Monday, 26 October 2015

The repurposing Bill

We are asking for your support to get a second reading of the Repurposng Bill

Please support this and get your MP to attend and get this debated

http://multiple-sclerosis-research.blogspot.com/2015/10/drug-repurposing-bill.html

The Bill would:

  • Create a route to market for off-patent drugs that have been repurposed.
  • Put a duty on the government to step in in the public interest where there is currently a market failure preventing some drug indications from being licensed by MHRA and appraised by NICE.
  • Seek to replicate the existing system for drug licensing and appraisal.
  • Provide clarity for both prescribers and patients by ensuring that the only factor that affects whether a drug is licensed and NICE-appraised is the strength of the evidence, and not commercial viability.
  • Only take effect where there is a published (or anticipated) phase 3 clinical trial proving benefit in the new indication.
  • Require the government to partner with an existing manufacturer of the generic drug to provide it and undertake pharmacovigilance for its new indication. Alternatively, it could partner with Porton Down Ltd, a pharmaceutical company owned solely by the Secretary of State for Health.

The Bill would not:

  • Change anything about the existing licensing and drug appraisal system in the UK.
  • Change the evidence threshold required for licensing or drug appraisal.
  • Mandate the MHRA to license the drug in its new indication – the MHRA would still be free to approve it or not, based on the strength of the evidence presented.
  • Mandate NICE to recommend the drug in its new indication – NICE would still be free to approve it or not, based on the strength of the evidence presented.

This is not going to plain sailing because if academics have to follow the pharma lead then there are problems ahead. 

It is going to be difficult to get enough money to support two phase III trials or is one now enough? If it is enough for academics why would it not be enough for pharma as this just slows down the process and costs more.


If it has to be to pharma standard then again it could be a problem as pharma spend millions getting their trials monitored properly and the paper work appropriately sorted.

Are the MHRA going to bite off the hand of their pharma paymasters?...They are 100% funded by pharma, so will they accept anything less than what industry have to do?

Maybe academics have put their head in the sand and say we will come to that hurdle when we get there and hope that they can bend their ears. It will be very embarassing if they can not. Pharma have been turned away and told to do trials again.


With a Cheap Drug you don't need the NICE cost effectiveness calculator: It exists to make expensive drugs cheaper!  So with cheapt drugs you don't need NICE.


In phase III trials the companies also put everyone on drug after the trial are academics going to do this?. Where is the cash coming from?

         DON'T LET PHARMA HAVE THE LAST LAUGH
              AT LEAST YOU CAN SAY YOU TRIED &
                      YOU HAVE LAZY ARSED MPs IF IT FAILS

                  WILL THE SNP USE THEIR POWER TO 
                       MAKE WESTMINSTER DO THIS.

           THEY SEEM TO BE RUN BY AQUATIC ANIMALS:-)
               FIRST THE SALMON, NOW THE STURGEON
                     WILL THEY BE AN AMPHIOXUS?:-) 
                           (Spineless fish-like creature)


The Bill is supported by a number of charities including Alzheimer’s Society, Breast Cancer Now, Prostate Cancer UK, Leukaemia Care, The Cure Parkinson’s Trust, and the Institute for Cancer Research,The MS Society

So if this bill fails surely  they mobilise 100,000 signatures to petition the government of debate this. 

15,000 on MS register alone

8 comments:

  1. A pity about the lack of responses to these political posts. The system is broken which requires some political fixing... I'm not sure the Australian MPs will help, but I appreciate (from Australia) what you're trying to do

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    Replies
    1. There is no need to respond to these posts on this blog. We are emailing our MPs, but they aren't responding. I live in a marginal area where there is a neurological rehab centre and cancer charities, which I reminded him, but he still is too busy to send a personal reply. Too busy helping his colleagues cut welfare I assume.

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    2. Surprising they get a metric on their responses, but luckily you live in a marginal and so your vote counts...tell you MP to remember this so you know where not to put that X come election time

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    3. Surprising they get a metric on their responses, but luckily you live in a marginal and so your vote counts...tell you MP to remember this so you know where not to put that X come election time

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    4. Still haven't heard from him.

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  2. I twist long before you are able, the way they face the treatments of various diseases have to change, especially of MS ...

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  3. I got no reply from my MP but my friend got this.


    Letter from my MP - Dear Mrs Ellis

    Thank you for contacting me about the Off-Patent Drugs Bill.

    I understand your concerns and I agree that it is of utmost importance to ensure that patients have access to the latest and best drugs as part of their care and treatment.

    I would like to take this opportunity to assure you that off-label drugs can already be prescribed where there is robust evidence to support their use.

    I am informed that in February, officials held an event for interested parties called 'Translating evidence into practice' which was prompted by a previous Bill on this topic. Attendees discussed what action, short of legislation, could be taken to ensure that robust evidence about new uses for existing drugs is produced, disseminated and then used to inform clinical decision making about these medicines.

    You may be interested to learn that the Government has recently established the Accelerated Access Review which aims to develop ways to speed up access to innovative drugs, devices and diagnostics for NHS patients in a cost-effective way.

    Please feel free to feed in your comments on the various lines of enquiry here https://engage.dh.gov.uk/acceleratedaccess/

    Thank you again for taking the time to contact me.

    Yours sincerely

    Tim Loughton MP

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    Replies
    1. So the Tories are against the Bill.

      They are being fed the line that we do not need this because we can do this already.

      The UK Government launched the Accelerated Access Review to assess the pathways for the development, assessment, and adoption of innovative medicines and medical technology.

      The review will consider how to speed up access for NHS patients to cost-effective new diagnostics, medicines and devices. It will focus on innovative types of product, in particular, drugs based on stratified medicine, new diagnostics and digital health technologies.

      New, Innovative and Cost Effective are not words that go together properly (Cost effective means this will be £30,000 per QALY

      so buzz words for lets make some money and do nothing to change the status quo

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