WHO meeting with the Medical Technology Industry World Health Organization

1. WHO meeting with the Medical Technology Industry World Health Organization 09 October 2012 Geneva, Switzerland DITTAOverview and Contribution Olivier Denève, DITTA Representative

2. What is DITTA? • DITTA is the Global Diagnostic Imaging, Healthcare IT, and Radiation Therapy Trade Association • DITTA is associations of manufacturers that represent medical imaging, radiation therapy, healthcare IT, electromedical and radiopharmaceutical manufacturers. • Member companies manufacture: medical x-ray equipment; computed tomography (CT) scanners; ultrasound; nuclear imaging; radiation therapy equipment; magnetic resonance imaging (MRI); imaging information systems; medical software and health IT; and radiopharmaceuticals. NEW NEW NEW 2

3. Since our last meeting, DITTA has… • Incorporated in the United States as a non-profit trade association • Added three new member associations and developed a formal membership structure: CAMDI, IMEDA and THAIMED • Created four new DITTA task forces bringing experts from its constituency on RPS (Regulated Product Submission), UDI (Unique Device Identification), GRP (Refurbishment/Remanufacturing) and Medical Software • Submitted an IMDRF future work template on medical software • Been actively participating in the IMDRF activities (RPS and UDI working groups) • Attended the special session with representatives from GMTA and DITTA of the IMDRF Management Committee meeting (September 25, 2012) and the IMDRF open Stakeholder meeting (September 26, 2012). • Hosted an event with the World Bank in Washington, DC on 27 September on procurement of medical technology • AHWP agreed to host a DITTA medical software workshop during their November conference in Taipei, Taiwan www.globalditta.org

4. Conclusions of WHO meeting on 07 May 2012 DITTA could contribute to : 1. Recalls of products of high public health concern → no information received as of today from WHO 2. Template and examples of technical specifications → DITTA is expecting this template and examples from WHO 3. Best practices on ethical business → Ref to COCIR Code of Conduct (http://www.cocir.org/uploads/documents/-1522-code_of_conduct_2012.pdf) 4. New regulation → WHO to clarify which new regulation (GHTF? IMDRF?) 5. “Key” devices needed to be developed or adapted → DITTA is expecting the list of key devices needed from WHO 6. NRA assessment tool → Clarification needed from WHO

5. Conclusions of WHO meeting on 07 May 2012 7. Help develop regulatory capacity as appropriate in an ethical and transparent way → WHO to specify which specific matters is needed 8. Capacity building to support devices that had been supplied → What is exactly needed from WHO? 9. Best tendering process → What is exactly needed from WHO? 10. Support the work on health care associated infections → Which infection targeted? What is expected from WHO? 11. Support the expansion of the medical devices management → WHO to provide list of key priorities (medical devices, countries) 12. Support the work on the UN Commission on life saving commodities as needed. → ref to item 2 of agenda meeting WHO of 09 October

6. Practical areas for cooperation with WHO(Agenda WHO meeting of 09 October) 1. Technical specifications for better procurement 2. Recommendations of the UN Commission on Life Saving Commodities 3. Local production and technology transfer to increase access of medical devices 4. Medical devices for ageing population 5. Second Global Forum on Medical Devices 2013 www.globalditta.org

7. 1. Technical specifications for better procurement • DITTA led an industry group in a first of its kind meeting between the medical device industry and the World Bank to improve procurement policy. • Industry feedback was well received by the World Bank • Regular meetings to work toward implementing some of the proposals made by the industry. → This work could also benefit WHO. www.globalditta.org

8. 2. Recommendations of the UN Commission on Life Saving Commodities Importance of Markets’ Regulation: Recommendations 1 (Shaping Global Markets) & 2 (Shaping Local Delivery Markets). Without concerted efforts of regulators we will have continued global products while still facing multiple local regulations → DITTA is recommending to: • Harmonize regulatory frameworks and product approval processes • Develop regulatory frameworks fostering innovation and considering global trade www.globalditta.org

9. 3. Local production and technology transfer to increase access of medical devices • Combination and integration of diverse technologies bringing innovative solutions for the benefits of patients but also increasing complexity • Due to complexity of the technology, higher number of suppliers • Efficient supplychainintegrity, especially as technological solutions becomecomplex (inclreliability, consistency and trust in the system) www.globalditta.org

10. 4. Medical devices for ageing population • DITTA –through COCIR – is contributing to EU Active and Healthy Ageing Innovation Partnership (AHAIP): • The aim of the partnership is to shorten the gap between research and the market: to get the outcomes of research implemented more quickly into people daily lives. → This work could also benefit WHO. www.globalditta.org

11. 5. Second Global Forum on Medical Devices 2013(01-05 July in Tunisia) • DITTA is ready to contribute to the elaboration of the program. • DITTA is ready to advertise this event and to bring DITTA’s companies members support. More information needed from WHO on the organisation and content of this event. www.globalditta.org

12. DITTA co-operation with WHO • DITTA is enhancing its network across the globe to better understand the needs of stakeholders and to support efforts in line with our focus and objectives • DITTA is interested to learn more about WHO’s interests, and appreciates the invitation to continue this dialogue • We look forward to expanding this important relationship in the interest of patient safety and access to advanced medical imaging technologies • DITTA members are committed to supporting WHO initiatives for “safe, effective, and affordable technology for very low resource settings for use at point of care”

13. Thank You