DDB approves new regulation for dangerous drugs

MANILA, Philippines — The Dangerous Drugs Board (DDB) has issued a new regulation that will improve access to some dangerous drugs for medical purposes.

DDB Regulation No. 8 will issue license to acquire, possess and use drug products containing dangerous drugs, which are registered in other countries and not locally, for compassionate use.

The license may be applied before the Philippine Drug Enforcement Agency (PDEA) directly by the patient or his relative or guardian.

The new regulation makes medicine containing dangerous drugs more accessible for patients, as previously only specialized institutions can file a request for the Compassionate Special Permit.

Patients with medical conditions involving life threatening and debilitating diseases, such as cancer and terminal diseases and other diseases with limited therapeutic options identified by the Department of Health (DOH) may apply for the license.

Products in medicine form containing dangerous drugs will only be authorized for use here if it has been registered by counterparts of the Food and Drug Administration (FDA) in reference countries.

“Apart from improving access to dangerous drugs for medical purposes, it is important for us to ensure that only registered products that have been proven safe for use will be allowed under these regulations,” DDB chairman Catalino Cuy said in a statement.

The DDB, PDEA and the DOH will formulate the procedural guidelines for license application within 60 days after the regulation was approved by the Board on Dec. 17, 2019.

The DDB, the lead drug-policy making body in the country, is mulling to reclassify medicine containing cannabidiol (CBD).

Public hearings and meetings with stakeholders will be conducted in the coming weeks for the proposed regulation.

The PDEA earlier warned against the use of CBD without permit as it is still illegal in the country.

CBD is supposedly being sold openly online despite the prohibition.