The Marker's Merav Arlozorov reports that Israel capitulated to the dictates of the COVID-19 vaccine manufacturers and absolved them of responsibility in the event of adverse effects. Instead, the State will probably compensate vaccine injury victims under the Vaccine Insurance Law.
"Vaccination is going to be a national-scale event. 4-8 million people will be injected with a vaccine that has undergone expedited approval processes, and is based on completely innovative technology. It is clear that in such an event people will die or be left with severe disabilities. Who covers it?"
A senior pharmaceutical marketing executive asked this question this week. "It is not a rhetorical question," writes Arlozorov. "Like everything else related to Israel's vaccination strategy, the question of liability for damages that will be, if any, as a result of the vaccines, arises with considerable delay. Just last week, the lights started to go on in the Health Ministry and Justice Ministry in an attempt to answer the question: 'Who is responsible, if it turns out the vaccines have serious side effects?'
"In fact, there is a clear preliminary answer to this question: Vaccine manufacturers are not responsible. The agreements with the vaccine manufacturers are confidential and their details are unknown, but as far as The Marker has been able to determine, Israel's two main agreements - the one with Moderna signed in May and the one with Pfizer signed last Friday - have the same draconian clause, the 'Lack of Liability for Vaccine Manufacturers' section.
"The manufacturers in fact disclaim responsibility in any case where it turns out that the vaccines had adverse effects. Apparently they are not responsible for anything - not for the damage caused by a malfunction in the logistics chain (for example, if the vaccine is accidentally thawed), and not for damage caused by the vaccine itself. It will be impossible to sue vaccine manufacturers."
"The FDA, the U.S. Food and Drug Administration, the largest and most important drug approval body in the world, approves the vaccines of American manufacturers and has repeatedly promised that there will be no cutting corners when it comes to COVID-19 vaccine approval. In addition, Moderna and Pfizer's innovative vaccine technology, genetic technology (mRNA), is considered much safer than old vaccine technologies. If in the past vaccination included injecting a weakened or killed virus into the body, which rarely caused the vaccinators to contract the disease itself, then genetic technology has no component of the vaccine injected into the body - so this technology is considered particularly promising in terms of its safety.
"It's just that all this is true on a theoretical level. Practically, COVID-19 vaccines are being approved during an emergency. What's more, this is a technology that has never been tried before, and there may be bad surprises in it. There is no such known expectation, but it can happen, even if it is a fraction of the population. And when counting the entire population, a fraction can be thousands of cases.
"This is the reason why the two companies, as far as is known, included in the agreements with Israel the draconian and exceptional clause that exempted them from any liability for vaccine damage. They had a good reason for doing so: the U.S., in an attempt to incentivize American manufacturers to develop the vaccine at record speed, passed exceptional legislation that exempted them from lawsuits by U.S. citizens. U.S. law gives manufacturers a sweeping protection umbrella - even if it turns out in retrospect that the vaccine was lethal, it will not be possible to sue the companies for their responsibility for it.
"Since the U.S. administration already gave them a blanket umbrella of protection, American manufacturers probably require a similar umbrella from other countries as well. According to some reports, there has apparently even been a demand for primary legislation similar to American legislation - one that would prohibit Israeli citizens from suing Moderna or Pfizer for damages that might be caused to them. As far as is known, at this point Israel finally took a stand and refused. There will no longer be legislation.
"But this does not mean that Israel did not submit to the dictates of the manufacturers. The fact is that the agreements included the removal of liability for claims from the manufacturers. How is it possible? Israel is apparently considering taking two steps:
"One, to expand the Vaccine Victims Insurance Act, and to include the COVID-19 vaccine within it. The 1989 law was intended to assist those who have been harmed as a result of a vaccine. Such severe injuries existed, for example, in polio vaccines. Until the law was enacted, victims could sue the vaccine manufacturers in court, with the burden of proving that the vaccine manufacturers were negligent in developing the vaccine. This is a very difficult burden of proof, which left those affected by the vaccines, some of whom contracted polio as a result of the vaccine and remained paralyzed, without compensation."
The Financial Times reports COVID-19 vaccine makers are also lobbying the European Union for legal protection, urging an exemption from civil liability in case their hastily-developed inoculations go wrong.