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Special Law on Cheaper and Quality Medicines

REPUBLIC ACT No. 9502 June 6, 2008 Amending RA8293, RA6675, RA5921 AN ACT PROVIDING FOR CHEAPER AND QUALITY MEDICINES, AMENDING FOR THE PURPOSE REPUBLIC ACT NO. 8293 OR THE INTELLECTUAL PROPERTY CODE, REPUBLIC ACT NO. 6675 OR THE GENERICS Be it enacted by the Senate and House of Representatives of the Philippines in Congress assembled: CHAPTER I GENERAL PROVISIONS Section 1. Short Title. - This Act shall be known as the "Universally Accessible Cheaper and Quality Medicines Act of 2008". SEc. 2. Declaration of Policy. - It is the policy of the State to protect public health and, when the public interest or affordable quality drugs and medicines for all. Pursuant to the attainment of this general policy, an effective competition policy in the supply and demand of quality affordable drugs and medicines is recognized by the State as a primary instrument. In the event that full competition is not effective, the State recognizes as a reserve instrument the regulation of prices of drugs and medicines, with clear accountability by the implementing authority as mandated in this Act, as one of the means to also promote and ensure access to quality affordable medicines. SEC. 3. Construction in Favor of Protection of Public Health. - All doubts in the implementation and of protecting public health. SEc. 4. Definition of Terms. - For purposes of this Act, the following terms are to mean as follows: (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; (b) "Drug outlet" refers to drugstores, pharmacies, and any other business establishments which sell drugs and medicines; (c) "Drugs and medicines" refers to 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 but not limited to: (1) any article recognized in the official United States Pharmacopoeia-National Formulary (USP-NF). official Homeopathic Pharmacopoeia of the United States, Philippine Pharmacopoeia, Philippine Pharmacopoeia, Indian Pharmacopoeia, any national compendium or any supplement to any of them; (4) any article intended for use as a component of any articles specified in clauses (1), (2), and (3) not including devices or their components, parts, or accessories; and (5) herbal and/or traditional drugs which are articles of plant or animal origin used in folk medicine which are: (i) recognized in the Philippine National Drug Formulary; (ii) intended for use in the treatment or cure or mitigation of disease symptoms, injury or body defects in humans; (iii) other than food, intended to affect the structure or any function of the human body: (iv) in finished or ready-to-use dosage form; and (v) intended for use as a component of any of the articles specified in clauses (i), (ii), (iii), and (iv); (d) "Essential drugs list or national drug formulary" refers to a list of drugs prepared and periodically updated by the Department of Health on t