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Low Dose Naltrexone

I begin by congratulating the hon. Member for Llanelli (Nia Griffith) on securing the debate and hope that by the end of my comments, particularly the last section, she will feel that there is a mechanism and a way forward that she will find helpful. Like her, I am well aware of the interest in the subject from those who feel that LDN is a suitable treatment for a number of conditions, including multiple sclerosis, HIV and various cancers. I am grateful to her for the opportunity to clarify the Government's position. I will begin by talking about the process for licensing drugs in general. An unlicensed medicine is not necessarily illegal in the way an unlicensed driver is; it just means that the regulator has not yet been given the evidence it requires to support a routine place in the market. The Medicines and Healthcare products Regulatory Agency is responsible for the regulation of medicines used in the UK, which includes authorising applications for clinical trials and granting licences for medicines. MHRA gives licences for medicines only after evidence has been submitted to demonstrate the quality, safety and efficacy of the product for the conditions it is intended to treat. That system, whereby licences follow evidence, protects patients and means that there is always a robust, systematic and independent assessment of the safety and suitability of licensed medicines. In the UK, naltrexone is currently only fully licensed in 50 mg tablet form. That dosage is used to help patients remain free from dependence on heroin, methadone and similar opiates and to help those who are dependent on alcohol, but the drug is not currently licensed at any dose for the treatment of the other conditions that the hon. Lady rightly mentioned, because the evidence necessary for a licence does not currently exist. However, naltrexone is being prescribed by some doctors in doses of up to 7 mg on an individual patient basis. This is referred to as low-dose naltrexone. The reason MHRA has not looked into licensing LDN is that it has not received any application or evidence to support it, which means LDN is currently unlicensed. That does not mean that it is necessarily unsafe; it is just that a licence for its use in this country does not exist. The current position is that when a patient needs a medicine an appropriate licensed product should be used. If it is not available, doctors can prescribe a different licensed medicine if they think that it will do the job. If neither of those options is available, an unlicensed medicine may be considered. LDN currently falls into that last bracket. As it involves a significantly lower dose than the licensed form of naltrexone, and as it is untested, it is regarded as an unlicensed medicine. Legislation supports clinicians when they want to prescribe an unlicensed medicine that they think is necessary to meet a patient's particular needs. The MHRA checks that the medicine is being manufactured to the right standards, in a safe environment and with suitable materials. Any unlicensed product manufactured in the UK must be manufactured to the specification of the doctor, nurse, dentist or whichever professional prescribed it in the first place. The important point is that the use of an unlicensed medicine is the direct personal responsibility of the professional who prescribed it. They are aware that it is unlicensed, and they prescribe it with that knowledge. The position is reflected in professional guidance, including that of the General Medical Council. Given that a licensed LDN product is not available in the UK, it can be supplied only as an unlicensed product either manufactured in the UK or imported from somewhere else. Most of the LDN used in this country is manufactured in the UK, but anyone who wants to import it must be authorised by the MHRA. In the UK, manufacturers produce a number of formulations, including LDN capsules, at strengths ranging from 1 mg to 6.5 mg, and these are produced under a ““specials”” licence. The importation of any medicinal product not licensed in the UK must be in compliance with the Medicines for Human Use (Manufacturing, Wholesale Dealing and Miscellaneous Amendments) Regulations 2005, which provides for the import of products when a special clinical need exists for individual patients and when the regulatory authority has not objected to the import. Objections may be made on grounds of known safety or quality issues, or if an equivalent UK licensed product is available. In the case of LDN, there is no ban on the import of products of acceptable quality and safety, and I hope that those comments go some way to reassuring the hon. Lady on her point about the fears of some GPs who had been or were not prescribing the drug. When medicines are unlicensed, such as LDN, the National Institute for Health and Clinical Excellence does not generally assess them, so it has not issued any guidance on the use of LDN in the NHS. When NICE guidance on a particular drug for a particular condition does not exist, it is for local primary care trusts in England to make funding decisions based on their own assessment of the available evidence. On behalf of their patients, doctors can, through an individual funding request, request treatments that are not usually funded, if they feel that there are exceptional clinical circumstances. In this situation, a special panel that includes clinicians would carefully consider individual cases. They would use the latest available evidence and make a decision on the basis of a patient's individual circumstances, but we recognise that there is demand from the NHS and from patients for better access to information about drug treatments, particularly when no licensed product is available, so we are keen to explore whether more can be done to support clinicians, NHS commissioners and patients in their own decision-making by giving them easier access to the best available information. That is why the Department of Health asked NICE to provide a service to support the NHS in deciding whether an unlicensed drug can be used to address an unmet need. Under our plans, NICE will commission expert assessments of the evidence that supports—or does not support—the use of unlicensed medicines, including in rarer conditions. That will help clinicians make decisions about effective treatments and address one of the access problems that patients face. As I said earlier, it is important that we preserve the integrity of the medicines licensing scheme, which is so vital to protecting patients. Any information provided will be designed to inform doctors' decision making and patients' choices, not to provide a simple yes or no recommendation. The Medicines and Healthcare products Regulatory Agency is responsible for the enforcement of the advertising regulations—another important area with regard to this subject. There are also self-regulatory controls operated by the industry body—the Prescription Medicines Code of Practice Authority—and general controls on advertising operated by the Advertising Standards Authority. Regulations state that"““no person shall issue an advertisement relating to a relevant medicinal product which is a medicinal product in respect of which no marketing authorisation or traditional herbal registration is in force””." The regulations apply to any person and are not specific to the pharmaceutical industry. This prohibition does not prevent independent patient charities from providing balanced and factual information about treatment options, including any that are not licensed. The MHRA has published guidance on its website. The MHRA would investigate any complaint about a breach of the legislation, but has not received any complaint about the advertising of low-dose naltrexone. Whether a charity or another third party was promoting a medicine or providing non-promotional information would be decided on the facts of any specific case. The hon. Lady will no doubt appreciate that it is in everyone's interest to see a booming medical research industry in the UK that is successful, is meeting its requirements, and is pushing forward our development and use of advanced medicines to help to bring relief to those suffering acute illnesses or long-term conditions and to help them to manage those conditions better.