2010/SOM3/LSIF/035 Asia-Pacific Regional Medical Device Regulatory Harmonization: Is There a Business Case?

Transcription

1 /SOM3/LSI/35 sia-pacific Regional Medical evice Regulatory Harmonization: Is There a usiness ase? Submitted by: Medtronic Life Sciences Innovation orum Sendai, September

2 sia-pacific Regional Medical evice Regulatory Harmonization: Is there a business case? P Life Sciences Innovation orum VIII Sendai; September 24-Sep- M. Gropp; Medtronic, Inc., Minneapolis, Introduction Is there a business case for international/regional medical device regulatory harmonization in P? Hypothetical ti model* d l Global Harmonization Task orce (GHT) starting point Personal views * Presentation adapted from RPS Horizons onference, March, altimore, presentation 2 1

3 Introduction Regulatory harmonization: Progressive voluntary convergence in technical regulatory requirements Intended to provide high level of protection and promotion of public health, encourage innovation, and facilitate international trade Not: International regulation Standardization Mutual recognition pproved once, accepted everywhere Verbatim adoption of same text in laws, regulation, and guidance 3 usiness influencers Source: McKinsey Global Survey: How business interacts with government; McKinsey & o., 4 2

4 Sources of medical technology, 11% razil, 1% hina, 2%, 45% urope, 33% Source: ucomed, russels, osts of compliance 8 7 anada Hypothetical example: US-based manufacturer 6 3

5 xternal Quality Management System udits Y5-Y Other uthorities Notified odies Number of udits/inspections 5 Q4 5 Q3 5 Q2 5 Q1 6 Q4 6 Q3 6 Q2 6 Q1 7 Q4 7 Q3 7 Q2 7 Q1 8 Q4 8 Q3 8 Q2 8 Q1 9-Q4 9-Q3 9-Q2 9-Q1 11-Q1 -Q4 -Q3 -Q2 -Q1 7 osts of compliance 8 7 anada Hypothetical example: US-based manufacturer 8 4

6 osts of compliance 8 7 anada Hypothetical example: US-based manufacturer 9 osts of compliance 8 7 anada Hypothetical example: US-based manufacturer 5

7 osts of compliance Incremental costs of compliance 8 7 anada Hypothetical example: US-based manufacturer Shifting demand for medical devices Where will growth come from for medical technology suppliers? What is the incremental sales revenue from each additional country? What are the incremental costs of compliance in each additional country? How do costs affect in R&? 12 6

8 osts of compliance 8 7 Incremental costs of compliance 7 8 anada Hypothetical example: US-based manufacturer 13 Regulation of medical devices ~ 85 countries regulate medical devices today More are considering regulation efault is often pharmaceutical regulation World Health Organization (WHO) increasingly asked by Member States for advice on medical device regulation, assessment, and procurement 14 7

9 osts of compliance 8 7 Incremental costs of compliance What forces would determine the shape of this curve in other markets? anada Hypothetical example: US-based manufacturer osts of compliance 8 7 anada Hypothetical example: US-based manufacturer 16 8

10 osts of compliance 8 7 Incremental costs of compliance 7 8 anada Hypothetical example: US-based manufacturer 17 How much of your company revenue comes from home economy? How much of your company profit comes from home economy? How much from other countries/regions? 18 9

11 Sales revenue osts of compliance 8 7 anada Hypothetical example: US-based manufacturer 19 Sales revenue osts of compliance 8 7 Incremental sales revenue anada Hypothetical example: US-based manufacturer

12 pliance ntal costs of com Increme Incremental sales revenue 21 pliance ntal costs of com Increme Possibly attractive Incremental sales revenue 22 11

13 Increme ntal costs of com pliance Possibly attractive Possibly attractive Incremental sales revenue 23 Increme ntal costs of com pliance Possibly attractive Possibly attractive ttractive Incremental sales revenue 24 12

14 Increme ntal costs of com pliance Unattractive Possibly attractive Possibly attractive ttractive Incremental sales revenue 25 Increme ntal costs of com pliance an regulatory harmonization help drive creation of more Possibly attractive Unattractive markets for? attractive Possibly attractive ttractive Incremental sales revenue 26 13

15 pliance ntal costs of com Increme an regulatory harmonization help drive creation of more Possibly attractive Unattractive markets for? attractive and does that help bring public health benefits to more people and more societies? Possibly ttractive attractive Incremental sales revenue 27 uture sources of medical technology razil, 1% hina, 2%, 11% urope, 33%, 45% Israel? Korea?? urope?? Malaysia? India?? hina? Others? razil?

16 In which countries does your company do R&? In which h countries does your company do clinical i l trials? Where do your components and raw materials come from? How do you efficiently assure the quality and compliance of those activities? 29 Regulators Thousands of critical medical products are manufactured outside of the United States. Increased funding for import safety will allow to better understand and respond to the growing challenge of foreign manufacturing and globalization, including counterfeit products. Source: Statement of ommissioner r. M. Hamburg to US Senate ppropriations ommittee, 9 March 15

17 Regulators will increase foreign inspections. will identify and inspect the highest risk foreign facilities. will also protect patients through increased inspections of human subject trials. Source: Statement of ommissioner r. M. Hamburg to US Senate ppropriations ommittee, 9 March 31 Regulators will review and use third party International Organization for Standardization (ISO) [13485] audits of fforeign device manufacturers. s a result, will leverage device inspections conducted for foreign governments Source: Statement of ommissioner r. M. Hamburg to US Senate ppropriations ommittee, 9 March 32 16

18 Regulators International ooperative ctivities Leverage/create synergies with the human, scientific, and financial resources and the knowledge and experience of other key regulatory authorities to promote and protect public health by: Source: W. atts, OIP, Office of the ommissioner, US ; Presentation to US ept of ommerce International Trade dvisory ommittee; Jan. 33 Regulators International ooperative ctivities avoiding duplication of effort (e.g., harmonization), making activities more efficient (e.g., reduce the burden of regulation) allowing us to focus our limited resources on higher risk areas of concern, working with counterparts to build regulatory capacity around the world Source: W. atts, OIP, Office of the ommissioner, US ; Presentation to US ept of ommerce International Trade dvisory ommittee; Jan

19 Regulators 21 st entury Reality Our borders are still boundaries, but not barriers orders can no longer be the first line of defense We can no longer inspect out bad products at the border orders must be places where we audit that indeed quality has been built in at the point of manufacture We must: ngage more effectively abroad in order to be more effective at home Source: W. atts, OIP, Office of the ommissioner, US ; Presentation to US ept of ommerce International Trade dvisory ommittee; Jan. 35 Regulators os sts of enforcemen nt Incremental costs of assessing and enforcing compliance 8 7 anada Hypothetical example: US-based regulator

20 oes regulatory harmonization benefit only rich country suppliers? Public confidence (at home and abroad) bility to enter larger markets acilitation of trade 37 International and regional medical device regulatory harmonization initiatives P GHT HWP LSI P Harmonization enter PHO LHWP P unded Training Seminars SQ MWPG (SN) 38 19

21 doption of GHT harmonized guidance GHT guidance forms substantial basis for: medical device provisions of Therapeutic Goods ct anada Medical evices Regulations medical device directives revised Pharmaceutical ffairs Law (2) (partial, e.g., QMS, ST, standards) 39 doption of GHT harmonized guidance GHT guidance forms substantial basis for regulatory systems in: Singapore (7) Malaysia medical device regulatory bill (?) Kingdom of Saudi rabia (9) SN medical device directive (15) India draft Schedule M-III (?) South frica (1X?)

22 Observations and conclusions Interconnected world interconnected risks interconnected responses Public health inance Trend toward more regional/multilateral economic integration and free trade agreements Requires technical harmonization 41 Observations and conclusions Technical barriers to trade are also barriers to patient access Regulatory harmonization frees resources for in R& and innovation to address unmet clinical and public health needs 42 21

23 P Life Sciences Innovation orum apacity building for the harmonization of standards and regulatory practices for bio-medical products and services according to international best practices where the need is most pressing and obstacles are the greatest. Source: P Life Sciences Innovation orum: