PHARMACEUTICAL DATA PROTECTION AMENDMENT APPROVED,

UNCLAS SECTION 01 OF 02 ISLAMABAD 002802 SENSITIVE SIPDIS E.O. 12958: N/A TAGS: ECON KIPR PGOV PK SUBJECT: PHARMACEUTICAL DATA PROTECTION AMENDMENT APPROVED, DEGREE OF PROTECTION UNCLEAR ¶1. (SBU) Summary: Director General for Health Dr. Rashid Jooma told EconCouns and Econoff that the Ministry of Health is at last moving forward with long-stalled data protection for pharmaceutical products. According to Jooma, representatives from both domestic and international pharmaceutical industries agreed on draft data protection regulations, but the draft was subsequently watered down at the behest of the domestic pharmaceutical lobby. Despite these amendments, industry and the GOP alike agree it is a significant step forward for the protection of intellectual property rights in Pakistan. End Summary. -------------- A Significant, If Imperfect, Step -------------- ¶2. (SBU) In a series of recent meetings, EconCouns and Econoff met with government officials and legal counsel to the local Pharma bureau for an update on Pakistan's data protection legislation. After languishing for over two years, the Director General at the Ministry of Health (MOH) Dr. Rashid Jooma reported that representatives from the Pharmaceutical Research and Manufacturers of America (PhRMA), domestic pharmaceutical industry, and the MOH had reached agreement on an amendment to the 1976 Drug Law. Although he would not share the actual text with Emboffs, Jooma said that the amendment has already been approved by both the MOH and the Ministry of Law. Because it is an amendment rather than a new piece of legislation, Cabinet approval is not required. ¶3. (SBU) Despite his obvious satisfaction with the movement on this long-standing U.S. complaint, Jooma expressed some reservations about the scope of two specific protections the new amendment affords drug companies. According to the DG, members of the Pakistan Pharmaceutical Manufacturers Association (PPMA),the local association of domestic pharmaceutical companies, lobbied successfully to have the period during which a "new chemical entity" is protected during the drug registration process reduced from the agreed 18 months to six. The PPMA also succeeded in limiting the geographic scope of the protection: chemical entities registered in Pakistan will be protected but, should a competitor obtain access to the chemical entity in a foreign country, the competitor would also be able to register the chemical entity in Pakistan. Jooma worried that these would be disincentives for international pharmaceutical companies to work in Pakistan, despite the overall improvement in IPR protection the new amendment is expected to provide. -------------- Industry Agrees -------------- ¶4. (SBU) Hasan Irfan Khan, the attorney for PhRMA members Merk and Pfeizer, also conveyed his support for the new amendment in a separate meeting with Econoff. Khan, who was present during the negotiations of the draft Jooma hosted at MOH, was well aware of the agreement reached. He had also heard of the subsequent changes made to the draft and added a third area of concern to Jooma's list: the definition of what constitutes undisclosed test data had also been modified. Although Khan characterized the local pharmaceutical companies' actions as deceptive, he still lauded the amendment as "a huge step" for the GOP and drug developers. ¶5. (SBU) Comment: The long-awaited amendment to the 1976 Drug Rule, while not perfect, is a significant positive step in the right direction. Rashid Jooma, since his arrival on the scene as DG health some ten months ago, has been working quietly but steadily to unblock this critical amendment. He has told us, and now shown us, that he is determined to resolve some of these long-standing irritants and hopes to see Pakistan removed from the Priority Watch List. We understand the amendment will be made public by the end of November. End Comment. ISLAMABAD 00002802 002 OF 002 PATTERSON