Medicinal productsMedicinal products are substances or preparations of substances intended for use in or on the human or animal body and intended as agents having properties for the cure or mitigation or prevention of human or animal diseases or pathological conditions, or which may be used in or on the human or animal body or administered to a human or animal, either to restore, correct or influence physiological functions by a pharmacological, immunological or metabolic action, or to make a medical diagnosis (Section 2(1) of the German Medicines Act).
Differentiation from other products
The above definition of medicinal product determines that the preparations mentioned therein are subject to the provisions of the Medicinal Products Act, the main purpose of which is to ensure the safety of medicinal products. Pharmaceuticals are distinguished by definition from other sometimes similar products, such as medical devices, dietary supplements or cosmetics, to which other regulations apply.
Finished medicinal products are medicinal products prepared in advance and placed on the market in a package intended for distribution to the consumer, or other medicinal products intended for distribution to consumers, the preparation of which otherwise involves an industrial process, or which are prepared commercially, except in pharmacies. Finished medicinal products are not intermediate products intended for further processing by a manufacturer (§ 4 paragraph 1 AMG).
Finished medicaments in the sense of the medicament law may be brought only on the market, if they have a German or European medicament permission and/or a European medicament permission. Have registration. Placing on the market within the meaning of the AMG already includes holding for sale or other distribution, displaying, offering for sale and distribution to others.
Pharmacy and prescription drugs
According to § 43 of the German Medicines Act, there is a basic pharmacy obligation for medicines in Germany. The ordinance on pharmacy-required and over-the-counter drugs contains regulations on the basis of § 44-46 of the Medicines Act on which drugs are subject to compulsory pharmacy and which are freely available for sale outside pharmacies.
Due to § 48 of the German Medicines Act, medicines with special risks of use are subject to prescription only. The Federal Ministry of Health, with the approval of the Bundesrat and after consulting experts, regulates which drugs are to be prescribed in the Ordinance on the Prescription of Medicines.
Drug co-payment in the statutory health insurance system
Those insured under the statutory health insurance system pay a co-payment of ten percent of the sales price for each drug prescribed, up to a maximum of ten euros and a minimum of five euros. However, the co-payment is never more than the actual cost of the drug. For example, if a medicine costs 75 euros, the co-payment is 7.50 euros. If a drug costs 200 euros, the co-payment is ten euros. If a drug costs 15 euros, you pay five euros extra. Children and adolescents up to the age of 18. Persons under the age of 18 are exempt from co-payments for medicines.
Seriously chronically ill patients such as diabetics are subject to the same co-payments as all other insured persons. But their special situation is taken into account with a lower charge limit. The same co-payment rules apply to prescribed dressings as to prescription drugs. The amount of the co-payment is based on the total cost of the prescription per prescription line. Non-prescription drugs can be purchased by anyone without a prescription at their own expense (self-medication). In certain exceptional cases, if prescribed by a doctor, they are also paid for by the statutory health insurance funds.
Not every preparation that is taken or used is a drug within the meaning of the AMG. For example, low-dose vitamins, dietary supplements that are not reimbursed by the SHI, or solutions to replace tear fluid can be medical devices.
Ask your pharmacy for cheaper medicines. Pharmacists are obligated to provide you with drugs with the same effect but at a lower price – so-called generics – if the doctor has prescribed only one active ingredient instead of a specific drug. The same applies if the doctor does not explicitly exclude replacing the prescribed drug with another one. Due to this so-called "aut-idem-regulation" If you receive a drug of the same quality, you pay less, because the co-payment is based on the price of the drug. The health insurance companies can agree on price reductions or rebates with the pharmaceutical companies for all drugs.
Pharmacists are obligated to supply insured persons primarily with the contracted preparations of this health insurance fund. This only does not apply if the doctor has prescribed "Aut idem" excludes on the prescription, i.e. prescribes a specific drug. Particularly inexpensive medicines are free of co-payment for insured persons of all health insurance companies. Each health insurance fund can also halve or waive the co-payment for additional drugs if it has agreed favorable prices with the manufacturers.
Pricing for non-prescription drugs
The prices for non-prescription drugs are not fixed. This means that every pharmacist decides for himself or herself how inexpensively he or she offers these products. Competition for pharmacy customers is not only about the best quality of advice, but also about the lowest price. Medicines with certain active ingredients, such as headache remedies, are often offered by several manufacturers. Here it is worthwhile to ask for a low-priced preparation.
Non-prescription drugs are generally not reimbursed by the statutory health insurance funds (§ 34 SGB V). Exceptions: Children under twelve years of age. Adolescents with developmental disorders according to a doctor's prescription. Even severely ill patients may be reimbursed by their health insurance for non-prescription drugs. This may be the case for drugs containing essential active ingredients for the treatment of serious diseases such as cancer or myocardial infarction. The Federal Joint Committee determines which drugs are included in this list. It publishes the information in the so-called OTC exception list. OTC is an abbreviation of the English term "Over The Counter", literally means "over the counter" and includes all non-prescription drugs.
Drugs to improve private lifestyles: they are generally not paid for by the statutory health insurance system. These include medications for potency problems, smoking cessation, appetite suppressants or hair growth products.
Patent protection for drugs and analog preparations
For a newly developed drug, a pharmaceutical manufacturer in Germany can apply for patent protection for 20 years and market it exclusively. The price that the manufacturer can charge for this drug on the market and also from the statutory health insurers covers its research and development costs. Once patent and documentation protection has expired, this active ingredient can also be offered at lower prices by other manufacturers, as research and development costs are saved. As a result of this competition, prices fall.
Drugs that contain molecular variants of already known active ingredients and have pharmacologically identical or similar effects to the first preparation of this group of active ingredients can also be patented. Such drugs are referred to as "analog preparations".
Patent protection alone is not proof that a drug works better. It also does not give the pharmaceutical entrepreneur the right to have his drug prescribed at the expense of the SHI system or to have the health insurers pay high prices for it. The Federal Joint Committee can determine the conditions under which drugs can be prescribed. The GKV-Spitzenverband can determine the level of reimbursement through fixed amounts. Limiting reimbursement ceilings. The benefits and costs of drugs are evaluated by the Institute for Quality and Efficiency in Health Insurance (IQWIG).