Duque signs IRR of cheap medicine law

MANILA, Philippines – Health Secretary Francisco Duque III has signed the implementing rules and regulations (IRR) of the law allowing Filipinos access to quality, low-cost medicine.

In a telephone interview, Health Undersecretary Alex Padilla said yesterday Republic Act 9502, the Universally Accessible and Affordable Quality Medicines Act of 2008 would take effect two weeks after the 67-page IRR shall have been published in newspapers.

“I think it will be in the newspapers tomorrow and after two weeks (it will take effect),” he said.

Duque signed the IRR after a series of consultations with consumer groups, pharmaceutical organizations, hospital organizations and other stakeholders.

RA 9502 was passed last July 4 amid reports that the prices of medicines in the Philippines are 40 to 200 percent higher than those in neighboring countries.

RA 9502 amends Republic Act 8293, the Intellectual Property Code; RA 6675, the Generic Act of 1988; and RA 5921, the Pharmacy Law.

The IRR empowers the DOH secretary to determine the “maximum retail prices” of drugs and medicines and to impose price regulations on certain products.

“Private parties may course through PPI (Philippine International Trading Corp.) to avail of its facility for undertaking procurement, sourcing and marketing of quality essential and low priced medicines through drug importations and sourcing of medicines from reputable and reliable suppliers and ensuring the widest distribution of these medicines nationwide as determined with the Bureau of Food and Drugs (BFAD),” read the IRR.

The IRR excludes from “patent protection all discoveries, scientific theories, mathematical methods; and in the case of drugs and medicines: the mere discovery of a new form or 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,” among others.

Others excluded are plant varieties or animal breeds or essentially biological process for the production of plants or animals and “anything which is contrary to public order or morality.”

The IRR provides that any government agency or a third party authorized by the state may “exploit an invention even without agreement of the patent owner” in situations like when public interest is concerned; when “manner of exploitation by the owner of patent or his license is anti-competitive;” or when there is a national emergency or other circumstances of extreme urgency in the case of drugs and medicines.

Drug manufacturing firms operating in the Philippines are also required under the IRR to “produce, distribute and make widely available to the general public” an unbranded generic counterpart of their branded product.

Other key features of the IRR is the strengthening of BFAD by authorizing it to retain “all the fees, fines, royalties and other charges” it has collected under the law.