American drug major AbbVie Healthcare’s Indian arm, which is under the scanner for sponsoring foreign trips of 30 doctors in violation of the Uniform Code for Pharmaceutical Marketing Practices (UCPMP) rules, may be in for more trouble as the government is mulling taking action against the company executive who signed the self-declaration to abide by the rules, government sources said.
According to UCPMP 2024, a self-declaration is to be signed by the executive head of the company regarding compliance to the marketing practices code. It has to be made within two months of the end of every financial year.
This could be the Managing Director or the CEO of the company.
If taken, it would be a first-of-its-kind action under the UCPMP 2024.
The case has sent jitters down India’s pharma circles who are watching with keen interest to understand implications of a breach of ethical marketing practices.
“Suitable action would be taken against the company executive who has signed the self-declaration under the UCPMP,” said a senior government official, without specifying the nature of penal action.
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He further added the doctors involved may lose their registration to practice if the allegations are proved.
AbbVie Healthcare India is under the lens for breach of the ethical marketing code by sponsoring foreign trips to Monaco and Paris for 30 doctors to improve their “knowledge” on popular anti-aging products Botox and Juvederm.
The Department of Pharmaceuticals (DoP) has also asked tax authorities to assess the liability of the company and the physicians. The department has also asked the National Medical Commission (NMC) to take action against doctors for professional misconduct. 24 of them went to Paris, and six to Monaco.
On its part, Allergan Aesthetics which is an arm of AbbVie Healthcare, said, “We are disappointed in the Department of Pharmaceuticals’ (DoP) decision to find Allergan Aesthetics in violation of the Uniform Code for Pharmaceuticals Marketing Practices (UCPMP).”
At the moment Suresh Pattathil is the Managing Director and General Manager, AbbVie India. He was also the president of the Organisation of Pharmaceutical Producers of India (OPPI), which represents multinational pharma companies in India.
Meanwhile, this breach has implications for the medical practitioners as well. NMC is also planning to take action against the doctors who took part in the foreign trip sponsored by AbbVie Healthcare India, according to government sources.
While the NMC did not respond to queries till the time of going to print, but any action, if taken, would be on the basis of the Indian Medical Council (Professional Conduct, Etiquette and Ethics) Regulations of 2002 which range from censure to removal of registration from the Indian Medical Register for a period of three months to one year depending on the severity of violation.
Industry sources said that the firm had rejected an offer of undertaking remedial action by extending support to underprivileged patients receiving treatment in government hospitals for an amount equivalent to the violations computed by DoP’s audit team. In this case the amount is Rs 1.9 crore spent on travel tickets and hotel accommodations of doctors.
Medical conferences by pharma cos have fallen sharply:
Doctors that Business Standard reached out to said that there has been a dramatic decrease in medical conferences (continuing medical education or CMEs as they are commonly called) since the UCPMP rules were notified in March.
The CEO of one such mid-sized firm explained, “Most pharma companies are appointing third-party organisers for CMEs. We recently did one conference, and did not find this arrangement fool-proof.
As such the organiser can pay for the travel and accommodation of faculties (who are doctors) through industry funds, and if the sponsoring company is putting up any product ad at the venue, then the pharma company can be charged for the banquet hall as well.”
He further explained delegates attending the function have to pay for attending the conference and for food and accommodation. This norm is often flouted by firms, the industry says as attending delegates (doctors) don’t pay for attending conferences.
In this case, the initial investigation led by the OPPI had pointed out the allegations involving the two conferences are governed by UCPMP 2014 and not UCPMP 2024.
However, the DoP’s special audit team found AbbVie to be in contravention of both sets of rules.
Commenting on the issue, an OPPI spokesperson said that the association’s Ethics Committee for Pharmaceutical Marketing Practices (ECPMP) was of the view that in the absence of any specific provision on industry engagement with healthcare professionals (HCPs) in their professional capacity in UCPMP 2014, the provisions of the Medical Council of India Code, 2002 (MCI Code) would become applicable.
“Regulation 6.8.1 (g) of the MCI Code allows a doctor to work for pharmaceutical and allied healthcare industry in a wide variety of capacities viz. advisory capacities, as consultants, as researchers, as treating doctors, or in any other professional capacity,” the OPPI spokesperson added.
Under the lens
> The Department of Pharma (DoP) pulled up AbbVie Healthcare for sponsoring foreign trips and hotel stays for 30 doctors worth Rs 1.9 crore
> DoP asked tax authorities to assess the liability of the company and the physicians
> The National Medical Commission may take action against doctors involved in the issue