Cedric Stephens | Vaccine negligence and indemnity

If a Jamaican citizen were to develop adverse reactions to a COVID-19 vaccine, would he, or she, be able to initiate a lawsuit against the vaccine manufacturer

Why will the government have to develop and execute an indemnity agreement to protect the vaccine manufacturers from lawsuits in order to get supplies?

These are questions that first-year students at Norman Manley Law School at the Mona campus of the University of the West Indies could answer without opening a textbook. But most persons without a basic understanding of tort law or negligence would be challenged to find the correct answers.

Chief Medical Officer Dr Jacquiline Bisasor-McKenzie, according to Loop, answered the two questions last month. She said, “the Government has started the process of developing ‘indemnity documents’ that will protect vaccine manufacturers from being sued by Jamaicans”, and that “all countries intent on obtaining the vaccines must sign these documents before the vaccines are supplied”.

The protection of manufacturers from lawsuits and the signing of indemnity agreements concerning COVID-19 vaccines to access these medications are some of the measures that makers have imposed to manage their risks.

“We are using a new drug, a drug that has emergency use approval in the jurisdiction in which it is manufactured; and so, the manufacturers require for there to be some kind of indemnity process that would prevent them from being sued, essentially, if something goes wrong … and all countries actually using the drug would have gone through the process of signing these agreements, and every country that is to receive will have to sign an indemnity agreement to say that we are not going to expect any liability from these manufacturing companies,” said Bisasor-McKenzie.

“So, we are going through the process of developing those indemnity documents now, and we will have to sign off on those before we are able to get these drugs, whether it is through the WHO [World Health Organization] Emergency Use Listing, or whether it is through bilateral agreements.”

An indemnity agreement is a contract where those involved agree that the other be ‘held harmless’ for losses or damage, or where the parties agree that the other is legally exempt from losses or damages incurred. Many high-risk activities, like skydiving or heli-skiing, bungee jumping, or zip-lining require individuals to sign an indemnity agreement before they can participate. Indemnity agreements or clauses are also found in many contracts that companies and individuals execute in the normal course of business. They are drafted to protect the business or company from liability in the event of an accident.

Jamaica, according to the report, is to receive its first doses of vaccines, costing some $3 billion, from the COVID-19 Vaccines Global Access Facility, known as COVAX, on April 21. The COVAX facility is designed to accelerate equitable access by countries globally to safe COVID-19 vaccines.

Missing from the chief medical officer’s report to Parliament’s Joint Select Committee was any information about the logistics and supply chain process of the vaccine distribution and how those risks would be managed.

Representatives of one overseas insurance company that specialises in the pharmaceutical industry wrote: “A successful vaccine distribution process in our mind starts with the transportation of the raw materials – active pharmaceutical ingredients – that make up the vaccine all the way to the point of injection into the individual receiving the dose of the vaccine. Our goal as an insurer of this cold chain from start to finish is to have no loss of product as a result of temperature deviations, security breaches or simply physical damage during transit.

“The logistics and supply chain process of a vaccine are substantial. This can involve multiple methods of transit and storage ranging from speciality integrated transport providers that move ultra-cold product that can be fragile during transit and requiring a narrow temperature range that it ships within before it begins to degrade the potency of the vaccine.

“Additional methods of transit will include trucking in conjunction with air, and with more stable vaccines. All methods of transit and packaging of vaccines need to be validated by a governmental body, to preserve the cold chain from origin to destination. This is done by the use of multiple means of transport and packing methods inclusive of envirotainers, temperate controlled trucks and containers and speciality packaging containing dry ice or cold packs depending on the temperature range the vaccine is required to ship within.”

A news item, ‘No green light yet on vaccine indemnity’, in the February 25 issue of this newspaper, gave me some measure of comfort that the supply chain process in Jamaica was being addressed.

The Minister of Health & Wellness Dr Christopher, who was photographed visiting two Kingston storage facilities, gave an overview of the logistics and supply chain distribution process for the vaccines that will be arriving soon.

Even though the matter of the vaccine indemnity agreement remains unresolved, I felt more confident that the risks which are being assumed by our government in this part of the fight against COVID-19, are being assessed and managed than when I first read the Loop report.

- Cedric E. Stephens provides independent information and advice about the management of risks and insurance. For free information or counsel, write to: aegis@flowja.com