Cheaper Medicines Bill Seen to Weaken Pharmaceutical IPR
Byline: Bernie Cahiles-Magkilat
American drug research and manufacturers have strongly recommended that the Philippines be downgraded again into the Priority Foreign Country List in the 2008 Special 301 report of the US Trade Representative (USTR) on grounds that government and Congress are in tandem in pursuing measures that would seriously weaken intellectual property rights for the pharmaceutical industry via the proposed Cheaper Medicines Bill.
In its submission to the USTR, which is currently reviewing the status of countries with IPR violations, the powerful Pharmaceutical Research and Manufacturers (PhRMA) said that Senate Bill 1658 and House Bill 2844 seek to amend the IP Code of the Philippines with TRIPS-inconsistent discriminatory provisions.
TRIPS refer to the Agreement on Trade-Related Aspects of Intellectual Property of the World Trade Organization.
Foremost, PhRMA has complained that the pending bills would authorize the parallel importation of drugs and medicines, mandates generics only prescriptions, worsens the proliferation of counterfeit drugs and impedes US trade.
"Given these concerns, we recommend that the Philippines be designated as a Priority Foreign Country in the 2008 Special 301 report," the PhRMA said in a position paper submitted to USTR Director for Intellectual Property Jennifer Choe Groves.
This powerful lobby group impressed upon the USTR that in 2003 alone, the US biopharmaceutical industry employed 406,700 people contributing $ 63.9 billion in total real output to the U.S. economy.
Biopharmaceutical firms invest between 10 to 20 percent of sales in research and development. In 2006 alone, PhRMA member companies claimed they have invested more than $ 42 billion in research worldwide to develop and bring to market new medicines.
The U.S. drugmakers said that both bills are inconsistent with TRIPS Article 27.1, which requires that patents be made available without discrimination with respect to the field of technology, are detrimental to their trade.
House Bill 2844 would create a new ground for compulsory licensing under existing Philippine law: "Where the demand for patented drugs or medicines is not being met to an adequate extent and on reasonable terms, as determined by the Department of Health."
If implemented, this new ground for compulsory licensing is applicable only to drugs and medicines and, therefore, is inconsistent with the non-discrimination requirements of Article 27.1 in TRIPS.
When this new ground is utilized, the position paper stated, amendment under the House Bill would waive the requirement under the existing IP Code that a compulsory license can only be granted after the petitioner has made efforts to obtain authorization from the patent owner on reasonable commercial terms and conditions over a reasonable period of time.
Under Article 31 of TRIPS, a WTO member can only waive the requirement to make efforts to obtain authorization from the patent holder on reasonable commercial terms and conditions before issuing a compulsory license in three specific cases: national emergency or other circumstances of extreme urgency; public non-commercial use and; to remedy anti-competitive practices.
The PhRMA further raised concern of the removal by the Department of Health Administrative Order of the patent linkage system and intellectual property protection from the responsibilities of the Bureau of Food and Drug Administration (BFAD).
The DOH AO permits BFAD to accept and process applications for product registration without the need to verify whether or not the pharmaceutical being submitted for registration is under patent protection. Even if BFAD is made aware of a valid patent, it is "exempted" from honoring such patent and can grant approval for marketing of the infringing product. …