PHILIPPINES: Updated Draft Guidelines for Availing Compassionate Special Permit for the Restricted Use of Unregistered or Unauthorized Drug Products including Vaccines and Medical Devices

PHILIPPINES: Updated Draft Guidelines for Availing Compassionate Special Permit for the Restricted Use of Unregistered or Unauthorized Drug Products including Vaccines and Medical Devices – March/April 2023

2023-03-27

A compassionate special permit (CSP) is a permit issued by the FDA that allows a qualified institution and hospital, or a qualified licensed physician, to procure an unregistered or unauthorized drug product, vaccine, or medical device for limited use through an FDA-licensed establishment.

In the past, several regulations were issued to tackle CSP conditions and requirements which includes the following:

1. Administrative Order No. 4 s. 1992- This is the first regulation issued in the country to provide access to products for patients which are terminally or seriously ill. The regulation only considers AIDS, cancer and life-threatening conditions as acceptable patient medical conditions.

2. FDA Memorandum Circular No. 2015-008- This regulations included medical devices, which are not yet registered or are in the process of registration in the Philippines by patients who need immediate medical attention. However, only one-time CSP can be issued for a specific device.

3. Administrative Order No. 2020-0028- This includes emerging and re-emerging infectious diseases considered as public health emergencies or public health threats as one of the conditions for the grant of a CSP and allow access to investigational products.

The new regulation provides a more detailed guidelines and widens the scope of products that can be applied for a CSP even further. Unregistered or unauthorized vaccines with no registered counterparts, drugs and products used to treat/manage rare diseases and diseases which may lead to permanent disability will be illegible for a CSP when the official regulation is released.

The following table summarizes the important points of these regulations and the similarities and differences with the proposed regulation.

Particulars/ Details	Administrative Order No. 4 s. 1992	FDA Memorandum Circular No. 2015-008	Administrative Order No. 2020-0028	Proposed Draft Regulation
Date	03 November, 1992	25 June, 2015	06 July, 2020	26 January, 2023
Regulation Title	Policy and Requirements for Availing of Compassionate Special Permit (CSP) for Restricted Use of Unregistered Drug and Device Product / Preparation	POLICY AND REQUIREMENTS FOR AVAILING OF COMPASSIONATE SPECIAL PERMIT FOR REGISTRABLE MEDICAL DEVICES	Amendment to Administrative Order No. 4 s. 1992 entitled “Policy Requirements for Availing Compassionate Special Permit (CSP) for Restricted Use of Unregistered Drug and Device Product Preparation”	Updated Guidelines for Availing Compassionate Special Permit for the Restricted Use of Unregistered or Unauthorized Drug Products including Vaccines and Medical Devices
Highlight	Access to products for patients which are terminally or seriously ill is allowed through the grant of a CSP	Medical devices which are not yet registered or are in the process of registration in the Philippines by patients who need immediate medical attention.	Include emerging and re-emerging infectious diseases considered as public health emergencies or public health threats as one of the conditions for the grant of a CSP, and allow access to investigational products	inclusion of unregistered or unauthorized vaccines with no registered counterparts include rare diseases and diseases which may lead to permanent disability
Acceptable conditions	There is no existing superior or alternative therapy that can likely or adequately control their conditions	1. The device shall be used for patients suffering from life-threatening conditions. 2. There is no other registered medical device of the same kind available in the Philippine market. 3. The device is brand new. 4. No other CSP was previously issued to the applied product.	No additional details	1. The medical device shall only be used for patients suffering from life-threatening conditions; 2. Product registration status: a. There is no other registered/authorized medical device of the same kind/technology available in the Philippine market; b. The device is brand new.
Patient medical conditions	1. Acquired Immune Deficiency Syndrome (AIDS) 2. Cancer 3. Life-threatening conditions	none specified	1. Acquired Immune Deﬁciency Syndrome, 2. Cancer, 3. Life- Threatening Conditions, and 4. Emerging or re-emerging infectious diseases considered as Public Health Emergencies or Public Health Threats.	a. Acquired Immune Deficiency Syndrome (AIDS) b. Cancer c. Life-Threatening Conditions d. Emerging or re-emerging infectious diseases declared as Public Health Emergencies (PHE) or Public Health Threats (PHT) e. Diseases which may lead to permanent medical impairment f. Rare diseases
Product registration status	Unregistered drugs and devices product / preparation	Unregistered drugs and devices product / preparation	Unregistered drugs and devices product/ preparation	a. A product which does not have a valid FDA registration or authorization. b. An investigational drug product (for the same disease it is sought to be used) for the following conditions: i. the requested investigational drug product must be the same product that has an ongoing Phase III clinical trial in the country of origin or in other countries; ii. is in a global or national registry; iii. there is an ongoing clinical trial in the Philippines but the enrollment of the patient in the clinical trial is not possible; or iv. the investigational drug product has entered the process of marketing authorization application in the country of origin or in the Philippines. c. For imported products, CSP may only be issued for a product that is currently registered/authorized in the national regulatory authority (NRA) of the country of origin or other NRAs.
Requirements	1. 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. 2. An estimate of the total requirement of the product for one year. 3. A waiver of BFAD responsibility from any damage or injury arising from the use of the unregistered drug or device to be signed by the responsible official of the Institution or Specialty Society.	1. Letter of intent which will include a brief description of the patient, attending physician, list of specialists who will perform the administration of the medical device, quantity of the medical device required to perform the treatment and the proposed schedule of the medical attention. 2. Attending physician’s profile. 3. License to Operate as Medical Device Importer / Distributor if the product is to be supplied by a company. 4. Letter of information regarding the importer if the medical device is to be imported by a private individual. 5. Certificate of Product Registration from the country of origin of the medical device to be used. If the medical device is locally manufactured, copy of the License to Operate as Medical Device Manufacturer. 6. Technical description of the medical device from the manufacturer; not downloaded from the company’s website. 7. Justification letter from the attending physician regarding the urgency of the use of the medical device. 8. Medical abstract of the patient. 9. A waiver of FDA responsibility from any damage or injury arising from the use of the unregistered medical device to be signed by the applicant company, relative of the patient and the attending physician. 10. A commitment letter from the applicant that a medical report shall be submitted after the operation or use of the medical device in the patient. Only one time CSP will be given for a specific device, no other CSP shall be issued again.	1. A written commitment on the part of all 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, at the end of each year. 2. An estimate of the total requirement of the product for one year. 3. A waiver of FDA responsibility from any damage or injury arising from the use of the unregistered drug or device to be signed by the responsible ofﬁcial of the Institution or Specialty Society. 4. In addition to the foregoing requirements, a CSP may also be issued to a Specialized Institution. Specialty Society or the Department of Health (DOH) even for an investigational product, provided that the rationale with supporting documents is submitted establishing the following conditions: a. The requested investigational product must have an ongoing Phase III clinical trial in the country of origin or other countries or there is an ongoing clinical trial in the Philippines but the enrollment of the patient in the trial is not possible; or: b. The investigational product has entered the process of marketing authorization application in the country of origin or in the Philippines.	Named Patient Use: a. Accomplished e-Application Form as prescribed by FDA regulations b. Curriculum vitae of the qualified physician applying for CSP c. Medical abstract of the patient d. Proof of payment e. Letter of information regarding the importer (for products to be imported by a private individual) f. Additional requirements: i. For drugs including vaccines - Medical prescription ii. For vaccines - A report of the risk-benefit assessment conducted by the applicant on 26 the risks and benefits surrounding the use of the vaccine on the target 27 recipient iii. For medical device - Technical description of the medical device from the manufacturer; not downloaded from the company’s website - Justification letter from the attending physician regarding the urgency of the use of the medical device
Requirements				Institutional Use: a. Accomplished e-Application Form as prescribed by FDA regulations. b. Rationale for volume/quantity requested c. Distribution agreement d. Proof of payment e. For imported products: i. For products to be imported by a private individual, a letter of information regarding the importer shall be submitted. ii. For products which has prior approval or registration from another NRA, a proof or certification of such shall be submitted. f. For investigational drug products, the rationale with supporting documents establishing the conditions stated above under V.C.4 g. Additional requirements: i. For drugs including vaccines - Medical prescription ii. For vaccines- The immunization scheme issued by the DOH with justification for the identified target recipients/groups under the scheme - A report of the risk-benefit assessment conducted by the applicant on the risks and benefits surrounding the use of the vaccine on the target recipients/groups iii. For medical devices - Technical description of the medical device from the manufacturer; not downloaded from the company’s website; and - Justification letter from the attending physician regarding the urgency of the use of the medical device.
Importation Requirements	The specified drug establishment shall secure clearance to import from BFAD and its applications shall be accompanied by: a. A certificate that the product is currently registered in the country of origin. b. A true copy of the CSP issued to the Specialized Institution (SI)/Specialty Society (SS).	No details	The specified drug establishment shall secure clearance to import from the FDA and its applications shall be accompanied by: a. A certificate that the product is currently registered in the country of origin b. A true copy of the CSP issued to the Specialized Institution (SI)/Specialty Society (SS).	(see previous rows)
Post-approval Commitments	A. The SI/SS shall submit the Clinical Study Reports through the drug/device establishment at the end of the year. B. The drug/device establishment shall be responsible for the submission of the Clinical Study Reports from the SI/SS and the report of the total volume of the drug/device imported for the year.	The company or attending physician shall submit the medical report after the procedure.	A. The SI/SS shall submit the Clinical Study Reports through the drug/device establishment at the end of the year. B. The drug/device establishment shall be responsible for the submission of the Clinical Study Reports from the SI/SS and the report of the total volume of the drug/device imported for the year.	1. The CSP holder shall submit the reports of the clinical study conducted, adverse drug reactions (ADR) (for drugs), adverse events following immunization (AEFI) (for vaccines), adverse events involving the medical device, and the manufacturing and reconciliation data through the drug /medical device establishment at the end of the treatment or the immunization monitoring, or upon the request for additional quantity whichever comes first. The report shall follow the format in Annex A for the Clinical Study and ADR/AEFI reports. Post-approval commitment report for medical devices shall follow the format in Annex B. 2. The drug/medical device establishment shall be responsible for the submission of the report of the total volume / quantity of the drug / vaccine / medical device imported along with the importation documents. 3. Submission of data and reports as part of the post-approval commitment shall be from the start of treatment, administration, or use and updated quarterly, and shall be through the official applications platform as implemented through the latest FDA issuance.
Review and Evaluation	No details	No details	No details	1. The review shall be based on the assessment for compliance of the submitted application documents to the requirements. The FDA shall consider the benefits and risks as they apply to the Philippine context based on the available data provided by the CSP applicant and may consider seeking opinions from clinical experts as necessary. 2. Compliant applications shall be approved for CSP. 3. For non-compliant applications, the disapproval shall be communicated to the applicant as well as the deficiencies and / or clarifications.
Grounds to deny the application	Failure on its part to submit these reports will be a ground to deny applications of CSP through or using its establishment and / or future applications for import clearances of the unregistered drug / device under a valid CSP.	The company or attending physician shall submit the medical report after the procedure. Failure to submit the medical report shall be a ground for denial of future applications of CSP by the same applicant.	Failure on its part to submit these reports will be a ground to deny applications of CSP through or using its establishment and / or future applications for import clearances of the unregistered drug / device under a valid CSP.	Failure on the part of the CSP Holder to submit the required reports will be grounds to deny the applications for CSP through or using its establishment and / or future applications for import clearances of the unregistered or unauthorized drug / vaccine / medical device under a valid CSP.