The medical cannabis industry needs to invest in clinical trials if products are to be made available on the NHS, says a Conservative Lord.
Speaking to the House of Lords on Tuesday 12 July, Conservative Peer, Lord Kamall, said the Medicines and Healthcare Regulatory Authority (MHRA) was “ready to regulate medical cannabis” – but more support was needed from those in the industry.
During a debate on medicinal cannabis, Lord Kamall, the parliamentary under-secretary of state for Technology, Innovation and Life Sciences, said cannabis companies must come forward to help fund clinical trials.
The Government is said to be “encouraging” producers to work with them to get MHRA approval, but that many were “choosing not to” instead preferring to sell products unlicensed.
The MHRA is responsible for ensuring that new medicines meet applicable standards of safety, quality and efficacy. Once a drug has an MHRA licence, the National Institute for Health and Care Excellence (NICE) can recommend that it be prescribed on the NHS.
Lord Kamall said: “We know that there is a barrier because companies have not come forward to have it regulated or go through the clinical trials, but we are trying to work with those companies and encourage them to come forward.
“In fact, we have also found some NIHR research money available to help with those trials. My request to the industry is: ‘You make a lot of money out of this—please come forward and go through those trials with the MHRA’.
He added: “The MHRA is ready to regulate medicinal cannabis; it just needs companies to come forward and spend money on the trials.”
Members of the House of Lords discussed the blocks to accessing medical cannabis in the UK, following the recent uncertainty over the importation of the privately prescribed product Celixir20.
The product, which is imported from Israel by Bol Pharma, does not meet EU GMP standards and therefore cannot be accepted for import by the MHRA.
A six-month extension has now been approved, meaning patients – many of whom are children with severe epilepsy – will have access to the product until the end of the year while a more permanent solution is reached.
The need for NHS access
The news has reignited ongoing calls from politicians for medicinal cannabis to be more widely available.
Following the legalisation in November 2018 only three prescriptions have been issued on the NHS.
Baroness Molly Meacher, a long standing supporter of the campaign, raised the case of Bailey Williams, 20, who was hospitalised every week throughout his childhood until the last four years since being prescribed medical cannabis.
Bailey’s family were told his only option was palliative care when they asked his NHS consultant to prescribe cannabis to ease their financial burden.
Thank you Baroness @MeacherMolly for your continued support for families in your question in the @UKHouseofLords today. It is shocking that doctors discussed palliative care with @BaileysShakes instead of prescribing #medicalcannabis on the #NHS. pic.twitter.com/snMLIRC3X6
— End Our Pain (@End_Our_Pain) July 12, 2022
Earlier this year, the government announced that the NHS and the National Institute for Health Research (NIHR) were working on two “pioneering” randomised control trials (RCTs) into the use of cannabis medicines for epilepsy.
But while these trials are welcome by campaigners, they will not be suitable for children currently being prescribed whole plant cannabis for epilepsy. Participation in the trials would mean coming off their current medication and the risk of being given a placebo.
These families continue to call for the government to put in place an urgent, temporary solution to help fund private prescriptions until the evidence needed for MHRA regulation and NHS access is collected.
Bailey’s mum, Rachel Rankmore commented: “Our son is at risk of death, we do not have the luxury of time to wait for trials to be complete.”
Khiron announces opening of first Zerenia medical cannabis clinic in Brazil
The new clinic will increase patient access to medical cannabis.
European medical cannabis group, Khiron, has opened its first Zerenia medical cannabis clinic in Ipanema in Rio de Janeiro, Brazil, as it continues its expansion into the country.
As part of its expansion into a number of jurisdictions across the globe, including Germany and Spain following recent developments, Khiron has now opened its Zerenia Rio clinic.
The clinic will provide physical consultations and telehealth services, connecting patients with medical specialists trained in the ethical, safe and responsible prescription of cannabinoid-based medications.
The medications focus on the treatment of conditions such as chronic pain, neurological pathologies, palliative care, rheumatology, psychiatry, geriatrics, endocrinology, gastroenterology, gynecology, otorhinolaryngology and dermatology.
Located in Ipanema, a city with more than 12 million people, the clinic’s initial phase will have a total capacity of approximately 23,000 patient consults per year.
The clinic will be under the leadership of Dr Eduardo Faveret as medical director and will open with more than 13 doctors for both in-person and telehealth models.
Dr Faveret commented: “Brazil continues to experience exponential growth in prescribing doctors and demand for medical cannabis products by patients. Zerenia Rio, is positioned as a comprehensive and humanised pioneer in patient health service and prevention to improve the quality of life of Brazilian families.
“We have assembled a multidisciplinary medical team that covers diverse medical cannabis specialties and treatments, which makes our Zerenia Rio clinic unique in Brazil.”
Dr Faveret and the Zerenia Rio clinic will be supported by Khiron’s strategic alliances with doctors and patient associations, including CANNAB in Salvador de Bahia, and leading medical distributors such as TAIMIN in Rio de Janeiro and Sao Paulo.
Later this year, Khiron is expecting to launch additional THC medical cannabis products in the country, which will complement its current global portfolio.
CEO and director of Khiron Life Sciences, Alvaro Torres, said: “Khiron has developed a unique, successful, and sustainable model with the implementation of Zerenia in Colombia, Perú, and the United Kingdom.
“Brazil is Latin America´s largest addressable market with more than 210 million people and we believe that our Zerenia model will replicate the success we have experienced around the world.
“We have served more than 25,000 individual patients across the globe through our model, with high peer patient acquisition and retention rates. We have a fantastic team on the ground in Brazil composed of doctors, nurses, patient advocates, and administrative staff in our Zerenia™ Rio clinic that will elevate our patient-first model to new levels.
“Khiron’s Zerenia Rio clinic in Brazil will also allow us to continue to generate more patient-based evidence on the pharmacoeconomic benefits of our Khiron-branded medical cannabis products, and through this data, Khiron could eventually be able to provide insurance benefits for patients as we have done in Colombia.”
Akanda and Cansativa to supply German patients with cannabis flower
The collaboration will see patients have access to two novel cultivars.
Akanda Corp and Cansativa are collaborating to supply the German market with dried flowers from Akanda’s EU-GMP certified indoor grow facility in Sintra, Portugal.
Under the collaboration, Akanda is expected to deliver at least 1,000 kg of flower to Cansativa over the first 12 months of the agreement.
All pharmacies in Germany will be able to purchase the products through the Cansativa platform. Since the award of the Federal Institute for Drugs and Medical Devices (BfArM) in August 2020, Cansativa Group is the only company with approval for the distribution of medical cannabis from German cultivation.
Co-founder and CEO of the Cansativa Group, Benedikt Sons, commented: “We are very glad about this agreement that allows us to introduce two novel medical cannabis flowers to the German market.
“This enables patient access to an additional supplier with a new and innovative range of medical products. This exciting cooperation marks another step in improving the product diversity and security of supply on the German market.
“We look forward to a long-term relationship with Akanda, with whom we share an important part of our mission: We want to enable physicians, pharmacies, and patients by giving them access to an extensive medical product portfolio and help improve the quality of life with the help of medical cannabis.”
CEO of Akanda, Tej Virk, added: “Our prized purpose-built indoor grow facility is the only one of its kind in Portugal that can produce EU-GMP medical cannabis equivalent to the adult-use grades available in North America.
“It has both the quality and scalability to meet the growing demand for medical cannabis in fast-growing markets across the EMEA region, such as Germany.
“We are equally excited to be partnering with the Cansativa Group to bring some of our best strains to Germany through their platform. This supply agreement represents one of the largest agreements in the nascent European medical cannabis industry and is certainly Akanda’s most substantial commercial development to date, enabling new patient experience.”
Khiron gains German distribution capabilities with new acquisition
Khiron Life Sciences has completed the acquisition of Pharmadrug Production GmbH.
Through its acquisition of Pharmadrug Production, Khiron will have access to EU-GMP manufacturing capabilities and a distribution hub for medical cannabis.
It will also allow Khiron to accelerate the expansion of its medical product portfolio with additional exclusive flower varieties and a THC‑dominant full spectrum extract that combines the medicinal properties and areas of application of the established THC isolate formulations (dronabinol) with the specific advantages of a full-spectrum extract.
President of Khiron Europe, Franziska Katterbach, stated: “We are very pleased that we have now received all the necessary permits and licenses in connection with the acquisition and integration of Pharmadrug Production and that we can continue our growth course in Europe on an expedited pace with full control over the value chain up to the pharmacy. We are very excited to take advantage of the Pharmadrug Production’s excellent infrastructure and experienced team, which will enrich us professional and personally.
“After opening our Zerenia clinic in London last year and now adding a powerful asset in Germany, our European force is complete and ready to ramp our sales in Germany.
“Now we expect to sell our products faster and at higher margins directly to German pharmacies, which will save distribution fees. A first signal in this direction is the imminent expansion of our medical portfolio for European patients.
“These are products manufactured exclusively in Europe, and our medical portfolio now covers the entire spectrum of chemotypes and forms of administration. We will provide more detailed information on our new products in a timely manner.”
The development is in line with the Khiron’s strategy to strengthen its foothold in Europe, having also recently welcomed Spain’s progression on the regulation of medical cannabis, stating it is looking forward to bringing its clinical expertise and evidence from Khiron-owned Zerenia Clinics to Spanish patients.
Khiron, which recently reported a record 2022 Q1 with revenue of $4.6m, has stated that additional new products are already in the pipeline, that will comprise the entire spectrum of therapies with medical cannabis to be able to offer the right therapy for every patient.
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