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Updates on F1 Reforms in Health Regulation

Updates on F1 Reforms in Health Regulation. ALEXANDER A. PADILLA Undersecretary Policy and Standards Development Team for Regulation 4 th National Staff Meeting, January 24-26, 2007. Outline. 3 rd NSM Resolution on Health Regulation Other F1 Accomplishments

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Updates on F1 Reforms in Health Regulation

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  1. Updates on F1 Reforms in Health Regulation ALEXANDER A. PADILLA Undersecretary Policy and Standards Development Team for Regulation 4th National Staff Meeting, January 24-26, 2007

  2. Outline • 3rd NSM Resolution on Health Regulation • Other F1 Accomplishments • F1 Activities for implementation

  3. 3rd NSM Resolution on Health Regulation • Harmonization of hospital regulation • Relief of DOH hospitals from licensing process • Adherence to internationally accepted standards • Half-priced Medicine Program

  4. Harmonization of hospital regulation • One-Stop Licensing for Hospitals • Unified licensing • one application, single basic hospital license fee, unified inspection and single license for hospital and its ancillary services • Decentralized to the regional (CHD) level • initial license and renewal of license • all categories of hospital • Permit to Construct application - still with BHFS

  5. Licensing Process Flow For Initial License: Certificate of Need - Center for Health Development Permit to Construct - Bu. of Health Fac. & Services License - Center for Health Development Oversight Function - BHFS, BHDT, BFAD

  6. Licensing Process Flow For Renewal of License: Automatic Issuance - Center for Health Development Monitoring - Center for Health Development - BHFS, BHDT, BFAD Oversight Function - BHFS, BHDT, BFAD

  7. Harmonization of hospital regulation • One-Stop Licensing for Hospitals • To be set up in those regions with the capability to implement • dependent on DOH rationalization • capability-building of CHDs needed

  8. Licensing Process Flow Where the CHD is not yet ready for decentralized function: For Initial License: Certificate of Need - Center for Health Development Permit to Construct - Bu. of Health Fac. & Services License - PSDT for Regulation

  9. Licensing Process Flow Where the CHD is not yet ready for decentralized function: For Renewal of License: Automatic Issuance - PSDT for Regulation Monitoring - BHFS, BHDT, BFAD - Center for Health Development

  10. Harmonization of hospital regulation • One-Stop Licensing for Hospitals • Draft administrative issuance for revision by TWG headed by BHFS Director • Effectivity - upon signing of the administrative issuance

  11. Relief of DOH hospitals from licensing process • DOH Hospitals – • to be licensed without undergoing inspection, • upon execution of an undertaking that they have complied with licensing requirements • Any change in status of license • usual licensing process • Monitoring – by CHD and regulatory bureaus • Sanctions - e.g. decrease in subsidy • BHFS, BFAD, BHDT - oversight

  12. Adherence to international standards - BFAD • Draft AO on Adoption of ASEAN Harmonized Common Technical Documents and Common Technical Requirements on the Pharmaceutical Product Registration for Human Use

  13. Adherence to international standards - 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

  14. Adherence to international standards - 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

  15. Half-priced Medicine Program • Expanded list of drugs for Parallel Drug Importation • Increased number of Botika ng Barangay from a ratio of 1:3 to 1:2 • Advocacy for generic prescribing/dispensing • Revision of Philippine National Drug Formulary • Essential Drug Price Monitoring System (EDPMS) • Identification of indicators for access to essential drugs

  16. Other F1 Accomplishments • Upgrading of regulatory capacities • Automation of systems and processes • BHFS – Integrated Drug Test Operation and Management Information System (IDTOMIS) • BHDT – Regulatory Information System (RSYS) • BFAD – BFAD Integrated Information System (BIIS)

  17. Other F1 Accomplishments • Upgrading of regulatory capacities • Strengthening enforcement mechanisms and regulatory oversight functions • Draft legislation – strengthen regulatory functions of BHFS, BHDT and BFAD

  18. Other F1 Accomplishments • Fees Restructuring • BHFS – Administrative Order 2007-0001 • BFAD, BHDT – drafted Administrative Order • Income Retention • BFAD - provision for income retention in the 2007 GAA • BHFS, BFAD, BHDT - provision for income retention in the Senate Bill

  19. While we may have accomplished this much..

  20. Further work is needed on… • Unified Seal of Approval System on Health Products, Devices, Services and Facilities • Existing quality seal systems under BFAD and BHDT • Goal - A single quality seal for all products devices, facilities and services

  21. Thank you!

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