Drug price regulation
The drug price regulation regulates prices and price ranges in the trade in drugs in Germany. The ordinance was issued on the basis of an authorization to issue ordinances in Section 78 of the German Medicines Act (AMG).
| Basic data | |
|---|---|
| Title: | Drug price regulation |
| Previous title: | Regulation on price ranges for finished medicinal products |
| Abbreviation: | AMPreisV |
| Type: | Federal Ordinance |
| Scope: | Federal Republic of Germany |
| Issued on the basis of: | Section 78 AMG |
| Legal matter: | Special administrative law , health law |
| References : | 2121-51-11 |
| Original version from: | May 17, 1977 ( BGBl. I p. 789 ) |
| Entry into force on: | January 1, 1978 |
| Last revision from: | November 14, 1980 ( Federal Law Gazette I p. 2147 ) |
| Entry into force of the new version on: |
January 1, 1981 |
| Last change by: |
Art. 2 Regulation of 9 October 2019 ( Federal Law Gazette I p. 1450, 1451 ) |
| Effective date of the last change: |
January 1, 2020 (Art. 3 of October 9, 2019) |
| Please note the note on the applicable legal version. | |
General
The Drug Price Ordinance in particular prescribes the prices (or, more precisely, the pricing) for prescription- only finished medicinal products when dispensed by public pharmacies to the end consumer. It also sets the prices for pharmaceuticals produced in pharmacies , but also the sales prices of pharmaceutical wholesalers when they are sold to pharmacies.
According to AMG, veterinarians in Germany have a dispensing right , i. In other words , they are allowed to sell certain medicines for use on animals in a veterinary medicine cabinet and to keep them in stock. The drug price regulation also regulates the price ranges in sales between wholesalers and veterinarians, as well as between veterinarians and animal owners.
Since 2004, prices in the distribution of non-prescription drugs have been excluded from the regulations of the Drug Price Ordinance. This is intended to promote competition for the benefit of end consumers. Also excluded are the prices for the distribution of drugs, vaccines and various other products by public pharmacies to hospitals and various state institutions and authorities.
For the dispensing of non-prescription drugs at the expense of statutory health insurance , the drug price regulation in the version valid until 2004 continues to apply.
On October 19, 2016, the European Court of Justice declared the price maintenance of prescription drugs for foreign mail-order pharmacies stipulated in the drug price regulation as incompatible with the free movement of goods under Union law . In contrast, fixed drug prices for German pharmacies (including German mail order pharmacies) continue to apply.
Special regulations
Wholesale margin
Pharmaceutical wholesaling takes on logistical tasks between pharmaceutical manufacturers on the one hand and pharmacies as retailers on the other. In the drug price regulation, gradually decreasing maximum surcharges are defined for these services: For finished medicinal products with a manufacturer selling price of up to and including 3.00 euros, the maximum permitted wholesale surcharge is 15%, for selling prices above 26.83 euros only 6%. For particularly high-priced drugs (from 1200.01 euros) the surcharge is limited to a maximum of 72.00 euros.
However, since January 1, 2012, these staggered surcharges only apply to veterinary medicinal products. For medicinal products for human use there is a (non-discountable) fixed surcharge of 70 ct and a proportional surcharge of a maximum of 3.15% of the manufacturer's selling price, albeit limited to an upper limit of 37.80 euros.
Pharmacy surcharge for finished medicinal products
Before 2004, the remuneration of pharmacies was also exclusively dependent on the price of the drug dispensed. However, this was changed as part of the Statutory Health Insurance Modernization Act: Since then, the surcharge for finished medicinal products has consisted of a variable portion of 3% of the manufacturer's sales price including a wholesale surcharge plus a flat rate of 8.35 euros and 0.21 euros to support the provision of the emergency service. The 3% can be understood as a reward for the logistical task of the pharmacy, for example for stock keeping and pre-financing. The 8.35 euros, however, honor the pharmacy's pharmaceutical service; a fixed flat rate, as opposed to a sales-related surcharge, is intended to strengthen the position of pharmacists as health professionals . Due to a regulation in § 130 SGB V (pharmacy discount in favor of the statutory health insurance companies), the remuneration of the pharmacies for those insured by the statutory health insurance companies is reduced by 1.49 euros (net) for finished medicinal products and 6.86 euros (net) remain with the pharmacy ( for other drugs: 5% on the pharmacy sales price).
Further pharmacy surcharges
According to Section 4 (1), the pharmacy charges a surcharge of 100% on the pharmacy purchase price (AEP) for substances that are refilled, filled, packed or labeled in the same condition. For preparations made from one or more substances, the pharmacy receives a surcharge of 90% on the purchase price plus prescription surcharge in accordance with Section 5 (1); this depends on the dosage form and the number or quantity to be produced and is at least 2.50 euros. The insurance associations can make different agreements with the pharmacists' associations. So was z. B. for parenteral solutions with cytostatics, antibiotics or painkillers a discount of 10% agreed. However, the AMPreisV in purchasing does not apply to finished medicinal products processed for this purpose.
Emergency service fee
The pharmacy emergency service in Germany ensures a nationwide supply of medicines even outside of regular opening times. The emergency service times and the emergency service fee (currently 2.50 euros) are defined in the Drug Price Ordinance and can be charged.
Narcotics
When dispensing narcotics , pharmacies have special documentation and storage requirements in accordance with the Narcotics Prescription Ordinance. A separate fee of currently 4.26 euros may be charged for this additional effort.
Adaptation of the drug price regulation
The drug price regulation was last changed in 2012 and 2013. With effect from January 1, 2013, the fixed surcharge for prescription drugs was increased from EUR 8.10 to EUR 8.35. A separate surcharge of EUR 0.16 was added to this on August 1, 2013. This is transferred to a fund administered by the German Pharmacists' Association, from which a flat-rate subsidy is paid to pharmacies that have performed an emergency service. As a consequence of the "Ordinance amending the Pharmacy Operation Regulations and the Drug Price Ordinance" announced by the Federal Ministry of Health on October 21, 2019, the emergency service surcharge was increased from EUR 0.16 to EUR 0.21 on January 1, 2020.
Individual evidence
- ↑ ECJ: Price maintenance of prescription drugs illegal . Zeit Online, October 19, 2016.
- ↑ Amendment of § 3 AMPreisV through Article 3 of the Pharmacy Emergency Service Assurance Act (ANSG)
- ^ Deutsche-Apotheker-Zeitung. ( Memento of the original from September 23, 2015 in the Internet Archive ) Info: The archive link was inserted automatically and has not yet been checked. Please check the original and archive link according to the instructions and then remove this notice. Article dated August 5, 2014. Retrieved October 24, 2014
- ↑ Sample calculation : finished medicinal products and formulations Accessed on March 9, 2017
- ↑ www.gkv-spitzenverband.de Result of the mediation
- ↑ Sample calculation of the ABDA on the "compulsory discount" for pharmacists
- ↑ compare § 6 of the drug price regulation (emergency service)
- ↑ Adaptation of the Drug Price Ordinance happens to the Federal Cabinet ( Memento of the original from November 19, 2012 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. (PDF; 24 kB) Press release from the Federal Ministry of Health from September 19, 2012
- ↑ Federal Law Gazette published ANSG DAZ.online on July 18, 2013
Web links
- Text of the drug price regulation (currently applicable version)
- Text of the drug price regulation (all versions applicable since 2006)
