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

While we may have While we may have accomplished this much..accomplished this much..

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

Thank you!Thank you!