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PEZA hopes to sign MoA next month to facilitate pharma ecozones dev’t

By Justine Irish D. Tabile, Reporter

THE Philippine Economic Zone Authority (PEZA) said that it is hoping to finalize its updated partnership agreement with the Food and Drug Administration (FDA) next month which will set the rules for the development of economic zones specializing in pharmaceutical-industry locators.

“We are in the process of finalizing the guidelines with our FDA counterparts and will soon be ready to sign this landmark document between our agencies,” PEZA Director General Tereso O. Panga told BusinessWorld.

According to Mr. Panga, the goal of revisiting PEZA’s decade-old memorandum of agreement (MoA) with the FDA is to ultimately improve access to healthcare for all.

He said that a revision incorporates changes to the policy landscape like the Ease of Doing Business Law, the Universal Healthcare Law, and President Ferdinand R. Marcos, Jr.’s Executive Order No. 18, which established green lanes for strategic investments.

“Given the introduction of new measures and priorities through the past years, it becomes highly necessary to update the PEZA-FDA MoA, not just to integrate changes in existing legal bases but also to reflect the duties and responsibilities of both agencies in carrying out this administration’s priorities,” he said.

The new MoA is expected to embody the national commitments of PEZA and the FDA under the Philippine Development Plan, particularly on the implementation of the ecozone transformation roadmap and strengthening health systems and health care access and delivery.

“With this revised MoA, we expect the FDA to commit to the prompt facilitation of our ecozone locators’ applications for FDA permits, licenses, and certifications,” Mr. Panga said.

He said that streamlined applications will help attract pharma-related investments such as the manufacturing of drugs, active pharmaceutical ingredients (APIs), and medical devices and equipment, including the conduct of clinical trials and research and development activity.

Meanwhile, PEZA is also working on the guidelines that will govern the establishment and registration of pharma zones.

“This will also provide the qualifications (including minimum infrastructure requirements) and processes for potential pharmazone developers and operators,” Mr. Panga said.

“Likewise, it will outline registrable activities that locator companies may undertake within a pharma zone in order for them to avail of the fiscal and non-fiscal incentives under the PEZA framework,” he added.

PEZA plans further meetings with the Philippine Chamber of Pharmaceutical Industries and the Philippine Pharmaceutical Manufacturers Association this month to consult them on the guidelines.

The investment promotion agency is also waiting on the comments of the FDA and other stakeholders.

“We are currently farming out the rough draft of the guidelines for relevant National Government agencies and private stakeholders, particularly pharmaceutical and medical device associations and manufacturing companies,” Mr. Panga said.

“The finalization of the guidelines will commence as soon as we consolidate and harmonize their comments and inputs on the existing version thereof,” he added.

Last week, Mr. Panga said that an ecozone in Victoria, Tarlac, has been approved by PEZA’s board and is now awaiting proclamation. The ecozone is due to become the country’s pioneer pharma zone.

Earlier this year, Mr. Marcos instructed his officials to establish pharma zones to lower the cost of medicine and medical devices.