OSAPIEA calls bureaucracy in healthcare approval process deterrent to investment 

BUREAUCRACY in the approvals process for healthcare products is hindering the entry of investments, according to the Office of the Special Assistant to the President for Investment and Economic Affairs (OSAPIEA).

In a keynote address on Monday delivered by OSAPIEA Undersecretary Jose Edwiniel C. Guilas on behalf of Secretary Frederick D. Go, OSAPIEA identified “pain points” most cited by the industry.

“Pain point number one: the bureaucratic nature of some of the existing processes of the regulatory agencies, as we all have experienced, is very structured with its complex rules and systems causing unnecessary delays,” Mr. Go was quoted as saying.

To address this, Mr. Go said that there is a need for a streamlined bureaucracy, which will require a review of the processes and requirements set by various agencies.

In particular, he said that companies, despite being compliant in countries with higher certified standards, still have to comply with Philippine standards.

“Industry stakeholders who have touched base with my office have often raised concerns about importing and most especially exporting drugs and food products,” he said.

This issue, Mr. Go said, can be addressed through streamlining the approval of export registration certificates for pharmaceutical products by exploring schemes of recognition and reliance.

“This way, applications that have already satisfactorily complied with the requirements of ASEAN and other markets, such as those already approved by the US Food and Drug Administration, will no longer have to undergo local reassessment,” he added.

A further pain point for investors is the difficulty faced by big international pharmaceutical companies in operating in the Philippines.

To address this, he said that OSAPIEA, together with the Philippine Economic Zone Authority and the Food and Drug Administration, has formed a technical working group to make it easier for pharmaceutical companies to set up operations in the economic zones.

“By having their companies here, we can create an ecosystem where research and development clinical trials in manufacturing are conducted in the country,” he said.

“Apart from technology transfer, there would be an uptick in production, which would lower the cost of medicine and medical devices due to increased supply,” he added. — Justine Irish D. Tabile