Indian Pharmaceutical Alliance Questions Data Exclusivity Survey; Says Transparency Lacking

NEW DELHI - The Indian Pharmaceutical Alliance - an association representing 12 leading Indian pharmaceutical companies - has raised strong opposition to a survey on data exclusivity being conducted by the New Delhi-based law firm Anand and Anand.

Titled "Study on Impact of Satwant Reddy Committee Recommendations on the Indian Pharmaceutical Industry; Data Protection," the study was commissioned jointly by the World Health Organization and the Indian Health Ministry to determine whether it is "in India's national interest to introduce data exclusivity legislation."

It also aims to find out whether India is required to "introduce data exclusivity legislation to fulfil its international treaty obligations under the Agreement on Trade Related Intellectual Property Rights."

The survey would also help determine whether data exclusivity should be limited to only data generated by patented new chemical entities or whether patent protection should be wider. It also asks what the terms of data exclusivity should be and how it should be calculated, as well as exceptions and limitations to data exclusivity.

IPA strongly objects to the survey because it is conducted by Anand and Anand, a firm that has mainly represented foreign IP owners in major patent disputes in India and has in the past refused to accept cases from Indian companies citing a conflict of interest.

"How can an agency that has a conflict of interest in representing domestic companies be selected to conduct such a survey?" asked DG Shah, secretary general of the IPA, in an interview with PharmAsia News. "The survey is biased and does not inspire confidence with respect to objectivity."

Data exclusivity essentially provides an innovator company exclusive rights to the clinical data of a new drug for an extended period of time independent of the patent. It is thus being opposed by domestic companies and public health groups as it would inevitably delay the launch of generic versions of the drug.

The Satwant Reddy Committee, formed by the government to look into the matter in 2007, recommended adopting a cautious approach toward implementing data exclusivity. Pravin Anand, the managing partner at the law firm, was a member of the Reddy committee.

[Editor's note: Anand & Anand provided an Insider Analysis column for (Also see "Insider Analysis From Anand & Anand, New Dehli: What’s The Secret Behind Your Medicine? Exclusivity Or Protection Of Clinical Trial Data In India (Part 2 of 2)" - Scrip, 21 Aug, 2008.) on the committee's findings.]

"This issue was debated and consulted over a period of two years by the Satwant Reddy Committee and the committee submitted its report. So what is the need for another survey at this moment?" asked Shah. "The report has been lying for three years and they want the survey in five working days. What is the urgency?"

Survey Methods Called Into Question

Shah has also raised questions about the transparency of the study. Sent by Pravin Anand and obtained by PharmAsia News, the emailed survey says that all the responses "submitted to the WHO as a part of the report may be available for public viewing in the future."

But according to Shah, when he asked Anand to specify the sample size and the statistical tools that would be used for the survey, the firm refused to share the details.

"There is an obvious lack of transparency," said Shah. "If each question has to be posted in the public domain, then what is the problem in sharing these details?"

Indian companies constitute almost 80 percent of the Indian drug market and the remaining 20 percent is held by multinational pharma companies, the majority of which are in favor of data exclusivity.

"What if a larger number of foreign companies are surveyed? Then the result would obviously be biased," Shah added.

The survey consists of three sets of questionnaires, each with a different scope and intention.

Questionnaire 1 covers interpretation of Article 39.3 of TRIPs and data protection versus data exclusivity. Questions include: "What is the nature of protection envisaged under Article 39 of TRIPS that can appropriately prevent 'unfair commercial use': 'data protection' which is limited to 'non-disclosure' of regulatory data or 'data exclusivity' which extends to 'non-reliance' of regulatory data for subsequent approvals?"

The second questionnaire is titled "Moving Beyond TRIPS - Public Health Implications of Data Exclusivity," and has questions like "Do you think that a data protection/exclusivity law will help in solving the current problem of Fixed Dose Combinations being launched in the Indian market without adequate clinical trials that help in validating the safety and efficacy of the FDC in question?"

The third questionnaire is related to the impact of potential data protection exclusivity legislation on the Indian pharmaceutical industry, and includes questions such as: "How will a data protection/data exclusivity legislation impact the competitiveness of the Indian Pharmaceutical Industry vis-à-vis the Chinese Pharmaceutical Industry?

Shah has also raised questions on the involvement of the WHO with the study. In his letter to Ashok Kumar, Secretary, Department of Pharmaceuticals, he sought clarification regarding the role of WHO.

"You may also consider seeking confirmation of the Health Ministry regarding the role of the WHO in the national policy, as it is contrary to its practice," says IPA's letter to Kumar.

When approached by PharmAsia News, Kumar confirmed receipt of Shah's email but refused to comment further on the issue. The health ministry official in charge of WHO could not be reached for comment.

Meanwhile, IPA will not be answering the survey. "Unless the surveyor, method of survey and the content inspires confidence, we would not waste our time in answering the survey," Shah said.

- Binny Sabharwal ([email protected])