Shangula procures unapproved Covid vaccines
JEMIMA BEUKES
WINDHOEK
The health ministry is forging ahead with plans to allow the importation of vaccines not approved by the Namibia Medicines Regulatory Council (NMRC) as well as with the procurement of vaccines worth N$535 million from middlemen.
Health minister Dr Kalumbi Shangula has granted exemption to some vaccines, with the exception of one, that are not currently approved for emergency use by the World Health Organisation (WHO).
The WHO’s emergency use listing allows countries to accelerate their own regulatory approval processes to import and administer the vaccine.
NMRC’s council chairperson Hendrina Gideon explained that countries are free to use and procure any product they want, but as a country that aligns itself with WHO, Namibia must adhere to WHO standards.
Namibian Sun understands NMRC and Shangula had a heated meeting last month where the council advised the minister not to grant an exemption to unapproved manufacturers due to the potential health implications.
Council members, sources privy to the meeting said, allegedly told Shangula to halt the process, but their pleas fell on deaf ears.
“The minister told the council members that the law only requires him to consult NMRC and not necessarily take their advice,” the source said.
Not untoward
Days after meeting the council members, Shangula on 9 March issued a gazette exempting certain medicines from NMRC approval.
“Under section 45 of the Medicines and Related Substances Control Act, 2003 (Act No. 13 of 2003), after consultation with the Namibia Medicines Regulatory Council, I exclude the Covid-19 vaccines, specified in the schedule, from the operation of section 18(1) of that Act, subject to the following conditions,” the Gazette reads.
Shangula yesterday said there is nothing wrong with what he has done, pointing out that the NMRC operates within the confines of the Medicines and Related Substance Act.
“I have acted within the power given by the same Act. There is no contradiction here. The legislators foresaw an emergency situation like the Covid-19 and made provision for that in the Act,” he said.
New route
Under normal circumstances, importers of medicine into Namibia must be in possession of a licence to import such medicine, issued by NMRC, and the vaccine’s labelling and package insert must be written or translated into English.
This is no longer necessary following Shangula’s gazette.
The exempted vaccines include Vero Cell, Sputnik V, Ad26.COV2.S, AZD1222 (AstraZeneca) and mRNA-1273 (Moderna).
A day after the gazette was issued publicly, NMRC issued a press release in which it listed the market authorisation status of different vaccines for which applications for registration have been lodged with the medicine regulator.
NMRC received six vaccine applications for emergency use between 3 and 18 February. These are Covishield, Vero Cell, Sputnik V, AZD1222 and BNT162b2/Comirnaty. Only Covishield was approved by NMRC.
Contradictory
When the health ministry on 18 February applied to the finance ministry for an exemption to procure Covid-19 vaccines and services needed for the roll-out of the vaccine on an emergency basis, one of the reasons given was that the procurement of the vaccines will be from approved manufacturers and pooled procurement agencies such as the United Nations International Children's Emergency Fund and manufacturer representatives who are duly approved.
An exemption to seek bids from local suppliers through the open bidding process was also sought.
Shiimi granted the exemption on 2 March.
Upon enquiry, Shiimi said his ministry had advised the health ministry to go for emergency procurement using direct procurement.
“We take note of the invitation that was sent out to procure from all potential suppliers. We are currently engaging the ministry of health to ensure that the procurement process is done in the public interest and that government gets value for money,” Shiimi said.
[email protected]
WINDHOEK
The health ministry is forging ahead with plans to allow the importation of vaccines not approved by the Namibia Medicines Regulatory Council (NMRC) as well as with the procurement of vaccines worth N$535 million from middlemen.
Health minister Dr Kalumbi Shangula has granted exemption to some vaccines, with the exception of one, that are not currently approved for emergency use by the World Health Organisation (WHO).
The WHO’s emergency use listing allows countries to accelerate their own regulatory approval processes to import and administer the vaccine.
NMRC’s council chairperson Hendrina Gideon explained that countries are free to use and procure any product they want, but as a country that aligns itself with WHO, Namibia must adhere to WHO standards.
Namibian Sun understands NMRC and Shangula had a heated meeting last month where the council advised the minister not to grant an exemption to unapproved manufacturers due to the potential health implications.
Council members, sources privy to the meeting said, allegedly told Shangula to halt the process, but their pleas fell on deaf ears.
“The minister told the council members that the law only requires him to consult NMRC and not necessarily take their advice,” the source said.
Not untoward
Days after meeting the council members, Shangula on 9 March issued a gazette exempting certain medicines from NMRC approval.
“Under section 45 of the Medicines and Related Substances Control Act, 2003 (Act No. 13 of 2003), after consultation with the Namibia Medicines Regulatory Council, I exclude the Covid-19 vaccines, specified in the schedule, from the operation of section 18(1) of that Act, subject to the following conditions,” the Gazette reads.
Shangula yesterday said there is nothing wrong with what he has done, pointing out that the NMRC operates within the confines of the Medicines and Related Substance Act.
“I have acted within the power given by the same Act. There is no contradiction here. The legislators foresaw an emergency situation like the Covid-19 and made provision for that in the Act,” he said.
New route
Under normal circumstances, importers of medicine into Namibia must be in possession of a licence to import such medicine, issued by NMRC, and the vaccine’s labelling and package insert must be written or translated into English.
This is no longer necessary following Shangula’s gazette.
The exempted vaccines include Vero Cell, Sputnik V, Ad26.COV2.S, AZD1222 (AstraZeneca) and mRNA-1273 (Moderna).
A day after the gazette was issued publicly, NMRC issued a press release in which it listed the market authorisation status of different vaccines for which applications for registration have been lodged with the medicine regulator.
NMRC received six vaccine applications for emergency use between 3 and 18 February. These are Covishield, Vero Cell, Sputnik V, AZD1222 and BNT162b2/Comirnaty. Only Covishield was approved by NMRC.
Contradictory
When the health ministry on 18 February applied to the finance ministry for an exemption to procure Covid-19 vaccines and services needed for the roll-out of the vaccine on an emergency basis, one of the reasons given was that the procurement of the vaccines will be from approved manufacturers and pooled procurement agencies such as the United Nations International Children's Emergency Fund and manufacturer representatives who are duly approved.
An exemption to seek bids from local suppliers through the open bidding process was also sought.
Shiimi granted the exemption on 2 March.
Upon enquiry, Shiimi said his ministry had advised the health ministry to go for emergency procurement using direct procurement.
“We take note of the invitation that was sent out to procure from all potential suppliers. We are currently engaging the ministry of health to ensure that the procurement process is done in the public interest and that government gets value for money,” Shiimi said.
[email protected]
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