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Reference ID	Created	Released	Classification	Origin
08MANILA2418	2008-10-27 09:41	2011-08-26 00:00	UNCLASSIFIED//FOR OFFICIAL USE ONLY	Embassy Manila

VZCZCXRO5401
OO RUEHCHI RUEHFK RUEHHM RUEHKSO RUEHNAG RUEHPB
DE RUEHML #2418/01 3010941
ZNR UUUUU ZZH
O 270941Z OCT 08
FM AMEMBASSY MANILA
TO RUEHC/SECSTATE WASHDC IMMEDIATE 2175
INFO RUEATRS/DEPT OF TREASURY WASHDC IMMEDIATE
RUCPDOC/USDOC WASHDC IMMEDIATE
RUEAWJB/USDOJ WASHDC IMMEDIATE
RUEHZU/ASIAN PACIFIC ECONOMIC COOPERATION IMMEDIATE
RUEHBK/AMEMBASSY BANGKOK IMMEDIATE 2973

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

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Viewing cable 08MANILA2418, PHILIPPINES CHEAPER MEDICINES ACT IMPLEMENTING RULES AND