As trade pacts sprout in Asia, medical device firms need to take note

Medical device companies should pay close attention as the mechanics grind along of getting a dozen countries to formally put the Trans-Pacific Partnership (TPP) trade pact into practice.

That was the advice of a panel of trade experts at the Asia Pacific MedTech Forum 2015 hosted by Asia Pacific Medical Technology Association (APACMed) conference in Singapore on Dec. 10 and 11, who noted that the deal was just one among many trade pacts in Southeast Asia that hold the promise of significant changes in market access.

But first, the bottom line is getting the U.S. Congress to pass the TPP as soon as possible, said Deborah Elms, executive director of the Singapore-based Asian Trade Centre.

Deborah Elms

"All member states of the TPP have to approve it domestically, but the U.S. is the key to allow it to go into force," Elms said, adding that because of the 2016 presidential race, there are two narrow windows in May and June of next year, or during a lame-duck session of the U.S. Congress after the November polls.

"In 2017 that's a new president and a new Congress," Elms said, noting that the pact goes into effect 60 days after all 12 nations perform the needed domestic approvals and legal changes.

Elms was joined by former U.S. ambassador to Vietnam Michael Michalak, chief TPP negotiator for Malaysia Datuk Jayasiri, former U.S. ambassador to East Timor Judith Fergin and Hans Vriens of Vriens & Partners on a panel to discuss the trade outlook.

The upshot, all agreed, was that the narrow focus on the data-exclusivity period for biologics missed the broader point about trade liberalization prospects in Asia.

"For Malaysia we now have access to the United States on a preferential basis," Jayasiri said. "That makes a big difference for our companies in medical devices and other areas, plus the other countries."

In the past few years, Malaysia and Singapore have revamped medical device registration rules and hospital procurement policies for both public and private centers. While there was some industry grumbling, the moves in effect set standards for other ASEAN nations such as Indonesia and the Philippines and reinforced a regional hub system.

Jayasiri noted that at the same time, a regional pact, the ASEAN Economic Community (AEC), formally launches at the start of 2016 with the promise of more uniform regional customs rules and regulatory approvals.

"We view TPP and AEC as complementary but distinct," Jayasiri said. "The goal however is wider access to trade opportunities in both cases. For example, AEC should boost trade between Malaysia and Indonesia."

In addition, ASEAN has developed a series of formulas to expand trade options with India, China and Japan and possibly wider in the region

Vriens warned, however, that the AEC won't be like turning on a light bulb in implementation.

"On Jan. 1, 2016, virtually nothing will change on trade in ASEAN," Vriens said. "But working groups among the 10 nations on healthcare will be bringing in changes over time. Medical device companies need to be on top of that process."

Japanese Prime Minister Shinzo Abe

Michalak noted that a key Asian player to watch on the TPP side is Japan, because the pact gives "a much needed cover" to Prime Minister Shinzo Abe to unleash a third arrow of regulatory reforms to go with monetary and fiscal easing.

But for all of the panelists, ground zero in the trade focus was Vietnam, which is busy working on trade pacts with the European Union and South Korea in addition to its presence in the TPP and AEC.

"What is happening in Vietnam is extraordinary," Michalak said. "The opening of that market to healthcare is moving briskly."

- here's a release on the APACMed conference