FDA to seek exemption from EoDB law

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THE Food and Drug Administration (FDA) said it will appeal the exclusion of health safety-related processes from the Ease of Doing Business (EoDB) law to avoid the recurrence of the Dengvaxia crisis.

“We will appeal. What we can follow with the Ease of Doing business is the general certificates (of drugs with no) safety issues. We don’t want another Dengvaxia crisis,” FDA Director-General Nela Charade G. Puno said in a phone interview on Wednesday.

Signed into law in May 2018, Republic Act No. 11032 or the EoDB law requires all government agencies to achieve uniform turnaround times for simple, complex, and highly-technical transactions of three, seven and 20 days, with the classification of the processes to be decided by each agency.

Officials are subject to penalties ranging from suspension and fines to dismissal, perpetual disqualification from the service, and forfeiture of retirement benefits depending on the number of times the law is violated.

Agencies with qausi-judicial functions have also raised concerns on implementing the law which initially targeted the release of certain business permits or certificates released in frontline transactions.

However, Deputy Director General (DDG) Ernesto V. Perez of the Anti-Red Tape Authority (ARTA), the agency which will oversee the implementation of the EoDB law, said he was willing to recommend an amendment to the law providing relief in case the rules are determined “to be causing undue burden.”

Pending the issuance of the law’s implementing rules and regulations, Ms. Puno noted that the FDA will still be able to shorten approval process of medicines to months from the current timeline of up to several years.

“In the first quarter we are planning a phased approach to implement the Ease of Doing Business law,” she said.

She added that part of the FDA’s efforts include coordinating with other countries and international health accrediting bodies in order to broaden cross-border engagement.

“FDA Philippines will work closely with other countries especially where we are importing (drugs) from to make sure we have access to drugs that are not available here to speed up the process, especially where the drugs have been approved,” she said, citing top source countries for drugs like the United States and India.

Separately, the Indian ambassador said the Philippine drug approval process is hampering the growth of Indian exports of pharmaceuticals.

Ambassador Jaideep Mazumdar said that Indian drug exports have been growing 10% annually, but the potential for more growth remains untapped because of regulatory processes could have been eliminated.

“You can easily talk about 10-30% growth every year. That’s just the tip of the iceberg. We need to facilitate that. With the current approval process, that is not going to happen,” Mr. Mazumdar told BusinessWorld in an interview in Makati City.

Mr. Mazumdar said securing FDA approval for a drug can take up to three and a half years, much worse than other jurisdictions where companies can secure approval in less than a year.

He cited the FDA’s current practice of duplicating the review of drugs that have been approved by international bodies.

“The Philippines doesn’t have to do anything that has been done (by) some internationally accredited bodies. The Philippines does not have to duplicate the work that had already been done,” Mr. Mazumdar said.

The Indian pharmaceutical industry is expected to grow by 15% per annum between 2015 and 2020, outperforming the global pharmaceutical industry, according to Johnny Chotrani, chairman of the Philippines-India Business Council.

“The market is expected to grow to $55 billion by 2020, thereby emerging as the sixth-largest pharmaceutical market globally by absolute size,” Mr. Chotrani added. — Janina C. Lim