Ladies and gentlemen, magandang hapon po sa inyong lahat!
The Department of Trade and Industry (DTI) is privileged to be part of this momentous Joint Memorandum Circular (JMC) signing to streamline and expedite the processing of permits and clearances for the establishment of local vaccine manufacturing facilities. This event is highly important as it also marks the completion of the task instructed by President Rodrigo Roa Duterte through the Presidential Directive (PD) No. 2021-029 last month.
The accomplishment of this JMC is proof that when many act purposely as one, then the objective is more efficiently achieved. Through our collaboration with the Anti-Red Tape Authority (ARTA) and our other partner agencies, it took us exactly just one month to complete the JMC and comply with the directive of the President.
The COVID-19 pandemic has exposed our vulnerabilities in terms of pharmaceutical needs, including the non-availability of any vaccine manufacturing capability. Thus, we actively sought investment interests in local vaccine manufacturing, so we can have our own manufacturing facility in the country.
With sheer dedication and resolve, the DTI’s Board of Investments is currently working on at least six investment leads that expressed their interest to manufacture vaccines locally. Details about these companies cannot be disclosed yet, as they are still in talks with potential foreign manufacturers and technology providers from India, Korea, China, and possibly from the US and Australia. If conditions permit, vaccine manufacturing operations may start as early as 2nd or 3rd quarter of 2022, even as early as 4th quarter of this year. Moreover, two of the six local company leads have signified that they can deliver at least 40M doses of imported COVID-19 vaccines in finished form by end of 2021 or early 2022, subject to Emergency Use Authorization (EUA) application and finalization of agreements.
This JMC is therefore in anticipation of the early fruition of these investment plans. We need to have our systems ready to make it easy for these investments to come in and be smoothly undertaken. This will apply to the enterprises that intend to establish and operate an import, fill and finish COVID-19 vaccine manufacturing facility in the country that will produce a shared product as defined in this JMC.
Furthermore, the JMC provides for the: (1) expediting of the processing of application for License to Operate and the EUA of the vaccine manufacturers; and the (2) facilitation of the registration of the vaccine manufacturers for applicable incentives under Republic Act (RA) 11534 or the “Corporate Recovery and Tax Incentives for Enterprises” (or CREATE) Act, and assistance to the manufacturers in the importation processing and requirements for bulk imports of vaccines.
Under the JMC’s Green Lane system, the processing of permits and clearances of enterprises can be expedited up to 21 days. Advanced information and documents can be submitted to the Food and Drug Administration (FDA) prior to the official assessment.
To conclude, let us again recognize and thank all the government agencies for their hard work in completing the JMC. This is a first and necessary step in our journey towards having our very own vaccine manufacturing facility. Even though the first investments may be just an import, fill and finish business model, we will ensure that we will eventually have formulation, fill and finish operations next.
In our whole-of-government approach, we can push for this whole-of-society initiative that prioritizes the health and safety of all Filipinos amid the ongoing pandemic. Hence, let us continue to build back better towards a healthier and more prosperous post-COVID future, where we can give our people a safer and more comfortable life.
Maraming salamat po, at mabuhay tayong lahat! ♦
Date of Release: 21 May 2021