By Riza R. Lozada
A Compassionate Special Permit (CSP) for restricted use of unregistered drug and devices product, a requirement from the Department of Health (DOH), can grant a Specialized Institution (SI) and Specialty Society (SS) the “privilege to avail of an unregistered drug and devices.
Based on The Market Monitor research, the CSP has been in existence since the signing of Administrative Order No.4 s. 1992 signed by the former late Health Secretary Juan M. Flavier, M.D., M.P.H.
A specialized institution and specialty society can file a request for CSP only for patients suffering from Acquired Immunity Deficiency Syndrome (AIDS), cancer and life-threatening conditions, according to the DOH order.
Malacanang has announced that it will be embarking on a massive information campaign to address concerns on COVID 19 vaccination program which the Palace early on identified at least six (6) vaccine brands in its lists of drugs that will be administered in its effort to reach nationwide implementation starting with the National Capital Region (NCR) and CALABARZON followed with regions down the line, this according to a cabinet secretary recently interviewed over national television.
As this developed, speculations have been raised largely on the local government units drive to participate on their own initiatives which President Rodrigo Roa Duterte has made clear in his recent public address that this local governments would be unhampered as to their respective vaccination plans.
Senator Pia Cayetano has already raised a howl as she asked pertinent information such as the magnitude of the allocation that the national government can align to the COVID 19 vaccination program taking into account that the local government and private sectors will be embarking on their respective COVID 19 vaccination program.
A cursory study on the DOH order on unregistered drugs and devices specified: “A Compassionate Special Permit for Restricted Use of Unregistered Drug and Devices Product shall refer to a special permit singed by the BFAD Director granting as Specialized Institution (SI) and Specialty Society (SS) the privilege to avail of an unregistered drug and device product through a certain licensed establishment for certain kind/type of patients, specific volume and period.”
The CSP permit will also be approved once the requirement on Clinical Study Report for every patient will be submitted to the Bureau of Food and Drug Administration (BFAD).
“A written commitment on the part of all the authorized specialists to submit a Clinical Study Report for every patient given the product describing the quantity administered/use, therapeutic/desired effect and any adverse reaction, to the Institution or Specialty Society for BFAD, at the end of each year,” the administrative order said.
The same order required application to include the estimated volume needed and the licensed drug/device establishment through which the unregistered drug may be procured.
“It shall also identify the names and address of the specialists qualified and authorized to use the product,” according to the DOH.
The specified drug establishment shall secure clearance to import from BFAD and its applications shall be accompanied by a certificate that the product is currently registered in the country of origin.
The Philippine government is steadfast in its drive to give COVID 19 vaccination with priority implementation covering the frontline sector and the senior citizens.