Transform to Redefine Marketing- Compliance and Transparency a Major Challenge

On March 12, 2024, the Department of Pharmaceuticals issued a policy communication to all pharmaceutical associations, enclosing the Uniform Code for Pharmaceutical Marketing Practices 2024 (referred to as 'UCPMP 2024' or 'the Code') for dissemination among members, urging strict adherence. It covers critical areas such as the conduct of medical representatives (‘MRs’), the provision of brand reminders and free samples, Continuing Medical Education & relationships with Healthcare Professionals.

UCPMP 2024 delineates permissible & impermissible activities for ethically promoting drugs and addressing complaints regarding unethical marketing practices by pharmaceutical companies.

Through this communication, the DoP requested all associations to establish an Ethics Committee for Pharmaceutical Marketing Practices, create a dedicated UCPMP portal on their website and initiate necessary steps toward implementing the Code.

BACKGROUND

On December 12, 2014, the central government released the Uniform Code of Pharmaceutical Marketing Practices to be voluntarily adopted and complied by pharma industries with respect to marketing practices. It was mentioned that if the code is not found to be effectively implemented by pharma associations/ companies, the government may consider making it a statutory code.

Federation of Medical and Sales Representatives Association of India?(FMRAI), the organisation that had approached the Supreme Court, calling for an enforceable legal code

CHALLENGES

The challenge in implementation is that the issue falls between two different ministries. The UCPMP is issued by the DoP, under the Ministry of Chemicals and Fertilizers, while much of the activity of the pharmaceutical industry in terms of research, manufacturing, and marketing approvals etc, for its medicines, comes under the Ministry of Health and Family Welfare, as does the governance of the medical profession. It is not clear how a pharmaceutical company running foul of the guidelines would be penalised.

While the current Code retains the contents of the previous code with certain modifications, it additionally addresses crucial topics such as brand reminders, CMEs, and support for research. Nonetheless, further clarity may be necessary regarding its interplay with other regulations.

The DoP has issued a policy communication to all pharmaceutical associations on March 12, 2024, enclosing the Uniform Code for Pharmaceutical Marketing Practices 2024 (referred to as 'UCPMP 2024' for dissemination among members, urging strict adherence.

All-important Clauses are retained – Very little change in the language

Clause 2. – Claims & Comparisons

Clause 3. – Textual and Audio-Visual Promotion

Clause 4. – Medical Representatives

Old sanctions will continue – But few new exceptions added

• Gifts
• Travel – Exceptions, CME / CPD speaker (Newly introduced)
• Hospitality – Exceptions, CME / CPD speaker (Newly introduced)
• Monetary Grants

Expressly Permitted for the First Time

• Brand Reminders
• Free Samples
• Continuing Medical Education (CME)
• Continuing Professional Development (CPD)
• Research Support
• Brand Reminders

Informational & educational items

• Free samples

Giver / Recipient – Comply with Income Tax Act

NEW PROVISIONS on Brand Reminders and Informational & educational items

• BRAND REMINDERS

Refer Clause 5.1. –

“Brand Reminders are permitted in the following two categories, viz., (i) Informational and education items and (ii) Free samples provided by the companies to medical professionals.”

Refer Clause 5.3.

“The giver and recipient of brand reminders should comply with the relevant provisions of the Income Tax Act, 1961 with respect to deductions and reporting of income.”

Brand Reminders --- “May not be construed as endorsement activity”?????

Refer Clause 5.2.

Receipt of brand reminders from pharmaceutical companies by healthcare practitioners may not be construed as endorsement activity if it does not amount to recommendation or issuance of a statement by a healthcare professional w.r.t. use of the respective brand.

• EDUCATIONAL & INFORMATIONAL ITEMS

Giving these 100% safe – Rest all in the grey zone. Value not exceeding Rs. One thousand per item

1. Books
2. Calendars / diaries
3. Journals (including e-journals)
4. Dummy device models
5. Clinical treatment guidelines

These items should not have an independent commercial value for the healthcare professionals

Refer Clause 5.1.i.

“Informational and educational items mean books, calendars, diaries, journals (including e-journals), dummy device models and clinical treatment guidelines for professionals used in healthcare settings value of which does not exceed Rs. 1000 per item. Such items should not have an independent commercial value for the healthcare professionals.”

• FREE SAMPLES

1. Name / address of doctor must be "noted for records”
2. To one doctor in one year - 12 packs of a drug (Each pack maximum dosage for 3 patients)
3. Value of free samples - Not to exceed 2% of domestic sales of the company per year

Refer Clause 5.1.ii. – Free samples

“Where samples of products are distributed by a medical representative, the sample must be handed directly to the person qualified to prescribe such product, or to a person authorized to receive the sample on their behalf, and the name and address of the healthcare practitioner noted for records.”

Refer Clause 5.1.ii.b.

“Sample packs should be limited to prescribed dosage for not more than three patients for the required course of treatment and no company should offer more than twelve such sample packs per drug to any healthcare practitioner per year;”

Refer Clause 5.1.ii.f.

“Each company should maintain details such as product name, doctor name, quantity of samples given, date of supply of free samples to healthcare practitioners etc, and the monetary value of samples so distributed should not exceed two percent of the domestic sales of the company per year.”

• Continuing Medical Education (CME) / Continuing Professional Development (CPD)

1. Foreign locations prohibited
2. Pharma can do it alone or in collaboration with others
3. Expenditure - Company (pharma) to display on website
4. Statement of funding / Selection of participants & speakers - Organizers also to display on their website
5. Company (pharma) / Organizers / Speakers / Participants – Comply with Income Tax Act (”194R”)

Refer Clause 6.1.d

• Pharmaceutical companies, including their trusts/associations, either alone or in collaboration with professional bodies, institutions as stated in a, b & c above.
• Entities incurring expenditure on such events, as well as participants and speakers, must comply with the relevant provisions of the Income Tax Act 1961 as amended from time to time

Research Support

Approval from competent authority necessary. Consultancy fee / honorarium can be paid – Consultancy Agreement

Allowable expenditure - Income Tax Act

Refer Clause 7. - Support for Research

• Engagement of healthcare professionals in consultant-advisory capacity shall be for bona-fide research services, under a consultancy agreement involving a consultancy- fee or an honorarium-based payment, subject to the relevant provisions of the Income-Tax Act, 1961. Such engagements should ensure the patient interest is not compromised and integrity of the healthcare professional is maintained in line with the NMC regulations.
• Expenditure on research by pharmaceutical companies is an allowable expenditure subject to the provisions of the Income Tax Act 1961 as amended from time to time.

OTHER IMPORTANT PROVISIONS

1. Complaint Handling Mechanism (Clause 9 – 13)?
2. All Associations of pharma will have an “Ethics Committee for Pharma Marketing Practices (ECPMP)”
3. Associations will decide the procedure for lodging complaints.
4. Associations will share on their websites details of complaints received.
5. Complaint to be made within 6 months of alleged breach of Code.
6. Complainant should be identifiable – No anonymous complaint.
7. Media reports may be treated as a complaint
8. Non-refundable amount of Rs. 1000/-
9. Professional auditors may be involved
10. Complaint to be decided within 90 days of receipt of complaint
11. Appeal before Apex Committee for Pharma Marketing Practices (ACPMP) – Decision within 6 months

PENALTIES & REFERENCES (Clause 12)

1. Suspend from Association
2. Reprimand
3. Issue a corrective statement in the same media (promotional material)
4. Recover money / items given to others in violation of Code
5. Inform Govt agencies / authorities if it is within their domain

Relationship with HCPs

The Code prohibits pharmaceutical companies and their agents (i.e. distributors, wholesalers, retailers, etc.) from offering or providing gifts for personal benefit of any HCPs or their family members (both immediate and extended). Similarly, it prohibits the offering, supplying, or promising of any pecuniary advantage or benefit in kind to any person qualified to prescribe or supply drugs.

Additionally, the Code specifies that pharmaceutical companies or any person acting on their behalf should not extend travel facilities or hospitality to HCPs or their family members, unless the person is a speaker for a CME or a CPD program.

Companies or their representatives should not pay cash or monetary grant to any HCP or their family members under any pretext. ? In instances where the Code does not address matters concerning relationship with HCPs, the guidelines outlined in the Indian Medical Council (Professional Conduct, Etiquette, and Ethics) Regulation of 2002, as amended periodically, will prevail.

Other directives

? The Code incorporates directives for lodging complaints, handling of unaddressed issues, complaints, penalties, reference, and appeals, along with delineating responsibilities of pharmaceutical company CEOs. ― The ECPMP in each association can take appropriate action, including suspension or expulsion of the entity from the Association, and other remedial actions once it is established that a breach of the Code has been made by an entity.

In cases where disciplinary, penal or remedial action falls under the jurisdiction of government agencies, the Committee may forward its recommendations to the relevant authorities through the DoP.

The Code introduces a new appeal mechanism allowing parties to the complaint to file an appeal with the Apex Committee for Pharma Marketing Practices (‘ACPMP’) in cases of disagreement with the decision of the ECPMP1 . The ACPMP may prescribe any penalties or refer to an appropriate government agency or authority. The decision in appeal shall be final and binding on both the parties.

― The CEO's of pharmaceutical companies bear responsibility for ensuring compliance with the Code and are required to submit a self-declaration in the prescribed format within two months of the end of every financial year, to the Association, for uploading on their website , or directly on the UCPMP portal of the DoP, in case he is not a member of such a body , or a member of more than one such bodies.

CONCLUSION

New guidelines are a wake-up call, challenging us to introspect and realign our strategies to prioritize ethical practices, patient well-being, and collaborative partnerships with HCPs. The Code lacks teeth to penalise the unethical practice of paying for prescriptions. The industry top management are in a fix now how to go about in the new budget year 2024-25 as most of the budget plans were ready prior to the announcement. UCPMP guidelines are a wake-up call for the pharmaceutical industry to shift gears and embrace a patient-centric, value-based marketing approach.

Brainstorming continues as its not clear how a pharma company running foul of the 'UCPMP 2024' guidelines be penalised??

Source: Secondary Research