This article is part of our special report Shedding light on medical cannabis.
Patients deserve faster access to safe medical cannabis. Legalization is not enough – governments and businesses need to work together to reduce barriers and lessen patients’ reliance on the illicit market.
Catherine Jacobson is Vice President, Regulatory & Medical Affairs at Tilray.
Not long after medical cannabis was legalized in the UK last year, a woman from Northern England approached me to ask how she could obtain a cannabis-based medicinal product (CBMP) for her husband with terminal pancreatic cancer.
He was in tremendous pain and traditional pain medications had not worked. He wanted to try a CBMP to find out if it might alleviate some of his suffering – the therapeutic potential of CBMPs for pain has been well documented – and she asked how she might gain access to the medicines.
I explained the process to her: find a specialist willing to prescribe the CBMP, submit that prescription to the regulator for approval, locate a pharmacy willing to receive the medicine, find a licensed importer willing to apply to the Home Office for an import permit, and submit the import permit to our company, Tilray. We would then apply for an export permit and expedite the shipping to a pharmacy for dispensing. At best, it would take 3 months.
Sadly, the lengthy process took more time than her husband had. He died four months later, without having had the chance to try a medicine that might have reduced pain in his last months. More than a year after legalization in the UK, millions of patients still face the same arduous path to access. Similar burdensome processes exist in the majority of the 41 other countries that have legalized medical cannabis in some form.
This problem is largely the result of legal access being granted before CBMPs are put through the traditional drug approval process, which is overseen by health regulatory agencies. In many countries, politicians have acted on intense demand from patients, moving quickly through legislation to legalize medical cannabis. In others, courts have ruled access to medical cannabis as a patient right. Regulations have struggled to keep up.
There is no precedence for providing access to a medicine without first receiving approval from a country’s health regulatory agency. This has resulted in confusion at every level: doctors, patients, regulators, policymakers, and the public. So much misinformation is circulated on all fronts that it can be hard to tease out the critical issues, the evidence from which to make informed decisions about this complex topic and, most importantly, how to generate the right evidence to guide policy and regulations.
The therapeutic potential of CBMPs has been well documented, though a discussion about the level of evidence that should be required for specific medical conditions is still necessary. Multiple studies by leading scientists around the world have shown that CBMPs are generally safe or safer than other drugs approved for conditions such as pain and epilepsy. For any drug that is being prescribed, the doctor goes through an individual risk/benefit analysis for the patient. In the case of CBMPs, while the specific benefits may still be under debate, the risks are comparatively low.
Yet, regulations and standards set by the medical community are failing patients. This year, Tatterton & Walker1 reported that over 87% of respondents from children’s hospices in the UK know that their patients are receiving illicit cannabis preparations but cannot provide legal CBMPs. According to a survey conducted by the UK’s largest medical cannabis advocacy organization, United Patients Alliance, 72% of patients turn to the illicit market for a product to treat their symptoms. A recent YouGov Poll estimates that 1.4 million people in the UK alone may be obtaining cannabis through illicit means to treat medical conditions.
This estimate is not surprising given the hurdles of access to legal, pharmaceutical cannabis products via prescription in the UK. Not only does obtaining illicit cannabis from drug dealers pose safety risks to patients, they also don’t receive the medical supervision they need and deserve.
There are solutions. We need to build a new cannabis-specific approach that safely serves patients while mitigating the risks to public health. Industry, government, and healthcare professionals all have a role to play.
Companies must continue to ensure doctor and patient confidence. This could be done by ensuring that their medicines meet pharmaceutical-grade global product quality standards based on guidelines set by the leading standard-setting body for medicines, the International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH) or are manufactured under Good Manufacturing Practices (GMP).
Regulators must develop medical regimes that get CBMPs to patients in a time frame that matters and allow doctors the flexibility to prescribe the medicines. Creating a new process that speeds up approvals for CBMPs while working with the industry to develop real time patient registries to generate data on treatment, effectiveness, problems, and cost, will be critical.
A new regulatory approach is needed for several reasons. First, CBMPs do not contain novel chemical entities; rather, they are composed of the generic active ingredients, Cannabidiol (CBD) and Tetrahydrocannabinol (THC), that have been therapeutically used by humans for millennia. Second, cannabis-based medicine is personalized; not only does individual tolerability vary greatly, but the data to inform definitive clinical trials on a specific dose of a specific drug product for a specific indication does not yet exist. And finally, requiring costly and lengthy clinical trials – and placing the burden of the investment squarely on industry – will result in significant price increases. This reduces the likelihood that the drug would achieve cost coverage by the national health insurance agencies and increases the probability that patients will continue to turn to the illicit market.
Finally, we all need to work together to better understand and address public health concerns about less restricted access to CBMPs, such as recreational use in youth, impaired driving, and addiction potential. These should be driven by reliable and robust data collection programs. We also need to make a clear distinction between therapeutic use of CBMPs and adult (recreational) use of cannabis. While the global debate on ending prohibition continues, it should not come at the expense of patients suffering today.
The time has come to move the discussion about the therapeutic use of CBMPs from one steeped in historical stigma around cannabis to a rational one based on data and common sense.