Unfair Marketing Practices in Pharma Industry – Explained, pointwise

Introduction

At the peak of the Coronavirus pandemic, Dolo-650 mg tablets became synonymous with management and treatment of COVID-19 in India. The manufacturer of the drug, Micro Labs, saw its profits soar. In early 2022, the company came under income tax scanner for evasion of tax. Later on, Federation of Medical & Sales Representatives Association of India (FMRAI) accused the manufacturer of distributing freebies worth INR 1000 crores to doctors to prescribe Dolo-650 mg as the go-to drug. The incident has brought into attention the use of unfair marketing practices by Pharma companies to lure the doctors to prescribe their drugs.

About the Controversy

Dolo-650 is the brand name of a fixed-dose-combination drug that contains 650 mg of paracetamol. It is antipyretic and analgesic, meaning it helps decrease fever and pain. It is a non-steroidal anti-inflammatory drug that is available over the counter.

Since the primary symptoms of COVID-19 were fever and pain, sales of all fever medicines shot up exponentially during the pandemic. According to a market research, the revenue generated by paracetamol increased by 138.42% between 2020-2021. However, the sales of Dolo-650 went up by 289.6% during the same period.

Now, the manufacturer Micro Labs has been accused of offering freebies worth INR 1,000 crore to doctors to promote this anti-fever drug. A PIL has also been filed in the Supreme Court by the Federation of Medical & Sales Representatives Association of India (FMRAI), claiming that the Dolo makers offered freebies to doctors.

Meanwhile, medical regulator National Medical Commission (NMC) is seeking details from the Income Tax department of doctors whose names have been unearthed during the raids at the pharma company.

How Pharma companies build a nexus with doctors?

Drug firms offer freebies in cash and kind to physicians to incentivise them to prescribe ‘their drugs’. Mostly, drug firms would offer branded souvenirs like pen stands, calendars, diaries or and sanitizers to doctors. The idea is to ensure ‘top-of-the-mind recall’ of their brands. The Indian market is price-controlled. Therefore, the differentiator here are the brands and this is common practice followed by all pharma companies.

Further, Doctors are utilized for reputation-building exercises. For example, getting help to get their articles published in journals, or speaking at prestigious conferences. Reputed senior doctors or those with oratory skills are chosen as guest speakers, but companies often take a battery of doctors to these conferences. All of them are paid some fees for attending the conference.

Doctors are also made lead investigators in clinical trials, or made part of committees for which they earn a hefty fee.

What are the factors that drive unfair marketing practices by pharma companies?

In healthcare, the decision of the patients is driven solely on the recommendation of the doctor There’s a huge information asymmetry between the doctor and patient. Doctors have a commanding position and patients know little about the medicine. Patients will consume whichever medicine is prescribed. This unequal situation gets exploited.

To address this asymmetric relationship and promote ethical behaviour by Pharma companies, the Uniform Code of Pharmaceutical Marketing Practices (UCPMP) has been drafted the Government. It is a guidance for pharma companies on do’s and don’ts while marketing products. However, it is a voluntary code and not binding on companies. Despite requests by multiple lobbies and NGOs, the Government has not made the UCPMP mandatory. Critics argue that Pharma Companies lobby with the Department of Pharmaceuticals to keep the Code as voluntary.

Pharma companies need to inform and update doctors about their products. But there is a thin dividing line between legitimate promotional activities and illegitimate incentivisation and it becomes difficult to distinguish the two. A pharma company executive has argued, “Around 95% of the items being gifted have a value less than INR 500. It does not constitute a bribe. It is done to make the doctor remember a brand among the hundred others with a similar price point“.

What are the key features of UCPMP?

It is a voluntary code issued by the Department Of Pharmaceuticals relating to marketing practices for Indian Pharmaceutical Companies and as well medical devices industry. 

At present, the UCPMP Code is applicable to Pharmaceutical Companies, Medical Representatives, Agents of Pharmaceutical Companies such as Distributors, Wholesalers, Retailers, and Pharmaceutical Manufacturers Associations.

Key Provisions

No gifts, pecuniary advantages or benefits in kind may be supplied, offered or promised, to persons qualified to prescribe or supply drugs, by a pharmaceutical company or any of its agents.

As regards travel facilities, the Code prohibits extending travel facilities (domestic or abroad) to Healthcare Professionals and their family members for vacation or for attending conferences. The companies should also refrain from extending hospitality services (like hotel accommodation) to healthcare practitioners (and family members) under any pretext.

The Code also provides that free samples of drugs shall not be supplied to any person who is not qualified to prescribe such product.

What are the harmful effects of such unfair marketing practices?

First, unethical drug promotion can adversely influence doctors’ prescription attitudes and harm human health by over-use/over-prescription of drugs, prescription of higher doses, or for longer period, and prescription of an irrational combination of drugs. For instance, during COVID-19, many doctors prescribed dolo-650 instead of the usual 500 mg tablet. Taking 2-3 dolo-650 a day for the period of the fever would not necessarily cause harm. But excessive use of paracetamol is linked to severe liver damage. Dolo-650 is contraindicated for those who have liver disease, kidney disease and suffer from chronic alcoholism. In the US, pain management pills were prescribed by doctors and their addictive and harmful after-effects were hidden or ignored.

Second, apart from health concerns, this causes a severe financial stress for patients as doctors would be inclined to prescribe a branded drug rather than the cheaper generic version.

Third, it is against the spirit of competition and can jeopardize the survival of small pharma companies which lack in financial resources in comparison to the big players.

Fourth, it induces the doctor to work in the interests of the company and not the patient thereby undermining the hippocratic oath. Further, continuance of such practices erodes patient’s trust on doctors and the entire medical system.

What should be the approach going ahead?

The Federation of Medical and Sales Representatives’ Associations of India emphasises on making the Uniform Code for Pharmaceutical Marketing Practices (UCPMP) a legally binding code of ethics. The President of FMRAI advocates that if Pharma companies are found guilty of unethically promoting drug brands to doctors, they should face the same penal action as is mentioned in the Indian Penal Code for bribery and other similar unethical practices

Apart from other provisions, the code must mandate periodic disclosures of payments made by companies towards doctors and professional bodies, directly or indirectly via other parties. It should be accessible to the public and include the amount, purpose of expenditure, and the party paid.

Conclusion

The matter is sub judice and it may be too early to say if Micro Labs indulged in unfair marketing practices. However, it is an issue that can no longer be ignored. The Government should consult all stakeholders, National Medical Commission, FMRAI, Doctors Associations and Pharma Companies etc. to establish a comprehensive framework to check such unethical practices.

Source: Mint, Business Standard, Economic Times, The Times of India