India may allow data protection for pharma companies

India is likely to consider a specific period of safeguard against disclosure  the trial data submitted by pharmaceutical companies for obtaining regulatory approval.

The Indian government is reportedly open for providing a limited term of  ’protection against disclosure’ to the pharma companies in line with the recommendations included in Dr Satwan Reddy committee report submitted to the government around 2 years ago.

A committee headed by former secretary, Department of Chemicals & Petrochemicals, Ministry of Chemicals & Fertilizers Government of India, Dr Satwant Reddy’ Report on Steps to be taken by Government of India in the context of Data Protection Provisions of Article 39.3 of TRIPS Agreement submitted to the government on 31st July,2007.

The report recommended that “Government should take adequate steps to ensure that pecified undisclosed data submitted for seeking marketing approval for pharmaceutical products is not disclosed to any third party.”

Officials in the office of Drug Controller General of India should be under obligation to keep secret the undisclosed information submitted to Drug Regulator for approval of new drug,” the Dr Reddy committee had recommended.

Though the government has agreed to the non-disclosure clause, it may still take a while to take a call on protection of the submitted trial data from ‘unfair commercial use’ by other companies.

Data protection under Trade Related Intellectual Property Rights (TRIPS) section 39.3 spells out two distinct components: i) Protection against unfair commercial use and ii) Protection against “non disclosure”.

TRIPS, under WTO agreement in which India is a signatory makes data protection/exclusivity mandatory for all member countries along with product patents.

It was to comply with its international obligations under the TRIPS Agreement, the Government of India designated Dr Satwant Reddy Committee to consider whether data protection can be offered under the existing legal provisions in February 2004.

The Reddy report found that the present Indian legal provisions on data protection are not adequate to meet the spirit of Article 39.3 of TRIPS Agreement, though it concludes that existing legislation may be amended to achieve TRIPS consistency.

The report also recommended that an explicit legal mechanism in the Drugs and Cosmetics Act, 1940 and the Insecticides Act, 1968, and the Rules framed under these Acts, should be provided to ensure that undisclosed test data of the originator is not put to unfair commercial use by others.

However, pharmaceutical companies from India expressed several concerns on Dr Satwant Reddy committee report. Following this, the government put the report in back burner.

Data protection is one of the longstanding demand of MNCs and other innovator companies operating in India as they want a level playing filed in the country’s pharma market.

Sources said the government is finally considering their demand by offering to take adequate steps to ensure that specified undisclosed data submitted for seeking marketing approval for pharmaceutical products is not disclosed to any third party.

Multinational pharmaceutical companies, backed by the US and the EU, had lobbied for a five-year data protection term. They feared that Indian firms use their data for unfair commercial purposes.

However, he domestic pharmaceutical industry and public interest groups had opposed this. They argued that data protection is just another means for foreign owned pharma companies to resist competition and make extra profits on drugs with expiring patents or drugs that were not patented because they lacked innovation.

Data Exclusivity under TRIPS

The core concept of data exclusivity became part of the 1994 multinational Agreement on Trade-Related (Aspects of) Intellectual Property Rights (TRIPS Agreement), in which Article 39(3) reads as follows:

“Members, when requiring, as a condition of approving the marketing of pharmaceutical or of agricultural chemical products which utilize new chemical entities, the submission of undisclosed test or other data, the origination of which involves a considerable effort, shall protect such data against unfair commercial use. In addition, Members shall protect such data against disclosure, except where necessary to protect the public, or unless steps are taken to ensure that the data are protected against unfair commercial use.”

Internationally, three distinct trends may be seen in the way countries apply this Article.

1) One set of countries denies that the article mandates data exclusivity application.

Countries such as Australia, Canada and New Zealand have 5 years only for NCEs.

In the United States, data exclusivity provisions consist of the following:

 5-year data exclusivity period is granted to the NCE.

 3-year data exclusivity period for any new indications.

 6-month data exclusivity period for paediatric indications.

2) Another set of countries does not restrict data exclusivity to NCE. Notably, EU countries do not make such a distinction.

3) A third set of countries denies that the TRIPs mandate “data exclusivity” legislation per se. India belongs this third group.

Recently, the Indian health ministry has asked to resubmit the Mashelkar report. The Mashelkar Committee Report seeks to extend the scope of India’s patentability criteria for new drugs in India to include incremental pharmaceutical inventions.