QUEZON CITY -- The Anti-Red Tape Authority (ARTA), Department of Health (DOH), Food and Drug Administration (FDA), and Philippine Economic Zone Authority (PEZA) are collaborating to improve the efficiency of the pharmaceutical industry in the Philippines.
The initiative aligns with President Ferdinand "Bongbong" R. Marcos' focus on bureaucratic reform and in accordance with Republic Act 11032, or the “Ease of Doing Business Law”.
In his opening remarks, ARTA Deputy Director General for Operations Undersecretary Gerald G. Divinagracia said as part of its mandate, ARTA has been in the forefront of implementing RA 11032, or the “Ease of Doing Business Law”.
Divinagracia added that none of these accomplishments would not be possible without the Divine intervention.
“Together, let us embrace this opportunity to ‘Bagong Pilipinas’,” he said.
In his keynote message on initiatives on medical drug and device manufacturers on Monday (July 1) at Novotel, Special Assistant to the President for Investment and Economic Affairs (OSAPIEA) Secretary Frederick D. Go, represented by Undersecretary Jose Edwiniel C. Guilas, who spoke in behalf of Secretary Go.
Go said that he is pleased to witness the gathering of the government agencies, private sector and the stakeholders in the pharmaceutical industry.
He added that the OSAPIEA is supporting the “Ease of Doing Business Law”.
Go noted that there are many families who have fallen into debt because of expensive medicines.
“We will make medicines and medical devices more affordable to our countrymen,” Go said.
He cited the bureaucratic processes that everybody has experienced.
“An administrative order is now being drafted by Health Secretary Ted Herbosa, and hopefully, will be finished before the SONA (State-of-the-Nation Address),” Go said.
President Marcos is set to deliver his Third SONA before the Joint Session of the 19th Congress on July 22, 2024.
The OSAPIEA, ARTA, DOH, FDA, PEZA and private sector representatives made their respective pledge of commitment.
Secretary Ernesto V. Perez, ARTA Director General, on ARTA's overview on collaborative initiatives with the health sector, was excited to share ARTA’s programs and initiatives in the health sector.
“ARTA is one with you in coming up with a one-stop shop and a digital process gathering all the regulatory offices, particularly, the FDA, the DOH, with the support of the private sector,” Perez said.
“All the parties here are well represented, both the private and public sector,” he added.
Perez expressed his gratitude to the government agencies, stakeholders and the private sector in participating in the gathering.
“President Marcos envisions a red carpet, especially for the entrepreneurs. This is the essence of the ‘Ease of Doing Business’,” he said.
Perez cited the PEZA and other regulatory offices to oversee the health sector so as to unburden both the public and private sector.
ARTA has been recommending and leading policies and reforms, facilitating dialogues and collaboration among public and private sector, and reforms and innovations for streamlined processes for a one-stop shop.
Perez stressed that the FDA is finalizing its proposed amendments to Administrative Order No. 67 series of 1989 and draft Administrative Order on fees and charges.
He noted that the FDA Administrative Order 2016-003 and LTO integration with the Philippine Business Hub, formerly known as the Central Business Portal.
In 2024, Perez said, ARTA held several clarificatory meetings with the FDA.
He added that the ARTA has been recommending and leading policy and process reforms for inter-agency process such as whole-of-government (WOG) reengineering and process streamlining workshops.
The workshops involve analyzing current processes and workflows within and between organizations; then, working out how to get rid of any of the gaps and bottlenecks in the bureaucratic process to get it running smoothly.
The ARTA has set the workshop schedule for FDA and its centers on August 22, 27 and 29, 2024.
On the upcoming initiatives, Perez cited the adoption of 2021 Joint Memorandum Circular establishing a Green Lane for Covid-19 Vaccine Manufacturing Facilities for Green Lanes for Tatak Pinoy Projects and Exports.
He added the proposed Executive Order on the “Streamlining and Harmonization of the Provision of Medical and Financial Assistance in Government Hospitals”.
Perez also cited the proposed Joint Memorandum Circular assigning Competent Authority and delineating the Functions of FDA and BFAR on the Export of Fisheries/Aquatic Products to address the recurring issues on export of Fisheries and Aquatic Products, the ARTA, FDA and BFAR is finalizing a JMC.
On the implementation of pharmaceutical economic zones, Perez said, “ARTA supports the implementation of Pharmaceutical EcoZones to streamline the regulatory frameworks and attract investors in the sector.”
On legal services and public assistance, Perez said, of the 20,536 total number of complaints and concerns as of May 17, 2024, 20,218 cases were resolved.
“Let us work hand-in-hand to write a new chapter in the Philippines’ economic story characterized by efficiency, transparency, and shared prosperity,” he said.
“Our ultimate objective is for a reasonable and affordable medical drugs,” he added.
A pledge of commitment was signed by Health Secretary Teodoro J. Herbosa, represented by Rowena C. Lora, Director IV of the Internal Audit Service Lead of CART Secretariat of DOH, Dr. Samuel A. Zacate, FDA Director General, Department Manager Ludwig O. Daza, of PEZA-Ecozone Development Department, Liza S. Pajarillo, President and Regulatory Affairs Associate Director of the Philippine Association of Medical Device Regulatory Affairs Professionals (PAMDRAP)/Alcon Laboratories (Phils.), Inc., and Higinio P. Porte, Jr., President of the Philippine Pharmaceutical Manufacturers Association (PPMA).
Dr. Samuel A. Zacate, FDA Director General on FDA's current and future initiatives on the medical and device manufacturers, noted that in 2020 or 2021 they had problems on finding simple medicines on Covid-19 for the then citizen Ferdinand “Bongbong” R. Marcos, Jr.
“You must trust your people. FDA people are good people. Be a part of the technical innovation,” Dr. Zacate said.
Dr. Zacate is the personal doctor of President Marcos.
He told President Marcos that he could not talk to everyone such as the DOH, DBM and the ARTA.
Dr. Zacate studied the short-term and long-term solutions to the “backlog” of problems at the FDA.
He worked out for the structural administrative orders such as the extension of the unified license to operate (LTO), which was transferred to the DOH on May 12, 2024, except the SMES (Small and Medium Enterprises), among others.
The Administrative Order No. 67 will be transferred by the first week of July 2024.
On the five-point agenda, Dr. Zacate cited the harmonization, digitalization, modernization, organization and education.
“A new house for the FDA costing PHP1.9 billion will be raised,” he said.
“We are facilitating the process, without compromising the safety and efficacy of drugs. We at the FDA is more on regulation,” he added.
