Why Does the NHS Still Seldom Prescribe Medicinal Cannabis After 5 Years?

Beyond the existing restricted alternatives, additional clinical data is required to verify the efficacy of the products for the ailments they are recommended for before the NHS may prescribe medicinal cannabis to patients. The NHS policy is to only prescribe drugs that have received commercial approval. This procedure entails multistage clinical trials, with each stage permitting the treatment or therapy to go to the next stage. Because of the nature of clinical research, there is an inescapable time restriction that each step necessitates. The procedure also necessitates the purchase of equipment and experience in order to conduct the tests in the most efficient manner, which brings us to our second obstacle to the release of a licenced medicine: the cost.

Let’s take a closer look at the procedure to see how cannabis may become a medication on the NHS.

What exactly is medicine?

The Medicines and Health Regulatory Authority (MHRA) defines a medication in the United Kingdom as:

“Any substance or combination of substances which may be used in, or administered to, human beings, either with a view to restoring, correcting, or modifying physiological functions by exerting a pharmacological, immunological, or metabolic action, or to making a medical diagnosis”

The current history of prescription medications in the United Kingdom begins in 1852 with the introduction of the first edition of The Pharmacy Act, which was later reworked in 1868 so that only chemists may sell the specified medicines and poisons. Later, around the turn of the twentieth century, international drug accords such as “The Opium Convention” were established. Following World War II, the United Nations was established to replace the League of Nations. They replaced the Opium Convention with the Single Convention on Narcotic Drugs in 1961, and member countries were required to establish stricter regulations on the international trade of drugs and medicines.

How can a molecule become medically recognised?

A chemical gains medical recognition after passing a battery of tests meant to demonstrate that it functions better than a placebo. Most medications begin with a pre-discovery stage in which researchers examine the target condition and attempt to learn about the physical processes that are going on in order to determine whether a certain receptor or protein may be targeted. The following step is discovery. A selection of identical molecules will be generated using ingeniously devised chemical methods and tested to discover which ones exhibit evidence of action and do not kill the subject in synthesised medications. Thousands of novel and existing compounds might be screened in this procedure.

The components are then constructed in the development stage to evaluate bioavailability using various combinations of the materials to see what works best. When absolutely necessary, the tests might be computerised, performed on cells, or performed on animals. The next stage of development involves determining the best delivery method, which will take into account a variety of factors such as how easy it is to deliver, the potential dose size, how easy it is for the patient to administer, how much of the drug gets into the system, and how long it takes to take effect or wear off. It may entail inventing new technologies to administer the medicine in the most appropriate way.

After all of the foundation has been laid, it is time for scientists and drug developers to find out if the medicine they have been working on is safe and effective or if they need to go back to the drawing board.

Phase 1: Consists of a small group of healthy participants (20–100). The data collection process might take several months. In rare cases, a trial medicine is administered to very ill or terminally ill individuals. Tests on healthy people make it simpler to discover any adverse effects or significant responses that are not the result of a complication of an underlying medical condition.

Phase 2: This entails a larger number of patients (100–300). The data collection process might take several months to two years. The goal of this phase is to not only answer the question “Does the drug improve the disease?” but also to determine the appropriate dose and frequency of administration. These studies are often randomised, so participants have no idea whether they will get the experimental medicine, a placebo, or regular care. They are also double blind, so the investigators have no idea which patients are in which group, further eliminating therapeutic bias. The placebo and regular therapy serve as control groups, allowing researchers to determine if they work worse, equally well, or better than nothing or the present drug. If it does not function as well as the current treatment, it may not be worth continuing, and if the placebo performs better, it is not regarded as successful. Larger research groups and individuals with the illness being studied have a higher risk of experiencing adverse effects.

It is crucial to note at this point that only 33% of successful Phase 1 and 2 studies go to Phase 3. Due to regulatory authority, trial effectiveness, planning, and participant recruitment, each step may take many years to begin.

Phase 3: Hundreds to thousands of patients (300–2000+). The data collection process might last up to four years. In Phase 2, trials are double-blind and randomised, with all of the same preventive procedures. Larger data sets and participant monitoring allow researchers to learn more about side effects and supply most of the information seen in the safety brochure included in each drug box.

The medication developer can now apply to the MHRA and the European Medicines Agency (EMA) for marketing authorization to validate the medicine’s quality, safety, and efficacy. However, it is not fully done; continuing monitoring will take place over the next 20 years.

Phase 4: Ongoing monitoring for the duration of the medicine’s life. The studies will continue after the medicine has acquired marketing authorization and may be prescribed to patients by doctors. Selective patient monitoring assists medication makers in understanding the most uncommon adverse events, other drug contraindications, and long-term user safety data that can only be gathered over time.

In the case of medicinal cannabis, we are looking at the existing chemicals THC and CBD and how they can progress through this process to become an NHS-approved drug. As you can see, it’s not as easy as “look, it works.” It is noteworthy to note that numerous pharmaceutical firms are in the research and development stages of developing synthetic cannabinoids that target particular symptoms of certain illnesses.

When may the NHS prescribe a medicine?

The NHS can only prescribe a prescription if it has passed through a Health Technology Assessment (HTA), which evaluates the cost effectiveness and clinical efficacy to assess whether supporting a certain treatment is in the best interests of the patient and the taxpayer. This is the National Institute of Health and Care Excellence (NICE), the All Wales Medicines Strategy Group (AWMSG), and the Scottish Medicines Consortium (SMC) in the United Kingdom. Once a new drug has received a technology appraisal from NICE, it must be included in the NHS formulary within three months. The NHS is required to prescribe and source this drug after it has been granted a TA and is on the formulary. When a medication is on the NHS formulary, doctors are more likely to prescribe it.

What distinguishes medicinal cannabis from other medications?

Because of the increased scrutiny that prescribers face when prescribing medicinal cannabis, it differs from other drugs. Because cannabis products have not yet been subjected to the normal marketing authorization procedure that all medications must follow, there is still a high level of anxiety and apprehension. Cannabis-based therapeutic products are currently unlicenced, placing them in the “specials” category and sometimes referred to as off-licence. Specials refer to prescriptions issued under “exceptional circumstances.”

The Home Office has granted specialised doctors registered with the GMC prescription rights but has so far refused to enable GPs (even private ones) to do so. Seeing a consultant specialist doctor on the NHS needs a referral from an NHS GP, which is normally only done when there is an obvious concern that requires additional investigation or you have failed to react to the medications that a GP may prescribe. You can also self-refer to a private cannabis clinic and see the same type of professional consultant.

How was medical cannabis legalised in the United Kingdom?

Medical cannabis was legalised in the United Kingdom following a succession of concerted efforts by corporate and patient lobbying organisations that kept the government under continual pressure to acknowledge cannabis’s therapeutic advantages. Patients’ tales were featured in newspapers, with epileptic youngsters resonating the most with the general public. Concerned about the possibility of children being exploited as publicity stunts in the press, policing minister and MP Nick Heard met with patient organisations, carers, parents, and other cabinet members. These public campaigns not only tugged at the heartstrings but also at the strings of power, and the Home Secretary, Sajid Javid, made the announcement in July, and the law went into effect on November 1st, 2018. A modification to the Misuse of Drugs Act of 1971 reclassifies CBMP as a Schedule 2 substance, indicating that it has a high potential for misuse and the capacity to induce psychoactive effects. This may change when more data is released, but only if further clinical studies have been conducted and finished with a good outcome.

Is the government interested in medicinal cannabis clinical trials?

Yes, the government wants to see additional clinical research on THC and CBD. Contrary to common assumption (and perhaps owing to their documented history of opposition), the UK government welcomes fresh research supporting the usefulness of cannabis-based therapeutic goods.

When the Home Office declared medicinal cannabis lawful, the National Institute for Health Research (NIHR) established a financing programme that allows medical cannabis firms to conduct clinical studies with the government covering 50% of the costs. This sparked some curiosity, but it did not result in a fruitful relationship, and it was refused. While businesses want to preserve their financial investments, the unfortunate side consequence is that patients suffer in the long term, and doctors are precluded from confidently prescribing drugs in courses they know are successful at curing the target illness.

Are there any medicinal cannabis clinical studies underway?

Yes, multiple large clinical trials are underway to investigate the effectiveness of THC as a treatment for various illnesses. Jazz Pharmaceuticals is continuing GW Pharmaceuticals’ study with marijuana to investigate diabetes, although little progress has been made in a couple of years. Jazz Pharmaceuticals and the Wellcome Foundation have invested £16.5 million in CBD research at Oxford University to see whether it is a useful treatment for schizophrenia and psychosis. A double-blind randomised clinical study on cannabis and immediate postoperative pain, nausea, and vomiting is being developed at Imperial College London.

Celadon, which has a licence to grow cannabis in the UK and has recently received marketing authorization for the specials medicine market, has also been granted permission to conduct a large-scale clinical trial in up to 4,900 patients aged 18–85 with non-cancerous chronic pain conditions.