An Insider’s Look at the EU Cannabis Space

Medical cannabis is gaining steam all around the globe because of its various beneficial health offerings. The European market, in particular, is poised to take research and medical cannabis drug development to the next level. Here, Carl Esprey, CEO of Botanical Holdings, an investment holding company which focuses on all aspects of the legal medicinal cannabis industry, discusses the company’s path in the industry, the European cannabis industry and what the US can learn from other countries and more.

Can you tell us about your company, Botanical Holdings? How did it get started? What is your vision for the future?

Carl Esprey: Botanical Holdings (BH) is a new entrant in the medical cannabis industry, with plans to cultivate, manufacture, distribute, import and export EU-GACP (European Union good agricultural and collection practice for starting materials of herbal origin) & EU-GMP standard (European Union good manufacturing practice) medical cannabis and derivative products.

We have two cultivation units; construction has been completed and cultivation has commenced in Lesotho and construction is underway in Portugal; having cultivation facilities in both hemispheres, supports low-cost, year-round production. Both of these operations will include cultivation, manufacturing, processing/storage, shipping/receiving, and quality control facilities, (comprising several internal testing labs), comprised of several connected structures built using state-of-the-art design to provide superior strength and energy efficiency.

BH intends to be a key player in the European medicinal cannabis industry and be a global leader in the production and export of quality, legally approved dried cannabis flower and manufactured cannabis products for medical use.

BH intends to sell its products through distributors (drug product), pharmaceutical companies (drug substance) and directly in pharmacies (drug product). With this strategy in mind, BH is negotiating strategic partnerships across Europe.

The main mission of BH is to play a role in the growth of the worldwide legal cannabis industry for the benefit of all stakeholders, participants and consumers, thereby contributing to the alleviation of illness, disease and suffering.

What are some of the unique challenges faced by developers in bringing cannabis-based drugs to market and what role does your company play in solving those challenges?

Esprey: One major challenge currently being faced is the relative lack of scientific research and completed clinical trials into the therapeutic benefits of the cannabis, despite the fact that it has been used for various purposes over thousands of years. Despite this, a vast range of opportunities are now opening up to cannabis-based drug developers as the number of new cannabinoids being discovered grows. Understanding of their properties and applications broadens as we see an increase in consumer interest in cannabis-based products as alternatives to traditional therapies.

By being the first to bring products to market, drug developers could be in the forefront and privileged position to establish themselves as industry leaders.

The ability for product developers to be closely involved with cultivators from the start of the plant’s cultivation provides the opportunity to customize active pharmaceutical ingredients (APIs) or products from the very start of the production chain; this may offer significant opportunities in relation to creation of full spectrum oils or extracts containing specific ratios of molecules, designed as therapies for specific medical conditions.

Cultivators and producers will also have the opportunity (with improvements in the agri-tech field) to develop cultivar catalogues tailored for medical use, which can be important in relation to improving stability, alongside cannabinoid and terpene profiles.

Can you tell us about some of the technology you’ve developed to isolate specific cannabinoids for pharmaceutical drug development? What role does your company play in this development (are you creating the isolates and formulating the drugs or sending them to a third-party)?

Esprey: BH's manufacturing facility in Portugal (held through its wholly owned subsidiary division, EuroCan) will have the ability to customize more than 100 types of product for licensed importers in the European Union, providing much needed supplies and access to a greater variety of treatments for patients who are suffering.

Licensed buyers of our Portuguese produced products will use our products within their own medical-use products. These products will provide patients with an alternative to the traditional mode of consuming cannabis, delivering its medical benefits without the health risks associated with smoking.

EuroCan is in the process of establishing working relationships with a number of university partners; ideally this group will include at least one partner based in Portugal. It is intended that research professionals from university partners, in collaboration with EuroCan´s management and technical team, will initiate and oversee research programs to help Botanical Holdings reach long-term goals for diversifying its product line, including developing intellectual property, and writing technical reports & journal manuscripts.

We hope that these relationships will lead to scientific developments (and creation of intellectual property or trade secrets) in the context of new products and services, as well as more broadly in terms of proving the efficacy of cannabinoids for medical and wellness purposes.

What kind of challenges do you face operating in Europe? Do you have any plans to expand or collaborate with companies in the US, Canada, or other countries outside of Europe?

Esprey: The principal challenge of operating in Europe is that the industry is in a nascent and growing phase in the region. This means that learning curves are steep for all participants, but this is offset by the availability of a high-quality, well-educated workforce.

We believe that as the global legal cannabis industry develops, collaboration between parties at different levels will become commonplace as specific expertise is developed in different areas and sectors. We intend to be an active player in the sector and therefore will always be open to collaboration with suitable partners.

What do you think the US can learn from Europe about cannabis legislation or vice versa?

Esprey: Lowering legal barriers for cannabis investment in general and legalizing medical cannabis at a federal level is the first step that the US needs to take to drive cannabis-based drug development. Although it has not yet been approved at the federal level in the US, medical cannabis has already been legalized at the state level in some states—a process still ongoing for others. This lack of cohesion has acted as a block in development from large pharmaceutical businesses.

On the other hand, despite there being no legal harmonization across the EU, there is a clearer framework in Europe to boost cannabis-based products being developed and used for therapeutic purposes. Europe has developed its own regional outlook for how it wants to regulate cannabis and implement access programs. Regulatory barriers have inhibited commercial research; however, positive and faster progress is underway.

Are there any laws or regulations in Europe that restrict your operations?

Esprey: The proposal for rescheduling substances under control and the necessary formal review was approved in an historic vote based on the increase use of cannabis and its components for medical purposes, the emergence of new cannabis-related pharmaceutical preparations for therapeutic use and the fact that cannabis had never been subject to a formal pre-review or critical review by the World Health Organization’s Expert Committee on Drug Dependence (ECDD).

This represents a very important step so countries can now re-evaluate cannabis classification on their own lists of narcotic drugs, easing the way for more research into medical cannabis sustained on the previous evaluations of potential harm, dependence, abuse from a public health perspective as well as their therapeutic usefulness.

As more EU Member States permit the use of cannabis for medical and non-medical purposes, more evidence is emerging, and even more is expected to come about their health and wellness effects. Relaxing their national or local regulations as they align with other states, is key by supporting and creating the advantageous legal and regulatory framework needed to overcome the stigma. From a regulatory perspective, this is also key as it helps remove barriers to access for medical cannabis-based products more easily.

Governments across Europe are quickly responding to scientific research on the health benefits of legalized medical cannabis products. According to the analysis of current trends, Europe is set to become the world’s largest legal cannabis market over the next five years.

What is EuroCan? Can you tell us how this differs from Botanical Holdings?

Esprey: Botanical Holdings is a dynamic investment holding company focused on selective investments across all verticals of the legal cannabis industry with cultivation, processing, CBD and retail divisions in Europe and Africa.

EuroCan is the name of Botanical Holdings’ cultivation division; it is in the vanguard of the fast-growing, legalized medicinal cannabis industry and is intent on becoming a global leader in the production of high quality, legally-approved cannabis products. EuroCan has established locations in Koro-Koro, Lesotho, and Mação, Portugal.

What kind of safety protocols do you have in place for your medical cannabis cultivation facilities (for example, clean room environment, etc.)?

Esprey: To cultivate and process pharmaceutical grade cannabis, which can include cannabis for pharmaceutical use, Botanical Holdings needs to operate under the most demanding rules and practices. This is one of the reasons why Botanical Holdings has undertaken the project of construction of its own, brand new, state-of-the-art facilities to be able to cultivate, process, transform and analyse the full range of products such as dry flower, extracts, oils, and isolates from the plant. Botanical Holdings will be able to get the purest forms (>99.5%) of several cannabinoids after analysing the product against a very tight specification in a EU-GMP laboratory located inside our Portuguese facility.

To achieve that we will use the most recent and effective technologies to make sure the highest yields are achieved, and the final quality of the product is preserved by all means. 

With both Good Agricultural and Collective Practices (EU-GACP) and Good Manufacturing Practices (EU-GMP) certifications, Botanical Holdings will be able to mitigate any risks associated to the operations involved. The operations will be taken under clean rooms (ISO 8) and all environmental conditions within the facility will be monitored and controlled through a building management system.

How many cultivation facilities do you have and where are they located? Do you have plans to expand?

Esprey: EuroCan operates a cultivation facility in Lesotho and is constructing its second cultivation facility in Portugal.

The Lesotho facility is fully-licensed to cultivate and manufacture medicinal cannabis and currently comprises five greenhouses totalling 2800 m2, with plans to increase by 400% to 20 greenhouses (10,000 m2). A GACP and GMP certification process has commenced at the facilities in Lesotho and will be finalized within a year.

Once construction is completed at our 31-hectare site in Mação (1.5 hours form Lisbon), the facility in Portugal will be fully licensed for cultivation, extraction, isolation, purification and distribution from with a phase 2 project to increase to 20,000 m2 of greenhouses and a 2-hectare solar panel park. Phase 1 construction works are on-going and comprise 5000 m2 of GACP greenhouses and a 3600 m2 ancillary/support building (including administration, manufacturing and cultivation support services, QC laboratory and warehousing). Completed construction will include a full, on-site GMP extraction, purification and isolation unit.

The project also includes a capacity to produce 2,2 MW of energy through solar panels.

Reference

1. https://botanicalholdings.com