Wednesday, October 27, 2021
HomeCoverSalient Provisions of Executive Order No. 121, s.2020 (Emergency Use Authorization)

Salient Provisions of Executive Order No. 121, s.2020 (Emergency Use Authorization)

From a paper delivered during the Dec. 10 webinar, “Health and Economic Outlook for 2021—Sparking Hope: Will a Vaccine see an end to the Pandemic?” conducted by the Philippines Graphic-BusinessMirror, in partnership with the Pharmaceutical & Healthcare Association of the Philippines (PHAP).

An Emergency Use Authorization is a risk-based procedure for assessing unlicensed and this means under development vaccines and therapeutics. It is only issued during public health emergencies of international concern and its aim is to expedite availability of the drug or vaccine.

Before I start, let me just give you a background of what the mandate of FDA is. The mandate of the FDA is to come up with a system of regulating health products here in the Philippines and that is through Health Product Registration.

This means that any company, before engaging in any marketing activity, should secure a Certificate of Product Registration from the Food and Drug Administration. As provided in Republic Act 3720 as amended by Republic Act 9711, it is required that registration of drugs and vaccines is needed before commencement of marketing activities.

With respect to drugs and vaccines, it is specifically provided under the law that there must be a full report of investigation to show whether or not that drug is safe, efficacious and of good quality based on clinical studies prior to manufacture, sale, importation, exportation, distribution or transfer thereof.

It has already been discussed earlier that a product needs to undergo a very rigorous process of clinical trial before one can be granted a Certificate of Product Registration. However, during the COVID19 public health emergency, there is no registered drug or vaccine for COVID19 and there will be no access to COVID19 drugs and vaccines that are still under development because of the fact that they are still under development and not yet eligible to be granted a Certificate of Product Registration.

That is why our President, through Executive Order 121, has given authority to the Director General of the Food and Drug Administration to issue an Emergency Use Authorization for COVID19 drugs and vaccines.

Before I proceed, let me discuss briefly what is an Emergency Use Authorization and how it is different from a regular Certificate of Registration.

An Emergency Use Authorization is a riskbased procedure for assessing unlicensed and this means under development vaccines and therapeutics. It is only issued during public health emergencies of international concern and its aim is to expedite availability of the drug or vaccine. And lastly, it is based on an essential set of available quality, safety and efficacy performance data.

As you already know, UK has recently granted an emergency use authorization for a COVID19 vaccine. The model of granting emergency use authorization is a widely accepted practice. We have similar mechanisms in the US, China, European Medicines Agency, Australia and Japan. I will be discussing our particular framework of emergency authorization here in the Philippines.

SALIENT FEATURES

We will start with the conditions for issuance. The first condition is that there must be evidence and that the totality of the evidence available at the time of registration would show that there is reason to believe that the product may be effective to prevent, diagnose or treat COVID19.

Our second condition is that the known potential benefits of the product when used to diagnose, prevent or treat COVID19 outweigh the known and potential risks of the COVID19 drug or vaccine.

Lastly, it must be shown that there is no adequate, approved and available alternative to the product for diagnosing, preventing or treating COVID19.

The executive order makes mention of the applicants and the requirements of applicants. It has specifically mentioned that either the industry or the government agency such as the national procurer or the public health program implementer can apply for the emergency use authorization.

The requirements is a certificate, this is just specific to the executive order. This executive order mandates that the FDA should look for a CGMP or a Certificate of Good Manufacturing Practice.

This means that prior issuance of the emergency use authorization, the manufacturing side has been inspected and has passed the standards for manufacturing. And also, there must also be an undertaking of the manufacturer to complete the development of the drug or the vaccine. These two, plus the other requirements of the FDA, that will be submitted will be the conditions for the issuance of the emergency use authorization.

RELIANCE, RECOGNITION

The FDA was also given the power to implement reliance and recognition processes. Reliance is defined by the World Health Organization (WHO) as an act whereby the National Regulatory  Authority in one jurisdiction may take into account and give significant weight to assessments performed by another NRA or trusted institution or to any other authoritative information in reaching its own decision.

In contrast, recognition is the acceptance of the regulatory decision of another trusted institution.

We find value in reliance and recognition in conducting the review of the application considering that considerable expertise, time and effort is needed. This means that if another National Regulatory Authority has given an emergency use authorization, the Philippine FDA may rely or recognize on the regulatory decision of that other NRA in order to expedite the review of the application for that.

Another important provision is an expert panel. The executive order provides that there must be an expert panel who will conduct a review of the safety and the effectiveness of the drug or the vaccine being applied for an EUA. This expert panel is very distinct to the EUA because this expert panel will come from outside FDA and will give their recommendations on the application.

Another important provision is the validity which is provided under the executive order that the EUA should only be valid within the duration of the declared public health emergency.

The last important provision is the post authorization monitoring considering that the review will be expedited and that the post authorization monitoring would be more intensive. The FDA together with other concerned offices of the DOH will conduct post authorization monitoring and at the same time, the holder of the EUA is obliged to complete specific pharmacovigilance obligations.

EXPERT PANEL

In summary, the salient provisions of EO 121 are number one, the conditions. We identified three. This is based on the totality of the evidence, there is reasonable belief that the product may be effective in treating COVID19.

Second is that, the benefits outweigh the risks, and the third condition is that there is no adequate, approved alternative to the product.

The second salient provision is that you have identified applicants and identified requirements. Identified applicants are the government or the government agency. The requirements are the certificate of Good Manufacturing Practice and undertaking to complete development of the drug or vaccine.

The FDA is also empowered to use reliance and recognition principles. In reviewing the application, there must be an expert panel who will recommend to the Director General the action on the application. The validity should only be during the public health emergency and that the FDA should conduct post authorization monitoring that the holder of the EUA is required to complete specific pharmacovigilance obligations.

Right now the FDA is already drafting its implementing guidelines of this executive order and given the urgency of the situation, we see that the guidelines will be issued as soon as possible.

Atty. Langley Gratuito
Langley P. Gratuito is a lawyer and works at the Office of the Director General of the Food and Drug Administration (FDA). He provides legal assistance, which includes reviewing contracts, drafting policies and legal documents, and formulating legal opinions, among others.

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