Centre appoints high-level committee to examine pharma marketing of drugs  

Pharma and healthcare firms in India do not have anti-bribery legislation applicable to private practitioners/HCPs, in contrast to the US Federal Anti-Kickback Law applying to Health Care Professionals (HCP). Additionally, unlike the UK Anti-bribery Act, which governs interactions among private business companies, India lacks private anti-bribery regulations.

The Prevention of Corruption Act, 1988 (PCA), which is now in force in India, calls for the participation of a public official/public servant. Section 9 of the PCA, which went into effect in July 2018, introduces the concept of bribing a public official by a commercial organisation. The Uniform Code for Pharmaceutical Marketing Practices (UCPMP) applies to pharma companies, medical representatives, agents of pharma companies such as distributors, wholesalers, retailers and pharma manufacturers’ associations.

UCPMP prohibits gifts, pecuniary advantages, or benefits in kind supplied, offered, or promised by a pharma company or its agents to persons qualified to prescribe or supply drug, companies or their associations/representatives shall not extend any travel facility inside or outside the country, any hospitality like hotel accommodation to healthcare practitioners and their family members under any pretext. It also prescribes additional conditions that are to be observed while providing samples and companies or their associations/representatives shall not pay any cash or monetary grants to any healthcare professional under any pretext.

Further, as per the UCPMP Code, the appointment of medical practitioners/HCPs can take place, as affiliates, only upon satisfaction of certain conditions, including:

• a written contract,
• identifying a legitimate need for the services,
• setting out criteria for selecting affiliates that are directly related to the identified need, and
• finally, the number of affiliates retained must not be greater than the number necessary to achieve the identified need; and the compensation must be reasonable.

The Indian Medical Council (Professional Conduct & Ethics) Regulations, 2002 (MCI) applies to all HCPs registered under the MCI Code of Ethics for doctors and professional association of doctors in their relationship with the pharma and allied health sector. While the Medical Council Act has been replaced by the National Medical Commission Act, 2019, the Code of Ethics are still applicable.

In terms, thereof, a physician is prohibited from giving, soliciting, or receiving, and also offering to give, solicit or receive, any gift, gratuity, commission, or bonus, in consideration of, or in return for, referring or recommending, from a pharma company representative. A medical practitioner is also barred from accepting any travel facility inside the country or outside, including rail, air, ship, cruise tickets, paid vacations, etc from any pharma or allied healthcare industry or their representatives for self and family members for vacation or for attending conferences, seminars, workshops, CME programme, etc. as a delegate.

How is this impacting the pharma sector?

Bribery impairs lives. Its immediate victims include companies or firms that lose out unfairly.

Anti-Bribery and Anti-Corruption (ABAC) risk receives significant attention from senior management and the Board. The recent anti-bribery actions call for overall ABAC risk management and compliance for corporations. These offences are serious in nature, the goodwill and reputation of a firm or a person can be affected even by a single allegation of bribery.

Pharma companies invest millions of dollars to develop a drug, and, thereafter, maintain quality and vigilance. The research and development need scientific promotion of medicine to enable doctors to know the latest development in lifesciences. The scientific promotion can be achieved also with dialogue among the various stakeholders, which is facilitated, inter alia, by seminars, symposia and CME activities. Thus, a complete prohibition on the scientific promotion of drugs/research will not have a long-term positive effect. This calls for a balanced approach between anti-bribery laws prohibiting complete interaction with HCPs and regulating certain activities that may be bribery.

Why is there a need for the panel?

The UCPMP, for pharma companies, has been in effect since 1^st January, 2015, and has been adopted by all the major pharma associations. The code provides for the procedure of filing complaints, an inquiry by the Apex Committees of the Associations, penal actions, etc to be taken by the pharma association of which the company is a member.

However, the code is not enforceable under any law/statute of the government the code is voluntary.

Further, a CBDT circular, dated 1^st August, 2012, was upheld by the Supreme Court in a decision on 24^th February, 2022, in “Apex Laboratories Vs DCIT.” This circular sought to bring out and focus on the nexus between pharma companies and doctors with respect to pharma marketing practices.

Hence, to examine the issue holistically and align the interventions by various stakeholders, and also to examine all the related issues on the requirement of a legally enforceable mechanism for regulating marketing practices, a high-level committee was constituted.

The central government has formed a five-member committee led to consider a legally enforceable mechanism for regulating the marketing practices of pharma companies. The committee is expected to submit its report in 90 days. It will examine the provisions government departments have to regulate pharma marketing practices and align interventions for implementation by the healthcare industry.