Taiwan TIFA: U.S. and Taiwan agree to move ahead on

UNCLAS SECTION 01 OF 04 TAIPEI 000136 SIPDIS SIPDIS STATE PASS TO AIT/W STATE FOR EAP/RSP/TC, EAP/EP and EB/TPP/MTA/IPC STATE PASS to USTR for BOLLYKY and ALTBACH, STRATFORD USDOC for 4431/ITA/MAC/AP/OPB/TAIWAN/JDUTTON USDOC FOR 3132/USFCS/OIO/EAP/WZARIT E.O. 12958: N/A TAGS: ECON ETRD EIND TW SUBJECT: Taiwan TIFA: U.S. and Taiwan agree to move ahead on pharmaceutical working groups REF: TAIPEI 2947 Summary -------------- ¶1. Assistant USTR Timothy Stratford urged Taiwan's Bureau of National HEALTH Insurance (BNHI) and Department of HEALTH (DOH) to consult actively with US firms and the U.S. as it contemplates major changes to its national HEALTH insurance system. USTR promised to provide by early January a proposal on technical working groups to deal with long-term problems. AUSTR Stratford also urged Taiwan to address a number of issues of interest raised by U.S. pharmaceutical firms and to find a way for American-qualified chiropractors to practice in Taiwan. An ongoing prosecutorial investigation has raised the stakes at BNHI. It has cost the President of BNHI his job and put local drug firms, hospitals and BNHI itself under a spotlight. U.S. firms are trying to calibrate their next moves. End summary. Introduction -------------- ¶2. During their December 18-19 visit to Taiwan that covered the full range of economic and trade issues, Assistant USTR Timothy Stratford and Deputy Assistant USTR Eric Altbach discussed pharmaceutical and other HEALTH sector trade issues with the Department of HEALTH (DOH) and the Bureau of National HEALTH Insurance (BNHI). They also met with local representatives of U.S. pharmaceutical firms. Other issues and meetings are reported Septel. Prosecutor Raids Make Them Nervous -------------- ¶3. The Bureau of National HEALTH Insurance is in a state of upheaval. Prosecutors have raided hospitals, drug suppliers, and BNHI itself. The prosecutors are investigate fraudulent drug transaction pricing reporting which results in BNHI reimbursing hospitals and clinics amounts in excess of the actual cost of drugs. Prosecutors have "discovered" what the USG and industry have been complaining about for years: Some drug firms and hospitals overstate the cost of their drug transactions in order to claim higher reimbursements from the Bureau of National HEALTH Insurance (BNHI). Most of these cases are believed to involve low cost generics produced in Taiwan which are reimbursed at rates close to those of name-brand drugs. These excess payments are known in Taiwan as the "black hole." In particular, prosecutors are looking at data submitted last year as part of the 5th Price Volume survey, which is used to set reimbursement levels for individual drugs made by the insurance system to medical care providers. ¶4. Initial ramifications of the investigation are clear: BNHI's CEO has been replaced by a technocrat with a strong financial background, and BNHI staff warn of more personnel shuffles to come. Vice Minister of HEALTH Chen Shih-chung has publicly stated that the prosecutors' investigation revealed systemic problems and that BNHI needed to reevaluate its finances. ¶5. So far more than 12 hospitals are involved, including some of Taiwan's largest private hospitals. Although six BNHI employees have been interviewed, no ONE at BNHI is yet a target in the investigation. The scope of the investigation continues to expand. One U.S. industry rep reports "rumors" that U.S. and European firms may have been investigated, but BNHI is unaware of any foreign firms under investigation. Impact on U.S. Firms -------------- ¶6. On December 20, the Prosecutor's Office and the Department of Health held a joint news conference and announced that drug firms and hospitals who wished to resubmit corrected data would be able so do before a January 22, 2007 deadline. U.S. industry is already working to try to evaluate how to respond. The instructions specify that firms are to disclose all benefits, discounts, rebates or other considerations that firms make to drug buyers. These could include items such as donations to a hospital-affiliated charity, conference sponsorships, administrative fees levied by the hospital, or TAIPEI 00000136 002 OF 004 anything else of value paid or charged by buyer or seller. ¶7. Although foreign firms are seen by BNHI as largely complying with reporting requirements, U.S. firms tell AIT they are working hard to make sure that they report all data accurately. In the past, they say, it was not always clear which information needed to be reported. They are also concerned how the data will be used. It is possible, they fear, that new data could lower prices further. Industry Meets USTR -------------- ¶8. On December 19, AUSTR Stratford and DAUSTR Altbach met with representatives of US drug firms. The representatives stated that the investigation as had the potential to force improvements in the quality of the data gathered in the Price Volume Survey. They also hoped it would encourage movement towards the goal of Actual Transaction Pricing (ATP). At the same time, they also hope that the investigation and any efforts to correct data reporting would be as transparent as possible. ¶9. Industry reps stressed the need for BNHI and USTR to implement the working groups as agreed in earlier TIFA meetings (REFTEL) in order to deal with the system's long-term reform goals, namely the separation of dispensing and prescribing (SDP) and actual transaction pricing (ATP). They also urged BNHI to continue consultations with industry and with AIT as the DOH contemplates any major changes to the HEALTH care insurance system. Specifically they highlighted four priorities for follow-up in the TIFA framework: --NEW DRUG PRICING - Industry believes that the process for approving and setting prices for new drugs is too time-consuming, and that prices are too low. They criticized BNHI's new policy of three-tired pricing for breakthrough, me-too, and line extension drugs. Industry recommended setting prices based average prices in OECD countries with GDP levels similar to Taiwan, removal of pricing tiers, and a renewed commitment to no therapeutic grouping. --ATTACKING THE BLACK HOLE THROUGH ATP AND SDP - Structural reforms are needed to eliminate the black hole, i.e. ATP and SDP. Working groups to deal with these problems should start as soon as possible. BNHI should implement a standardized contract as soon as possible to improve quality of transaction data. As a first step for SPD, the DOH should require public hospitals to release prescriptions for chronic disease patients. --PATENT LINKAGE - There is currently no system of patent linkage in Taiwan. Industry urges Taiwan to set up such a system that will protect an originator's rights while providing a safe harbor for generics to conduct registration trials. --FIGHT BALANCED BILLING - BNHI has proposed implementing balanced billing, which would give BNHI authority to set a price for a certain drug or class of drugs and allowing the patient to pay the difference for an alternative medication. Firms believe that this will lad to a shrinking of drug expenditures and more hospital demands for discounts. Balanced billing should only be considered after ATP is in place. Taiwan HEALTH Officials Eager to work with USTR -------------- -- ¶10. Immediately following the meeting with U.S. pharmaceutical firms, Stratford and Altbach met with Vice Minister of HEALTH Chen Shih-chung and staff from the Department HEALTH and BNHI. The new president of BNHI did not attend the meeting. Vice Minister Chen opened the meeting by reviewing U.S.-Taiwan consultations over the past few months on drug pricing. Responding to U.S. concerns, BNHI had delayed the implementation of price cuts from the last price volume survey (PVS) to allow for consultations and was following through on commitments to improve PVS data accuracy. ¶11. Furthermore, DOH has already commenced working on the development of a standard contract and welcomed AIT/USG comments. TAIPEI 00000136 003 OF 004 He stated that DOH planned to start with a voluntary standard contract and gradually move to its mandatory use. He also noted that DOH was considering establishing balanced billing. Amcham, he said, had proposed this idea ONE or two years ago. (Note: Vice Minister Chen is undoubtedly aware that U.S. firms are currently opposed to the idea. End note) ¶12. Responding to questions about the ongoing investigation and the possibility of the need to gather revised transaction data, Chen noted, in line with the press conference of the following day, that companies would have the option of revising incorrect or incomplete data over the next month. He added that he did not think that U.S. firms needed to worry since they had done accurate reporting. BNHI's Vice President Lee stated that any revised data submissions should have minimal impact on U.S. firms, noting that patented drug prices will only be affected by revisions to cost data for that particular drug. Off-patent brand-name drugs could be affected by cost revisions of BA/BE generics, but because the number of BA/BE generics is relatively small their impact was expected to be marginal. Prices of common generics, which face intense competition, will probably be most affected. ¶13. Stratford emphasized the importance of transparency, noting that as transparency increases, honesty and trust increase, causing costs to go down because firms operate more efficiently. The U.S., Stratford noted, supports Taiwan's efforts to make reporting more honest and transparent. Starting the Working Groups -------------- ¶14. Stratford stated that he would like to get U.S.-Taiwan working groups started as soon as possible. The uncertainty due to the investigation was ONE good reason for dialogue. He asked when working groups could begin. ¶15. BNHI Vice President Lee stated that BNHI already held bi-monthly meetings with IRPMA, which included Japanese, European and American firms. He offered to set up an additional channel for AIT or USG if it would be helpful. Altbach suggested two working groups: ONE to focus on a fair trade environment which would build on the work already done on the standard contact. The other would focus on HEALTH policy matters such as counterfeit pharmaceuticals, SDP, and ATP. He offered to present a more detailed proposal by mid January and suggested launching these groups by late January or early February 2007. The Vice Minister agreed. Therapeutic Grouping -------------- ¶16. AUSTR Stratford then turned to other issues raised by industry. He noted although BNHI had not used therapeutic grouping in the last PVS, industry was concerned that BNHI was considering it for the future. BNHI Vice President Lee stated that although the FIFTH PVS did not use therapeutic grouping, in the future BNHI will refer to the practice of other countries, and pointedly cited Australia, the EU and Canada. He added that such therapeutic grouping would be related to competition between breakthrough, me too, and line extension (he called them "me three") drugs. It was not a national treatment issue or an attempt to favor local firms. Timing for New Drugs -------------- ¶17. Altbach then raised the issue of length of time it took for new drugs to get approved prices for the local market. He noted that U.S. firms informed him that the period seemed to be getting longer. USTR urged that this process move as fas as possible so that patients have access to the newest drugs and therapies as soon as possible. Vice President Lee of BNHI replied that the goal was to get these procedures completed in 120 days, but the relevant office only had 15 staff members. If they are pulled to participate on working groups, he said, it will further constrain their ability to respond quickly. Chiropractors TAIPEI 00000136 004 OF 004 -------------- ¶18. Turning away from drugs, AUSTR Stratford raised the concern that American-qualified chiropractors had difficulties practicing in Taiwan. The U.S. understands that Taiwan has the authority to regulate medical care, but hopes that an appropriate mechanism can be found for chiropractors to practice in Taiwan. The Vice Minister replied that chiropractic is considered medical behavior and therefore practitioners must have recognized academic training, pass a local exam and complete a residency. Doctors, stated the Vice Minister, need a local regulatory framework. Stratford noted that in the U.S. the system was able to distinguish between medical doctors and chiropractors and that Taiwan and the U.S. needed to find an appropriate mechanism to discuss and work on the issue. Medical Devices from China -------------- ¶19. AUSTR Stratford then raised the issue of Taiwan bans on imports of medical devices made in China. This was affecting American firms. As more and more top manufacturers transferred their production to China, these bans will have an increasing impact. Stratford noted that he would also raise the issue with the Minister for Economic Affairs, but also wanted to mention the issue at the DOH because of its broader HEALTH implications. Patent Linkage -------------- ¶20. Stratford raised the issue of patent linkage. Vice Minister Chen responded that DOH was already working on the issue and had contacted a local law firm to assist them in reviewing the issue. He also asked for assistance from AIT to arrange consultations with the U.S. FDA to understand U.S. practice. Stratford replied that this issue should also be an important part of our IPR dialogue and effective patent linkage would create confidence for more rapid introduction of new drugs and therapies for Taiwan patients. Comment -------------- ¶21. BNHI and the DOH have been put under enormous pressure due to the prosecutor investigation. US firms believe that the investigation will help to push badly needed reforms, but are also cautiously evaluating how to respond to requests for more information that stem from a judicial investigation. The Vice Minister was echoing conventional wisdom when he said that U.S. firms are seen as having already properly and completely disclosed price data, but firms are concerned that calls for additional information may capture costs that will be difficult to quantify and evaluate - such as conference sponsorships - and may lead to further price cuts. Firms are also concerned that with BNHI under severe financial trouble, this next year could be unpredictable. It will be very important for the U.S. to stay engaged with DOH and BNHI over the next few months so we can have an early voice in the discussion of any possible reforms. YOUNG