MGLE01: JOINT AMBASSADORIAL-PHARMACEUTICAL

C O N F I D E N T I A L SECTION 01 OF 02 BEIRUT 001392 SIPDIS SIPDIS STATE PASS USTR NSC FOR ABRAMS/DORAN/WERNER/SINGH E.O. 12958: DECL: 05/03/2016 TAGS: ECON EINV EFIN KIPR LE SUBJECT: MGLE01: JOINT AMBASSADORIAL-PHARMACEUTICAL INDUSTRY DELEGATION DISCUSSES IPR WITH PM SINIORA Classified By: Ambassador Jeffrey Feltman for Reasons 1.4 (b) and (d). ¶1. (C) Summary. The Ambassador, French Ambassador Emie, and European Commission Head of Delegation Renauld, together with a delegation that included members of the pharmaceutical industry, discussed the problems of the intellectual property rights (IPR) climate concerning pharmaceuticals in Lebanon with Prime Minister Siniora, Health Minister Khalifeh, and Economy and Trade Minister Haddad. The Ambassador and Ambassador Emie emphasized the need to implement existing legislation on drug registration and amend legislation concerning data protection and patent protection in order to improve the existing IPR climate in the pharmaceutical industry. EU Representative Renauld reminded the GOL of its bilateral commitments to the EU. Health Minister Khalifeh stressed to the delegation that his ministry respects IPR and insisted that the GOL is trying to uphold international standards, although he had concerns about the ethics of many pharmaceutical firms. Industry representatives stressed how the current IPR climate inhibits further investments and stifles innovation and defended their ethics in the Lebanese market. PM Siniora concluded the meeting by offering a proposal for a joint task force between industry and the Ministries of Health and Economy and Trade to improve the regulatory environment for pharmaceutical companies. End Summary. ¶2. (C) The Ambassador introduced the members of the delegation and began the delegation's presentation by stressing how the strength of the delegation reflected its commitment to working with the GOL and its concern with the current IPR regime in Lebanon. He emphasized that the status quo does not serve Lebanon well and needs to change. He stressed that the time has come for the implementation of the July 2003 law 530 and action on data protection. He reminded PM Siniora that the weak enforcement of IPR prevents businesses from investing in new technologies and could significantly slow other economic reforms. ¶3. (C) French Ambassador Emie followed with a presentation underlining the importance of the economic impact of pharmaceutical companies in Lebanon. He reminded PM Siniora that research-based pharmaceutical companies in Lebanon employ 2000 highly qualified people directly and an additional 2000 people indirectly. He stated that France exports USD 130 million worth of pharmaceuticals, and the French pharmaceutical industry has a 20 percent market share in the Lebanese market. Emie offered three specific GOL actions to improve the IPR climate among pharmaceuticals: (1) amending the current data protection law to ensure that new provisions will be implemented transparently; (2) accepting the sending to new laboratories and embassies the draft of new legislation in order to give industry and embassies the opportunity to offer comments or suggestions; and (3) increasing technical cooperation between Lebanese registration committees and other foreign committees. Emie also emphasized the need for the GOL to show progress on IPR issues in order to move forward on further WTO accession talks. ¶4. (C) EU Representative Renauld reminded the GOL officials that it was important for Lebanon to apply the rules of the EU-Lebanon Association Agreement that entered into force on April 1, including Article 38 of the agreement which mentions the need for the protection of IPR. ¶5. (C) After listening to the presentations of the Ambassador, Ambassador Emie, and head of Delegation Renauld, PM Siniora welcomed the members of the delegation and confirmed his intention to establish the rule of law to encourage more investment in Lebanon. He asked for patience with the GOL, as the current political environment has made implementing new economic reforms more difficult. He told the group that "the bigger the ship, the longer it takes to change directions," when referring to the challenge of offering the right incentives to create a proper business environment in order to provide jobs for Lebanon's highly educated population. ¶6. (C) Health Minister Khalifeh confirmed that IPR issues are important to the GOL and his ministry. He stated that 95 percent of Ministry of Health medical purchases do not go towards copycat drugs. He insisted that there are many countries that do not always have the best data protection laws with regards to pharmaceuticals, including Canada. He BEIRUT 00001392 002 OF 002 said that the pharmaceutical firms in Israel, Egypt, and India had suffered far more economic damage than firms in Lebanon. He told the delegation that he was serious about quality control of drugs and that the Ministry of Health had studies several ways to improve procedures and legislation regarding pharmaceuticals. He told the industry representatives that many pharmaceutical companies do not behave ethically in their marketing of products, as he questioned the need of pharmaceutical firms to offer cruises to doctors who prescribe their drugs. ¶7. (C) Pharmaceutical industry representatives emphasized that the lack of data protection for their products was serving as a significant impediment towards future investment in the Lebanese market. They stressed to GOL officials that Lebanon needed the quick implementation of law 530 to enable Lebanese patients to have better access to innovative and quality pharmaceutical products. They responded to Minister Khalifeh's concerns about ethics by stressing the existence of the Code of Pharmaceutical Promotional Practices for the Middle East. The industry representatives stressed their view that Lebanese regulatory authorities should recognize both the non-disclosure of data submitted by pharmaceutical companies and the non-reliance of such data from generic producers and importers for a minimum period of time. Industry representatives also offered technical assistance to help the Ministry of Health and the Ministry of Economy and Trade with IPR issues. ¶8. (C) Ghassan Hamadeh, an advisor to Minister Khalifeh, told the gathering that the Ministry of Health was working diligently on an action plan to improve the IPR climate with regards to the pharmaceutical industry, although results were slower than desired. He said that a secret task force of industry and GOL representatives had been reviewing law 530. He stated that the problem of copycat registration of drugs should improve with GOL commitments to the EFTA Agreement it signed. He also stressed the need for an ethical code of conduct for local producers and distributors in Lebanon. ¶9. (C) PM Siniora concluded the meeting by offering his blessing for a working task force composed of members from the Ministries of Health and Economy and Trade and industry to resolve the IPR problems facing the pharmaceutical industry. He also confirmed his desire to provide the proper investment environment for the pharmaceutical industry, saying that one of the dreams of the late PM Rafiq Hariri was to have a thriving pharmaceutical industry in Lebanon. ¶10. (U) Immediately following the meeting, Ambassador Emie delivered a press statement in the presence of the Ambassador and EU head of Delegation Renauld that highlighted the issues discussed with PM Siniora. The release stressed the need for better patent protection and data protection for pharmaceutical firms in Lebanon, the effective implementation of law 530 concerning pharmaceutical registration, and the need to stop parallel imports. ¶11. (SBU) As follow-up, the three COMs are conveying a letter to PM Siniora, with copies to his ministers, expressing appreciation for the meeting but asking for immediate action on some specific issues raised. FELTMAN