SUBJECT: NOTIFICATION DEMARCHE DELIVERED: TUNISIA

UNCLAS TUNIS 002140 SIPDIS SIPDIS STATE FOR EB/IPE (CLACROSSE/MANDAMO) AND NEA/MAG(MAYA HARRIS) STATE PLEASE PASS USTR (DBELL) STATE PLEASE PASS USPTO (MADLIN) USDOC FOR CLDP (MTEJTEL) AND ITA/MAC/ONE (NMASON) E.O. 12958: N/A TAGS: ECON ETRD KIPR TS SUBJECT: SUBJECT: NOTIFICATION DEMARCHE DELIVERED: TUNISIA 2006 SPECIAL 301 (INTELLECTUAL PROPERTY) REF: A. STATE 75848 ¶B. TUNIS 1091 ¶C. STATE 66147 ¶1. ON AUGUST 7, ECONOFF DELIVERED REVISED DEMARCHE POINTS TO AMOR TOUMI, THE MINISTRY OF PUBLIC HEALTH'S (MOH) DIRECTOR GENERAL OF THE NATIONAL LABORATORY FOR THE CONTROL OF MEDICATIONS. DEMARCHE POINTS WERE ALSO DELIVERED ON AUGUST 11, TO THE MINISTRY'S DIRECTOR GENERAL OF HEALTH, MR. NOUREDDINE BOUZOUAIA AND DIRECTOR GENERAL OF THE INTERNATIONAL COOPERATION UNIT, DR. HICHEM ABDESSELEM. ECONOFF INFORMED MOH OFFICIALS THAT TUNISIA WOULD NOT BE LISTED IN USTR'S 2006 SPECIAL 301 REPORT, BUT THAT THE USG HAS CONTINUING INTELLECTUAL PROPERTY RIGHTS (IPR) CONCERNS WITH REGARD TO DATA PROTECTION, PATENT LINKAGE, BORDER ENFORCEMENT, AND WIDESPREAD SALE OF PIRATED PRODUCTS IN TUNISIA. DISCUSSION THEN TURNED TO THE SPECIFIC DETAILS RELATED TO TUNISIA'S INTERNATIONAL IPR COMMITMENTS UNDER THE WTO'S AGREEMENT ON TRADE-RELATED ASPECTS OF INTELLECTUAL PROPERTY RIGHTS (TRIPS). ALL THREE INTERLOCUTORS REITERATED THAT PUBLIC HEALTH CIRCULAR NO. 40 IS 100 PER CENT TRIPS COMPLIANT AS THE LANGUAGE USED IN THIS CIRCULAR IS IDENTICAL TO TRIPS ARTICLE NO. 39.9. WHEREVER TRIPS ARTICLE NO. 39.3 USES THE WORD 'COUNTRY' CIRCULAR NO. 40 REPLACES IT WITH 'TUNISIA'. THIS IS THE ONLY DIFFERENCE IN LANGUAGE BETWEEN THE TWO PUBLICATIONS. ¶2. INTERLOCUTORS ALSO EXPLAINED THAT CIRCULAR NO. 78 NO LONGER EXISTS AS IT WAS SUPERSEDED BY CIRCULAR NO. 40. ARTICLE 3 OF CIRCULAR 40 GRANTS A FIVE YEAR TERM OF DATA PROTECTION IN TUNISIA. THE CIRCULAR PROTECTS DATA AGAINST ANY DIVULGENCE UNLESS NECESSARY FOR PUBLIC HEALTH. THEY STRESSED THAT GENERICS ARE NOT ALLOWED UNTIL AFTER THE FIVE YEAR DATA PROTECTION PERIOD HAS EXPIRED. AFTER THIS FIVE YEAR PERIOD ANY GENERICS GRANTED MARKET ACCESS ARE REQUIRED TO ADOPT THE CHARACTERISTICS OF THE PATENTED DRUG. DATA PROTECTION ALSO EXTENDS TO VETERINARY MEDICATIONS. ¶3. ACCORDING TO MOH OFFICIALS, CORRELATION IS SCHEDULED TO END ON DECEMBER 31, 2006. MR. TOUMI POINTED OUT THAT CORRELATION DEALT WITH ONLY 2 PER CENT OF THE PHARMACEUTICAL MARKET AND THAT HE BELIEVED THAT THE END OF CORRELATION WILL PRESENT ITS OWN PROBLEMS. THE MARKET WILL NOW BE OPEN TO DRUGS FROM ALL COUNTRIES. THE GOT'S CENTRAL PHARMACY, THE NATIONAL IMPORTER OF ALL DRUGS ENTERING TUNISIA, HAS BEEN ONLY IMPORTING DRUGS LISTED IN U.S., JAPANESE, AND EU PHARMACOPIA. THE END OF CORRELATION MEANS THAT TUNISIA WILL BE FACED WITH PERHAPS LESS RELIABLE DRUGS FROM INDIA, CHINA, OR OTHER COUNTRIES. ¶4. WHILE DISCUSSING THE DEVELOPMENT OF A PATENT LINKAGE SYSTEM TO PREVENT PATENT-INFRINGING PRODUCTS FROM BEING REGISTERED, ALL THREE INTERLOCUTORS STATED THAT TUNISIA DOES NOT INTENTIONALLY REGISTER OR ACCEPT PATENT-INFRINGING DRUGS. THEY ALSO POINTED OUT THAT DEVELOPING A PATENT LINKAGE SYSTEM WOULD BE TRIPS-PLUS. ¶5. CUSTOMS OFFICIALS HAVE CONFIRMED THAT THEy DO HAVE EX OFFICIO AUTHORITY. CUSTOMS HAS THE AUTHORITY TO INTERCEPT AND SEIZE PIRATED OR COUNTERFEIT PRODUCTS WITHOUT A COMPLAINT FROM THE PATENT HOLDER. ¶6. ON MAY 29, 2006, IN OBSERVANCE OF NATIONAL CULTURE DAY, PRESIDENT BEN ALI ORDERED THE UPDATING OF THE COPYRIGHT LAW 1994-36 ON THE PROTECTION OF ARTISTIC AND LITERARY PROPERTY. NEW LEGISLATION CURRENTLY BEFORE PARLIAMENT SEEKS TO GRANT ENHANCED AUTHORITY TO THE TUNISIAN COPYRIGHT AUTHORITY, (ORGANISME TUNISIEN DE PROTECTION DES DROITS D'AUTEURS - OTPDA). ¶7. COMMENT. THERE HAS BEEN A MARKED CHANGE IN ATTITUDE TOWARDS IPR AMONG TUNISIAN OFFICIALS, LEGAL EXPERTS, AND BUSINESSES. THEY NOW CONSIDER IPR NOT ONLY A LEGAL TOOL FOR THE PROTECTION OF A PRODUCT BUT ALSO AN INCENTIVE TO STIMULATE ECONOMIC DEVELOPMENT. THE GOT HAS LAUNCHED A CAMPAIGN TO EXPAND IPR AWARENESS AND TO FIGHT COUNTERFEITING AND PIRACY. CONCURRENTLY, THERE HAS BEEN A NOTABLE INCREASE IN THE NUMBER OF MEDIA REPORTS ON PROBLEMS RELATED TO COUNTERFEIT PRODUCTS AVAILABLE IN THE COUNTRY'S MARKETS. THIS HAS LED THE GOT TO TAKE A PROACTIVE LEGAL POSITION ON IPR FOR THE FIRST TIME, AND TO INSTRUCT LOCAL AUTHORITIES TO GIVE CUSTOMS OFFICIALS GREATER AUTHORITY TO SEIZE COUNTERFEIT PRODUCTS WITHOUT REQUIRING A PRIOR COMPLAINT BY THE PATENT HOLDER. GOVERNMENT OFFICIALS HAVE STEPPED UP RAIDS AGAINST THE WELL-KNOWN PARALLEL MARKETS IN THE TUNIS AREA. THAT SAID, PERHAPS FOR POLITICAL REASONS, THERE DOES NOT SEEM TO BE ANY CONCERTED EFFORT AFOOT TO PREVENT LARGE RETAIL ESTABLISHMENTS, SUCH AS CARREFOUR, FROM OPENLY SELLING PIRATED OPTICAL DISCS. END COMMENT. BALLARD