Civil society groups hit ‘preservation of rights’ provision in IRR of Cheaper Meds Law

PRESS RELEASE

9 October 2008

 

  

Consumer group Cut the Cost, Cut the Pain Network (3CPNet) criticized a provision in the Implementing Rules and Regulations (IRR) of the Cheaper Medicines Law, as it falls short of ensuring that public health will be fully protected in the Philippines through lower medicine prices.

 

In particular, 3CPNet notes that the IRR seeks to preserve existing rights prior to the implementation of the law.  One of the provisions in the draft of the IRR produced by the Intellectual Property Offices states, “Nothing herein shall adversely affect the rights or the enforcement of rights acquired in good faith prior to the effective date of these Implementing Rules and Regulations.”

 

“This provision will contradict the purpose for which the Universally Accessible Cheaper and Quality Medicines Act was legislated in the first place.  The provision is vague and may defeat the spirit of the Act, thus denying Filipinos access to affordable medicines they need,” noted Salvacion Basiano, spokesperson of 3CPNet.  Basiano continued: “The Intellectual Property Office should remove the provision from the draft immediately.”

 

 International non-government organization Oxfam also urged the IPO to clarify in the IRR that the law’s provisions shall take effect on existing patents.

 

“Public health must take primacy over the assertion of private rights provided for by the Intellectual Property Code of the Philippines. The IRR can be further improved to emphasize the flexibilities provided for by the WTO TRIPS Agreement, and affirmed by the Doha Declaration on TRIPS And Public Health,” said Elmira Bacatan, Oxfam Campaigner on Access to Medicines.

 

The groups said RA 9502 shall have safeguards to ensure that generic medicines can enter the market immediately upon patent expiration, that the government can override patent protection to introduce inexpensive versions of medicines to protect public health, or import a patented product marketed in another country at a lower price.

 

The IPO is holding a public consultation today as the agency released its draft IRR of RA 9502. 3CPNet and Oxfam will present their position covering the provisions on government use, experimental use, parallel importation and Bolar exception.

 

According to the groups, the IRR should stipulate any that license for government use is essential to promoting public health, and no conditions should be imposed on the use of government use licensing.

 

Furthermore, the groups expect the government to ensure a provision in the IRR for experimental use of patents should include reverse engineering and improving on the patented medicines.

 

The position paper that the groups submitted also includes recommendation to allow third parties besides the Philippine International Trading Corporation (PITC) to engage in parallel importation to promote adequate competition. Related to this, the groups emphasize that parallel importation shall subsist with the international exhaustion policy.

 

“The IRR should be clear that the patentability criteria are determined by the Department of Health (DOH) and the agency’s decisions shall be upheld by the patent examiners. We also find it alarming that other mechanisms that ensure affordable medicines can reach poor people quickly could be affected by unnecessary oversight by the Intellectual Property Office.  In particular, we hope that the use of the Bolar exception to speed up marketing approval of medicines is only enforced by the Bureau of Food and Drugs (BFAD), and that their operations should be deemed independent from any petition at the IPO that could limit the use of the Bolar exception,” Bacatan explained. (END)