Rs 1.91 Crore spent on Doctors Travel: Pharma Company faces UCPMP heat, soon action against 30 doctors

Published On 2024-12-24 07:13 GMT   |   Update On 2024-12-24 12:16 GMT

New Delhi: In a first of its kind case under the Uniform Code for Pharmaceutical Marketing Practices (UCPMP) 2024, the Apex Committee for Pharma Marketing Practices has issued a reprimand against AbbVie Healthcare India Private Ltd, a subsidiary of US-based AbbVie Inc., for unethical marketing practices. The company was allegedly found guilty of sponsoring international trips for nearly Rs 1.91 crore for 30 Healthcare Professionals (HCPs) under the pretense of professional development, contravening the UCPMP guidelines.

The case began with an anonymous complaint submitted to the Department of Pharmaceuticals (DoP) on May 21, 2024. The complaint, supported by internal company documents, alleged that AbbVie provided foreign travel and accommodation for 30 doctors attending the Aesthetics & Anti-Aging Medicine World Congress 2024 held in Monaco (February 1–3, 2024) and Paris (March 26–29, 2024). The alleged expenses totaled Rs 1.91 crore, covering flights and hotel stays.

Both the UCPMP 2014 and the newly introduced UCPMP 2024 strictly prohibit pharmaceutical companies from offering travel and hospitality to healthcare professionals. Paragraphs 7.1, 7.2, 8.2, and 8.3 of the codes emphasize that such actions undermine ethical practices in the industry.

The 2014 code outlines restrictions in paragraphs 7.1 and 7.2, state as follows:

7.1 Travel facilities: Companies or their associations/ representatives or any person acting on their behalf shall not extend any travel facility inside the country or outside, including rail, air, ship, cruise tickets, paid vacations, etc., to HealthCare Professionals and their family members for vacation or for attending conference, seminars, workshops, CME programme etc., as a delegate. It is hereby clarified that in any seminar, conference or meeting organized by a pharmaceutical company for promoting a drug or disseminating information, if a medical practitioner participates as a delegate, it will be on his/her own cost.

7.2 Hospitality: Companies or their associations/ representatives shall not extend any hospitality like hotel accommodation to Healthcare Practitioners and their family members under any pretext.

Paragraph 8 of UCPMP-2024, along with other provisions, details the relationship between a company and HCPs, imposing restrictions on travel and hospitality. Paragraphs 8.2 and 8.3 of the Code state as follows:

8.2 Travel: Companies or their representatives, or any person acting on their behalf, should not extend travel facilities inside or outside the country, including rail, air, ship, cruise tickets, paid vacations, etc., to healthcare professionals or their family members (both immediate and extended) for attending conferences, seminars, workshops etc., unless the person is a speaker for a CME or a CPD Program.

8.3 Hospitality: Companies or their representatives, or any person acting on their behalf, should not extend hospitality like hotel stay, expensive cuisine, resort accommodation etc., to healthcare professionals or their family members (both immediate and extended) unless the person is a speaker for a CME or a CPD program '1

Also Read: Centre notifies Uniform Code for Pharmaceutical Marketing Practices - UCPMP 2024 for Pharma Industry, details

To verify the claims against AbbVie, the DoP forwarded the case to the Ethics Committee for Pharma Marketing Practices (ECPMP) under the Organisation of Pharmaceutical Producers of India (OPPI). Simultaneously, a special audit committee was established to examine AbbVie’s conduct.

While the ECPMP found no irregularities, the special audit committee reported severe breaches of the UCPMP. It came to light that ‘AbbVie was in breach of UCPMP 2014 and UCPMP 2024. The total expenditure for 24 doctors travelling to Paris and 6 doctors to Monaco amounted to INR 1,91,24,991/- (One crore ninety-one lakh twenty-four thousand nine hundred ninety-one rupees only) for travel tickets and hotel accommodations in foreign locations, which was an explicit contravention of the codal provisions.’

The findings revealed that AbbVie’s spending on travel and accommodation was a direct violation of the UCPMP guidelines. Moreover, the company’s justification that these trips were intended to enhance doctors’ knowledge about products like Botox and Juvederm was deemed insufficient.

On the other hand, the pharma giant attempted to justify its breach as acceptable industry practice. AbbVie sought to persuade that Self Declaration determines when the Code takes effect. However, the Apex Committee explained that;

"Self Declaration is only a sensitization provision that does not mean that the UCPMP 2024 is inapplicable prior to that date. As an example, the Code of 2014, which was announced on December 12, 2014, was given an effective date of January 1, 2015. Without any indication of relaxation, it can be concluded that the 2024 Code is effective from the date of its notification. In any case, the previous code is applicable till the new code takes effect."

AbbVie argued that the trips were an industry norm and claimed compliance through "Professional Service Agreements" with the participating doctors. However, the Apex Committee noted that these agreements were vague and lacked clarity on the specific services provided by the doctors. It noted;

“These Agreements lack specifics on what services HCPs are expected to deliver. The paragraph is deliberately structured in a vague manner: " Services. Counterparty will conduct a Knowledge Dissemination Activity ('RDA ") as identified and in a manner required by AbbVie on a date that is mutually agreed in writing."”

The committee highlighted that such arrangements appeared to be a strategy to create the impression of compliance while enabling unethical practices. It questioned why highly trained HCPs required foreign travel for knowledge dissemination on widely recognized commercial aesthetic procedures. It observed;

“Such Agreement(s) were a clever ploy to present an impression of compliance with the regulations, while facilitating foreign travel and hotel accommodations funded directly from the M/S. AbbVie's budget. The agreements entered into by M/S. AbbVie do not clarify why such highly trained HCPs need to be provided with foreign travel opportunities to gain knowledge about simple procedures in medical aesthetics, such as administration of "Botox and Juvederm." Such medical interventions are widely recognized as a lucrative commercial service and evidence attached to the complaint links HCPs directly to the sale, purchase, or administration of such aesthetic products of M/ s AbbVie. There seems to be no justifiable reason for 30 healthcare professionals to journey abroad to Monaco and Paris for this purpose, nor can any •prudent person overlook the conclusion that such preferential treatment or largesse towards HCPs will not aid in promotion of M/S AbbVie's products, regardless of the terms of the Agreement(s). This arrangement seriously undermines the scope and intent of UCPMP 2014 and UCPMP 2024 and fractures the tenet of public good that is sought to be achieved through these Codes.”

Citing the Supreme Court judgment in Apex Laboratories (P) Ltd. v. CIT (2022), the committee reiterated that offering freebies to healthcare professionals violates ethical and legal provisions. The judgment emphasized that indirect methods to influence medical professionals are as unacceptable as direct ones.

The committee offered AbbVie an opportunity to undertake remedial action by providing support to underprivileged patients in government hospitals, equivalent to the calculated violations. However, AbbVie rejected this proposal on December 10, 2024, leading the committee to take stricter actions.

Subsequently, on December 23, 2024, the Apex Committee issued a formal order against AbbVie. It noted;

“AbbVie has violated the provisions of the Uniform Code for Pharmaceutical Marketing Practices by sponsoring foreign vacations to Monaco and Paris for 30 HCPs in violation of the coda] provisions. Therefore, in exercise of powers conferred by the UCPMP 2024:
i. The Apex Committee reprimands M/S. AbbVie Healthcare India Pvt Ltd for unethical marketing practices. A copy of this order be published on the website in accordance with the provisions contained therein.
ii. The Central Board of Direct Taxes (CBDT) is requested to evaluate the tax liability of M/S. AbbVie Healthcare India Pvt Ltd along with 30 HCPs and take action in accordance with the provisions of the Income Tax Act, 1961 read with the subordinate circulars issued in this regard.
iii. The National Medical Council (NMC) is requested to take action against the 30 offending HCPs as per Indian Medical Council (Professional Conduct, Etiquette and Ethics) Regulations, 2002.”
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