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With the second law on the amendment of pharmaceutical law and other regulations, the Bundestag on June 28, 2012 also passed amendments to the Therapeutic Products Act (HWG), which became legally binding on October 19, 2012 after approval by the Federal Council.
The changes in the AMG and other provisions became necessary due to EU guidelines and supreme judge decisions, which were taken into account in the currently applicable version. Overall, the amendment to the HWG shows that legislators are now taking the "responsible citizen" more seriously and that the image of the "underage" fellow citizen who needs to be looked after by everyone is a thing of the past. So we see reliefs and improvements, unfortunately not entirely.
What's new? Only the changes that are relevant for naturopaths in advertising, from flyers to websites, are shown here.
This applies in passing to § 10:
§ 10 Advertising bans for prescription drugs and psychotropic drugs old version (2)
(2) Medicines which are intended to eliminate insomnia or mental disorders in people or to influence the mood may not be advertised outside the specialist circles.
New version (2)
(2) Medicines containing psychotropic substances with a risk of dependency and which are intended to eliminate insomnia or mental disorders in people or to influence the mood may not be advertised outside the specialist circles.
The risk of violating the paragraph has thus been reduced. So far, you could occasionally see violations on websites here, for example the advertising of preparations that promote sleep through the night. That is now a thing of the past, since the decisive criterion is potential dependency.
§ 11 Advertising ban outside the specialist circles Most changes refer to § 11, paragraph 1, which has been deleted:
1. "with reports, certificates, scientific or technical publications and with references to them"
§1, paragraph 2
2. "with information that the medicinal product, the procedure, the treatment, the object or the other means is medically, dentist, veterinarian or otherwise technically recommended or tested or used,"
was changed to:
2. "with statements or representations that refer to a recommendation by scientists, health professionals, animal health professionals or other people who, due to their popularity, may stimulate drug consumption". You can now name the sources of your therapy procedures without "pull-ups".
3. "with the presentation of medical histories and with references to them,"
was changed to:
3. "with the presentation of medical histories and with references to them, if this occurs in an abusive, repulsive or misleading manner, or can lead to a false self-diagnosis by a detailed description or presentation,"
The legal terms abusive, repulsive and misleading must first be interpreted in this context through case law. So please do not understand it as a license.
4. "with the pictorial representation of people in work clothes or in the exercise of the activity of health professionals, the medical trade or the pharmaceutical trade" was deleted without replacement.
5. "with the graphic representation a) of changes in the human body or its parts as a result of illness, suffering or physical damage,
b) the effect of a drug, a process, a treatment, an object or another agent by comparing the body condition or appearance before and after use,
(c) the action of a medicinal product, a process, a treatment, an object or another agent on the human body or its parts, "
was changed to:
5. "with an image depicting, in an abusive, repulsive or misleading manner, changes in the human body due to illness or damage or the effect of a medicinal product in the human body or in parts of the body," This is also an improvement in the provisions, unfortunately again with the uncertainty of the undefined legal terms.
6. "with foreign or technical language designations, insofar as they are not included in the general German language use," deleted without replacement, which was overdue. Until then, you could only be warned by using an unexplained term such as magnetic therapy or kinesiology, because this was incomprehensible to the layperson.
7. "with an advertising message that is likely to evoke or exploit feelings of fear,"
was changed to:
7. "with advertising claims suggesting that normal good health could be affected by the non-use of the medicinal product" This affects you now only marginally, while the previous determination led to many warnings.
10. "with publications that lead to the detection of certain diseases, ailments, bodily harm or pathological complaints in humans themselves and to treat them with the medicinal products, objects, processes, treatments or other means indicated in the advertisement, as well as with corresponding instructions in audiovisual Media, "deleted without replacement, but note the prohibition in number 3.
11. "with statements by third parties, in particular with letters of thanks, acknowledgment or recommendation, or with references to such statements," was changed to:
11. "with statements by third parties, in particular letters of thanks, acknowledgment or recommendation, or with references to such statements if they are made in an abusive, repulsive or misleading manner,"
While this change is an improvement, it is not without problems.
13. "with competitions, raffles or other procedures, the outcome of which depends on chance,"
was changed to:
13. "with competitions, raffles or other procedures, the outcome of which depends on chance, provided that these measures or procedures encourage inappropriate or excessive use of medicinal products". So that has become pretty unimportant for you.
15. “by the submission of samples or samples of other means or objects, or by vouchers for them. Sentence 1 nos. 7 to 9, 11 and 12 apply accordingly to medical devices. "
was supplemented by:
15. "Furthermore, the surgical plastic surgery mentioned in § 1 number 2 may not be promoted with the effect of such treatment by comparing the state of the body or the appearance before and after the application."
The case law could also assume this for a wrinkle injection, which the case law will show shortly. Avoid before and after pictures. You cannot publish them.
These are all important changes for you. With all the joy of the relief you should not forget, most warnings result from violations of § 3 HWG and it has not been changed. (Heinz-Georg Bramhoff Communication and Legal Office of the Bund Deutscher Heilpraktiker (BDH) e.V.)