Drug firms say stable regulation key to encouraging investment

THE pharmaceutical industry said further initiatives to streamline permit and approval processes and make regulation predictable will be key to inducing the industry to expand or attract investment.

Diana M. Edralin, Pharmaceutical and Healthcare Association of the Philippines (PHAP) said the industry is looking to the government to further improve the investment climate.

“One of the requests is some predictability in terms of the regulatory approval process. How do you (issue) licenses here? The tax incentivizes are only one aspect. Can I set up a site like in two weeks? Will I get my permit in two weeks’ time? The regulatory process is also critical,” Ms. Edralin said in a chance encounter with BusinessWorld.

Ms. Edralin said upgrades to the workforce are also needed ahead of any expansion or new investment.  

“When you talk about ease of doing business, it has to be expansive, going beyond the taxes. We need to prepare what the capabilities are needed so that when they invest in us, it is actually something that we can sustain,” Ms. Edralin said.

While tax incentives are “super helpful… how do we ensure that (when investors manufacture here at scale) that we have the manpower and technical expertise here?” she added.

According to Ms. Edralin, the Philippines has improved the process of drug approvals with the reliance pathway used by the Food and Drug Administration (FDA), which takes into account drug approvals by other countries.

“The average (time) used to be two to three years; that’s long. But now, the FDA has made very significant progress. The FDA learned a lot during the pandemic with the approval of the vaccines. We managed to get a drug approval in 48 days with the reliance pathway,” Ms. Edralin said.

Ms. Edralin said that the group is not expecting logistics issues to disrupt the medicine supply this year.

“I don’t think we are anticipating any for this year. But as a country, we need to be prepared in terms of what did we learn from the pandemic,” Ms. Edralin said.

Ms. Edralin said PHAP members have been monitoring the Russia-Ukraine war for its potential to affect the supply of pharmaceuticals.

“All of our companies have a very strong global supply chain team… With these global organizations, we have the ability to anticipate and we’re doing our best,” Ms. Edralin said.

“Should (supply issues) happen, we will inform ahead of time but right now that has not happened because we heavily invest in ensuring continuity of supply of life-saving medications,” she added. — Revin Mikhael D. Ochave