Pharmaceutical Compliance Congress and Best Practices Forum

Transcription

1 Pharmaceutical Compliance Congress and Best Practices Forum Dubai - May 5-7, 2014 Mini summit #15 Emerging compliance issues: Public Procurement, Tendering, Reimbursement & pharma pricing update Compliance challenges for healthcare companies Nathalie Raynaud - Sanofi Nathalie Raynaud - PCF - Mini Summit # 15 - Dubai

2 Nathalie Raynaud - PCF - Mini Summit # 15 - Dubai

3 Public procurement Possible integrity violations in the field of public procurement: Various forms of corruption Fraud and theft of resources Conflict of interest in the public service and in post-public employment Collusion Abuse and manipulation of information Discriminatory treatment in the public procurement process Anti-competitive practices Risks Level Criminal sanctions (prison + fines) Civil fines + + Immediate impact on reputation + + Impact on long term trust + + Class actions + Nathalie Raynaud - PCF - Mini Summit # 15 - Dubai

4 Public Procurement What can be done from a supplier s perspective? Governments and their policy makers are the main target of international regulation and guidance on public procurement Suppliers are encouraged to closely co-operate with governments to maintain high standards of integrity: dialogue is critical to foster a trustful relationship Supplier could Seek clarification before the tendering Have a key role in contract management to enable problems to be quickly identified and resolved Government (the buyer) could Provide elements of good practice Promptly respond to questions for clarification in a consistent manner to provide a level playing field. Create dispute boards Make public the grounds for selecting the winner Provide minimum, debriefing to unsuccessful tenderers Nathalie Raynaud - PCF - Mini Summit # 15 - Dubai

5 Public Procurement What can be done from a supplier s perspective? A number of international multi-stakeholder initiatives are promoting open contracting, understood as enhanced transparency and equal access to information and opportunity for participation, as a means to reduce the opportunity for unethical and especially corrupt behaviours in the award of government contracts, such as the: Extractive Industry Transparency Initiative (EITI) The Construction Sector Transparency Initiative (COST) The Medicines Transparency Alliance (META) The Global Principles of Business Ethics adopted by the defense and aerospace industry Raise the business s voice toward governments through B20 (business) proposals in the frame of G20 BIAC in the frame of the OEDC Nathalie Raynaud - PCF - Mini Summit # 15 - Dubai

6 Tendering Possible integrity violations in the field of (non public) tendering: Various forms of corruption, including private parties corruption Anti-competitive practices / Cartels Market allocation by product (Company X not to produce product A which is reserved for Company Y) or by territory (Company X not to supply product A to the home market of company Y) Customer allocation (wholesalers, hospitals, pharmacists) Uncontrolled or improperly monitored third parties could dramatically increase companies risk exposure Risks Criminal sanctions (prison + fines) Civil fines Immediate impact on reputation + + Impact on long term trust + Class actions Level Nathalie Raynaud - PCF - Mini Summit # 15 - Dubai

7 Reimbursement and pricing Possible integrity violations : Various forms of corruption (e.g. inappropriate entertainment or gifts) Conflict of interest Inappropriate lobbying or advocacy activities Risks Level Criminal sanctions (prison + fines) Civil fines + Immediate impact on reputation Impact on long term trust Class actions + + Nathalie Raynaud - PCF - Mini Summit # 15 - Dubai

8 Public Procurement, Tendering, Reimbursement & pricing What the Compliance function has to do? Clearly target for each topic the risky managers and departments in the organization Don t rely on basic e-learning trainings only Develop not only policies but practical guidelines (does & donts) to help exposed employees to identify and properly handle risky situations Compliance teams must play an active role in local associations to advocate: For industry initiative promoting open contracting, transparency and ethical behaviors in the award of government contracts For an Industry responsible approach for lobbying activities To gain recognition from the local authorities on companies compliance efforts in preventing corruption and anti-competitive practices Nathalie Raynaud - PCF - Mini Summit # 15 - Dubai