Medicines Advertising Act

from Wikipedia, the free encyclopedia
Basic data
Title: Law on Advertising in the Medical Sector
Short title: Medicines Advertising Act
Abbreviation: HWG
Type: Federal law
Scope: Federal Republic of Germany
Legal matter: Special administrative law
References : 2121-20
Original version from: July 11, 1965
( BGBl. I p. 604 )
Entry into force on: July 15, 1965
New announcement from: October 19, 1994
( BGBl. I p. 3068 )
Last change by: Art. 6 G of April 28, 2020
( Federal Law Gazette I p. 960, 1007 )
Effective date of the
last change: 		May 26, 2022
(Art. 18 G of April 28, 2020)
GESTA : M030
Weblink: Text of the law
Please note the note on the applicable legal version.

The Heilmittelwerbegesetz (HWG), in addition to the law against unfair competition (UWG) and the professional regulations, form the legal framework for advertising in the German healthcare system. It applies to the manufacturers and suppliers of drugs and medical devices as well as the service providers, etc. a. Hospitals , pharmacies and - to a limited extent - doctors .

The drug advertising law is primarily intended to counter dangers that threaten the health of the individual and the health interests of the general public through improper self-medication, regardless of whether they actually occur in individual cases. The advertising bans of the Heilmittelwerbegesetz are intended to prevent sick people from being misled to make wrong decisions about the use of drugs through inappropriate advertising.

scope of application

According to § 1 Abs. 1 HWG, the law applies to advertising for

  • drug
  • Medical devices
  • other means, procedures, treatments and objects (...) as well as medically non-indicated plastic-surgical interventions (e.g. " cosmetic surgery ").

The term advertising is broadly defined in the HWG. It includes all product or performance-related statements that are designed to promote the sale of the advertised drug. The naming of a certain drug name regularly presents itself as a suitable measure for the sales promotion of the product and is understood by the public as a measure also serving this promotion. For the application of the provisions of the Therapeutic Products Advertising Act, it is sufficient, according to its protective purpose, that the measure in question is aimed at the sale of one or more specific medicinal products in addition to other purposes.

content

Mandatory information

§ 4 HWG obliges to provide the mandatory information listed in § 4 Paragraph 1 HWG when advertising a drug. In their place, in advertising outside the specialist circles, the obligation to provide the well-known information "For risks and side effects, read the package insert and ask your doctor or pharmacist".

Prohibition of misleading advertising

In addition, the Therapeutic Products Advertising Act fundamentally differentiates between advertising the products and treatments mentioned in § 1 HWG to specialist groups, which are defined in § 2 HWG, and to laypeople. Misleading advertising or advertising for unapproved drugs is generally prohibited.

Lay advertising

It is not allowed to advertise prescription drugs outside of specialist circles. Section 11 of the HWG also contains a catalog of advertising statements , content and measures that are generally prohibited in advertising with pharmaceuticals outside the specialist community. This includes B.

  • the prohibition of advertising with recommendations by scientists, persons working in the health sector or celebrities,
  • the prohibition of the reproduction of medical histories if they are abusive, repulsive or misleading,
  • the prohibition of depicting before-and-after depictions or symptoms of illness if these depictions are abusive, repulsive or misleading,
  • the prohibition of advertising claims that suggest that health will deteriorate if a product is not used,

or

  • the prohibition of advertising with contests or raffles if these encourage the inappropriate use of pharmaceuticals.

In 2012, the HWG experienced some major innovations with regard to this catalog. Before-and-after presentations and medical histories - up to now completely forbidden - were allowed with the stipulation that they must not be abusive, repulsive or misleading. In addition, the following previously applicable bans have been lifted:

  • the prohibition of advertising with doctors or pharmacists in work clothing or while exercising their profession,
  • the prohibition of advertising stating that the product or treatment is recommended, tested or used by a doctor, dentist or other specialist
  • the prohibition of advertising with foreign or technical terms, as long as they are not used in general German,

and

  • the prohibition of publications that could encourage self-diagnosis.

Prohibition of promotional gifts

Another important provision is contained in Section 7 of the HWG, which prohibits gifts and other promotional gifts for the purposes of drug advertising, unless very narrowly defined exceptions are made. An exception is the giving of gifts and other promotional gifts, insofar as they are minor items. The limit of low value is exceeded at a value of more than 1 euro.

According to Section 12 of the HWG, advertising for treatments that focus on the alleviation or elimination of certain diseases in humans (Annex Section A, e.g. notifiable diseases according to IfSG , cancers, etc.) or animals (Annex Section B, e.g. B. Diseases according to TierSAnzV and TierKrMeldeV, cancer, colic in horses and cattle, etc.).

Penal regulations

In § 14 HWG there is a criminal provision which makes misleading advertising under § 3 HWG a criminal offense. The HWG is thus part of ancillary criminal law . All other violations will be punished as administrative offenses.

Legal standing

The provisions of the Therapeutic Products Advertising Act are market behavior rules within the meaning of Section 3a UWG. Violations of these legal regulations can therefore u. a. are pursued by all competitors, or by associations that are active to promote the commercial interests of their members. The Berlin-based Association of Social Competition with 142 proceedings in 2017 alone is known for such legal disputes .

literature

  • Ulf Doepner: Medicines Advertising Act. 2nd Edition. Vahlen Verlag, 2000, ISBN 3-8006-1541-X .
  • Peter Bülow , Gerhard Ring, Markus Artz, Kerstin Brixius: Heilmittelwerbegesetz. Comment: Law on Advertising in the Field of Healing (HWG). 4th edition. Heymanns Verlag, 2011, ISBN 978-3-452-26673-6 .
  • Hans-Georg Riegger: Heilmittelwerberecht "Verlag CH Beck, 2009, ISBN 978-3-406-58522-7

Web links

Individual evidence

  1. ↑ Decision of the Federal Constitutional Court, decision of the 2nd Chamber of the First Senate of April 30, 2004 - 1 BvR 2334/03 - Rn. (1–23)
  2. ↑ BGH, judgment of March 26, 2009, I ZR 213/06, Item 17 - Fixed amount fixing
  3. ↑ Section 1, Paragraph 1 of the HWG
  4. ↑ BGH, judgment of March 26, 2009 - I ZR 213/06, Item 13 - Fixed amount determination
  5. ↑ § 4 HWG
  6. ↑ § 2 HWG
  7. ↑ § 3 HWG
  8. ↑ § 3a HWG
  9. ↑ § 11 HWG
  10. ↑ Second law amending pharmaceutical law and other regulations. (2nd AMGuaÄndG) of October 19, 2012, Federal Law Gazette I p. 2192 (No. 50)
  11. ↑ § 7 HWG
  12. ↑ BGH, judgment of September 9, 2010 - I ZR 98/08, Item 22 - Bonus points
  13. ↑ § 12 HWG
  14. ↑ § 14 HWG
  15. ↑ § 3a UWG
  16. ^ Lawsuit against Cathy Hummels “I see myself as a women's magazine” . Spiegel Online , February 11, 2019; accessed on February 12, 2019
  17. ↑ This is behind the wave of warnings from the Association of Social Competition . Horizont , July 22, 2018; accessed on February 12, 2019