Heilmittelwerbegesetz 2013 This is new

On June 28, 2012, the Bundestag also passed amendments to the Therapeutic Products Advertising Act (HWG) with the second law amending drug legislation and other regulations, which became final after approval by the Federal Council on 19 October 2012.

16/01/2013

The amendments to the AMG and other provisions were required by EU directives and decisions of the highest court, which were taken into account in the current version. Overall, the amendment of the HWG shows that now the legislature of the "responsible citizens" is taken more seriously and the image of the "underage" on all sides to be cared for citizen of the past. So we see relief and improvements, unfortunately not quite consistent.

What's new?
Only changes that are relevant for non-medical practitioners in advertising, from flyers to websites, are shown here.
That concerns on the edge the § 10:

§ 10 advertising bans on prescription drugs and psychotropic drugs
old version (2)
(2) For medicinal products intended to eliminate insomnia or mental disorders in humans or to influence their mood, it is not permitted to advertise outside the medical community.

New version (2)
(2) Medicinal products containing psychotropic drugs with a risk of addiction and which are intended to eliminate insomnia or mental disorders in humans or to influence their mood must not be advertised outside the medical community.
The risk of violations of the paragraph has been reduced. So far, it has been possible to occasionally see violations on websites, for example, the application of preparations that promote sleep. This is now past, because the decisive criterion is the potential dependence.

§ 11 Advertising ban outside the professional circles
Most changes are related to the § 11, para. 1, which has been deleted:
1. "with reports, certificates, scientific or technical publications and references to them"

§1, para. 2
2. "indicating that the medicinal product, the process, the treatment, the article or other article is or is being recommended or applied for by a medical, dental, veterinary or other professional means,"

has been changed to:
2. "information or presentations referring to a recommendation by scientists, by healthcare professionals, by persons working in the field of animal health or by other persons who may encourage the consumption of medicinal products by reason of their reputation". So you can now call the sources of your therapy procedures without "pull-ups".

3. „with the reproduction of medical histories and with references to "
has been changed to:

3. "reproducing case histories, as well as references to them, if they are abusive, repugnant or misleading, or if they can lead to a false self-diagnosis through a detailed description or presentation"
The legal terms abusive, repulsive and misleading must be interpreted in this context, however, by case law first. So, please do not understand as a license.

4. "depicting persons in work clothes or in the exercise of the activity of health professionals, the medical profession or the pharmaceutical trade" was canceled without replacement.

5. "depicting a) changes in the human body or its parts due to illness, suffering or bodily injury,

(b) the effect of a medicinal product, a process, a treatment, an article or other means by comparing the physical condition or appearance before and after use,
(c) the action of a medicinal product, process, treatment, object or other agent on the human body or its parts, "

has been changed to:
5. „with a pictorial representation that reproduces, in an abusive, repulsive or misleading manner, changes in the human body due to illness or injury or the effect of a medicinal product in the human body or parts of the body " Again, this is an improvement of the provisions, unfortunately again with the uncertainty of indefinite legal concepts.

6. "with foreign or technical language designations, as far as they are not in the general German language use," deleted without replacement, which was overdue. Until then, you could be warned by the use of an unexplained term such as magnetic therapy or kinesiology alone, because the layman was not understandable.

7. "with an adage that is capable of evoking or exploiting anxiety,"
has been changed to:
7. „with advertising claims suggesting that normal good health could be affected by non-use of the drug " This touches you now only marginally, while the previous provision led to many warnings.

10. "containing publications designed to identify certain diseases, ailments, physical injuries or pathological conditions in humans themselves and to treat them with the medicinal products, articles, procedures, treatments or other means specified in the advertising, as well as with appropriate instructions in audiovisual Media, "deleted without replacement, but note the ban in the number 3.

11. "with statements by third parties, in particular with letters of thanks, recognition or letters of recommendation, or with references to such statements," has been changed to:

11. "with statements by third parties, in particular with letters of thanks, recognition or letters of recommendation, or with references to such statements, if they are made in an abusive, repugnant or misleading manner,"

This change is an improvement, but not without its problems.
13. "by competitions, raffles or other procedures the result of which depends on chance"
has been changed to:

13. "by competitions, sweepstakes or other procedures the result of which depends on chance, provided that those measures or procedures encourage the inappropriate or excessive use of medicinal products" . This has become quite unimportant for you.

15. „by the unsolicited submission of samples or samples of other means or items or vouchers therefor. For medical devices, sentence 1 numbers 7 to 9, 11 and 12 apply accordingly. "

was supplemented by:
15. "Furthermore, for in § 1 point 2 surgical plastic surgery are not advertised with the effect of such treatment by comparing the body condition or the appearance before and after the application. "
That could also accept the case law for a Faltenunterspritzung, which will show the case law in the near future. Dispense with before-and-after pictures. You may not publish them.

These are all important changes for you. For all the enjoyment of the facilities you should not forget, most of the warnings result from violations of the § 3 HWG and that has not been changed. (Heinz-Georg Bramhoff Communication and Legal Office Association of German Non-medical Practitioners (BDH) e.V.)