Inside the COVID test muddle

The World Health Organization (WHO) last month flagged Jamaica as one of two countries in the region which had imported COVID-19 test kits which were substandard.

This was disclosed by Cynthia Lewis-Graham, director of the Ministry of Health’s Standards and Regulation Division, in response to a report by the Jamaica Observer last Tuesday that 100,000 test kits not approved by the WHO or the United States Food and Drug Administration (FDA) had been imported in breach of Jamaica’s Disaster Risk Management Act (DRMA).

“The WHO surveillance system for substandard and falsified products, on October 13, 2021, forwarded an e-mail regarding the potential presence of unregulated Standard Q COVID-19 Ag in the Caribbean, manufactured in India and being sold at a price much lower than the average for this type of product, and was acted upon.

“Jamaica was named as one of the two countries in which the product was being used, the other being The Bahamas. The possibility of the product being in other Caribbean countries was highlighted,” Lewis-Graham said, adding that the Pan American Health Organization (PAHO) had requested that the kits be detected, samples obtained, and the matter reported.

The health ministry’s Standards and Regulation Division is the entity mandated under the Food and Drugs Act to regulate health care products to include medical devices through product registration and permit processes.

According to Lewis-Graham, the division, acting upon information that the product SD Biosensor Standard Q COVID-19 Antigen Test Kits had obtained WHO EUL (emergency use listing) and was approved for use in the country proceeded to approve import permits for facilities authorised by the ministry for testing, while requiring submission of manufacturer’s product information. A manufacturing site for the product was not specified by the WHO at that time.

“Analysis by the Standards and Regulation Division in August 2021, of permits approved for COVID-19 antigen tests revealed that import permits were issued for SD Biosensor Standard Q COVID-19 antigen test kits from two manufacturing sites  [South] Korea and India  the product information submitted differing only in the name of the manufacturing site stated.

Lewis-Graham said that, “Research undertaken to determine the difference and legality of both sites revealed that SD Biosensor Healthcare Private Limited, India, is a subsidiary of SD Biosensor, Inc, South Korea, the manufacturing site awarded WHO EUL.”

She pointed out that subsequent action taken was to discontinue the issuing of import permits for products from the Indian manufacturing site and to determine the status of the permit already issued. The investigation revealed that the total number of products issued on the permit  100,000  were already imported and therefore did not require the withdrawal of the import permit.

“The importer of the Indian manufactured product was contacted immediately  October 13, 2021  and instructed to quarantine the products and to provide the ministry with samples of the products warehoused. Product samples were delivered to the division on October 14, 2021. The division commenced discussion with the NPHL [National Public Health Laboratory] regarding the validation of the kits given that PAHO/WHO was still conducting investigations into the authenticity of the kits,” said Lewis-Graham.

On October 7, the Observer had submitted several questions on the 100,000 imported test kits to Dr Michelle Hamilton, head of the National Laboratory Services, and other officials in the health ministry, but the answers were not provided up to when the story was published on November 2, almost one month later.

Among the questions were: “Did the National Public Health Lab give approval to the Standards and Regulation Department in the Ministry of Health to issue a permit to [the company] to import into Jamaica the referenced antigen test which is not approved by the WHO or the FDA ? and,

“Has any action been taken against [the company] further to its importation of 100,000 tests which were not approved for use in Jamaica?”

Hamilton had indicated that the information arm of the ministry would provide the answers, but these were never delivered.

However, the attorney representing the company said it has acted in accordance with the laws of Jamaica, as well as guidelines and directions issued by the Ministry of Health and Wellness from time to time insofar as it concerns the importation and administration of WHO-approved COVID-19 test kits in Jamaica.

According to the attorney, the approved test kits used by the company provide acceptable accuracy rates; hence, its approval for use across the world.

“The only complaint my client has received has been resolved by the supply of the necessary permits and approvals concerning the importation and use of the approved test kits,” added the lawyer as he hinted that the company had received the green light to import the kits from the health ministry.

Last week, Health and Wellness Minister Dr Christopher Tufton explained that when the WHO flagged the kits the ministry’s standards agency contacted the importer and told them to quarantine the kits.

“So it wasn’t a deliberate attempt to import unapproved kits, it was a case of the kits being imported but from another jurisdiction, and then being manufactured in another, but the WHO saying that they need to validate that process first. That’s basically what it was,” Tufton told the Observer.

Responding to a claim by Dr Carolyn Gomes that the health ministry is failing to do sufficient COVID-19 tests and that its approach has kept testing out of the reach of Jamaicans who are unable to pay “anywhere between US$20 and US$50, sometimes more” Tufton said “part of the narrative around the cost of testing that is overlooked by those who, rightfully so, would like cheaper testing is that, firstly, the Government does provide free testing once someone goes through the public health system and the doctor advises that they need to be tested based on symptoms and assessment”.

He also said that “The widescale testing in the US, which is what we tend to be compared against, is a function, to some extent, of significant subsidies being applied by the state or federal government.”

However, he said that if people don’t qualify for that subsidised testing, the cost to them “is very expensive”.

According to Tufton, a few weeks ago when he was on his way back to Jamaica from the US he went to an emergency care facility in Tennessee and was quoted US$235 to do a test to qualify him to return to Jamaica.

“So if you don’t qualify for those subsidised kits you’re still going to have to pay upwards of US$80 to US$200, depending on where you do it,” Tufton said.

However, he acknowledged that the Government needs to do something about the high cost of testing here and said he had no problem meeting with Dr Gomes, who had told the Observer that she had been trying, with little success, to get the Government to make greater use of diagnostic test kits that were developed with money raised by the Global Fund and a partner organisation.

Those tests, said Dr Gomes, who is a member of the board of the Global Fund, were up to standard and pre-qualified by the WHO.

However, Dr Tufton responded: “We have never refused to listen or to communicate. I take calls from everybody, and particularly where organisations have been a critical party of the stakeholder group. So if Dr Gomes has a particular position we’re always open.”


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