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A mural outside the Mission Hospital in Pasig City, Philippines. Photo: AP

Coronavirus vaccine roll-out in Philippines gets boost with law to give drug companies immunity from lawsuits

  • Covid-19 Vaccination Programme Act gives public officials and drug makers immunity from civil and criminal lawsuits except in cases of gross negligence and wilful misconduct
  • Senate President Vicente Sotto III says it will have no effect on charges against Sanofi executives involved in the 2016 Dengvaxia scandal
The Philippine Congress has given its approval to a new law that is expected to speed up the roll-out of coronavirus vaccines in the Philippines by protecting the drug companies that make them from most lawsuits.
The Covid-19 Vaccination Programme Act was passed by both the Senate, in a 22-0 vote, and the House of Representatives on Tuesday and is now expected to be signed into force by President Rodrigo Duterte.
The development follows the news last week that deliveries of 117,000 vaccine doses from Pfizer BioNtech and 5.5 million doses from Oxford-AstraZeneca (under the World Health Organization’s Covax Facility) had stalled because the drug makers were demanding that indemnity clauses be inserted into the purchase contracts. It is hoped that with the new law, the drug makers will no longer see the need for such clauses.

Philippines gets Sinovac jab, but vaccine roll-out stalls on liability fears

Under the law, all “public officials and employees, contractors, manufacturers, volunteers” and representatives of private companies carrying out authorised Covid-19 vaccination programmes will be immune from criminal and civil lawsuits, except in cases involving wilful misconduct and gross negligence.

The law also paves the way for a 500 million pesos (US$10 million) indemnity fund that will be used to compensate victims or their families in cases where vaccine usage causes “death, permanent disability or hospital confinement”. The fund will be covered by the government and there is no requirement for vaccine makers to contribute.

A health worker participates in a simulated Covid-19 vaccination in Pasig City, Metro Manila, Philippines. Photo: Reuters

Dr Kenneth Hartigan-Go, a former health undersecretary who is now a non-resident research fellow at the Ateneo School of Government, welcomed the new law saying it addressed the drug companies’ concerns.

However, Dr Beaver Tamesis, president of the Pharmaceutical and Healthcare Association of the Philippines, said his group was still “checking with the lawyers” about its implications. He compared it to the situation in the United States, where “wilful misconduct” lawsuits are allowed, but “gross negligence” ones aren’t.

But, he said – citing a comment made by an association member – “they are comfortable with the language in the proposed law”, because their legal counsel had said that Philippine law was “very clear [and] not subject to abuse or misuse” in misconduct and negligence lawsuits.

The Philippine law will have other effects too. It will make all vaccine imports tax free and authorise local governments and the Philippine Red Cross to buy vaccines directly from manufacturers – provided they act under the provision of the National Task Force and the vaccines have been approved by the Food and Drug Agency (FDA).

It will also allow the FDA to grant emergency use authorisation to vaccines still in phase three trials, such as the Chinese developed Sinovac, and to license pharmacists and midwives to administer jabs. The law also directs the Department of Health to issue a “Vaccine Card” to everyone who gets a jab, though it clarifies that the public will not need these cards to access education, employment or government services.

Senate President Vicente Sotto III, who shepherded the speedy passage of the law, said it “protects health workers” except in cases of gross negligence or misconduct.

Demonstrators in Metro Manila, Philippines, demand free, safe, and effective Covid-19 vaccines. Photos: Reuters

In response to a question on Wednesday he also stressed the law was specific to the coronavirus pandemic and had “no effect on previous or other medical issues” such as the pending criminal cases facing government officials charged over a scandal involving a dengue fever vaccine in 2016.

Hundreds of schoolchildren died after receiving the Dengvaxia shot, which was developed by the French firm Sanofi and administered in a programme run by the Philippine Department of Health, and the scandal is thought to have fuelled vaccine scepticism in the country. While the exact role of the Dengvaxia shot in the deaths is a matter of dispute, senior health department officials and three Sanofi executives have been charged with “reckless imprudence resulting in homicide”.

Philippines offers nurses in exchange for vaccines from UK, Germany

On February 2, a Philippine court issued arrest warrants for the three Paris-based Sanofi executives after they failed to attend a hearing.

Duterte’s “vaccine tsar”, ex-military chief Carlito Galvez, Jnr, had claimed the court’s order was the real reason the deliveries from Pfizer and AstraZeneca had stalled.

However, Dr Gene Nisperos, a faculty member of the University of the Philippines College of Medicine, dismissed Galvez’s claim as “blatant lies”, pointing out that the WHO’s Covax Facility programme had required indemnity provisions since November. The delay had “nothing to do with Dengvaxia”, he said, but everything to do with “the failed leadership and preparation of the Duterte government”.

Ramon Tulfo. Photo: Facebook

ENVOY PROBED OVER JAB BRAG

Meanwhile, the Philippines’ special envoy to China Ramon Tulfo is being investigated after he bragged in his newspaper column that he and other public officials had been inoculated with a Chinese vaccine that had been smuggled into the country.

On Wednesday the FDA said it was investigating Tulfo for knowingly using a smuggled and unauthorised vaccine.

In his February 20 column in The Manila Times, Tulfo had written: “I now confess to the public: I had myself vaccinated – along with some government officials whose names I won’t mention here – with the Sinopharm vaccine last October.”

He added, “don’t ask me where I got the vaccine because I will never tell you.”

Tulfo said he received the jab because he had “applied to be one of the distributors of the Sinopharm vaccine in the country, that’s why I risked my life to have myself inoculated ahead of the public.”

He also said he had told Duterte about it and the president had replied that maybe he too should get the jab.

“It doesn’t look good that we hear about someone having himself vaccinated without going through the proper process,” said FDA chief Eric Domingo.

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