Do you want the good news or the bad news first? Let’s start with the good news: the National Health Service (NHS) has approved cannabis-based medicine, a brisk year after cannabis garnered approval for Schedule II prescription dispensation. Bad news: the NHS-approved program is one of the most restrictive programs in Europe. But, in a disjointed pre-Brexit climate, that might be the least of their worries.
Through the program, cannabis-based medicine is carefully prescribed by physician specialists, and treatment options are minimal. From those qualifying for NHS coverage, a tiny percentage of the population is eligible for the treatment — it’s strictly limited to two rare forms of childhood epilepsy, chemo-induced cancer treatment nausea, and Multiple Sclerosis.
The Cannabis Industry Journal reported on November 14 that federal cannabis reforms in the United States would undoubtedly open the doors for strategizing cannabis as a part of NHS medical coverage for the U.K.’s most impoverished and sickest citizens, with the end game a marketplace where patients could purchase the strains and consumption method they wanted.
Some envision a recreational market like Colorado.
But much like the United States, even if widespread medical cannabis use were allowed tomorrow, the NHS, like U.S. health systems, would have to figure out if they would cover it (or not), and if they did cover it, what conditions would it apply to? Critics of the current allowances question why dying children get dibs while millions of adults who could gain immediate relief from cannabis-based treatments are ignored. Why are adult epileptics, or those in chronic pain, or those afflicted with non-MS muscular spasticity left out in the cold by the NHS?
Then there is the issue of cost if the NHS doesn’t issue a diagnosis that qualifies for cannabis-based treatment, which is prohibitively expensive to pay out of pocket. On the private market, cannabis costs upward of $3,000 per month through retail pharmacies. There are a few lucky swans out there that pay a tiny percentage of that — around $12 per month — through pre-claim insurance coverage. That’s the exception and not the rule, of course.
This sort of treatment discrimination will serve the grey and black market well. Those that don’t qualify for NHS coverage will be forced to pay exorbitant private market prices or seek their medicine illegally. Even in Germany, a country not typically associated with ganja, is ahead of the game, although the term ‘gray market’ is tossed about a bit when discussing German cannabis control measures as it relates to quality protocol.
While nobody’s received citations, the lack of standardization globally plus the Brexit situation poses a problem — and therein lies the gray marketplace. And it’s not strictly those operating in the fringes of start-up allowances, either. It includes publicly traded companies, too. The issue at hand is that global standards are different, and Good Manufacturing Practice (GMP) certifications in each country aren’t the same thing across the board.
That explains recent trade agreements and why the new EU-US mutual recognition agreement (MRA), where the European Union (E.U.) and United States (U.S.) regulators completed assessments of GMP inspectors for human medicines (cannabis included) was signed. Signatures were gathered regionally first and then signed on an individual state-by-state basis across the E.U.
While each agreement has a different parameter, the MRAs allow the E.U. authorities and their counterparts to rely on each other’s GMP inspection system, share inspection details and quality defect information, and waive batch testing of products imported into their territories. In essence, the aim is to promote market access, develop higher international compliance standards, and protect consumer safety, all while expanding the global supply chain. In the case of cannabis-based medicine, these MRAs specifically support pharmaceutical trade — minimizing manufacturer cost, reducing inspections, and eliminating testing fees when products are imported.
