Doing Business in Ireland

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Doing Business in Ireland

• Sharon Higgins
• Director IMDA
• The Second Annual Medical Device Regulatory,
  Reimbursement and Compliance Congress
• Harvard University
• 29 March 2007

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• Why do business in Ireland?
• Because Ireland has and continues to do the
  business for companies operating here
• Dont take my word for it

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Trajectory of Irelands Economy
1988
1997
2004

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1,000 overseas companies have chosen to invest in
Ireland as their European base
ICT
Pharmaceuticals
Medical Devices
Financial International Services
E-business
Engineering
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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

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Ahead of the Curve - Enterprise Strategy Group
Comparative Advantage
Competitiveness
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Medical Devices and Diagnostic Sector in Ireland
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Irish Medical Devices and Diagnostics
SectorEmployment continues to rise steadily
Source - forfas
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Companies Ranked by Medical Device Revenues 2005
(US, Million)

• 1 Johnson Johnson
• 2 General Electric
• Medtronic
• Baxter International
• 5 Siemens
• 6 Fresenius
• 7 Philips
• 8 Tyco International
• 9 Boston Scientific
• Stryker
• B Braun
• Guidant
• Zimmer
• Becton Dickinson
• 11 of worlds top 14 in Ireland (7 with multiple
  locations)
• Red manufacturing/ RD MD based in Ireland

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Irish Export Markets
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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

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Challenges Opportunities
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Skills Education
Support for Business
Innovation
Supportive Regulation
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Regulatory Infrastructure Challenges

• European Framework
• Global Market

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Medical Device Legislation - EU
pacemakers implantable infusion
pumps Inmplantable cardiac defibrillators
related software and accessories
Directive 90/385/EEC Active Implantable Medical
Devices S.I. No. 253 of 1994
US, X-ray, heart valves hip-implants, ECG,
EEG, intravascular catheters, stents, syringes,
wheelchairs, dental materials ...
Directive 93/42/EEC General Medical Devices S.I.
No. 252 of 1994
Lab analysers, reagents , HIV/hepatitis tests,
pregnancy tests, assays, calibrators, control
materials specimen receptacles ...
Directive 98/79/EC In-vitro Diagnostic Medical
Devices S.I. No. 304 of 2001
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Irelands CA and NB

• Competent Authority
• The Irish Medicines Board
• Notified Body
• The NSAI

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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

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IMB - relationship with industry

• Firm but fair
• IMB/ IMDA Liaison Group
• Quarterly meetings
• Two way discussion forum
• User Fees
• Guidelines
• Online registration
• Vigilance

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NSAI
3,000 Registered / Certified Firms Medical

Carry out in excess of
6,000
assessments per year
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Regulatory Challenges for Irish Industry

• Reach
• MDD Review
• E-labelling
• Risk Management
• FDA Small business Fees
• IMB - 2007

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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.

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Reach - timelines

• 1 June 2007 REACH enters into force
• 1 June 2008 European Chemicals Agency (ECA) in
  operation and main titles of REACH apply
• 1 June 2008 New substance registration
• 1 June 2008 November 2008 Pre-registration
  for phase-in of existing substances
• November 2010 1st phase-in substance deadline
• June 2013 2nd phase-in substance deadline
• June 2018 3rd phase-in substance deadline

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Medical Devices Directive Review

• Changes proposed to
• Definition medical purpose
• Conformity assessment
• Clinical evaluation requirements
• Post market surveillance
• Transparency
• Co-operation

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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

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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

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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 legislation
• Working group in Europe focusing on guidance for
  IVDs

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E-Labelling, contd

• 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

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Risk Management

• ISO 14971 is being reviewed
• Expected to be published by April 07.
• Currently there are about 190 proposed
  amendments.

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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 eligibility
• Raised with EU Commission discussions ongoing
  to address

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Irish Medicines Board

• Resources
• Combination products
• User Fees

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Irish Medical Devices Association
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IMDA Vision

• Ireland the location of choice for research and
  development, manufacture and marketing of
  innovative products in the Medical Device and
  Diagnostic Sector.

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IMDA working structure
81 member companies
IBEC and IMDA Executive Group
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Quality/ Regulatory Affairs

• Regulatory Steering Committee
• Quality Working Group
• Quality Mailing List

Eucomed EDMA
Advamed
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IMDA

• Influence Legislation
• Training and education
• Information
• Network

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Collaboration key to futureVision 2020 and
MTC convened
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Reach Support available

• REACH helpline to assist members to prepare
• alanna.mcguinness_at_ibec.ie, 01 605 1584
• aoife.clarke_at_ibec.ie, 01 605 1519
• marian.byron_at_ibec.ie, 01 605 1624
• Working closely with the Health Safety
  Authority who also have also a designated hotline
• Locall , 1890 289 389. reachright_at_hsa.ie

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MDD related Legislation

• IMDA RSC
• Eucomed
• EDMA
• Department of Health and Children
• Irish Medicines Board
• National Standards Authority of Ireland
• European Commission

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Clinical Trials activity..
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Training and Education
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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 listed
• Company Lists for School Tours Graduate
  placement programs

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Feel free to contact me at

• Sharon Higgins
• Director IMDA
• 84-86 Lower Baggot Street
• Dublin 2
• Ireland
• 353 1 6051564
• 353 87 2313437
• Sharon.higgins_at_ibec.ie
• www.imda.ie