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