FDA : 'Compassionate permits' for imported cannabis-based drugs allowed, but no request yet

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Metro Manila (CNN Philippines, October 16) — An act to legalize the use of medical marijuana is moving forward in Congress, but the health department said there's already an existing mechanism that allows terminally-ill patients to source such prescribed drugs.

As of October 14, when Congress went on recess, the Philippine Compassionate Medical Cannabis Act was on second reading in the lower house.  But the Department of Health (DOH) said patients are allowed to import drugs and other devices not yet available in the country, including processed cannabis for medical purposes.

The Food and Drug Adminsitration (FDA), an agency under the DOH, gives out compassionate special permits under the its Administrative Order no.4s.1992. These permits grant hospitals "the privilege to avail of an unregistered drug, medical device, or food product through a licensed importer for a specific kind/type of patients, specific volume and period."

Paolo Tonolete, an FDA regulation officer, says doctors or hospitals can apply for a permit on behalf of a patient with cancer, HIV-AIDS, and other life-threatening diseases.

"The DOH  and FDA deemed it morally, socially, and ethically justified to allow access of these unregistered drug products. It is the right of every Filipino to have access to these meds especially terminally ill," he said .

The FDA receives an average of 50 applications a month for compassionate special permits, mostly for cancer medication.

In 2016, 558 of of 565 applications were approved.

As of September 30 this year, only two of 585 applications were denied.

"There were applications denied because the drug product being requested has an available counterpart, meaning we have a similar drug already registered and sold in the Philippine market," Tonolete explained.

Since these special permits were first issued in 1992, the FDA has received only one application to import cannabis oil. When the FDA asked the applicant for more details, the applicant did not reply.

Tonolete says the importation of cannabis oil is prohibited.

"Our position maintains that what's allowed in medical cannabis is only in processed form, where active ingredients are really measured and allowed for specific therapeutic action or level of cure. We minimize possible risks or side effects with this approach," he said.

Expensive cannabis-based drugs

The Philippine Cannabis Compassion Society (PCCS) tells CNN Philippines at least three of its members tried and failed to get a compassionate special permit from the FDA  to import cannabis oil.

Anna Kapunan, a member of  the PCCS executive committee, says many of their colleagues prefer to import cannabis oil  because there are only a  few cannabis-based drugs available in markets abroad, making them very expensive.

According to Kapunan, Sativex, an oromucosal spray for the treatment of multiple sclerosis, costs ₱32,340 ($1,656,778) for a month's supply. Since the FDA only approves bulk importation, this would amount to ₱194,060 for a six-month supply.

Another cannabis-based drug for chemotherapy-induced nausea and vomiting, Drobanidol or Marinol, is priced at ₱53,824/month or almost ₱323,000 for a half-year supply.

Even as the government intensifies its campaign against illegal drugs, the PCCS vows to continue pushing for the legalization of medical marijuana in the country, including its cultivation and manufacture.

"Mahigpit ang war on drugs ngayon, sabi nila suntok sa buwan daw pinaglaaban namin kasi marijuana. Sana magbago ang  isip ng mga tao na pang-adik lang iyon, kasi gamot siya eh," says PCCS spokesperson, Dr. Donnabel Cunanan.

[Translation: "With the intensified war on drugs, they say what we're fighting for is impossible because it's marijuana. We hope they change their thinking that marijuana is just for addicts because it's a medicine."]

The country's biggest group of doctors, the 76,000-strong Philippine Medical Association (PMA), insists there are many drugs in the market for diseases that medical cannabis is claimed to treat.

The group also says more tests and research should be done to confirm the medical properties of cannabis.

"In the Philippines, without a thorough study on the matter — evidence-based studies, the medical profession can't just accept anything as basis. Testimonials are not enough," says PMA president, Dr. Irineo Bernardo.

Medical cannabis bill in Congress

Before the House of Representatives went on recess, House Bill No. 180 or the proposed Philippine Compassionate Medical Cannabis Act was scheduled for sponsorship and interpellation at the plenary but this was postponed as the chamber got busy with other matters.

In the Senate, Majority Leader Tito Sotto said a medical cannabis bill would face rough sailing because there is not enough scientific basis to justify the use of marijuana to cure or alleviate certain illnesses. He also points to the FDA compassionate special permits, stressing there's no need for a new law.

"Ginagamit mo cannabis, gumaling ka? Eh di bumili ka. Huhulihin ka ba namin? Di ka naman huhulihin eh, bakit idadamay mo kami? Ikaw lang makikinabang. Ikaw lang ang may sakit… Once binigyan na natin, nabukas na pintuan for medical marijuana to be legalized. The penchant of Filipinos, tiyak 'yan sa likod ng bahay may nakatanim na," says the lawmaker, main author of  Republic Act 9165 or the Comprehensive Dangerous Drugs Act of 2002. The law classifies cannabis or marijuana as  a prohibited substance.

[Translation: "You use cannabis and you got better? Go buy it. Will we arrest you? You will not be arrested so why are you including us in this? You're the only one who needs it, you're the only sick one... Once we give this, open the door to legalize medical marijuana, with the penchant of Filipinos, for sure this will be planted in backyards."]

He adds it would not be easy to legalize canabis in the Philippines because the country is a signatory to the United Nations Single Convention on Narcotic Drugs, which classifies marijuana in the most tightly-restricted category, Schedule IV - with a high potential for abuse and no accepted medical use.