• Getting Ready for a Taiwan FDA
  Following last year's melamine incident, the Department of Health is accelerating plans for reorganizing food and drug regulation.
  
  

  By Don Shapiro

• More Attention for U.S. Visa Waiver
  President Ma has raised the issue several times recently. What needs to be done to move it forward?
  
  By Don Shapiro
  
  

Getting Ready for a Taiwan FDA

Following last year's melamine incident, the Department of Health is accelerating plans for reorganizing food and drug regulation.

For around a decade, the Department of Health (DOH) has been intermittently considering the idea of consolidating various functions inside and outside the ministry to create an agency roughly equivalent to the U.S. Food and Drug Administration (FDA). Then last fall the "melamine scare" – the discovery that toxic additives originating in China had contaminated portions of the Taiwan food supply, including some baby formula – delivered a shock wave in regulatory and consumer-protection circles. The incident brought about the resignation of the health minister under a barrage of media criticism. It also prompted realization within DOH, health officials say, that it needs to improve its ability to respond to such crises quickly, consistently, efficiently, and professionally.

As a result of the new sense of urgency, a draft law has already been submitted to the Legislative Yuan to authorize the establishment of a Taiwan FDA and define its basic structure. Once the bill is passed, DOH expects that about a year will be needed before the TFDA's launch to develop the multitude of new procedures and mechanisms that will shape the work of the new agency.

One of the key expected changes will be to bring in-house, under the TFDA, responsibility for regulating food safety, especially of imported goods. In the past, that duty was outsourced to the Bureau of Standards, Metrology and Inspection under the Ministry of Economic Affairs. Another new development will be the creation of a risk analysis division to strengthen the department's capability in risk assessment and risk management – areas widely considered to have fallen short during the melamine incident. Even before the TFDA's establishment, DOH has received authorization to add 10 specialists in risk analysis and control to its staff.

Deputy Health Minister Sung Yen-jen says he believes industry will be pleased with the regulatory reforms that the TFDA will introduce, such as expediting the approval process for new drugs. In a process that was frequently criticized by the AmCham Pharmaceutical Committee in the annual Taiwan White Paper, licensing decisions currently are a two-step process that includes review by an outside panel of "advisors." The result is often long delays and sometimes confusion about lines of authority. Sung says that the technical panel will either be eliminated or relegated to a genuinely advisory position. For medical devices, he notes, new product applications will in future be centralized in a single office, whereas currently the three classes of products are handled by three different sections.

The three AmCham committees likely to be most affected by establishment of the TFDA – Pharmaceuticals, Medical Devices, and Retail (for food and cosmetics products) – are generally welcoming of the planned reorganization. But they are requesting more information from DOH on the expected new procedures, and are particularly concerned that TFDA staff should be highly trained before taking on their new duties.

Sung gives assurances on both counts. He has offered to provide briefings to industry representatives, and he notes that training is among the top priorities in the TFDA plan. In fact, the aim of a DOH delegation due to visit Washington D.C. next month is to study USFDA practices for training its professionals.

- By Don Shapiro

More Attention for U.S. Visa Waiver

President Ma has raised the issue several times recently. What needs to be done to move it forward?

The question of Taiwan's eligibility to be included in the United States' Visa Waiver Program has been the subject of public discussion for a number of months. It was last discussed in this column in the December 2008 TOPICS, when a U.S. decision to grant visa-waiver privileges to seven countries – including South Korea – prompted many in Taiwan to ask "why not us?"

But recently the issue has been receiving increased public attention, and it appears to be very much on the mind of Taiwan President Ma Ying-jeou. During a mid-February interview with The New York Times, Ma noted that just a few days earlier, the United Kingdom had announced that Taiwanese travelers would be accorded visa-free entry. "If we are able to do that with the U.S., obviously Taiwan tourists to the U.S. will increase dramatically," Ma told the Times. He added that after Taiwan and Japan gave each other reciprocal visa waiver treatment, the number of tourists to Japan surged.

Ma further brought up Taiwan's interest in gaining visa waiver privileges from Washington two more times in early March – once in his keynote speech at AmCham's Hsieh Nien Fan banquet on March 5 and the following week when meeting with the visiting chairman of the American Institute in Taiwan, Raymond Burghardt.

The topic is also one that AmCham's Discover America Committee has had high on its agenda. The committee has repeatedly sought to remind Washington of the potential gains for the U.S. travel industry, and more broadly for the U.S. economy during a period of recession, of encouraging the entry into the United States of more relatively well-off and high-spending travelers such as those from Taiwan. The objective would be to counter the slump in Taiwanese tourism to the United States that has been experienced since the U.S. government imposed more rigorous security measures in the wake of the 9/11 terrorism attacks. 

If incorporating Taiwan into the Visa Waiver Program would be in the economic interest of the United States – and if Taiwan meets most of the conditions (such as a low rate of visa-application rejections) for inclusion – what is the obstacle to moving forward?

As previously reported in TOPICS, the best insight into the source of the problem came from remarks delivered by American Institute in Taiwan Director Stephen M. Young at an AmCham luncheon last December. "Taiwan should enhance efforts to ensure that its passports are issued only to those qualified to obtain them," he said, as "too often we have found instances where people who were not Taiwan citizens have been able to obtain genuine Taiwan passports."

 From what TOPICS has been able to ascertain, discussions about that problem have been underway between the U.S. side and the Taiwan authorities. But to date it appears that the U.S. side is still seeking further concrete evidence that Taiwan's passport application procedures have been strengthened sufficiently to ensure that passports are not inadvertently issued to non-citizens.

 — By Don Shapiro