Health & Medicine

Evaluation of medicines_shortages_in_europe_by_birgli

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We have published our first industry report. Commissioned by the EAEPC, birgli put together an independent report on the causes of shortages of medicines in Europe with a more in depth look at France, Greece, Poland, Spain, and the United Kingdom. We would like to thank the EAEPC for commissioning the report and to everyone who contributed and provided support. Attached is the report and in a separate post (I am unable to load the two reports on one post) the EAEPC contribution to the report. Each document represents our independent views on shortages.
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  • 1. An Evaluation of Medicines Shortages in Europe with a more in-depth review of these in France, Greece, Poland, Spain, and the United Kingdom by birgli® ag Baarerstrasse 8 6300 Zug Switzerland
  • 2. This report has been commissioned by the European Association of Euro-Pharmaceutical Companies (EAEPC). Zug, July 2013 Authors & Contributors: Charles Gloor - Collation, Poland, United Kingdom, Europe Maurice Dantés - Parallel Distribution Ernesto Graefenhain - Spain Anastasios Pantazis - Greece Jeremy Poole - United Kingdom Jacques Pujol - France James Chitwood - Supplemental research Disclaimer: Birgli is acting as an independent researcher for a review of medicines shortages in a number of European markets. In rendering our research service, we will assume that the information given to and received by us, be it orally or in writing, is true and correct and that we have not been deprived of material information by the various parties from whom we have collected it as well as with respect to our own knowledge, evaluation, and analysis. Birgli, its network, and sources shall not be responsible for any loss whatsoever sustained by any person who relies on this publication 2 …
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  • 4. Table of Contents 1. Executive Summary ........................................................................................... 8 1.1. What this report does and does not present ......................................................... 8 1.2. Data collection ............................................................................................ 9 2. Core Principals ................................................................................................. 9 2.1. Patients needs / rights................................................................................... 9 2.1.1. vs commercial aspects .............................................................................. 9 2.1.2. Vs economic capacity .............................................................................. 10 2.2. Principle of pro-activity ................................................................................ 10 2.3. Anticipation & Prevention.............................................................................. 11 3. Definition and categorisation of shortages ............................................................... 11 3.1. Word "shortages" is misleading ........................................................................ 11 3.2. Primary reasons for shortages ......................................................................... 11 4. Shortages – some causes and an analysis of these ...................................................... 13 4.1. Economic challenges and austerity ................................................................... 13 4.1.1. Price reductions & reductions in spending...................................................... 14 4.1.2. International Reference Pricing .................................................................. 17 4.1.3. Delays in payment .................................................................................. 18 4.1.4. Tendering (in particular generics) ............................................................... 19 4.1.5. Legislation supporting parallel distribution..................................................... 19 4.2. Business ................................................................................................... 20 4.2.1. Tightening of payment terms ..................................................................... 20 4.2.2. Reduced product introductions and market withdrawals..................................... 20 4.2.2.1. Lower priced markets ......................................................................... 20 4.2.2.2. Tender markets................................................................................. 22 4.2.3. Parallel distribution ................................................................................ 22 4.2.4. Implementation of quotas and other artificial supply chain filters (as a partial reaction to parallel distribution) ..................................................................................... 23 4.2.5. Increased risk of counterfeits and unscrupulous market behavior .......................... 24 4.3. Manufacturing & Supply Chain ......................................................................... 24 4.3.1. Manufacturing ....................................................................................... 24 4.3.2. Change in API legislation .......................................................................... 26 4.3.3. Just-in-time – Supply chain considerations ..................................................... 26 4.3.4. Channel Strategy including DTP .................................................................. 27 4.4. An illustrative summary of the causes of shortages ................................................ 28 5. Regulation ..................................................................................................... 28 3 …
  • 5. 5.1. Implications of existing European legislation ....................................................... 29 5.2. Summary - Other markets .............................................................................. 32 5.2.1. Germany, ............................................................................................. 32 5.2.1.1. §52b of the 15th amendment to the AMG .................................................. 32 5.2.1.2. §15 Apothekenbetriebsordung ............................................................... 32 5.2.1.3. Germany - 5% requirement ................................................................... 32 6. Country Analysis .............................................................................................. 33 6.1. Benchmark/Comparator ................................................................................ 33 6.1.1. USA .................................................................................................... 33 6.1.1.1. Shortages in the US, ........................................................................... 33 6.1.1.2. Legislation in the US addressing shortages................................................. 34 6.2. United Kingdom (UK) .................................................................................... 35 6.2.1. Available list of shortages ......................................................................... 35 6.2.2. Agencies .............................................................................................. 35 6.2.3. Definition/understanding of shortages by stakeholders ...................................... 36 6.2.4. Primary causes based on analysis by stakeholders & interviews ............................ 37 6.2.4.1. Manufacturers .................................................................................. 37 6.2.4.1. Pharmacies, Hospitals, Wholesalers, and Prescribing Physicians ....................... 37 6.2.5. Current consequences of shortages .............................................................. 37 6.2.5.1. Primary Care .................................................................................... 37 6.2.5.2. Secondary Care ................................................................................. 38 6.2.5.3. Patients .......................................................................................... 38 6.2.6. Current market specific solutions/suggestions................................................. 39 6.2.7. Regulations in place on shortages ................................................................ 39 6.3. France ..................................................................................................... 40 6.3.1. Available list of shortages ......................................................................... 40 6.3.1.1. Agencies ......................................................................................... 40 6.3.2. Definition/understanding of shortages by stakeholders ...................................... 40 6.3.3. Primary causes based on analysis by stakeholders & interviews ............................ 40 6.3.3.1. Manufacturers .................................................................................. 40 6.3.3.2. Wholesalers ..................................................................................... 40 6.3.3.3. Hospitals......................................................................................... 41 6.3.3.4. Pharmacies ...................................................................................... 41 6.3.3.5. General Comments............................................................................. 41 6.3.4. Current consequences of shortages .............................................................. 41 6.3.5. Current market specific solutions ................................................................ 42 6.3.5.1. Centrally driven solutions..................................................................... 42 4 …
  • 6. 6.3.5.2. Creative approaches ........................................................................... 42 6.3.5.3. Association driven proposals ................................................................. 42 6.3.6. Regulations in place on shortages ................................................................ 42 6.3.6.1. Article R 5115-13 Code de la Santé Publique requires every wholesaler to: ......... 42 6.3.6.2. Decret 2012-1096 2012/09/28 ............................................................... 43 6.4. Greece..................................................................................................... 44 6.4.1. Available list of shortages ......................................................................... 44 6.4.2. Definition/understanding of shortages by stakeholders ...................................... 44 6.4.3. Primary causes based on analysis by stakeholders & interviews ............................ 45 6.4.3.1. Survey summary ................................................................................ 47 6.4.4. Market notification process ....................................................................... 48 6.4.5. Current consequences of shortages .............................................................. 48 6.4.6. Current market specific solution ................................................................. 48 6.5. Poland ..................................................................................................... 48 6.5.1. Available list of shortages ......................................................................... 49 6.5.2. Primary causes based on analysis by stakeholders & interviews ............................ 49 6.5.2.1. The Reimbursement Act ...................................................................... 49 6.5.2.2. Quotas from MAH............................................................................... 49 6.5.2.3. Parallel Exports................................................................................. 50 6.5.2.4. Lack of financial capacity of pharmacies & wholesalers................................. 51 6.5.2.5. Reduced market access / reduction of product lines available (from MAH).......... 52 6.5.2.6. General manufacturing shortages ........................................................... 52 6.5.3. Regulations in place on shortages - Market notification process ............................ 52 6.5.4. Current consequences of shortages .............................................................. 53 6.6. Spain ....................................................................................................... 53 6.6.1. Available lists of shortages ........................................................................ 53 6.6.2. Definition/understanding of shortages by stakeholders ...................................... 53 6.6.3. Primary causes based on analysis by stakeholders & interviews ............................ 53 6.6.3.1. Austerity and budget cuts .................................................................... 53 6.6.3.2. Parallel distribution ........................................................................... 54 6.6.3.3. Survey Summary................................................................................ 54 6.6.4. Market notification process ....................................................................... 55 6.6.5. Regulations in place on shortages ................................................................ 55 6.6.5.1. RD. 4 / 2010 .................................................................................... 55 6.6.5.2. RD. 8 / 2010 .................................................................................... 55 6.6.5.3. RD. 9 / 2011 .................................................................................... 56 6.6.5.4. RD. 16 / 2012 ................................................................................... 56 5 …
  • 7. 6.6.5.5. Pending legislation............................................................................. 56 6.6.6. Public service obligations.......................................................................... 56 6.6.6.1. Circular 2/2012................................................................................. 56 7. Recommendations ............................................................................................ 56 7.1. Common Ground – the patient......................................................................... 57 7.2. Common threads ......................................................................................... 57 7.2.1. There are definitely shortages of medicines throughout Europe............................ 57 7.2.2. Lack of a common definition...................................................................... 57 7.2.3. Lack of data and the need for transparency.................................................... 57 7.2.4. Lack of communication ............................................................................ 58 7.3. Centralized & Member State recommendations .................................................... 58 7.3.1. Centralized reporting – use of the “Rapid Alert System”..................................... 58 7.3.2. Strengthen current central legislation to rapidly move products to areas of shortages. 58 7.3.3. Create a central unit of all stakeholders to review and develop solutions together with legislative bodies (central and national) ................................................................. 59 7.3.4. Legal “Teeth” ....................................................................................... 59 7.4. Practical Recommendations ........................................................................... 59 7.4.1. Providers (hospitals, pharmacies) ................................................................ 59 7.4.2. Trading companies (wholesalers, parallel distributors)....................................... 60 7.4.3. Systematic approaches............................................................................. 60 8. Conclusions .................................................................................................... 60 9. Bibliography ................................................................................................... 61 9.1. Interviews with European Bodies – birgli research ................................................. 61 9.2. Interviews with European HQ’s of Marketing Authorization Holders ............................ 61 9.3. Country Level Discussions/Interviews – birgli research ............................................ 61 9.3.1. France research by birgli .......................................................................... 61 9.3.2. Greece research by birgli.......................................................................... 61 9.3.3. Poland research by birgli .......................................................................... 61 9.3.4. Spain research by birgli ............................................................................ 61 9.3.5. UK research by birgli ............................................................................... 62 9.4. Documents, Articles, Websites, and other Sources ................................................ 62 9.4.1. Articles, documents, websites .................................................................... 62 9.4.2. Policy review – birgli research .................................................................... 65 9.4.3. birgli analysis ........................................................................................ 66 10. Glossary ........................................................................................................ 66 11. Who is birgli® ? ................................................................................................ 68 6 …
  • 8. Tables Table Table Table Table Table Table Table Table Table Table Table 1 : Reasons for Shortages ................................................................................. 12 2: Price cuts undertaken in selected European Countries from 2010-2012 ....................... 14 3: Pricing Policy Measures 2010-2011 ................................................................... 14 4: Reference Pricing in the EU ........................................................................... 17 5: Policies to promote the use of parallel distribution (2004) ...................................... 19 6: Market Access: Availability of 70 innovative drugs approved by the EMA...................... 21 7: Summary of relevant European directives ......................................................... 29 8: Shortage situation in France .......................................................................... 41 9: Decret 2012-1096 2012/09/28 (decree in France)................................................. 43 10: Survey summary - Greece ............................................................................ 47 11: Key price differences between Poland and Germany............................................ 50 Figure Figure Figure Figure Figure Figure 1: 2: 3: 4: 5: 6: Figures Pharmaceutical drugs price index – vs Portugal ................................................... 15 Pharmaceutical drugs price index (*birgli estimate) ............................................. 16 2008 - filing for pricing and/or reimbursement status ........................................... 21 An overview of the causes of shortages ............................................................ 28 Pharmaceutical Sales in Greece ..................................................................... 45 Parallel exports from Greece ........................................................................ 46 7 …
  • 9. 1. Executive Summary Medicine shortages have consistently been in the media over the past few years and have seemingly, with the economic crisis and austerity programmes, become a crisis in their own right. Many have laid the blame squarely in one area or another with almost casual references to others. Our review shows the causes are quite varied and indeed vary according to market, time, product, and of course cause. Thus any particular case is actually only a snapshot of that specific case and may not apply to others. This report seeks to shed a little more light on the causes behind shortages, current action to reduce shortages, and will propose a number of solutions (most of which are existing proposals from various parties) that stakeholders can review. During the course of the research conducted, one item does appear to be consistent throughout and this is a lack of communication and coordi
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