The future of Medical Cannabis and the Current Pharmaceutical Industry

With the approval of medicinal cannabis use in many countries worldwide, the sector has drawn significant interest from small and medium-sized companies. However, this growing market has not gone unnoticed by large multinational pharmaceutical companies, which are eager to secure their share of this lucrative industry. Consequently, we've seen many of these major players entering the market, either directly or by acquiring stakes in existing cannabis companies. As research into the medicinal benefits of cannabis continues to advance, it's expected that even more pharmaceutical giants will join or expand their presence in this rapidly evolving sector.

At this contextual moment, the global position on this medical cannabis market and multinational pharmaceutical companies is approximately distributed as follows:

GW Pharmaceuticals (Now part of Jazz Pharmaceuticals)

Headquarters: United Kingdom

Highlight: GW Pharmaceuticals has pioneered the development of cannabis-based medicines, with Epidiolex, approved by the FDA for treating severe epilepsy in children, and Sativex, used to treat spasticity in patients with multiple sclerosis. In 2021, the company was acquired by Jazz Pharmaceuticals, a global pharmaceutical company focused on neurology and oncology.

AbbVie Inc.

Headquarters: USA

Highlight: AbbVie is known for the drug Marinol (dronabinol), which contains synthetic THC and is used to treat nausea and vomiting associated with chemotherapy, as well as loss of appetite in AIDS patients.

Tilray

Headquarters: Canada

Highlight: Tilray is one of the largest medical and recreational cannabis companies in Canada and the world. Following the merger with Aphria, Tilray expanded its global presence, providing medical cannabis products in several countries.

Canopy Growth Corporation

Headquarters: Canada

Highlight: One of the largest cannabis companies in the world, Canopy Growth also has a strong presence in the medicinal market. The company collaborates with Constellation Brands (which holds a significant stake in Canopy) to develop cannabis products.

Aurora Cannabis

Headquarters: Canada

Highlight: Aurora is another Canadian cannabis giant with a strong emphasis on medical cannabis. The company operates in multiple international markets and has a diverse portfolio of products.

Cronos Group

Headquarters: Canada

Highlight: Cronos Group is a leading medical and recreational cannabis company. With investment from Altria (maker of Marlboro), the company is focused on expanding its global operations and researching and developing new products.

Boehringer Ingelheim

Headquarters: Germany

Highlight: Boehringer Ingelheim has explored the therapeutic potential of cannabinoids and established partnerships for the development of cannabis-based medicines, especially aimed at the area of animal health.

Pfizer

Headquarters: USA

Highlight: Although not directly involved in the cannabis sector, Pfizer has made strategic acquisitions, such as the purchase of Arena Pharmaceuticals, which develops therapies for the treatment of inflammatory and immunological diseases, including cannabinoid compounds.

Novartis

Headquarters: Switzerland

Highlight: Novartis, through its Sandoz division, has partnered with cannabis companies to distribute medicinal cannabis products, focusing on international markets where medical cannabis is legal.

Sanofi

Headquarters: France

Highlight: Sanofi has explored the use of synthetic cannabinoids in its research and, despite not being a dominant player in the sector, is attentive to market opportunities related to medicinal cannabis.

Other Companies also featured we can consider:

Merck & Co.: Involved in research into the use of cannabinoids in specific treatments.

Johnson & Johnson: Through its JLABS incubator, it supports startups researching the use of medical cannabis.

Bayer: Bayer has interests in medical cannabis, especially following its partnership with GW Pharmaceuticals and its presence in the medical cannabis market in Canada.

Within this concept and given the increasingly evident need in the field of medical cannabis to carry out clinical trails for the entry of any pharmaceutical product into the market, it is clear that there is a need for million-dollar investments in this sector, which are only possible by companies in this sector qualified and with the knowledge of the pharmaceutical sector. In any case, the purchase of a large part of existing cannabis companies by pharmaceutical multinationals with interests in the sector is evident for the future. I would even go so far as to say that many cannabis companies were created for this purpose.

Imperative need for Clinical Trials

Unfortunately, many doctors and patients still harbor distrust toward products containing cannabis derivatives. This skepticism can only be reverted through rigorous clinical studies that after approved and accredited by national health authorities regulatory authorities in each country, as well as by EMA (European Medicines Agency) in Europe or the FDA in the United States.

The imperative need for clinical trials in the commercialization of pharmaceutical products based on cannabis is rooted in the principles of safety, efficacy, and regulatory compliance. Clinical trials are essential to ensure that cannabis-based medications meet the rigorous standards required for pharmaceutical products, particularly under the legislative frameworks of individual countries and the regulatory authorities in case of Europe European Medicines Agency (EMA) .

Here is a breakdown of the main key reasons, which can also be associated with the previously mentioned distrust from doctors and patients. Compliance with these properly structured steps within the scope of following pharmaceutical industry procedures, is without a doubt the only way to create credibility at all levels for the commercialization and production of cannabis-based products :

Safety and Efficacy Validation

• Patient Safety: Clinical trials provide essential data on the safety of cannabis-based products, identifying potential side effects, interactions with other medications, and appropriate dosing. This is crucial for ensuring that the products do not cause harm to patients.
• Efficacy: These trials are necessary to prove that the cannabis-based product effectively treats the condition it is intended for. Without robust clinical evidence, the therapeutic claims of cannabis products cannot be substantiated, which is crucial for both healthcare providers and patients.

Regulatory Compliance

• European Medicines Agency (EMA): The EMA requires comprehensive clinical trials for any new pharmaceutical product before it can be approved for market use in the EU. This ensures that the product meets the high standards of quality, safety, and efficacy set by European regulations.
• National Legislation: Many countries have their own regulatory bodies that require clinical trial data to approve cannabis-based medicines. These trials must be conducted according to Good Clinical Practice (GCP) standards to meet national requirements.

Market Authorisation

• Product Approval: In most jurisdictions, including the EU, a pharmaceutical product cannot be legally marketed without obtaining market authorisation, which is granted only after successful clinical trials. This authorisation confirms that the product is safe and effective for public use.
• Insurance and Reimbursement: In many countries, health insurance providers will only cover medications that have been approved following rigorous clinical trials. Without such trials, patients may have to pay out of pocket, limiting access to the medicine.

Public and Medical Trust

• Healthcare Provider Confidence: Doctors and other healthcare providers rely on clinical trial data to make informed decisions about prescribing medications. Without this data, healthcare professionals may be reluctant to prescribe cannabis-based products.
• Public Confidence: The general public is more likely to trust and use cannabis-based medications if they know these products have undergone rigorous testing and are approved by regulatory authorities.

Legal and Ethical Considerations

• Ethical Responsibility: Conducting clinical trials is an ethical obligation to ensure that any medicinal product, including those based on cannabis, is safe and effective for human use.
• Legal Requirements: In many countries, it is illegal to market or prescribe cannabis-based products without the backing of clinical trial data. This legal framework helps prevent the proliferation of unverified and potentially dangerous products.

Advancement of Medical Knowledge

• Understanding Cannabis Pharmacology: Clinical trials help researchers and clinicians understand how different cannabinoids interact with the human body, leading to better-targeted therapies and personalized medicine approaches.
• Development of New Therapies: The data from clinical trials can lead to the development of new and more effective cannabis-based therapies, expanding treatment options for various conditions.

Global Market Access

• International Standards Compliance: For companies looking to market their cannabis-based products globally, adhering to international standards like those set by the EMA is crucial. Clinical trials conducted according to these standards can facilitate access to multiple markets.

Pharmaceutical companies are undoubtedly better equipped to navigate the complexities of the cannabis industry than any other extraction cannabis companies. With their superior infrastructure, financial resources, and established distribution networks, they are far more capable of driving the market forward. It is these pharmaceutical giants, along with emerging players, that are setting the pace of progress in this sector—often perceived as slow-moving by some.

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