THE COUNCIL that will provide technical advice on the price regulation of certain medicines, which took effect June 2, is expected to get to work soon following Sunday’s issuance of guidelines by the Health department.

Under Administrative Order No. 2020-0039 dated Aug. 20 and published Aug. 30, the Department of Health (DoH) outlined the rules for implementing the maximum prices for both retail and wholesale of drugs listed in a presidential order.

A total of 133 drug formulas are covered by Executive Order No. 104, titled Improving the access to healthcare through the regulation of prices in the retail of drugs and medicines, which was signed by President Rodrigo R. Duterte on Feb. 17 and came into effect June 2.

Under the DoH guidelines, the Drug Advisory Council will be created to provide technical assistance and guidance to the government in implementing measures for affordable  drugs and medicines.

It will be composed of experts on public health, epidemiology, pharmaceutical, policy, law, clinical, and economy.

The group is tasked to draft procedures for the selection of medicines that will be placed under regulation, conduct drug price evaluations, and recommend the maximum prices.

It is also mandated to consult with health professional organizations, patient and consumer groups, as well as civil society organizations, among others.

A separate expert panel will also be formed to provide technical guidance to the council.

The Pharmaceutical and Healthcare Association of the Philippines (PHAP) appealed to the government in late May to recall the price control policy, citing a potential P28 billion in foregone public revenues with a P57 billion decrease in sales.

The DoH is mandated to conduct a regulatory impact assessment, through a third-party research firm, after a year of the policy’s implementation.

“The said assessment considers whether or not the MRP (maximum retail price) has led to (1) improved patient compliance  adherence to medication, (2) reduce out-of-pocket health expenses; and (3) patient satisfaction,” the DoH guidelines say.

The existing list of medicines, on the other hand, will be reviewed after three to six months of implementation.

With the policy in effect, the DoH Pharmaceutical Division together with the Food and Drug Administration (FDA) and the Department of Trade and Industry (DTI) are authorized to monitor and penalize violators.

The MRP order applies to “all those who manufacture, trade, distribute, import, export, and wholesale or retail FDA-registered drugs and medicines, including medical and allied health practitioners, and to all persons, juridical or natural, involved in the provision of healthcare,” according to the guidelines.

Penalties range from P50,000 to P500,000 for the first violation, depending on the gravity and extent, and up to P5 million on the 5th and succeeding offenses. — Vann Marlo M. Villegas