BBM OKs pharma-zones for cheaper generics

To ensure the availability of affordable medicines, President Marcos is pushing for measures to encourage both local and foreign pharmaceutical firms to take part in drug manufacturing in the country.

During a sectoral meeting at Malacañang yesterday, Marcos agreed with the establishment of so-called pharma-zones, a onestop shop scheme that consolidates companies that are engaged in all aspects of drug manufacturing including research and development, clinical testing and trials as well as regulation.

According to the President, the pharma-zones would promote the development and manufacture of common generic drugs that will boost local supply and bring down prices to the “true generic level similar to India.”

“So, if we produce it locally, we are going to bring down, but we have to get the accreditation, we have to get the authority to be able to produce those drugs and to be able to distribute them as quickly as possible,” he added.

The President likened the pharma-zones to the ecozones monitored and evaluated by the Philippine Economic Zone Authority (PEZA), in which investors get certain tax and other financial incentives in order to bring down the cost of manufacturing.

Food and Drug Administration (FDA) director general Samuel Zacate said the pharma-zones would result in a higher influx of essential and generic drugs.

“As of now, there are three main (pharma-zones)... I think one is in Clark, but the two have yet to be determined by the PEZA,” he said at a Palace briefing.

Zacate, who was Marcos’ former lead physician, said the President also directed the FDA to streamline the country’s drug regulatory processes.

He said he is set to issue a memorandum, cutting down the application process for new generic drugs from 120 to just 45 days.

The FDA, he explained, has two types of regulations: a full review and the recognition and reliance.

FDA director Jesusa Joyce Cirunay said despite the shortening of the application period, the agency would not reduce its requirements.

He added that the FDA would also rely on the evaluation made by foreign regulatory agencies such as the United States FDA and Japan’s Pharmaceuticals and Medical Devices Agency as well as the common technical documents used by the Association of Southeast Asian Nations.

Zacate said the FDA would also extend the validity of the license to operate and the certificate of product registration from the initial three years to five years’ renewal to five years’ initial and 10 years’ renewal.