MAJOR players in the Island’s burgeoning cannabis growing industry – which posted a profit for the first time last year – say that all the good work so far could be eroded by government inaction over licensing.
Two locally-owned businesses that have invested tens of millions of pounds in developing highly secure and regulated facilities say they just need the government to issue a manufacturing licence that will allow them to package their medicinal products in patient-friendly quantities.
St Lawrence-based Green Island and St Martin-based Caprica say that they already exceed the required standards – with the latter already having been audited and approved by the UK medicines regulator – and it should be a simple endorsement from Jersey.
Caprica already has permission to cultivate and sell bulk quantities of medicinal cannabis; however, both they and Green Island argue that the global market wants producers like them to ‘finish’ off their product before it enters the European market – and Jersey is perfectly placed to do that.
Both growers also want to be able to sell their end-product directly to Jersey patients, which they say would push down costs and drive up efficiencies.
However, they say that government inertia is putting this potential huge inward investment – potentially worth millions to the Jersey economy – in jeopardy.
Neel Sahai is founder and chief executive officer of Green Island. He said: “The government has done so much good work to develop this industry but there is an imminent danger that a lot of that effort will be wasted.
“This is a complicated, capital-intensive business and, to be honest, it has taken longer than everyone anticipated at the beginning to set up.
“As it developed, we realised that, in order to make it a success, we needed to move up the value chain and go into more complicated areas and attain the very highest standard, which is called GMP, or Good Manufacturing Practice.”
GMP is regarded as the gold standard of licensing, and there are two types: GMP Part Two allows cultivators to produce an Active Pharmaceutical Ingredient, such as cannabis flower or liquid, in bulk.
It is what Jersey’s largest and best-known cannabis producer Northern Leaf has, and the St Lawrence-based business is exporting tonnes of product to European markets, including the UK and Germany.
However, what Caprica has done, and what Green Island plans to do this summer, is achieve GMP Part One. That is a higher bar to surmount, which allows them to produce and release a finished medicine onto the market.
Mr Sahai said: “Understandably, there is a higher level of risk and responsibility attached to that, and the UK Medicines and Healthcare products Regulatory Authority [MHRA] needs to see a robust set of processes in place to enable someone to receive that.”
Caprica founder Giles Castleton added: “Only a handful of companies in Europe have that, and we are the only grower in the British Isles to be GMP Part One. That should be the highest hurdle to overcome, which should then allow our government to issue what is known as a manufacturer’s licence.
“Once we have that, we will then be able to put a finished medicine onto the market. From Jersey, we would be able to supply a local pharmacy, wholesaler or other licensed business directly.
“The real value in this industry is that finishing, higher value activity – delivering labelled prescription drugs ready to be prescribed to patients.”
Mr Sahai continued: “Jersey’s government was hugely forward-thinking in taking an early decision on cannabis and it absolutely made the right decision. It has taken a lot longer than everyone expected but we are now at a stage where there is a genuine opportunity for the Island.
“Northern Leaf has become successful and is exporting good volumes, which is fantastic. We are focusing more at the top-level, value-added service, which will also capture a lot more value here in Jersey.
“There is a genuine opportunity to really bed this industry in. We are having active and advanced discussions with a major player in the Canadian market and some of the big players in the UK market, who want to send their bulk API product to us in Jersey to finish and release as a finished product.
“They are attracted to Jersey because of its regulatory setup. They also view the Island as a place which should be agile and nimble and, to some extent, we have proven that in the past – around making changes to Jersey’s proceeds of crime law and how it has gone about licensing so far.
“However, if we cannot get these manufacturing licences across the line fairly quickly, we will not be able to take advantage of those opportunities. That is what these firms are interested in; it is not us growing a bulk flower.”
He added: “There is a big surging demand in Europe: the UK and Germany being two key markets. You have a lot of supply sitting in North America, Thailand and other countries but there is a pinch point to getting access to those markets, and Jersey has the ability to sit at that bottleneck and unblock it. That provides a huge potential for this industry.
“Jersey’s Health Minister has commissioned a review of the medicines law and regulations, and we are starting to hear back some of the results of that review.
“We commend the vast majority of what is proposed – but our biggest fear is that the government will not issue these manufacturing licences until they have got to the end stage, which could be years away … and that is going to be too late.
“Ministers talk about wanting to diversify the economy and they have set up a lot of good strategy, and there has been a lot of good talk. But now it’s time to execute; we need action.”
Mr Sahai continued: “We also need to have better communications with the Health team to understand what concerns they might have.
“For our part, we have looked closely at this, including taking legal advice, and we believe that there is no reason why the government cannot issue these licences to enable us to take advantage of these opportunities.
“If that major player in Canada decides to use Jersey as a platform for high-value work, that would be excellent news which would put the Island on the map, which would have its own snowballing effect through the industry.
“Because of the scale we will be operating at, the vast majority of product is going to be exported but we would also like to supply domestically because why not supply better, more cost-effective medicine to our local population?”
Caprica was audited by both the MHRA and the government last July and received certification by the UK body in October. The business was then informed by Jersey’s chief pharmacist that “the manufacturing licence and associated report are currently with the Minister for consideration.”
This April, the Island’s biopharma industry was told that the government could not grant manufacturing licences because the necessary framework was not in place.
Mr Castleton said: “If I could pack locally, I could offer a much lower price to the local market and elsewhere. The trouble is, we are getting wrapped up with everyone else. The government has said that they need to review clinical trials before they give us an answer on our licence.
“But we are not interested in clinical trials or testing; that is a different ballgame. We have been given a licence by the MHRA but the Jersey government will not sign it off.
“We are in real danger of missing the boat here. We missed the boat on cannabis flower because if we had got it to market a year before, we would have had a brand name. Now it is coming from everywhere.”
Mr Sahai added: “It has been a five-year project to get to where we are, and to be told at this late stage that the government is not yet able to issue manufacturing licences is a little bit crazy to be honest.
“The message we want to give is that the opportunity is real, it is ready to be grasped, and the producers are ready to grab hold. We just need the government to embrace it as well.”
“We have significant plans to expand this year, if the government acts quickly. If they do not, some businesses may be forced to move to the UK and others will not come to Jersey.
“There is a lot of good work going on in the government, and the team in Health are really starting to focus on this, which we have asked them to do; it just cannot get caught up in this wider project. Jersey has long said that is agile, fleet of foot and can make critical decisions quickly.
“It now needs to prove that.”
A spokesperson for Health and Care Jersey said: “Medicines manufacturing regulatory systems exist to protect the public from potential harm.
“As medicines manufacturing is an emerging industry on the Island, an initial review of Jersey’s system for governing medicines manufacturing was undertaken. The review concluded that the current system is not sufficiently robust.
“Work has already started on strengthen existing arrangements on a phased basis. This includes improving matters related to medicines manufacturing licencing processes ahead of considering future clinical trials arrangements.”
