Taiwan Pharma: 6th PVS Underway, Big Pricing Reforms

UNCLAS SECTION 01 OF 04 TAIPEI 000760

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SENSITIVE

SIPDIS

E.O. 12958: N/A
TAGS: ECON ETRD KIPR TW
SUBJECT: Taiwan Pharma: 6th PVS Underway, Big Pricing Reforms
Unlikely

REF: A) 2007 Taipei 2326; B) 2007 Taipei 2498; C) 2008 Taipei 950;
D) 2007 Taipei 2257; E) 2008 Taipei 572; F) 2007 Taipei 2551; G)
Taipei 73


Summary
--------------

1.(SBU) The Taiwan Department of Health (DOH) Bureau of National
Health Insurance (BNHI) will announce the results of the sixth
price-volume survey (PVS) in July, and implement revised
reimbursement prices in September. BNHI is following through on a
Ma administration campaign promise to reform Taiwan's overall
Pharmaceutical Benefits Scheme (PBS),and will finalize PBS guidance
in July. Although original-drug manufacturers are unhappy with the
current draft PBS reform, industry has failed to agree on a detailed
counter-proposal.


2. (SBU) The Bureau of Pharmaceutical Affairs (BOPA) wants to speed
up drug-approval times by reducing documentation requirements, but
the proposed conditions for reduced documentation are insignificant,
and will likely be little-used by drug-makers. Neither separation
of dispensing and prescribing (SDP) nor patent linkage--two of
industry's long-standing goals for Taiwan--have the support of
Taiwan industry or bureaucracy, though a newly-established Taiwan
Food and Drug Administration (TFDA) may make implementing
patent-linkage in Taiwan more feasible. BNHI continues to press
industry and AIT to support LY passage of a draft law requiring
hospitals to use a standard drug-purchasing contract. End summary.

Pricing Background
--------------


3. (SBU) Taiwan implemented a National Health Insurance (NHI) system
in 1995, and its health-care system comprises six large public
medical centers, 16 large privately-owned medical centers, and 417
regional and district hospitals. The 22 large medical centers
dominate the pharmaceutical market, and are able to negotiate very
low drug prices. Hospitals derive up to half of these revenues from
the difference between the lower prices they have negotiated with
drug companies and the higher amounts that BNHI reimburses for the
same drugs--the source of the so-called "Black Hole" in Taiwan's
pharmaceuticals budget. BNHI, in turn, uses biannual price-volume
surveys (PVS) to collect price data from hospitals and drug makers
to use in calculating new, lower drug reimbursements.

6th PVS Underway, Big Pricing Reform Unlikely
--------------


4. (SBU) Taiwan law requires hospitals that accept reimbursements
from BNHI to provide price data for all pharmaceutical purchases.
Foreign original-drug manufacturers, however, initially refused to
supply pricing data in protest over past PVS methodology. After a
pause in the PVS process to allow BNHI to collect views from
industry, hospitals, and other stakeholders on reforming Taiwan's
Pharmaceutical Benefits Scheme (PBS)--including hosting a December
2008 industry-wide conference--in February, BNHI again requested
that companies submit pricing data.


5. (SBU) Lawyers for the foreign drug-makers' industry group in
Taiwan, the International Research-based Pharmaceutical Manufactures
Association (IRPMA),think BNHI does not have legal grounds to
compel companies to submit price data. However, both IRPMA and
AmCham Pharmaceutical Committee leaders asked member companies to do
so as a show of industry's good will, and in March, all member
companies submitted price data to BNHI. According to BNHI Vice
President Lee Cheng-hua, the new reimbursement prices will go into
effect on September 1.


6. (SBU) Foreign original-drug manufacturers fear the sixth PVS,
like the five before it, will significantly reduce reimbursements
for their drugs, as well as start another round of price-cut demands
from the large hospital groups. Foreign firms, however, have been
unable to reach consensus on how to respond concretely to BNHI's PVS
methodology. They will discuss instead their ideas on reforming the
overall PBS, and their plans to commission an economic model on
pharma pricing reform in Taiwan.

PBS Reform Request Backfires
--------------

7.(U) In response to a Ma campaign promise to reform Taiwan's
overall Pharmaceutical Benefits Scheme (PBS) and resolve the price

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gap problem, BNHI hosted a one-day drug-pricing conference on
December 31, 2008. Representatives from all eight major drug
industry groups plus AmCham attended the conference, which produced
a PBS reform outline now under study by BNHI.


8. (SBU) Over the following months, however, BNHI made no moves to
implement the proposed changes. In May, IRPMA sent a petition to
DPP Legislator and former DOH Minister Twu Shiing-zher requesting
Twu push BNHI to move forward on PBS reform. Soon afterwards, Twu
asked DOH Deputy Minister Cheng Shou-hsia to work with industry to
finalize within three months a benefit scheme reform proposal, and,
in late May, the Legislative Yuan (LY) Health and Environment
Committee passed a Twu-backed non-binding resolution calling for the
same.

9. (SBU) In response to the LY pressure, BNHI notified industry in
May that the Bureau plans to produce a final PBS reform plan in
July, and asked for industry's input on the current draft plan.
However, despite a series of industry-BNHI meetings over the past
month, U.S. and other original-drug makers have failed to reach
consensus on industry's PBS reform counter-proposal. On June 5,
BNHI again informed AmCham and PhRMA representatives that the Bureau
will finalize the plan by mid-July, with or without industry input.
Proposed CPP Changes Not an Improvement
--------------


10. (U) A Certificate of Pharmaceutical Product (CPP) is a document
provided either directly by the manufacturer or by the release
country to attest that a drug has been approved for use in the
release country, has been manufactured in compliance with food and
drug safety in that country, and is labeled in the same manner as in
the original country. In most cases, drug manufacturers will supply
a CPP from a developed economy such as the United States or European
Union market to the drug-approval authorities in a second market in
order to demonstrate the drug is already for sale in another market,
and thereby reduce the time and paperwork needed to gain approval
for sale in the second market.


11. (U) When a pharmaceutical company applies for regulatory
approval to market a drug in a country, the authorities in that
country typically ask manufacturers to supply one CPP as proof that
the drug is approved for sale in another market. Taiwan, however,
requires CPPs from two countries. The two-CPP requirement
disadvantages U.S. firms because BOPA regards a CPP from the
European Union as the equivalent of multiple CPPs, while the same
document from the United States counts only as one CPP. In
addition, although CPPs from all countries follow a standard,
WHO-approved format, Taiwan requires notarization of CPPs by the
Taiwan representative office in the CPP-issuing country.


12. (U) For the past two years, original-drug manufactures have been
urging the DOH Bureau of Pharmaceutical Affairs (BOPA) to reduce the
required number of CPPs to one in order to shorten the drug-approval
process. In response, BOPA recently announced plans to reduce the
number of required CPPs from two to one if the manufacturer conducts
two phases of clinical trials in Taiwan for the drug in question.
[Note: Pharmaceutical companies conduct clinical trials to gather
data on the safety and efficacy of new drugs or new indications for
old drugs. Typically, three phases are needed before a country's
drug authorities will grant approval, with each successive phase
including a larger group of subjects. End note.]


13. (SBU) The deadline to submit public comments on the proposed
changes was June 8. BOPA's Dr. Liao told econoff on June 5 that
since the CPP requirement is an administrative guideline and not a
law, once DOH decides on the final rule change, BOPA will be able to
post the requirement within two weeks.


14. (SBU) However, local general managers of American drug companies
tell us that because Taiwan is a relatively small market, companies
are unlikely to conduct extra trials in Taiwan just to take
advantage of the reduced CPP requirement. Instead, the companies
will simply wait for a second country to issue a CPP for the drug
and then apply for Taiwan approval. In addition, because BOPA's
plan would increase the required number of trial subjects for some
of the phases, the change will often make doing clinical trials in
Taiwan less attractive.


15. (SBU) IRPMA member companies instead propose relaxing the
requirement to one CPP if the company performs one phase of trials
in Taiwan, or waiving the CPP requirement completely if a company
conducts two clinical trials in Taiwan. On June 5, econoff discussed
these alternatives with Dr. Liao, who agreed the latter change would
be more attractive for companies, and urged manufacturers to take

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advantage of the public comment period to submit their ideas.

Still Little Support for SDP
--------------


16. (SBU) Currently, when a patient sees a doctor in a Taiwan
hospital, the patient will almost always fill his prescription at
the pharmacy owned by and located in the hospital. Because Taiwan's
hospitals get much of their revenues from the difference between the
lower prices they have negotiated with drug companies and the higher
amounts that BNHI reimburses for the same drugs (ref A),hospital
administrators and doctors have an incentive to both over-prescribe
and push down contract prices for drugs. Separating dispensing and
prescribing (SDP) would eliminate this incentive.


17. (SBU) The U.S. and Taiwan discuss SDP under the bilateral Trade
and Investment Framework Agreement (TIFA),and Taiwan has done some
small-scale SDP pilot programs. However, Taiwan's powerful
hospitals and doctors' associations do not support any move toward
SDP because it would sap hospitals' revenues. During a recent
AIT-hosted roundtable on SDP, hospital administrators and doctors
again objected loudly to any such moves, and BOPA is not actively
planning larger SDP initiatives. Any progress toward SDP will
require continued high-level engagement with the Taiwan
authorities.

Bureaucracy Opposes Patent Linkage
--------------


18. (SBU) Taiwan lacks a patent-linkage notification requirement and
allows generic-drug licensing before patent expiry, practices that
foreign pharmaceutical manufacturers claim allow local generic drug
makers to infringe on patent-holders' rights, as well as secure a
higher initial reimbursement price from BNHI (ref B).


19. (SBU) The U.S. and the Taipei American Chamber of Commerce have
pushed the Taiwan authorities to implement a U.S.-style
patent-linkage system that would continue to allow generic-drug
testing before the original drug's patent expiration, but would
include protections for the patent-holder's IPR and prevent
generic-drug makers from licensing a generic form of a patented drug
while the original patent is still valid.


20. (SBU) The Taiwan pharmaceutical authorities, however, do not
want to implement a U.S.-style patent linkage system. On June 5,
BOPA Director General Chi-chou Liao reiterated to econoff that BOPA
does not think Taiwan needs to introduce patent linkage, since
Taiwan's court system, including the specialized Intellectual
Property (IP) Court (ref C) can efficiently resolve such IPR
disputes. As evidence, Liao pointed to a recent case in which
Pfizer sued several local firms for releasing generic versions of
Pfizer's Lipitor prior before the original drug's patent expired.
Although Pfizer lost, Liao said the case shows the specialized court
can effectively handle drug-related IPR disputes.

BNHI Wants Industry, U.S. Support for Mandatory SC
-------------- --------------


21. (SBU) In response to U.S. concerns about the lack of
transparency in drug procurement by Taiwan hospitals, during the
2007 TIFA meetings in Washington, Taiwan committed to implementing a
mandatory standard contract (SC) that would require all hospitals to
use the same contract for all drug purchases (ref D).


22. (SBU) In September 2007, the Taiwan Executive Yuan(EY) forwarded
to the Legislative Yuan (LY) draft legislation that would require
hospitals to use an SC for pharmaceutical purchases. If the law
passes, BNHI would then finalize the text of the contract by
administrative order. The current draft SC would require full
disclosure of the actual price and allow the Bureau of National
Health Insurance (BNHI) to more accurately establish real
transaction prices in their price surveys.


23. (SBU) According to IRPMA Chief Operating Officer Carol Cheng,
hospitals do not support the current BNHI draft SC because it would
bring more transparency to their current pricing practices,
potentially reducing the pricing gap that funds their operations.
Foreign original-drug manufacturers also object to the proposed SC
language, which would codify a practice whereby hospitals
automatically renegotiate price contracts with drug companies
whenever BNHI announces new, lower prices.


24. (SBU) Without industry or hospital support, the draft

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legislation authorizing SC has languished in the LY since 2007.
Acting BNHI President Lee has repeatedly asked IRPMA and member
companies, as well as AIT, to lobby the LY for the proposed changes.


Comment
--------------


25. (SBU) Because Taiwan has no major new-drug makers, hospitals
that rely heavily on profits from BNHI drug reimbursements, and
consumers who are largely satisfied with the current system, there
is limited domestic support for reforming pricing practices. In
addition, with an economy in the doldrums and the national health
care system at least USD two billion in the red (ref E),financial
pressures will undercut any near-term move to spend more on
reimbursement for on-patent drugs, or increase hospital funding in
conjunction with implementing SDP.


26. (SBU) Therefore, the U.S.' pharma priority in Taiwan should be
support for low-cost reforms such as passing the draft standard
contract (SC) legislation and implementing patent linkage. While
U.S. industry dislikes BNHI's current SC language, the U.S. should
support passage of the bill authorizing BNHI to require that
hospitals use SCs, while working with industry and the authorities
to improve the draft SC language. Because SC is one of two
pharma-related TIFA topics, supporting SC plans could create
momentum within BNHI for addressing other pharma issues under the
TIFA rubric. In addition, although the Taiwan health bureaucracy
does not favor implementing patent linkage, the upcoming merger of
the DOH Bureau of Food Safety, Bureau of Pharmaceutical Affairs,
Bureau of Food and Drug analysis, and the National Bureau of
Controlled drugs into the Taiwan Food and Drug Administration (TFDA)
offers a chance for fresh engagement with new TFDA leadership.


27. (SBU) In the longer term, the U.S. should encourage Taiwan to
foster the policies and environment needed to commercialize Taiwan's
nascent biotech and biomedical industries. The authorities have
long identified biotech as a future strength of the Taiwan economy
(refs F and G),and an indigenous biotech industry developing
innovative drugs could kindle Taiwan interest in positive
pharmaceutical pricing and IP reforms. End comment.

YOUNG