Vol 18 - June 2008
 
Tweaking the PTAC appointment protocols will not
deliver the necessary transparency


Initial high hopes that the new national medicines strategy would cast some light on the opaque and clouded PHARMAC decision making processes have evaporated.

Many submitters, including the NZMA and the Access to Medicines Coalition, representing some 26 patient groups, called for a separation of clinical assessment from the commercial imperatives of PHARMAC’s drug purchase activities.

Indeed the NZMA said “the fact that PTAC, in determining clinical efficacy blends the issue of affordability into its decision-making has caused NZMA concern for many years.”

The RMI’s Chief Executive Officer, Ken Shirley said “the fundamental problem is that the appointment of PTAC members and the operation of the Committee are controlled by PHARMAC.  The only way to achieve the level of transparency and independence required is to change section 50 of the Health and Disability Act to deliver a model similar to the Australian Pharmaceutical Benefits Advisory Committee.

The tweaking of appointment protocols as proposed by Government is an inadequate response that will not deliver any meaningful change.  Is it attempting to hoodwink us?

However, the lack of transparency is really a symptom of the extraordinary contortions PHARMAC has devised to ration medicines in the face of insufficient funding. 

Where the parties stand on the issue of transparency

At the Medicines Political Forum held earlier this year the health spokespeople of the political parties responded to the following question:

“Do you believe that the bundling of clinical assessments with procurement decisions distorts the pharmaceutical funding process and do you support the evaluations of clinical merit being made independently of the procurement agency?”

The following are extracts of their replies:

• Hon David Cunliffe, Minister of Health“We have a semi-bundled system and are moving towards a more transparent system.”

• Jackie Blue, National“We do have concerns regarding this … there needs to be greater transparency.”

• Sue Kedgley, Green Party“We think that that the existing system is acceptable and that we wouldn’t be seeking a change.”

• Judy Turner, United Future“In the course of the work done in developing the medicines strategy we have been persuaded that there is adequate separation in the decision making between PTAC and PHARMAC.”

• Heather Roy, ACT Party“The independence between evaluations of clinical merit and procurement must be independent.  That is enormously important.”

 
Medsafe Fees

Medsafe is to undertake a review of their fees following a complaint from the RMI to Parliament’s Regulations Review Committee.

Medsafe increased their fees in August 2006 by up to 700% in anticipation of the establishment of a joint regulatory agency (ANZTPA) with Australia. However, the Therapeutic Products and Medicines Bill which would have established the ANZTPA was parked indefinitely in July 2007 as the Government doesn't have the numbers to progress it.

The RMI argued that the fees consultation document gave the reason for the increase as a transitional arrangement in the lead up to ANZTPA.  It said this premise was no longer valid as ANZTPA was unlikely to proceed. The RMI also argued that the methodology used to set the new fees for medicines evaluation did not take into account the actual costs incurred by Medsafe.

The RMI asked for the fees to be revised to a level commensurate with the current situation in New Zealand.

Medsafe acknowledged that the circumstances which were projected to occur have not occurred and has committed to a fees review. A consultation paper is expected shortly.


 




This newsletter is published on behalf of the
Researched Medicines Industry Association of New Zealand. The views and opinions expressed in this publication are not necessarily those of the RMI.

For further information:

Researched Medicines Industry Association
PO Box 10447 Wellington
Phone 04 499 4277
http://www.rmianz.co.nz



Some ommissions in Budget 

The New Zealand Medical Association (NZMA) issued a very thoughtful and balanced response to the Government’s budget announcements welcoming some initiatives but highlighting some serious omissions. 

The RMI fully endorses the following observation of the NZMA

   “Also missing in the Budget was any indication of significantly increased funding for the Gvernment’s drug-purchasing agency PHARMAC.  A good case has been made for the funding of many new pharmaceuticals, which would improve the health of many New Zealanders.”



 

750 medicines and vaccines in development offer hope in the fight against cancer

Pharmaceutical researchers are now working on 750 medicines for cancer.  Many are high-tech weapons to fight the disease, while some involve innovative research on using existing medicines in new ways. 

The medicines in development, all in either clinical trials or under FDA review include 110 for lung cancer, 90 for breast cancer, 64 for colorectal cancer and 88 for prostate cancer.  Additional medicines target brain, kidney, ovarian, pancreatic, skin and other cancers.

Ref:  PhRMA 2008 Report Medicines in Development for Cancer 

 

Cancer charity starts research programme with drug 'borrowed' from industry

The charity Cancer Research UK has started work on its first clinical research programme in a new partnership arrangement with the pharmaceutical industry. This enables it to ‘borrow’ candidate drugs that have been shelved by companies so it can further explore their potential.

The cancer research charity and its commercial arm Cancer Research Technology, is starting the programme with the clinical development of tyrosine kinase inhibitor AZD0424, provided by the drug company AstraZeneca. 

Ref: BMJ 2008; 336:1155(24 May)

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