On June 6 2008, the president of the Philippines signed into law Republic Act no 9052 entitled Universally Accessible Cheaper and Quality Medicine Act of 2008. The director-general of the Intellectual Property Office and other appropriate government agencies are mandated to issue the implementing rules and regulations of the Act within 120 days. Republic Act no 9052 contains a number of important points.
First, it amends the IP Code to state as non-patentable the mere discovery of a new form of a new property of a known substance which does not result in the enhancement of the known efficacy of that substance, or the mere discovery of any new property or new use for a known substance, or the mere use of a known process unless such known process results in a new product that employs at least one new reactant.
Second, the owner of a patent has no right to prevent third parties from using a patent without his authorization after a drug or medicine has been introduced in the Philippines or anywhere else in the world by the patent holder or by any party authorized to use the invention. The Act also grants the right to import drugs and medicines to any government agency or any private third party.
In the case of drugs and medicines, the patent owner has no right to prevent the testing, using, making or selling of the invention including any data related thereto, solely for purposes reasonably related to the development and submission of information and issuance of approvals by government regulatory organizations required under any law of the Philippines, or of another country that regulates the manufacture, construction, use or sale of any product.
Upon recommendation of the secretary of the Department of Health, the director-general of the Intellectual Property Office can grant compulsory licence for the importation of patented drugs and medicines, to ensure access to quality affordable medicines, with reasonable compensation to the patent owner.
The president of the Philippines has the power to impose maximum retail prices over any or all drugs and medicines listed in Section 23 of the Act. Examples of drugs and medicines listed in Section 23 which are subject to price regulation include: those indicated for treatment of chronic illnesses and life threatening conditions such as but not limited to endocrine disorders, cardiovascular diseases, skin diseases, pulmonary diseases, neuro-psychiatric disorders, other infectious diseases; those indicated for prevention of pregnancy; and anaesthetic agents.
The Generics Act or RA 6675 is amended so to state that a label of a generic drug should contain the statement that the product has the same therapeutic efficacy as any other generic product of the same make.
Every drug manufacturing company operating in the Philippines shall be required to produce, distribute, and make widely available to the general public an unbranded counterpart of their branded product.
Finally, the Pharmacy Act or RA 5921 is amended to allow supermarkets, convenience stores, and other retail establishments to sell to the general public, non-prescription or over the counter drugs in their original packages, bottles or containers, or in quantities not in their original containers.