A committee set up by the Indian Ministry of Chemicals and Fertilisers to review the protection of undisclosed information in the light of intellectual property rights in the pharmaceuticals industry, has concluded that there is no need to change the laws that govern drug registration in India, which currently does not enforce data protection.

The Satwant Reddy Committee has recommended against allowing pharmaceutical companies exclusive rights to clinical trials and other test data they submit when registering a new drug for sale in the country. Instead, it proposed that data be treated as a trade secret under common law.

Multinational pharma companies wanted a five-year data protection term, which domestic companies resisted on grounds that if the drugs regulator cannot refer to the clinical data of an original drug to approve generic versions that are bio-equivalent, it would lead to unnecessary delays and increased costs for the generic manufacturer. Multinationals claim that the Indian practice is unfair and contravenes the internationally agreed guidelines laid down by the World Trade Organisation on intellectual property.

The committee did however say that there should be transparent legal mechanisms to protect undisclosed test data.

It recommended separate provisions for three different sectors:

• Test data for pharmaceutical drugs should be protected as a trade secret under common law.
• Three years of exclusive rights to test data for companies registering new agro chemicals.
• Five years of exclusive rights to test data for companies registering new traditional medicines.

According to the committee, there was “enough flexibility in the TRIPS (Trade-Related Aspects of Intellectual Property) Agreement for a country to determine the appropriate means of protecting test data”.

It pointed to Paragraph 4 of the Doha Declaration, which states that the WTO Agreement should be “interpreted and implemented in a manner supportive of WTO members’ right to protect public health and... promote access to medicines”.

It also recommended that in order to ensure confidentiality of data, additions should be made to the Drugs and Cosmetics Act 1940 to specify third-party liability for unauthorised use, and make data protection enforceable through the courts.

However, the committee kept the door open for higher standards of data protection for a pharmaceutical innovator in the future. It suggested a five-year data exclusivity model for discussion, with 14 safeguards to prevent excessive monopolies and enable the government to override data protection in the case of a public health emergency.

Various health and public interest groups have welcomed the committee’s report. Vineeta Gupta, Director SHAII (Stop HIV/AIDS In India) said however that much has still to be done to ensure that “India continues to develop policies that promote access to medicines, not just out of responsibility to its own people but as a lifeline to millions of people in other developing countries”.

June 11, 2007