Medicines Act 101 - IFPMA€¦ · Medicines Act 101 of 1965 Section 22G Section 18C18B Section 18A...

29

Transcript of Medicines Act 101 - IFPMA€¦ · Medicines Act 101 of 1965 Section 22G Section 18C18B Section 18A...

Page 1: Medicines Act 101 - IFPMA€¦ · Medicines Act 101 of 1965 Section 22G Section 18C18B Section 18A Ban on bonusing, rebates & incentives Ban on sampling Pricing ... Other disciplinary
Page 2: Medicines Act 101 - IFPMA€¦ · Medicines Act 101 of 1965 Section 22G Section 18C18B Section 18A Ban on bonusing, rebates & incentives Ban on sampling Pricing ... Other disciplinary
Page 3: Medicines Act 101 - IFPMA€¦ · Medicines Act 101 of 1965 Section 22G Section 18C18B Section 18A Ban on bonusing, rebates & incentives Ban on sampling Pricing ... Other disciplinary

Medicines Act 101 of 1965

Section 22G

Section 18C

Section 18B

Section 18A

Ban on

bonusing,

rebates &

incentives

Ban on

sampling

Pricing

Regulations Makes

provision for a

Marketing Code

No

Regulations

Regulated Self-Regulated

No

Regulations

Page 4: Medicines Act 101 - IFPMA€¦ · Medicines Act 101 of 1965 Section 22G Section 18C18B Section 18A Ban on bonusing, rebates & incentives Ban on sampling Pricing ... Other disciplinary
Page 5: Medicines Act 101 - IFPMA€¦ · Medicines Act 101 of 1965 Section 22G Section 18C18B Section 18A Ban on bonusing, rebates & incentives Ban on sampling Pricing ... Other disciplinary
Page 6: Medicines Act 101 - IFPMA€¦ · Medicines Act 101 of 1965 Section 22G Section 18C18B Section 18A Ban on bonusing, rebates & incentives Ban on sampling Pricing ... Other disciplinary
Page 7: Medicines Act 101 - IFPMA€¦ · Medicines Act 101 of 1965 Section 22G Section 18C18B Section 18A Ban on bonusing, rebates & incentives Ban on sampling Pricing ... Other disciplinary
Page 8: Medicines Act 101 - IFPMA€¦ · Medicines Act 101 of 1965 Section 22G Section 18C18B Section 18A Ban on bonusing, rebates & incentives Ban on sampling Pricing ... Other disciplinary

July 2007 – Marketing Steering Committee

2009 – SAMED & SALDA join

Feb 2010 – Interim Board of the MCA

Oct 2010 – Agreed version of the Code

May 2011 – Agreed MOU

Further Updates to Code

Jan 2013 - New EO appointed

Interim Phase

14 Mar 2012 - Constitution signed

Page 9: Medicines Act 101 - IFPMA€¦ · Medicines Act 101 of 1965 Section 22G Section 18C18B Section 18A Ban on bonusing, rebates & incentives Ban on sampling Pricing ... Other disciplinary
Page 10: Medicines Act 101 - IFPMA€¦ · Medicines Act 101 of 1965 Section 22G Section 18C18B Section 18A Ban on bonusing, rebates & incentives Ban on sampling Pricing ... Other disciplinary
Page 11: Medicines Act 101 - IFPMA€¦ · Medicines Act 101 of 1965 Section 22G Section 18C18B Section 18A Ban on bonusing, rebates & incentives Ban on sampling Pricing ... Other disciplinary
Page 12: Medicines Act 101 - IFPMA€¦ · Medicines Act 101 of 1965 Section 22G Section 18C18B Section 18A Ban on bonusing, rebates & incentives Ban on sampling Pricing ... Other disciplinary
Page 13: Medicines Act 101 - IFPMA€¦ · Medicines Act 101 of 1965 Section 22G Section 18C18B Section 18A Ban on bonusing, rebates & incentives Ban on sampling Pricing ... Other disciplinary
Page 14: Medicines Act 101 - IFPMA€¦ · Medicines Act 101 of 1965 Section 22G Section 18C18B Section 18A Ban on bonusing, rebates & incentives Ban on sampling Pricing ... Other disciplinary
Page 15: Medicines Act 101 - IFPMA€¦ · Medicines Act 101 of 1965 Section 22G Section 18C18B Section 18A Ban on bonusing, rebates & incentives Ban on sampling Pricing ... Other disciplinary

Company

• Reprimand; caution or warning

• Prosecution and/or fines

• Loss of business

• Damage to Company

• good name/reputation

• trade & customer relations

• loss of business opportunities

• Making headlines for the wrong

reasons

Employees

Prosecution/fines/Imprisonment

(Section 42 of Act 101)

Termination of employment

Loss of incentives & annual increases

Other disciplinary action as

determined by the Company

Damage to personal reputation

Patients & Public

• Compromised product safety

• Risking patient’s lives

Customers

• Loss of good faith in their dealings

with company

Investors

• Loss of confidence in company

• Loss of investment value

Page 16: Medicines Act 101 - IFPMA€¦ · Medicines Act 101 of 1965 Section 22G Section 18C18B Section 18A Ban on bonusing, rebates & incentives Ban on sampling Pricing ... Other disciplinary
Page 17: Medicines Act 101 - IFPMA€¦ · Medicines Act 101 of 1965 Section 22G Section 18C18B Section 18A Ban on bonusing, rebates & incentives Ban on sampling Pricing ... Other disciplinary
Page 18: Medicines Act 101 - IFPMA€¦ · Medicines Act 101 of 1965 Section 22G Section 18C18B Section 18A Ban on bonusing, rebates & incentives Ban on sampling Pricing ... Other disciplinary
Page 19: Medicines Act 101 - IFPMA€¦ · Medicines Act 101 of 1965 Section 22G Section 18C18B Section 18A Ban on bonusing, rebates & incentives Ban on sampling Pricing ... Other disciplinary
Page 20: Medicines Act 101 - IFPMA€¦ · Medicines Act 101 of 1965 Section 22G Section 18C18B Section 18A Ban on bonusing, rebates & incentives Ban on sampling Pricing ... Other disciplinary
Page 21: Medicines Act 101 - IFPMA€¦ · Medicines Act 101 of 1965 Section 22G Section 18C18B Section 18A Ban on bonusing, rebates & incentives Ban on sampling Pricing ... Other disciplinary
Page 22: Medicines Act 101 - IFPMA€¦ · Medicines Act 101 of 1965 Section 22G Section 18C18B Section 18A Ban on bonusing, rebates & incentives Ban on sampling Pricing ... Other disciplinary

“Zero Tolerance”

approach to

unethical conduct

Commitment to

upholding Aspen’s

reputation

Ethics

management

programme

implemented

throughout Group

Endorses the

ethical marketing

of medicines

Page 23: Medicines Act 101 - IFPMA€¦ · Medicines Act 101 of 1965 Section 22G Section 18C18B Section 18A Ban on bonusing, rebates & incentives Ban on sampling Pricing ... Other disciplinary

Confirming Aspen’s ethical foundation – statements,

policies and procedures constituting the ethics frame of

reference for the Aspen employees:

Aspen’s Values-statement

Code of Conduct

Conflict of Interest Policy

Gifts and benefits Policy

Whistleblowers’ Standard Operating Procedure

Applicable marketing codes for sales representatives /

marketing employees

Page 24: Medicines Act 101 - IFPMA€¦ · Medicines Act 101 of 1965 Section 22G Section 18C18B Section 18A Ban on bonusing, rebates & incentives Ban on sampling Pricing ... Other disciplinary

Covers:

Acting in accordance with Aspen’s values – being an Aspen

ambassador

Business integrity – avoiding and declaring conflicts of interest

Gifts, entertainment and bribery

Integrity of qualitative and quantitative information –

misstatement, misrepresentations and/omissions

Protection and use of property

Ensuring an effective system of business controls – approvals

framework (“act within your authority”) and comply with policies

and procedures

Confidentiality and insider trading provisions

SHE & employment practices

Compliance with legal requirements (including competition law)

Page 25: Medicines Act 101 - IFPMA€¦ · Medicines Act 101 of 1965 Section 22G Section 18C18B Section 18A Ban on bonusing, rebates & incentives Ban on sampling Pricing ... Other disciplinary
Page 26: Medicines Act 101 - IFPMA€¦ · Medicines Act 101 of 1965 Section 22G Section 18C18B Section 18A Ban on bonusing, rebates & incentives Ban on sampling Pricing ... Other disciplinary
Page 27: Medicines Act 101 - IFPMA€¦ · Medicines Act 101 of 1965 Section 22G Section 18C18B Section 18A Ban on bonusing, rebates & incentives Ban on sampling Pricing ... Other disciplinary
Page 28: Medicines Act 101 - IFPMA€¦ · Medicines Act 101 of 1965 Section 22G Section 18C18B Section 18A Ban on bonusing, rebates & incentives Ban on sampling Pricing ... Other disciplinary
Page 29: Medicines Act 101 - IFPMA€¦ · Medicines Act 101 of 1965 Section 22G Section 18C18B Section 18A Ban on bonusing, rebates & incentives Ban on sampling Pricing ... Other disciplinary