Attempt at healing
The healing attempt (also individual healing attempt ) is a medical treatment that deviates from the medical standard , for example with a new drug or a new method. However, their effects and side effects cannot yet be sufficiently overlooked. The attempt at healing is aimed at healing a particular patient, not research . It is so different from the clinical experiment . This distinction is legally significant, because the legal provisions for the protection of subjects in scientific studies do not apply to individual healing attempts.
Every attempt at healing requires a scientifically plausible hypothesis that could change the medical standard. This means that methods of alternative medicine that are clearly implausible or that have already been tried and tested as ineffective may not continue to be used indefinitely if they are labeled as "attempted healing".
Off-label use is an attempt at healing with drugs that are not approved for the respective indication. Compassionate use is not an attempt at healing, but concerns cases specifically regulated by the Medicines Act, in which medicines are used clinically before they are approved.
The attempt at healing is an expression of the medical freedom of therapy , which is formulated, for example, in the Declaration of Helsinki : When treating a single patient for whom there are no proven measures or other known measures were ineffective, the doctor [...] can use a measure that has not been proven when, in the judgment of the doctor, it gives hope to save life, restore health or alleviate suffering. In its current version, however, the declaration also makes it clear that the new process must then be systematically researched scientifically; it does not give doctors license to act erratically.
Current case law in Germany requires doctors who want to deviate from the standard a much higher standard of care than usual. This concerns the planning, clarification, implementation and follow-up control of the procedure. Liability can arise even with simple treatment errors.
It can be difficult to differentiate in individual cases whether there is a therapeutic attempt or a study regulated by the Medicines Act . This is especially true for "therapeutic trial series" or "pilot studies". A test plan or a control group can indicate that research interests are not just subordinate .
Individual evidence
- ↑ Julia Achtmann: The protection of the test person during clinical drug testing: with special consideration of the liability of those involved and the test person's insurance . Springer-Verlag, August 31, 2012, ISBN 978-3-642-31996-9 , pp. 18–9.
- ↑ Katrin Schumacher: Alternative medicine: Medical liability, drug law and social law limits of medical therapy freedom . Springer-Verlag, August 17, 2016, ISBN 978-3-662-49633-6 , pp. 24–5.
- ^ World Medical Association : Declaration of Helsinki. Revision 2013, § 37 (PDF)
- ↑ Gerd Brudermüller: Research on humans: ethical limits of medical feasibility . Königshausen & Neumann, 2005, ISBN 978-3-8260-2881-6 , p. 181.
- ^ Hopf, Hanns Christian; Philipowich, Gerhard: Treatment with drugs that have not yet been approved: Between hope and adherence. Dtsch Arztebl 2008; 105 (11): A-552 / B-494 / C-482
- ^ Friedrich von Freier: Law and duty in medical human research: To the legal limits of the controlled study . Springer Science & Business Media, June 25, 2009, ISBN 978-3-540-95876-5 , p. 98.