Philippines Urged to Draft Strong IRR on Cheap Medicines Law

International and national non-government organizations urge the government to ensure a strong Implementing Rules and Regulations (IRR) of the Universally Accessible Cheaper and Quality Medicines Act of 2008 to ensure that the real intents of the law to uphold public health interests will prevail.

The proposed IRR that seeks to prevent abuses by pharmaceutical companies of their patent privileges come from international NGOs Oxfam and Third World Network (TWN) and was recently submitted to the Intellectual Property Office (IPO). Also joining the groups are Cut the Cost, Cut the Pain Network (3CPNet), Ayos na Gamot sa Abot Kayang Presyo (AGAP) coalition and the patient group Cancer Warriors Foundation (CWF).

“The process of ensuring patent flexibilities and reform was not completed with the passage of RA 9502. This law should not give big, foreign pharmaceutical industry any opportunity to exploit the law’s weaknesses, which would harm the interests of poor Filipinos to avail of affordable, quality medicines,” said Mira Bacatan, Oxfam Campaigner on Access to Medicines.

The groups urge the government to clarify in the IRR the public non-commercial use of patented medicines, which empowers the government to issue a compulsory license without the consent of the patent owner.

The groups propose that the IRR enhances the provision on the application of international exhaustion of patents. This empowers the government to identify and import inexpensive versions of the same patented medicine from another country or region to reduce medicine prices without the consent of the patent owner.

Bacatan explained that the provision on the protection of data from unfair commercial use should not introduce any form of ‘data exclusivity’ under the data protection law.

Data exclusivity creates a new system of monopoly power, separate from patents, by blocking the registration and marketing approval of generic medicines by five or more years, even when no patent exists.

“This new law puts in place flexibilities that can preserve and strengthen the right to health in the country’s IP law. The proposed IRR ensures that the patent holders cannot use the weaknesses in the wording of the Cheaper Medicines law to block the public’s access to affordable and quality medicines,” said Elpidio Peria, Third World Network associate.

“Another worrisome aspect that may undermine the positive intent of the law is the provision allowing the Supreme Court to issue injunctions on litigation involving legal disputes under this law. We only hope that the Supreme Court will issue specific rules that will define how and when it will only intervene in these cases so that the public’s access to medicines will not be impaired,” explained Bacatan.

According to Oxfam, courts in other countries, including the United States, are increasingly hesitant to issue injunctions in intellectual property disputes, especially where the public interest is at stake.

“We know of no greater public interest than ensuring affordable medicines, and thereby strongly encourage the Philippine government to ensure affordable medicines will not be denied,” said Peria.

The groups declare their commitment to work closely with the IPO and the DOH in crafting IRR provisions that will promote access to medicines and the public’s right to health and avoid creating impediments to these policy reforms.

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