Drug-trial data issue invites pharma fire

The controversial issue of exclusivity of drug-trial data — which saw overseas multinational companies and Indian pharma companies taking opposite positions — is back on the table.

A Delhi-based law agency, Anand and Anand, has circulated a series of questionnaires on the subject, which it claims are a part of a World Health Organisation (WHO)/health ministry survey.

This has irked the Indian Pharmaceutical Alliance (IPA) — a grouping of the 12 leading domestic pharmaceutical companies — as Anand and Anand has many MNC pharma companies as its clients. The IPA is also upset at the limited time of one week, till December 8, given for responses to the questionnaire.

Data exclusivity essentially delays the introduction of generic versions of a drug, according to domestic companies and public health groups who are against its grant.

In a letter to the department of pharmaceuticals, IPA said it was "stunned" to “receive an email from Anand and Anand, a firm representing foreign intellectual property (IP) owners”, seeking response to the “WHO commissioned survey” over the impact of the data exclusivity.

“We are stunned for three reasons – one, the obvious and gross bias in the questionnaire, two, the selection of a firm representing mainly IP owners which has in the past refused to take up patent litigations in favour of Indian generic companies on the ground of conflict of interest with their foreign clients and third, as Pravin Anand, the key person behind Anand and Anand was a member of the Satwant Reddy committee (that had originally prepared the 'data exclusivity’ report for the government)”, D G Shah, secretary-general of IPA, told Business Standard.

Satwant Reddy, former secretary to the government, chaired the 15-member committee which went into the question of data exclusivity. The panel, which finalised its report in 2007, favoured the introduction of data exclusivity, though only after further studies of its impact.

Pravin Anand was part of the committee. When asked, Anand declined comment.

The IPA has also requested the department of pharmaceuticals to confirm the role of the WHO in a national policy debate, "as it is contrary to its practice.”

The health ministry official in charge of WHO affairs said he was not aware of the development.

Data exclusivity has been a subject of heated debates since 2005, soon after India implemented a product patent regime in pharmaceuticals. The initial debate was whether data exclusivity was a Trips (Trade Related Aspects of Intellectual Property Rights) requirement under World Trade Organisation (WTO) rules. Foreign multinational pharmaceutical companies, which own intellectual property rights for almost all medicines, and developed countries like the US, have been pressurising the central government to introduce data exclusivity based on their interpretation of the Trips agreement.

Domestic drug companies had been opposing this, as they felt India was not obliged to give data exclusivity under Trips. Instead, it was a Trips-plus clause meant only to delay the entry of low-cost generic medicines, they argued. Public interest groups had also maintained that data exclusivity could prevent the registration of low-cost quality generic versions of medicines even when there is no patent on a medicine.