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Alt 09-09-2011, 06:43   #1
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WIKILEKS EN SON HABERLER
Salı, 08/30/2011 - 13:19 — haberler
Reference id aka Wikileaks id #249119  ? 
Subject Turkey: Health Ministry Proposes Scenarios For Drug Approvals
Origin Embassy Ankara (Turkey)
Cable time Wed, 17 Feb 2010 09:36 UTC
Classification UNCLASSIFIED//FOR OFFICIAL USE ONLY
Source http://wikileaks.org/cable/2010/02/10ANKARA256.html
History First published on Wed, 24 Aug 2011 03:21 UTC

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WIKILEAKS TÜRKİYE İLAÇ SEKTÖRÜ DEVAM.. YERLİ SANAYİİ UYUYOR YABANCILAR YÜRÜYOR!!>
Pzt, 08/29/2011 - 22:51 — haberler
UNCLAS SECTION 01 OF 02 ISTANBUL 000173 SIPDIS COMMERCE FOR GTAEVS FCS ISTANBUL E.O. 12958: N/A TAGS: ECON [Economic Conditions] EFIN [Financial and Monetary Affairs] FCSC [Foreign Claims Settlement Commission of the US] PHUM [Human Rights] TU [Turkey]
SUBJECT: AMBASSADOR MEETS WITH PHARMACEUTICAL REPS AND PROMISES TO PRESS GOT ON REGULATORY REFORM ¶

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WIKILEAKS TÜRKİYE İLAÇ SEKTÖRÜ DEVAM.. AMERİKAN BÜYÜK ELÇİSİNİN SAYIN PROF.DR. RECEP AKDAĞ İLE GÖRÜŞMESİ
Pzt, 08/29/2011 - 22:41 — haberler
UNCLAS SECTION 01 OF 02 ANKARA 002346 SIPDIS SENSITIVE COMMERCE FOR DEFALCO DEPT PASS USTR FOR LERRION STATE FOR EUR/SE, AND EB/TPP/MTA/IPC E.O. 12958: N/A TAGS: ETRD [Foreign Trade] ECON [Economic Conditions] SENV [Environmental Affairs]
SUBJECT: AMBASSADOR'S MEETING WITH HEALTH MINISTER ¶

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WIKILEAKS TÜRKİYE İLAÇ SEKTÖRÜ DEVAM.. TÜRK İLAÇ FİYATLANDIRMASINI KİMLER NASIL HAZIRLAMIŞ!!!
Pzt, 08/29/2011 - 22:35 — haberler
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 [Foreign Trade] KIPR [Intellectual Property Rights] TU [Turkey] SUBJECT: Pharmaceuticals Update: Multinationals Threatened by New Pricing Decree Ref: Ankara 977 and previous Summary -------

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WIKILEAKS TÜRKİYE İLAÇ SEKTÖRÜ DEVAM.. ESKİ İEGM SAYIN HAYRİYE MIHÇAKLA TOPLANTILAR
Pzt, 08/29/2011 - 22:25 — haberler
UNCLAS ANKARA 005808 SIPDIS DEPT FOR EB/TPP/MTA/IPC DEPT PASS USTR FOR MARK WU/LISA ERRION DEPT PASS LIBRARY OF CONGRESS USDOC FOR ITA/MAC/DDEFALCO SENSITIVE E.O. 12958: N/A TAGS: ETRD [Foreign Trade] KIPR [Intellectual Property Rights] TU [Turkey] SUBJECT: Pharmaceuticals IPR Update

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WIKILEAKS TÜRKİYE İLAÇ SEKTÖRÜNÜ YAYINLADI.. KİMLER NELER ÇEVİRMİŞ????
Pzt, 08/29/2011 - 21:57 — haberler
KAPALI KAPILAR ARKASINDA NELER DÖNDÜRÜLMÜŞ!!!!! İBRETLE OKUNMASI GEREKIİR. HANGİ FİRMALAR NELER YAPMIŞ......
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Alt 09-09-2011, 06:45   #2
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WIKILEKS EN SON HABERLER

Salı, 08/30/2011 - 13:19 — haberlerReference id aka Wikileaks id #249119  ? 
Subject Turkey: Health Ministry Proposes Scenarios For Drug Approvals
Origin Embassy Ankara (Turkey)
Cable time Wed, 17 Feb 2010 09:36 UTC
Classification UNCLASSIFIED//FOR OFFICIAL USE ONLY
Source http://wikileaks.org/cable/2010/02/10ANKARA256.html
History First published on Wed, 24 Aug 2011 03:21 UTC
VZCZCXRO5458 RR RUEHDA DE RUEHAK #0256/01 0480936 ZNR UUUUU ZZH R 170936Z FEB 10 FM AMEMBASSY ANKARA TO RUEHC/SECSTATE WASHDC 2141 INFO RUCPDOC/DEPT OF COMMERCE WASHDC RUEAUSA/DEPT OF HHS WASHDC RHEHAAA/NSC WASHDC RUEHIT/AMCONSUL ISTANBUL 6971 RUEHDA/AMCONSUL ADANA 4502
Hide headerUNCLAS 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 [Foreign Investments] ECON [Economic Conditions] ETRD [Foreign Trade] EFIN [Financial and Monetary Affairs] TU [Turkey]
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
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http://www.kfd.org.tr/?q=node/848
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Alt 09-09-2011, 06:45   #3
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WIKILEAKS TÜRKİYE İLAÇ SEKTÖRÜNÜ YAYINLADI.. KİMLER NELER ÇEVİRMİŞ????

Pzt, 08/29/2011 - 21:57 — haberlerKAPALI KAPILAR ARKASINDA NELER DÖNDÜRÜLMÜŞ!!!!! İBRETLE OKUNMASI GEREKIİR. HANGİ FİRMALAR NELER YAPMIŞ......
UNCLAS SECTION 01 OF 02 ANKARA 008635 SIPDIS TREASURY FOR OASIA STATE FOR EB/TPP/MTA/IPC - JURBAN AND EUR/SE DEPT PLEASE PASS USTR FOR DBIRDSEY/KALVAREZ DEPT PASS PATENT AND TRADEMARK OFFICE USDOC FOR ITA/MAC/DDEFALCO SENSITIVE E.O. 12958: N/A TAGS: ETRDhttp://cablegatesearch.net/images/magnifier.png); background-attachment: initial; background-origin: initial; background-clip: initial; background-color: transparent; background-position: 100% 50%; background-repeat: no-repeat no-repeat; "> [Foreign Trade] KIPRhttp://cablegatesearch.net/images/magnifier.png); background-attachment: initial; background-origin: initial; background-clip: initial; background-color: transparent; background-position: 100% 50%; background-repeat: no-repeat no-repeat; "> [Intellectual Property Rights] TUhttp://cablegatesearch.net/images/magnifier.png); background-attachment: initial; background-origin: initial; background-clip: initial; background-color: transparent; background-position: 100% 50%; background-repeat: no-repeat no-repeat; "> [Turkey] SUBJECT: Update on Intellectual Property Protection Summary -------
¶1. (SBU) Econoff discussed intellectual property and market access priorities with American pharmaceuticals companies and with the copyright-based industry associations in Istanbul. The drug companies agreed that they need to make the case with the new Turkish Government on data exclusivity. With the objective of refuting GOT and generics producers' arguments that dataexclusivity is too expensive to implement, Eli Lilly has prepared detailed estimates of the cost of this policy to the Turkish Government (approximately USD 3 million annually). Organizations representing the motion picture, music and software industries continue to identify enforcement as their main concern. Some interlocutors believe the new government will be more receptive to their concerns, and these industries plan to call on new policymakers in the near future. End Summary.
¶2. (U) Econoff met with representatives of U.S. pharmaceuticals companies and the U.S. copyright-based industries in Istanbul on November 21 and 22 to discuss developments in intellectual property protection and market access. Econoff met with the pharmaceuticals companies as a group, which included Eli Lilly, Pfizer, Bristol-Myers Squibb, Wyeth, Abbott Laboratories, Merck Sharp & Dohme, Schering Plough, Pharmacia Upjohn, Janssen Cilag (Johnson and Johnson). We also held a group discussion on problems facing the copyright industries with Erol Ozkur, Anti-Piracy Marketing Manager, Microsoft/ Business Software Alliance (BSA); Nasser Ali Khasawneh, Vice President, BSA; Baha Ozyukseler, General Manager, AMPEC/ MPA (film industry); Nilufer Sapancilar, General Manager AMPEC; and Daghan Baydur, Chairman of MSG (composers/songwriters). Econoff met separately with Mehih Ayracman, Sony Music Managing Director and Board Member of MUYAP (Musical Work Producers Society). Drug Companies on Data Exclusivity, Price Discrimination --------------
¶3. (U) In their roundtable meeting at the U.S. Consulate on November 21, the pharmaceuticals firms did not, in depth, address the question of reversing GOT cost-saving measures in the health and pension funds favoring reimbursement of generic drugs. The discussion focused primarily on data exclusivity and price controls and how to address these issues with a new GOT. Ahmed Esen, Pfizer's General Manager, and Roberto Giusti, Eli Lilly's General Manager, dominated the discussion.
¶4. (U) Data Exclusivity: Roberto Giusti and his Corporate Affairs Manager Sebnem Kocaalp made the case that GOT implementation of data exclusivity would cost the Turkish treasury as little as USD 3 million annually in the form of higher reimbursements for pharmaceuticals covered by the health and pension funds, well below the USD 1 billion cost estimate promoted by Turkish generic drugs manufacturers. Lilly presented a detailed in- house analysis to back up its estimate. Other U.S. companies responded very favorably to Lilly's analysis and discussed various options for presenting it to the GOT, including commissioning an independent study through a Turkish university. ¶5. (U) Price Discrimination: There was less consensus on the need to press the GOT on price controls, and even on whether the controls discriminated against imports. Ahmed Esen, Pfizer's General Manager, argued that the entire system of price controls, for both local and imported drugs, was not transparent and needed reform. He suggested that a study be commissioned to examine the impact of price controls on imported and local products. Giusti contended that current price/margin controls were clearly discriminatory, and noted that the European pharmaceuticals industry association had examined the issue and would report its conclusions in the near future. Roundtable participants were in general agreement that the current margin control system, which encourages companies to inflate costs to obtain government approval for price increases, depresses reported profits and tax payments by the industry. Copyright Industries Focused on Improving Enforcement

http://www.kfd.org.tr/?q=node/842
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Alt 09-09-2011, 06:46   #4
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WIKILEAKS TÜRKİYE İLAÇ SEKTÖRÜ DEVAM.. TÜRK İLAÇ FİYATLANDIRMASINI KİMLER NASIL HAZIRLAMIŞ!!!

Pzt, 08/29/2011 - 22:35 — haberlerUNCLAS 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 [Foreign Trade] KIPR [Intellectual Property Rights] TU [Turkey] 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

http://www.kfd.org.tr/?q=node/845
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Alt 09-09-2011, 06:46   #5
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WIKILEAKS TÜRKİYE İLAÇ SEKTÖRÜ DEVAM.. YERLİ SANAYİİ UYUYOR YABANCILAR YÜRÜYOR!!>

Pzt, 08/29/2011 - 22:51 — haberlerUNCLAS SECTION 01 OF 02 ISTANBUL 000173 SIPDIS COMMERCE FOR GTAEVS FCS ISTANBUL E.O. 12958: N/A TAGS: ECON [Economic Conditions] EFIN [Financial and Monetary Affairs] FCSC [Foreign Claims Settlement Commission of the US] PHUM [Human Rights] TU [Turkey]
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
http://www.kfd.org.tr/?q=node/847
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Alt 09-09-2011, 06:47   #6
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WIKILEAKS TÜRKİYE İLAÇ SEKTÖRÜ DEVAM.. AMERİKAN BÜYÜK ELÇİSİNİN SAYIN PROF.DR. RECEP AKDAĞ İLE GÖRÜŞMESİ

Pzt, 08/29/2011 - 22:41 — haberlerUNCLAS SECTION 01 OF 02 ANKARA 002346 SIPDIS SENSITIVE COMMERCE FOR DEFALCO DEPT PASS USTR FOR LERRION STATE FOR EUR/SE, AND EB/TPP/MTA/IPC E.O. 12958: N/A TAGS: ETRD [Foreign Trade] ECON [Economic Conditions] SENV [Environmental Affairs]
SUBJECT: AMBASSADOR'S MEETING WITH HEALTH MINISTER ¶
1. (Sbu) Summary: In a meeting with Minister of Health Recep Akdag, the Ambassador reiterated U.S. pharmaceutical companies' concerns about data exclusivity and the pricing decree under consideration by the GOT. The Minister pushed back, claiming that there were differences of interpretation of Turkey's commitments under TRIPS and the EU Customs Union, and that the decree struck a balance between research-based and generic producers. The Minister noted the relatively high share of Turkish public health spending that goes to medicines in Turkey. The Ambassador recommended U.S. and Turkish trade experts exchange views in a DVC. The Ambassador also noted the danger that HIV/AIDS could become more prevalent in Turkey. End Summary. Pharmaceuticals: ---------------- ¶
2. (Sbu) In a meeting requested by the Ambassador, he reiterated USG and U.S. pharmaceutical companies' concerns about the GOT's proposed data exclusivity policy. Unless research-based companies could recoup their investment in research and development, the Ambassador said there was a danger they might stop investing. If these companies stopped investing in Turkey, he went on, there could be lost jobs in Turkey, and there could be an effect on the local availablity and cost of medicines. The Ambassador also said that the U.S. believes that the TRIPS agreement and Turkey's customs union with the EU both require Turkey to protect the exclusivity of data. ¶
3. (Sbu) Referring to the recent meeting between Trade Minister Tuzmen and USTR Zoellick, as well as to the imminent meeting between USDOC A/S Lash and Ambassador Logoglu, the Ambassador said he did not want the GOT to be surprised if the USG ruled that Turkey should be elevated the Priority Watch list under Special 301. ¶
4. (Sbu) The Minister responded by claiming that everything the GOT had done on this issue was done in close consultation with companies in the pharmaceutical sector. Admitting that imported pharmaceuticals had experienced low profit margins over the past two years, the Minister asserted that a new pricing decree eliminated the differential between the profit margins of imported and domestic drugs. He pointed out that the new pricing policy, like that of Greece, would help the state to save money by using the lowest price in five European countries as a reference. The Minister said the Turkish budget allocation for medicine is lower than any EU country's. In Turkey, the Minister said that majority of spending on medicine comes from public sector insurance, and that Turkey spends $150 per capita on health whereas the U.S. spends $4,000. Moreover, he contrasted the share of health spending that goes to medicines in Turkey, at 40 percent, with that in developed countries: 15 percent. He therefore was confident that the U.S. and European countries would approach the issue in an understanding way, taking into account Turkey's large budgetary allocation to cover the deficit in its Social Security system. Except for some companies pushing for higher prices, the Minister claimed that there was broad agreement with the pharmaceutical sector on the new pricing policy. ¶
5. (Sbu) On intellectual property rights issues, the Minister said Turkey will fulfill its Customs Union and TRIPS commitments. Throughout the process, the Minister believed that the only disagreement was one of interpretation. Regarding TRIPS he referred to the phase-in period for developing countries. ¶
6. (Sbu) The Health Minister reminded the Ambassador that other GOT agencies play important roles on this issue: the State Planning Organization and the Ministry of Finance, but most importantly the Foreign Trade and Industry Ministries, with the Minister of Industry chairing the Economic committee of the Council of Ministers. Coming back to the need for clarity in interpreting concepts in international agreements, the Minister likened the differences in interpretation to the story of the blind man describing the elephant based on the part he was touching. He implied that, on the data exclusivity issue, different sides were closing their eyes to the part of the elephant they could not reach. He called for the research-based companies and the generics to find common ground during the transition period, and then share their position with the public sector which is the major consumer of their products. ¶
7. (Sbu) Finally, the Minister made a vague reference to the possibility pharmaceutical companies would try to impose measures by force, in which case Turkey would need to react with protective measures. The Minister doubted such a situation would ever arise, however, because the pharmaceutical companies are likely to look to the attractive future of the Turkish pharmaceutical market, in which spending on medicines is likely to rise substantially in the years to come. ¶
8. (Sbu) The Ambassador agreed that the Turkish market would be attractive, but only if pharmaceutical companies could recoup their investment in R and D. In a globally integrating world, with Turkey poised to enter the EU, the Ambassador said protectionist measures are self-defeating. The data exclusivity issue is a problem not only for American companies, but for European companies as well. The Ambassador also said he was well aware of the interministerial nature of the issue for the GOT, and said he would continue to raise it with other ministers. ¶
9. (Sbu) In order to try to deal with the differing interpretations of TRIPS concerning data exclusivity, the Ambassador thought it would be useful to get U.S. and Turkish IPR experts together using a DVC to save time. The Ambassador also agreed that generic and research-based companies needed to have more dialogue: even though there are sharp differences, the two groups share some long-term interests. ¶
10. (Sbu) Noting the important role U.S. companies play in the global pharmaceutical industry, the Minister acknowledged the importance of the Ambassador raising the issue with him, and undertook to pass on the Ambassador's message to his GOT colleagues. The Minister reiterated his optimism that the issue could be solved. HIV/AIDS: ----------- ¶
11. (Sbu) At the end of the meeting, the Ambassador noted concerns about a potential increase in prevalence in HIV/AIDS in the Black Sea region: though Turkey is not the most at-risk country in the region, there is a danger that HIV/AIDS could become much more prevalent. The Minister agreed that Turkey had been fortunate so far. He said that there was a need to increase education for those who were not "monogamous." He asserted that the GOT attached great importance to education and prevention and that it would continue its efforts.
EDELMAN
http://www.kfd.org.tr/?q=node/846
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Alt 09-09-2011, 06:48   #7
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WIKILEAKS TÜRKİYE İLAÇ SEKTÖRÜ DEVAM.. ESKİ İEGM SAYIN HAYRİYE MIHÇAKLA TOPLANTILAR

Pzt, 08/29/2011 - 22:25 — haberlerUNCLAS ANKARA 005808 SIPDIS DEPT FOR EB/TPP/MTA/IPC DEPT PASS USTR FOR MARK WU/LISA ERRION DEPT PASS LIBRARY OF CONGRESS USDOC FOR ITA/MAC/DDEFALCO SENSITIVE E.O. 12958: N/A TAGS: ETRD [Foreign Trade] KIPR [Intellectual Property Rights] TU [Turkey] SUBJECT: Pharmaceuticals IPR Update
1. (SBU) Summary: Following heavy lobbying by the local generics industry, the GOT is contemplating introduction of data exclusivity protection for pharmaceutical test data only in 2007 and even watering down patent protection, but, to our knowledge, no final decisions have been taken on these matters. In contacts with the Health and Foreign Ministries and the Turkish Patent Institute, we have stressed the importance of these issues in the bilateral economic relationship and have urged that the GOT comply with its WTO commitments. End Summary.
2. (SBU) Citing a leaked report prepared for the GOT's Board for the Evaluation of Economic Problems in the Pharmaceuticals Sector, U.S. pharmaceutical companies operating in Turkey contacted the Embassy in late August and early September to register strong concern about reports that the GOT intends to delay implementation of data exclusivity protection until 2007 and to water down patent protection for pharmaceuticals. The report followed discussions in late August between the GOT and local generics producers. At the same time, Eli Lilly representatives noted some progress in diminishing price discrimination against imported drugs, including the beginning of a dialogue with the Health Ministry on margins and ad hoc suspension of reference pricing for some drugs.
3. (SBU) Econoff and Econ Specialist raised these issues with Hayriye Mihcak, Director General for Pharmaceuticals at the Turkish Ministry of Health on September 9. Mihcak confirmed that an interministerial board was developing reports on data exclusivity, patent protection and pricing. These reports are to form the basis for a response to the European Union on these issues.
4. (SBU) Mihcak hesitated in discussing the contents of the reports until Econoff shared an English translation of the one concerning data exclusivity and patent protection. We emphasized that data exclusivity and patent protection were not only an EU-Turkey issue, but also WTO requirements for Turkey and of great interest to the United States. Econoff underlined that delays in implementing data exclusivity and any movement to degrade patent protection would be received very negatively by the USG and U.S. industry. He also noted that at least one key stakeholder - the research-based industry - had not been consulted in preparing the report. Mihcak responded that the report was not yet finalized, and that she would take our points into consideration in future interagency discussions on this issue.
5. (SBU) Mihcak said she regarded the current pricing system in pharmaceuticals to be inequitable and said the GOT was considering changes to it, but she declined to go into the specifics of this issue.
6. (SBU) Econoff raised these issues with Selim Sengun, President of the Turkish Patent Institute (TPI), on September 10. Sengun stated that the report on data exclusivity and patent protection represented the maximum demands of the generic industry, and that there was a fair chance that the GOT would not decide to fully implement these provisions. In interagency discussions, TPI's representative urged against weakening patent protection. He also pointed out that weakening Turkish patent protection would have limited effect since, in the near future, most pharmaceuticals patents would be take effect on the basis of approvals made by European Patent Office. Sengun cautioned that local generics manufacturers constituted a strong lobby against IPR protections in its sector, one that apparently had the ear of the Health Ministry as well as other GOT agencies.
7. (SBU) Econ and Commercial Counselors also raised pharmaceuticals issues with MFA Deputy Director General for Bilateral Economic Affairs Mehmet Gucuk on September ¶12. Gucuk asked us to provide further details on these issues in writing, which Embassy will do in the near future. Edelman
http://www.kfd.org.tr/?q=node/844
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Alt 10-19-2011, 14:43   #8
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