Off-Patent Drugs Bill (November 2015)

I wholeheartedly agree that it is incredibly important to ensure that patients have access to the latest and best drugs as part of their care and treatment. To that end I spoke in the recent debate in November. You can view the content of my speech at:…

Off-label drugs are drugs that are used for a purpose other than that which they were specifically licenced. They can already be prescribed where there is robust evidence to support their use.  Off-patent drugs are drugs whose patent has expired and so other manufacturers may have made generic or non-branded versions of the drug. They are also widely used in the NHS at present. Legislation is not required to make this happen.

I believe that while existing legislation gives the NHS the flexibility to respond to the individual clinical needs of patients, whilst taking into consideration the latest research findings, current evidence would suggest that this is not happening quickly enough. Prescribing decisions should be a matter for doctors, in discussion with their patients, and guidance on this is available from a number of healthcare organisations.


In February, Government officials held an event for interested parties on this matter to discuss what action, short of legislation, could be taken to ensure that robust evidence about new uses for existing drugs is produced, distributed and then used to inform clinical decision making. Areas were identified which required improvement, including the mapping of clear pathways for those who want to “re-purpose” drugs. I am glad that officials have been engaging with interested parties to endeavour to put this into practice.

You may be interested to learn that the Government has also 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.

There are systems in place to ensure that the NHS obtains the best value in purchasing medicines. I know that the NHS tries to derive benefits from drugs coming off patent by ensuring that there is not excessive profiteering in the sector.

I look forward to ensuring more positive patient outcomes.

November 2015