Vol 20 - September 2008
 
Who is the regulator of medicines and who is not?

  With the ongoing Herceptin debate many New Zealanders must be pondering this same question, Ken Shirley, RMI, chief executive officer, observed.
  Medsafe, a business unit of the Ministry of Health is charged with the important task of evaluating the safety, efficacy and quality of medicines that it recommends for ministerial consent to distribute in New Zealand.
  On the other hand PHARMAC is a stand alone Crown agency given the task of procuring the medicines for people in need within New Zealand from within the funding provided.  Both roles are important but quite different.
  It seems that all too often PHARMAC’s innate zeal for cost containment entices them to pronounce on safety and efficacy matters, sometimes in a manner that puts them at odds with Medsafe, the regulator.
  Medsafe recommended the 12 month course of Herceptin treatment for women with HER-2 positive breast cancer on the basis of available clinical data worldwide.
  The nine week Herceptin treatment funded and vigorously promoted by PHARMAC as an alternative treatment regime was specifically rejected by the independent Medicines Assessment Advisory Committee on the basis that there was insufficient data of a regulatory quality to justify a change in the existing approved indication of 12 months.
  Undaunted by this clear unequivocal assessment PHARMAC continues a media campaign with its chief executive (a micro-economist) stating in an open letter:-
 “We don’t have confidence that taking the drug for longer (more than 9 weeks) would show better results . . . . . .  it would not be responsible to fund the longer treatment.”
  This contrasts directly with the regulator’s position based on their safety and efficacy evaluation.  In support of their case PHARMAC frequently refers to an article published in the Lancet.  What they don’t say is that this article was written and submitted for publication by PHARMAC staff. 
  The chief executive of PHARMAC has also stated:
 “Most countries only fund 12 months therapy because that is what Roche has applied for. . . . . . . .  Most countries can only consider funding the treatment regime applied for by the company.  In New Zealand we don’t have that constraint.”
  It was PHARMAC that applied for the registration of the alternative nine week Herceptin course and it was the regulator who said “no” on the basis of the independent efficacy and safety evaluation by recognised medical experts.
  As taxpayers we all benefit from the cost savings that PHARMAC can secure as a single purchaser although we should all be very wary when a commercially active agency like PHARMAC starts usurping the regulator whose focus is safety, efficacy and quality.




R&D spend increases
  America’s pharmaceutical and biotechnology research companies
invested a record $58.8 billion last year in the research and
development of new life-changing medicines and vaccines – an increase of nearly $3 billion from 2006, according to analyses by the Pharmaceutical Research and Manufacturers of America (PhRMA) and Burrill & Company.
  Over the past seven years, America’s pharmaceutical research companies have consistently invested around 18 percent of sales on R&D activities.
  As in past years, there are an increasing number of potential new drugs entering clinical testing. Today, there are more than 2,700 medicines in development in the U.S. for nearly 4,600 different indications. Five years ago, there were about 2,000 medicines in development.

Reference : PhRMA website


 


 




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



New medicines for mental health 
  A record 301 new medicines are currently in development for mental illnesses.  Many of these diseases, such as depression, were once misunderstood causes of shame and fear.  Fortunately today, many are highly treatable conditions.
  Included in the pipeline are 66 medicines for depression, 26 for addictive disorders, 54 for anxiety disorders, 89 for dementia, including Alzheimer ’s disease and 45 for schizophrenia. 
  The medicines are currently being trialled or yet to be reviewed by the FDA.  For more information click here
http://www.phrma.org/files/Mental%20Illness%202008.pdf 



australiaAustralian reforms to fund access to new medicines   
  
  Reforms to Australia’s PBS began last month with major price reductions for many older patent-expired and generic medicines and further reforms are expected.    
  Medicines Australia, the RMI equivalent, is working with the Federal Government through the Access to Medicines Working Group which will, hopefully, ensure future access to innovative medicines for Australian patients.
  “From this side of the Tasman we can only look with envy at the formal collaboration that exists between the Australian Government and stakeholders" the RMI chairman Dr Pippa MacKay commented.
  The Australians recognise there is still quite some way to go with their reforms.  While many older medicines took price cuts of up to 25% the savings – expected to be $3 billion over ten years – are supposed to fund new and innovative medicines in the future.
  The key difference between New Zealand and Australia is that their reforms have always been about using the savings from a more competitive generics market to ensure Australians continue to have a greater and more timely access to cutting edge therapies.
  While New Zealand places an even greater emphasis on generics, we fail to invest the same level in innovative medicines.
  “Seeing the latest funding allocation for the community schedule, which is less than the rate of inflation, just shows that investments in new medicines for New Zealanders will be a rare and remarkable event,” Pippa MacKay said.


RMI Secretariat - change of address
  From the 1st of October we will be located at Level 8, Primeproperty Towers, 86-90 Lambton Quay, Wellington.  Our phone, fax and postal details remain the same.
www.rmianz.co.nz

 

  

 



If you no longer wish to receive these emails, or you wish to update your profile, please click here.