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### Viewing cable 05ANKARA394, GOT's New Data Exclusivity Regulation - Major

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Reference ID | Created | Released | Classification | Origin
--- | --- | --- | --- | ---
05ANKARA394 | 2005-01-25 15:35 | 2011-08-24 01:00 | UNCLASSIFIED//FOR OFFICIAL USE ONLY | Embassy Ankara

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    This record is a partial extract of the original cable. The full text of the original cable is not available.

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    UNCLAS SECTION 01 OF 02 ANKARA 000394

    SIPDIS

    DEPT FOR E, EB/TPP/MTA/IPC, EUR/ERA, EUR/SE
    USTR FOR LERRION/BPECK
    USEU FOR CHRIS WILSON
    USPTO FOR ELAINE WU
    USDOC FOR ITA/MAC/DDEFALCO

    SENSITIVE

    E.O. 12958: N/A
    TAGS: ETRD KIPR TU
    SUBJECT:  GOT's New Data Exclusivity Regulation - Major
    Gaps in Protection

    SENSITIVE BUT UNCLASSIFIED.  PLEASE HANDLE ACCORDINGLY.

    ¶1. (SBU) Summary:  The GOT issued a revised regulation
    on January 19 providing a six-year term of data
    exclusivity protection for confidential pharmaceuticals
    test data effective January 1, 2005.  The regulation
    contains major loopholes, including lack of
    retroactivity and other provisions which effectively
    whittle down the six-year term.  The European Commission
    is evaluating Turkey's regulation in the context of its
    Trade Barrier Review (TBR) on barriers in the
    pharmaceuticals sector.  Research-based industry is also
    meeting to consider next steps.  End Summary.

    ¶2. (U) On January 19, the GOT announced its long-awaited
    policy on data exclusivity by publishing a revised
    pharmaceuticals marketing regulation in the State
    Gazette.  Based on a preliminary review of the
    regulation (see para for 5 a translation provided by
    Pfizer) and comments by one U.S. company, the policy
    seems similar to earlier, unsatisfactory drafts on data
    exclusivity.  The regulation provides a six-year term of
    data exclusivity protection beginning on January 1,
    2005, and in certain cases, beginning in 2001, but with
    exceptions that could reduce its benefits to research-
    based companies.  These include:

    -- Starting the six-year term on the date of licensing
    in an EU Customs Union country.  According to Pfizer,
    this provision cuts the effective term of protection
    because it can take over 200 days for a drug to go
    through the marketing approval process in Turkey;

    -- Limiting the term of data exclusivity to the term of
    the drug's patent in Turkey.  Note:  A Pfizer
    representative told us that this is unhelpful, but not
    inconsistent with existing EU regulations.  End Note;

    -- Original products licensed in a Customs Union country
    after January 1, 2001 can enjoy data exclusivity
    protection, unless generics manufacturers have applied
    for licenses in Turkey prior to 2005.  According to U.S.
    industry, there are hundreds, and possibly over 1,000
    pending applications in this category at the Ministry of
    Health.  With this vast loophole, relatively few drugs
    launched prior to 2005 will be able to benefit from data
    exclusivity protection.

    ¶3. (SBU) An EU diplomat told us that the GOT had
    provided no advance notice to Brussels of this
    regulation, despite the fact that the European
    Commission had raised data exclusivity and other
    pharmaceuticals concerns with the Turks in writing
    through the TBR process.  She told Econoff that Brussels
    would evaluate the regulation in meetings later this
    week.

    ¶4. (SBU) Comment and Recommendation:  It appears that
    the new GOT regulation falls far short of a satisfactory
    solution to our concerns on data exclusivity, and that
    this issue, along with patent linkage, will be leading
    subjects in the upcoming Special 301 review of Turkey.
    Although the EU declined an earlier U.S. request to do a
    joint demarche on this subject to the Turks, the time
    may be ripe for another approach to Brussels.  We
    recommend that Washington agencies consider the merits
    of a joint demarche, and, if appropriate, provide
    guidance to the Embassy and to USEU.

    ¶5. (U) Begin Text Pfizer Translation - Registration
    Regulation Article 9/Temporary Article 1:

    Article 9- Without prejudice to the provisions of the
    Decree Law dated 24/06/1995,with no. 551, on the
    Protection of Patent Rights;
    a) In abridged applications, the applicant shall not be
    required to present the results of toxicological and
    pharmacological tests and clinical trials, provided that
    one of the following points is proved:
    1) The medicinal product shall be mostly similar to a
    medicinal product which previously registered in Turkey
    and the marketing registration holder of the original
    medicinal product shall have consented to the use of the
    toxicological, pharmacological and/or clinical
    references contained in the dossier of the original
    medicinal product for the purpose of evaluating the
    referred application,
    2) Any constituent(s) of the medicinal product shall
    have a well-established medical use, determined by means
    of detailed scientific bibliography and with a
    reasonable efficiency and acceptable level of
    reliability,
    3) The medicinal product shall be essentially similar
    with a medicinal product which has been registered in
    accordance with the current legislative provisions and
    has completed its data exclusivity period. The data
    exclusivity period called for by this subparagraph,
    shall apply on the original products for which no
    generic registration application has been submitted in
    Turkey until 01/01/2005, among the original products
    registered for the first time after 01/01/2001 in one of
    the countries within the Customs Union Area and the
    original products to be registered for the time after
    01/01/2005 in one of the countries of the Customs Union
    Area and shall be 6 (six) years to begin as of the first
    registration date in the Customs Union Area and to be
    limited with the patent period of the  relevant molecule
    in Turkey.
    However, in the event of a different therapeutical
    indication, route of administration, dosage being
    envisaged from those of the medicinal products which
    have been introduced into the market, it shall be
    necessary to submit the results of the relevant clinical
    trials and where necessary the results of toxicological,
    pharmacological studies.
    b) With regard to new medicinal products containing
    recognized constituents, but which have not yet been
    used in combination for therapeutical purposes, it shall
    be necessary to present the results of the relevant
    toxicological and pharmacological tests and clinical
    trials. However, it shall not be obligatory to present
    the references pertaining to each constituent.
    In compliance with subparagraph (2) in item (a) of the
    first paragraph of this article, in the event of the
    presentation of bibliographical references based on
    published data, the applications shall be submitted in
    accordance with Annex I.
    In exceptional cases constituting a severe threat for
    public health, the Ministry may take into consideration
    the registration applications of generic products, which
    have been presented upon taking as basis the data
    pertaining to the toxicological, pharmacological and
    clinical data published on literature, independent from
    the provisions set forth in this article.

    Temporary Article 1- The registration/permit
    applications submitted before the enforcement of this
    Regulation, shall be evaluated in accordance with the
    legislative provisions in force on the date such
    applications are submitted.
    With regard to the abridged applications presented in
    accordance with article 9 of this Regulation of which
    all provisions except for article 9 shall be enforced on
    30/06/2005, the applications submitted in compliance
    with the application format indicated in the Regulation
    in force shall be accepted.

    End Text Pfizer Translation.

    Edelman

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