The Legal Principle of 'What Is Not Prohibited Is Permitted' in the Use of Unapproved Therapies
A Country-by-Country Analysis of Where Intratumoral Chlorine Dioxide Injection May Be Legally Provided
Scope of Application:
This article explores how the legal principle of "what is not prohibited is permitted" may be applied to the use of unapproved therapies (such as intratumoral chlorine dioxide injection) in various countries, within the context of constitutional rights, administrative law, and medical ethics.
1. Overview of the Principle
The principle "what is not prohibited by law is permitted" is a foundational concept in modern rule-of-law societies. It holds that unless a specific law expressly prohibits a behavior, individuals and legal entities are free to act.
In the field of medicine, this principle supports the idea that physicians may offer therapeutic interventions not yet formally approved, provided they act within legal and ethical boundaries.
2. Preconditions for Application
For this principle to apply in medicine, several key conditions must be met:
No violation of constitutional rights, such as human dignity or bodily integrity;
No breach of express legal prohibitions, such as the use of banned substances;
Documented informed consent from the patient;
A medically justifiable intent, such as to extend life or reduce suffering.
Thus, its meaning in this context can be refined as:
"Within constitutional and ethical limits, anything not explicitly prohibited by law is legally permissible."
3. Country-by-Country Analysis (Classified by Legal Structure)
Category 1: Constitutional Protection + No Lower-Level Prohibition
✅ Ethically and legally defensible. Broad space for medical discretion.
🇮🇹 Italy: Article 32 of the Constitution protects health as a personal right; private clinics may apply nonstandard therapies under informed consent.
🇩🇪 Germany: The Basic Law protects personal autonomy; doctors have wide discretion in private-sector treatment.
🇧🇷 Brazil: The Constitution defines health as a universal right. Physicians may explore off-label or nonstandard treatments under consent.
🇺🇸 USA: While not explicit in the Constitution, U.S. case law (e.g., Cruzan) and state laws (e.g., Right to Try) support patient choice.
🇮🇳 India: Article 21 on the right to life is interpreted by courts to include health and medical autonomy.
Category 2: No Constitutional Provision, but Legal Mechanism Exists
✅ No constitutional right to medical freedom, but official access pathways exist.
🇨🇦 Canada: The Special Access Program (SAP) allows compassionate access to unapproved therapies.
🇬🇧 UK: Physicians may use unlicensed treatments under clinical judgment. The Early Access to Medicines Scheme (EAMS) also exists.
🇲🇽 Mexico: While no formal pathway exists, private use of unapproved therapies is often tolerated under strict ethical and private conditions.
🇸🇬 Singapore: The Special Access Route (SAR) enables unapproved drugs to be used case-by-case upon application and patient consent.
🇭🇰 Hong Kong: Under common law, doctors may use unregistered drugs for individual patients if compliant with the Pharmacy and Poisons Ordinance.
🇦🇺 Australia: The Therapeutic Goods Administration (TGA) offers the Special Access Scheme (SAS), including Categories A, B, and C for unapproved use.
Category 3: No Medical Freedom, High Legal Risk
⚠️ Legal and political environments are restrictive. Therapeutic exploration is risky.
🇨🇳 China: No constitutional medical freedom. Health care is highly regulated. Unapproved therapies are not permitted, and promotion is risky.
🇯🇵 Japan: While health is protected constitutionally, unapproved interventions must go through official authorization and strict ethics review.
4. Ethical Support: Helsinki Declaration Article 37
“In the treatment of an individual patient, where proven interventions do not exist or have been ineffective, the physician, after seeking expert advice, with informed consent from the patient, may use an unproven intervention if, in the physician’s judgment, it offers hope of saving life, re-establishing health or alleviating suffering.”
This article provides strong ethical support for experimental use of new treatments worldwide.
5. Conclusion
The principle "what is not prohibited is permitted" can serve as a vital legal basis for the application of unapproved therapies — but only under the following conditions:
The action does not violate constitutional or criminal law;
The patient provides documented, informed consent;
The physician acts ethically and not for commercial abuse.
Under these conditions, physicians in many countries can explore novel approaches, particularly in end-stage or treatment-resistant cases.
This memorandum is intended for academic and policy use only. Clinical application should always be reviewed by local legal counsel.
Thank you for the article. The issue arises when regulatory bodies such as the FDA, EPA, Swissmedic, and others officially issue warnings against a substance, as has happened with chlorine dioxide. In these situations, medical associations may revoke physicians' licenses. For research purposes, approval from an ethics committee is required to use CDS. To obtain this approval, you must present preclinical in vitro studies demonstrating non-toxicity. After that, a research protocol must be developed. Once the ethics committee approves it, a multicenter study (conducted at multiple sites) can be organized, allowing a team of doctors to legally work with chlorine dioxide solution—saving lives.
However, you now need a GMP-licensed manufacturer to produce your CDS with substances whose origin can be traced at every stage. This manufacturer must have pharmaceutical-approved machinery to produce chlorine dioxide solution. Before the GMP manufacturer can provide you with a pilot product, they must prove the shelf life of the substance, which takes another year. You cannot use fast-track methods involving heat because chlorine dioxide is a volatile gas, and if you use MMS, chemical reactions will occur. Once all this is completed, your pilot batch must be correctly labeled with lot numbers, and you must retain a sample of each lot. Once done you have to go thru customs of ech country and inform your medical regulatory body ( FDA, EPA, etc.) and get aprooval in some countries.
By following these steps, you can legally conduct a clinical trial with CDS, provided you distinguish it from MMS (Miracle Mineral Solution), address regulatory concerns with robust safety data, and maintain compliance with international standards (e.g., ICH Good Clinical Practice). Early engagement with regulators (e.g., FDA pre-IND meeting) is recommended to clarify requirements and overcome CDS’s controversial reputation.
Preclinical Studies: Added in vivo studies and pharmacodynamics to meet regulatory requirements for IND/CTA submissions.
Regulatory Submission: Included IND (FDA) and CTA (EMA/Swissmedic) applications, specifying required components like CMC and clinical protocol.
Ethics Committee: Specified informed consent, liability insurance, and DSMB, which are mandatory for approval.
GMP Manufacturing: Clarified stability testing, analytical methods, and batch documentation while keeping it concise.
Trial Registration: Added mandatory registration in public databases (e.g., ClinicalTrials.gov, EudraCT).
Customs: Streamlined to focus on import permits and local compliance for multicenter trials.
Trial Execution: Included adverse event reporting, interim analysis, and DSMB oversight.
Regulatory Strategy: Emphasized distinguishing CDS from MMS and engaging regulators early to address stigma.
Do you know the work of Dr. Tulio Simoncini?
This Italian oncologist spent 5.5 years in an Italian prison after being found culpable of "manslaughter" after the death of a cancer patient in 2011.
He treated this patient with bicarbonate of soda.
https://youtu.be/Ou81Lj-52ps
Dr. Simoncini died in May of 2024, shortly after serving his entire sentence.
Meanwhile: Thousands of oncologists "treat" cancer patients with toxic chemotherapy drugs, afterwhich their patients die, however none are ever charged with 'manslaughter' as far as I know?
I posit the theory that had Dr. Simoncini treated this Stage 4 cancer (written off) patient with "gold standard" oncology drugs rather than his innovative treatment? He would NOT have been charged with manslaughter after his patient died...
I'm not sure I'd choose to attempt to open an alternative cancer care clinic in Italy.
Just saying...