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Congress to Palace: Please clarify rules on firms’ vaccine purchase

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AFTER rejecting the draft order prohibiting certain industries from procuring and donating Covid-19 vaccines to their employees, lawmakers asked the national government to clarify how the private sector can procure their vaccines.

Albay Rep. Joey Sarte Salceda called anew to national government to immediately release “simple and reasonable” implementing rules and regulations (IRR) of the Covid-19 Vaccination Program Act to allow private sector to help the government to secure vaccines.

“What is central now is the release of the implementing guidelines of RA 11525. We need clarity as to how the private sector can procure vaccines,” he said.

Relatedly, the Palace said private companies are not required to donate a portion of their Covid-19 vaccine, which they will purchase through a tripartite agreement with the government and pharmaceutical firms.

In an online press briefing on Tuesday, Chief implementer of the government’s national policy on Covid-19 Carlito G. Galvez Jr. clarified that firms could keep all of their purchased vaccine as long as they do not sell it.

In the case of the 17 million doses of vaccines purchased by private sector and local government units (LGU) from AstraZeneca, he said it was the British pharmaceutical firm, which required that 50 percent of the purchased vaccine be donated to the government.

“They have a provision [in the tripartite agreement], which they call corporate principle of equitable access and non-privilege access,” Galvez explained.

“This means the 50 percent of [the vaccine] purchased by the private sector should be given to marginalized target population of the public sector,” he added. The pharmaceutical firm had sold the vaccine at cost to private business.

Galvez noted other drug makers such as Moderna, Novavax, and Sinovac made no such stipulation in the tripartite agreements they signed with the private sector.

Currently, the vaccine czar said the private sector and LGUs have purchased around 40 million doses of Covid-19 vaccines, which are expected to arrive by the middle of the year.

Galvez issued the clarification amid criticism that the government imposed measures, which make it harder for the private sector to purchase Covid-19 vaccines for their workers.

He stressed that all companies could easily purchase vaccine as long as they enter into a tripartite agreement with government—something deemed necessary to ensure the government will pay, in case of severe adverse reactions, for the indemnity for vaccine use. This, provided it is not related to “willful misconduct and gross negligence” of the manufacturer as stipulated in Republic Act 11525 or the Covid-19 Vaccination Program Act.

On Monday, President Duterte reiterated the government will not pay for any liability related to the negligence of manufacturers such as breakage of vaccines vials due to mishandling and if the vaccine will lack efficacy as advertised.

Indemnification remark

Meanwhile, Salceda said President Duterte’s statement on indemnification should be taken only in the context of the law he signed, Republic Act 11525.

Last Monday, Duterte said the government could not assume liability and pay individuals for the adverse effects of the vaccines.

“The law sets a P500-million indemnification fund that the President can terminate. This hedges us from unwarranted fiscal risks,” Salceda, an economist, said.

“We have a practice called risk allocation. The burden of risk an entity bears should be proportional to the amount of control the entity has over the risk factors. Most of the risks associated with vaccines can be controlled at the production stage. The risks we control are only in administration and storage, so we can only competently answer for risks from these factors,” he added.

According to Salceda, the government cannot give pharmaceutical companies a blank check on the risks of the vaccine.

“I strongly believe that the vaccines are safe and effective. But that is a guarantee that pharmaceutical providers will also have to give us. Setting an unlimited indemnification fund sends a very bad signal that they can send vaccines of whatever quality to us. The wisdom in RA 11525 is that it is limited,” he added.

“That said, the vaccines have been proven to be safe and effective, so indemnification is only a peripheral topic,” Salceda said.

As for vaccine confidence, Salceda urged the public to shift the conversation away from picking among brands.

“The best vaccine is an available vaccine. I urge the government, the media, and civil society to work together to explain the vaccines from a fair and objective standpoint. Let us explain efficacy rates, side effects, and benefits in a satisfying way. We cannot afford to sensationalize vaccine science in this crisis,” he said.

“Once more vaccines arrive, I hope for a ‘who-wants-it-can-get-it’ approach to vaccination so that we do not waste any doses. Of course, due prioritization should be done, but I expect some in the priority groups to opt not to be vaccinated. We should vaccinate those who are willing and next in line,” Salceda added.

Legal framework

But Ako Bicol Rep. Alfredo Garbin explained that the Covid-19 Vaccination Law provides a legal framework for the vaccination program, including the participation of private entities under a tripartite agreements with the national government and the manufacturers.

“The requirement for a tripartite agreement is specified for three reasons: manufacturers of available Covid-19 vaccines require that indemnification be covered by the national government before finalizing any procurement deals; it is the national government that will shoulder the cost of adverse effects; and available vaccines are only those provided with EUA [emergency use authority],” he said.

RA 11525 mandates the creation of a P500-million Covid-19 National Vaccine Indemnity Fund to compensate all individuals who might experience adverse event following immunization (AEFI).

Proper training

Meanwhile, Salceda joined the call to the key implementers of the Covid-19 vaccination program to prioritize the fast-tracked training of personnel at the local-government level on the proper storage, handling and administration of the highly temperature-sensitive vaccine doses to avoid drug wastage.

“Training local governments and large private sector employers will be very important. We will benefit immensely from teaching these entities how to communicate the vaccines as a topic, how to handle and store them, and how to navigate the vaccination process. I expect the DOH to be on top of this need,” Salceda said.

Camarines Sur Rep. Luis Raymund Villafuerte said proper training will ensure the vaccine drive’s success when the anti-Covid shots become readily available in the provinces.

Villafuerte made his appeal after the World Health Organization (WHO) itself flagged the lack of trained people to give the anti-Covid shots in many low- and middle-income countries.

“The government should also ensure that the staff handling the vaccines in the communities are familiar with the hierarchy of priorities on who should get the vaccines; how these doses should be stored, especially in localities where there are no available cold storage facilities; and how to properly administer the shots to the target-beneficiaries,” he said.

“In CamSur, we already have a list of the priority beneficiaries across the province as well as the list of frontliners who are to administer the vaccines. But our frontliners need to be properly trained on how to administer the shots. LGU staff should also be trained on the proper storage of the meds,” he added,

Also, Villafuerte said certain municipalities have no adequate cold storage facilities to keep the vaccines.

He added the government needs to draw up and implement down to the cities and municipalities the guidelines on the safe and effective transport, storage and administration of the Covid-19 vaccines as soon as these arrive from overseas and are delivered to the provinces.

The government is expected to roll out its inoculation drive in the provinces in the next quarter as vaccine czar Galvez Jr. reported to Duterte a week ago that 20 million doses of Sinovac and AstraZeneca vaccines are due for delivery in the April to June months.

Although most governments in low- and middle-income economies have already drawn up their vaccination programs, the WHO was reported as noting that there were few trained people to give the jabs to the target-vaccinees.

According to the reported WHO study, while 85 percent of 128 countries had come up with their inoculation plans, there were only 30 percent trained people to give the shots, and that only 27 percent of the economies had drawn up public information campaigns.

“As a result of the lack of training and information drives, important matters such as advocacy, community engagement and risk and safety communication “remain largely unaddressed,” said the reported WHO study.

Image credits: PCOO

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