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Assessing Adherence to the PhRMA Code

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This session, "Assessing Adherence to the PhRMA Code" was presented at the 10th Annual Pharmaceutical Compliance Congress, hosted by CBI.
19
Assessing Adherence to the PhRMA Code Workshop C January 30, 2013
Transcript
Page 1: Assessing Adherence to the PhRMA Code

Assessing Adherence

to the PhRMA Code

Workshop CJanuary 30, 2013

Page 2: Assessing Adherence to the PhRMA Code

1

Introductions

• Eve Costopoulos - Vice President, Corporate Ethics and

Compliance/Internal Audit, Eisai

• Marjorie E. Powell - Senior Assistant General Counsel, PhRMA

• Paul Silver - Practice Leader, Huron Life Sciences

• Marci Juneau - Director, Huron Life Sciences

Eve MarjoriePaul Marci

Page 3: Assessing Adherence to the PhRMA Code

2

Our Session

• PhRMA’s Perspective on Assessing Adherence to the Code

• Providing Insights from Industry on Adherence

• Providing Guidance into the Independent Verification Review Process

• Open Questions for Panel

• Challenges You Are Seeing

• Action Items

Page 4: Assessing Adherence to the PhRMA Code

3

PhRMA CodeGeneral Overview of Code

The PhRMAceutical Research and Manufacturers of America (PhRMA) represents research-based

pharmaceutical and biotechnology companies.

The PhRMA Code on Interactions with Healthcare

Professionals was created to reinforce the intention that

PhRMA members’ interactions with healthcare professionals

(HCPs) are professional exchanges designed to benefit

patients and to enhance the practice of medicine. The Code

is based on the principle that an HCP’s care of patients

should be based, and should be perceived as being based,

solely on each patient’s medical needs and the HCP’s

medical knowledge and experience.

Page 5: Assessing Adherence to the PhRMA Code

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PhRMA’s Perspective on AssessingAdherence to the Code

PhRMA Code on Interactions with Health Care Professionals

• Code has 15 Provisions

• Agree to sign the PhRMA Code: Commit to comply with the PhRMA Code

– Need not be a PhRMA member company to sign the Code

• Submit name and contact information for Compliance Officer

• Yearly certification that the company has policies and procedures in place to

foster compliance with the Code

• Certify that the company:

– Has policies

– Has trained staff

– Has a system to monitor compliance

– Has a system to address non-compliance

Page 6: Assessing Adherence to the PhRMA Code

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PhRMA’s Perspective on AssessingAdherence to the Code

• External verification that the company has policies and procedures in place to

foster compliance with the PhRMA Code

– External verification need not be solely for PhRMA Code purposes

– Do not need to submit the findings or report

• PhRMA Code has evolved over the years

– Found code from the 1960s

– Code most recently revised in 2008, and effective in 2009

• Several states require compliance with the PhRMA Code or a similar state

code

Page 7: Assessing Adherence to the PhRMA Code

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Industry Insight on Adherence to the CodeOverlap with State Requirements

• Nevada

– “Does your company use one of the two model codes of conduct [Code of Interactions

with Healthcare Professionals by PhRMA] or Code of Ethics on Interactions with Health

Care Professionals by AdvaMed (for manufacturers or wholesalers of devices or

appliances)] without modification?”

• Massachusetts

– “Our company has adopted a program to routinely train appropriate employees, including,

without limitation, all sales and marketing staff regarding the marketing code of conduct,

as described in 105 C.M.R. 970.000.”

– “Our company has policies and procedures in place for conducting investigations into any

and all non-compliance with 105 C.M.R. 970.000, taking corrective actions in response to

all non-compliance…”

• California

– Annual Declaration of Compliance

Page 8: Assessing Adherence to the PhRMA Code

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Industry Insight on Adherence to the CodeExternal Verification Guidance

As of January 1, 2009, the revised PhRMA Code states that all companies (PhRMA

members and non-members) that interact with HCPs about pharmaceuticals should

adopt procedures to assure adherence to the Code including its 15 sections regarding

various aspects of pharmaceutical company interactions with HCPs.

The PhRMA Code encourages member companies to seek external verification

periodically – ideally at least once every three years – to evaluate whether the company

has policies, procedures, or guidelines in place to foster compliance with the Code.

In May 2012, PhRMA published external verification guidelines that outline the

organization’s expectations as they relate to confirmation of a company’s compliance

with the Code.

Page 9: Assessing Adherence to the PhRMA Code

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Industry Insight on Adherence to the CodeCredentials of External Verification

The Company should ensure that the entity it selects to conduct an external verification

of its policies and procedures in connection with the PhRMA Code possesses sufficient

expertise, objectivity, and independence from the Company to be credible in

performing the verification function.

• Objectivity means being independent in fact, maintaining an attitude of impartiality, and

having intellectual honesty.

• Independence means that the external verification entity and the person or persons who

conduct the verification evaluation must be free from personal, external, and organizational

impairments to independence.

• An external entity can be independent and objective even if it currently provides or has

previously provided other advice and services to the Company. The external verifying entity

can include outside counsel, external auditors, or another entity that has the relevant

knowledge and expertise to credibly perform the verification function.

– It is the responsibility of the Company and the verifying entity to ensure that any other interactions

between the Company and the entity will not compromise the entity’s ability to perform a full and fair

external verification of the Company’s policies and procedures in connection with the PhRMA Code.

Page 10: Assessing Adherence to the PhRMA Code

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Industry Insight on Adherence to the CodePurpose and Submission of External Verification

• The external verification need not be obtained by the Company solely for the purpose

of meeting the external verification criteria in the PhRMA Code. As long as the

verification satisfies the criteria set out in this guidance, it will be considered sufficient

to achieve recognition by PhRMA, even if the verification was originally sought for

another purpose.

• The Company need not submit the detailed findings or report of the external

verification entity to PhRMA, but may achieve recognition by PhRMA for satisfying

the external verification criteria if it submits a statement that it has successfully

completed the verification process.

– The statement must be signed by the Company's compliance officer responsible for the

US pharmaceutical business and should indicate the date that the external verification

process was completed.

Page 11: Assessing Adherence to the PhRMA Code

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Industry Insight on Adherence to the CodeAddressing Observations

• Discussion with company that performed external verification of adherence to the

PhRMA code:

– Come to final conclusion and decisions on list of observations (and

recommendations) from the external report including those that need to be

addressed by company

• Internally review observations and recommendations:

– Can include Compliance, relevant stakeholders (business), Legal, etc.

– Ensure buy-in on process and policy changes

• Make revisions to appropriate documentation, policies, processes, etc.

• Socialize changes throughout the Company through relevant communication and

training

Page 12: Assessing Adherence to the PhRMA Code

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Independent Verification Review ProcessExternal Verification Requirements

The external verification entity should confirm that the Company has policies,

procedures, or guidelines in place to foster compliance with the PhRMA Code:

I. Policies, procedures, or guidelines in place that address the topics covered in the 15 sections of the

PhRMA Code

II. Made any necessary revisions to relevant policies, procedures, or guidelines to reflect requirements

of the PhRMA Code and periodically evaluates the need for additional updates or revisions

III. Provided relevant company employees with information/training on the requirements of the PhRMA

Code and the company periodically evaluates and addresses the need to provide additional training

IV. Considered, planned, and implemented the steps it will take to monitor compliance with the

requirements of the PhRMA Code on an ongoing basis

V. Considered, planned, and implemented the steps it will take to address reported incidents of non-

compliance with the requirements of the PhRMA Code

Page 13: Assessing Adherence to the PhRMA Code

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Independent Verification Review ProcessReview of 15 Areas of PhRMA Code

1. Basis of Interactions

2. Informational Presentations and Meals

3. Entertainment & Recreation

4. Support for CME

5. Support for Third-Party

Educational/Professional Meetings

6. Consultants

7. Speaker Programs/Speaker Training

Meetings

8. HCPs and Formularies/Clinical Practice

Guidelines

9. Scholarships & Educational Funds

10. Non-Educational and Practice-Related Items

11. Educational Items

12. Prescriber Data

13. Independence & Decision Making

14. Training & Company Reps

15. Adherence to the Code

Page 14: Assessing Adherence to the PhRMA Code

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Independent Verification Review ProcessKey Operational Considerations

Operational areas to consider for PhRMA Code External Verifications by Independent Organization:

Review

Relevant

Documents/

Information

• Collect and review the following relevant documents:– Policies, procedures, guidelines, work instructions, etc.

– Training materials

– Other relevant documents

– Process documents for monitoring and corrective action plans

• These documents will help the Company understand the key written

controls and key processes to ensure compliance with the PhRMA Code.

• Previous and updated versions of the documents will provide insight into

necessary revisions made to address any changes needed to be compliant

with the PhRMA code.

• If applicable, an additional review of a Company’s Corporate Integrity

Agreement (CIA) to determine areas of overlap for those that are already

addressed in applicable areas or tested by the Independent Review

Organization (IRO)

Page 15: Assessing Adherence to the PhRMA Code

14

Independent Verification Review ProcessKey Operational Considerations

Conduct

Interviews

with Key

Stakeholders

• Conduct interviews with key stakeholders who play a role in

establishing/revising the relevant:– Policies and procedures

– Processes

– Training materials

– Other documentation reviewed

• Interviews may provide insight into: – Policies or unofficial practices that are not captured

– Correctly captured in existing relevant policies, procedures, training materials,

and other relevant documents

– Areas of PhRMA code not addressed by company or concerns on certain

areas

Operational areas to consider for PhRMA Code External Verifications by Independent Organization:

Page 16: Assessing Adherence to the PhRMA Code

15

Independent Verification Review ProcessKey Operational Considerations

Conduct

Assessment

& Creating

Observations

• Assess whether or not the Company has met the PhRMA Code Verification

Requirements as outlined in the guidance released by PhRMA in May 2012

• Create observations based on any areas that may not meet the five

requirements of the verification: – These observations may include policies and procedures that are missing key

information or process requirements.

– Any recommendations on deficiencies in training, monitoring, or corrective action

should be noted.

Provide

Independent

Report

• Independent Reports should include:– The steps review took to verify the company’s adherence to the PhRMA Code

– The relevant policies, procedures, training materials, and other documents

reviewed

– Interviews conducted

– Observations associated with the external verification

– Recommendations (if requested)

Operational areas to consider for PhRMA Code External Verifications by Independent Organization:

Page 17: Assessing Adherence to the PhRMA Code

16

Open Questions for Panel

Open Questions for PhRMA?

• What constitutes "sufficient expertise, objectivity, and independence” from the Company?

– Current IRO? Former IRO? External auditors? Internal audit group? Law firm? Consultant?

– If a current IRO is considered to be "objective and independent," does the IRO need to perform additional

activities outside of its current IRO activities or can it rely upon its IRO role to provide the verification?

– Can a series of activities performed throughout a year by a number of different external parties be relied upon by

a Company to provide verification?

• What does it mean to be "free from personal, external, and organizational impairments to

independence?”

• What types of interactions between Company and entity might be viewed as compromising the

entity's ability to perform a full and fair external verification of Company's policies and procedures?

• What is the penalty for non Compliance with PhRMA verifications (internal and external)? Does a

company get kicked out of PhRMA for not complying?

• When are external verifications due?

Page 18: Assessing Adherence to the PhRMA Code

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Open Questions for Panel

Questions to Audience

• Who has had an independent external verification completed or is in the process of a

verification?

• What type of company performed your independent verification?

• Have you made any specific assessment around independence of the external

company performing the verification? What criteria did you take into consideration to

establish independence?

Page 19: Assessing Adherence to the PhRMA Code

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Action Items

Eve Costopoulos

(201) 746-2703

[email protected]

Marjorie Powell

(202) 835-3517

[email protected]

Things to Consider Yes No Not Sure

1. Have all relevant employees been trained on the PhRMA Code? � � �

2. Have we completed the 2012 verification? � � �

3. Has our CEO and CCO signed the completed annual verification? � � �

4. Have we submitted our first external verification? � � �

5. Who will own observations coming out of external verification? � � �

Marci Juneau

(678) 672-6163

[email protected]

Paul Silver

(678) 672-6160

[email protected]

Questions?


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