Data exclusivity on its way ; Satwant Reddy panel report
Satwant Reddy Panel has recently submitted its report to the Indian Govt. This panel was set up to recommend Govt to decide on allowing MNC Pharma to prevent the domestic generic players from launching low cost generic drugs based on innovators research data (Data exclusivity). This protection of undisclosed information considered under the Article 39.3 of the TRIPS agreement.
Panel has recommended five year data exclusivity and several safeguarding measures to be compliant with the WTO norms. WTO expects the TRIPS member countries to have regulations to “protect undisclosed test data from unfair commercial use.”
But there is a catch; this data exclusivity won’t be forced on immediately. They have decided on a transition period to implement the recommendations quoting the ‘developing’ status of the country. This is similar to the transition period India had before implementing the WTO norms. Speculations figure that, this transition period may well beyond 10 years. That necessarily means, generic companies have enough time to work out next strategies and keep the revenues coming in the meantime.
This also necessitates an amendment in the ‘Drug & Cosmetics Act’ to provide protection to the research data.
This proposed data exclusivity period starts from the date the drug gets launched in any country, not necessarily India. That prevents the MNCs from getting monopoly on medicines which were in use in abroad for many years. Also the company has to get the marketing approval in India within 2 years of the global launch to enjoy this data exclusivity.
Good to see strong IPR regulations coming into place. Studies have to be done to see the impact of these laws on general healthcare and accessibility of essential drugs. Fortunately Govt reserves the right to allow generics in times of crisis. That wont block the regulation of ‘unfair commercial use’.
Panel has recommended five year data exclusivity and several safeguarding measures to be compliant with the WTO norms. WTO expects the TRIPS member countries to have regulations to “protect undisclosed test data from unfair commercial use.”
But there is a catch; this data exclusivity won’t be forced on immediately. They have decided on a transition period to implement the recommendations quoting the ‘developing’ status of the country. This is similar to the transition period India had before implementing the WTO norms. Speculations figure that, this transition period may well beyond 10 years. That necessarily means, generic companies have enough time to work out next strategies and keep the revenues coming in the meantime.
This also necessitates an amendment in the ‘Drug & Cosmetics Act’ to provide protection to the research data.
This proposed data exclusivity period starts from the date the drug gets launched in any country, not necessarily India. That prevents the MNCs from getting monopoly on medicines which were in use in abroad for many years. Also the company has to get the marketing approval in India within 2 years of the global launch to enjoy this data exclusivity.
Good to see strong IPR regulations coming into place. Studies have to be done to see the impact of these laws on general healthcare and accessibility of essential drugs. Fortunately Govt reserves the right to allow generics in times of crisis. That wont block the regulation of ‘unfair commercial use’.
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Seeji, Pharm House.
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Amazon :
The WTO and India's Pharmaceuticals Industry: Patent Protection, TRIPS, and Developing Countries
