The Problem with the BtMG, NpSG, and AMG: A Critical Look - Kratoein

The Problem with BtMG, NpSG and AMG: A Critical Analysis

Germany has a complex legal system for regulating substances – the Narcotics Act (Betäubungsmittelgesetz, BtMG), the New Psychoactive Substances Act (Neue-psychoaktive-Stoffe-Gesetz, NpSG) and the Medicines Act (Arzneimittelgesetz, AMG). At first glance this system looks like carefully considered harm prevention. A closer look reveals structural deficits that deserve serious public discussion.

This article is a factual, critical overview – not a call to circumvent any law.

The BtMG: structure and points of criticism

The Narcotics Act (BtMG) of 1971 lists substances in three schedules:

  • Schedule I: not marketable, not prescribable (for example heroin, or cannabis before legalization)
  • Schedule II: marketable, but not prescribable
  • Schedule III: marketable and prescribable (for example morphine, codeine)

Problem 1: analogy clauses. Section 2 (3) BtMG contains an analogy clause: substances whose effect "corresponds" to that of a listed substance and which are suitable for misuse may be treated as narcotics – even without being explicitly listed. That sounds pragmatic, but it is legally delicate. What does "correspond" mean? Who decides it? On what scientific basis?

In practice this creates considerable legal uncertainty – particularly with newer substances such as synthetic cannabinoids or certain phenethylamines, where the boundary between "similar" and "identical" is fluid.

Problem 2: a listing procedure without transparent evidence standards. The BtMG listing procedure – who decides, by which criteria, on what scientific basis – is hard for an outside observer to follow. There are no published evidence thresholds, no mandatory independent expert reports, and no formal route for research communities to file a counter-statement.

Problem 3: structurally different substances treated alike. Heroin and cannabis both sat in Schedule I for decades – the same category for a strongly dependence-forming substance associated with fatalities and for one that has meanwhile been placed under a moderate regulatory regime by political decision. In its listing process, the BtMG differentiates too little according to the actual harm profile.

The NpSG: the rapid prohibition law

The New Psychoactive Substances Act (NpSG) of 2016 was the answer to a genuine problem: the market for synthetic designer drugs (so-called "legal highs") was developing faster than the BtMG listing procedure. Barely had one substance been listed when the next chemical variant appeared.

The NpSG solved this with a blanket approach. Instead of listing individual substances, it prohibits all "new psychoactive substances" as a class – defined as substances that act psychoactively and are not explicitly exempted. The exemptions: substances already covered by the BtMG, the AMG or food law.

Problem 1: the vagueness principle. "Psychoactive" is not a pharmacologically sharp term. Caffeine is psychoactive. Valerian is psychoactive. In theory the NpSG creates an almost unlimited prohibition, contained only by its exemptions. What falls inside, what falls outside? The courts are still wrestling with that question.

Problem 2: prohibition before research. The NpSG bans substances before any reliable data on their actual harm profile exists. That may look pragmatic. It has a problematic consequence, though: substances that may be less harmful than legal alternatives such as alcohol or tobacco are criminalized – not because the evidence suggests it, but because they are new and unknown.

Problem 3: no distinction by harm potential. The NpSG applies the same legal logic to a strongly hepatotoxic designer drug and to a mild botanical substance. Harm potential plays no defined role in the prohibition decision.

The AMG: when anything could be a medicine

Section 2 of the Medicines Act (AMG) defines what a medicine is – and that definition is broad. A "functional medicinal product" exists where a substance, through application on or in the human body, influences physiological functions. In theory caffeine, hops, valerian and also kratom products could fall under it.

What matters here: if a product is classified as a medicinal product, it requires AMG marketing authorization – which is practically unobtainable without extensive clinical trials and registration costs in the millions. That is no accident. It is a market protection mechanism for the pharmaceutical industry, dressed up as safety regulation.

Conclusion

BtMG, NpSG and AMG are not a coherent system of harm prevention. They are historically grown legal structures with considerable gaps, unclear definitions and problematic incentive structures. This does not mean that every controlled substance is harmless. It means that the system deciding on their regulation is in need of serious democratic review – and that representatives from research, medicine, legal scholarship and civil society must be involved far more closely than they are today.

Further reading

Legal notice

This article is for informational purposes only and does not constitute legal advice. Its content is not intended to encourage consumption. Laws may change; the applicable regulations and information from official bodies are authoritative. Image source: https://www.kratoein.com/

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