Herrera

Solon seeks easier, cheaper access to life-saving drugs

May 18, 2021 Ryan Ponce Pacpaco 432 views

DEPUTY Speaker and Bagong Henerasyon (BH) party-list Rep. Bernadette Herrera has pressed the Department of Health (DoH) and the Food and Drug Authority (FDA) on her proposal to revert to the national guidelines on the registration of pharmaceutical products to improve availability and affordability of locally produced life-saving medicines.

Herrera said the Philippines can “pause” applying the stringent Association of South East Asian Nations (ASEAN) guidelines that have made it extremely difficult for local drug manufacturers to register their products in the country.

“I’d like to be updated on my proposal to pause the ASEAN guidelines because until now, I have not received a feedback on the position of FDA and DoH with regard to using the national guidelines,” Herrera said.

Herrera made the statement at Monday’s continuation of the hearing of the House committee on good government and public accountability on House Resolution (HR) No. 1711 that she and Speaker Lord Allan Velasco have filed.

The resolution called for an investigation into the guidelines and policies of the FDA and DoH for the registration, utilization, manufacture, distribution or sale of coronavirus disease-19 (COVID-19) treatment drugs that may hamper public health service delivery to the Filipino people.

Herrera said a pause on the implementation of ASEAN guidelines is in order considering that the “Philippines is not a signatory to it.”

“Let’s pause the ASEAN application kasi hindi naman tayo signatory pa rito. I-pause muna natin ito para mas madali para sa ating local pharma. Let us use our national guidelines,” she pointed out.

The party-list congresswoman insisted that using the national guidelines is something that would free up the process in FDA without sacrificing the efficacy and quality of the medicines that local drug companies will produce.

Herrera has been pushing for the strengthening of the local pharmaceutical manufacturing industry to improve the country’s access to quality, affordable, safe and effective medicines.

During the hearing, Herrera also followed up on the status of drug applications, including automatic renewal submissions, which the FDA had failed to act on.

It will be recalled that during the previous hearing, it was learned that the FDA sat on hundreds of applications for automatic renewal of certificate of product registration (CPR) filed by various pharmaceutical companies.

She said these applications should have been acted upon by the FDA within three days from its complete payment and submission of requirements, based on the provisions of the Anti-Red Tape Act, which she co-authored.

The Philippine Chamber of Pharmaceutical Industry Inc. and the Philippine Pharmaceutical Manufacturers Association had earlier disclosed that a total of 1,025 applications for CPR, 50 for license to operate, and 381 for automatic renewal have been pending with the FDA as of last March 29.

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