global promotional review

Alan BergstromSenior Director, Commercial Regulatory Affairs

ExL Pharma 2nd Promotional Review Committee Compliance & Best PracticesOctober 27-28, 2014

Interpretation and Execution of Global Regulatory Procedures: Global Promotional Review

The content, views, and opinions in this presentation are my own and do not in anyway represent the views or opinions of Daiichi Sankyo, Inc.

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What is in Scope?

All materials produced by the global marketing team•external – branded and unbranded•Internal – global brand books, global slide librariesLocal country-specific material out of scope

Presentation Name | CONFIDENTIAL

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Membership

Global Promotional Review Committee (GPRC)Global LegalGlobal Medical

Local Promotional Review CommitteeLocal LegalLocal RegulatoryLocal Medical


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Review standards

Global perspectiveConsistent with Company Core Data SheetScientifically accurate and truthfulNot misleadingDisclosure of product riskWell-documented, statistically and clinically or economically meaningful effect on a prospectively defined endpointNo off-label or preapproval promotion


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Responsibility of Global Reviewers

Global Medical – ensuring consistency with corporate core data sheet, scientifically accurate and substantiated, and fairly balanced

Global Legal – support Global Medical review by ensuring consistency with corporate policy


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Escalation

Global Promotional Review Steering Committee(VP level)

Global MedicalGlobal LegalGlobal Marketing


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Standards of Promotional Information

International Federation of Pharmaceutical Manufacturers & Associations (IFPMA) Code of Conduct

Article 4.2 – Accurate and Not Misleading: …should be clear, legible, accurate, balanced, and sufficiently complete to enable recipient to form his or her own opinion of the therapeutic value…

Article 4.3 – Substantiation: …either by reference to approved labeling or by scientific evidence.

International


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European Federation of Pharmaceutical Industries and Associations (EFPIA) HCP Code Article 3

Section 3.01 …must be accurate, balanced, fair, objective, and sufficiently complete to enable the recipient to form his or her own opinion…

Section 3.02 …must be capable of substantiationSection 3.05 Any comparison made between

products must be based on relevant and comparable aspects of the products.

Regional


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Association of the British Pharmaceutical Industry (ABPI) Code of Practice

Clause 7.2 – must be accurate, balanced, fair, objective and unambiguous and must be based on an up-to-date evaluation of all the evidence

Clause 7.3 – Comparisons allowed if not misleading; material, relevant, substantiable and representative features are compared; products of the same intended use or indication

Local


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Training

IFPMA Code of Conduct Article 12- Companies should establish and maintain appropriate procedures to ensure compliance with relevant codes and applicable laws- Companies should encourage that relevant employees receive training appropriate to their roles

EFPIA HCP Code Section 18.02 – All company staff …who are concerned with the preparation or approval of promotional material or activities must be fully conversant with the requirements of the Applicable Code(s) and relevant laws and regulations


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Training

ABPI Code of PracticeClause 16 – All relevant personnel …

concerned in any way with the preparation or approval of promotional material or information…must be fully conversant with the requirements of the Code and the relevant laws and regulations.


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Regulatory Authority vs Self-Regulation

Local Regulatory AuthorityOffice of Prescription Drug Promotion (OPDP) in the U.S. or The Medicines and Healthcare products Regulatory Agency (MHRA) in the U.K.

Self-Regulatory CodesPhRMA in the U.S. – DTC Guiding Principles and Interactions with Healthcare ProfessionalsAssociation of British Pharmaceutical Industry (ABPI) Codes of Practice


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Self-Regulation

IFPMA - responsible for administering complaints-validation of complaint

- genuine matter submitted in good faith- sufficient information supplied- concerns a country where IFPMA code applies- not already under investigation by a member association

-letter of complaint with supportive evidence sent by IFPMA to company-Inform company that a response is must be made normally within 30 days-Adjudication by ad hoc group normally within 30 days from receipt of company’s response-Complainant or respondent company may appeal within 30 days-Sanctions at a minimum to include confirmation that material no longer in use-Publication of case on IFPMA website


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Self-Regulation

EFPIA is conscious of the importance of providing accurate, fair and objective information about medicinal products so that rational decisions can be made as to their use. The EFPIA Code of Practice on the promotion of medicines to, and interactions, with Healthcare Professionals recognises the importance of voluntary control of advertising medicinal products by self-regulatory bodies and recourse to such bodies when complaints arise.


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Self-Regulation

The Prescription Medicines Code of Practice Authority (PMCPA) is the self-regulatory body which administers the Association of the British Pharmaceutical Industry’s (ABPI) Code of Practice for the Pharmaceutical Industry at arm’s length of the ABPI.The PMCPA is a not-for-profit body which was established by the ABPI on 1 January 1993.The PMCPA:•operates the complaints procedure under which the materials and activities of pharmaceutical companies are considered in relation to the requirements of the Code•provides advice and guidance on the Code•provides training on the Code•arranges conciliation between pharmaceutical companies when requested to do so•scrutinizes samples of advertising and meetings to check their compliance with the Code.

PMCPA Letters


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Resources

International Comparative Legal Guide to: Pharmaceutical Advertisinghttp://www.iclg.co.uk/practice-areas/pharmaceutical-advertising/pharmaceutical-advertising-2014IFPMA Code of Practicehttp://www.ifpma.org/ethics/ifpma-code-of-practice/ifpma-code-of-practice.htmlEFPIA HCP Codehttp://transparency.efpia.eu/uploads/Modules/Documents/efpia-hcp-code-2014.pdfABPI Code of Practicehttp://www.abpi.org.uk/our-work/library/guidelines/Pages/The-Code-of-Practice-for-the-Pharmaceutical-Industry-2014.aspx


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Thank you

Questions?
