Functional drugs

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Functional medicinal products are medicinal products which, through their effects, influence physiological functions. They differ from the presentation drugs , which, regardless of their actual effectiveness, are intended to cure or prevent human diseases. The distinction goes back to Art. 1 No. 2 of the Community Code for Human Medicinal Products .

Demarcation

Functional as well as presentation drugs are drugs within the meaning of § 2 AMG and may be used without approval under drug law according to § 21 para. 1 AMG, § 3a sentence 1 HWG are neither distributed nor advertised.

Both terms play a role in product delimitation and thus in marketing, because pharmaceuticals fall under a different law than, for example, food or medical products . These are subject to the Food and Feed Code (LFGB) or the Medical Products Act (MPG), which does not apply to medicinal or cosmetic products ( Section 2, Paragraph 5, MPG). In the case of medical products, for example, the particularly expensive clinical studies are no longer necessary. Compared to pharmaceuticals, they may also be advertised under less stringent conditions, for example with certain visual representations, such as a comparison of before and after .

The manufacturer's information is decisive for the classification as a medicinal product, medical product, cosmetic or dietary supplement . The authorities orientate themselves on it. Disputed individual cases must be clarified by the courts.

Legal basis

European Law

According to the European Directive 2001/83 / EC (Community Code for Human Medicinal Products) in the amended, currently valid version, are functional medicinal products

"All substances and compositions of substances that are administered in or on the human body in order to either restore, correct or influence the human physiological functions through a pharmacological, immunological or metabolic effect or to make a medical diagnosis."

According to a judgment of November 15, 2007 by the European Court of Justice (ECJ) in Luxembourg, which is binding for all EU member states , a requirement for a functional medicinal product is that it has a significant effect on the metabolism and that it really influences the functional conditions of the body .

On the other hand, according to Directive 2001/83 / EC, presentation medicinal products are

"All substances or compositions of substances which are intended as agents with properties for the healing or prevention of human diseases."

In addition, the so-called case of doubt rule applies as defined in Paragraph 2 Article 2 of the Directive, which states:

"In cases of doubt, where a product, taking into account all its properties, can fall under the definition of 'medicinal product' as well as the definition of a product regulated by other Community legislation, this Directive applies."

German law

Even though it was previously based on case law, the European regulation was also implemented in national law in 2009 with the 15th amendment to the Medicines Act.

Extract from a judgment: "The presence of a functional medicinal product within the meaning of Art. 1 No. 2 lit. b) Directive 2001/83 / EC is not to be determined by the effects described there, but by whether the product can fulfill a therapeutic purpose ( here negated with regard to certain bacteria). "

Examples of court rulings for delimitation

Below are examples of some decisions regarding the differentiation of functional medicinal products from other product groups that were particularly received.

Decisions regarding lactase

The Higher Regional Court (OLG) Stuttgart dealt in February 2008 with the assessment of powdery, sold in capsules agents that lactase included. Lactase is an enzyme that breaks down milk sugar and is taken by people with a lactose intolerance in order to be able to digest the milk sugar contained in many dairy products. The OLG ruled on the basis of German and primarily European law that these agents are not functional medicinal products. The OLG saw the condition that there was a disruption of physiological functions in the case of lactose intolerance. But the remedy is not able to influence the function of the body (namely the intestinal villi or the digestive secretions ), but only affects the condition of the food. Rather, an active bio-effect must be required, i.e. an exogenous substance must have a controlling effect on body functions in order to be allowed to be regarded as a functional medicinal product in the sense of the EU directives. The court also relies on a previous reasoning from the Federal Administrative Court.

Different decisions by German courts on lactase preparations were also before the OLG:

  • With the judgment of the Administrative Court (VG) Berlin in 2006 a product comparable to that judged by the Higher Regional Court Stuttgart in 2008 was classified as a drug subject to authorization.
  • In 2000, the Frankfurt Higher Regional Court classified a lactase preparation as a medicinal product and not as a dietary food. However, the EU directives had not yet come into force at this point. In addition, the product had met the requirements for a "presentation drug".

Decisions on preparations with herbal ingredients

In 2007, a product with the ingredients oligomeric proanthocyanidins was classified as a dietary supplement and not as a functional drug by a judgment of the Federal Administrative Court (BVerwG). In this and two other judgments of July 25, 2007, the BVerwG issued the following identical guiding principles:

  1. The use of a product only affects the physiological functions of the human body within the meaning of the EU drug definition if it leads to a significant change in the functional conditions of the organism and causes effects that are outside the normal life processes taking place in the human body.
  2. The classification of a product as a medicinal product requires that the effects attributed to it are proven by reliable scientific knowledge.

Also in 2007 the Federal Administrative Court confirmed in a judgment a care ointment containing small amounts of camphor and menthol as a care product (cosmetic). The court issued the guiding principle: A horse ointment declared as a care product does not become a medicinal product within the meaning of Section 2 (1) AMG due to a camphor content of 0.5%.

More recently, decisions about a product sold as a dietary supplement, which consists of mold-treated, red fermented rice (“red rice”) , also date back to more recent times . The Monacolin K contained in it is structurally identical to Lovastatin , a drug used in higher doses in the treatment of high cholesterol levels . For this reason, the supervisory authorities had denied the marketability of the “Red Rice” capsules as a food supplement and prohibited them from being placed on the market . In 2006, the Lower Saxony Higher Administrative Court ruled that the drug was to be regarded as a medicinal product subject to authorization and included the following principles in its judgment:

  1. ...
  2. In order to assess whether a product falls under the definition of a medicinal product “according to its function”, emphasis must be placed on the pharmacological effects.
  3. In the case of substances for which a dose-dependent pharmaceutical effect has not been clearly determined scientifically, the comparison with approved drugs and possible health risks are important delimitation criteria.
  4. The applicability of the rule of doubt in Article 2, Paragraph 2 of Directive 2001/83 / EC in the version of the amending directive 2004/27 / EC does not require that the medicinal product has been positively determined. It is rather sufficient that the relevant proof of the pharmacological effect cannot be provided with absolute certainty.

On the other hand, the ECJ ruled in its judgment of January 15, 2009 that the “Red Rice” capsules are not a medicinal product and thus once again confirmed its restrictive interpretation of the term medicinal product.

As early as 2007, the ECJ ruled that garlic extract powder capsules should not generally be regarded as medicinal products. He also referred to Directive 2001/83 / EC, according to which the disputed remedy does not correspond to the definition of a “medicinal product by name” or “by function”. A “generally beneficial effect on health” and a dosage form as a capsule are not sufficient to declare a food to be a medicinal product. With regard to the classification as a functional medicinal product , the court admitted that the garlic capsules serve to prevent arteriosclerosis and can have a pharmacological effect. However, the same effect can already occur with a daily intake of 7.4 grams of raw garlic . In the opinion of the ECJ, a product that has no other effects on the organism than a food has not exceeded the threshold of being a functional medicinal product. The federal government had previously classified the garlic capsules as medicinal products and prohibited an applicant from importing them as dietary supplements.

In contrast, cinnamon extract capsules were classified as medicinal products by two dishes. The courts classified the products not only as presentation medicinal products, but also as functional medicinal products, since they have a blood sugar-lowering effect that is also "medicinal".

Individual evidence

  1. ↑ Presentation drug website of the Federal Institute for Drugs and Medical Devices (BfArM), glossary, accessed on May 3, 2018
  2. ↑ Lars Hilbig: Borderline products: Is it all a matter of opinion? Pharmaceutical newspaper , edition 13/2008
  3. ↑ cf. BGH, judgment of June 25, 2015 - I ZR 205/13 No. 10
  4. ↑ Otto D. Dobbeck: Arzneimittel ( Memento of the original from May 5, 2018 in the Internet Archive ) Info: The archive link was automatically inserted and not yet checked. Please check the original and archive link according to the instructions and then remove this notice. Pro Honore , 2011 @1@ 2Template: Webachiv / IABot / www.pro-honore.de
  5. ^ Daniel Huber: Food or Medicines? 11th of June 2013
  6. ↑ Lars Hilbig: Borderline products: Is it all a matter of opinion? Pharmaceutical newspaper , edition 13/2008
  7. ↑ cf. Case law on the delimitation of drugs, medicinal products, medical devices, cosmetics and dietary supplements ECJ, German civil and administrative courts, accessed on May 4, 2018.
  8. ↑ a b ECJ, judgment of November 15, 2007, Az .: C-319/05
  9. ^ [1] from the guiding principles of the OVG North Rhine-Westphalia - judgment 13 A 1977/02 of March 17, 2006
  10. ↑ OLG Stuttgart, judgment of February 14, 2008, Az: 2 U 81/07
  11. ↑ a b BVerwG, judgment of May 16, 2007, Az .: 3 C 34.06
  12. ^ VG Berlin, judgment of July 19, 2006, Az .: 14 A 135.97
  13. ↑ OLG Frankfurt, judgment of April 27, 2000, Az .: 6 U 17/99
  14. ↑ BVerwG judgment of July 25, 2007, Az .: 3 C 21.06
  15. ↑ BVerwG judgment of July 25, 2007, Az .: 3 C 22.06
  16. ↑ BVerwG judgment of July 25, 2007, Az .: 3 C 23.06
  17. ↑ Lower Saxony OVG, judgment of March 23, 2006, Az .: 11 LC 180/05
  18. ↑ ECJ, judgment of January 15, 2009, Az .: C-140/07
  19. ↑ Administrative Court of Minden; Judgment of May 14, 2008, Az .: 7 K 727/06 [2]
  20. ^ OLG Hamm; Judgment of August 7, 2007, Az .: 4 U 194/06 [3]