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September, 2006 Pragati Maidan, New Delhi, India |
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Drug Mncs May Get Paid For Sharing Exclusive Data
Panel considering compensation
The Satwant Reddy panel on drug data exclusivity is now considering a plan to compensate multinational pharmaceutical corporations after deciding last week that India is not bound by the WTO to allow them the exclusive use of their costly research data.
The inter-ministerial panel’s idea is to compensate MNC drug makers, backed by the US government, with a negotiated royalty from Indian companies seeking to sell cheaper copies of the innovator’s new non-patentable brands.
Data exclusivity is important for MNCs as most of the new drugs are just new cousins in an existing family of drugs, which are not eligible for market monopoly under Indian patent law.
The panel neither wants to totally block the arrival of cheaper copies of non-patentable drugs for a limited term as MNCs demand, nor discourage their investments in drug development by freely allowing follow on applications.
The middle path suggested by the ‘compensatory liability model’ now under examination, would not directly affect the availability of cheaper copies of new drugs, but their price may not be as low as they are now.
“The model is under examination. We need to discuss it further to finalise a national policy,” said a source in the panel comprising chemicals, health, commerce, industrial policy and biotechnology departments.
The model, followed by the US in the agrochemical sector, allows the regulator to approve a copy without the second applicant having to re-invent it by generating data; in this case, generating the safety and efficacy data by trying the medicine on humans a second time.
The Federal Insecticide, Fungicide and Rodenticide Act requires the originator to submit the cost of data generation along with the marketing application. Other companies could get a license to sell the product after adequately compensating the innovator. If the companies couldn’t agree on the compensation in three months, they could elect for arbitration.
Date: 29-Jul-2006
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