By Stephanie Jacob
Malaysia is one of the few countries in Trans-Pacific Partnership (TPP) which has secured an “access window” which will make help bring biologics and other new drugs to Malaysia faster and will also allow for generics to come on to the market sooner, said International Trade and Industry Ministry deputy secretary-general and chief TPP negotiator J Jayasiri.
Under this provision, innovators wanting to protect their data in Malaysia must submit their application for marketing approval in Malaysia within 18 months of the first date of registration of their product anywhere in the world. This makes it likely that innovators will introduce new medicines to Malaysia faster.
“Malaysia is one of the few countries that negotiated an access window for pharmaceuticals and in the biologics area too. The access window says that if innovators want data protection on its biologics or chemical products, they must come and register in Malaysia within 18 months of the first date of registration anywhere else in the world.
“What does this do for Malaysia? It means that our patients will have earlier access to new innovative drugs. Otherwise the innovator can wait until almost the last day of his patent and then come and file for data protection and he can get a much longer period of protection. So this way not only do we get our consumers to enjoy new innovatives drugs faster but it will also pave the way for generics to come in much earlier,” he said.
Jayasiri also said Malaysia obtained most of what it wanted from its negotiating partners in the TPP negotiations. He said: “Although negotiations are not a zero-sum game and you have to make some concessions, we actually had all our concerns taken on board in these negotiations.
“If you look carefully, it (the TPP agreement) has recognised our affirmative action policy either in the rules or through our own schedules. It has also recognised halal as something that is needed for religious purposes. These are instances where I can say that the rules have actually taken on board our requirements, and also given us the policy development space we require.”
Jayasiri said this along with factors such as trade liberalisation, increased investment, the adoption of international standards, good governance, and being part of those setting the international trade agenda and standards, are why Malaysia should sign on to the trade deal.
He pointed out that are four TPP countries with which Malaysia does not have trade agreements with, namely Canada, Mexico, Peru and the US. And this means Malaysia does not have preferential access to these countries’ markets.
Under the TPP, Malaysia will gain preferential access to this four markets and upon entry into force of the agreement, the four will eliminate almost 90% the duties they currently charged on Malaysian imports to their markets.
Currently through Malaysia 13 free-trade agreements (FTAs), 65% of its global trade is done on a preferential basis. Under the TPP, this will increase by 8% to 9% and therefore almost 75% of Malaysia’s global trade will done under preferential access conditions.
Jayasiri also highlighted the investment benefits which could come through the TPP. He said: “The TPP provides liberalisation, protection and facilitation for investments. And we may not think that FTAs actually bring in investments because there is probably no empirical evidence of this. But I can tell you anecdotally, that even while we were negotiating the TPP a few investors from non-TPP countries were already making enquiries to locate their manufacturing base in Malaysia.
“The reason is because they want to get into the US market and the rules of origin will prevent them from getting preferential treatment if they are outside the TPP. So that is an indication that the TPP as an impact on investment flows.”
He said that if Malaysia was not part of the TPP, then it might become a handicap to attracting foreign investment. “It would be more worrying if we are not in the TPP. Will we be able to draw in investments? And what about investors who are here in Malaysia? If we are out of the TPP while Vietnam is in the TPP, the natural decision for them would be to move to Vietnam.”
Jayasiri was speaking at the Asian Strategy & Leadership Institute’s roundtable discussion ‘What does the TPPA mean for Malaysia?’



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