Philippine Standard Time
Thursday, April 22, 2021 1:54 AM

Philippine Standard Time
Thursday, April 22, 2021 1:54 AM

regulatory issues (Healthcare)

Do you agree with the following issues? Do you think there are issues and concerns of the industry that we have not identified yet? Please share your opinions and/or personal experience in the comments section provided.


  1. Failure (of the agency) to transmit or explain the rationale of the regulation that is being proposed for implementation.
  2. Appetite for drug price regulation creates uncertainty (pharmaceuticals).
  3. Tendency for “populist” policy development instead of long term planning.
  4. No clear Implementing Rules and Regulations (IRR) for Persons with Disabilities (PWD) discounts. It is currently being shouldered by the drugstore companies and the pharmaceuticals. There is no government share in the form of tax refunds or the like.
  5. Overlapping regulations on veterinary medicines: Food and Drug Administration (FDA) vs. Bureau of Animal Industry (BAI).
  6. Overlapping regulations on dangerous drugs: FDA vs. Philippine Drug Enforcement Agency (PDEA). 
  7. Overlapping regulations on price control: Department of Health (DOH) vs. Department of Trade and Industry (DTI).
  8. Need for regulatory transparency: FDA proposed fees; FDA preparation of guidelines: Philippine National Formulary (PNF) inclusion process. Fees, guidelines and processes involved are not transparent.
  9. Confusion on the classification of birthing homes (as to the type of business: small, med or large and the applicable labor law requirements).
  10. Long processing time (3-4 years) to register a new chemical entity results to missed opportunity and patient access. This delay breaches the prescribed 10-month processing time indicated in ARTA.
  11. Overlapping requirements DOH, PhilHealth, LGU and Barangay Clearance. 
  12. Redundancy of requirements: DENR National vs. DENR-LGU.
  13. Burdensome and bureaucratic proces in the accreditation of medical representatives.
  14. Hybrid online and manual system of application/submission only results to more backlogs to regulatory agencies.
  15. Website of regulatory agencies are not updated and information is not available.
  16. Inadequate consultation with stakeholders on new/upcoming guidelines; lack of consultation of government agencies to private sector (FDA, DOH and Philhealth).
  17. Drug price reference index as basis – not realistic.
  18. Private-Public partnership is discouraged in building capability because of lack of trust by government.
  19. Weak intellectual property protection for innovative medicines.


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Last updated on 09/16/2019