Herbs, Tradition and Lex Szarlatan:
the botanical amendment to Parliamentary Print 2598

The "Lex Szarlatan" draft bill (UD207, Parliamentary Print 2598) penalises pseudo-medical practices. The objective is sound: protecting patients from fraudsters posing as doctors. The problem is that the current definition of "pseudo-medical practice" does not distinguish between quackery and lawful communication about herbal products based on EU law. Below is an analysis of the gap and a proposal to close it.

The problem: a definition that casts too wide a net

Print 2598 defines pseudo-medical practice as an activity consisting in suggesting the health efficacy of methods, products or services without confirmation in current evidence-based medical knowledge. At first glance this sounds reasonable. In legal practice, however, it potentially covers three categories of lawful activity:

• Health claims on food supplements authorised by the European Commission under Regulation (EC) No 1924/2006 and entered in the register established by Regulation (EC) No 432/2012. Example: "Vitamin C contributes to the normal function of the immune system."
• Information about traditional herbal medicinal products registered under Directive 2004/24/EC and covered by monographs of the HMPC Committee at the EMA. Example: a product leaflet for a valerian preparation indicating traditional use for the relief of nervous tension.
• Phytotherapy advice provided by pharmacists, herbalists and dietitians on the basis of current EMA monographs and the European Pharmacopoeia.

None of these three categories constitutes quackery. Each is grounded in the European regulatory framework. Yet under a literal reading of the definition in Print 2598, an enforcement authority could initiate proceedings against a pharmacist who recommends chamomile for digestion by reference to an EMA monograph.

Regulatory context: the three pillars of herbal product protection in the EU

European Union law creates a coherent system for communicating about herbal products, comprising three mutually complementary instruments:

1. Regulation (EC) No 1924/2006 (nutrition and health claims): defines the rules for health communication on food supplements and foodstuffs. Authorised claims have undergone EFSA assessment.
2. Directive 2004/24/EC (traditional herbal medicinal products): establishes a simplified registration pathway for products with a documented 30-year history of traditional use.
3. HMPC/EMA monographs: scientific documents describing the traditional and well-established indications of medicinal plants, dosage and safety. A regularly updated body of monographs.

This system is not "alternative medicine" in an anti-medical sense. It is a regulated, assessed and supervised layer of health-promoting products that complements conventional medicine. The Lex Szarlatan draft should respect this legal architecture.

Diagram 1: Current definition vs. the botanical amendment

graph TD
  A["Communication about a herbal product"] --> B{"Is it based on:"}
  B -->|"Authorised health claim\n(Reg. 1924/2006)"| C["EXCLUDED\nfrom Lex Szarlatan"]
  B -->|"EMA/HMPC monograph\n(Dir. 2004/24/EC)"| C
  B -->|"Pharmaceutical Law\n(registered herbal medicinal product)"| C
  B -->|"No legal or\nscientific basis"| D["SUBJECT TO sanction\nunder Lex Szarlatan"]
  C --> E["Lawful information\nabout a herbal product"]
  D --> F["Pseudo-medical practice\n= punishable quackery"]
  style C fill:#065f46,color:#d1fae5
  style D fill:#991b1b,color:#fecaca
  style E fill:#064e3b,color:#a7f3d0
  style F fill:#7f1d1d,color:#fca5a5

Text of the proposed amendment

It is proposed to add to Article 2 of the draft bill (definitions) a paragraph reading as follows:

"The provisions of this Act shall not apply to the communication of information about a product where that information derives from:
(a) health claims authorised in accordance with Regulation (EC) No 1924/2006 of the European Parliament and of the Council, or applied under the transitional provisions set out in Article 28(5) and (6) of that Regulation;
(b) information obligations arising from the registration of a traditional herbal medicinal product in accordance with Directive 2004/24/EC, as implemented in the Pharmaceutical Law, including the content of monographs or entries on the Community list of the Committee on Herbal Medicinal Products (HMPC) of the European Medicines Agency on which that registration is based."

Justification for the amendment: proportionality and legal certainty

The principle of proportionality (Article 31(3) of the Polish Constitution, Article 5(4) TEU) requires that legislative interference be adequate to its objective. The objective of the draft bill is to combat quackery that endangers health. Communication based on EMA monographs and authorised health claims does not endanger health. It is regulated, scientifically assessed and supervised by the Polish Chief Sanitary Inspectorate (GIS), the Office for Registration of Medicinal Products (URPL) and the European Commission.

Without an explicit exclusion, a "chilling effect" arises: food supplement manufacturers, pharmacists and herbalists will restrict their communications for fear of criminal proceedings, even if a court would ultimately acquit them. The patient loses access to reliable information about products they could lawfully use.

Diagram 2: Winners and losers under the current wording vs. the amendment

graph LR
  subgraph BEZ["Without the botanical amendment"]
    direction TB
    P1["Ashwagandha food\nsupplement manufacturer"] -->|"risk of prosecution"| R1["Chilling effect:\nrestrict communications"]
    P2["Pharmacist\nin a pharmacy"] -->|"risk of prosecution"| R2["Do not advise\non herbal products"]
    P3["Quack\npromising cancer cure"] -->|"sanction"| R3["Criminally prosecuted"]
  end
  subgraph POP["With the botanical amendment"]
    direction TB
    Q1["Ashwagandha food\nsupplement manufacturer"] -->|"exclusion"| S1["Communicates safely\nunder Reg. 1924/2006"]
    Q2["Pharmacist\nin a pharmacy"] -->|"exclusion"| S2["Advises in accordance\nwith EMA monograph"]
    Q3["Quack\npromising cancer cure"] -->|"sanction"| S3["Criminally prosecuted\n(unchanged)"]
  end
  style BEZ fill:#1e293b,color:#e2e8f0
  style POP fill:#0f2a1e,color:#d1fae5
  style R1 fill:#78350f,color:#fde68a
  style R2 fill:#78350f,color:#fde68a
  style R3 fill:#065f46,color:#d1fae5
  style S1 fill:#065f46,color:#d1fae5
  style S2 fill:#065f46,color:#d1fae5
  style S3 fill:#065f46,color:#d1fae5

Practical examples

Example 1: Food supplement containing fenugreek (Trigonella foenum-graecum)

A manufacturer places on the packaging the claim: "Fenugreek contributes to the maintenance of normal blood glucose levels." This is a health claim from the so-called pending list, applied under the transitional provisions — Article 28(5) and (6) of Regulation 1924/2006 — pending the Commission's adoption of the final list under Article 13(2). Without the amendment: risk of interpretation as a pseudo-medical practice. With the amendment: clear exclusion, provided the claim appears in the Commission's register or on the pending list and does not exceed the permitted wording.

Example 2: Traditional herbal medicinal product containing St John's wort (Hypericum perforatum)

A pharmacy sells a registered traditional herbal medicinal product containing St John's wort (URPL marketing authorisation number). The leaflet states the traditional use for the relief of low mood. A pharmacist repeats this information to a customer. Without the amendment: theoretical risk of an allegation of promoting a method without clinical evidence (since traditional registration does not require RCT studies). With the amendment: information from the leaflet of a registered medicinal product is excluded from the Act by operation of law.

Example 3: A quack promising cancer treatment with herbs

A person without medical or pharmaceutical qualifications advertises a proprietary herbal blend as a "cancer cure", relying on anecdotes and non-peer-reviewed sources. Without the amendment: subject to sanction. With the amendment: subject to sanction identically, because the communication is not based on any of the three pillars (no authorised health claim, no EMA monograph, no URPL registration).

Risks of rejecting the amendment

• Chilling effect on the food supplement and pharmacy sectors: Restriction of communications about herbal products for fear of criminal prosecution, even where the communication is fully lawful under EU law.
• Conflict with EU law: Prohibiting the communication of information required or permitted by Regulation 1924/2006 and Directive 2004/24/EC may constitute a breach of the principle of sincere cooperation (Article 4(3) TEU) and the free movement of goods.
• Interpretive uncertainty: Enforcement authorities do not have the competence to assess whether a given health claim has been authorised by the European Commission. Without an explicit statutory exclusion, the decision depends on the prosecutor's knowledge of EU food law.
• Consequences for the patient: The patient loses access to reliable, regulated information about herbal products and is left with only two options: silence from professionals or unlawful promises from online quacks.

Conclusion: precision rather than prohibition

The botanical amendment does not weaken the "Lex Szarlatan" draft bill. It strengthens it, because:

1. It eliminates the risk of the provisions being struck down by the Constitutional Tribunal or the CJEU on grounds of disproportionality.
2. It gives enforcement authorities a clear test: is the communication based on EU law (lawful) or not (punishable)?
3. It protects the patient from losing access to regulated health information.
4. It preserves the full force of sanctions against actual quacks.

Legislation designed to protect patients should not simultaneously deprive them of access to information about products that are lawful, assessed and supervised. The botanical amendment draws that line.