Keeping USTR informed regarding AmCham committee positions.
One of AmCham Taiwan’s major roles is to help communicate Chamber members’ views – through their respective industry committees – to the relevant authorities in both the Taiwan and U.S. governments. That responsibility is carried out not only by means of the annual Taiwan White Paper, but also via other communications channels throughout the year. After a recent video conference with the Office of the U.S. Trade Representative, AmCham last month responded to a USTR request by providing additional information on the following topics:
Together with AdvaMed, the U.S.-based association for advanced medical technologies, AmCham’s Medical Devices Committee has called attention to difficulties arising from the current policy of Taiwan’s National Health Insurance Administration (NHIA) of steadily shifting self-pay items to the insurance reimbursement schedule without adequate industry consultation. To receive a self-pay code, a new and innovative medical device frequently must first obtain approval for a new medical procedure. The whole process can take three to five years to complete, by which time the product may be nearly obsolete considering the rapid technological changes in the medical device market.
In addition, manufacturers often find that the reimbursement price eventually being offered is unacceptably low. While a premium price is theoretically available for innovative products, companies have no practical opportunity to make the case that their product meets the criteria. The recommended solution is commitment by Taiwan to follow Good Regulatory Practices principles like those set out in the U.S.-Mexico-Canada trade agreement of 2018. Those principles call for regular dialogue between industry and regulators on vital issues. In the absence of a final resolution, AdvaMed and the AmCham Medical Devices Committee further suggest that NHIA issue temporary self-pay codes to facilitate the entry of innovative medical devices into the market.
The two issues raised by the Pharmaceutical Committee also concern regulatory practices related to procedures for reimbursing hospitals and other healthcare providers. The first involves what are called Managed Entry Agreements (MEAs) – agreements between NHIA and pharmaceutical companies that are designed to share the financial risks of bringing new drugs into the market to meet patient needs. As with medical devices, the lack of adequate consultation is a central issue. The Committee contends that when it comes time to renew or terminate an agreement, NHIA sets the terms unilaterally. Also worrisome to industry is the lack of guarantees protecting confidential price information from being released.
The second issue concerns the Health Technology Reassessment (HTR) process to evaluate the clinical, social, ethical, and economic implications of selected health technologies. Given the lack of clear rules on how HTR is implemented, the Committee cites examples of its misuse for adjusting drug prices, changing the scope of reimbursement, or delisting certain drugs. As a remedy, it urges adherence to established international mechanisms.
The Committee’s submission refers to Taiwan government efforts to review its regulatory policies in light of new gene-editing technologies that have created new plant varieties. The Taiwan Food and Drug Administration (TFDA) in recent years has launched a series of projects to study the matter, but to date there has been no definite conclusion. Besides the lack of clarity, there is concern about the potential impact of one proposal: to create a new food category to incorporate such gene-edited variations. “That would inevitably lead to trade disruptions due to asymmetric regulations with Taiwan’s trading partners, considering that gene-edited products are indistinguishable from conventional ones,” the Committee notes.
The AmCham members of the Taiwan Society of Chiropractic Doctors stress that their subject of concern – Taiwan’s deviation from international practice in failing to accommodate chiropractic as a recognized form of treatment – is now the oldest unresolved White Paper issue, going back over a decade. The chiropractic doctors practicing in Taiwan are mainly U.S.-trained and U.S.-licensed, but need to function in Taiwan in a state of legal limbo without even being able to operate a website.
Potential progress in addressing the issue with the help of the National Development Council was disrupted by the advent of the Covid-19 pandemic. The chiropractic AmCham members now hope that the matter could be taken up under the Good Regulatory Practices framework of the 21st Century Initiative currently being negotiated between Taiwan and the U.S.