MEDICINES SHORTAGES TOPICS PATIENTS AND HEALTHCARE PROFESSIONALS PROPOSE TO FOCUS ON IN 2020-20205
• Why this presentation? • Patients, consumers, healthcare professionals agreed on a common position to address medicines shortages back in 2013 • EMA and NCAs issues recommendations and established a task force • Industry set up working groups • Nevertheless International Coalition of Medicines Regulatory Agencies added shortages to their agenda • Number of shortages doubled • Regular workshops kept all stakeholders up-to-date between 2018 and 2019 • A European Cooperation in Science and • A twenty-fold increase since Technology was launched (COST Action 15105) 2008 2 Classified as public by the European Medicines Agency
E URORDIS EAHP I NT al F ABRY AND EMA Concerns and FABRAZYME, CEREZYME MYOZYME 1 st Hospital recommendations on supply Impact analysis Pompe disease Fabry and Gaucher pharmacists survey shortage of medicines 2010 Q1 2009 2008 2013 W HAT WE ’ VE DONE Q2 Meeting request EC Series of conferences (PCWP-HCPWP) No response DIA, Krakow, Berlin, Abu Dhabi 2008-today Q3 Q 2 2014 12 years. And now? COMMON POSITION on SHORTAGES 1 st EMA workshop 45 organisations Presentation main proposals 2 nd EMA workshop Letter to HMAs Q4 Council Paper 3rd EMA workshop And conference call SSRAP implemented Common position mentioned Economic aspects Q2 Q3 2018 Q2 2015 2016 To bring back Meetings Perm Reps Council Conference production in Europe? Bratislava Latvia etc 03 Cost Action 15015 + DIA
To discuss where we are in 2020 An abundance of measures already taken, but do they work? Industry Inter- Communication on EMA/HMA task force Association Task Force shortages • • • On the availability of Risk-based approach for the Implementation of the authorised medicines for prevention / management of Guidance Human and Veterinary Use shortages (product based, • Are MS implementing it? systems based) • • Do we have concrete Presentation of the task examples to share? • force deliverables and ISPE Drug Shortage • Are MS informing the EMA? national measures Assessment and Prevention • Tool Recent report from the • Discussion on their Dutch governement implementation at national • Collected success stories of level implementation of deliverables • Notification rules: are they • • Asked EMA to provide baseline Discussion on follow-up now harmonised? metrics on the number of actions with stakeholders shortages due to manufacturing/quality issues so that impact can be measured 4
1. Risk-based triage of products How to establish preventive controls based on product criticality and patient impact 2. Establish a Drug Shortage Risk Register & a Prevention and Risk-based triage approach Response Plan A holistic framework and simple templates at a product level Patient impact first Drug Shortage Prevention and Response Plan Drug Shortage Risk Register PDA’s Risk -Based Prevention & Management of Drug Shortage EMA Workshop - London October 09, 2015 5
Recent measures adopted by MS Do they work? Are they coordinated? Or do they worsen the situation? When no alternative Limiting parallel trade Brexit preparedness exists anywhere re-export prior authorisation 1 year for the transition • • • Slovak Presidency How frequent is this? National viewpoint from the Conference in 2016, Cost UK regulator: MHRA • See Hospital Universitario Action 15105 Virgen de la Victoria, Málaga, • European viewpoint from Spain: what is the % of • Belgium (Laure Geslin, the Industry: EFPIA / situations where no FAMHP, Céline Van Wetter, Medicines for Europe / alternative exist and criteria hospital pharmacist, Koen AESGP must be decided upon on Straetmans, pharmacist) which patients need to stop • • Viewpoint from a country Slovakia: National Authority, treatment? 10%? Zuzana Baťová likely highly affected by • Who then decides? • Brexit such as Ireland or Czech Rep: Reasons for • Ethics committee involved? unavailability of medicinal Malta products. State Institute for • Coordination of supply at EU Drug Control level? • How the Commission • Or remaining supply sold evaluates if measures are elsewhere? proportionate 6
TOPICS WE THINK DESERVE MORE FOCUS AND DISCUSSIONS WITH ALL PARTIES 7 Classified as public by the European Medicines Agency
More work / reflection needed To understand the EU coordination Market withdrawal Relocating Substitution causes for commercial manufacturing in EC study on the root How can we improve the reasons the EU In some MS, causes of shortages European coordination pharmacists can for managing what’s left substitute a missing Russia doing it (bringing Obligation on MAH to Joint EMA/EC of the supply equally product by themselves, back from Eastern notify regulators a few among MS, and within under conditions (not EPSCO meeting Siberia to Moscow months ahead MS? systematic, and based November 2019 region) on a risk assessment) Is it enough? Does it If tomorrow a major Do we really need this Germany and France provide enough time to antibiotic disappears for This is helpful, no need study before proposing exploring it find another a long time, what will to wait for a new new actions? MAH/manufacturer? happen? prescription. What about the EU? See: A critical look at erroneous What about military Do we need a stress Can we generalise this incentives and lacking legal pharmacies? framework as drivers of test? practice? medicines shortages and objectors to problem-solving EU legal tools? approaches. H Jenzer, Uni Bern 8
An abundance of published literature on drug shortages Time to act, more than to write 29 references on Causes, plus Thesis 9
“The Tree of Causes” 127 causes identified 24st Congress of the EAHP Active pharmaceutical ingredients General Causation, e.g. Barcelona, Spain Globalisation of production Hazard, turbulences 27-29 March 2019 Lack of capacity / responsibility Abstract 1ISG-034 • LFB Lille, 11/2018 electricity failure National shortage of blood products Mergers to maximise gains / Manufacturing lower production costs Defect, contaminations • Genzyme 2009, ERTs • Trisenox 2017, Sartan 2019 Closure manufacturing site Wholesaling and retail trade • MACI in 2014 • Arbitrage and parallel import/expert Issues at GMP Inspections provoke secondary shortages in low price • Ben Venue laboratories 2013, 12 medicines suspended countries (e.g. Greece 2008) • GVK Bio 12/2014 and 25 generic suspended (substandard • Tendering / taxes ECG in bioequivalence CTs) • Belgium, Romania 2017 • Disorganisation of distribution chain (HIV Outcomes products, France 2010) Financial outcomes Clinical needs Price of alternative, product at New standards / medical knowledge “too low” price (vaccines) • Myozyme 2008, for early onset Pompe disease, Drivers of medicines shortages Bern University of Applied Sciences Market withdrawal high demand late onset 10
Banking industry Pharma industry Financial crisis Risk based Analysis to determine whether a bank has Analysis to determine whether a MAH enough capital to withstand an economic has enough agility to withstand an or financial crisis, using a computer- economic or technical crisis (using a simulated scenario computer-simulated scenario?) Regulatory authorities require MAHs Banks that fail their stress tests must take Financial authorities require banks of a of a certain risk to conduct stress tests steps to preserve or build up their capital certain size to regularly conduct stress and report the results tests and report the results reserves Industry drug US $ 50 bio+ Level 1 shortage risk in assets register 11
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Other topics Do we also want to address: Liability Others • • Obligations of MAH and Epidemiology of shortages, Distributors, Art. 81 Directive their clinical impact? 2001/83 • A mobile app for patients to • The MAH and the distributors receive information and shall, within the limits of their comment on the shortages? responsibilities, ensure • Dialogue with HCP when appropriate and continued looking for alternatives? supplies to pharmacies and • persons authorised to supply Transparency on remaining medicines so that the needs supply? of patients are covered • Patients who need to pay extra for alternative product? 13
An in-depth multi-stakeholder workshop Addressing all topics, including economic issues – over 2 days? Concrete All stakeholders examples • Regulators • • National authorities (regulatory, market Different shortages from which important lessons can be learned organization) • Industry (MAH, distributors, exporters..) • European Commission • Other international actors • Patients • Healthcare professionals • Communication expert • … 14
To update the Common Position signed from 2013? • We could elaborate more on some topics And better • Substitution communicate about it? • Information • Liabuility • Relocation in the EU • Economic aspects…. 15 Classified as public by the European Medicines Agency
Team François Kaisa Jan de Belie Houÿez Immonen PGEU E URORDIS EPF PCWP co-chair Stephanie Tjalling van Ulrich Jäger Kohl der Schors EHA EAHP EAHP HCPWP co-chair 16
THANK YOU 17
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