Accessing unlicensed medications

The Medicines and Healthcare products Regulatory Agency (MHRA) is the agency that regulates all new medicines.  They weigh up the risks and benefits of each new medicine, following the completion of phase III trials and then decide whether to license it or not.  Some of us with Birdshot will know that we are unable to get some medications that may be licensed elsewhere (e.g. in the US) or that have been tested at phase III trials, but have to go through the sometimes lengthy procedure to be licensed.

The MHRA is now consulting on whether they should provide early access to medicines before they are formally licensed.  The consultation period ends on 5 October, and if the MHRA goes ahead with this scheme, it may mean that those of us who have tried all the more traditional approaches to controlling our Birdshot without success can get hold of newer medications earlier.

There are a few provisos, of course!  The scheme will be voluntary and limited to medicines that show a “significant advance in treatment in an area of unmet need”.  The MHRA also expects to limit the scheme to only one or two medicines each year.  Finally, the scheme will be limited to those medicines that have reached phase III trials (apart from exceptional cases – yet to be defined).  If this scheme goes ahead, the MHRA will provide an opinion of the risks and benefits of the medicine on its web site to help clinicians and patients decide, and it would then be up to the funding body (your local clinical commissioning group made up of GPs in your area; or specialist commissioning group) to decide whether to fund the medicine or not.

So, even if the scheme is launched, there will still be hurdles to jump over, but at least it provides hope for those of us who are struggling to get hold of medicines on the NHS which are not licensed here.

It would be really, really helpful if our patient and professional members could give their comments to the MHRA

To read more about the proposed scheme, please click on the link below:

http://www.mhra.gov.uk/NewsCentre/Pressreleases/CON174774

If you want to give your comment on this scheme, you can email earlyaccess@mhra.gsi.gov.uk by 5 October 2012

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