Off-patent Drugs Bill

David Nuttall Excerpts

Friday 7th November 2014 Commons Chamber

[Mr David Nuttall (Bury North) (Con)]

I congratulate my hon. Friend the Member for Cardiff North (Jonathan Evans) on bringing this fairly short, but very important, Bill before the House. I am delighted to be named as one of its sponsors. I have to say that I am perhaps the least well qualified of them all. My right hon. Friend the Member for North Somerset (Dr Fox) and my hon. Friends the Members for Bracknell (Dr Lee) and for Totnes (Dr Wollaston) are all real doctors. The fact that they are real doctors and have felt it appropriate to lend their names to this Bill is, in itself, something of which the House should take careful note.

This Bill is required because when a drug whose patent has expired is found to be effective in treating a different condition from that for which it was originally licensed, doctors are reluctant to prescribe it because it is not licensed for its new use. As I understand it, the Bill would put the onus on the Secretary of State to take steps to secure licences for clinically proven off-patent drugs for their new use when no other body has taken on that role.

In essence, the Bill would put an end to a postcode lottery. Patients are left in limbo. Until they go to their GP, they do not know whether they are registered with a GP who is prepared to take this risk. The Bill would remove that postcode lottery and give security to millions of patients. If the process has been followed and the drug licensed for its new use, whichever GP they are registered with will have the confidence and security of being able to prescribe it for its new use.

I am pleased to say that the Bill has the support of many charities: the Association of Medical Research Charities, the Breast Cancer Campaign, Leukaemia & Lymphoma Research, Breakthrough Breast Cancer, the Alzheimer’s Society, the Multiple Sclerosis Society, Leukaemia CARE, Breast Cancer Care, and the Cure Parkinson’s Trust. That is a wide range of charities, all of which, for their own individual reasons, can see the sense of having a new procedure in place to bring back to life drugs that are found to be of new use but are off-patent.

The Bill also has the support of many of my constituents. I thank all those who have taken the time and trouble to write to me personally to express their support for the Bill and to urge me to continue to support it. I am delighted to do so.

[Bob Stewart]

A lot of us have received letters from constituents, including me, and I am absolutely delighted that we are here to support the Bill and get it through as fast as possible.

[Mr Nuttall]

I am grateful to my hon. Friend for that intervention.

This Bill will cut through the red tape that exists at the moment. It aims to get drugs off the shelves and into the hands of the patients who need them. I hope it receives the wholehearted support of this House.

--- Later in debate ---

[George Freeman]

I am not sure it is quite as simple as that. There is a significant and substantial ongoing series of discussions in the sector at the moment on issues such as the cancer drugs fund, specialist commissioning and whether we should be ring-fencing different medicines and therapeutic areas. The truth is, for reasons I described earlier, that the landscape is changing dramatically. I totally understand that charities that rightly support greater use of off-label medicines would like to think it is possible for us to legislate for these drugs to be put into use, but from the conversations I have had, it is apparent that clinical opinion is very varied. Nobody I have spoken to in the clinical profession wants the Government to go down the slippery road of starting to legislate for particular uses of particular drugs, which is effectively what this mechanism seeks to begin to do.

I commit today to working with NHS England, the MHRA, NICE and patient and professional groups to explore in depth the issues around the cultural challenges on unlicensed and off-label prescribing in general. We know that we need to look at the issue of clinical leadership. We need to take steps to improve how new evidence is translated into prescribing practice, and how hospitals and GPs work together and how that works within the care pathway. I am absolutely committed to doing what needs to be done and what can be done now within the existing system, and to looking at the evidence to ensure we adopt the approach most likely to succeed. Most trusts have robust governance arrangements set up to consider innovative treatments that clinicians may want to prescribe. A trust’s drug and therapeutics committee, or indeed the clinical ethics committee, provides an opportunity for doctors and pharmacists to explore the clinical and patient safety implications of doing so.

I am delighted to confirm that we have begun to work with NHS England and other stakeholders including NICE to get a handle on this and to accelerate the use of off-label drugs. I restate the invitation to interested Members to come and join the project. We are absolutely committed to looking at why there may be delays in translating new evidence and research into clinical practice, including why some clinicians are reluctant to prescribe drugs outside of their licensed indications when many others are not, and to consider what further arrangements might be put in place to assist in implementing new evidence into care pathways. This is a problem we face across the system, with variable uptake of NICE guidance. It is one of the central objectives of my new role in the Department of Health to drive consistency of uptake across the system.

I believe this offers the prospect of a more appropriate, sustainable and rapid approach to this problem that can apply to a range of different drugs and clinicians.

[Mr Nuttall]

The Minister has just used the word “rapid”. How quickly will these drugs become available?

[George Freeman]

I am not clear which particular drugs my hon. Friend is referring to, but let me answer in a generic way. I would like us to become a place where, instead of it taking 10 or 15 years and $1 billion to bring innovative drugs to market, we use the NIHR platform and our investment in genomics to become a country where for some cancers we could be getting drugs to the most needy patients through the early access to medicine scheme that I have been championing and that the Department launched earlier this year. Potentially, we could be getting drugs to patients five, six, seven or eight years earlier than would normally be the case through the traditional model of phase one, two, three, four.