Litigation Safety Legal guidelines Crucial To Vaccine Improvement – World

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Litigation Protection Laws Critical To Vaccine Development - World

A Walgreens pharmacist prepares to administer vaccines for coronavirus disease (COVID-19) at the King David Center for Nursing and Rehabilitation, a nursing home facility, in the Brooklyn neighborhood of Bath Beach, New York on January 6, 2021. [Photo/Agencies]

Shakespeare’s work is full of notable characters. In Part 2 of Henry VI. From 1591, Dick the Butcher said, “Let’s kill all the lawyers.” This is read regularly to reflect how attorneys were known over 400 years ago for twisting words and events for the benefit of clients and their own benefit.

It is worth remembering that in the past lawyers were not obliged, like doctors, to swear first not to cause harm when entering their profession.

In 1986, the United States established the National Vaccine Injury Compensation Program in response to a threat to vaccine supplies resulting from several major legal disputes seeking damages for side effects of certain vaccines administered in the 1980s. US health officials said claims of side effects are consistently unfounded, although the juries have consistently ruled in favor of the plaintiffs.

Nowhere in the industrialized world are civil lawsuits more common than in the United States. However, the legislation establishing the NVICP halted almost all vaccination violation lawsuits by effectively banning them. Instead, anyone who claimed to have been harmed by vaccination had to file a lawsuit first in order to recover from the NVICP itself by establishing an injurious link according to the rules set out in that program.

Deadlines for filing legal action and limitation periods have been set. The error did not need to be proven, but a clear link between the vaccine and the injury needed to be established. Funding came from a small excise tax of 75 cents on every dose of vaccine purchased that falls under the compensation program.

The vaccination injury compensation program was a radical step for the US. The alternative, however, has either been a drying up of vaccine supply and research, or a potentially huge increase in vaccine costs to cover possible legal claims. Both results were at odds with the broader public interest, and vaccine development and production were restarted.

Additional protection for US vaccine manufacturers became somewhat controversial in 2005, when avian flu concerns were high, with the Public Preparedness and Emergency Preparedness Act.

Among other things, it dealt with the development, production and use of new vaccines – after a public health emergency was reported.

This powerful litigation shield, passed by Congress, was a key factor in enabling Pfizer-BioNTech and Moderna to develop and deploy two COVID-19 vaccines in the United States at an extraordinary rate using a new vaccine technology.

Numerous other jurisdictions have passed similar laws to protect vaccine manufacturers from relentless lawyers to protect the public interest.

There can never be a guarantee that vaccines will be absolutely free from side effects. When given to a large population, there will be a very small number who, due to their personal physiology and medical history, may be particularly susceptible to side effects of varying severity. This risk increases with the use of emergency vaccines. The compensation programs listed above are designed to mentor such individuals while closing the door to escalating litigation.

Vaccine manufacturers can not only rely on a legal protective shield, but also protect themselves with contracts. It is not possible to do this individually when every person is immunized. However, as we see with COVID-19 vaccines, it is common for governments to be the main buyers of vaccines. It is also no exception for governments to have contracts stipulated that they will not bring legal action in relation to certain matters relating to the manufacture and supply of vaccines. This speeds up delivery and lowers costs.

We have to remember that making and producing vaccines is very complex and demanding. The reputation concerns of the manufacturers offer a decisive first protection against the risk of scientific ruthlessness. More importantly, vaccines are subject to rigorous public review protocols before they are approved for public use.

Can we be sure that nothing can go wrong, especially with vaccines made during a major, ongoing public health emergency? No we can’t. But if we constantly hesitate to remove all possible risks, will many more die and more suffer? Yes they will.

Taking into account the pressure and safeguards described above, many jurisdictions have agreed that certain newly created, widely tested COVID-19 vaccines should be granted emergency use status in order to avoid the delay in waiting for such vaccines to be fully registered.

Hong Kong took this approach sensibly. We are also fortunate that the government has now received enough doses of vaccine from three sources – Sinovac, AstraZeneca and Fosun-Pfizer-BioNTech – to vaccinate the entire population of the Hong Kong SAR.

The COVID-19 pandemic has disrupted life around the world in an extraordinary manner. The consequences were devastating and often fatal on many levels. One positive story that emerged from this immense calamity was the development – at record speed – of a number of promising vaccines. These offer the clearest chance of laying the groundwork for a return to long-term normalcy in public health. Additionally, this experience signals what could be possible if more pandemics emerge. There are now some inspiring, fresh avenues to follow.

We didn’t have to “kill all the lawyers” to get that result, nor did we want to. Shakespeare would surely agree too. Fortunately, however, smart legislation begun decades ago has kept the predatory advocacy unable to postpone or stop much-needed vaccine research to tackle the worst public health crisis in over 100 years.

The author is visiting professor at the Law School of Hong Kong University.