I congratulate my hon. Friend the Member for Daventry (Chris Heaton-Harris) on his success in bringing the Bill so far. The fact that we have reached even this stage is no small testament to his hard work on the Bill, particularly the discussions about the removal of the areas of concern—clauses 3 and 4—and the fact that he has been gracious enough to allow me and the hon. Members for Torfaen (Nick Thomas-Symonds) and for Central Ayrshire (Dr Whitford) to badger or cajole him into allowing us to table new clauses 1 to 6, but specifically my new clauses 4 and 6.
The Minister was not in the Chamber on 6 November to hear the arguments of the Members who proposed and supported the Off-patent Drugs Bill. Since then, however, he has engaged with many of us, for which I thank him. We felt that his Department’s response simply was not correct. Doctors may have been able to prescribe medicines for uses outside their licence or off-label where that was in the best interest of their patients, as the guidance says, but they just did not do so, or at least not consistently throughout the medical profession or the field and irrespective of the patient’s postcode. The prescribing of such drugs is more common in oncology, paediatrics, pain management and palliative care, which adds to the lottery effect for the patient.
The need for an action plan for an off-patent drug pathway is undeniable. When there is a strong indication of effectiveness, their routine use for an alternative indication should be secured. For example, the use of bisphosphonates, which were originally developed to treat osteoporosis, are now commonly used by 36,000 women living with secondary breast cancer in this country. Those drugs have already been through phased trials. No one in this place is suggesting that the highest levels
of safety should not be applied to drug research and licensing at all times, but efficacy should drive clinicians’ decision making.
Patients, too, have a voice on this issue. I found my patient’s voice after my second primary cancer, and I wanted to use it for the benefit of others. Here I am now asking the Minister—not for the first time—to use his position to find a way to unleash the potential of research in this country and to unblock the system for everyone. My oncologist told me that a second primary cancer was luck—bad luck, but just luck—and I hope that we can all improve the odds just a little bit today.
I believe in the power of patients, clinicians, charities and pharmaceuticals to do the right thing—to increase their knowledge for those whose daily lives are dominated by serious disease and debilitating illnesses, and to ensure that treatments exist to help them. Particularly in the area of off-patent repurposed drugs, they need to be supported by key players, such as NICE, the MHRA, NHS England and medical research charities.
I assure the Minister that it is not mere chance the new clauses and amendments are supported by Members from all four corners of our nation. It is to show solidarity with our constituents—north to south, east to west—who want a co-ordinated approach. One of the most frustrating things for patients is the clogged nature of our drugs pathway. It seems to be beyond us to get drugs licensed, whether repurposed or not, and to the patient in a timely way. I ask the Minister to provide a timeline to support any action that can be taken.
New clauses 2 and 3 would require the National Institute for Health Research to develop and introduce a mechanism for gathering and recording evidence. Last week, I was surprised to learn from Professor Bruce, a clinician at the NIHR working in the musculoskeletal biomedical research unit, that in 50 years only one drug has been licensed for the treatment of lupus. Sadly, that licensed drug has spent four years being considered by NICE and is not available for wider use. To avoid the heavy use of steroids for the condition, rituximab is often used—a drug that was originally developed for lymphoma and rheumatoid arthritis.
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The biomedical research unit is conducting studies in this area and has been successful in drafting an interim policy to provide a framework for governance. The register has been successful in recruiting 400 patients to date. I am hopeful that such an exemplar of best practice could be used to encourage the NIHR to establish a dedicated stream for researching off-patent, repurposed drugs in a more broad-based way.
We need patients and the public to take part in research. The NIHR has a research system that is more inclusive and representative of the population than anywhere else in the world. We need to use it to harness information to benefit patients. Interestingly, it is well documented that those who take part in clinical trials experience better outcomes, so it is a win-win. The opportunities that the NIHR affords us need to be fully explored and, if it is not the most appropriate body, I would like the Minister to commit to finding out what is.
In tandem with any assessment, there will need to be cost-effectiveness to get the drugs into routine commissioning, thereby allowing them to benefit patients.
A lighter-touch approach that makes better use of NICE’s resources should be explored, as it could have the benefits of acting as a business case for adoption, reducing duplication and speeding up access to treatments. A commitment from the Minister to introduce such guidance today would be nothing short of great.
New clause 4, which stands in my name and those of my colleagues, states:
“Where there is an off-patent, repurposed drug with strong evidence of its effectiveness in a new indication, the Secretary of State shall require NHS England to produce and disseminate a national commissioning policy.”
Let us get treatments that are effective and safe to the patients who can benefit from them. A precedent for this is NHS England’s recent work with Prostate Cancer UK to draw up a policy for—you guessed it—an off-patent, repurposed drug. It strikes me that where there’s a will, there should be a way. If there is a way for us in England, I am sure that it is possible to ensure that there is a co-ordinated approach for our friends in Wales, Scotland and Northern Ireland.
In this place last November, I referenced the use of tamoxifen and other drugs as a preventive pathway. The purpose of new clause 5 is to look at introducing more accessibility into the system to make organisations such as academia and charities more connected with the licensing process. We are hoping for a commitment that the Department of Health will work with the MHRA to achieve that.
Finally, I will speak to new clause 6. Back in November, when the hon. Member for Torfaen told us why we needed the Off-patent Drugs Bill, I stated that drugs such as tamoxifen, simvastatin and zoledronic acid, among others, were not getting to patients. Tamoxifen and zoledronic acid, in particular, could benefit the women I have spent many years campaigning for, whose fight against breast cancer is often not only one of the most difficult things they endure, but one of the most difficult any member of their family goes through. We still lose 12,000 women a year to this disease. If there is something that we can do to ensure that fewer women die, we should do it.
In November, the hon. Member for Central Ayrshire, with the expert knowledge of a senior clinician, explained that although there was the ability to prescribe, it did not happen. We therefore propose that the “British National Formulary” includes off-patent, repurposed drugs to end the situation whereby experts are prescribing, but other professionals do not feel confident to do so. Like a bilingual dictionary, whichever way someone approaches the BNF—by disease type or drug—it tells them what they need to know as a prescriber, whether they are a pharmacist, a doctor or a nurse practitioner. The BNF generally includes all the licensed indications of a drug. If it supported the adoption of well-evidenced, off-label treatments, it would serve to provide validity. We hope for a commitment that the Minister will fully explore that proposal with NICE and the BNF.
I commend the Minister for his complete openness in engaging with our group of interested, committed MPs from across the House and across the parties to move the situation forward and find solutions. I urge him to look at the accelerated access review, the interim report of which says that we should put the patient “centre stage” and
“accelerate and manage…emerging products”.
The AAR did not mention repurposed drugs, so I will call them emerging products. It also speaks of, “Supporting all innovators”. We are being innovative. It challenges the NHS to galvanise itself to
“adopt new products and systems”.
What we are discussing could be a new system. Finally, it speaks about, “Delivering change”. I look to the Minister to make those five commitments work with off-patent, repurposed drugs for everyone in the UK.