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

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

Definition of ‘corruption’ Loss of funds from global healthcare system of 5% per annum Wide-ranging nature of non-compliant behaviour 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 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 Overview of compliance issues in Asia

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

blacklisting of corrupt firms January 2008 – new regulations to: –record advertising of medical devices to monitor and assess performance –control corrupt officials China

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 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’ India

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 Indonesia

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 Malaysia

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 Philippines

2004 – Prevention and Combating of Corrupt Activities Act SA Health Department ‘Operation Cure’ to eradicate corruption South Africa

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 South Korea

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

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