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Be (pharmaco)vigilant! Important changes in the PV-legislation 23-11-2012

Be (pharmaco)vigilant! Important changes in the PV-legislation 23-11-2012. The Pharmacovigilance legislation after 2012. Does a safe environment guaranty safety ?. M.Sangeleer , MD Medical Affairs Manager, Eli Lilly Benelux Lecturer at the Free University of Brussels (ULB).

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Be (pharmaco)vigilant! Important changes in the PV-legislation 23-11-2012

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  1. Be (pharmaco)vigilant! Important changes in the PV-legislation 23-11-2012 BeAPP pharma.be, Brussels Nov 23 12

  2. The Pharmacovigilance legislation after 2012 Does a safeenvironmentguarantysafety? M.Sangeleer, MD MedicalAffairs Manager, Eli Lilly Benelux Lecturerat the Free University of Brussels (ULB) BeAPP pharma.be, Brussels Nov 23 12

  3. Does a safe environment guaranty safety? 09/12/10: BeAPP Cultural event: Johan Braeckman: « Evolutionism & creationism » BeAPP pharma.be, Brussels Nov 23 12

  4. Does a safe environment guaranty safety? There isalways variation There are more organismsthat are bornthat the amountwhichcan survive (struggle for life) The one who survive are the fitests There isnatural + sexualselection The processisrepetitivefromgeneration to generation (positive feed-back) At the end, adaptations arise BeAPP pharma.be, Brussels Nov 23 12

  5. Pharmacovigilance evolution Thalidomide Computerised system Internationalisation Proactive approach EU reg 1235:risk based regulation • Ad hoc surveillance& risk management plans • Involvement of all staleholders • Improvement collaboration • Risk Management systems/plans • Embryo of EU worksharing • Signal detection • Worldwide databases MAH • Collaboration between states (WHO,…) Collection of AR 2000 2012 1962- 1995 1990- 2000 BeAPP pharma.be, Brussels Nov 23 12

  6. Objectives and Key measures of the new PV law • Reinforcement and modernisation of current system (more rapid decisions): • Additional Monitoring - ↗signal detection • Pro-active Risk Management Plan for all products = CONDITION for registration • Harmonisation of decisions and work sharing: reduction of redundancy • Harmonisation of post –marketing, non- interventional studies for safety and efficacy (PAES/PASS) • Reinforce the link between safety evaluations and regulatory actions • Reinforcement of patient protection &engagement - increase the communication and transparency • Direct reporting to the Agencies (web portals) • Information Available on the webportal of Agencies • Introduction of impact of drugs on the environment BeAPP pharma.be, Brussels Nov 23 12

  7. More actors ICHCIOMS ECNCAs EMAHCPsMAHs Quality? (faster, better, perceived severity, final outcomes, impact on QOL, motivation?)- Role of Advocacy groups Patients: Awareness and engagement – reporting, acting on information BeAPP pharma.be, Brussels Nov 23 12

  8. Adverse event reporting • Expedited reporting of ICSR • Periodic reporting • Labels updates (4.8) • Proactive surveillance • Risk management plan • Risk assessment • Risk minimisation plan • Risk minimisation activities • Studies: PASS- PAES • Labels updates (4.4) MAH operational pharmacovigilance tasks BeAPP pharmabe, Brussels Nov 23 12

  9. Legislationmainchangesfor the MAH AE expedited reporting 9 BeAPP pharma.be, Brussels Nov 23 12

  10. Which AE? Which AE? Consequences for MAH • Volume • Electronic transmission (E2B)- • signal detection • Differenttimelines • Identification and « medical validation » of patient reports • Assessingcausality? • Performfollow-up with patients? • What about precriptionmedicines? • Effect on treating HCP, if more administration isrequired? • Duplicate reports? Resources, Training, adaptations of rules and procedures BeAPP pharma.be, Brussels Nov 23 12

  11. Adverse event reporting • Expedited reporting of ICSR • Periodic reporting • Labels updates (4.8) • Proactive surveillance • Risk management plan • Risk assessment • Risk minimisation plan • Risk minimisation activities • Studies: PASS- PAES • Labels updates (4.4) MAH operational pharmacovigilance tasks BeAPP pharmabe, Brussels Nov 23 12

  12. Legislationmainchangesfor the MAH Periodic reporting BeAPP pharma.be, Brussels Nov 23 12 12

  13. MORE EXPLICIT EVALUATIONS OF B/R On the grounds: more pragmatic approach • Ad hoc periodicity according to risk • close link with RMP • Scientific evaluation > data • Tabulations> line listings • Cumulative data starting +new information of this period • Summaries of studies incl in unauthorised indications • Extensive chapters on signal detection; benefit/risk evaluation Therefore , MAH isgranted 10 extra days for 6 or 12 monthly reports after the datalock point 30 days for reports of a longer frequencyafter the datalock point BeAPP pharma.be, Brussels Nov 23 12

  14. PSUR-PBRER: worksharing & simplifications On the format • Unique List of Union Reference Dates & frequencies: EURD list • Single assessment (variation, suspension, revocation all over EU) • Repository for submission of PSURs (Common European Submission Platform) • No PSUR anymore for generics and « well established use » medications Lessworkthanks to worksharing? BeAPP pharma.be, Brussels Nov 23 12

  15. Adverse event reporting • Expedited reporting of ICSR • Periodic reporting • Labels updates (4.8) • Proactive surveillance • Risk management plan • Risk assessment • Risk minimisation plan • Risk minimisation activities • Studies: PASS- PAES • Labels updates (4.4) MAH operational pharmacovigilance tasks BeAPP pharmabe, Brussels Nov 23 12

  16. Legislationmainchanges Transparency BeAPP pharma.be, Brussels Nov 23 12 16

  17. Scope and timelines Timelines broken down into steps: July 2, 2012 : MAH submit information on ALL medicinal products in EVPDM • 2 July 2012 : variations/suspensions/revocations within 15 calendar days >1 Jan 2015 : MAH can submit using the new standard (IDMP ) >31 Dec 2015: All product information must be resubmitted according to ID MP. ISO IDMP standards, a set of internationally harmonised specifications for the unique identification of medicines BeAPP pharma.be, Brussels Nov 23 12

  18. Consequences for MAH They state reading the label might harm the eyes • Resources to holdtimelines • Questions from patients? • Volume of events ? • Risk of inducedeffects? BeAPP pharma.be, Brussels Nov 23 12

  19. Adverse event reporting • Expedited reporting of ICSR • Periodic reporting • Labels updates (4.8) • Proactive surveillance • Risk management plan • Risk assessment • Risk minimisation plan • Risk minimisation activities • Studies: PASS- PAES • Labels updates (4.4) MAH operational pharmacovigilance tasks BeAPP pharmabe, Brussels Nov 23 12

  20. Legislationmainchangesfor the MAH: Proactive PV 20 BeAPP pharma.be, Brussels Nov 23 12

  21. Consequences of RMP provisions Public summary on the European Web Portal Readibility for lay reader Linked with list of products with additional monitoring Compulsory assessement of impact: studies, surveys,... cost + burden for HCP MEDIA ATTENTION 21 BeAPP pharma.be, Brussels Nov 23 12

  22. Media consequences Media trainedResources –Crisis and communication management BeAPP pharma.be, Brussels Nov 23 12

  23. RMP in Belgium: Introduction of timelines….. • PAES-PASS: • Writtenapproval/denialgiven by belgianauthorities/PRAC after 60 days • MAH has 30 daysto express itswish to react to PASS/PAES requirement • Need to report on the progress reports ( timing to beagreed) • Risk minimisation activities local approvalprocess: • 2 months if no Medicines Commission • 4 months if Medicines Commission and external expert • Clock stops and timelines for MAH too Enough staff needed : reactivity BeAPP pharma.be, Brussels Nov 23 12

  24. Legislationmainchangesfor the MAH : Organisation BeAPP pharma.be, Brussels Nov 23 12 24

  25. Contributions in Belgium?? • Funding for PV resources/staffingat the AFMPS/FAGG: • 58€/registration-All products • 0,0118€/sold pack / National-MRP products • 650€/DSUR for IMPs • program law published 06/04/12 (entry into force 17/04/12) • Circulars 588- 589 • RD 16 jul 2012 on DSURs payments: (effective 18 oct 12) BeAPP pharma.be, Brussels Nov 23 12

  26. Conclusions: Does a safe environnement guarantysafety? • Maximising benefit, minimising risk of medicines, so focus on benefit/risk • More pragmatic , risk-basedapproach • Focus on transparency • Volume of events – balanced by more efficient signal detection- duplicates? • Effect of increased patients/media interactions ? • New formats & cycles • Processes & workload: willincreaseat first • Simplification/harmonisation: reduce duplicate workat long term • Timelines: more dynamic system • reactivitywillbeneeded (on demand PASS, PBRER, RMAs) • Fees?: willthey put staffingatrisk? (SME) BeAPP pharma.be, Brussels Nov 23 12

  27. Does a safe environment guaranty safety? Basic principle remains unchanged It is still no rocket science:… There is a human factor ….There is always variation… BeAPP pharma.be, Brussels Nov 23 12

  28. Conditions for a safer PV?: Learn to cope with « variation »= Mitigating the « Human Factor » • Awareness & education of all stakeholders including patients, patients associations and HCP- (manage duplicates) • Resources to hold timelines at both MAH/NCA/…PRAC? • Sufficient skilled users of signal detection tools • Multidisciplinary teams (RMPs) • Learn to cope with media BeAPP pharma.be, Brussels Nov 23 12

  29. Does a safe environment guaranty safety? Probably,… a fitest pharmacovigilance,…..adapted to the variation Maybe we shouldn’t disturb the medical community for such a minor manifestation? BeAPP pharma.be, Brussels Nov 23 12

  30. Does a safe legal environment guaranty safety? An industry perspective.Impact on SME’s Bart De Greef, pharma.be Katleen Vandeweyer, Biocodex Benelux

  31. Stability pact

  32. Stability pact

  33. Major challenges for SMEs • SMEs oriented towards Rx, OTC medicines, MD, food, cosmetics…. • Less complaints • We take our responsibility! • Requirements on • Update EUDRAPharm:(European medicines database) • Submitting product data =>mandatory from 2 July 2012 • EXtended EudraVigilance Medicinal Product Dictionary (XEVMPD) specific tool for SME foreseen in EVWEB • PSMF (audits/inspections, patients support programs, subcontracts,…) • RMP-RMA-PASS/PAES • Patients/public management=>who will manage media reactions?

  34. IMPACT FOR SMEs • Guidance from NCAs - has there been enough and oriented for SMEs? • Complying with the Electronic transmission As an SME, I cannot afford to spend tens of thousands of Euro on a PV database and a gateway: • EVWeb: one off-training course, free tool • Contract it out:Stakeholder roles and responsibilities =>importance of well defined contract (detailed description of delegated tasks, data exchange, agreed timelines, definitions,…) • MAH retains full responsibility • MAH need to ensure an effective quality system =>Evaluate risk/benefit • Impact on competitiveness and business profit

  35. Costs for a SME? • Workload…will it be reduced or augmented? • Software tools and technology costs? • MEdDRAtermsis free to use in EVWEB for Small & micro-sized but not for medium sized • Human Resources and training needs – what impact will these have on SME business? • Insourcing vs. outsourcing? • Fees: EU vs Belgium as NCA • Specialfee for inspections ?

  36. Thankyouforyourattention

  37. Before and after 1235: legislation review Pharma.be/BEAPP Thierry ROISIN – 23/11/2012

  38. Plan New legal framework as regards pharmacovigilance of medicinal products for human use GVPs Legislation : main changes PRAC Union-wide assessment of phvig issues Strengthened transparency and communication Impact for SME

  39. New legal framework as regards pharmacovigilance of medicinal products for human use Regulation (EU) No 1235/2010 of the European Parliament and of the Council of 15 December 2010 amending, as regards Pharmacovigilance of medicinal products for human use, Regulation (EC) No 726/2004 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency, and Regulation (EC) No 1394/2007 on advanced therapy medicinal products (specific provisions on centrally authorised products and EMA tasks) Directive 2010/84/EU of the European Parliament and of the Council of 15 December 2010 amending, as regards pharmacovigilance, Directive 2001/83/EC on the Community code relating to medicinal products for human use(nationally authorised products and common provisions) Adopted by both Council and EU parliament and publication on 31 Dec 2010 Most of the provisions came into force in July 2012

  40. GVPs

  41. GVPs

  42. GVPs

  43. Legislation : main changes

  44. Legislation : main changes

  45. PRAC New scientific committee within the Agency Pharmacovigilance Risk Assessment Committee- Reg art. 56(1)(aa) Mandate– Reg. art. 61a §6 “ All the aspects of the risk management of medicines … having due regard to the therapeutic effect of the medicinal product …”: • Recommendations to CHMP and CMD(h) on Phvig issues • Role in agreement and monitoring of RMPs • Prioritisation and review of emerging safety signals • Review of PSUR assessments • Evaluation of protocols and results of PASS • Decision on products under additional monitoring • …

  46. PRAC - composition Appointed by each Member State: Appointed by the European Commission following a public call for expressions of interest: • 1 member + alternate • 27 + EEA countries non voting members • 1 patient organisations rep + alternate • 1 healthcare professionals rep + alternate • 6 members to ensure relevant expertise available

  47. PRAC – activities

  48. PRAC – activities

  49. PRAC • Interaction with CHMP and CMD(h) • PRAC provides recommendations to CHMP and CMD(h)– Reg. art. 56(1)(aa) • CHMP / CMD(h) shall rely on the scientific assessment and recommendations of PRAC for the fulfilment of its phvig tasks, including the approval of risk management systems and monitoring their effectiveness – Reg. art. 5(2) / Dir. art. 27 • Explanation on the scientific grounds for differences if opinion / agreement is not in accordance with PRAC recommendation

  50. PRAC • Decision-making process • PSUR • PASS • Union procedures (art. 31, 107i) PRAC recommendation: regulatory action CHMP (at least 1 CAP) CMD(h) (no CAP) Opinion = maint., var., susp., revoc. Position = maint., var., susp., revoc. If consensus: agreement NO consensus: position majority COMMISSION Decision modifying MA (CAP) MS: adopt measures Decision addressed to MS MAH: submit variation

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