Explicit rules on importation of cheaper patented medicines and registration and research of generic medicines of patented drugs urged in Cheap Meds Law IRR

PRESS RELEASE
29 October 2008

“Public health is foremost in the Cheap Meds Law and patents should clearly not get in the way of poor Filipinos’ access to affordable and quality medicines,” said Salvacion Basiano, Spokesperson of the consumer group Cut the Cost, Cut the Pain Network (3CPNet).

Civil society groups 3CPNet, Oxfam and Ayos na Gamot sa Abot Kayang Presyo (AGAP) urge the Department of Health to craft clear, explicit provisions in the Implementing Rules and Regulations (IRR) allowing importation by the government, private sector or any third party group of patented medicines that are available anywhere in the world.

“The people deserve to have access to patented medicines that are priced lower than the same patented brand of medicines here. That is the purpose of the law and its implementation should not be hampered by rigorous registration and accreditation process, said Basiano.

The groups proposed that government purchases should be done through the Philippine International Trading Corporation (PITC) and the third party or private sector has the option to course it through the PITC, other than directly importing on their own. Non-government
organisations with very little capital should be allowed to purchase in bulk through PITC but at a reasonable price that may or may not be different from the retail price in PITC’s retail outlets – the Botika ng Bayan,  to give the people more choices at competitive prices.

The groups also ask the health agency to define the rules allowing local generics manufacturer to register and conduct research of patented medicines at any time, even before the patent expiration.

“The Intellectual Property Office failed to craft rules on parallel importation and early working of patents in its draft IRR. It is now in the hands of the DOH and we strongly believe the agency will uphold public health and the rights of patients over the patent privileges of pharmaceutical companies,” said Elmira Bacatan, Oxfam campaigner on access to medicines.

The proposed IRR of civil society groups stated that the data of pharmaceutical companies that are sought to be protected from unfair commercial use should first be disclosed to BFAD and the same may be used by the applicant in registering a generic equivalent at anytime within the life of the patent. The group noted that the IRR should explicitly state that the early registration of generic equivalents at BFAD cannot be stopped by the pharmaceutical  company holding the patent unless the Intellectual Property Office (IPO) rules that it constitutes unfair commercial use.

The groups found the draft IRR of the two agencies amiss with these important provisions that were among the core amendments of the existing laws governing patents of drugs and medicines.

In the position paper submitted by the groups, they also proposed that the DOH decide on the efficacy of a drug seeking patent application and the patent examiner should follow whatever the DOH decides on the matter.

“The DOH, along with BFAD are mandated by law to ensure the safety, efficacy, purity, and quality of drugs, among others, for the protection of public health. Hence, they have the adequate expertise and means on assessing whether the patent application for drugs and
medicines resulted to enhancement of known efficacy,” said Paula Tanquieng, Ayos na Gamot sa Abot-kayang presyo (AGAP) Program Officer.

According to the law, the IRR needs to be done on November 4, 2008. The DOH is set to hold the last public hearing today in Davao while the IPO is yet to release to the public its final copy of the rules.(END)