Question & AnswerQ&A (Republic Act No. 9502)
The short title of Republic Act No. 9502 is the "Universally Accessible Cheaper and Quality Medicines Act of 2008."
The main policy objective is to protect public health and to promote and ensure access to affordable quality drugs and medicines for all, including adopting appropriate measures under circumstances of extreme urgency.
A 'Compulsory License' is a license issued by the Director General of the Intellectual Property Office to exploit a patented invention without the permission of the patent holder, either by manufacture or through parallel importation.
Drugs and medicines are any chemical compound or biological substance, other than food, intended for use in the treatment, prevention or diagnosis of disease in humans or animals, including articles recognized in various pharmacopoeias, herbal/traditional drugs recognized in the Philippine National Drug Formulary, and others as detailed in the law.
Government may use a patented invention without agreement if there is public interest such as national security, nutrition, health; if exploitation by the patent owner is anti-competitive; in cases of national emergency or extreme urgency for drugs and medicines; public non-commercial use without satisfactory reason; or if demand in the Philippines is not met adequately and reasonably.
The penalty includes imprisonment for 5 to 15 years or a fine ranging from Php100,000.00 to Php10,000,000.00, at the court's discretion, and may also include suspension or revocation of licenses.
The President of the Philippines, upon recommendation of the Secretary of the Department of Health, has the power to impose maximum retail prices on drugs and medicines.
The Secretary of Health must submit bi-annual monitoring reports to the Office of the President (published in newspapers) and annual reports to both Houses of Congress; orders imposing price controls must be published in newspapers and posted at drug outlets.
Drug outlets shall not refuse to carry drugs and medicines legally brought into the country and approved by the Bureau of Food and Drugs. Such products must be displayed with equal prominence as other products.
Fines ranging from Php100,000.00 to Php500,000.00 for the first offense, and Php500,000.00 to Php1,000,000.00 for succeeding offenses, plus suspension or revocation of business or professional licenses.
It mandates government health agencies and personnel to use generic names in all transactions; requires medical practitioners to write prescriptions using generic names; mandates manufacturers and distributors to prominently display the generic names on products and advertising; and requires drug outlets to inform buyers about other products with the same generic name and prices.
The Committee oversees the effective implementation of the Act, is composed of members from both Houses of Congress, and is responsible for continuous oversight and related functions.
The Secretary is authorized to establish a price monitoring and regulation system, recommend maximum retail prices, implement cost-containment measures, impose administrative fines for violations, and deputize government entities for assistance.
The Intellectual Property Office, Department of Health, and other relevant agencies are mandated to promulgate implementing rules and regulations within 120 days of enactment to effectively implement various provisions of the Act.
There shall be no infringement of trademarks or tradenames of imported or sold patented drugs and off-patent drugs if the registered marks have not been tampered with or unlawfully modified.