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Originally posted on Australian Tobacco Harm Reduction Association website

THE AUSTRALIAN GOVERNMENT has continued its vendetta against Australian smokers by making vaping nicotine even more difficult to access. Under the new interim announcement by the TGA (medicines regulator) today, vapers will need to get a doctor’s prescription and visit a pharmacy for nicotine supplies. The ruling is set to commence on 1 June 2021.

No other western country requires vapers to have a doctor’s prescription for nicotine liquid, yet alone visit a pharmacy to buy it

Reasons for the decision

The reasons given for the decision were flawed and show a strong bias in interpreting the evidence

  • Potential uptake of smoking in young adults (vaping is diverting young people from smoking)
  • Potential for adolescent brain development (no evidence in humans)
  • Uptake by non-smokers (rare)
  • Risks of nicotine addiction (minimal)
  • Unknown long-term effects (far less than smoking)
  • Insufficient evidence that vaping is effective as a quitting aid (more than sufficient evidence is available)
  • The result will be that fewer smokers will be able to switch to vaping, a far safer alternative, and more people will die a smoking-related death.

How does the pharmacy model work?

  1. Vaper or smoker consults doctor and pays fee
  2. Doctor assesses the patient and discusses other options if appropriate
  3. If appropriate, doctor completes complex online form for an ‘SAS-B’ approval
  4. TGA decides if approval will be granted
  5. Patient returns to pick up the script if application accepted. A second fee may be charged.
  6. Patient goes to pharmacist
  7. Pharmacist orders supplies from wholesaler
  8. Patient purchase from pharmacist with a generous pharmacy mark-up
  9. Repeat yearly

Will it work?

The proposed plan is complex, time-consuming, costly and unworkable.

Vapers won’t do it. Vapers currently require a simple nicotine prescription to vape legally but only about 1-2% have one. Very few will visit a doctor to get one. Vapers don’t see themselves as patients and don’t want medical treatment. Nicotine liquid is a consumer product, not a medicine.

GPs will not do it. Only 8 GPs in Australia have shown any interest in writing nicotine prescriptions. Most know very little about vaping and very few know how to write a prescription The new requirements are time-consuming and won’t be welcomed by GPs.

Pharmacist. The Pharmacy Guild stated in a submission earlier this year that it will not support the sale of vaporing products. Pharmacy staff have no expertise or training in vaping and will not be able to provide the expert support and advice of vape shops.

Nicotine imports to be banned

Vapers can still import nicotine with a prescription for now but this loophole will be closed soon with changes to the Customs (Prohibited Import) Regulations. Personal imports of nicotine will be banned from 1 January 2021 with a penalty of up to $222,000 for offenders without a prescription from a doctor.

Why the TGA has failed again

The TGA has missed an opportunity to have nicotine vaping products regulated in Australia. Australian consumers deserve manufacturing and safety standards, labelling standards, health warnings and child-proof containers. In spite of the Health Minster’s concerns about dodgy products and child poisoning, no steps have been taken to correct these concerns.

The complex regulations will discourage smokers from switching to vaping. The black market will continue to thrive and Australia will continue to fall further behind other western countries in reducing smoking.

Australia’s retail vape industry will be decimated. Vape shops play a valuable role in helping smokers to quit. Staff are former smokers who vape and can give invaluable advice and support. Vape shops rely on e-liquid sales and will not survive without them.

If Australia’s 520,000 vapers visit a doctor each year as advised, costs will range from $60-100 million per year for the taxpayer.

What can vapers do?

If you are concerned about these changes, please contact your local federal MP and senators with a video call, visit or phone call and explain how this will affect you.

Make a submission to the TGA by 6 October explaining what you think of this interim decision. A final decision will be issued later in the year.

Donate to ATHRA’s campaign fund so we can continue to fight this on your behalf.

Documents
TGA interim decision

Information sheets for consumers, medical practitioners, pharmacists and Q&A

Originally Posted by Colin Mendelsohn, 23 September 2020 on athra.org.au