Title
Order for Flu Vaccine Compulsory Licensing
Law
Op Administrative Order No. 268
Decision Date
Jul 20, 2009
To combat profiteering and ensure sufficient vaccine supply during the Influenza A(H1N1) pandemic, Administrative Order No. 268 promotes low-cost competition, explores local vaccine production, prosecutes excessive mark-ups, and mandates the Department of Health to purchase the majority of vaccine deliveries for high-risk groups.

Legal basis and policy intent

  • The order is grounded on the authority of the President under law.
  • Sections 10–13 of Republic Act No. 9502 establish compulsory-licensing-related authority for situations of national emergency or other circumstances of extreme urgency.
  • The order’s policy intent is to show government action against the Influenza A(H1N1) pandemic.
  • The order signals vaccine makers and dealers that they face low-cost competition if they engage in profiteering and supply curtailment.
  • The order directs that price controls should not be imposed for the moment, to avoid adverse effects on supply allocation.

Scope: flu vaccines and emergency posture

  • The order covers Influenza A(H1N1) vaccines.
  • The order is implemented through actions tied to national health emergencies and emergency-like circumstances.
  • The order targets both local manufacturers and foreign manufacturers for vaccine replication-related activity.

Department of Health responsibilities

  • The Department of Health must take preliminary steps toward local manufacturers and low-cost importation of flu vaccines under compulsory licensing mandated by law during national health emergencies.
  • The Department of Health must begin contacting local and foreign manufacturers for possible production so firms can begin studying the vaccines for replication.
  • The Department of Health must ensure that profiteering is prosecuted based on excessive mark-ups on vaccines bought from distributors and manufacturers at reasonable prices.

Procurement and allocation for high-risk groups

  • The Department of Health, directly or through any authorized government agency, must buy the bulk of Influenza A(H1N1) vaccine deliveries.
  • Bulk purchasing must be carried out to ensure enough supply for high-risk groups.

Operational compliance linkage to profiteering

  • Profiteering is to be prosecuted using excessive mark-ups as the basis, measured against reasonable prices.
  • Enforcement actions apply to mark-ups on vaccines purchased from distributors and manufacturers.

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