A product delimitation is the distinction between different product categories that result from different laws or regulations. While most objects are easy to recognize (“a table is a table”), it is sometimes difficult and can even seek help from the highest court to classify certain objects in accordance with the law. One then speaks of delimitation problems . This applies in particular to the demarcation between drugs and food and between drugs and medical devices.
Part of the problem of product delimitation is that even within Germany (e.g. in Germany) there is no uniform legal practice.
Medicines - Food
The demarcation between pharmaceuticals and foodstuffs (the demarcation from food supplements is often particularly controversial ) usually succeeds at the first attempt, but not in every case without demarcation problems.
The significance of the delimitation is that finished medicinal products may not be sold in Germany without authorization and that food in Germany may not be advertised health-related ( Heilmittelwerbegesetz , HWG).
The European Health Claims Regulation , which has been in force across Europe since 2007, has exacerbated the problem: After health-related statements were previously reserved for medicinal products, such claims can now also be approved for food, which has made a key differentiating criterion less sharp.
Excerpt from the judgment: "When distinguishing between food / food supplements and pharmaceuticals, the precedence of the pharmaceutical regulations resulting from Community law also applies in national law, possibly by way of the guideline-compliant interpretation."
The German legislator defines the drugs in the Medicines Act (AMG), the food in the food law ( food, consumer goods and feed code (LFGB / LMBG) or in the food supplements ordinance (NemV)). The two German sets of laws on European regulations are linked.
Section 2 (3) AMG says: Medicines are not: ... 1. Food within the meaning of Section 2 (2) of the Food and Feed Code ...
Section 2 (2) LFGB defines: Food is food within the meaning of Article 2 of Regulation (EC) No. 178/2002.
Article 2 of Regulation (EC) 178/2002 defines:
For the purposes of this ordinance, "food" means all substances or products that are intended or that can reasonably be expected to be consumed by humans in a processed, partially processed or unprocessed state. "The definition then has a lot to do with it and excludes others, as in sentence d): “Medicines within the meaning of Directive 65/65 / EEC and 92/73 / EEC of the Council”, so that their definitions are also essential for delimitation.
RL 65/65 / EEC and RL 92/73 / EEC have now been repealed and replaced by Directive 2001/83 / EC . In the current version of Directive 2001/83 / EC, Article 2 (2) states that in cases of doubt, in which a product [..] can fall under both the definition of "medicinal product" and the definition of a product, the is regulated by other Community legislation, Directive 2001/83 / EC, i.e. pharmaceutical law, is to be applied.
In essence, however, it can be assumed that products which are primarily used for nutrition and which, as intended, only convey health-related effects are foods, while products which, as intended, primarily convey disease-related effects in a pharmacological, immunological or metabolic way are drugs.
What this is to be understood in a specific individual case sometimes requires interpretations by the highest court.
For more information, see also: Functional Medicines
Judicial decision making
The Federal Administrative Court in Leipzig ruled in three cases in 2007: Products that are brought onto the market by their manufacturer as dietary supplements can only be classified as medicinal products by the authorities and designated as not marketable due to lack of approval if reliable scientific evidence proves that they significantly influence the functional conditions of the human body.
Medicinal product - medical device
The rating naturally falls on the floor of a member of the EU . Should another country not be able to support this decision and come to a different assessment, this is permissible, ruled the European Court of Justice (ECJ) on October 3, 2013 with file number C-109/12 in the case of a French manufacturer's lawsuit against the Korkein hallinto-oikeus (Supreme Administrative Court of Finland) .
The EU has set up a group of experts for the delimitation of medical devices, which is supposed to develop EU uniform bases for delimitation decisions. First decisions to delimit previously unresolved issues were published in May 2008.
Within the EU, the EU regulations have priority over national regulations. Germany and Austria define and regulate the drugs in their drug laws (AMG), the medical devices in their medical device laws (MPG), in each case in accordance with the EU regulations.
The Medicines Act in Germany defines medicinal products as "... substances and preparations made from substances that are intended to reveal the nature, condition or functions of the body or mental states through use on or in the human or animal body." And borders they abolish the medical products by "Medicines are not: ... 7. Medical products and accessories for medical products within the meaning of § 3 of the Medical Devices Act, unless they are medicinal products within the meaning of § 2 Para. 1 No. 2 ... “ This formulation also defines an exception, namely that physically effective in vivo diagnostics such as B. Contrast media , which according to the MPG and the European Medical Devices Directive would actually be medical devices, are still considered medicinal products in Germany.
The Medical Devices Act in Germany defines medical devices based on the relevant European directives; there is also a separate legal definition in the Medical Devices Act for in-vitro diagnostics, which represent a subgroup of medical devices.
The scope of the Medical Devices Act is delimited by the stipulation "... does not apply to medicinal products within the meaning of Section 2, Paragraph 1, No. 2 of the Medicinal Products Act." , Whereby the 5th MPG amendment regulates: "... the decision on Whether a product is a medicinal product or a medical product is made taking into account the main mode of action of the product (...) ” .
In a very simplified way, medical devices achieve health-related effects for people, which also applies to drugs. In contrast to medical devices, however, drugs achieve their main intended effect through pharmacological , immunological or metabolic mechanisms. In contrast, the effects of medical products on the human body are predominantly of a physical nature. In the case of medical products, the concept of effectiveness is therefore to be understood in the sense of (technical) functionality .
The problem now exists because no legal definition has been given for what lawyers understand by “pharmacologically” or “immunologically” acting agents or “metabolism”. There are supreme court judgments, including contradicting ones. A European guideline MEDDEV document 2.1 / rev has existed for years to legally delimit the areas of “medical devices” and “pharmaceuticals” . 3 , which is recognized by the German courts as state of the art and is used to justify decisions.
Disinfectants with an identical composition are classified as pharmaceuticals, medical device (s), biocide (s) or consumer goods, depending on their intended use.
Medicines should be them when they are intended for
- specific disinfection of sick patients
- Hand disinfection by surgeons
- specific disinfection of sick animals
They should be a medical device if they are intended for use
- Disinfection of medical devices
- unspecific body disinfection in a physico-chemical way
They should be a biocidal product if they are intended for use
- Disinfection of other surfaces such as treatment chairs, shelves, rooms, devices, systems, cultivation areas and other and no components or residues in food or feed will occur
- unspecific body disinfection without direct disease reference
- unspecific disinfection of animals
They should be a commodity if they are intended for
- Disinfection in the production of feed or food (e.g. food production plants) and these or their residues could be found in the feed or food product
Cosmetic - food
As a rule, there are no delimitation problems here. This can arise with products that are to be chewed or sucked for (alleged) care purposes.
This is where the further problem of delimitation compared to presentation drugs arises .
Medicines - cosmetic
In particular , it can be difficult to differentiate between cosmetics , which are characterized by care or hygienic properties, and pharmaceuticals, if they are used preventively or for defense against pathogens . In the gray area between cosmetics and pharmaceuticals, preparations containing prosthesis to promote eyelash growth (" eyelash growth serums ") are located.
Medical device - food
As a rule, there are no delimitation problems here. This can arise with products that are to be swallowed, chewed or sucked for medicinal purposes.
Medical device - cosmetic
As a rule, there are no delimitation problems here. This can arise with products that are to be distributed on the skin for medical purposes or to be used to care for the oral cavity.
Judgment excerpt : "Tooth bleaches that are to be used by the dentist are medical devices and not cosmetics."
Consequences of the delimitation problem
Some of the decision-making processes took several years to go through. During this time there is considerable legal uncertainty, especially among experts, companies and authorities. That has z. In some cases far-reaching consequences: During this time, illegal products are later launched and sold for at least a few years, but legal products are later also not realized due to legal uncertainty.
Since only large companies can get through the lengthy, difficult to understand and costly legal battle, this contributes to a concentration of power of supranational corporations in the health and nutrition sectors. In addition, such a legal dispute usually mixes with Europe-wide lobbying , which is not limited to one nation.
- Classification of the laxative polyethylene glycol (PEG) - differentiation dispute drug versus medical device has existed since 2006 and will hardly be finally decided before 2011.
- Classification of vitamins - the dispute between pharmaceuticals and food has existed since the 1980s. In the meantime the practice of many states (including Austria) has been corrected by some judgments of the European Court of Justice, but the subject of dispute is extraordinarily productive.
- Lactic acid bacteria in donors has been certified as a medical device in France and classified as a medicinal product in Finland. The ECJ before the case found both classifications to be compatible with EU law.
- Electronic cigarette - This raises the question of whether nicotine depots should be treated as drugs and inhalers as medical devices. Such a classification was made by the delimitation committee in Austria. A German state minister also took this view. The German courts made the opposite decision.
- Anti-caries candy was classified by court decision as a cosmetic (as claimed by the manufacturer) and not as a food (as claimed by the plaintiff competition association)
- Garlic extract capsules were classified as medicinal products in Germany. In contrast, the European Court of Justice (ECJ) ruled on November 15, 2007 that the amount of extract, which corresponds to 7.4 g of raw garlic, is an “appropriate” amount for food. What is interesting about this demarcation is that, according to currently valid relevant monographs , this amount is assigned a pharmacological effect, so that the presentation by the manufacturer is decisive for the classification as a food or drug.
- There are contradicting decisions regarding the enzyme lactase as a functional drug or dietary supplement, most recently for dietary supplements, for more see below functional drugs # Decisions regarding lactase .
- For decisions on other functional medicinal products, see under Functional medicinal products # Examples of court rulings for differentiation .
Bodies for delimitation issues
In Austria, a delimitation advisory board was set up to prepare expert reports on the delimitation of drugs and other products. The delimitation advisory board is an organ set up by the Federal Ministry for Health, Family and Youth (BMGFJ) in accordance with Section 49a AMG . Reports on demarcation issues that are subject to a fee can be requested from the Federal Office for Health Safety (BASG). Some of the results of decisions can be viewed on the BASG website.
In Germany, the Federal Office for Consumer Protection and Food Safety (BVL) and the Federal Institute for Drugs and Medical Devices (BfArM) set up a joint commission of experts for the classification of substances. Substances that have hitherto been mainly or exclusively used in pharmaceuticals are increasingly being marketed as food or food ingredients, although in some cases there are concerns on the part of the authorities with regard to the safety and marketability of such products.
- Peter Bichsel : A table is a table . Suhrkamp, Frankfurt am Main 1995.
- Ina Gerstenberg: In the Thicket of Plants ... , Newsletter Dietary Supplements 2008 of the Euroforum , p. 8
-  from the guiding principle of the OVG North Rhine-Westphalia - judgment 13 A 1977/02 of March 17, 2006
- Az .: 3C 21.6, 22.6, 23.6
- Matthias Runge: A product can be a medical product and a drug at the same time - in case of doubt, the rule of doubt? In: Medizin Produkte Recht 6, 2013, pp. 199–207.
- Medical Devices Expert Group on Borderline and Classification List of Members (pdf)
- Manual on borderline and classification in the Community Regulatory framework for medical device (pdf)
- see also the poster of the Federal Ministry of Health in Germany : Market access regulations for medical devices compared to pharmaceuticals ( Memento from January 31, 2012 in the Internet Archive ) (PDF file; 64 kB)
- Paragraph 1, No. 2 AMG
- (3) AMG
- Art. 1 Paragraph 2 Letter 93/42 / EEC (medical devices) and 98/79 / EC (in vitro diagnostics). No. 1 MPG based on Art. 1 Paragraph 2 Letter a) - in each case - of Directives 90/385 / EEC (active implants),
- No. 4 MPG in implementation of Art. 1 Paragraph 2 Letter b) of Directive 98/79 / EC (corresponds to Art. 1 Paragraph 2 Letter c) of Directive 93/42 / EEC).
- Paragraph 5 No. 1 MPG
- Article 11 of the Second Act to Change Pharmaceutical Law and Other Provisions of October 19, 2012, Federal Law Gazette I, p. 2192, of October 25, 2012, in force since October 26, 2012
- Synopsis on § 2 MPG , www.buzer.de
- , Paragraph (1) 2. a) AMG
- see also judgment excerpt: "drug are to the effect delineate opposite medical devices that, for predominantly pharmacological effect a medicine, mainly physical effect of a medical device is present." ,  from the guiding principle of the OVG-North Rhine-Westphalia - Decision 13 A 3903 / 06 of June 11, 2007.
- Medical Devices: Guidance document - Borderline products, drug delivery products and medical devices incorporating, as an integral part, an ancillary medicinal substance or an ancillary human blood derivative (PDF file; 182 kB), as of December 2009.
-  Guiding principle of the OVG North Rhine-Westphalia - decision 13 A 5022/00 of August 14, 2003
- Ministry of Health, Care and Old Age, Minister Barbara Steffen, in a press release and decree of December 16, 2011
- OVG NRW, 13th Senate, decision of April 23, 2012–2013 B 127712 (previously VG Düsseldorf, 16 L 2043/11)
- LG Cologne, July 10, 2007
- Differentiation between food and pharmaceuticals ( Memento from July 16, 2012 in the Internet Archive ), Austrian Agency for Health and Food Safety (AGES), February 1, 2011.
- AGMP (Working Group Medical Devices of the ZLG) project group delimitation and classification issues: " Working aid : Classification and classification of medical devices " from June 29, 2007 (PDF with 33 pages)