Drug delivery bottleneck

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Failures in the production of active ingredients resulted in repeated delivery bottlenecks in Germany for certain dosage strengths of the popular pain reliever ibuprofen .

A drug supply bottleneck is a longer-term supply bottleneck caused by interrupting the supply chain for drugs , e.g. B. by production losses. For human medicinal products, the German Federal Institute for Drugs and Medical Devices (BfArM) defines a delivery bottleneck as an inability to deliver for at least two weeks. Delivery bottlenecks have increased in recent years, including for essential medicines.

General

Drug delivery bottlenecks are a subtype of delivery bottlenecks and belong to the availability gaps . Delivery bottlenecks can specifically represent a supply gap , but they can also be traced back to excess demand and affect all conceivable products . Such bottlenecks are of particular importance if there are no substitute goods available as alternatives or if life-threatening or serious illnesses cannot be treated due to the bottleneck ( supply bottleneck ).

In view of the global concentration of the pharmaceutical active ingredient production on a few companies, large-scale delivery bottlenecks due to unforeseen production losses, for example caused by disasters, cannot be ruled out. The 2019 coronavirus epidemic outbreak in China alarmed consumers in various parts of the world. Most of the producers of pharmaceutical raw materials are located in the central Chinese province of Hubei with the capital Wuhan , the center of the outbreak. Around 80 percent of the raw materials that India's pharmaceutical industry processes into drugs for the global market come from China. According to India's pharmaceutical manufacturers, the coronavirus is already leading to bottlenecks and price increases as of March 2020. Previously, in 2018, the failure of one of six manufacturing plants worldwide for the widely used pain reliever ibuprofen in Texas and the resulting shortages caused a sensation in 2018 .

Germany

In 2012, the problem of drug shortage, which had been observed in the USA for some time, came to the fore through publications on possible analogous developments for Germany. As a result, the focus is on globalization, in the course of which a large part of the active pharmaceutical ingredients are manufactured in emerging countries such as India and China , which in addition to quality problems also creates dependencies in supply. The tendering procedures of the statutory health insurances (discount contracts with pharmaceutical manufacturers) and the control instrument of the " early benefit assessment according to § 35a SGB V " created with the drug market reorganization law (AMNOG) are still problematic . After the German Hospital Association (DKG) expressed its alarm about the supply situation in clinics in November 2012, the Federal Ministry of Health (BMG) recognized the need for action and considered measures.

In 2013, the BfArM published a list of delivery bottlenecks. The entries are based on voluntary reports from the manufacturers and mainly only contain bottlenecks that are likely to last longer than 14 days for drugs that are "mainly intended for the treatment of life-threatening or serious diseases and no alternative drugs are available" ( supply-relevant drugs ).

Since 2016, higher federal authorities and specialist groups have been dealing with the observation and evaluation of delivery bottlenecks and their effects on the supply situation as a result of the federal government's “Pharmadialog” as part of a specially set up “Jour Fixe”. According to the authority, a delivery bottleneck does not always mean a supply bottleneck, since alternative drugs are often available that can continue to ensure supply. Pharmaceutical companies see the causes of delivery bottlenecks in the “... increase in regulatory requirements, production problems or bottlenecks in raw materials. Other reasons for bottlenecks are fluctuations in demand, 'price and discount pressure', distribution and storage problems as well as business decisions. "

In 2018, 264 delivery problems were reported to the BfArM, not counting vaccines. In October 2019, the Berlin Chamber of Pharmacists estimated the number of drugs that could not be delivered at around 300 to 500. In July 2019, the parties involved adopted recommendations for purchasing and contracting practices in hospitals, which should improve the ability of supply-relevant drugs to be delivered in hospitals in the long term.

Numerous local and national media reported repeatedly on problems with the supply of medicines.

At the end of 2019, the federal government announced its intention to take legal measures to counter the problem of delivery bottlenecks. The Fairer-Kassenwettbewerb Act of March 22, 2020 ( Federal Law Gazette I p. 604 ) provides for stricter reporting obligations for pharmaceutical companies and wholesalers, and the authorities can order them to be stored in the event of a shortage. In order to be able to react quickly and unbureaucratically to a lack of medication, the government gives pharmacies more leeway in dispensing medication in the event of bottlenecks.

According to an opinion from February 2020, which was prepared on behalf of the GKV-Spitzenverband (GKV-SV), no connection can be derived between bottlenecks and tendering instruments such as discount agreements.

Also in February 2020, the BfArM turned to the German pharmaceutical industry to clarify impending drug delivery bottlenecks due to the coronavirus epidemic. The Federal Association of the Pharmaceutical Industry (BPI) reported: "Research by the BfArM has shown that an active ingredient manufacturer is registered for 19 drugs in the city of Wuhan, the epicenter of the corona virus". 17 active ingredients are classified as relevant for supply. For the province of Hubei a total of 136 medicinal products are given, the active ingredient manufacturers of which are based there. 48 of the active substances concerned are classified as relevant for supply. For a long time now, various parties have been calling for active ingredient production to be relocated from China and India back to Europe. Centralization and possible susceptibility to failure make the European pharmaceutical supply increasingly vulnerable.

Austria

Since 2018 pharmaceutical companies in Austria have been able to report delivery bottlenecks electronically to the Federal Office for Health Safety (BASG), many more reports have been received. Due to the steady increase in delivery problems, a group of experts from members of the Chamber of Physicians and Pharmacists, the pharmaceutical wholesalers, the patient advocacy , the BMASGK , the Chamber of Commerce, the interest groups of the pharmaceutical industry as well as science and the main association of the Austrian social insurance institutions are concerned with measures that help intended to secure the supply of medicines in the country.

The BASG has drafted an ordinance that provides for the introduction of a statutory reporting obligation for sales restrictions on prescription drugs and an export ban, and presented it to the EU Commission for notification in 2019.

Other EU countries

Significant delivery bottlenecks have also been reported from other European countries. Since 2016, a task force set up by the European Medicines Agency (EMA) and the Heads of Medicines Agencies (HMA) has been dealing with availability problems, including drugs that have been approved but not placed on the market and disruptions in the supply chain. The EMA publishes information on current drug delivery bottlenecks that affect or could affect several EU member states in a Shortages Catalog .

In May 2018, the EU Commission published the results of a survey on the measures that Member States are taking to ensure the continuous supply of pharmaceuticals required under EU legislation.

Switzerland

Swiss newspapers reported in 2019 that drug delivery bottlenecks were a "long-term issue" because some drugs had not been available in Switzerland for years. Almost 600 drugs and vaccines were missing as of June. In the previous years, the specialist press had provided information on the supply situation in Swiss hospitals due to delivery problems. In 2015, the federal government stipulated an obligation to notify in the event of a shortage or delivery bottleneck of essential medicines. In addition, compulsory warehousing for manufacturers and importers was introduced, which includes certain important drugs such as antibiotics , strong pain relievers and opiates, as well as anti-tuberculosis drugs . In addition to other reasons, there are also said to be shortages in Switzerland because products are discontinued for reasons of profitability or approvals are not even applied for, as the Swiss market is rather small.

Hospital pharmacists complained about the time-consuming and expensive changes in therapy that would result from the supply bottlenecks and that could worsen further in the event of export bans in surrounding countries. Occasionally, doctors would have had to switch to veterinary drugs if the labor medication oxytocin was not available in winter 2018.

United States

In the USA, drug delivery bottlenecks have also been observed for several years, which is why the US FDA set up a task force in July 2018 . This should find out the causes of the delivery bottlenecks and work out measures to avoid them. According to a study by the task force , parenterals in particular were said to have been affected between 2013 and 2017 , a large part of them in the generic market. The causes are multifactorial, a role that is untypical in terms of a free economy, inadequate quality assurance and too much bureaucracy play a role .

literature

K. Pauwels, I. Huys, M. Casteels, S. Simoens: Drug shortages in European countries: a trade-off between market attractiveness and cost containment? In: BMC Health Services Research . tape 14 , no. 438 , September 26, 2014, doi : 10.1186 / 1472-6963-14-438 .

Web links

Individual evidence

  1. ↑ Delivery bottlenecks , glossary of the Federal Institute for Drugs and Medical Devices (BfArM), accessed on October 22, 2019.
  2. ↑ Martin U. Müller : In Germany, even vital medicines are becoming scarce. In: Der Spiegel . May 24, 2019, accessed January 26, 2020 .
  3. ↑ J. Simmank: "Transplants had to be postponed" , Zeit Online , April 27, 2017.
  4. ↑ In pharmacies, important drugs are repeatedly not available , Welt , March 25, 2018.
  5. ↑ Dieter Cassel / Volker Ulrich, AMNOG-Check 2017: Health economic analyzes of the supply of pharmaceutical innovations , 2017, p. 124 restricted preview in the Google book search
  6. ^ Lothar Wildmann, Introduction to Economics, Microeconomics and Competition Policy , Volume I, 2007, p. 55 limited preview in the Google book search
  7. ↑ Norbert Bach / Wolfgang Buchholz / Bernd Eichler (Eds.), Business Models for Value Creation Networks , 2003, p. 335
  8. ↑ H. Blasius: USA and India fear drug delivery bottlenecks due to Corona , DAZ.online, February 4, 2020.
  9. ↑ India / Germany: Antibiotics are becoming scarce , Peter Gerhardt (ARD-Studio New Delhi), Marie-Kristin Boese (SWR). Weltspiegel, Das Erste, March 2, 2020.
  10. ↑ P. Hollstein: Ibuprofen: BASF is slowly starting up again , Apotheke adhoc, March 1, 2019.
  11. ↑ a b J. Schweim, H. Schweim : "Drug Shortage" , German Apotheker Zeitung (DAZ), March 29, 2012th
  12. ↑ J. Schweim, H. Schweim: A consequence of austerity policies and price competition in pharmaceuticals? , Deutsche Apothekerzeitung, February 28, 2013.
  13. ↑ B. Wessiger: Unsolvable Problem? , Deutsche Apothekerzeitung , March 10, 2016.
  14. ^ A. Mende: Register as the first step . Pharmaceutical Newspaper , February 26, 2013.
  15. ↑ a b H. Korzilius: Delivery bottlenecks for pharmaceuticals: a grievance that is no longer acceptable , Dtsch Arztebl 2019; 116 (45): A-2060 / B-1690 / C-1654, dated November 8, 2019.
  16. ↑ Jour Fixe on delivery and supply bottlenecks , BfArM website, accessed on November 20, 2019.
  17. ↑ B. Rohrer: State authorities decide on the demand for rebate contract reform , Deutsche Apothekerzeitung, May 4, 2018.
  18. ↑ a b Frontal 21: Bottleneck in the pharmacy , apotheke adhoc, October 21, 2019.
  19. ↑ "Estimated there are currently 300 to 500 drugs not" , interview of the rbb with the President of the Berlin Chamber of Pharmacists, October 16, 2019.
  20. ↑ S. Kramer: Important drugs often not available for months , Der Tagesspiegel , June 20, 2016.
  21. ↑ When vital medication becomes scarce , Wirtschaftswoche , February 13, 2017.
  22. ↑ C. Müller: Pharmaceutical delivery bottlenecks in the Tagesschau , Deutsche Apothekerzeitung, July 29, 2019.
  23. ↑ Martin U. Müller: Delivery bottleneck for an important cancer drug. In: Der Spiegel . January 24, 2020, accessed January 26, 2020 .
  24. ↑ Spahn confirms stricter action against delivery bottlenecks for pharmaceuticals , aerzteblatt.de, November 18, 2019.
  25. ↑ K. Sucker-Sket Research-based pharmaceutical companies: Inventories are not a "taboo break " , DAZ.online, November 18, 2019.
  26. ↑ Package against delivery bottlenecks decided , apotheke-adhoc, February 13, 2020.
  27. ↑ Expert opinion shows: Delivery bottlenecks for pharmaceuticals cannot be attributed to discount agreements , PM GKV-SV of February 10, 2020, accessed on February 12, 2020
  28. ↑ BfArM worried: drug shortage due to coronavirus? Apotheke Adhoc from February 4, 2020, accessed on February 4, 2020
  29. ^ Round table on "Pharmaceutical Supply in Austria" , BASG, November 28, 2018.
  30. ↑ Round table on October 21, 2019 , BASG, October 21, 2019.
  31. ↑ Pharmaceutical supply: finding solutions for delivery bottlenecks together , Pharmig - Association of the Austrian Pharmaceutical Industry; accessed on November 20, 2019.
  32. ↑ H. Blasius: Austria: Export ban and reporting obligations against delivery bottlenecks , DAZ.online, October 22, 2019.
  33. ↑ B. Rohrer: "Unprecedented" drug delivery bottlenecks in France , Deutsche Apothekerzeitung, March 2, 2018.
  34. ^ E. Mauritz, M. Eber: Vital medicines: Bottlenecks are becoming more frequent , Kurier , March 18, 2017.
  35. ↑ Poland faces shortage of almost 500 medicines, pharmacists warn , Poland In, July 10, 2019.
  36. ↑ J. Deutsch: Europe comes up short on drug supplies , Politico , October 7, 2019.
  37. ↑ HMA / EMA Task Force on Availability of Authorized Medicines for Human and Veterinary Use (TF AAM) , accessed November 20, 2019.
  38. ↑ Shortages catalog of the EMA , accessed on October 22, 2019.
  39. ↑ Summary of Responses to the Questionnaire on the Measures implemented in the Member States territories in the context of Article 81 of Directive 2001/83 / EC , EU Commission, May 28, 2018 (PDF).
  40. ↑ Coping with the problem of drug shortages by means of a commitment to continuous supply - discussion paper . EU Commission, May 28, 2018 (PDF).
  41. ↑ a b Up to 600 drugs are not available in Switzerland - the eight most important questions and answers Aargauer Zeitung, June 21, 2019.
  42. ↑ There is a lack of vital medicines in Switzerland , Tages-Anzeiger , June 9, 2019.
  43. ↑ H. Plagge, p Zeggel: What about the provision of healthcare in Swiss hospitals? , Swiss Medical Journal - Bulletin des Médecins Suisses - Bolletino dei Medici Svizzeri 2017; 98 (33): 1040-1042. (PDF)
  44. ↑ H. Blasius: Swiss hospital pharmacists fear export ban in Germany , DAZ.online, November 1, 2019.
  45. ↑ In front of empty shelves - causes of drug delivery bottlenecks and measures to avoid them , Der Arzneimittelbrief , 49 (2015), 25.
  46. ↑ B. Rohrer: FDA: New quality checks and more money to avoid bottlenecks , DAZ.online , October 30, 2019.