March 16, 2007	Friday	Safar 26, 1428

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ISLAMABAD, March 15: Ministry of Health and Ministry of Commerce on Thursday agreed to amend the Drugs Act of 1976 for protecting undisclosed data of pharmaceutical companies seeking registration of new generics, which could delay the entry of cheaper brands in the market.

The draft amendment would now be sent to the federal cabinet for approval.

Consumer groups believe that once introduced, the amendment would have far-reaching ramifications for access to medicines by intense brand competition and preservation of artificial high prices.

A ministry of health spokesman said the amendment is in pursuance of the obligation under Agreement on Trade Related Intellectual Property Rights (TRIPS), to which Pakistan is signatory.

The proposed amendment pertains to the information provided to drug registration authority, as evidence of the medicine’s safety, effectiveness and quality of a drug for which registration is being sought.

Subsequently, other companies applying for the same generic drug generally do not repeat these studies while applying for registration of their brands. Rather, they rely on the data submitted to the regulator by the company which had originally applied for that particular generic. They only demonstrate that their product is therapeutically the same as the original one. To fulfil the efficacy and safety requirements, the drug authority relied on the registration data of the original manufacturer.

This approach enabled the swift introduction of generics into the market without registration data-related costs.

These tests are not replicated for economic, practical and ethical reasons. The tests may take several years to complete and delay the entry of cheaper brands into the market. Also, it has been argued that it is unethical to replicate some testing of drugs on humans.

There are concerns in the local pharmaceutical industry that the government while implementing the “data protection” amendment may go beyond the minimum obligations under the TRIPS Agreement and misuse it for granting “marketing exclusivity” to multinational companies.

WHO’s position on the issue is that it should be ensured that data protection did not become the means to block timely entry of affordable generic medicines of public health importance.