VZCZCXRO6912
PP RUEHAG RUEHAST RUEHDA RUEHDBU RUEHDF RUEHFL RUEHIK RUEHKW RUEHLA
RUEHLN RUEHLZ RUEHNP RUEHPOD RUEHROV RUEHSK RUEHSR RUEHVK RUEHYG
DE RUEHIT #0173/01 1381402
ZNR UUUUU ZZH
P 181402Z MAY 09
FM AMCONSUL ISTANBUL
TO RUEHZL/EUROPEAN POLITICAL COLLECTIVE PRIORITY
RUEHC/SECSTATE WASHDC PRIORITY 8953
INFO RUEATRS/DEPT OF TREASURY WASH DC PRIORITY
RUEKJCS/DIA WASHDC PRIORITY
RUCPDOC/DEPT OF COMMERCE WASHDC PRIORITY
RUEAIIA/CIA WASHDC PRIORITY
RUFOADA/JAC MOLESWORTH RAF MOLESWORTH UK PRIORITY

UNCLAS SECTION 01 OF 02 ISTANBUL 000173 
 
SIPDIS 
 
COMMERCE FOR GTAEVS FCS ISTANBUL 
 
E.O. 12958: N/A 
TAGS: ECON EFIN FCSC PHUM TU
SUBJECT: AMBASSADOR MEETS WITH PHARMACEUTICAL REPS AND 
PROMISES TO PRESS GOT ON REGULATORY REFORM 
 
¶1.    (SBU)   (Summary)    Ambassador Jeffrey recently met 
with representatives of the U.S. pharmaceutical industry in 
Istanbul.  The discussion centered upon familiar and 
long-standing industry problems in Turkey such as market 
access, patent protection and data exclusivity, as well as 
conformity with EU standards.   The company officials asked 
the Ambassador for assistance in getting their "Road Map" 
report into the hands of key Turkish officials, including the 
Prime Minister.  The Ambassador agreed do this, and offered 
to assist (perhaps combining efforts with the EU 
representative to Turkey) to push the GOT on passing the new 
Patent Law.  He also promised to try to persuade Alpaslan 
Korkmaz of the Investment Support and Promotion Agency of 
Turkey (ISPAT) to reconsider his decision not to send 
officials to a May 18-21 biomedical convention in Atlanta. 
End Summary. 
 
¶2.    (U)    On March 6 in Istanbul  the Ambassador met with 
Jeff Kemprecos of Merck Sharp and Dohme, Chris L. J.J. 
Stijnen of Bristol-Myers Squibb, Muhittin Bilgutay of 
Schering-Plough and Serkan Yagcioglu of GlaxoSmithKline to 
discuss issues of concern to the pharmaceutical industry. 
 
¶3.    (SBU)    Ambassador Jeffrey noted that, although the 
United States no longer produces as much steel or 
manufactured goods as it once did, it still produces and 
exports high quality products like pharmaceuticals.  He added 
that in Turkey the drug industry is a politically sensitive 
sector because it is plugged in to a highly socialized 
medical system, and because poor people need access to 
affordable drugs.  If intellectual property rights are not 
protected by the government there will be less incentive for 
the industry to invest and produce in Turkey.  "Turkey must 
play by the rules," he emphasized.  The Ambassador agreed to 
pursue diplomatic efforts to help move the GOT on regulatory 
reform, the industry Road Map and, hopefully, the Atlanta 
Biomed convention. 
 
THE ROAD MAP 
 
¶4.    (SBU)    In October 2008 the industry completed an 
advocacy report known as Vision 2015, also known as "The Road 
Map", which followed up on earlier reports that called for 
critical regulatory reforms in Turkey, and which cited 
Ireland and Singapore as success stories in the realm of 
biomedicine.   In late December of 2008 industry 
representatives presented the Road Map to Alpaslan Korkmaz, 
President of the Investment Support and Promotion Agency of 
Turkey (ISPAT) and his team.   Jeff Kemprecos stated that the 
presentation was a "huge hit" and that Korkmaz promised to 
arrange a meeting where industry could present the report to 
the Prime Minister and the Ministers of Health, Labor and 
Industry.  However, 2009 thus far has proved to be a 
disappointment, with local elections in Turkey dominating the 
government's focus in the first quarter of the year, and with 
recent cabinet changes creating an uncertain vetting process 
for complex regulatory reform issues in the near term. 
 
THE ATLANTA BIO 2009 CONFERENCE BLOW-OFF 
 
¶5.    (SBU)    According to the pharmaceutical 
representatives, the Atlanta BIO 2009 Conference which begins 
on May 19 is hugely important to the industry.  Kemprecos 
described it as "our Davos."  In early 2009 GOT had confirmed 
that it would send a fact finding team to Atlanta consisting 
of seven officials and two ISPAT representatives.   However, 
just a few weeks before the conference all the officials 
cancelled their trip, citing reasons ranging from the swine 
flu crisis to the recent cabinet shuffle. 
 
REGULATORY PROBLEMS IN TURKEY 
 
¶6.    (SBU)     In Turkey it takes about two to three years 
for new medicines approved in the United States or Europe, 
including cancer drugs, to reach Turkish patients, a period 
that sector representatives view as far too long.  Pricing 
and licensing approvals are determined by the Ministry of 
Health (MOH), and the process can take 12 to 24 months or 
more.  Reimbursement for drugs purchased through the 
socialized health system involves 9 to 12 months or more of 
negotiations with the Social Security Institute (SGK).  In 
Europe the final price discount on a new drug should be about 
11% below the industry reference price, but in Turkey 
companies routinely are pressured to discount the price 
 
ISTANBUL 00000173  002 OF 002 
 
 
16-17% below the lowest comparable level in the EU.  In 
Europe the registration (licensing) phase is no more than 210 
days and the reimbursement decision is given within 90 days. 
Industry representatives believe that the whole process 
should take about nine months:  six months for licensing plus 
three months for reimbursement. 
 
¶7.    (SBU)    In Turkey, data exclusivity (DE) for drugs is 
limited to six years, and the GOT counts the DE period from 
the first registration in Europe.  Subtracting the two to 
three years of regulatory approval time required to get a 
product on the market, a company may only have three years of 
DE before the generic drug firms can use confidential test 
data in their own marketing applications.  This is roughly 
one third of the European standard.  Europe has an "8 2 1" 
system which allows a company to apply for up to 11 years of 
protection.   Industry representatives believe the effective 
protection period in Turkey should be at least six years and 
that, as in Europe, a company should receive compensation if 
the effective DE protection period for one of its drugs is 
shortened due to regulatory delays. 
 
¶8.    (SBU)    The pharmaceutical industry has pushed hard 
for Turkey to enact a new patent law which would replace the 
1995 Decree.  They would like the United States to help push 
this through, without any amendments.  "We have a great 
opportunity to get a first-class patent law," enthused 
Kemprecos, but this will require a continued push.  Kemprecos 
stated that the Turkish Patent Law Office (TPI) has been 
helpful in this regard ("objective and informative") but not 
the MOH. 
 
¶9.    (SBU)      (Comment)     The strategic relationship 
between the United States and Turkey is strong, but the 
bilateral commercial relationship has not always kept pace. 
Biomed is a sector where an improved regulatory regime could 
foster significant growth in U.S. investment into Turkey. 
Turkey is in the top 13 in the world as a health care market, 
but receives only a USD 140 million share of the annual USD 
90 billion research and development (R&D) market in biomed. 
In contrast, as Kemprecos noted, biomed now accounts for 40% 
of Singapore's total exports, and Ireland has been so 
successful in this sector that the industry publicizes "The 
Irish Miracle."  Sector representatives believe that the GOT 
lacks both the vision and the strategic plan to realize its 
potential in this field, but that a concerted push to create 
a better regulatory and legal climate could lead to a 
substantial payoff for both Turkey and the pharmaceutical 
sector. 
 
 End Comment. 
Wiener