TGA and Cannabis

[Guest niall]

Yeh, Sativex sounds the best too.

 

The majority of patient reports I've seen are that it is somewhat helpful for some conditions, but is extremely expensive and the standard dose is very, very small. Still, I think it's a positive step to have at least one legal option for patients that has had positive outcomes for some people. It may not work for everyone, and most won't be able to afford it, but it proves that cannabis works.

 

But wouldn't they need THC and CBD on schedule 8 to gave Sativex?

 

Yep see previous page, the TGA is reviewing both for schedule 8.

[Guest niall]

Hmm, some interesting quotes from NDPSC's Record of Reasons Feb 2009 (pp151-157):

 

In regards to the current classification of cannabidiol in relation to the Convention on

Psychotropic Substances 1971 and the Single Convention on Narcotic Substances 1961,

XXXXX has advised that cannabidiol, as such, is not under international control.

However, XXXXX did point out that as the pharmaceutical product THC+CBD contains

cannabis extracts and cannabis extracts are included in Schedule I of the Single

Convention on Narcotic Drugs of 1961, then this convention would apply to THC+CBD.

According to Article 2 of the Single Convention, drugs included in Schedule I are subject

to all control measures applicable to drugs under the Single Convention, including the

mandatory submission of annual estimates and statistical returns as well as the control of

international trade. That is to say, the obligations upon signatories for substances

included in Schedule I relate to mandatory reporting of movement of these substances

and these do not necessarily translate to mandatory restrictions on access. It was also

pointed out that the substance delta-9-tetrahydrocannabinol in its isolated (synthetically

manufactured) form is contained in Schedule II of the Convention on Psychotropic

Substances of 1971.

 

and to summarise (yes this is clearly about Sativex) they will be discussing this over the next few days starting TOMORROW (16/6/09):

 

DISCUSSION – RELEVANT MATTERS UNDER 52E

 

Some jurisdictional Members noted that XXXXX it has been difficult for jurisdictions to

approve access to these products as cannabidiol was considered a Schedule 9 substance.

It was noted that access would be facilitated if cannabidiol was a Schedule 8 substance.

 

The Members noted the policy advice provided by the NCCTG in relation to the

scheduling of dronabinol at the November 1994 NDPSC Meeting. However, the

Committee did not consider it necessary to seek policy direction from the NCCTG on this

occasion.

 

It was noted by a Member that enquiries received by jurisdictions to date were mostly

from individuals (i.e. patients) or from general practitioners under instruction from their

patients. It was asserted that this was not a routinely accepted treatment for multiple

sclerosis-related neuropathic pain.

 

One Member requested that the Secretariat ascertain whether this product contained any

other cannabinols, even in trace amounts. As this product was derived from an extract, it

may contain other cannabinols.

 

RESOLUTION 2009/55 - 26

 

The Committee confirmed that tetrahydrocannabinol was captured by the current

Schedule 8 entry for ‘dronabinol’ (delta-9-tetrahydrocannabinol) and agreed to

foreshadow consideration of the scheduling of cannabidiol in Schedule 8 when prepared

and packed for therapeutic use at the June 2009 NDPSC Meeting.

 

So let's hope they make a sound decision based on the proven science of cannabinoid medicine. By co-incidence I'm meeting with my pain specialist tomorrow morning so I've prepared a pack on all of this to see if we can pursue it (I have chronic neuropathic pain, been suffering from this quietly for almost 10 years now - cannabis has worked where nothing else has, and an order of magnitude better than anything we've tried in terms of both relief from severe muscle spasm and the underlying nerve pain that's triggering this).

 

Fingers crossed that my Dr has an open mind!

[Guest niall]

just realised this was all quoted back in luciddreaming's original post

[luciddreaming]

Hehe oh well, at least you can understand it

Also on the price, I thought it was just dronabinol that was expensive not sativex?

I heard dronabinol is like 400 a month or some insane shit like that.

But as more people get it it will go down anyway.

[Guest niall]

Hey guys the NDPSC dates and meetings page has been updated:

 

http://www.tga.gov.au/ndpsc/meetings.htm

 

NDPSC 56 - Jun 2009

Gazette notice published and posted with Record of Reasons to NDPSC website: 5 Aug 2009

Public comment closes: 19 Aug 2009

SUSDP Amendment effective date: SUSDP 24/2 - 1 Jan 2010

 

NDPSC 57 - Oct 2009

20 wk cut-off for scheduling submissions: 22 May 2009

16 wk cut-off for scheduling submissions: 19 Jun 2009

Cut-off for Gazettal: 11 Aug 2009

Pre-meeting Gazette notice published & posted to NDPSC website: 19 Aug 2009

Public comment closes: 16 Sep 2009

NDPSC MEETING (Tue-Thurs): 20-21 Oct 2009

Gazette notice published and posted with Record of Reasons to NDPSC website: 2 Dec 2009

Public comment closes: 16 Dec 2009

SUSDP Amendment effective date: SUSDP 24/3 - 1 May 2010

 

Let's see if we can get prepared for the public comment period from 5th August to 19th August, and the October meeting!

[luciddreaming]

Awesome mate thanks!