Malaysia will not require further patent protection extension under TPPA

The Ministry of International Trade and Industry (Miti) is optimistic that Malaysia will not require a further extension to the pharmaceutical patent under the Trans-Pacific Partnership Agreement(TPPA), to allow for a reduction in the price of medicine.

Deputy Secretary General (Strategy and Monitoring) Datuk J. Jayasiri said under the TPPA, patent protection for pharmaceutical data was agreed at a 20-year period, meaning the price of medicine will remain at the current level upon implementation.

Under the access window for the pharmaceutical chapter, he added, Malaysia had opted for five years of data exclusivity from the date of first marketing approval of a product compared to eight years of market protection.

"This access window says, if you want to mention data protection for your chemical products, registration in Malaysia must be within 18 months of the date of first approval in any other country.

"We can not only get our consumers to enjoy new innovative drugs early, but also create a pathway for generics to come in much earlier," Jayasiri said.

He was speaking to the media after his keynote address at the roundtable discussion on, "What does the TPP agreement mean for Malaysia?", here today.

He said given the efficiency of Malaysia's patent process and marketing approval for drugs, it was very unlikely for the Ministry of Health to require an extension from the five-year patent to give marketing approvals for generic drugs.

"The process at present to grant the marketing approval for generic drugs is 245 working days, barring unnecessary delays.

"When the patent term (for pharmaceuticals) is not extended upon expiry, generic drugs, which are much lower compared to biologic drugs, can come into the market and prices will go down.

"However, if the patent is extended, and in the event of Malaysia being late in giving the marketing approval, patients will continue to pay the same medicine price as now," he added.

Biologics are preparations from biological sources, including vaccines, anti-toxin, proteins? and monoclonal antibodies, costing on average 22 times more than non-biologic drugs.

Meanwhile, the generic version, which is the biosimilar drugs, is cheaper as manufacturers can just use data from clinical trials submitted by the maker of the original biologic.