PHILIPPINES CHEAPER MEDICINES ACT IMPLEMENTING RULES AND

UNCLAS SECTION 01 OF 02 MANILA 002418 STATE FOR EAP/MTS, EAP/EP, AND EEB/TPP/IPE STATE PASS USTR FOR BWEISEL, RBAE AND KEHLERS STATE ALSO PASS USAID, OPIC TREASURY FOR OASIA USDOC FOR 4430/ITA/MAC USDOC PASS USPTO FOR KSUKHAPINDA BANGKOK FOR JENNIFER NESS SENSITIVE SIPDIS E.O. 12958: N/A TAGS: ETRD KIPR EINV ECON RP SUBJECT: PHILIPPINES CHEAPER MEDICINES ACT IMPLEMENTING RULES AND REGULATIONS REF: A) Manila 00497 B) 07 Manila 1370 ¶1. (U) See Para 9 for action request. ¶2. (SBU) Summary: The Philippine government is currently drafting implementing rules and regulations for the Cheaper Medicines Act. Both the Philippines' Intellectual Property Office and Health Department have conducted initial public hearings to solicit comments. Local and multinational stakeholders have participated in public hearings, and the Health Department will compile and release the final implementing rules by November 4, 2008. USTR is currently reviewing the texts. USG comments are needed ASAP. End summary. Background -------------- ¶3. (U) The Philippine Congress passed the Cheaper Medicines Act (ref A) on June 6, 2008, and the final implementing rules and regulations are scheduled for release on November 4, 2008. The Intellectual Property Office (IPO),the Department of Trade and Industry (DTI) and the Bureau of Food & Drugs, will issue the implementing rules for the amendments of the Intellectual Property Code (Republic Act 9504). The Health Department (DOH) will promulgate all other implementing rules, including those implementing amendments to the Generics Act (Republic Act 6675) and Pharmacy Law (Republic Act 5921). IPO Public Consultation and Draft Implementing Rules -------------- -------------- ¶4. (U) After reviewing the position papers and comments submitted by stakeholders during and following the first public consultation, IPO released to the public on September 25, the draft language of the implementing rules for the provisions of RA 9502 that pertain to amendments of the IP Code. ¶5. (U) EconOffs attended the first public hearing on the implementing rules, chaired by IPO Director General Adrian S. Cristobal, Jr. Participants included representatives from the Philippine government, civil society organizations, law firms, local pharmaceutical companies, the Pharmaceutical and Healthcare Association of the Philippines (PHAP),academia, and other stakeholders. IPO elicited comments on the different sections of the amended provisions of the IP code. Most of the comments, which IPO posted on its website, concerned the provisions granting compulsory licenses, and the use of inventions by the government. Implementing Rules from the Department of Health -------------- -- ¶6. (SBU) DOH Undersecretary Alexander Padilla spearheaded the public consultations for the Health Department. After conducting a public hearing early in October, the Department released draft rules covering the sections of the Cheaper Medicines Act that amended the Generics Act and the Pharmacy Act on October 21. Post transmitted the draft rules to USTR by e-mail the same day. In a digital video conference with IPO and Philippine Department of Health representatives on October 3, USTR committed itself to providing written comments on the draft regulations. Private Sector Engagement -------------- ¶7. (SBU) Philippine government and local pharmaceutical companies have commented to econoffs on multiple occasions that local and foreign pharmaceutical companies have been attending the public consultations. However, foreign pharmaceutical firms have not been actively participating and have yet to submit their positions on the draft implementing rules to the appropriate agencies. Their passivity has created the impression that they are just watching from the sidelines and want to avoid participating in the open public consultation process. One embassy interlocutor opined that PHAP and the American pharmaceutical companies are being low-key in seeking support for their positions because of their experiences during the plenary deliberations of the Medicine Bill in the previous Congress (reftel B). ¶8. (SBU) Comment: We are concerned about this process. With international pharmaceutical companies less than fully engaged, MANILA 00002418 002 OF 002 there is some danger that important US interests could be neglected. ¶9. (SBU) Action Request: It is crucial that we receive USTR comments in time for them to have an impact on the final regulations. Please provide them ASAP. KENNEY