Medical Device Compliance Congress:

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• Medical Device Compliance Congress
• Emerging Compliance Issues in Asia
• Anne Trimmer

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Agenda

• Overview of compliance issues in Asia
• Selected country by country analysis
• Conclusions

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Overview of compliance issues in Asia

• Definition of corruption
• Loss of funds from global healthcare system of 5
  per annum
• Wide-ranging nature of non-compliant behaviour

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Overview of compliance issues in Asia

• Identification of corruption as significant
  impediment to economic development
• ADB/OECD Anti-Corruption Initiative
• Effect of corruption surveys, FTAs

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Overview of compliance issues in Asia

• ADB OECD Anti-Corruption Action Plan Pillar 2
  predicated on support from global business
  community
• Promotion of good corporate governance
• Adequate internal controls such as codes of
  conduct
• Review of public procurement laws
• Progress made in strengthening integrity in
  public service but less success in private sector

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China

• Recent exposure of corruption at highest levels
  of SFDA new awareness and regulatory response
• Highly competitive market

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China

• Framework for integrity
• Government Procurement Law specifies punishment
  for procurement officials and organisations that
  breach integrity requirements
• Gifts, treats specifically prohibited
• Penalties for bidding companies found to have
  colluded or bribed officials

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China

• 2007 - blacklisting of corrupt firms
• January 2008 new regulations to
• record advertising of medical devices to monitor
  and assess performance
• control corrupt officials

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India

• Recent surveys indicate that of public services,
  health most corrupt
• World Bank review of projects identified
  significant corruption, fraudulent and financial
  discrepancies
• Proposals for health profession-led reform

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India

• Framework for integrity
• Conduct Rules prohibit government employees from
  accepting all forms of inducement
• Protection given to whistle-blowers
• Penal provisions for corruption
• Procedures for blacklisting
• Move to include Integrity Pact

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Indonesia

• Framework for integrity
• Broad code of ethics
• Bidder can be liable to administrative sanctions,
  claims for compensation and criminal penalties
• July 2007 introduced new company laws with
  regulations for corporate responsibility

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Malaysia

• Framework for integrity
• Anti-Corruption Act 1997
• Blacklisting of offending bidders
• September 2006 all listed companies to report
  on corporate responsibility policies and programs
• October 2007 preventative clauses against
  corruption included in all government offers

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Philippines

• Recent survey by TI shows direct correlation
  between corruption and health outcomes
• Framework for integrity
• No government-wide code at present
• Moves to introduce institutional reform
• Penal sanctions and possible suspension for
  bidding companies

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South Africa

• 2004 Prevention and Combating of Corrupt
  Activities Act
• SA Health Department Operation Cure to
  eradicate corruption

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South Korea

• Government has taken on corruption early
  identification as a block to economic development
• Proactive efforts to combat and educate
• October 2007 penalties for unfair luring of
  customers

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Vietnam

• Framework for integrity
• Bidder found guilty of corruption for public
  contract must compensate loss and prohibited from
  further bidding
• Public notification of infringement finding

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Conclusions

• Heightened awareness among State regulators and
  justice administrators
• TI recommendations to address corrupt practices
  in health sector
• Need for global industry support for initiatives

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