Medicinal Products Price Ordinance (AMPreisV) – price controls for medicinal products and legal framework

Significance of the Pharmaceutical Price Regulation

The Medicines Price Ordinance (AMPreisV) is the central legal basis for price controls on prescription medicines in Germany. It is intended to ensure, in the public interest, nationwide and equitable access to prescription medicines. This deliberately restricts price competition at the final point of sale—between pharmacies and consumers.

While there is no price-fixing system for OTC medicines (non-prescription medicines), the Medicinal Products Price Ordinance ensures that consumers pay the same pharmacy retail price for prescription medicines.

Medicines Act and Medicines Price Ordinance

Under Section 78(2) of the German Medicines Act (AMG), in conjunction with Sections 1 and 3 of the German Medicinal Products Price Ordinance (AMPreisV), manufacturers must ensure a uniform retail price when distributing medicinal products. Pharmacies may therefore not sell prescription medicines at different prices. Breaches of the Medicinal Products Price Ordinance are considered unfair commercial practices and are frequently challenged by competition-law cease-and-desist letters.

Court decisions (e.g. Federal Administrative Court, judgment of 9 July 2020 – 3 C 20.18) regularly confirm that this price regulation is reasonable and necessary to ensure security of supply.

Exceptions to the Medicinal Products Price Ordinance

The German Drug Price Regulation provides for various exceptions to fixed pricing. These include:

• Foreign mail-order pharmacies: They are not subject to the AMPreisV, since fixed pricing is considered a restriction on imports contrary to EU law (ECJ v. 19.10.2016 – C-148/15 – DocMorris).
• Non-prescription medicinal products (OTC): Under Section 1(4) of the German Medicinal Products Price Ordinance, no price-control system applies.
• Patient-specific dispensing of medicines: No price controls apply to partial quantities of finished medicinal products, provided their composition and strength remain unchanged.
• Parenteral preparations: The obligation to comply with price controls does not apply under certain conditions.
• Special levies: For example, payments to hospitals, correctional facilities, public health authorities or for certain vaccines.

Medicinal Products Price Ordinance and Discount Ban

The price controls under the Pharmaceutical Price Regulation also entail a ban on discounts for prescription medicines. Pharmacies may not offer discounts or free gifts when dispensing them. Even low-value benefits—such as bread-roll vouchers or small promotional items—have been held by the courts to be unlawful promotional gifts (e.g. Federal Court of Justice, 6 June 2019 – I ZR 206/17 – Bread-roll voucher).

Examples of unlawful promotional gifts under the German Drug Price Ordinance:

• Vouchers (e.g. €1 vouchers or bread-roll vouchers)
• Prize competitions involving recipes
• Gifts such as socks, gift wrap or vouchers

These restrictions are intended to protect public health and prevent pharmacy customers from being influenced by price benefits.

The Medicinal Products Price Ordinance in the context of medicinal products advertising law

In addition to pharmaceutical price controls, the German Medicinal Products Advertising Act (HWG) also plays a role. Under Section 7 HWG, benefits and promotional gifts are prohibited if they contravene the price regulations set out in the German Medicinal Products Price Ordinance. Even if discounts are permitted under pharmaceutical law, they may be prohibited under the medicinal products advertising rules.

Conclusion: The importance of the German Medicinal Products Price Regulation

The German Medicinal Products Price Ordinance is a key part of German law governing medicinal product prices. Its purpose is to:

• Uniform prices for prescription-only medicinal products
• Consumer protection and ensuring nationwide access to supplies
• Restrictions on unfair business practices involving discounts and promotional gifts

Pharmacies, pharmaceutical companies and advertisers need a thorough understanding of the AMPreisV to advertise with confidence and avoid costly cease-and-desist notices.

👉 Tip: Anyone wishing to explore advertising for medicinal products and health products in greater depth will find detailed case-law analyses and practical examples in the practitioner’s handbook on the law governing advertising for medicinal products and health products:

The practical guide to advertising law for medicinal products, food supplements, balanced diets, medical devices, cosmetics and health claims – available from bookshops or Amazon

Advertising for health-related products is subject to particularly strict legal regulation. Courts set high standards for health-related claims. Advertising for medicines and other remedies, medical devices, food supplements, foods for special medical purposes and cosmetics is also restricted by specific laws and regulations. The risk of cease-and-desist notices and legal disputes is particularly high for these products. This book sets out the current legal position using several hundred examples from case law.

Contents:

• Selection of terms, texts and media
• Advertising with Trademarks
• General principles of competition law, misleading and comparative advertising, advertising with prices and discounts
• Search engine optimisation and search engine advertising, social media and influencer marketing
• General requirements for health-related advertising
• Prohibitions and restrictions under medicines advertising law
• Advertising for medicinal products, pharmaceutical price controls, and advertising discounts and benefits
• Advertising medical devices
• Advertising food supplements, especially HEALTH CLAIMS
• Advertising for foods for special medical purposes
• Advertising for cosmetic products

Back to table of contents

1st edition, November 2024, 408 pages, XchangeIP Verlag, available from bookshops or Amazon

ISBN 978-3-00-079406-3

Author: Thomas Seifried, Attorney specialising in healthcare advertising law and certified specialist in intellectual property law

Cease-and-desist letters over misleading medicinal product prices

Cease-and-desist letters from competitors and trade associations

Competitors and associations often take action against violations of pharmaceutical price regulations, challenging them with a cease-and-desist notice under competition law requiring the recipient to issue a cease-and-desist undertaking backed by a contractual penalty. Such cases are usually pursued in court by means of a preliminary injunction. Every detail matters. Contact us.

What should businesses do after receiving a cease-and-desist letter over unlawful advertising of medicine prices?

If you receive a cease-and-desist letter alleging violations of pharmaceutical pricing law, the following steps are recommended:

1. Note the deadlines in the cease-and-desist letter. Do not wait until the deadline expires; act immediately.

A short deadline of just one week is often set for submitting a cease-and-desist undertaking backed by a contractual penalty. Failure to respond in time may result in court proceedings for an interim injunction. Don’t wait until the deadline expires—seek advice from a competition law lawyer immediately.

2. Document the alleged violations

Keep copies of all challenged advertising materials, websites, social media posts, product images and packaging. Provide information about the alleged violations.

3. Don’t sign a cease-and-desist undertaking prematurely

The attached cease-and-desist undertaking backed by a contractual penalty serves the interests of the sender. It is often too broadly worded. This alone may make it an abusive cease-and-desist letter. Whether it should be signed in this form requires careful legal review.

4. Have the prospects of legal success assessed

Not every cease-and-desist letter concerning the advertising of medicinal product prices is justified. In particular, the following points should be checked

• the standing of the party issuing the cease-and-desist notice,
• standing to be sued
• whether the alleged unfair competition violation has occurred,
• the scope of the claims for injunctive relief and
• the amount of the claimed costs of the cease-and-desist notice.

Send us your cease-and-desist letter for a free initial assessment of your case.