Patients with legitimate medical needs can now access locally unregistered medicines containing dangerous drugs after approval of a Regulation by the Dangerous Drugs Board (DDB).
In consultation with concerned agencies including the Department of Health (DOH) and the Food and Drug Administration (FDA), the DDB approved Board Regulation No. 8, Series of 2019 providing for the issuance of license to acquire, possess and use drug products containing dangerous drugs that are not registered in the Philippines but are registered in other countries.
This development is a result of the earlier initiative undertaken by the Senate Committee on Health and Demography which is chaired by Senator Christopher Lawrence “Bong” T. Go that aims to guarantee safe, affordable and accessible medicines for public consumption and compassionate use.
The license may be applied with the Philippine Drug Enforcement Agency (PDEA) by the patient, his/her parent, spouse, guardian, or relative within the fourth degree of consanguinity or affinity. Previously, under the Compassionate Special Permit for Restricted Use of Unregistered Drug and Device Product/Preparation by the FDA (DOH Administrative Order No. 4, Series of 1992), only specialized institution or specialty society can file a request for Compassionate Special Permit.
As per the new regulation, the license will be issued for the use or acquisition of drug products for patients with medical conditions involving diseases covered by Republic Act 10747 or the “Rare Disease Act of the Philippines,” life threatening and debilitating diseases, cancer and terminal diseases, rare forms of neurological conditions, and other diseases with limited therapeutic options identified by the DOH.
For unregistered products without dangerous drugs, DOH AO No. 4, Series of 1992 still apply.
Amid queries received by the DDB regarding this development, the DDB explained that license shall only be granted for the use of products in medicine form that have been registered in FDA counterparts in reference countries. Other than registered medicines with existing dosage delivery system, no other products with dangerous drugs will be authorized.
“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 (Secretary) Catalino S. Cuy clarified.
The DDB with the PDEA and the DOH shall formulate the procedural guidelines for license application within sixty (60) days from the approval of the regulation. The regulation was approved by the DDB on 17 December 2019.
In relation to this, the DDB is also exploring the possibility of reclassifying medicines containing cannabidiol with no more than 0.1 percent tetrahydrocannabinol from Schedules 1 and 2 to Schedule 4 of the Philippine Schedule. In the Philippines, substances with no currently accepted medical use in treatment and no accepted safety use under medical supervision are classified under Schedule 1 while substances with currently accepted medical use in treatment but has high potential for abuse that may lead to severe psychological or physical dependence are classified under Schedule 2. From these schedules, it is proposed that medicines with no more than 0.1 percent tetrahydrocannabinol be classified under Schedule 4 for substances with currently accepted medical use in treatment. The 0.1 percent threshold was based on the approved tetrahydrocannabinol threshold of the United States Drug Enforcement Agency.
The DDB will schedule public hearing and meetings with stakeholders in the coming weeks in line with this proposed regulation.