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Simms calls TGA to order on PrEP and blood bans on MSM
Feb11

Simms calls TGA to order on PrEP and blood bans on MSM

LAST UPDATED // Thursday, 11 February 2016 14:17 Written by // Cec Busby

Australian Greens sexuality spokesperson Senator Robert Simms is calling on the government to expedite removing the barriers preventing people from accessing HIV prevention medication, PrEP, and called for a six month deferral period on men who have sex with men (MSM) donating blood.

Simms raised the issues with Adjunct Professor John Skerritt at the Senate Community Affairs Legislation Committee. Skerritt who heads up the regulatory Services Group was appearing at the Committe on behalf of the Therapeutic Drugs Administration (TGA).

Questioned as to whether the TGA would recommend reducing the deferral period for MSM, Skerritt informed Simms it was not currently under review.

“We completed an extensive view with the Red Cross some years ago at their request – and we looked at a range of factors including reports from the Kirby Institute and assessments from an expert panel review. Our decisions are measured on risk benefit to the blood supply.”

Skerritt said he did want to clarify one thing which had been misrepresented in the media:

“Our therapeutic goods regulations infectious disease order actually establishes a deferral period for donation of blood and I’ll quote; from a donor whose sexual practices put them at increased risk of acquiring infectious diseases that can be transmitted via blood cells or tissues.

So it is not TGA’s role to specify groups in the population. It is actually the Red Cross Blood Services role that determines and therefore decides to exclude or defer donors that have an increased risk in their behaviours.”

“What we have said is we would be happy to consider new evidence,” Skerritt said.

Skerritt said recent discussions with the Red Cross have not revealed any new evidence but the Red Cross suggest there may be some new evidence shortly.

Simms questioned whether access to PrEP and the recent success in trials was being considered.

Skerritt suggested PrEP is not a registered medicine in Australia and it was difficult to actually get a handle on reduction in transmission.

Simms drew attention to the Senate’s November motion which had called for immediate access to PrEP and asked what efforts had been made by the TGA to ensure PrEP would be available for Australian use.

Skerritt stressed that Gilead had not approached the TGA regarding PrEP until late 2015.

“The company could have put the application in a decade ago, the same time they made similar approaches to regulators overseas,” said Skerritt.

Skerritt added: “We did originally have a deadline of March – but we didn’t receive information back from the company in time to reach the deadline. Our deadline is now May. I am hopeful the product will be considered by advisory committee at the beginning of April and available soon after.

Simms also questioned Skerritt on overseas orders of PrEP being held up by Border Forces.
Skerritt suggested he was not in a position to comment on Border Force policies and said the TGA had in place a personal administration scheme allowing for Australian’s under a physician’s care to order PrEP for personal use.

“My understanding is some had consolidated shipments. And that made it look like a commercial shipment,” he explained.

The Senator also put on notice a call for PrEP trials in South Australia.

Watch Simms's in action

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Cec Busby

Cec Busby

Cec Busby is the news editor of SX and online editor of GayNewsNetwork.com.au

Comments (2)

  • Rodney Ellis

    12 February 2016 at 11:57 |
    While we all seem very focused on TGA approval of PrEP it tends to distract from the immediate access we have now via the Personal Importation Scheme. It perfectly legal, safe and now affordable ($44.31/month Inc. delivery via PrEPaccessNOW and Green Cross Pharmacy) to get a script from a doctor and order online. Gilead want to charge the taxpayers about $900 per bottle for their brand name Truvada. Considering if it gets through TGA/PBS the co-pay is likely to be about $38 anyway I feel like I have a civic duty to keep buying my three monthly supply of generic PrEP on line. Maybe the TGA is a red herring and mass education of gay men should be the goal.

    reply

  • Rodney Ellis

    12 February 2016 at 11:56 |
    While we all seem very focused on TGA approval of PrEP it tends to distract from the immediate access we have now via the Personal Importation Scheme. It perfectly legal, safe and now affordable ($44.31/month Inc. delivery via PrEPaccessNOW and Green Cross Pharmacy) to get a script from a doctor and order online. Gilead want to charge the taxpayers about $900 per bottle for their brand name Truvada. Considering if it gets through TGA/PBS the co-pay is likely to be about $38 anyway I feel like I have a civic duty to keep buying my three monthly supply of generic PrEP on line. Maybe the TGA is a red herring and mass education of gay men should be the goal.

    reply

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