gupta

The government had recently set up an inter-ministerial group to opine on the issue of data exclusivity (DE) and it is understood the PMO has convened a meeting in July to arrive at a final position.
DE refers to a practice whereby, for a fixed period (usually five years), drug regulatory authorities do not allow the data filed by the originator company to get marketing approval to be used to register a generic version of the same medicine. Many assume that if national laws allow for patent protection, they also need to allow for DE. Incorrect on several grounds. Patents and DE are entirely different concepts. In fact, enforcement of DE can have the biggest impact in situations when patents cannot or are not being enforced. Second, the TRIPS Agreement does not mention DE, but ‘Data Protection.’ Prominent intellectual property experts have said if regulatory agencies do not share the data with other companies or make it public, the requirements under TRIPS are met. This does not prevent regulatory agencies from registering generic drugs if the innovator firm’s drug has already been approved. Thus, in India’s case, very little needs to be done—possibly a small insertion in the Drugs and Cosmetics Act, clarifying that test data from an innovator company will not be made public or shared with its competitors for a fixed period.
Under the guise of DE, drug regulatory authorities are being asked to reject the application for marketing of a drug by a local company if it doesn’t submit fresh data from its own clinical trials. If the same agency has approved a drug based on clinical data provided by one company, there is no logical reason why the same drug should be refused marketing approval if another company produces it, as the issues of safety and efficacy have already been taken care of when the originator company’s drug got approval.
For India, the principal instrument to curb the monopoly of MNCs is the use of a compulsory licence. But if India allows for DE, such a licence would be useless, as the DGCI would then insist Indian firms conduct fresh clinical trials before getting marketing approval. Such trials are expensive and would add to the cost of the drug, and being time-consuming, delay its introduction. If we know a drug is useful and safe, to conduct trials again on humans is unethical.
There are clear reasons why India need not allow for DE. It is not required under TRIPS. It is unfortunate the government should seriously consider amending domestic laws under foreign commercial pressure. To allow for DE, the Drugs and Cosmetics Act has to be amended. Parliament should reject it.

—The writer is general secretary, All India Peoples Science Network, Delhi