1. Prepared for; Conference on Multi-Level Regulatory Governance in Canada Addressing; Multi-Level Regulatory Governance in the Health Sector Prepared by; Joan Murphy Carleton University Carleton Research Unit on Innovation, Science & Environment (CRUISE) Carleton Research Unit on Innovation, Science & Environment (CRUISE) Oct 28 th, 2004 Rules, Rules, Rules! …. Multi-Level Regulatory Governance in the Health Sector Rules, Rules, Rules! …. Multi-Level Regulatory Governance in the Health Sector

2. Presentation Overview  Define concepts and sets the context.  Comment on key themes and challenges, and coordination issue related to health regulation.  Discuss emerging opportunities and related tensions.  Conclusions

3. Context Multi-Level Regulation, regulatory flux and quality regulations  Multi-level regulation is driven by the realization that, “some of the most challenging problems cut across departmental mandates, political jurisdictions and national borders.” (Auditor General 2000)  We are in a period of regulatory flux - e.g., an era when non-linear, dramatic regulatory, deregulatory, and re-regulatory shifts are occurring simultaneously. (Braithwaite & Drahos 2000)  “Combining both good regulation where needed to protect health, safety, and the environment, and to enhance the functioning of markets, and deregulation where free markets work better.” (OECD 2002)

4. Key Themes & Challenges The credibility of health regulations depends on:  Development, enforcement, compliance, capacity and collaboration  The health regulator must keep up with technological changes,  Understand the pressures of economic competitiveness,  Take into consideration international agreements,  Use good management practices to ensure compliance and evaluation,  Apply new roles for science in the regulatory process (e.g., pre-market versus post-market assessment and surveillance), and  Have the capacity to enforce regulations.

5. Key Themes & Challenges Rethinking regulation and economic performance  2 b.$ in goods cross Canada’s borders every day potentially raising a host of health issues.  Disease transmission (BSE, SARS, West Nile),  Product and Food Safety, and  Pollution.  New technologies impact strongly on the health sector (e.g., bio-technology, nano-technology and pharmaceuticals)  These technologies are driving whole new commercial sectors not even thought possible 15 yrs. ago.

6. Coordinating Principles Some of the most challenging problems cut across departmental mandates, political jurisdictions and national borders.  Developing, implementation and monitoring health regulations requires a broad horizontal reach and deep vertical connections.  Government-to-Government (G to G)  Government to Businesses (G to B  Government to Citizen (C to G)

7. Opportunities and Tension  Multi-level regulation addressing complex issues versus too many rules and a complex regulatory environment  Social Democracy versus commercial confidentiality  Accountability – the state as a rule taker versus a rule maker  Competing Mandates – protecting health versus promoting industry  Collaboration versus capacity  Systems of governance versus specific mandates

8. Conclusion Multi-level health regulation in the health sector  Economic and social interests  Opportunities and tension  Public confidence

9. Questions