TGA recalls for Herbal Medicines (via email) and Response

Australian Government Department of Health – Private Health Insurance Branch
13 August 2018 10:10 AM
For attention: Prof. John Skerritt – Department of Health

Dear Professor Skerritt,

I am writing to you on behalf of ANPA members and the public.

Naturopaths offer millions of Australians health support often filling gaps in the health care system where mainstream medicine has no answers or where the side effects of mainstream medicines are prohibitive.

The recent removal of important herbal medicines due to an oversight of a cross reference in the Poisons Standard has created a serious issue for naturopaths in offering comprehensive treatments using herbal medicines that up until recently have a track record of safe use.

The removal and restriction of Arctostaphylos uva ursi (Bearberry – leaf) should never have occurred.

If there had been oversight by a suitably trained person appointed to the National Drugs and Poisons Schedule Committee (NDPSC) that also understood the implications for plant medicines I would not be writing to you today.

In this instance, a plant medicine with international recognition as being safe was removed for a technicality, not a factual issue of safety or harm.

In the plant medicine the level of arbutin even though greater than 10 ppm has been widely used as an effective remedy for Urinary Tract Infections.

Other herbal medicines that are potentially affected are known to be safe and have been widely used in this country and overseas for many years.

(Achillea millefolium,  Yarrow and Turnera diffusa, Damiana).

The ridiculousness of this removal is that arbutin is found in pears and marjoram. These food items have not been recalled.

The public is now being denied a very valuable medicine for the treatment of Urinary Tract Infection.

In a time of serious antibiotic resistance for these types of infections, this plant medicine is critical to the public who are seeking alternatives to antibiotics for these kinds of health concerns.

The public have been disadvantaged and so too the manufacturers of these excellent and efficacious medicines.

The ANPA is requesting that the TGA

  • exempts plant medicines that contain arbutin from the Schedules
  • create an entirely different schedule for plant medicines
  • invites a suitably qualified expert in plant chemistry onto the TGA Advisory Committee on Medicines Scheduling
  • the CAM Advisory Panel has its role extended to review any scheduling that could affect natural or plant medicines
  • fast track these inappropriately removed medicines back onto the dispensary shelves

Professor Skerritt I look forward to your update on the actions taken in the TGA to respond to this important issue.

Kind regards,

eta-brand-sig
B.Naturopathy, BSc Public Health, Med.Tech
ANPA President


21 August 2018 – Response from Department of Health

Dear Ms Brand,

Thank you for raising concerns about your understanding that TGA has removed or restricted herbal medicines containing Arctostaphylos uva ursi (bearberry). You also proposed some changes to the medicines scheduling process.

I will address your understanding about herbal medicines containing A. uva ursi first. Your understanding is incorrect. There has been no change to the TGA requirements for listing medicines containing herbs such as bearberry on the Australian Register of Therapeutic Goods. The current requirements have been in place since 2010.

It is a legislative requirement that listed medicines (including herbal medicines) must not contain substances that are scheduled in the Standard for the Uniform Scheduling of Medicines and Poisons (otherwise known as the Poisons Standard). When a sponsor lists a medicine through the TGA’s electronic listing facility one of the things they must do is to declare that their product complies with all the legislative requirements including those of the Poisons Standard.

As you note, Arbutin is a chemical substance contained in herbs such as bearberry that may be used as ingredients in listed medicines. The decision to Schedule Arbutin was made in 2009, by the former National Drugs and Poisons Scheduling Committee (NDPSC) because of safety concerns they had around Arbutin. Arbutin, above certain levels, has been a scheduled substance since 2010. For listed medicines, the legislative instrument specifies that this is at concentrations not exceeding 0.0025% (equivalent to 0.001% hydroquinone). Arbutin is considered unscheduled (and therefore exempt from the requirements of the Poisons Standard) when it is below this level in medicines. I should also clarify that the scheduling requirement is for the concentration of Arbutin in the medicine and not in individual herbs that contain Arbutin.

In June this year, an updated version of the Therapeutic Goods (Permissible Ingredients) Determination made clear the Poison Standard restrictions applying to Arbutin that have applied to listed medicines since 2010. The Determination provides a consolidated, publically available list of all permissible ingredients and associated requirements for use in listed medicines. It is regularly updated.

Sponsors of listed medicines must comply with the requirements of the Determination. They were first notified of the updates proposed for the June version of the Determination in February 2018, which included reflecting the Scheduling requirements of any ingredients that contained Arbutin.

Under revised scheduling arrangements, which took effect on 1 July 2010, the Advisory Committee on Medicines Scheduling (ACMS) was established to advise and make recommendations to a delegate of the Secretary of the Department of Health on appropriate access controls for substances in medicines and chemical products. The implementation of the Poisons Standard is given legal effect through state and territory drugs, poisons and controlled substances legislation.

Membership of ACMS is not decided by officials at TGA. It composition comprises representatives of the states and territories and members appointed by the Commonwealth Minister for Health.  Membership comprises professionals with specific scientific, medical or clinical expertise, as well as appropriate consumer health issues relating to medicines.

To supplement expertise on ACMS, we maintain a specialist advisor list that enables experts to be called on by any committees to provide advice as required. I would welcome further experts in plant chemistry to contact the TGA Committees Section (via committees@health.gov.au) and request to join our specialist advisor list.

Scheduling is a national classification system that controls how medicines and chemicals are made available to the public. At present, none of the Schedules are product or source specific.  Creation of a new Schedule for ‘plant medicines only’ would need to be a policy decision of government and would require approval from the Australian Health Ministers’ Advisory Council, which comprises Secretaries and Directors-General of is the advisory and support body to the Council of Australian Governments Health Council

Consideration would also need to be given to the fact that substances from plants are currently found in all schedules including those for controlled (schedule 8) drugs (opiates, cannabis).  Indeed, there is nothing that makes a plant derived substance special or safer than a chemically-synthesised one – some of the most toxic substances known to man come from plants.

If you would like to propose that plant medicines that contain Arbutin are exempt from Scheduling, you could lodge an application to amend the Poisons Standard. There is no fee charged for lodging an application.  The application form and information on how to lodge an application can be found on the TGA website at http://www.tga.gov.au/industry/scheduling-forms-poisons-standard-amend.htm.

Lastly, to your point about a role for a Complementary and Alternative Medicine Advisory Panel to review any scheduling that could affect natural or plant medicine, the Minister of Health has already appointed the ACMS as the expert committee to advise on Scheduling matters including those that may relate to herbal medicines. However the TGA does have the Advisory Committee on Complementary Medicines that was formed in January 2010 to advise and make recommendations to the TGA on the safety, efficacy and manufacturing quality of a complementary medicines or other listed medicine in the Australian Register of Therapeutic Goods.. For example, in recent meetings, ACCM has provided advice on the appropriate safety restrictions that should be in place in the Permissible Ingredients Determination for a number of listed medicine ingredients.

Yours sincerely

John Skerritt
Adjunct Prof John Skerritt FTSE FIPAA (Vic)
Deputy Secretary for Health Products Regulation
Department of Health