Leah Fletcher, Founder & CEO of Dunbar Pharmaceuticals – Interview Series

While the United States continues to debate the ripple effects of federal rescheduling, European nations are moving forward with groundbreaking medical cannabis research and manufacturing. Because the European Union enforces strict Good Manufacturing Practice (GMP) standards, this research is conducted under rigorous regulation and without the threat of federal interference. Although it may take time for more European countries to fully legalize cannabis alongside leaders like Canada, nations such as Ireland are fast becoming pioneers in medical cannabis research and pharmacology.

To take a deeper look into the fascinating medical cannabis research happening in Ireland, MyCannabis spoke with Leah Fletcher, Founder and CEO of Dunbar Pharmaceuticals.

What subjects did you mainly study while obtaining your Master’s degree in Leadership, Governance & Policy at Ulster University? How did studying those subjects give you a better understanding of problematic drug laws in Ireland, but also how reforms could be implemented?

The areas I concentrated on most were leadership, governance, public policy, strategic decision-making and the implementation of change. My Master’s did not give me a predetermined position on cannabis or Irish drug laws. My studies gave me a certain skill set but it was my underlying interest in policy that peaked my interest in this area. I was always interested in why policies can remain in place after the evidence or public need has changed, and why even well-intentioned reforms can fail during implementation.

I enjoy looking beyond legislation itself and asking who designed the policy, what outcome it was intended to achieve, how success is measured, which organisations are responsible for delivery and whether the people most affected are involved in the process. Drug policy is particularly complex because it sits at the intersection of public health, criminal justice, medicine, politics and deeply held social attitudes, particularly in Ireland and Europe.

Effective reform requires reliable evidence, appropriate safeguards, cross-government ownership and a mechanism for reviewing whether the policy is actually reducing harm.

When did your interest in cannabis science and cannabinoid biochemistry first begin? Since your studies were more government- and policy-focused at Ulster, where did your professional interest in working with cannabis companies and research begin?

My interest began while I was living in Canada in the years leading up to federal cannabis legalisation in 2018. I had originally moved to Canada as a teacher, but I became fascinated by the speed at which the conversation around cannabis was changing and by the enormous gap between public enthusiasm, political decision-making and the scientific and regulatory infrastructure needed to support a serious industry.

At the same time, I was following Irish families, many of them mothers who were campaigning for access to cannabinoid medicines for children with complex conditions. I was a new mother myself, and that stayed with me. It made the issue much more human than a debate about whether somebody was “for” or “against” cannabis. The real questions were about patient safety and responsible access.

My route was not laboratory-first; it was problem-first. Myself and my husband started Arbutus Health Group, and began working with Canadian and North American cannabis businesses that wanted to understand European, pharmaceutical expectations and market entry. That exposed me to cannabinoid chemistry, extraction, formulation, quality systems and the difficulty of transferring technology between a North American cannabis framework and a European pharmaceutical framework.

I am interested in the chemistry, of course, but I have never presented myself as a chemist. My expertise lies in understanding how policy, science, manufacturing, regulation and commercial strategy fit together, and then how to weave expertise together with teams to execute on plans. I continue to learn by working alongside chemists, pharmacists, formulation scientists, quality professionals and regulatory experts and by asking a great many questions. Expertise is not pretending to know everything yourself; it is knowing which questions matter and building the right team to answer them.

What inspired you to found deDANÚ, and what went into forming the company? What experts did you consult and work with throughout the process?

The idea for deDANÚ began while James and I were living in Vancouver. We saw growing interest in botanical skincare, hemp, cannabinoids and aromatherapy, but we also saw a great deal of noise and very little clarity about formulation quality, ingredient sourcing or responsible claims.  We launched during the pandemic, which was not exactly the market-entry plan we had imagined, but it forced us to be resourceful and build a close relationship with customers from the beginning.

The formation of deDANÚ involved far more than creating attractive packaging and putting CBD on a label. We had to consider ingredient identity and purity, supplier qualification, formulations, compatibility, cosmetic safety assessments and regulations.

We spent time conducting structured product evaluations and gathered user feedback rather than relying entirely on marketing language. deDANÚ continues to collaborate with botanical suppliers, skincare experts and scientific professionals in its product development.The company taught me an important lesson that later influenced Dunbar Pharmaceuticals: science, manufacturing, compliance and storytelling all have to agree with one another. A brilliant marketing story cannot rescue a poor formulation, and an excellent formulation will struggle if the company cannot explain its value clearly and honestly.

Based on your experience and research conducted at deDANÚ, what are some clever and useful ways that cannabinoids and other hemp or cannabis-based plant extracts can help with proper skincare? Were some skincare product types more effective than others?

The first useful distinction is that hemp seed oil and cannabinoids are not the same thing. Hemp seed oil is valued primarily for its fatty-acid profile and emollient qualities. Ingredients such as purified cannabidiol, or CBD, and cannabigerol, or CBG, are chemically distinct ingredients with different formulation, concentration, stability and regulatory considerations.

There is credible biological interest in cannabinoids for skincare. Laboratory research has shown that CBD can influence inflammatory signalling, lipid production and the activity of sebocytes and keratinocytes. However, the human evidence is still developing and should not be exaggerated. Small studies have reported encouraging changes in parameters such as hydration, transepidermal water loss and erythema, while other controlled trials have not demonstrated a benefit for the particular condition or formulation being studied. That tells us that “contains CBD” is not a formulation strategy. The specific ingredient, dose, carrier, delivery system and intended use all matter.

No format is automatically superior for every person. Skin type, ingredient concentration, packaging, fragrance sensitivity and the complete formulation are more important than the trend attached to any one ingredient. We were always careful to position deDANÚ products as cosmetics and wellness products rather than medicines. Good skincare should support the skin and the person using it without making claims the evidence cannot sustain.

When did you decide to co-found Dunbar Pharmaceuticals? What types of cannabinoid research and production did you hope to complete that were not currently happening?

The decision to build Dunbar Pharmaceuticals took shape between 2019-2021. There were a few years of market research and regulatory background work and validation before we officially began. The full company and facility build-out accelerated from late 2022 and early 2023. Through my previous work, I had seen that many businesses could cultivate cannabis or produce a relatively crude extract, but far fewer could transform plant material into a defined, highly purified and reproducible pharmaceutical active ingredient.

James and I chose the difficult end of the value chain. We wanted to build the capability in Ireland to manufacture plant-derived cannabinoid active pharmaceutical ingredients under EU GMP conditions, beginning with dronabinol API. That meant going beyond initial processing and developing the advanced organic chemistry processes, analytical methods, impurity understanding, stability data, quality systems and controlled-drug infrastructure needed to supply regulated pharmaceutical markets.

We deliberately built a platform rather than a single product. Dunbar combines research and development, process engineering, in-house analytical quality control, stability programmes, GMP manufacturing and controlled-drug compliance. Our objective is to provide international pharmaceutical partners with a reliable, scalable and traceable source of pharmaceutical-grade cannabinoid APIs.

The underlying opportunity was clear to me: cannabinoid medicines cannot scale globally if manufacturers cannot guarantee identity, purity, consistency and supply. A physician, pharmacist or pharmaceutical company should not have to treat cannabinoid ingredients as an exception to normal pharmaceutical standards.

What were some unforeseen issues or other roadblocks you faced when starting the company? Where did those issues mainly come from?

The greatest challenge was not one dramatic obstacle. It was the interaction of controlled-drug law, pharmaceutical GMP, novel organic chemistry process engineering and the realities of financing a start-up before commercial revenue begins.

In pharmaceutical manufacturing, almost everything is connected. A change to one valve or transfer line can affect equipment qualification, cleaning validation, operating procedures and the documentation supporting the process. A raw-material change can affect purification, analytical methods, impurity profiles and stability. The difficult part is not merely solving each issue; it is understanding every other controlled system that the solution touches.

Controlled-drug manufacturing also adds another layer of security, recordkeeping, storage, personnel controls and import or export permissions. Ireland’s regulators were not the enemy in that process; the standards are demanding because they need to be. The challenge was sequencing the work correctly and building a technically sophisticated facility while recruiting the team, raising capital and educating stakeholders who sometimes confused pharmaceutical cannabinoid manufacturing with the consumer cannabis industry. Irish operators producing controlled drugs require appropriate annual licences, records, security systems and, where applicable, consignment-specific import or export permissions.

Coming from a non-traditional pharmaceutical background was challenging as well. I had to become comfortable being the least experienced person in a technical conversation, listen closely and learn quickly. Over time, that became a strength because I was willing to question assumptions and bring together people from quality, chemistry, engineering, operations, regulation and commercial strategy.

The greatest surprise was how invisible a pharmaceutical company is. Years of work can happen before the public sees the first commercial product. But that invisible work is ultimately where the value of the company is created.

What is the process of creating active pharmaceutical ingredients in Ireland like? How strictly regulated is it, and how many processes must be perfect to produce effective APIs?

API manufacturing in Ireland is extremely well regulated, but I would slightly challenge the word “perfect”. Pharmaceutical manufacturing does not assume that variation can be eliminated from the universe. It requires variation to be understood, controlled, documented and kept within scientifically justified limits.

The process begins long before production. Suppliers and raw materials must be qualified. Incoming materials must be identified, tested, approved and stored under appropriate conditions. Equipment and utilities must be designed, installed and qualified. Manufacturing instructions must be controlled, and the critical process parameters that affect the API’s critical quality attributes must be identified.

During production, we manage each stage through defined operating ranges and in-process controls. Analytical methods must be suitable and a lot of work is carried out with regard to cleaning procedures, environmental conditions, packaging systems and storage requirements. The quality system surrounding the chemistry is equally important as is stability of the API product. Changes must be assessed before implementation and absolutely everything is documented. 

Manufacturers, importers and distributors of active substances established in Ireland must register their activities with the HPRA before releasing active substances. Manufacturers and importers must comply with EU GMP requirements for active substances and are subject to initial and routine inspection. EU GMP Part II covers the complete lifecycle from receipt of materials through production, quality control, release, storage and distribution.

A phrase I use with the team is: “a batch is not finished when the chemistry is finished; it is finished when the evidence demonstrates that it meets specification.” That is also why a compliant API platform is much more than a building full of equipment. Its real value lies in the accumulated process knowledge, analytical data, validated systems and experienced people behind every batch.

How is Dunbar able to produce the products and conduct the research it does without interference from Irish law-enforcement agencies?

I would reframe the premise slightly. Dunbar does not operate without oversight; we operate under extensive legal and regulatory oversight. Irish law distinguishes between unauthorised controlled-drug activity and legitimate medical, pharmaceutical and scientific activity conducted under licence. The Misuse of Drugs framework restricts the production, possession, supply, import and export of controlled drugs, but it also permits those activities when the legal conditions and licensing requirements are satisfied. The Department of Health is the competent authority, while the HPRA processes controlled-drug licence applications and carries out associated inspections on its behalf.

Our activities are therefore conducted under the licences, active-substance registrations and pharmaceutical quality requirements applicable to the work. That involves secure premises, controlled access, appropriate storage, detailed inventory and reconciliation records, validated systems, trained personnel and consignment-specific import or export permissions where required. Irish rules require an annual licence for the production of controlled drugs, with separate licences for relevant import and export consignments.

We are not operating around the law, and nobody is turning a blind eye. We are operating inside a clearly defined framework designed to ensure controlled substances are available for legitimate medicine and science while preventing diversion or misuse. Transparency, traceability and control are what make the work possible.

Both within Ireland and abroad, what are the major ways policies surrounding cannabis-derived medicines are changing? Which countries, in particular, are becoming the big innovators in European cannabis?

The direction of travel is more nuanced than a simple wave of cannabis legalisation. What we are seeing is broader lawful access in some markets combined with increasingly demanding expectations around clinical governance, product quality, prescribing, evidence and reimbursement.

In Ireland, general drug-policy reform and access to cannabis-derived medicines are related but separate discussions. The Oireachtas Joint Committee on Drugs Use has recommended moving personal drug possession towards a health-led rather than criminal-justice response, but that recommendation has not itself changed the law. Medical access remains structured through authorised medicines, the Medical Cannabis Access Programme and individual ministerial licences. The MCAP remains limited to specific circumstances and conditions after standard treatments have failed.

Germany remains one of the most commercially important and closely watched European medical cannabis markets. Its 2024 Medizinal-Cannabisgesetz created a more accessible framework, but policymakers are now considering tighter rules for cannabis flower, online prescribing and telemedicine. That shows the next stage of the European market: access may expand, but clinical accountability will expand with it. The proposed German amendment was still undergoing the legislative process following a parliamentary hearing in January 2026.

Denmark is another important example because its medical cannabis pilot became a permanent scheme on 1 January 2026. Switzerland removed the special federal exemption previously needed for medical cannabis prescribing in August 2022 and introduced a regulated framework with physician prescribing and data collection. The United Kingdom is also reviewing the impact of its 2018 medicinal-cannabis reforms, including whether the current framework has achieved its intended outcomes.

For me, the most innovative countries are not necessarily those with the loudest cannabis markets. They are the countries developing systems that combine patient access, physician responsibility, pharmaceutical quality, useful data and a sustainable supply chain.

Ireland may not become Europe’s largest consumer cannabis market, but it can become a highly credible centre for cannabinoid research, analytical science, pharmaceutical formulation and EU GMP cannabinoid API manufacturing. That is a far more strategically valuable role for a country with Ireland’s existing life-sciences expertise.

What do you envision the next few years holding for cannabis research and large-scale cannabis reform in Ireland and neighbouring nations? Furthermore, how do you think federal cannabis rescheduling in America would ripple through European markets?

I expect cannabis research to become much more precise. The useful question is no longer simply, “Does cannabis work?” Cannabis is not one product. Research needs to identify which cannabinoid or combination is being studied, the dose, formulation, route of administration, pharmacokinetics, patient population, drug interactions, long-term safety and clinically meaningful endpoint.

Defined cannabinoid APIs will be central to that transition because high-quality research is very difficult when the investigational material changes from batch to batch. We will also see greater use of real-world evidence, pharmacovigilance and health-economic data as payers ask whether products deliver measurable value as well as clinical promise.

In Ireland, I expect reform to be incremental rather than dramatic. We need more clinician education, stronger data collection, clearer access pathways and greater participation in properly designed research. Ireland also has an opportunity to lead through manufacturing and scientific infrastructure even if its domestic prescribing framework remains cautious. We can produce APIs, develop formulations, conduct analytical research and support regulated global markets from here.

Broader US rescheduling would have significant international ripple effects. It would strengthen the legitimacy of cannabinoid research, attract more institutional capital, support new pharmaceutical partnerships and increase merger and acquisition activity. It would also bring greater scrutiny. Large American operators seeking to enter Europe will need more than a successful domestic brand; they will need compliant European infrastructure, local regulatory knowledge, controlled-drug capabilities, validated quality systems and reliable pharmaceutical supply chains.

Europe will not simply copy the American model. Each European country will continue to operate through its own medicines, prescribing, reimbursement and controlled-drug frameworks. However, closer alignment would make cross-border research and strategic partnerships more realistic. The companies that ultimately succeed will not be the ones that export the most hype. They will be the ones capable of exporting evidence, quality systems and reliable medicines.

Thank you for joining us, Leah! For more information on Dunbar Pharmaceuticals, please visit its website.