The vaccination program in the Philippines is currently underway, but it seems that the virus is spreading faster than the government can vaccinate its people. One of the solutions proposed to ease the burden from the government and augment its current efforts is to allow the private sector to procure and import vaccines directly from the manufacturers and pharmaceutical companies. However, the current Philippine regulations on the sale and importation of vaccines makes this challenging.
Under Philippine laws, only pharmaceutical companies that have been granted an authorization by the Philippine Food and Drug Administration (“FDA”) are allowed to sell or manufacture any new drug. Particularly, Section 21 of Republic Act No. 3720 (“RA 3720”), or the “Food, Drug and Cosmetic Act”, as amended, provides that any new drug should have an authorization from the FDA prior to the manufacture, sale, importation, exportation, distribution or transfer thereof. The authorization is granted based on an application containing full reports of investigations to show whether or not such drug is safe, efficacious and of good quality for use based on clinical studies. Likewise, the authorization can take the form of a permit, a license, a certificate of registration, of accreditation, of compliance, or of exemption, or any similar document. In general, the authorization required is the authority to register such drug or vaccine (i.e. with a certificate of product registration (“CPR”)).
Unfortunately, due to the limited amount of time to study the efficacy and safety of available vaccines, no foreign or local pharmaceutical company has obtained the necessary authorization from the FDA for the sale and distribution of COVID-19 vaccines. However, in order to address the need for such vaccines, the President of the Philippines issued Executive Order No. 121, series of 2020, (“EO 121”) entitled “Granting Authority to the Director General of the Food and Drug Administration to Issue Emergency Use Authorization (“EUA”) for COVID-19 Drugs and Vaccines, Prescribing Conditions therefore and for other Purposes”, which gave the FDA Director General the power to issue EUAs for COVID-19 vaccines. As of this writing, only four vaccines have been issued the necessary EUA, namely: Pfizer BioNTech, Oxford AstraZeneca, Sinovac CoronaVac, and Gamelaya Sputnik V.
Under Republic Act No. 11525 or the “COVID-19 Vaccination Program Act of 2021”, private entities may procure COVID-19 vaccines only in cooperation with the DOH and the NTF through a multiparty agreement which shall include the DOH and the relevant supplier of the COVID-19 vaccine. Due to this restriction, private entities are trying to convince the government to do away with the multiparty agreement as the government’s monopoly on the supply of the vaccine is creating a bottleneck in the importation of the vaccines into the Philippines.
However, the FDA has already stated that an EUA is not equivalent to a marketing authorization or a CPR. Hence, COVID-19 vaccines are not to be treated as commercial products even if issued with an EUA. Additionally, the vaccines are also still under constant review. As a matter of fact, recent reports of rare cases of blood clots with low platelets detected in some individuals injected with the AstraZeneca vaccine caused the Department of Health to temporarily stop the inoculation of people below 60 years old with the said vaccine.
Admittedly, government regulation is still a big part in ensuring that the vaccines procured meet the minimum standard to be allowed to be sold and imported in the Philippines. However, in order to address the pressing needs of this nation, private entities should also be given a bigger role in the vaccine procurement. It appears that employers and business owners, especially those that belong to the micro, small and medium enterprises, are not fully aware of the process of procurement of the COVID-19 vaccines. There was even confusion as to the requirement to donate 50% of the procured vaccines by the private entities. This discouraged private entities to procure vaccines through the multiparty agreements because of their inability to cover for or shoulder the cost of the additional vaccines to be donated. What added to the confusion is the government asserting that it was the suppliers of AstraZeneca and not government which required such donation. In any case, what may be needed right now is transparency in the process of procuring COVID-19 vaccines either by the government or the private sector.
The government is still miles away from reaching its target of vaccinating at least 70% of the population to achieve herd immunity. Since the start of the pandemic, the private sector has proven its capability of filling in the gaps in the government’s pandemic response. Giving the private sector more freedom in their vaccine procurement as well as streamlining the entire process would definitely result in achieving targets and the desired results faster.
This article is for informational and educational purposes only. It is not offered and does not constitute legal advice or legal opinion.
Zyra Frances P. Aquilizan is an Associate of the Corporate and Special Projects Department of the Angara Abello Concepcion Regala & Cruz Law Offices (ACCRALAW). ACCRALAW’s Head Office is located at Bonifacio Global City, Taguig City, Metro Manila, Philippines.