Transcript 03-day1 - CHD

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
Outline
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3rd NSM Resolution on Health Regulation
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Other F1 Accomplishments
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F1 Activities for implementation
3rd NSM Resolution on Health
Regulation
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Harmonization of hospital regulation
Relief of DOH hospitals from licensing process
Adherence to internationally accepted
standards
Half-priced Medicine Program
Harmonization of hospital regulation
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One-Stop Licensing for Hospitals
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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
Licensing Process Flow
For Initial License:
Certificate of Need
- Center for Health Development
Permit to Construct
- Bu. of Health Fac. & Services
License
Oversight Function
- Center for Health Development
- BHFS, BHDT, BFAD
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
Harmonization of hospital regulation

One-Stop Licensing for Hospitals
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To be set up in those regions with the capability to
implement
 dependent
on DOH rationalization
 capability-building
of CHDs needed
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
Licensing Process Flow
Where the CHD is not yet ready for decentralized
function:
For Renewal of License:
Automatic Issuance
Monitoring
- PSDT for Regulation
- BHFS, BHDT, BFAD
- Center for Health Development
Harmonization of hospital regulation

One-Stop Licensing for Hospitals

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Draft administrative issuance for revision by TWG
headed by BHFS Director
Effectivity - upon signing of the administrative
issuance
Relief of DOH hospitals from licensing process
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DOH Hospitals –
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Any change in status of license
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usual licensing process
Monitoring – by CHD and regulatory bureaus
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to be licensed without undergoing inspection,
upon execution of an undertaking that they have
complied with licensing requirements
Sanctions - e.g. decrease in subsidy
BHFS, BFAD, BHDT - oversight
Adherence to international
standards - BFAD
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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
standards - BHDT
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Draft guidelines for the regulation of
medical devices
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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
standards - BHDT
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Strengthening the BHDT mandate on
medical device regulation
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Department Order appointing BHDT as
technical arm of BFAD on medical device
regulation - for approval
BHDT Bill
Half-priced Medicine Program
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Expanded list of drugs for Parallel Drug Importation
Increased number of Botika ng Barangay
from a ratio of 1:3 to 1:2
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Advocacy for generic prescribing/dispensing
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Revision of Philippine National Drug Formulary
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Essential Drug Price Monitoring System (EDPMS)
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Identification of indicators for access to essential
drugs
Other F1 Accomplishments
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Upgrading of regulatory capacities
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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)
Other F1 Accomplishments
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Upgrading of regulatory capacities
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Strengthening enforcement mechanisms and
regulatory oversight functions
 Draft
legislation – strengthen regulatory
functions of BHFS, BHDT and BFAD
Other F1 Accomplishments
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Fees Restructuring
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BHFS – Administrative Order 2007-0001
BFAD, BHDT – drafted Administrative Order
Income Retention
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BFAD - provision for income retention in the
2007 GAA
BHFS, BFAD, BHDT - provision for income
retention in the Senate Bill
While we may have
accomplished this much..
Further work is needed on…
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Unified Seal of Approval System on Health
Products, Devices, Services and Facilities
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Existing quality seal systems under BFAD and
BHDT
Goal - A single quality seal for all products
devices, facilities and services
Thank you!