doing business in ireland - global health · pdf fileequipment & diagnostics abbott ......
TRANSCRIPT
Doing Business in Ireland
Sharon HigginsDirector IMDA
The Second Annual Medical Device Regulatory, Reimbursement and Compliance Congress
Harvard University29 March 2007
Medical Device Regulatory, Reimbursement ad Compliance Congress – 29 March 2007
www.imda.ie
www.ibec.ie
Medical Device Regulatory, Reimbursement ad Compliance Congress – 29 March 2007
www.imda.ie
www.ibec.ie
Why do business in Ireland?
– Because Ireland has and continues to ‘do the business’ for companies operating here
Don’t take my word for it……
Medical Device Regulatory, Reimbursement ad Compliance Congress – 29 March 2007
www.imda.ie
www.ibec.ie1988 1997 2004
Trajectory of Ireland’s Economy
Medical Device Regulatory, Reimbursement ad Compliance Congress – 29 March 2007
www.imda.ie
www.ibec.ie
1,000 overseas companies have chosen to invest in Ireland as their European base
Medical Devices
E-business
ICT
Pharmaceuticals
Engineering
Financial & International
Services
Medical Device Regulatory, Reimbursement ad Compliance Congress – 29 March 2007
www.imda.ie
www.ibec.ie
Ireland - The knowledge Economy
Free and pro business economy especially for foreign business– 3rd of 157 (2006 index of economic freedom)
A quality education system – – 4th of 60 IMD World competitive framework– 5th for level of university education attained
A dynamic information infrastructure– Lowest leased line costs in the OECD
Innovation systems– Science Technology and Innovation Strategy– Science Foundation Ireland
Medical Device Regulatory, Reimbursement ad Compliance Congress – 29 March 2007
www.imda.ie
www.ibec.ie
‘Ahead of the Curve’- Enterprise Strategy Group
Comparative Advantage
Competitiveness
Medical Devices and Diagnostic Sector in Ireland
Medical Device Regulatory, Reimbursement ad Compliance Congress – 29 March 2007
www.imda.ie
www.ibec.ie
Interventional Wire & TubingAccellentCregannaFort Wayne MetalsLake RegionMerit MedicalTeleflex MedicalUlbrich
Opthalmic / VisionAlconAthlone OpticalBausch & LombCarl ZeissEssilorJ&J VistakonOakleyOphtechsRupp & HubrachTransitions Optical
Abbott Vascular Boston ScientificBrivantClearstreamConormedsystemsLabcoatMedtronicNova ScienceUSCI
Vascular Intervention
Solution Providers
Equipment & DiagnosticsAbbottAerogenBayer DiagnosticsBeckman CoulterBiotrin TechnologiesTyco (Puritan Bennett)VitalographWelch AllynAccellentANSAmed*Contech MedicalEndura CoatingsHarmacGoodmanMedisize Donegal Healthcare
Orthopaedic & ImplantsAllergan (Inamed)Bio-medical ResearchBBE HealthcareDonovan MedicalJ&J DePuyStryker HowmedicaStryker InstrumentsStryker OrthopaedicsViasys (Intermed)
FiltrationFiltertekListalMillipore
Hospital ProductsAbbottBaxter HealthcareB BraunBecton DickinsonDe RoyalHollisterOral BTyco (Sherwood & Mallinckrodt)Utah Medical
Pack, Print & SterilisationAmcor FlexiblesField BoxmoreIsotron (Gammaster)NelipakSteripack*
Shared ServicesAllerganAMOBayer DiagnosticsBaxter Financial ServicesCook IrelandDe RoyalJ&J DePuy
Cook IrelandEssilorJ&J VistakonOphtecsStryker HowmedicaTeleflex Medical
Boston Scientific (IVT) Medisize(DHC)Zeus Industrial Products
Abbott DiabetesMoll Industries Ireland
Abbott - 3 plantsAmcor FlexibleAndrew MedicalHospiraLotus Automation*Pro-Tek Medical*
B Braun HospicareCharles River
Hollister
Allergan - 2 plantsAMO Isotron (Gammaster)Field Boxmore
Baxter Healthcare - 2 plantsFort Wayne Metals
Transitions Optical
Harmac
OlympusEssidevVitalograph
Listal
Donovan Medical(Tornier)
Abbott VascularBoston Scientific Lake Region
Boston Scientific IsotronMidland Bandages*Tyco Healthcare
Abbott
BBE HealthcareEndura Coatings
Becton Dickinson
Allergan(Inamed)
Clearstream*
Carl ZeissWaters Corp.
Rupp & Hubrach
Athlone Optical Conor MedsystemsElanTyco MallinckrodtUtah MedicalInnocoll
De RoyalWelch- Allyn
Vistamed*
University College Cork
Dublin UniversitiesDublin City UniversityTrinity CollegeUniversity College
Sligo Institute of Technology
National University of Ireland
University of Limerick
National Centre for Laser ApplicationsNational Centre for Biomedical Engineering Science
National Microelectronics(Nanotechnology) Research Centre
National Pharmaceutical Biotechnology Centre
Institute of Technology
National Tool-making Centre
Legend :University, Institute of TechnologySpeciality / Research Centre
IDA Regional Offices
* Indigenous Irish Companies
Piercan
Oral B
Microbrush
Galway
Cork
Limerick
Athlone
Sligo
Biomedical & Environmental Sensor Technology Centre
Bausch & Lomb
Waterford
Dublin
Filtertek
ANSAmed*Innocoll Technologies
Letterkenny
Alcon J&J DePuyGE Healthcare MilliporeAudit Diagnostics* Stryker InstrumentsBoston Scientific Stryker Orthopaedics
Medical Device Companies
Airports
Institute of Technology
Institute of TechnologyInstitute of Technology
Institute of Technology
Institute of Technology
Institute of Technology
Institute of Technology
Institute of Technology
The Conway Institute of Biomolecular and Biomedical Research
Dublin Institutes of TechnologyBlanchardstownDublinTallaght
Northern Ireland
Medical Technology Companies in Ireland
CavanDundalk
Steripack*
Abbott B Braun
Abbott Vascular DevicesAccellentAerogen (Nektar)Beckman-CoulterBioniche Lifesciences IncBoston ScientificBrivant*Caragh Meditech*Contech MedicalCreganna*LabcoatGoodmanMedtronic Merit MedicalMicron Clean*NelipakTyco (Puritan Bennett)UlbrichXenith BiomedZerusa*
Perfecseal
AMOBayer DiagnosticsBecton DickinsonBiotrin TechnologiesJ&J ConsumerKCI MedicalNova ScienceNypro IrelandOmega TeknikaSmith & NephewSpecialty CoatingTech GroupTrinity BiotechTyco
Enfer ScientificPhardiag*
Oakley
Regenerative Medicine Institute (REMEDI)
Biomedical Electronics Centre
Biomedical Diagnostics Institute
Viasys (Intermed))
Institute of Technology
USCI Georgia Tech Irl.
J & J Cordis
Medical Device Regulatory, Reimbursement ad Compliance Congress – 29 March 2007
www.imda.ie
www.ibec.ie
Irish Medical Devices and Diagnostics SectorEmployment continues to rise steadily
14,02315,920
17,06818,922
19,92720,41120,80621,32022,99523,701
0
5,000
10,000
15,000
20,000
25,000
1997 1998 1999 2000 2001 2002 2003 2004 2005 2006
Source - forfas
Medical Device Regulatory, Reimbursement ad Compliance Congress – 29 March 2007
www.imda.ie
www.ibec.ie
Companies Ranked by Medical Device Revenues 2005 (US$, Million)
1 Johnson & Johnson2 General Electric 3 Medtronic 4 Baxter International 5 Siemens 6 Fresenius 7 Philips 8 Tyco International 9 Boston Scientific 10 Stryker11 B Braun12 Guidant13 Zimmer14 Becton Dickinson
11 of worlds top 14 in Ireland (7 with multiple locations)
Red – manufacturing/ R&D MD based in IrelandBlue – not manufacturing MD in IrelandPink – since taken over by Abbott/ Boston Scientific
Medical Device Regulatory, Reimbursement ad Compliance Congress – 29 March 2007
www.imda.ie
www.ibec.ie
Irish Export Markets
Medical Device Regulatory, Reimbursement ad Compliance Congress – 29 March 2007
www.imda.ie
www.ibec.ie
Key Success Driver – Global Access
Facilitated by..– Centers that promote Innovation– Convergent Technologies– Focus on high value-added activity– Competence & Skills to suit future needs – A competitive and proactive regulatory
environment
Challenges & Opportunities
Medical Device Regulatory, Reimbursement ad Compliance Congress – 29 March 2007
www.imda.ie
www.ibec.ie
Support for Business Innovation
Skills & Education
Supportive Regulation
Regulatory Infrastructure & Challenges
European Framework Global Market
Medical Device Regulatory, Reimbursement ad Compliance Congress – 29 March 2007
www.imda.ie
www.ibec.ie
Medizinprodukte - RichtlinienMedical Device Regulatory, Reimbursement ad Compliance Congress – 29 March 2007
www.imda.ie
www.ibec.ie
Medical Device Legislation - EU
Directive 90/385/EEC
Active ImplantableMedical Devices
S.I. No. 253 of 1994
Directive 93/42/EECGeneral Medical Devices
S.I. No. 252 of 1994
Directive 98/79/EC
In-vitro DiagnosticMedical Devices
S.I. No. 304 of 2001
pacemakers;implantable infusion pumps;
Inmplantable cardiac defibrillators + related software and accessories
US, X-ray, heart valveship-implants, ECG, EEG,
intravascular catheters, stents, syringes, wheelchairs,
dental materials ...
Lab analysers, reagents , HIV/hepatitis tests, pregnancy tests,
assays, calibrators, control materialsspecimen receptacles ...
Medical Device Regulatory, Reimbursement ad Compliance Congress – 29 March 2007
www.imda.ie
www.ibec.ie
Ireland’s CA and NB
Competent Authority– The Irish Medicines Board
Notified Body– The NSAI
Medical Device Regulatory, Reimbursement ad Compliance Congress – 29 March 2007
www.imda.ie
www.ibec.ie
Role of the IMB
To authorise the manufacture, preparation, importation, distribution and sale of human and veterinary medicinal products
To regulate the post marketing surveillance of medical devices, grant approval for clinical investigations, manage a register of low risk medical devices, monitor Notified Bodies for conformity assessment in Ireland, etc
To provide information on medicinal products and medical devices to healthcare professionals
To advise the Minister for Health and Children and the Minister for Agriculture and Food, as required
To enforce the Regulations made pursuant to the Act
Medical Device Regulatory, Reimbursement ad Compliance Congress – 29 March 2007
www.imda.ie
www.ibec.ie
IMB - relationship with industry
Firm but fair
IMB/ IMDA Liaison Group– Quarterly meetings– Two way discussion forum– User Fees– Guidelines
Online registrationVigilance
Medical Device Regulatory, Reimbursement ad Compliance Congress – 29 March 2007
www.imda.ie
www.ibec.ie
Carry out in excess of 6,000 assessments per year
3,000+ Registered / Certified Firms – Medical ++
NSAI
Medical Device Regulatory, Reimbursement ad Compliance Congress – 29 March 2007
www.imda.ie
www.ibec.ie
Regulatory Challenges for Irish Industry
ReachMDD ReviewE-labellingRisk ManagementFDA Small business FeesIMB - 2007
Medical Device Regulatory, Reimbursement ad Compliance Congress – 29 March 2007
www.imda.ie
www.ibec.ie
Reach
Single system for the registration, evaluation and authorisation of all chemical substances manufactured, imported or used in products or processes in the EU. Companies that manufacture, import or use such substances in excess of one tonne per annum, will be required to register the substance with a central competent authority. A company, if unprepared, could discover that crucial raw materials are no longer available or that the use of the raw material is simply no longer permitted.
Regulation (EC) No 1907/2006 of the European Parliament and of the Council of 18 December 2006 and Directive 2006/121/EC of the European Parliament and of the Council of 18 December 2006 amending Council Directive 67/548/EEC were published in the Official Journal on 30 December 2006.
Medical Device Regulatory, Reimbursement ad Compliance Congress – 29 March 2007
www.imda.ie
www.ibec.ie
Reach - timelines
1 June 2007 – REACH enters into force1 June 2008 – European Chemicals Agency (ECA) in operation and main titles of REACH apply1 June 2008 – “New” substance registration1 June 2008 – November 2008 – Pre-registration for phase-in of existing substancesNovember 2010 – 1st phase-in substance deadline*June 2013 – 2nd phase-in substance deadline*June 2018 – 3rd phase-in substance deadline*
Medical Device Regulatory, Reimbursement ad Compliance Congress – 29 March 2007
www.imda.ie
www.ibec.ie
Medical Devices Directive Review
Changes proposed to
• Definition – medical purpose• Conformity assessment• Clinical evaluation requirements• Post market surveillance• Transparency• Co-operation
Medical Device Regulatory, Reimbursement ad Compliance Congress – 29 March 2007
www.imda.ie
www.ibec.ie
Timelines MDD
European Parliament due to vote in plenary on 29 March or during April session (depending on progress)
Issues to be overcome:– reuse and reprocessing of single-use
devices– proposed for a ban on hazardous
substances in devices
Medical Device Regulatory, Reimbursement ad Compliance Congress – 29 March 2007
www.imda.ie
www.ibec.ie
Bear in mind that …..
Markos Kyprianou, European Commissioner for Health and Consumer Protection, at a meeting at the European Parliament on February 27
Modernisation of the EU's legislation for medical devices (envisaged for discussion 2008)
Reviewing the legal framework on pharmaceuticals
Medical Device Regulatory, Reimbursement ad Compliance Congress – 29 March 2007
www.imda.ie
www.ibec.ie
E-Labelling
New paragraph proposed in article 11 of Directive 93/42/EEC stating “the Commission may in accordance with the procedures referred to in article 7(2) adopt measures allowing instructions for use to be provided by other means”Not prohibited in IVD legislationWorking group in Europe focusing on guidance for IVDs
Medical Device Regulatory, Reimbursement ad Compliance Congress – 29 March 2007
www.imda.ie
www.ibec.ie
E-Labelling, cont’d
Subgroup has prepared a draft MED.DEV for consideration (drafting group led by Ireland)
IMB support moving in this direction under defined circumstances and only for devices for professional use and not at point of care
Pilot in Ireland under discussion
Medical Device Regulatory, Reimbursement ad Compliance Congress – 29 March 2007
www.imda.ie
www.ibec.ie
Risk Management
ISO 14971 is being reviewedExpected to be published by April ’07. Currently there are about 190 proposed amendments.
Medical Device Regulatory, Reimbursement ad Compliance Congress – 29 March 2007
www.imda.ie
www.ibec.ie
FDA - Small business Fees
MDUFMA pre-market approval (PMA) application fees for US firms with annual gross sales of US$ 30 million or less do not pay a fee for their first PMA filing Those with gross sales of US$ 100 million or less can receive a reduction of 38% (US$ 98 648). Non-US companies are unable to apply because the current system requires that they submit Federal tax returns to show eligibilityRaised with EU Commission – discussions ongoing to address
Medical Device Regulatory, Reimbursement ad Compliance Congress – 29 March 2007
www.imda.ie
www.ibec.ie
Irish Medicines Board
Resources
Combination products
User Fees
Irish Medical Devices Association
Medical Device Regulatory, Reimbursement ad Compliance Congress – 29 March 2007
www.imda.ie
www.ibec.ie
IMDA VisionIMDA Vision
Ireland; the location of choice for Ireland; the location of choice for research and development, manufacture research and development, manufacture and marketing of innovative products in and marketing of innovative products in the Medical Device and Diagnostic the Medical Device and Diagnostic Sector.Sector.
Medical Device Regulatory, Reimbursement ad Compliance Congress – 29 March 2007
www.imda.ie
www.ibec.ie
IMDA working structure
HRD
SCM
R&D
QA/ RA
MarketingIMDA IMDA BoardBoard
IBEC and IMDA Executive Group
Medical Device Regulatory, Reimbursement ad Compliance Congress – 29 March 2007
www.imda.ie
www.ibec.ie
Quality/ Regulatory Affairs
Regulatory Steering Committee
Quality Working Group
Quality Mailing List
EucomedEDMA
Advamed
Medical Device Regulatory, Reimbursement ad Compliance Congress – 29 March 2007
www.imda.ie
www.ibec.ie
IMDA
Influence Legislation
Training and education
Information
Network
Medical Device Regulatory, Reimbursement ad Compliance Congress – 29 March 2007
www.imda.ie
www.ibec.ie
Collaboration – key to future
Vision 2020 and MTC convened
Medical Device Regulatory, Reimbursement ad Compliance Congress – 29 March 2007
www.imda.ie
www.ibec.ie
Reach – Support available
REACH helpline to assist members to prepare– [email protected], 01 605 1584– [email protected], 01 605 1519– [email protected], 01 605 1624
Working closely with the Health & Safety Authority who also have also a designated hotline
– Locall , 1890 289 389. [email protected]
Medical Device Regulatory, Reimbursement ad Compliance Congress – 29 March 2007
www.imda.ie
www.ibec.ie
MDD related Legislation
IMDA RSCEucomedEDMADepartment of Health and ChildrenIrish Medicines BoardNational Standards Authority of IrelandEuropean Commission
Medical Device Regulatory, Reimbursement ad Compliance Congress – 29 March 2007
www.imda.ie
www.ibec.ie
Clinical Trials activity…..
Medical Device Regulatory, Reimbursement ad Compliance Congress – 29 March 2007
www.imda.ie
www.ibec.ie
Training and Education
Medical Device Regulatory, Reimbursement ad Compliance Congress – 29 March 2007
www.imda.ie
www.ibec.ie
Imagine! Careers in Medical Technology
19 Scientists & Engineers describe working in the Med Tech sector. They describe their:– Responsibilities– Educational Background– Products/Services their company
makes– Tips for success to future graduates
Postgraduates in Med Tech (30)Useful CAO/Postgraduate Websites listedCompany Lists for School Tours & Graduate placement programs
Medical Device Regulatory, Reimbursement ad Compliance Congress – 29 March 2007
www.imda.ie
www.ibec.ie
Feel free to contact me at:
Sharon HigginsDirector IMDA84-86 Lower Baggot StreetDublin 2Ireland
++353 1 6051564++353 87 [email protected]