Updates on F1 Reforms Updates on F1 Reforms in Health Regulationin Health Regulation
ALEXANDER A. PADILLAALEXANDER A. PADILLAUndersecretaryUndersecretary
Policy and Standards Policy and Standards Development Team for Development Team for
RegulationRegulation
44thth National Staff Meeting, January 24-26, National Staff Meeting, January 24-26, 20072007
OutlineOutline
33rdrd NSM Resolution on Health NSM Resolution on Health RegulationRegulation
Other F1 AccomplishmentsOther F1 Accomplishments
F1 Activities for implementationF1 Activities for implementation
33rdrd NSM Resolution on Health NSM Resolution on Health RegulationRegulation
Harmonization of hospital regulation Harmonization of hospital regulation Relief of DOH hospitals from licensing Relief of DOH hospitals from licensing
process process Adherence to internationally accepted Adherence to internationally accepted
standardsstandards Half-priced Medicine ProgramHalf-priced Medicine Program
Harmonization of hospital regulationHarmonization of hospital regulation One-Stop Licensing for HospitalsOne-Stop Licensing for Hospitals
Unified licensing Unified licensing one application, single basic hospital one application, single basic hospital
license fee, unified inspection and single license fee, unified inspection and single license for hospital and its ancillary serviceslicense for hospital and its ancillary services
Decentralized to the regional (CHD) levelDecentralized to the regional (CHD) level initial license and renewal of license initial license and renewal of license all categories of hospitalall categories of hospital Permit to Construct application - still with Permit to Construct application - still with
BHFSBHFS
Licensing Process Flow Licensing Process Flow
Certificate of Need
Permit to Construct
License
- Center for Health Development
For Initial License:
- Center for Health Development
- Bu. of Health Fac. & Services
Oversight Function - BHFS, BHDT, BFAD
Licensing Process Flow Licensing Process Flow
Automatic Issuance
Monitoring
- Center for Health Development
For Renewal of License:
- Center for Health Development - BHFS, BHDT, BFAD
Oversight Function - BHFS, BHDT, BFAD
Harmonization of hospital regulationHarmonization of hospital regulation
One-Stop Licensing for HospitalsOne-Stop Licensing for Hospitals
To be set up in those regions with the To be set up in those regions with the capability to implementcapability to implement
dependent on DOH rationalization dependent on DOH rationalization
capability-building of CHDs neededcapability-building of CHDs needed
Licensing Process Flow Licensing Process Flow
Certificate of Need
Permit to Construct
License
- Center for Health Development
For Initial License:
- PSDT for Regulation
- Bu. of Health Fac. & Services
Where the CHD is not yet ready for decentralized function:
Licensing Process Flow Licensing Process Flow
Automatic Issuance
Monitoring
For Renewal of License:
- Center for Health Development
- BHFS, BHDT, BFAD
Where the CHD is not yet ready for decentralized function:
- PSDT for Regulation
Harmonization of hospital regulationHarmonization of hospital regulation
One-Stop Licensing for HospitalsOne-Stop Licensing for Hospitals
Draft administrative issuance for revision by Draft administrative issuance for revision by TWG headed by BHFS DirectorTWG headed by BHFS Director
Effectivity - upon signing of the Effectivity - upon signing of the administrative issuanceadministrative issuance
Relief of DOH hospitals from licensing processRelief of DOH hospitals from licensing process
DOH Hospitals – DOH Hospitals – to be licensed without undergoing to be licensed without undergoing
inspection, inspection, upon execution of an undertaking that they upon execution of an undertaking that they
have complied with licensing requirementshave complied with licensing requirements Any change in status of license Any change in status of license
usual licensing processusual licensing process Monitoring – by CHD and regulatory Monitoring – by CHD and regulatory
bureausbureaus Sanctions - e.g. decrease in subsidySanctions - e.g. decrease in subsidy
BHFS, BFAD, BHDT - oversight BHFS, BFAD, BHDT - oversight
Adherence to international Adherence to international standards - BFADstandards - BFAD
Draft AO on Adoption of ASEAN Harmonized Common Technical Documents and Common Technical Requirements on the Pharmaceutical Product Registration for Human Use
Adherence to international Adherence to international standards - BHDTstandards - BHDT Draft guidelines for the regulation of
medical devices
being aligned with ASEAN and Asian standards
Existing standards on X-ray devices and facilities harmonized with IAEA International
Basic Safety Standards
Adherence to international Adherence to international standards - BHDTstandards - BHDT
Strengthening the BHDT mandate on medical device regulation
Department Order appointing BHDT as technical arm of BFAD on medical device regulation - for approval
BHDT Bill
Half-priced Medicine ProgramHalf-priced Medicine Program Expanded list of drugs for Parallel Drug Expanded list of drugs for Parallel Drug
ImportationImportation
Increased number of Botika ng Barangay Increased number of Botika ng Barangay from a ratio of 1:3 to 1:2from a ratio of 1:3 to 1:2
Advocacy for generic prescribing/dispensingAdvocacy for generic prescribing/dispensing
Revision of Philippine National Drug FormularyRevision of Philippine National Drug Formulary
Essential Drug Price Monitoring System (EDPMS) Essential Drug Price Monitoring System (EDPMS)
Identification of indicators for access to essential Identification of indicators for access to essential drugsdrugs
Other F1 AccomplishmentsOther F1 Accomplishments
Upgrading of regulatory capacities Upgrading of regulatory capacities
Automation of systems and processesAutomation of systems and processes
BHFSBHFS – Integrated Drug Test Operation – Integrated Drug Test Operation and Management Information System and Management Information System (IDTOMIS)(IDTOMIS)
BHDTBHDT – Regulatory Information System – Regulatory Information System (RSYS)(RSYS)
BFADBFAD – BFAD Integrated Information – BFAD Integrated Information System (BIIS)System (BIIS)
Other F1 AccomplishmentsOther F1 Accomplishments
Upgrading of regulatory capacities Upgrading of regulatory capacities
Strengthening enforcement mechanisms Strengthening enforcement mechanisms and regulatory oversight functionsand regulatory oversight functions
Draft legislation – strengthen regulatory Draft legislation – strengthen regulatory functions of BHFS, BHDT and BFADfunctions of BHFS, BHDT and BFAD
Other F1 AccomplishmentsOther F1 Accomplishments
Fees RestructuringFees Restructuring BHFS – Administrative Order 2007-0001 BHFS – Administrative Order 2007-0001 BFAD, BHDT – drafted Administrative OrderBFAD, BHDT – drafted Administrative Order
Income Retention Income Retention BFAD - provision for income retention in BFAD - provision for income retention in
the 2007 GAA the 2007 GAA
BHFS, BFAD, BHDT - provision for income BHFS, BFAD, BHDT - provision for income retention in the Senate Bill retention in the Senate Bill
Further work is needed on…Further work is needed on…
Unified Seal of Approval System on Unified Seal of Approval System on Health Products, Devices, Services Health Products, Devices, Services and Facilitiesand Facilities
Existing quality seal systems under Existing quality seal systems under BFAD and BHDTBFAD and BHDT
Goal - A single quality seal for all Goal - A single quality seal for all products devices, facilities and servicesproducts devices, facilities and services