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### Viewing cable 04ANKARA1157, Pharmaceuticals Update: Multinationals

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Reference ID | Created | Released | Classification | Origin
--- | --- | --- | --- | ---
04ANKARA1157 | 2004-02-27 11:34 | 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.

` `

    UNCLAS SECTION 01 OF 05 ANKARA 001157

    SIPDIS

    DEPT FOR EB/TPP/MTA/IPC - SWILSON/JURBAN AND EUR/SE
    DEPT PASS USTR FOR LERRION/BPECK
    DEPT PASS LIBRARY OF CONGRESS
    DEPT PASS USPTO FOR ELAINE WU
    USDOC FOR ITA/MAC/DDEFALCO

    SENSITIVE

    E.O. 12958: N/A
    TAGS: ETRD KIPR TU
    SUBJECT: Pharmaceuticals Update:  Multinationals
    Threatened by New Pricing Decree

    Ref:  Ankara 977 and previous

    Summary
    -------

    ¶1. (SBU) U.S. companies have complained that a new GOT
    pricing caps threaten the commercial viability of many
    of their product lines, and could lead them to delay or
    suspend the launch of new pharmaceuticals in Turkey.  In
    a letter to USTR, the Foreign Trade Undersecretary
    maintains that the GOT views data exclusivity as an EU
    Customs Union obligation rather than a WTO TRIPS
    requirement, and that this policy will be introduced
    with an unspecified transition period.  The GOT's
    Council of State rendered a decision limiting the
    application of "cheapest generic" reimbursement policy
    in the state pension fund.  Embassy requests guidance on
    the pricing decree, and urges Washington agencies to
    pursue sustained engagement with the GOT on intellectual
    property and other WTO issues affecting the
    pharmaceuticals sector.  End Summary.

    New Price System A Blow to Research-Based Firms
    --------------------------------------------- --

    ¶2. (U) At a February 20 briefing for the Ambassador,
    U.S. companies expressed serious concern with a February
    14 pricing decree.  The decree, which is already in
    force, limits pharmaceuticals prices in Turkey to a
    maximum of 90 percent of the average of the lowest two
    prices prevailing in a group of five European countries.
    While the measure does not appear to address any
    intellectual property issues, it may contain WTO-
    inconsistent provisions allowing higher prices for
    domestically-produced generic drugs, and does not set
    objective pricing criteria or remedy mechanisms for
    companies applying under the decree (reproduced in para
    9).

    ¶3. (U) Research-based companies had pressed for changes
    to the previous pricing system, which applied
    discriminatory price limits on imported pharmaceuticals,
    and had even suggested some forms of reference pricing.
    While the new system eliminates many of those
    provisions, research-based companies have told us that
    the new system will render sale of some medicines
    unprofitable, and could lead to delay or suspension in
    the launch of new molecules in Turkey.  AIFD, the
    Turkish research-based pharmaceuticals association, has
    written to the Prime Minister to register its concerns
    with the decree.

    ¶4. (SBU) Econoff raised U.S. company concerns with
    Hayriye Mihcak, the Health Ministry's Director General
    for Pharmaceuticals, Dilek Emil, the Treasury
    Undersecretariat's Deputy Director General for Foreign
    Investment, and Husnu Dilemre, Foreign Trade's Deputy
    Director General for Multilateral Agreements.  All
    expressed some surprise that research-based companies
    did not consider the decree an improvement over the
    previous pricing system.  Foreign Trade told us that the
    Turkish decree was modeled on Portugese and Spanish drug
    pricing systems.

    Data Exclusivity
    ----------------

    ¶5. (SBU) The GOT has not made an announcement on data
    exclusivity, though Mihcak told us that the Government
    planned to make an announcement on this by the end of
    March.  Dilemre also said that a decision on data
    exclusivity would be announced soon, but emphasized that
    Turkey viewed this as an EU Customs Union obligation
    rather than a WTO TRIPS requirement.  In a February 11
    letter to A/USTR Novelli (reproduced in para 10),
    Foreign Trade Undersecretary Tuncer Kayalar also made
    these points, but argued that Turkey would need a
    transition period for implementation.

    Legal Challenge on Reimbursement Policy
    ---------------------------------------

    ¶6. (U) In January 2004, the Council of State (Danistay)
    issued a ruling restricting application of the "cheapest
    generic" pharmaceuticals reimbursement policy for the
    GOT's pension fund.  The decision, a preliminary
    injunction, calls for the GOT to stop implementation,
    within 30 days, of "cheapest generic" reference pricing.
    However, industry sources have said that the injunction
    is likely to be overturned as the case moves through the
    courts.  The Danistay also limited reimbursement of
    generics to those which the GOT has certified as
    "bioequivalent" with the brand name molecule.  While
    research-based companies have welcomed the decision, the
    impact will be limited:  industry sources relate that
    there is now a bioequivalent generic for most original
    drugs.

    Comment/Action Request
    ----------------------

    ¶7. (SBU) Research-based industry is alarmed by the new
    pricing decree, though its concerns seem to lie more
    with the pricing formula for brand name drugs than with
    the parts of the decree (generic pricing, transparency)
    that could be WTO-inconsistent.  Embassy requests
    Washington agencies' guidance on whether to advocate for
    change in the pricing formula.

    ¶8. (SBU) As noted reftel, elevating Turkey in the
    Special 301 Watch List system, combined with sustained
    Washington engagement, is our best hope for prodding the
    GOT to action on data exclusivity and WTO-inconsistent
    practices.  We understand that Commerce A/S Lash and
    Senator Lugar plan to write to top GOT officials on
    pharmaceuticals issues.  Embassy continues to recommend
    that Washington agencies also consider dispatching an
    interagency IPR delegation to Ankara, and sending
    additional high-level correspondence on these issues,
    and particularly to rebut the GOT's position that the
    TRIPS Agreement does not require data exclusivity.

    ¶9. (U) Begin Text - AIFD Translation of GOT Pricing
    Decree:

    Decision No: 2004/6781
    It has been decided to enforce the attached "Decision
    Regarding the Pricing of Medicinal Product for Human
    Use" upon the letter dated 21/1/2004 and 003149 of the
    Ministry of Health, by the Council of Ministers on
    6/2/2004.

    Decision Regarding the Pricing of Medicinal Products for
    Human Use

    Article 1 - In accordance with "the Law no. 1262 on
    Pharmaceutical and Medicinal Products" and "the
    Fundamental Law no. 3359 on Healthcare Services", the
    Ministry of Health (the Ministry) shall determine the
    maximum prices by adopting the necessary measures that
    will be taken to ensure the affordability of medicinal
    products for human use (products).  Companies may
    request prices below the maximum price. The price
    approved by the Ministry of Health shall be in effect as
    of the date of its approval.

    Article 2 - The Ministry of Finance shall be authorized
    to investigate the suitability of these prices to the
    principles set forth in this Decision.

    Article 3- The maximum price of original products,
    excluding VAT, shall be determined as follows: 2
    reference countries with the cheapest prices of the
    product for which a price is to be determined in Turkey
    shall be selected out of 5 countries, namely France,
    Italy, Spain, Portugal and Greece in the year 2004 and
    to be deemed as suitable among the European Union (EU)
    countries by the Ministry; the retailer sale price of
    the product shall be determined by taking as basis
    maximum 90 percent of the average ex-factory price
    (sales price to the wholesalers calculated by deducting
    pharmacy and wholesaler profits from the retailer sale
    price) of these 2 reference countries and by adding the
    profit rates of wholesalers and pharmacies to be
    calculated in accordance with article 10. Should the ex-
    factory price in the country from where the product is
    imported be lower than the determined reference price,
    the profit rates of wholesalers and pharmacies shall be
    added to the price in the country from where it is
    imported.

    Article 4 - The retailer sales price of generic
    products, excluding VAT, shall be determined by taking
    as basis maximum 70 percent of the average of the ex-
    factory sales price of the original drugs of these
    products, calculated in accordance with article 3 and
    adding the profit rates of wholesalers and pharmacies.
    Yet, the maximum rate may be increased to 80 percent in
    case it is documented that locally manufactured raw
    materials have been utilized as the active ingredient of
    the drug in the production of generic products. In case
    the ex-factory sales price in the country from where the
    product is imported, results to be lower than the price
    determined for the EU countries, the profit rates of the
    wholesaler and pharmacies shall be added to the price in
    the pertinent country.

    Article 5 - The price of the products not marketed
    outside Turkey and the products not marketed by the EU
    countries shall be determined by taking into
    consideration the principles and the cost factors set
    forth in articles 3 and 4, provided it does not surpass
    the price of similar products.

    Article 6 - The ex-factory price of the products packed
    for hospitals shall be determined by taking into
    consideration the principles and the cost factors set
    forth in articles 3 and 4, provided it remains at least
    10percent below the unit prices of the original
    products.

    Article 7 - A "Price Evaluation Commission" shall be
    established and convene on a quarterly basis upon the
    participation of the representatives of the Ministry of
    Finance, the State Planning Organization and the Turkish
    Treasury under the coordination of the Ministry of
    Health, in order to submit proposals  to the Ministry of
    Health for the increase, decrease, or freezing of the
    price of medicinal products. In case of a change of more
    than 5percent in the foreign exchange rate within a
    minimum period of 30 days, the Price Evaluation
    Commission shall convene on an extraordinary basis, upon
    the invitation of the Ministry of Health to re-evaluate
    the prices of products. The secretarial services of the
    commission in question shall be executed by the Ministry
    of Health.

    A "Reimbursement Commission" shall be established and
    convene once every 6 months upon the participation of
    the representatives of the Ministry of Health, the State
    Planning Organization and the Turkish Treasury, the
    Social Insurance Institution, Emekli Sandygy and Bad-Kur
    and upon consulting the views of civil society
    organizations, under the coordination of the Ministry of
    Health, in order to submit proposals to the pertinent
    ministries. The secretarial services of the commission
    in question shall be executed by the Ministry of Health.

    Article  8 - Product manufacturers and importers shall
    be obligated to document that their products are
    original or generic. Manufacturers and importers shall
    be obligated to submit to the Ministry the ex-factory
    prices in the reference countries together with their
    requests for obtaining, increasing or decreasing a
    price. The TL equivalent of the prices determined shall
    be calculated upon the foreign exchange sales rate of
    the Central Bank of the Turkish Republic. The price
    which is deemed suitable shall be approved by the
    Ministry within 10 working days. The justification for a
    price which is not deemed suitable shall be communicated
    by the Ministry to the concerned company within 10
    working days. The pricing transaction shall be executed
    within 90 working days upon the submission of the valid
    documentation by the concerned company. This period may
    be extended by 60 working days in case of accumulation
    of applications and in periods of heavy workload. In
    case of failure of the concerned companies to submit
    their valid documents, the price determined by the
    Ministry shall be retained valid.

    Article 9 - In case of a decrease of 5percent or more in
    the price of the original product in the reference
    countries, the company manufacturing or importing the
    product shall be obligated to apply to the Ministry
    within 30 days to obtain a new price. A second degree
    withdrawal transaction shall be implemented on the
    products for it is determined by the Ministry that no
    such notification has been made and the registration
    shall be suspended for a period three times longer than
    the period in which no notification has been made,
    including 30 days. The suspension transaction shall be
    annulled by issuing the new price at the end of this
    period.

    Article 10- The wholesaler and pharmacy profit rates to
    be implemented when determining the retailer sales
    price of products in accordance with article 3 and 4,
    shall be determined in segments as follows, for both
    imported and local products:

    Out of the sales price to wholesalers/Wholesaler
    (Percent)/Pharmacy (Percent):

    Part up to/including 10 million TL: 9, 25
    Part between 10 - 50 million TL: 8, 24
    Part between 50 - 100 million TL: 7, 23
    Part between 100 - 200 million TL: 4, 16
    Part above 200 million TL: 2, 10

    The Ministry of Health shall be authorized to review
    these rates by taking into consideration the annual
    wholesale price index of chemical products of the State
    Statistics Institute of the former year and the
    allocation of the total sales of medicinal products in
    the last 3 years.

    Article 11 - Product manufacturers and importers are
    obligated to adhere to the principles set forth in this
    Decision.  Legal action within the pertinent
    legislation shall be taken against those in violation
    of these principles.

    Article 12 - The Ministry shall be authorized to issue
    notifications with regard to the implementation of this
    Decision.

    Article 13 - The Council of Ministers Decision dated
    6/2/2002, with no. 2002/4331 has been revoked.

    Temporary Article l- As of the publication date of this
    Decision, the prices of registered products shall be re-
    determined in accordance with the principles set forth
    in this Decision. The concerned companies shall apply to
    the Ministry upon having compiled the necessary
    documents in accordance with this Decision, within 45
    days as of the publication date of the Decision, in
    order to establish a basis for the determination of the
    new prices.  The registrations of the products for which
    no application is submitted within this period shall be
    suspended until the application date. The sales prices
    excluding VAT, to be determined in accordance with this
    article, shall not surpass the price in TL, excluding
    VAT, on the date of this Decision for local products,
    and the amount in TL, excluding VAT, corresponding to
    the foreign exchange sales rate of the Central Bank of
    the Turkish Republic, on the application date for the
    product for imported products.

    Temporary Article 2- The prices of imported products
    shall be re-determined ex-officio by the Ministry over
    the foreign exchange sales rate of the Central Bank of
    the Turkish Republic on the publication date of this
    Decision. The new prices shall be retained valid as of
    the approval date.

    Article 14- This Decision shall be enforced as of its
    publication date.

    Article 15- This Decision shall be executed by the
    Council of Ministers.

    End Text - AIFD Translation of GOT Pricing Decree.

    ¶10. (U) Begin Text - Foreign Trade U/S - USTR Letter

    February 11, 2004
    Ms. Catherine A. Novelli
    Assistant US-Trade Representative for
    Europe and the Mediterranean
    Dear Ms. Novelli,

    I would like to thank you for your letter dated January
    14, 2004 which has provided me with the opportunity to
    clarify the misconception about the compliance of
    Turkey's IPR legislation with the TRIPS Agreement.

    As you will recall, the WTO Members unanimously
    confirmed the consistency of Turkey's IPR legislation
    and implementations with the TRIPS Agreement at the
    TRIPS Council's meeting in Geneva on November 30, 2000.

    Besides, as referred in your letter, our authorities are
    working on a plan to introduce and implement rules and
    regulations regarding data exclusivity in
    pharmaceuticals in line with our commitments arising
    from the Customs Union with the EU.

    As you may appreciate, this plan will not only have
    negative impacts on the consumers and the current public
    health policies but on the generic industry as well.
    Therefore, the transition period turns out to be a
    necessity to offset to a certain extent the economic and
    social pressures and to avoid any further economic
    damages that would be recovered at a higher cost
    otherwise.

    On the other hand, I would like to note that my
    colleagues are doing their best to figure out an option
    that keeps the transition period as short as possible.
    At this point, supportive approaches from our trading
    partners will certainly contribute to the early
    conclusion of their studies.

    Expressing my best wishes and highest regards to you, I
    remain,

    Sincerely Yours,

    Tuncer Kayalar
    Undersecretary

    End Text Foreign Trade/USTR Letter.
    Edelman

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