Universally Accessible Cheaper and Quality Medicines Act of 2008

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Republic Act No. 9502, also known as the Universally Accessible Cheaper and Quality Medicines Act of 2008, is an act providing for cheaper and quality medicines, amending for the purpose R.A. 8293 (Intellectual Property Code of the Philippines), R.A. 6675 (Generics Act of 1988) and R.A. 5921 (Pharmacy Law). This Act is a consolidation of Senate Bill No. 1658 and House Bill No. 2844, which was finally passed by the Senate and the House of Representatives on 29 April 2008, and signed by President Gloria Macapagal-Arroyo on 6 June 2008.


Contents

Declared Policy of the State

It is the policy of the State to protect public health and, when the public interest or circumstances of extreme urgency so require, it shall adopt appropriate measures to promote and ensure access to 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 R.A. 9502, as one of the means to also promote and ensure access to quality affordable medicines.[1]


Construction in Favor of Protection of Public Health

All doubts in the implementation and interpretation of the provisions of R.A. 9502, including its implementing rules and regulations, shall be resolved in favor of protecting public health.[2]


Definition of Terms

For purposes of R.A. 9502, the following terms are to mean as follows:

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.[3]

Drug outlet refers to drugstores, pharmacies, and any other business establishments which sell drugs and medicines.[4]

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:[5]

(1) any article recognized in the official United States Pharmacopoeia-National Formulary (USP-NF), official Homeopathic Pharmacopoeia of the United States, Philippine Pharmacopoeia, Philippine National Drug Formulary, British Pharmacopoeia, European Pharmacopoeia, Japanese Pharmacopoeia, Indian Pharmacopoeia, any national compendium or any supplement to any of them;
(2) any article intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in humans or animals;
(3) any article other than food intended to affect the structure or any function of the human body or animals;
(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);

Essential drugs list or national drug formulary refers to a list of drugs prepared and periodically updated by the Department of Health on the basis of health conditions obtaining in the Philippines as well as on internationally accepted criteria.[6]

Importer refers to any establishment that imports raw materials, active ingredients and finished products for its own use or for distribution to other drug establishments or outlets.[7]

Manufacture includes any process or part of a process for making, altering, finishing, packing, labeling, breaking or otherwise treating or adapting any drug with a view to its sale and distribution, but does not include the compounding or dispensing of any drug in the ordinary course of retail business.[8]

Manufacturer refers to any establishment engaged in the operations involved in the production of a drug with the end view of storage, distribution, or sale of the product.[9]

Multisource pharmaceutical products refers to pharmaceutically equivalent or pharmaceutically alternative products that may or may not be therapeutically equivalent. Multisource pharmaceutical products that are therapeutically equivalent are interchangeable.[10]

Retailer refers to a licensed establishment carrying on the retail business of sale of drugs and medicines to customers.[11]

Trader refers to any licensed establishment which is a registered owner of a drug product that procures the materials and packaging components, and provides the production monographs, quality control standards and procedures, but subcontracts the manufacture of such products to a licensed manufacturer.[12]

TRIPS Agreement or Agreement on Trade-Related Aspects of Intellectual Property Rights refers to the international agreement administered by the WTO that sets down minimum standards for many forms of intellectual property regulation.[13]

Wholesaler refers to a licensed establishment or drug outlet who acts as merchant, broker or agent, who sells or distributes for resale or wholesale drugs and medicines.[14]


Congressional Oversight Committee

For the effective implementation of this law, there shall be created a Congressional Oversight Committee, hereinafter referred to as the Quality Affordable Medicines Oversight Committee, to be composed of five (5) members from the Senate, which shall include the Chairpersons of the Senate Committees on Trade and Commerce and Health and Demography, and, five (5) members from the House of Representatives, which shall include the Chairpersons of the House of Representatives Committees on Trade and Industry and Health. The Quality Affordable Medicines Oversight Committee shall be jointly chaired by the Chairpersons of the Senate Committee on Trade and Commerce and the House of Representatives Committee on Trade and Industry. The Vice-Chair of the oversight committee shall be jointly held by the Chairpersons of the Senate Committee on Health and Demography and the House of Representatives Committee on Health.[15]


Appropriations

For the initial implementation of this law, the amount of Twenty-five Million Pesos (PhP25,000,000.00), in addition to the budget of the Department of Health, shall be provided for the operations of the Office of the Secretary of the Department of Health. The Quality Affordable Medicines Oversight Committee shall be provided an initial budget of Five Million Pesos (PhP5,000,000.00) to perform its functions as mandated under this law. Thereafter, such sum as may be necessary for its continued implementation shall be included in the annual General Appropriations Act.[16]


References

  1. Republic Act No. 9502, also known as the Universally Accessible Cheaper and Quality Medicines Act of 2008, Sec. 2
  2. Republic Act No. 9502, also known as the Universally Accessible Cheaper and Quality Medicines Act of 2008, Sec. 3
  3. Republic Act No. 9502, also known as the Universally Accessible Cheaper and Quality Medicines Act of 2008, Sec. 4(a)
  4. Republic Act No. 9502, also known as the Universally Accessible Cheaper and Quality Medicines Act of 2008, Sec. 4(b)
  5. Republic Act No. 9502, also known as the Universally Accessible Cheaper and Quality Medicines Act of 2008, Sec. 4(c)
  6. Republic Act No. 9502, also known as the Universally Accessible Cheaper and Quality Medicines Act of 2008, Sec. 4(d)
  7. Republic Act No. 9502, also known as the Universally Accessible Cheaper and Quality Medicines Act of 2008, Sec. 4(e)
  8. Republic Act No. 9502, also known as the Universally Accessible Cheaper and Quality Medicines Act of 2008, Sec. 4(f)
  9. Republic Act No. 9502, also known as the Universally Accessible Cheaper and Quality Medicines Act of 2008, Sec. 4(g)
  10. Republic Act No. 9502, also known as the Universally Accessible Cheaper and Quality Medicines Act of 2008, Sec. 4(h)
  11. Republic Act No. 9502, also known as the Universally Accessible Cheaper and Quality Medicines Act of 2008, Sec. 4(i)
  12. Republic Act No. 9502, also known as the Universally Accessible Cheaper and Quality Medicines Act of 2008, Sec. 4(j)
  13. Republic Act No. 9502, also known as the Universally Accessible Cheaper and Quality Medicines Act of 2008, Sec. 4(k)
  14. Republic Act No. 9502, also known as the Universally Accessible Cheaper and Quality Medicines Act of 2008, Sec. 4(a)
  15. Republic Act No. 9502, also known as the Universally Accessible Cheaper and Quality Medicines Act of 2008, Sec. 45
  16. Republic Act No. 9502, also known as the Universally Accessible Cheaper and Quality Medicines Act of 2008, Sec. 46
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