Govt issues draft rules of cheaper medicines law

MANILA, Philippines - Medicines can be imported freely once they are advertised or sold in the Philippines or anywhere else in the world under the first draft of rules implementing the cheaper medicines law. The rules make use of the legal principle of "exhaustion," reversing the current practice in which a drug manufacturer can sue for patent infringement if another entity imports cheaper versions of the same-patented medicine from abroad. The Intellectual Property Office of the Philippines (IP Philippines) has released the first draft of rules for the intellectual property portion of Republic Act 9502, or the "Universally Accessible Cheaper and Quality Medicines Act of 2008." The agency will conduct public consultations on October 9. The draft is a result of a previous consultation in July. "[W]e decided [on the provisions] based on consistency with the law and in line with our international obligations," Nevah D. Velasco, IP Philippines intellectual property rights specialist, Thursday said. "The intellectual property rights over drugs and medicines are deemed exhausted ... when it has been introduced in the Philippines or anywhere else in the world," the draft read, noting that introduction refers to the donation, promotion, prescription and sale of a certain drug or medicine. Previously, exhaustion applied only when a good has been introduced in the Philippines. But documents, test results and other data relating to medicines submitted to the Bureau of Food and Drugs will be protected against unfair commercial use. Compulsory licensing, which allows the government to break patents and allow other manufacturers to produce drugs in cases of health emergencies, will be awarded through a hearing where both petitioner and the patent owner get to file their arguments. The agency’s Bureau of Legal Affairs will make the decision within 30 days after the case is submitted and the IP Philippines’ director-general will have the authority to uphold or deny the decision. In times of national emergencies or in the interest of the public, the draft proposes that the procedure for granting compulsory licenses be fast-tracked. It provides that the patent owner be paid "adequate remuneration" except when the license was granted to correct anti-competitive practices. The draft further proposes that the definition of "inventive step" — a requirement needed for a patent to be granted — be constrained to include only those that are able to improve a substance’s ability to produce desired effects. Drug firms have been critical of the Cheaper Medicines Law, which was signed into law last July, claiming parallel importation would give undue advantage to imported drugs, as they are not made to undergo the same strict registration and testing. — Jessica Anne D. Hermosa, BusinessWorld