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.

Questions (OP ADMINISTRATIVE ORDER NO. 268)

The Order cites Sections 10-13 of Republic Act No. 9502 (the “Universally Accessible Cheaper and Quality Medicines Act of 2008”), which provide for compulsory licensing in cases of national emergency or extreme urgency and waive the requirement to obtain a compulsory license for importation of patented drugs on reasonable commercial terms in such situations.

It aims to address the Influenza A(H1N1) pandemic by taking government steps toward local manufacturing and low-cost importation of flu vaccines, while discouraging profiteering and ensuring supply for high-risk groups.

The Department of Health (DOH) is directed to take preliminary steps toward local manufacturers and low-cost importation of flu vaccines under compulsory licensing mandated by law during national health emergencies.

The DOH must begin contacting local and foreign manufacturers so they can study the vaccines for replication—i.e., preparation for local production.

Section 3 states that profiteering is to be prosecuted based on excessive mark-ups on vaccines bought from distributors and manufacturers at reasonable prices.

No. The recitals state that price controls should not be imposed for now because doing so might lead the rich to buy the supply and the Philippines may not receive vaccine allocation from global manufacturers.

The DOH, directly or through an authorized government agency, shall buy the bulk of Influenza A(H1N1) vaccine deliveries to ensure enough supply for high-risk groups.

High-risk groups are identified as the beneficiaries who should have sufficient vaccine supply.

It applies during national health emergencies and other related circumstances of extreme urgency.

It implies that in national emergencies or extreme urgency, importation on reasonable commercial terms may not require a separate compulsory licensing process, thereby facilitating faster access to patented medicines or vaccines.

The administrative order operationalizes and directs government agencies (primarily the DOH) to take actions consistent with the statutory authority and mechanisms in RA 9502—specifically, steps toward compulsory licensing and low-cost vaccine procurement/manufacturing during emergencies.

Section 5 states the Order is effective immediately.

It indicates a deterrent purpose: the government’s intention to encourage fair pricing and adequate supply by making it likely that local manufacturing and low-cost importation under compulsory licensing will compete with profiteering or supply curtailment.

It is a concrete example of how executive orders translate statutory public-health powers into specific administrative directives, including procurement, negotiations, and enforcement against profiteering.

While the Order specifically mentions prosecution based on excessive mark-ups, in practice it would likely rely on existing laws and enforcement bodies tasked with regulating unlawful pricing or unfair trade practices during emergencies.


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