Manufacturers planning to import Covid-19 vaccines into Kenya must be ready to take responsibility for any adverse effects the drugs might have on users.
The indemnity agreement is among the mandatory requirements by the government before any supplier is cleared to ship in the drug, the Nation has learnt.
This will ensure that the manufacturers or their local agents importing the vaccine take responsibility for any adverse effect on patients — hence liable to pay compensation should an aggrieved party successfully petition the court —and protect the government from any claim.
The move might delay the procurement of vaccines or discourage manufacturers who would have wished to apply for a permit to import the drugs.
Some countries, including the United Kingdom, United States of America, Japan, Germany, Canada, Vietnam, France, South Korea, Austria, Italy, New Zealand and others in the European Union, have shifted part of the liability for vaccines to the government.
This is considering vaccines were licensed through an emergency use authorisation (EUA) and the urgency to develop a Covid-19 antidote.
“The government of Kenya will not be responsible [for the adverse effects], so someone has to take responsibility, and who will that be? Of course the person who brought in the vaccine,” said an official who did not wish to be named, citing the sensitivity of the issue.
According to the World Health Organization (WHO), countries are required to give a national authorisation for any vaccine before it is used on its citizens.
“All countries must sign the agreements with any manufacturer they are procuring from before the doses are received through Covax,” WHO said in a statement.
So far, no manufacturer or company has applied for a permit to import the vaccine from the Pharmacy and Poisons Board.
However, two organisations have applied for registration of two vaccines to be used in the country. One has since been cleared, while the other is still under investigation.
The vaccine will be supplied by Sai Pharmaceuticals, the local agent of Serum Institute of India and AstraZeneca’s supply partner for the vaccine.
Under evaluation is the application by Nairobi West Hospital to bring in Russia's Sputnik V coronavirus vaccine.
Associate Professor Lim Poh Lian, the director of the High-Level Isolation Unit at the National Centre for Infectious Diseases, said there are small risks in vaccination.
“Signing of the agreement protects everyone, including governments, distributors, administrators and providers, and the no-fault compensation mechanisms are protecting patients. The purpose of this is to create an environment where people are protected and empowered to go ahead and ask for a vaccine and get the vaccine administered,” she said.
