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

• 2007 - 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