TPP has 5-year protection for conventional drugs, says Miti

comments     Bernama     Published     Updated

The Trans-Pacific Partnership Agreement (TPPA) does provide for a five-year data protection for small molecules or conventional drugs.

International Trade and Industry Minister (Miti) Mustapa Mohamed said this in response to Lembah Pantai Member of Parliament, Nurul Izzah Anwar's statement, alleging that he had been misleading the public on data protection under the TPPA.

He said for biologics, the TPPA recognises that the protection for it can be achieved through different means.

"The TPPA provides options for counties to choose from, namely to provide eight years of data protection, or in the alternative, five, along with other measures while recognising market circumstances for biologics.

"These measures and circumstances may include existing regulatory and patent approval for biologics and biosimilars," Mustapa said in a statement today.

He said Malaysia chose the alternative option of providing five-year data protection, which reflects the country's existing regime in providing data protection for conventional drugs.

Mustapa said the agreement on data protection on biologics will be reviewed in 10 years.

"For Malaysia, we have five years from the date of entry into force of the agreement. This means the TPP provision on biologics will take effect only from then.

"It has been explained a number of times before to the Parliamentary caucus members as well as other stakeholders. But, we would like to repeat that the issue of ‘modified’ medicines is consistent with Malaysia’s current practice," he added.

Nurul Izzah made the allegations in an interview with an online portal.

- Bernama



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