What is Lex Szarlatan?
This is the colloquial name for a bill amending the Act on Patients' Rights. It gives the Polish Patient Rights Ombudsman tools to pursue so-called pseudo-medical practices: public warnings, orders to cease activities, and financial penalties of up to one million Polish zloty.
The objective is unquestionably sound. People lose their health and their lives when, instead of oncological treatment, they end up with a quack. The problem does not lie in whether to pursue quackery, but in how the instrument has been designed — because in several places it cuts far more broadly than it should.
Where the bill stumbles
Three weaknesses recur throughout the entire structure. First, the bill can silence a party before any penalty is imposed. Second, it assumes that medical knowledge is static — which it is not. Third, it describes "misleading" so broadly that it also catches truthful statements.
The four amendments below address each of these points individually. Each can be voted on separately; together they close the gaps.
Amendment 01: Hear first, then penalise
PROBLEM: The bill allows a burdensome interim decision to be issued without hearing the party, disapplying the standard procedural safeguards of administrative proceedings. And we are talking about orders, public censure and financial penalties.
FIX: Return to the principle: a party has the right to be heard before a decision is made. Where a threat is real and urgent, the Ombudsman can still act immediately — but must hear the party without delay and promptly review the decision.
An administrative penalty of this magnitude operates like a criminal sanction, so the standard of a fair hearing is not a luxury here — it is the minimum. Speed can be reconciled with the right of defence; the proceedings before the Office of Competition and Consumer Protection (UOKiK) work in a similar way.
Amendment 02: When knowledge changes, so should the decision
PROBLEM: Medicine changes. A drug considered safe today may be withdrawn tomorrow. If someone was penalised on the basis of the knowledge available at the time, and that knowledge has since been reversed, the decision and the penalty persist — the bill makes no provision for correcting them.
FIX: Add a reopening mechanism — that is, the re-opening of a concluded case when medical knowledge genuinely and durably changes. It should operate in both directions: both when a "prohibited" method turns out to be effective, and when a penalised warning turns out to have been correct. The strongest signal of change is a regulatory decision — the authorisation or withdrawal of a medicinal product. A single study is not sufficient; what counts is a well-established change.
The classic example is rofecoxib (Vioxx): authorised in 1999 as consistent with the knowledge of the time, withdrawn in 2004 after cardiovascular risks were demonstrated. Someone who had warned about it early could — under the bill's logic — have been penalised, and after the drug's withdrawal would have been left with a finding against them, despite having been right.
graph TD
A["Method consistent with current medical knowledge"] --> B["Decision: classified as pseudo-medical practice + penalty"]
B --> C["Time passes: knowledge reverses"]
C --> D{"Correction mechanism?"}
D -- "WITHOUT amendment" --> E["Decision and penalty persist despite change in knowledge"]
D -- "WITH amendment 02" --> F["Reopening → annulment → penalty refunded"]
style E fill:#ef4444,color:#fff
style F fill:#22c55e,color:#fff
Amendment 03: Define the concept on which the penalty depends
PROBLEM: The entire structure rests on the concept of "current medical knowledge", yet the bill neither defines it nor specifies the point in time at which it is to be assessed. Whether someone commits a punishable act depends entirely on this concept.
FIX: Introduce a definition grounded in evidence-based medicine and the guidelines of scientific societies, and — in their absence — in the best available research. Add a principle that is fair to the speaker: a statement is assessed according to the knowledge available at the time it was made, not with the benefit of hindsight.
A provision that threatens a penalty must be sufficiently precise for everyone to know in advance where the boundary lies. Other jurisdictions have resolved this problem in the same way — Germany, Switzerland and England all tie liability to a verifiable scientific standard rather than to the adjudicator's intuition.
Amendment 04: Stop penalising the truth
PROBLEM: The provision penalises the presentation of information in a way that "may give a patient the impression" that a method is harmful or ineffective. This does not require the information to be false. Falsehood and manipulation are already caught by the two earlier limbs of the provision.
FIX: Remove the third limb — or tie it to actual misleading. False warnings remain punishable. Truthful ones cease to be.
The doctor who first argued that stomach ulcers are caused by a bacterium rather than stress sounded "irresponsible" to the medical establishment — and was awarded the Nobel Prize for it. Early warnings about Vioxx also "could have given the impression". The law must not chill the truth simply because it happens to be ahead of the consensus.
graph LR
A["Form 1: False information"] --> R1["✓ Rightly penalised — requires falsehood"]
B["Form 2: Distortion of information"] --> R2["✓ Rightly penalised — requires manipulation"]
C["Form 3: 'May give the impression'"] --> R3["✕ Penalises the truth — does not require falsehood"]
style R1 fill:#22c55e,color:#fff
style R2 fill:#22c55e,color:#fff
style R3 fill:#ef4444,color:#fff
What follows from this
These four amendments do not protect charlatans. They protect the patient against dangerous quackery — which remains in the statute in its entirety. And they protect the citizen against a law that incidentally penalises reliable information and is incapable of correcting its own mistakes. A good objective deserves a good instrument; here, four targeted changes are all it takes to make it one.
The above text is general and informational in nature. It does not constitute legal advice in any individual matter.