Uniform Code for Pharmaceutical Marketing Practices (UCPMP.pptx

This slide deck is solely dedicated to UCPMP 2024. This presentation is a summary of the guidelines.

1. Uniform Code for Pharmaceutical Marketing Practices (UCPMP) 2024 By: Dr.Nayan Motghare

2. Introduction to UCPMP Definition and Purpose UCPMP 2024 is a regulatory framework governing interactions between pharmaceutical companies and healthcare professionals. Its primary aim is to ensure ethical marketing practices and transparency in the pharmaceutical industry. UCPMP compliance is essential for promoting ethical pharmaceutical marketing practices, safeguarding the integrity of healthcare and patient welfare. The UCPMP outlines guidelines for promotional materials, gifts, and hospitality provided by pharmaceutical companies to healthcare professionals, aiming to prevent unethical influence on prescription practices. Key Provisions Educational Emphasis UCPMP, Uniform Code for Pharmaceutical Marketing Practices

3. The UCPMP 2024 sets comprehensive guidelines to ensure ethical promotion, protect consumers, and maintain industry integrity. Definition of "Promotion" as per WHO guidelines – It refers to all informational and persuasive activities by manufacturers and distributors to induce prescription, supply, purchase and/or use of medical drugs. Promotional activities must align with the terms of marketing approval granted by regulatory authorities. Ethical marketing practices are important to maintaining trust and credibility in the pharmaceutical industry. Introduction UCPMP, Uniform Code for Pharmaceutical Marketing Practices; WHO, World health organization

4. Key Regulatory Authorities UCPMP, Uniform Code for Pharmaceutical Marketing Practices

5. Marketing approval and promotion timeline - A drug must not be promoted prior to receiving marketing approval from the competent authority. Balanced, up-to-date, and verifiable information - Information about drugs must be balanced, up-to-date, verifiable, not misleading, accurately reflect current knowledge, and be capable of substantiation. Substantiation and accountability - Substantiation must be provided without delay when requested by medical and pharmacy professionals. General Points

6. Claims and Comparisons Evidence-based claims - Claims for the usefulness of a drug must be based on an up-to-date evaluation of all available evidence. Appropriate use of words like "safe" and "new" - The word "safe" must be qualified, and "new" can only be used for drugs/interventions promoted for less than a year. Fair and substantiated comparisons - Comparisons must be factual, fair, capable of substantiation, and not misleading by distortion, omission, or undue emphasis. No disparagement of competitors or healthcare professionals - Brand names of competitors cannot be used without consent, and their products, services, promotions, or clinical/scientific opinions must not be disparaged.

7. Textual and Audio-Visual Promotion Compliance with the Code - All promotional material must be consistent with the Code's requirements. Promotional material must include details like the drug name, active ingredients, dosage, adverse reactions, warnings, and a statement about additional information availability. Distinguishing promotional material from editorial content : Promotional material in journals must not resemble editorial matter and must be clearly identified as such. Ethical guidelines : Promotional material must conform to good taste, respect recipients' professional standing, not cause offense, and not use healthcare professionals' names or photographs.

8. Medical Representatives Medical representatives are sales and company representatives who interact with healthcare professionals, and they must maintain high ethical standards. They must not employ inducements or subterfuge to gain interviews or pay for access to healthcare professionals. Companies are responsible for ensuring their employees' and third-party representatives' compliance with the Code.

9. Brand Reminders Permitted items include books, calendars, journals, models, and guidelines with a value not exceeding Rs. 1000 per item and no independent commercial value. Free samples can only be provided to qualified prescribers, with limitations on quantity, dosage, sample pack size, and record-keeping requirements.

10. Continuing Medical Education (CME) Guidelines for conducting CME/CPD events : Events must follow guidelines on location, organizers, participant and speaker selection, funding transparency, and potential audits. Companies must share event details and expenditures on their websites, and organizers must disclose procedures, funding sources, and expenditures, subject to potential audits. Restrictions: Prohibited conduct includes offering travel facilities or hospitality to healthcare professionals, except in certain circumstances such as speaking engagements for CME or CPD programs. CPD, Continuing professional development

11. Support for Research Research studies must have requisite approvals and be conducted at recognized sites. Healthcare professionals can be engaged for bona fide research services under consultancy agreements, ensuring patient interest and professional integrity. Expenditure on research by pharmaceutical companies is allowable subject to Income Tax Act provisions.

12. Relationship with Healthcare Professionals Companies or their agents must not offer personal benefits like gifts, travel, hospitality, or monetary grants to healthcare professionals or their family members. Exceptions for CME/CPD speakers : Travel and hospitality can be provided to healthcare professionals who are speakers at CME or CPD programs. CPD, Continuing professional development; CME, Continuing Medical Education.

13. Ethics Committee for Pharma Marketing Practices (ECPMP) Role and composition : Each pharmaceutical association will have an ECPMP chaired by the CEO and comprising 3-5 members to handle complaints. Complaint handling process : Associations will upload the UCPMP and complaint lodging procedure on their websites, handle complaints against their members, and share complaint details on their websites and the government portal. UCPMP, Uniform Code for Pharmaceutical Marketing Practices

14. Lodging Complaints Procedure and timeline : Complaints must be addressed to the ECPMP within 6 months of the alleged breach, with a maximum extension of another 6 months for reasonable delay. Non-refundable fee : A non-refundable fee of Rs. 1000 must be deposited with the complaint. Complaint requirements : Complaints must identify the complainant, the company alleged to have breached the Code, details of the alleged breach, supporting evidence, and authorized signatories. ECPMP, Ethics Committee for Pharma Marketing Practices

15. Handling Complaints Inquiry process : The ECPMP will request a response from the company, suggest supporting material, and the company must submit a full response within 30 days. Potential engagement of auditors : Associations may engage professional auditors to assist in the examination. Decision timeline and notification : The ECPMP must render a decision within 90 days and promptly notify the parties in writing. ECPMP, Ethics Committee for Pharma Marketing Practices

16. Penalties and Reference Possible actions for breach of the Code : Actions include suspension/expulsion, reprimand, corrective statements, recovery of items, and recommendations to government agencies. Referral to government agencies : For statutory violations, the ECPMP may send recommendations to relevant government agencies through the Department of Pharmaceuticals. ECPMP, Ethics Committee for Pharma Marketing Practices

17. Appeal Process Apex Committee for Pharma Marketing Practices (ACPMP) : Dissatisfied parties can appeal to the ACPMP headed by the Secretary, Department of Pharmaceuticals. Timeline and final decision : The appeal must be filed within 15 days (with an additional 15 days for reasonable delay), and the ACPMP will give a final decision within 6 months after hearing both parties.

18. Appeal Process 1 2 3 4 5 7 6 ECPMP Decision Party Dissatisfied with ECPMP Decision? File Appeal before ACPMP within 15 days (additional 15 days for reasonable delay with reasons) ACPMP gives notice to both parties, the opportunity to be heard ACPMP gives a final decision/ruling within 6 months Decision ACPMP may prescribe penalties or refer to government agency Decision ACPMP decision is final and binding on the parties ECPMP, Ethics Committee for Pharma Marketing Practices; ACPMP, Apex Committee for Pharma Marketing Practices

19. Miscellaneous The Department may issue standing orders for furtherance or removal of difficulties in the Code's operation. The Code's provisions shall apply to medical devices and companies dealing with such products, unless exempted or modified. The Department will notify a panel of auditors, including CAG- enpanelled firms and reputed commercial audit firms. The company's CEO is responsible for adherence, and a self-declaration must be submitted annually to the Association or the government portal.

20. Application in Ethical Marketing Practices Patient-Centric Approach Adhering to UCPMP guidelines promotes a patient-centric approach, emphasizing the rational use of medicines and safeguarding patient welfare. Professional Conduct UCPMP compliance fosters professional conduct, ensuring that interactions with healthcare professionals are based on ethical principles and scientific evidence. Industry Reputation Compliance with UCPMP enhances the reputation of the pharmaceutical industry, reinforcing its commitment to ethical marketing practices and transparency. UCPMP, Uniform Code for Pharmaceutical Marketing Practices

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