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  1. EUCOMED HEALTH GOVERNANCE , 19th April 2012 Dario Pirovano Consultant Regulatory Affairs - Eucomed

  2. A diverse sector

  3. Patch with Cells Next generation imaging Miniaturization Drug device combinations Implantable electronics Medical Devices Technology convergence and smart devices Harvester/Collector Mincer Molecular and cellular diagnostics Contact lens with chip New biomaterials (incl. biosurgicals) Cartilage Repair Kidney Reconstruction An exciting future

  4. Comparison with Pharmaceuticals • Pharmaceuticals • Industry with longer history • Primarily large multinationals • Medical Devices • Relatively young industry • 80% are small- and medium-sized companies

  5. Comparison with Pharmaceuticals • Pharmaceuticals • Limited number of products • Development by trial and selection on the basis of quality, safety and efficacy • Therapeutic • Based on pharmacology, chemistry, biotechnology, and genetic engineering • Biologically active and effective when absorbed by the body • Medical Devices • More than 10,000 products (different sizes, models, etc.) • Designed specifically to perform certain functions based on quality, safety and performance • Diagnostic, therapeutic, monitoring • Based on mechanical, electrical and/or materials engineering • Generally act by physical means

  6. Comparison with Pharmaceuticals • Pharmaceuticals • Continuous innovation and some improvements based on new science and technology • Innovation primarily the result of laboratory work • Extensive product lifetime and long investment recovery period • “Breakthrough drugs” • Medical Devices • Continuous innovation and iterative improvements based on new science, technology and available materials • Innovation primarily the result of insights from clinicians • Short product lifetime and investment recovery period (~18 months) • New devices bring added functions and clinical value based on incremental improvements

  7. Comparison with Pharmaceuticals • Pharmaceuticals • Low distribution cost • No service or maintenance • Limited training required (compared to high-tech medical devices) • Medical Devices • High cost of distribution • Training and education essential • High cost of training and education • Extensive service requirements

  8. Comparison with Pharmaceuticals • Pharmaceuticals • Randomized control trials are ‘gold standard’ • Efficacy and efficiency can be largely demonstrated prior to market • Drugs either work or don’t work: efficacy and efficiency easy to demonstrate • Medical Devices • Randomized control trials not always scientifically informative or possible and hence not ‘gold standard’ • Efficacy and efficiency can be only truly be demonstrated through actual use and uptake in the market • Medical devices are part of whole system and their efficacy relies on the skills and experience of the physician, the quality of the hospital, and other factors x + y = z x + y - b / q * r - d ... = ?

  9. EU Regulatory Framework for Medical Devices Last update 10 April 2012 CLASSIFICATION OF MEDICAL DEVICES (MD): Manufacturer determines the CLASSIFICATION of his MD based on Annex IX of MDD and related guidelines (Meddev) Class I(low risk) Class IIa(low/medium risk) Class IIb(medium/high risk) Class III (high risk) CONFORMITY ASSESSMENT PROCEDURE (ART. 11): ’Technical documentation’ (TD): to be created by the manufacturer. It demonstrates the safety and performance of the device by proving that all ‘Essential Requirements’ laid down in the MDD are met (Annex I) and includes a clinical evaluation (Annex X) and a risk assessment . All are based on clinical data. PRE-market • ‘Quality Assurance System’ (QAS): to be set up by the manufacturer. Ensures that each individual device fully meets • the standards defined in the technical documentation. Achieved through clearly defined procedures for every step of the • manufacturing process, from design phase to final inspection (Annex II or V). Notified Body (NB) audit: NB assesses the TD and the QAS through an on-site inspection of the manufacturing premises, which takes 2-5 days. NB issues a Conformity Assessment ‘Certificate’ (Annex II 3.3. or Annex V 3.3.) Pre-market approval for class III: Manufacturer submits TD as a ‘Design dossier’ to the NB. NB assesses it and issues a ’Design-examination Certificate’(Annex II or III) • Manufacturer’s self-assessment of his device 1 DECLARATION OF CONFORMITY AND CE MARKING: Manufacturer issues a declaration of conformity stating that each device is in compliance with the all applicable Directives and affixes the CE marking Manufacturer must keep TD and QASupdated and adapt according to all gained post-market experience . NB regularly audits both, typically once per year (Annex II, paragraph 3.1) POST- MARKET SURVEILLANCE (preventive): • The manufacturer must have a post-market surveillance system in place, as an integrated part of the ‘quality assurance system’ and audited by a NB, in order to collect, review and assess all information gained on a device in the post-market phase (Annex II, paragraph 3.1) • Competent Authorities are responsible to monitor all devices on the market , i.e. through audits, product samples, complaints (Article 2) POST-market VIGILANCE SYSTEM (in case of incidents): • Manufacturer is obliged to REPORT any incident related to his devices to the Competent Authority (Article10 and Annex II, paragraph 3.1) • A Member State may decide to WITHDRAW, RESTRICT or PROHIBIT the marketing of the device (Safeguard Clause, Art. 8) 1 For devices with measuring function or which are sold sterile there is an intervention from the Notified Body

  10. Revision could sort out weaknesses of current system? • Lack of Transparency = Lack of trust in System • Overly “confidential” system • Different expertise/performance of Notified Bodies • Perception that Authorities are divorced from the process, particularly for complex class III devices • Transparency of overall system, in particular no visibility of what’s on the market • Poor perception of system by those external to EU • Challenges to Innovation = Threat to patients’ choice • Public Health Authority understanding of new technologies • Lack of Guidance including regulatory predictability and agreed clinical guidelines, in particular on innovative new technology • Fragmented Market = Threat to legal market access • Multiple national registrations and overly bureaucratic processes • National ‘safeguard’ measures create multiple national requirements • Multiple national approaches to vigilance, borderline and classification

  11. 6 steps to a smarter legal framework for medical devices: 2 3 1 4 5 6

  12. October 2011: Eucomedfavours JRC CoordinatingCommittee of Member States with Administrative Support from: Oversight by Member States Option 1 Assistance of DG Research’s Joint Research Centre and/or DG SANCO’s Executive Agency for Health and Consumers Option 2 StandaloneAgency Option 3 Directorate in EMA Option 4 = Commission = Member States (Heads of Agencyapproach) = Agency

  13. Expected timeline for the MDD revision 08/2008 EU Presidencies 08/2011 DK, CY Q2/2012 IE, LT June 2014 EP Elections EL, IT 2014/15 LV, LU NL, SK 2017/18

  14. Why a European Trade Association? • The rules of the game are changing • Increasingly, policy-makers are staying ahead of industry • What to do to stay engaged? • More frequent exchange of views and updates on key policy dossiers are vital • Early warning on evolving crises • Coordinate messages and timing on advocacy on key issues

  15. Eucomed Secretariat Organisational Chart

  16. EUCOMED and Medical Technology Industry • Eucomed represents the medical technology industry in Europe. Our mission is to make modern, innovative and reliable medical technology available to more people. • Based in Brussels, Belgium • 24 staff • Members: • 25 national industry associations • 3 associate Members • 58 direct corporate members • Medical technology industry in the EU • About 22,500 medical technology companies in EU • 80% SMEs • 95 billion EUR annual sales; 8% re-invested in EU • Nearly 500,000 employees • > 500,000 products (10,000 generic groups) • One new European patent every 38 minutes* • * OECD 2010; European Patent Office 2006

  17. European MedTech Industry Source: World Bank, EDMA, Espicom and Eucomed calculations, 2009Europe refers to EU-27 plus Norway and Switzerland

  18. Global Healthcare Expenditure The total Global healthcare expenditure accounts for 5.7 trillion US$ in 2009*

  19. Total Healthcare vs. Medical Device Expenditure, Europe Source: Espicom, World Bank, Eucomed calculations, 2009 *IVD are not included

  20. Eucomed is active in the following spheres: • Economic affairs; including market data collection, health economics, funding and reimbursement, health technology assessment and new trends (homecare) • Regulatory affairs; including vertical legislation (such as medical devices directives and advanced products regulation), horizontal legislation (e.g. environmental) and standards • Science and innovation; including medical nanotechnology and other emerging technologies, research and innovation projects • International affairs; including global regulatory harmonization (GHTF), relations with the US, Japan, China and India • Ethics; including enforcement of the Eucomed Code of Business Practice • Public affairs; including outreach to and relations with the European institutions and the Member States • Communications and external relations; including partnerships with patient groups and medical associations, events, publications and media relations.

  21. Main sector groups at Eucomed are: • 1. Ophthalmic surgery & vision care • 2. Orthopaedic • 3. Cardiovascular • 4. E-health • 5. Patient Safety Groups • 6. Community Care • 7. Surgical care

  22. Ambition • Be a center of competency for policy-makers; • Show and demonstrate that the medical technology industry offers innovative and cost-effective solutions to improve patient lives; • Engage healthcare influencers across government, industry, patient advocacy, healthcare professionals to work toward consensus on health policy issues.

  23. Strategic Actions Short Term • Demonstrating the value proposition of the industry is critical • Communications (Eucomed/NA) • Public Affairs Machine (Eucomed/NA) • Ethical Campaign (Eucomed/NA/ADV) • Data generation • 2. Address threats and opportunities to address value • Regulatory burden (MDD Revision) (Eucomed) • Reimbursement / Procurement / Late Payment (Eucomed/NA) • Shaping HTA Environment (Eucomed/NA) Alignment of actions Eucomed and NA

  24. Likely scenario to support all sectors Mid Term of validations and trends/scenarios by key internal groups (NA, sector…) • Determine the optimum scenario • Align future position of the industry • Define action plan of Eucomed / NA • Build value proposition thorough targeted stakeholders • Patients • HCP • Governments • Payers • Monitor e-Health Development

  25. Programme and registration at Early bird rates: Save up to 20% by registering before 30 June!

  26. Grazie per l’attenzione