Pharmaceutical mail order business in Germany

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The pharmaceutical mail order business in Germany was placed on a legal basis in 2004 with the amendment of the Medicines Act (AMG) and the Pharmacy Act (ApoG), which enables pharmacies to send pharmacy-only and prescription-only medicines nationwide. Of the approximately 19,000 on-site pharmacies in Germany, just under 3,000 have an official license to ship pharmaceuticals (as of 2019). There are around 150 active mail-order pharmacies with a real web shop and a listing in price search engines.

In Germany, according to Section 43 (5) AMG (8), the dispatch of veterinary drugs for food-producing animals is prohibited for reasons of consumer protection law. This is to prevent drugs from being administered to animals used for food production in an uncontrolled manner.

Legal requirements

Mail order pharmacies may only be operated by pharmacies in Germany in accordance with Section 43 (1) sentence 1 AMG in conjunction with Section 11a ApoG. The responsible pharmacist, the postal address, the supervisory authority and other information must be given on the imprint of the website. All sent drugs must marketable in Germany drug to be. For all prescription drugs, the original prescription must be sent to the mail-order pharmacy by post. In addition, all mail-order pharmacies must have an emergency depot and participate in the reporting system for drug safety, as well as night and emergency services.

Also in 2004, fixed prices for non-prescription drugs were lifted. The resulting competition opens up new room for maneuver for pharmacists when it comes to the price structure.

In 2016, the European Court of Justice ruled that fixed price maintenance for prescription drugs is not permitted. Fixed prices would make it more difficult for foreign pharmacies to access the German market. The reason given was that mail order was the most important access point to the German market and that the price for mail order pharmacies was an important competitive factor. Price competition is a way of offsetting the advantages of traditional pharmacies (individual advice, prescription drugs ). In addition, price competition offers patients advantages and price maintenance is not suitable for promoting an even supply of drugs. The background was a dispute between the German Parkinson Association , which maintains a bonus system with DocMorris , and the headquarters for combating unfair competition . The judgment led to an increase in marketing activities by foreign mail-order pharmacies and acquisitions by competitors and service providers. A draft for a mail order ban submitted by the Federal Ministry of Health in 2017 was not introduced. A corresponding ban was also provided for in the coalition agreement for the 19th parliamentary term of the Bundestag . In 2019, the federal cabinet passed the Pharmacy Strengthening Act, which provides for a ban by amending SGB ​​V.

Mail order pharmacy market share

The market share of mail-order pharmacies in 2007 was four percent of the market for over-the-counter medicines in the mail order business; in 2008 it was five percent. This enabled mail-order pharmacies to steadily increase their share in the German market. According to figures from the market research company IMS Health, their share of the non-prescription market was already nine to ten percent in 2009. As a result, mail order pharmacies were able to increase their sales from 140 million euros to 622 million euros this year. In the area of ​​prescription drugs, the proportion was estimated at two percent. The sales and sales figures for OTC drugs show that the mail-order business is achieving an ever-increasing market share, which in 2018 already had a double-digit percentage market share of 13.6 percent (sales) and 17.7 percent (sales). Statutory health insurance expenditure has increased noticeably for prescription drugs since, according to the judgment of the European Court of Justice in October 2016, foreign mail-order companies are no longer bound by the German fixed prices for prescription drugs, the market share is 1.1 percent (sales) or 1, 0 percent (sales), however, significantly lower than in self-medication.

For 2018 alone, the sales of the two mail-order pharmacies, Doc Morris ( Heerlen / Netherlands ), which dominate the mail-order pharmaceuticals business in Germany and which is part of the Swiss Zur Rose Group , and Shop Apotheke ( Venlo / Netherlands), including several of German mail-order pharmacies acquired by these two mail-order pharmacies (including the acquisitions of Eurapon, Vitalsana and apo-rot by the Zur Rose Group and the Europa Apotheek by the Shop Apotheke) are each estimated at around 500 million euros. With the takeover of the mail order activities of the Medpex mail order pharmacy with effect from the beginning of 2019 and of the Apotal pharmacy in June 2020 by the Zur Rose Group, a further increase in the market shares attributable to the two market leaders can be expected.

The same quality requirements apply to the mail order business of pharmaceuticals as to an on-site pharmacy, such as the obligation to contract . This stipulates that all medicines that are available in Germany must also be delivered to the consumer.

The gap in personal advice, as given in stationary pharmacies, is closed by approved mail-order pharmacies with technical advice over the phone or email contact from pharmaceutical staff ( pharmacists , pharmaceutical engineers or PTAs ). In 2009, the ServiceBarometer AG published a study that shows that mail-order pharmacies have a high level of customer satisfaction, although personal advice is often lacking. The top value was 1.73, which stands for 46 percent completely satisfied and 36 very satisfied customers. According to an ABDA analysis (as of 2018), 93 percent of German citizens are either satisfied or even very satisfied with the local pharmacies.

Introduction of the electronic prescription

With the planned introduction of the e-prescription in spring 2020, the distribution of market shares will change further. According to a study available to the business newspaper “ Handelsblatt ”, the new regulation could strengthen the mail-order business, while the number of on-site pharmacies is likely to continue to decline. The authors of the study assume that the number of stationary pharmacies in Germany could fall to almost 12,000 by 2030. According to the Federal Association of German Pharmacists' Associations (ABDA), there were only 19,423 stationary pharmacies across Germany at the end of 2018. The number has been declining for years, at the time it was at its lowest level since the 1980s. The electronic prescription transmission to pharmacies should not become mandatory. In a response to a Green - request represents the Federal Ministry of Health realized that the complete abolition of the paper recipe was not planned.

The German Pharmacists Association announced in an interview in August 2019 that it had already developed its own e-prescription model with a corresponding app . He is committed to ensuring that the digital prescription process remains free from advertising, discrimination and commercial interests and that the patient should be free to decide where to redeem his prescription, be it in the mail order pharmacy or in the on-site pharmacy.

Counterfeit drugs

Counterfeit drugs rarely occur in the supply chain of German mail-order pharmacies. Rather, it is a problem of foreign suppliers who send their goods to Germany in an uncontrolled manner. The customs statistics for 2007 on the import of counterfeit drugs into Germany speak of counterfeit drugs worth 8.3 million euros, which means an increase in the number of counterfeit drugs imported into Germany. However, 90% of these “forgeries” were due to a patent dispute between Mundipharma and Cimex . It can therefore be assumed that the value of counterfeit drugs illegally imported into Germany and discovered has fallen from EUR 2.5 million in 2006 to EUR 0.6 million in 2007. This is the conclusion reached by Rolf Schwanitz , Parliamentary State Secretary in the Federal Ministry of Health , at the 172nd session of the German Bundestag . The 2018 customs statistics still list 42,590 pharmaceuticals with a value of 513,736 euros.

At the end of 2007, the Federal Criminal Police Office found that a large number of counterfeit drugs were reaching German consumers through mail-order pharmaceuticals, especially through illegal shipping from non-European countries. The Federal Criminal Police Office demanded that the ban on the mail order business for prescription drugs be reintroduced. However, the Federal Council in Germany is currently no longer concerned with the mail order ban for prescription drugs, since the dangers of selling drugs online are obviously less than the benefits. The legislative proposal of the Free States of Saxony and Bavaria ("Draft of a law to reduce the mail-order trade in pharmaceuticals to the extent required by European law") was removed from the agenda in December 2008. In mid-March 2008, Peer Steinbrück , the Federal Minister of Finance , expressed concern about the rapid increase in counterfeit medicines confiscated by German customs. Falsified sexual enhancers and doping agents , as well as other drugs such as fake heart medication, were particularly frequently used by customs investigators . These forgeries are sometimes modeled on the original perfectly and can only be differentiated through laboratory analyzes. A majority of drugs ordered on a test basis from foreign drug dispatchers, especially so-called lifestyle drugs such as Viagra, turned out to be falsified. Counterfeit drugs are not only of poor quality, they usually do not contain any medicinal substance, or they contain too much or too little of it and sometimes also toxic substances that can threaten the health and life of the user.

The EU Commission has also recognized the problem of massive counterfeit drugs and addressed it in its consultation paper published in March 2008. According to this, 384% more counterfeits were discovered in 2006 than in the previous year, including not only sexual enhancers, appetite suppressants and hair restorers, but also essential medicines, such as for cancer , heart disease or mental illness .

The pharmaceutical mail order business in Germany in a European comparison

In many European countries, mail order sales of prescription drugs are currently (as of November 2019) not allowed. As of 2016, it was allowed - besides Germany - in Denmark , Estonia , Finland , the Netherlands , Sweden and the United Kingdom .

In addition to German mail-order pharmacies, as of June 2018, distributors from Iceland, the Netherlands (if mail-order pharmacies also have a retail pharmacy), Sweden (only prescription drugs), the Czech Republic (only non-prescription drugs) and the United Kingdom are approved for the mail order trade of pharmaceuticals to Germany. After the introduction of the mail order business in Germany in 2004, the Federal Ministry of Health published in June 2005 in the Federal Gazette No. 113 (AZ 113 - 5028-3) that pharmacies in the Netherlands and in the United Kingdom initially met the requirements for such drugs are permitted in Germany to ship to Germany.

According to Section 73 AMG, pharmaceuticals from other countries are generally prohibited from being brought into Germany. Medicines that are subject to authorization may only be obtained by private end users from other EU countries under strict conditions, but not from third countries, by way of the permitted mail order business.

Other problems arise from the uncertainty as to whether a mail order pharmacy is actually based in Germany. In many cases this is unlikely to be understandable for the consumer. Medicines that are not approved in Germany may only be imported from German pharmacies in exceptional cases under strict criteria in individual cases and for a specific customer. This has already been circumvented by foreign mail order companies by setting up PO box or postcode companies in Germany. A pharmacy with a German name and z. B. Postcode in Leipzig as a German pharmacy, even if this only forwards the orders to a foreign pharmacy in the Czech Republic. Medicines were shipped that were not approved in Germany and that German pharmacies could not import. Official steps are usually taken late because the market has already become very confusing. Since April 21, 2009, the German Institute for Medical Documentation and Information (DIMDI) has maintained a mail order register on behalf of the Federal Ministry of Health. In it, with your consent, pharmacies and other dealers who have an official license to ship pharmaceuticals are published. This is linked to an EU safety logo that pharmacies and other retailers can use on their website.

A distortion of competition arises from the unequal legal situation of pharmacies in the European Community:

  1. German pharmacies are not allowed to accept discounts from the manufacturer for prescription drugs (exception: discounts and benefits of direct purchase up to about 3 to a maximum of 5 percent of the purchase). This does not apply to foreign pharmacies. Advantages of up to 20 percent and more are possible on average.
  2. In Germany, the full VAT rate of 19% applies to pharmaceuticals. For comparison: Netherlands 6%.
  3. Foreign mail-order pharmacies e.g. B. from the Czech Republic also send goods that are not approved in Germany, some of which are provided with translated and photocopied package inserts. Such pharmacies sometimes advertise with PO box addresses in Germany in order to disguise the origin of the goods.
  4. In comparison, German mail-order pharmacies and retail pharmacies are often cheaper than foreign mail-order pharmacies - at least for non-prescription drugs - but are not allowed to advertise them in the same way.

Pharmaceutical mail order business via pick-up points

The delivery of pharmaceuticals via collection or pick-up points is a form of the pharmaceutical mail order business. The customer orders the pharmaceuticals from the respective provider and picks them up at the pick-up point after presenting a collection slip and his / her ID card. In Germany, this form of mail-order pharmaceuticals was introduced by drugstore chains by setting up pick-up points in their branches.

After this form of drug distribution was initially prohibited by an ordinance issued by the dm drugstore chain , the Federal Administrative Court in Leipzig decided in its judgment of March 13, 2008 (3 C 27/07) that mail-order pharmacies were responsible for collecting orders and handing over the ordered drugs may use the service of drugstores.

Criticism of the pharmaceutical mail order business via pick-up points and the demand for a restriction of this type of mail order business came mainly from politics, the Federal Association of German Pharmacists' Associations (ABDA), the Federal Association of the Pharmaceutical Industry (BPI) and the Federal Association of Drug Manufacturers (BAH) . The FDP parliamentary group criticized the possibility of commercial enterprises collecting prescriptions and saw the danger of improper handling and storage of the drugs. She therefore only requested shipping directly to the end user. The parliamentary group Die Linke, on the other hand, demanded that mail-order sales be limited to non-prescription drugs in favor of the development of independent and comprehensive advice in pharmacies. However, the Federal Ministry of Health (BMG) rejected a complete ban on the drug mail order business via pick-up points, as required by the ABDA. The BMG's proposal for a draft law regulating the distribution of pharmaceuticals via pick-up points provides for a ban on the collection of prescriptions, regulations for the storage and delivery of pharmaceuticals as well as an obligation to return and free telephone advice from pharmaceutical staff. In addition, the pick-up points are to be monitored by the supervisory authorities. Nevertheless, the Ministry of Justice and the Ministry of the Interior still considered all proposals unconstitutional in 2012.

literature

Web links

Individual evidence

  1. ^ Judgment of the BGH of November 12, 2009 (Az .: I ZR 210/07).
  2. ↑ ECJ judgment judgment in the case C-148/15 (PDF)
  3. ^ Draft of a law prohibiting the mail order trade in prescription drugs (PDF)
  4. ↑ Mail order sales of pharmaceuticals . Fact sheet of the Federal Association of German Pharmacists' Associations (ABDA) from July 2019
  5. ↑ Coalition Agreement 2018-2021 (PDF)
  6. ↑ Pharmacy Strengthening Act and Collective Ordinance - Cabinet resolves pharmacy reform on deutsche-apotheker-zeitung.de
  7. ↑ apotheke adhoc: Mail order pharmacies increase by 30 percent ( Memento from February 16, 2011 in the Internet Archive )
  8. ↑ a b c ABDA: The Pharmacy - Figures, Facts, Statistics 2019 (PDF)
  9. ↑ Jürgen Salz: Aspirin in an hour , Wirtschaftswoche issue 41/2018 of October 5, 2018, pages 54–56, here page 54.
  10. ↑ Zur Rose also takes over the Apotal report from the Deutsche Apotheker Zeitung from June 26, 2020, accessed on August 6, 2020
  11. ↑ a b G. Waschinski: How the e-prescription is changing the market for pharmacies , Handelsblatt , April 20, 2019.
  12. ↑ DAZ.online theme week: Interiew “We want to create the basic technology for the e-prescription” , DAZ.online, August 21, 2019.
  13. ↑ A. Müller: Oxygesic dispute distorted customs statistics, apotheke adhoc, May 20, 2008.
  14. ↑ Intellectual property law - statistics for the year 2018 (PDF)
  15. ↑ Apotheker-Zeitung 12/2008: Steinbrück warns of counterfeit drugs: Customs investigation reports strike against illegal trade .
  16. ↑ Deutsche Apotheker-Zeitung 08/2008: Internet - Again counterfeit drugs discovered.
  17. ^ Schweim and Schweim: Mail order and counterfeit drugs. Med Klin (2009) 104 (2) pp 163-169.
  18. ^ Homepage ( Memento from February 22, 2014 in the Internet Archive ) of the ABDA : EU Commission alarmed: 384 percent more counterfeit medicines .
  19. ↑ Three quarters of all EU countries prohibit mail order sales of prescription drugs on abda.de.
  20. ↑ Illegal drug shipping and counterfeit drugs , DIMDI , accessed on June 7, 2018.
  21. ↑ Note: In the original text it says:
    “On the basis of a Europe-wide survey, the BMGS found that the Netherlands and the United Kingdom currently have safety standards comparable to German law for mail order and electronic trade in pharmaceuticals. This applies to the Netherlands if mail-order pharmacies also maintain a retail pharmacy. Pharmacies from countries other than those mentioned, in which this comparability does not currently exist, can apply for a mail order license for pharmaceuticals in accordance with the Pharmacies Act. “ There is no legal certainty, as this is only a publication by the BMGS. Future national restrictions, in particular with regard to prescription drugs, are not ruled out with regard to the decision of the ECJ.
  22. ↑ Mail order pharmacy register ( Memento from May 20, 2009 in the Internet Archive ) of the German Institute for Medical Documentation and Information (DIMDI) .
  23. ↑ Mail order pharmacies must not deceive consumers - ABDA President Wolf criticizes anti-competitive behavior ( Memento from February 22, 2014 in the Internet Archive ) ABDA press release.
  24. ^ Pharmaceutical Newspaper Online: Pick-up points as "hot potatoes" , August 21, 2009.
  25. ↑ Pharmazeutische Zeitung Online August 18/2008: The reasons for the judgment are available.
  26. ↑ German Bundestag (PDF; 57 kB) Print 16/9752, from June 25, 2008.
  27. ↑ German Bundestag (PDF; 55 kB) Print 16/9754, from June 25, 2008.
  28. ↑ apotheke adhoc: BMG wants to regulate pick-up ( Memento from May 20, 2009 in the Internet Archive )
  29. ↑ "Pick-up must and can be banned" , DAZ.online, March 14, 2012.