Compendial drug definition by whom


Differentiation from other products

The above definition of medicinal products determines that the provisions of the Medicines Act apply to the preparations named there, the main purpose of which is to ensure the safety of medicinal products. Medicines are differentiated by the definition from other sometimes similar products, such as medical devices, food supplements or cosmetics, for which different regulations apply.

Finished medicinal products are medicinal products that are manufactured in advance and placed on the market in a pack intended for delivery to the consumer, or other medicinal products intended for delivery to consumers that are otherwise prepared using an industrial process or, with the exception of pharmacies , are manufactured commercially. Finished medicinal products are not intermediate products intended for further processing by a manufacturer (Section 4 (1) AMG).

Finished medicinal products within the meaning of the Medicines Act may only be placed on the market if they have a German or European medicinal product approval or registration. Placing on the market in the sense of the AMG already includes keeping in stock for sale or other supply, keeping for sale, offering for sale and supplying to others.

Pharmacy only and prescription drugs

According to Section 43 of the Medicines Act, there is a general pharmacy obligation for medicinal products in Germany. The ordinance on pharmacy-only and over-the-counter medicinal products contains, on the basis of § 44-46 of the Medicines Act, regulations on which medicinal products are mandatory for pharmacies and which are released for use outside pharmacies.

On the basis of Section 48 of the German Medicines Act, medicinal products with special use risks require a prescription. The Federal Ministry of Health, with the consent of the Federal Council and after hearing experts, regulates which drugs these are in the drug prescription ordinance.

Drug co-payment in the statutory health insurance

Those insured with statutory health insurance pay a surcharge of ten percent of the sales price for each drug prescribed by the statutory health insurance, up to a maximum of ten euros and at least five euros. However, the co-payment is never more than the actual cost of the product. For example, if a drug costs 75 euros, the additional payment is 7.50 euros. If a drug costs 200 euros, the additional payment is ten euros. If a medicine costs 15 euros, you pay an additional five euros. Children and adolescents up to the age of 18 are exempt from co-payments for pharmaceuticals.

For seriously chronically ill people such as diabetics, the same co-payments apply as for all other insured persons. But their special situation is taken into account with a lower load limit. The same co-payment rules apply for prescribed bandages as for prescription drugs. The amount of the additional payment is based on the total costs of the prescription per prescription line. Anyone can buy non-prescription drugs at their own expense without a prescription (self-medication). In certain exceptional cases, if prescribed by a doctor, they are also paid for by the statutory health insurance companies.

Not every preparation that is taken or used is a drug in the sense of the AMG. For example, vitamins in low doses can be dietary supplements that are not reimbursed by the statutory health insurance, or solutions to replace tear fluid can be medical devices.

Inexpensive drugs

Ask at your pharmacy for cheaper medicines. Pharmacists are obliged to give you drugs that are equally effective but cheaper - so-called generics - if the doctor has only prescribed one active ingredient instead of a special drug. The same applies if the doctor does not expressly rule out replacing the prescribed drug with another. With this so-called "aut-idem rule", you receive a pharmaceutical of the same quality, but you have to pay less, as the additional payment is based on the price of the pharmaceutical. The health insurance companies can agree on price reductions or rebates for all pharmaceuticals with the pharmaceutical companies.

Pharmacists are obliged to provide the insured with the contracted drugs of this health insurance company as a matter of priority. This only does not apply if the doctor excludes "Aut idem" from the prescription, i.e. prescribes a very specific drug. Particularly inexpensive drugs are free of co-payments for insured persons of all health insurance companies. Each health insurance company can also halve or cancel the co-payment for other drugs if they have agreed favorable prices with the manufacturers.

Pricing for non-prescription drugs

The prices of non-prescription drugs are not fixed. That means: every pharmacist decides for himself how inexpensive he or she offers these products. The competition for pharmacy customers is not only a competition for the best quality advice, but also for the cheapest price. Medicines with certain active ingredients, such as headache medication, are often offered by several manufacturers. Here it is worth asking about an inexpensive preparation.

Medicines that are not subject to a prescription are generally not reimbursed by the statutory health insurance companies (Section 34 of the Social Code Book V). Exceptions: children under twelve years of age and adolescents with developmental disorders as prescribed by a doctor. Seriously ill people may also receive reimbursement for non-prescription drugs from their health insurance company. This can be the case with drugs that contain essential ingredients for the treatment of serious diseases such as cancer or heart attacks. The Federal Joint Committee determines which drugs are included. He publishes the information in the so-called OTC exception list. OTC is an abbreviation of the English term "Over The Counter", literally translated means "Over the counter" and includes all non-prescription drugs.

Medicines to improve private life: You are generally not paid for by the statutory health insurance. These include remedies for potency weakness, for smoking cessation, appetite suppressants or hair restorers.

Patent protection for pharmaceuticals and analog preparations

A pharmaceutical manufacturer in Germany can apply for patent protection for a newly developed drug for 20 years and market it exclusively. He covers his research and development costs through the price he can ask for this drug on the market and also from the statutory health insurance companies. If the patent and document protection has expired, this active ingredient can also be offered more cheaply by other manufacturers, as research and development costs are saved. This competition causes prices to drop.

Medicines that contain molecular variants of already known active ingredients and have pharmacologically identical or similar effects to the first preparation in this group of active ingredients can also be patented. Such drugs are called "analog preparations".

Patent protection alone is not enough proof that a drug works better. He also does not give the pharmaceutical entrepreneur any claim that his drug may be prescribed at the expense of the statutory health insurance or that the health insurance companies pay high prices for it. The Federal Joint Committee can determine the conditions under which drugs can be prescribed. The National Association of Statutory Health Insurance Funds can limit the amount of reimbursement through fixed amounts and maximum reimbursement amounts. The benefits and costs of drugs are assessed in statutory health insurance by the Institute for Quality and Efficiency (IQWIG).

April 15, 2021