Building a Culture of Compliance with Your Sales Force

Transcription

1 Building a Culture of Compliance with Your Sales Force Lora Posey, Mission Pharmacal Mark Jara, RxS LLC 2018 Sharing Alliance All rights reserved

2 Building A Culture Of Compliance With Your Sales Force This is an important workshop for attendees who want to increase and adopt strategies that couple sales initiatives with an overarching compliance mindset. Sales and Compliance don t always align and have the same goals in mind. Building a culture of compliance doesn t usually mean sacrificing sales initiatives and success. Learn how to instill compliance without impacting sales. We will review tactics and processes at various levels on how to keep compliance front and center.

3 Disclaimer The views and opinions expressed in this presentation are those of the presenters and do not necessarily represent official policy or position of both Mission Pharmacal and RxS. 3

4 Presenters Mark Jara RxS LLC Sample Management Lora Posey Current: Mission Pharmacal Women s Health District Manager Previous: National Manager, Sales and Training Development Contract Sales Operations Project Manager Territory Sales Manager 4

5 What is a compliance program? A compliance program is a management process comprised of formal reporting structures and risk mitigation systems designed to motivate, measure, and monitor an organization s legal and ethical performance around complex business practices. 5

6 OIG 2003 Guidance According to the OIG, "it is imperative for pharmaceutical manufacturers to establish and maintain effective compliance programs. These programs should foster a culture of compliance that begins at the executive level and permeates throughout the organization." 6

7 U.S. Federal Sentencing Guidelines 8B2.1(a)(2) To have an effective compliance program, an organization must establish and maintain an organizational culture that encourages ethical conduct and a commitment to compliance with the law. 7

8 Current Area of Scrutiny - Sales and Marketing 1. Contracting and Incentives 2. Marketing and Promotional Activity 3. Samples Management 8

9 In the News DSM pleads guilty violating the Federal Anti-Kickback Statute Created speaker programs for HCPs who increase script writing Schedule II Fentanyl Spray Novartis links bonuses to ethics, risk and compliance Employees receive a 1, 2 or 3 on their values and behavior Bonus cuts for Sales Reps who don t score a 2, meeting expectations 3 Role Model may be eligible for up to 35% bonus 9

10 The Landscape OIG, FDA, DEA PhRMA Code HCP Interaction Guidelines Medical Education Do s and Don ts States, Cities The need: Follow the rules while building a culture of compliance that drives sales 10

11 A Look Back It was simple Marketing by sales reps Gifts, meals Travel expenses Consultants, speakers Good times The environment is different Transparency in activity Consistency: in regulation, follow up, and in corrective action 11

12 Nothing New Compliance standards have been in place for many years Reassess your level of compliance Are you current with the changing landscape? Are lines of communication open between different functional groups? Does senior management stress / encourage compliance inclusion? What processes do we have in place to maintain compliance and correct behaviors that are not consistent with our goals? 12

13 Organizational Structure Corporate Compliance Compliance Finance Human Resources Manufacturing Samples Management Sales Management C Level Finance Human Resources Manufacturing Samples Management Sales Management Sales Operations Sales Teams Sales Operations Sales Teams An appropriate compliance structure is meaningless if there are inadequate (or non-existent) processes to identify risks, develop compliance policies and procedures, and conduct business while minimizing those risks 13

14 Key Elements for an Effective Compliance Program - OIG 1. High level company personnel who exercise effective oversight and have direct reporting authority to the governing body or appropriate subgroup (e.g. Audit Committee) 2. Written policies and procedures 3. Training and education 4. Lines of communication 5. Standards enforced through well-publicized disciplinary guidelines 6. Internal compliance monitoring 7. Response to detected offenses (including remediation of harm caused by criminal conduct) and corrective action plans (including assessment and modification of the compliance and ethics program) 8. Periodic risk assessments 14

15 Compliance Stretched to bridge both ends - Legal aspects - Organization Needs to monitor laws - Federal - State Needs to monitor organization Create appropriate compliance programs 15

16 Compliance Tactics Written Standards of Conduct Written Policies and Procedures Education and training for all employees - at least annually Discipline employees who have engaged in wrongdoing Investigate and remediate identified problems Promote compliance as an element in evaluating managers and supervisors Policy to include termination as an option for sanctioned individuals Maintain a hotline to receive complaints and ensure anonymity of complainants Create and maintain required documentation 16

17 Audit and Monitor Auditing at all levels of the organization Why Perform Ongoing Auditing and Testing? Need to know the strengths and weaknesses of your program Provides external stakeholders with documentation on your programs. (helpful and needed for CIAs) When to conduct one, who should conduct it, and what to do when you find evidence of non compliance. Ride Alongs, processes, Speaker programs 17

18 A Compliant Sales Structure Strategic (Senior Leadership) On a larger scale Planning The why Difficult to copy Longer time frame Tactical (Sales) On a smaller scale Getting it done How Easy to copy Short time frame Communication Consistency Monitoring Compliant Results 18

19 Compliance at All Levels Corporate/Senior Leadership Build a framework for compliance Set culture A culture of accountability Set the tone Corporate buy In, endorse it, fund it Do as I say AND Do as I do Incorporate compliance into initiatives Create a Chief Compliance Officer We mean business Sales Management Regional Management Corporate enforcers / reinforcers District Manager Core Stakeholder Has the pulse of the feet on the street 19

20 Tug of War Sales vs. Compliance 20

21 Messaging Mistakes happen! She is the top sales rep! He is great at sales but his paperwork is terrible Do you know who he knows? Can you clean it up? I ll talk to her Do we have to report her? Can t you just make it work out? 21

22 Regional Manager, Senior Level Reinforce compliance culture from top down Embed compliance into messaging Unifies both levels (corporate and sales) Reward and acknowledge - National Meetings - Trend positive results and reward - Gift cards Field rides with management and sales reps to monitor compliance Speaker bureau monitoring 22

23 District Manager Monitor behaviors, compliance from bottom up Manage sales initiatives within a compliant-based environment Reinforce corrective actions Follow up on actionable concerns Reconciliation Transactional activity - timeliness Reinforce noncompliance Pull through of ethical sales practices Ride along discussions and review Don t just make it about sales Storage unit review Introductory Yearly 23

24 Compliance at All Levels Sales Operations Create Rep Manual Establish SOPs and follow them! Monitor, Report, Escalate Escalation s Trending reports Educate Support Sales Training Embed compliance into sales training Provide guidance and then reinforce real world examples The what The why Tips/Reasons Retraining Not one and done and forgotten 24

25 Samples Management Review transactional timeliness Review reconciliation data Investigate falsified records and potential diversion Review SLT noncompliance Review actual activity against rules Be proactive rather than reactive Escalate non responsiveness Trend activity Create a Rep Report Card 25

26 QCR Quarterly Compliance Review Compliance, Sales Leadership, Operations (Sample Management), HR - High escalators - Messaging issues - Report cards - Monitor marketing and promotional activity - Sample management No surprises Provides checks and balances between sales and compliance Message out insight 26

27 Sales Team Must manage and deliver objectives from all organizational tiers Need support from every level of the organization Working on a Safe Island, quality systems for rep training All approved Labeling Prescribing Information (PI) Instructions for Use (IFU) Promotional materials Objection handling scripts 27

28 A Compliant Sales Structure Strategic (Senior Leadership) On a larger scale Planning The Why Difficult to Copy Longer time frame Tactical (Sales) On a smaller scale Getting it done How Easy to Copy Short time frame Best Practices to achieve Results and Compliance 28

29 Thank You Questions? Comments How do you foster compliance in your organization? 29

30 Log-in to Members Only after the Sharing Conference to view the workshop presentations. The content and opinions presented in this workshop are those of the individual presenter(s) and do not represent official policy or views of the Sharing Alliance or the company(s) where the presenter(s) are employed. It is provided as educational information of general interest and should not be construed as legal advice Sharing Alliance All rights reserved