UNIVERSALLY ACCESSIBLE CHEAPER AND QUALITY MEDICINES ACT OF 2008

Case Overview and Summary

Summary of the Universally Accessible Cheaper and Quality Medicines Act of 2008

Amendments to the Intellectual Property Code (Republic Act No. 8293):
- Defines what cannot be patented for drugs and medicines, including new forms or properties of known substances that do not enhance efficacy. (Sec. 5, 22.1)
- Clarifies the criteria for inventive step for drugs and medicines. (Sec. 6, 26.2)
- Allows parallel importation of patented drugs and medicines, including by private parties. (Sec. 7, 72.1)
- Exempts certain acts from patent infringement for drugs and medicines, such as testing for regulatory approval. (Sec. 7, 72.4)
- Allows compulsory licensing for drugs and medicines in cases of emergency, public interest, anti-competitive practices, or if demand is not met. (Sec. 10, 93)
- Establishes procedures for issuing special compulsory licenses for importing patented drugs and medicines. (Sec. 11, 93-A)
- Clarifies that trademarks of imported patented or off-patent drugs and medicines are not infringed upon. (Sec. 14, 147.1; Sec. 15, 159.4)

Drugs and Medicines Price Regulation:
- Grants the President the power to impose maximum retail prices on drugs and medicines upon recommendation of the Department of Health Secretary. (Sec. 17)
- Authorizes the Department of Health Secretary to establish a price monitoring and regulation system, recommend maximum retail prices, implement cost-containment measures, and impose administrative fines from PHP 50,000 to PHP 5,000,000 for violations. (Sec. 18, 19)
- Defines illegal acts of price manipulation, such as hoarding and cartel formation, with penalties of imprisonment from 5 to 15 years or fines from PHP 100,000 to PHP 10,000,000. (Sec. 24, 25)
- Requires display of maximum retail prices on drug labels and price lists from manufacturers and importers. (Sec. 26)
- Mandates reporting from local government units and the Department of Trade and Industry on drug price monitoring. (Sec. 27)
- Lists drugs and medicines subject to price regulation, including those for chronic illnesses, prevention, anesthesia, and essential drugs. (Sec. 23)

Strengthening the Bureau of Food and Drugs:
- Allows the Bureau to retain fees, fines, and charges collected for its operations without needing separate approval. (Sec. 31)
- Requires the Bureau to ensure drugs conform to international standards and follow WHO certification schemes. (Sec. 32)

Non-Discriminatory Clause:
- Prohibits retail drug outlets from refusing to carry or sell drugs and medicines allowed for parallel importation, with penalties of fines from PHP 100,000 to PHP 1,000,000 and potential license suspension or revocation. (Sec. 33, 35)
- Prohibits manufacturers, importers, and others from withholding sale of drugs and medicines without good reason. (Sec. 34)

Amendments to the Generics Act of 1988 (Republic Act No. 6675):
- Requires the Department of Health to publish generic and brand names of all drugs and medicines annually. (Sec. 37)
- Mandates the use of generic terminology by government agencies, medical practitioners, and drug companies in prescriptions, labels, and promotional materials. (Sec. 38)
- Requires drug manufacturing companies to produce unbranded generic counterparts of their branded products. (Sec. 39)
- Mandates a continuous public information campaign on generic drugs by the Department of Health, Philippine Information Agency, and Department of the Interior and Local Government. (Sec. 40)
- Establishes penalties for violations, including fines, license suspension, and imprisonment for repeated offenses. (Sec. 41)

Amendments to the Pharmacy Law (Republic Act No. 5921):
- Prohibits the sale of prescription drugs outside of drugstores or hospital pharmacies, while allowing over-the-counter drugs to be sold in retail establishments. (Sec. 43)

Miscellaneous Provisions:
- Creates a Congressional Oversight Committee to monitor the implementation of the law. (Sec. 45)
- Provides initial appropriations of PHP 25,000,000 for the Department of Health and PHP 5,000,000 for the Congressional Oversight Committee. (Sec. 46)