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FM AMEMBASSY ANKARA
TO RUEHC/SECSTATE WASHDC 2141
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RUEAUSA/DEPT OF HHS WASHDC
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RUEHIT/AMCONSUL ISTANBUL 6971
RUEHDA/AMCONSUL ADANA 4502

UNCLAS SECTION 01 OF 03 ANKARA 000256 
 
DEPT FOR EUR/SE, EEB/TPP/BTA 
DEPT PLEASE PASS USTR FOR MARK MOWREY 
COMMERCE FOR ITA/MAC CHERIE RUSNAK AND KRISTIN KNAJDI 
 
SENSITIVE 
SIPDIS 
 
E.O. 12958: N/A 
TAGS: EINV ECON ETRD EFIN TU
SUBJECT: TURKEY: HEALTH MINISTRY PROPOSES SCENARIOS FOR DRUG 
APPROVALS 
 
REF: A) ANKARA 143, B) 09 ANKARA 326 
 
This cable is sensitive but unclassified.  Please protect 
accordingly. 
 
¶1. (SBU) Summary.  The Ministry of Health (MOH) recognizes 
that its new rules on Good Manufacturing Practices (GMP) 
certificates for new drug approvals (described in Ref A) will 
have some impact on trade in the short term, but is sanguine 
about the long-term effect.  According to Saim Kerman, 
Director General of Pharmaceuticals and Pharmacies at MOH, the 
procedural change is aimed at stemming the flow of new generic 
drugs of questionable quality, for which there are nearly 2000 
pending applications, by increasing inspection requirements. 
He admitted that Turkey does not have the inspection capacity 
to carry out this new rule, however, and as such may endanger 
the flow of vital innovative drugs.  The GOT has proposed to 
the pharmaceutical industry five scenarios under which the 
requirement for an MOH-issued GMP certificate could be waived. 
Industry analysts tell us the scenarios are problematic, 
however, and the industry associations are composing a letter 
to the GOT outlining some of those problems.  In addition, 
recent statements to the press by Kerman's deputy, Halil Akar, 
suggest a far more protectionist intent to the new rule.  He 
was reported as saying, "Our objective is to encourage local 
manufacture.  We want to make imports of generics more 
difficult, thereby encouraging the production of original 
drugs."  End summary. 
 
¶2. (SBU) Econ Counselor, Commercial Counselor, and Econoff 
recently met with Saim Kerman, Director General of 
Pharmaceuticals and Pharmacies at MOH, to discuss changes to 
Turkey's rules on accepting GMP certificates issued by other 
countries that would effectively halt new drug approvals (Ref 
A). 
 
MOH Looks to Add Flexibility on GMP Acceptance 
------------------------- 
 
¶3. (SBU) Kerman acknowledged that Turkey's inspection capacity 
(currently at around 20 inspectors dedicated to drug 
facilities, not 11 as previously reported) is insufficient to 
conduct a GMP inspection of all foreign production plants, and 
that Turkey is not yet at a stage where it could join a 
multilateral reciprocal recognition agreements such as the 
Pharmaceutical Inspection Cooperation Scheme (PIC/S).  He 
noted that the goal of the rule is to stem the flood of 
applications for generic product imports of questionable 
quality, many from China and India, the number of which has 
mushroomed to nearly 2000 over the past year.  By increasing 
the inspection requirements, the GOT hopes to ensure the 
safety of products entering its market and also discourage the 
lowest-quality producers from even applying.  He recognized, 
however, that new drugs would be caught in the same net and so 
there is a need to introduce some flexibility in the system to 
allow access for drugs that Turkey needs. 
 
Approval Scenarios 
------------------ 
 
¶4. (SBU) Kerman observed that the GOT had provided to the 
Association of Research-Based Pharmaceutical Firms (AIFD) a 
list of scenarios under which the requirement for an MOH- 
issued GMP certificate could be waived (a GMP certificate 
issued by another competent authority would still be 
required).  According to Kerman, once AIFD accepts the list it 
will go to the Undersecretary for approval and then MOH will 
restart licensing of products that fit the scenarios.  The 
list includes (in order of priority): 
 
-- A pharmaceutical product that is "vitally important"; 
 
-- A product that provides a clear medical advantage over 
existing products, such as increased patient compliance, a 
more convenient method of administration, a new form of 
treatment, or a hitherto unmarketed health benefit of a 
currently marketed product; 
 
-- A product that cannot be manufactured in Turkey, whether 
for technical reasons (vaccines, blood products, 
biotechnological products, or a product that requires special 
manufacturing facilities or packaging) or because the low 
prescription level of a product or the structure of the 
 
ANKARA 00000256  002 OF 003 
 
 
producing company warrants global production; 
 
-- A product that can be manufactured in Turkey where the 
producer is willing to transfer all or part of the 
manufacturing process to Turkey (in the case of a product to 
be manufactured entirely in Turkey, conditional approval can 
be granted even prior to the submission of relevant test 
data); or, 
 
-- A product that provides an economic advantage in terms of 
daily treatment or the cost of treatment, or products that 
will not apply for reimbursement listing by the Social 
Security Institute (SSI). 
 
Comment: The list does seem to be geared toward screening out 
generic products, but the last two categories are illustrative 
of the GOT's less obvious goal of increasing local production 
(and thereby adding new jobs) and containing burgeoning health 
care costs.  End comment. 
 
Industry Reaction 
----------------- 
 
¶5. (SBU) Jeffrey Kemprecos, Executive Director of Public 
Policy and Corporate Responsibility at Merck, described the 
MOH proposal as problematic at best.  He was especially 
concerned that the list would not be used as a positive tool 
to exempt needed drugs but rather as a pretext for denying a 
drug because it is not, for example, sufficiently "innovative" 
or did not add to "patient convenience."  (Note: Merck has 
previous experience with MOH's use of vague terms like 
"innovative", as MOH in 2009 violated the data exclusivity of 
one of Merck's products and then responded to Merck's 
complaints by arguing that the product in question was 
insufficiently innovative to merit protection, as described in 
Ref B. End note.) 
 
¶6. (SBU) Kemprecos noted that the proposals also conflate what 
should be two separate processes - the decision on whether a 
drug is safe and effective and the haggling over the specific 
price.  In Turkey, the role of MOH is to determine the former, 
he argued, with the latter function falling to SSI.  He 
conceded that MOH's concerns about generics may be valid, but 
proposed that the way to deal with this is to adopt a risk- 
based approach to drug approvals rather than a broad change to 
the rules that seems more focused on cost containment and job 
creation than on health and safety.  He informed us that AIFD 
had held a meeting in Prague with representatives from the 
Pharmaceutical Research and Manufacturers of America (PhRMA) 
and the European Federation of Pharmaceutical Industries and 
Associations (EFPIA).  The conclusion of that meeting was that 
the industry associations would compose a letter offering to 
support MOH in its goal of improving its inspection capacity 
and working toward mutual recognition of GMP certificates, but 
that they would not agree to MOH's offer of exemptions. 
Comment: It is not clear whether MOH will simply go ahead with 
the classification system anyway even if AIFD does not agree. 
End comment. 
 
Blatant Protectionism? 
---------------------- 
 
¶7. (SBU) Lending some validity to Kemprecos' fears are recent 
press statements by Halil Akar, Deputy Director General within 
Kerman's department.  In a statement to the semi-official 
Anadolu Ajansi, Akar observed "Setting out from the idea that 
there are very good manufacturing sites in Turkey, we decided 
to make our country a medicine manufacturing hub of the Middle 
East and Balkans...Our objective is to encourage local 
manufacture.  We want to make imports of generics more 
difficult, thereby encouraging the production of original 
drugs."  Akar went on to say that there would be exemptions 
for some products and that when inspections are necessary 
priority would be given to essential medicines. 
 
¶8. (SBU) Comment: From discussions with interlocutors at the 
Foreign Trade Undersecretariat (FTU), it is clear that MOH did 
not discuss its protectionist ideas with the trade-related 
agencies (the rule was published in a form that did not 
require clearance through the Prime Ministry).  Kerman 
acknowledged that the new rule probably violates Turkey's EU 
Customs Union obligations to allow for the free transit of 
goods, but waved that problem away with a statement that the 
 
ANKARA 00000256  003 OF 003 
 
 
EU ignores its own obligations to Turkey when it is 
convenient.  Should the European Commission decide to insist, 
this argument is unlikely to pass muster.  End comment. 
 
JEFFREY