On 24 September, European regulators cleared the way for GW Pharma’s cannabinoid medicinal product to treat patients with two rare, severe forms of epilepsy. The European Commission approved Epidyolex to treat seizures associated with Lennox Gastaut syndrome (LGS) or Dravet syndrome in patients aged two and over. The drug is the first to be approved using the centralized procedure, meaning that it is authorized to be placed on the market throughout the 28 Member States of the European Union.
Undoubtedly, market researchers’ predictions of exponential growth in the European medical cannabis market will become reality. According to one market research firm, the European medical cannabis market could grow from $316 million in 2018 to nearly $8 billion in just five years. Despite the first EU-wide approval and liberalization of medical cannabis markets in many Member States, however, navigating the regulatory landscape across Europe will not be easy as each country has different legal and regulatory regimes.
Germany, for example, allows relatively broad access to cannabis and cannabinoid medicines and preparations in some form. The 2017 Cannabis as Medicine Act fully legalized the prescriptive use of medical cannabis in Germany and set out provisions for distribution and domestic cultivation. Under the Act, doctors are permitted some discretion in prescribing cannabis-based medical products to treat severe health problems, including multiple sclerosis, cancer and chronic pain. Insurance companies are required to cover the costs of these products for chronically and terminally ill patients. The main hurdles to medical cannabis production and supply in Germany so far have been popular prejudices, taxing administrative procedures, pharmacy shortages, and rapid price surges. The first contracts for the cultivation of medical cannabis were awarded a few months ago and a new law that simplifies administration for the prescription and sale of medical cannabis entered into force in August.
In contrast to Germany, the medical cannabis industry in France still is in its infancy. France has legalized only certain cannabis-based medicines under strict conditions. The cultivation of cannabis for medical purposes currently is prohibited, however, an experimental project could allow prescription of imported cannabis-based medical products as a last resort for serious illnesses such as multiple sclerosis, cancer, and epilepsy. The pilot programme may well pave the way for legalization of medical cannabis in France as early as the end of 2021.
Whether a more harmonized approach comes to fruition in the European Union may depend on how much energy the new European Parliament brings to the issue. The previous Parliament (2014-2019) adopted a resolution in early 2019 calling for EU-wide rules on medical cannabis, starting with a legal definition of “medical cannabis.” Among the stated goals of the resolution are improved access, product quality and accuracy of consumer information as well as increased research leading to a better understanding of public health effects. Given the significant commercial and patient interest in medical cannabis and the risk of barriers to the smooth functioning of the EU’s internal market, calls for EU-level action and greater regulatory harmony are expected.