1. 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

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

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

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

5. 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

6. 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

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

8. 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:

9. 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

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

11. Relief of DOH hospitals from licensing process DOH Hospitals – DOH Hospitals – to be licensed without undergoing inspection, to be licensed without undergoing inspection, upon execution of an undertaking that they have complied with licensing requirements upon execution of an undertaking that they have complied with licensing requirements Any change in status of license Any change in status of license usual licensing process usual licensing process Monitoring – by CHD and regulatory bureaus Monitoring – by CHD and regulatory bureaus Sanctions - e.g. decrease in subsidy Sanctions - e.g. decrease in subsidy BHFS, BFAD, BHDT - oversight 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 Expanded list of drugs for Parallel Drug Importation Increased number of Botika ng Barangay from a ratio of 1:3 to 1:2 Increased number of Botika ng Barangay from a ratio of 1:3 to 1:2 Advocacy for generic prescribing/dispensing Advocacy for generic prescribing/dispensing Revision of Philippine National Drug Formulary Revision of Philippine National Drug Formulary Essential Drug Price Monitoring System (EDPMS) Essential Drug Price Monitoring System (EDPMS) Identification of indicators for access to essential drugs Identification of indicators for access to essential drugs

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

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

18. Other F1 Accomplishments Fees Restructuring Fees Restructuring BHFS – Administrative Order 2007-0001 BHFS – Administrative Order 2007-0001 BFAD, BHDT – drafted Administrative Order BFAD, BHDT – drafted Administrative Order Income Retention Income Retention BFAD - provision for income retention in the 2007 GAA BFAD - provision for income retention in the 2007 GAA BHFS, BFAD, BHDT - provision for income retention in the Senate Bill 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 Unified Seal of Approval System on Health Products, Devices, Services and Facilities Existing quality seal systems under BFAD and BHDT Existing quality seal systems under BFAD and BHDT Goal - A single quality seal for all products devices, facilities and services Goal - A single quality seal for all products devices, facilities and services

21. Thank you!