The Ministry of Health, through the Spanish Agency of Medicines and Medical Devices (AEMPS), has opened a prior public consultation on amending Royal Decree 2829/1977, which regulates psychotropic substances and preparations and imposes control measures and criminal penalties. The proposed amendment would add new substances to the control lists, notably several cannabinoids not yet controlled and other psychoactive compounds. This AEMPS strategy of controlling emerging substances on the market raises an essential question:
Is control the most appropriate tool for tackling this problem?
A problematic consultation period: right in the middle of Christmas
The public consultation opened on 20 December 2024 and will close on 7 January 2025, coinciding almost entirely with the Christmas holidays. This timetable makes it difficult for small businesses, consumer organisations and other stakeholders to take part, as they barely have time to analyse the proposal and make meaningful contributions. Far from encouraging transparency and dialogue, the timing of the consultation suggests an intention to push the measure through almost unnoticed, limiting the impact of public opinion.
The content of the public consultation
According to the official text, the initiative aims to add new substances to Annex I of Royal Decree 2829/1977, thereby meeting the commitments made under the 1971 United Nations Convention on Psychotropic Substances. These substances have been placed under international control by decision of the UN Commission on Narcotic Drugs.
The aims of the update are:
- To prevent illicit trafficking in and consumption of new psychoactive substances.
- To protect public health from the associated risks.
- To align national rules with international standards.
The public consultation also sets out:
- Background to the rule: The need to comply with international obligations.
- Problems it seeks to solve: Fighting illicit trafficking and improving control.
- Aims of the rule: Protecting public health by controlling new substances.
- Alternative solutions: No regulation other than control is proposed.
It is worrying that no alternative to prohibition is proposed. This lack of options suggests a mere formality and confirms the impression that the date chosen for the consultation seeks to reduce participation and legitimise decisions already taken.
The list of proposed substances
The public consultation includes a wide variety of compounds that the AEMPS intends to add to the lists of controlled substances. Notable among them are synthetic cannabinoids sold under the protection of a legal loophole, as well as other psychoactive substances of similar status that have burst onto the international market.
Uncontrolled cannabinoids
- Hexahydrocannabinol (HHC)
- Hexahydrocannabinol acetate (HHC-O)
- Hexahydrocannabiphorol (HHCP)
- Hexahydrocannabiphorol acetate (HHCP-O)
- Delta-8-tetrahydrocannabiphorol (Delta-8-THCP)
- Tetrahydrocannabiphorol (Delta-9-THCP)
- Tetrahydrocannabiphorol acetate (THCP-O)
- Tetrahydrocannabinol acetate (THC-O)
- Delta-8-tetrahydrocannabinol-C8 (Delta-8-THC-C8)
- Delta-9-tetrahydrocannabinol-C8 (Delta-9-THC-C8)
- Hydrocannabidiol (H4-CBD)
- Tetrahydrocannabinolic acid (Delta-9-THCA)
Other psychoactive substances
- Dipentylone (bk-DMBDP)
- 2-Fluorodeschloroketamine (2-FDCK)
- Bromazolam
Impact on the CBD sector and online distribution
Adding cannabinoids such as HHC and its derivatives to the lists of controlled substances will directly affect CBD shops and online sales platforms, which until now have operated in a legal loophole. If approved, the measure would expose these businesses to considerable criminal risks. As well as restricting the range of products, this decision would criminalise the activities of small retailers and distributors who have invested in developing a legal and accessible market. As a result, thousands of jobs are at risk and consumers are deprived of regulated access to products in high demand.
Is control the solution?
The prohibitionist approach creates a cycle of control that ignores the roots of the problem. Instead of disappearing from the market, these substances move into the illicit sphere, where:
- There are no quality or safety standards.
- Consumers are more exposed to risks.
- The black market thrives unchecked.
A reactive and outdated strategy
The AEMPS and the Ministry of Health present these measures as essential to protect public health. However, the prohibitionist model mainly benefits:
- Large pharmaceutical companies, which dominate the market for regulated substances.
- Chemical laboratories, financially encouraged to create new uncontrolled variants.
Meanwhile, consumers and small business owners are left unprotected by confusing and restrictive rules.
What alternatives are there?
A comprehensive regulatory model would be more effective in tackling this problem. Instead of chasing each new substance, it would be possible to:
- Set quality and safety standards for all psychoactive substances.
- Encourage scientific research to better understand their effects.
- Regulate production and distribution within a clear legal framework.
- Fight the black market by offering legal, controlled products.
The endless cycle: new bans, new substances
After each ban, new cannabinoids and psychoactive compounds appear that are not on the list, perpetuating the cycle of control. This shows that the prohibitionist strategy, far from solving the problem, makes it worse, pushing substances underground and leaving consumers unprotected.
Regulate, don’t prohibit
The AEMPS public consultation once again shows the urgent need for a paradigm shift. Prohibition does not eliminate these substances or solve their associated problems; it merely shifts the risk into illegality. Adopting a modern, transparent regulatory model adapted to today’s reality would make it possible to protect consumers’ health, safeguard small retailers and fight the black market more effectively. Until progress is made in this direction, the list of controlled substances will keep growing without the underlying problems being solved. The current strategy, focused on control, does little to provide a real solution. The time has come to commit to comprehensive regulation that addresses the complexity of the phenomenon and protects both public health and free competition. Ultimately, the appearance and growing popularity of these uncontrolled cannabinoids is nothing more than a direct reaction to the absurd and unjustified prohibition of cannabis. When legal channels for access to and regularisation of the plant and its derivatives are closed, new formulas develop that, far from being removed from the market, end up proliferating underground.
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