Pharmaceutical Marketing Malpractices

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General Studies 2

• Government policies and interventions for development in various sectors and issues arising out of their design and implementation.

In News: A recent report by a public health group on pharmaceutical marketing practices has revealed widespread use of bribes and inducement by Pharma companies to the doctors in order to increase the sale of their products. 

• The medical representative respondents also disclosed that the pressure on them was “tremendous” adding to their stress levels as they were “tracked by their supervisors using iPads.”
• Medical representatives also cited that only 10-20% doctors follow the MCI code of ethics, while in some cases doctors even demand “incentives” to push a product.
• Medical representatives of not just allopathy, but even ayurvedic and homeopathic companies, reported being under massive pressure to meet high sales targets.
• The report cited medical representatives as saying that that company officials even monitor business generated by doctors on whom they have ‘invested’ money.
• Pharma companies are holding training workshops or sessions for medical representatives, focused more on salesmanship and ‘managing customer (doctors) relations’, instead of enhancing their technical knowledge about the product they are handling.
• The report also noted a new trend – the  propaganda-cum-distribution companies these days float new entities that are franchisees of the pharma companies who buy drugs in bulk from manufacturers, give their own brand names and directly sell them to retailers and doctors at huge discounts and incentives including gifts, cash, hospitality and travel facilities

Indian pharmaceutical companies received a third of the warnings the United States Food and Drug Administration (FDA) issued for misbranding, selling unapproved medicines and violating Current Good Management Practices (CGMP) so far this year. According to section 501(a)(2)(B) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) violations of CGMP by a drug manufacturer can result in its product being categorised as adulterated. Management oversight, non-conformity to standards, batch failures, contamination are some of the constituents of CGMP violations.

An unhealthy alliance between doctors and pharma firms

For doctors the Medical Council of India has a code of ethics which bars them from accepting any gifts, cash, travel facilities or hospitality from Pharma companies. However for the pharmaceutical companies there is a voluntary code known as Uniform Code of Pharmaceutical marketing practices or UCPMP which experts says is a not a very effective mechanism to check the prevailing malpractices. 

What’s alarming is that there is no law to punish those guilty of the unethical practice; and the government refuses to blink. Result: patients are forced to buy costly medicines.

In 2015, the government had notified the Uniform Code for Pharmaceutical Marketing Practices (UCPMP), crucial for an industry that until now had nothing to regulate it—neither a law nor any guidelines.

The Union government still sits on a 2015 proposal to enforce a uniform marketing practices code for pharma companies, entailing stringent penalties. A year and a half ago, a draft of regulatory codes which was sent to Law Ministry to reign in unethical practices under Essential Commodities Act was rejected. Yet, the Ministry of Health in a reply to a Right of Information (RTI) report said that the draft was being discussed

Source: DownToEarth

The AMR Threat

The health threat is posed to millions of unsuspecting people, who fall prey to irrational prescriptions pushing drugs that may be hazardous for health. 

Rising use of antibiotics is the main cause of antimicrobial resistance, one of the world’s greatest health threats. Bacteria evolve resistance to drugs naturally over time, becoming superbugs, but mass or inappropriate use dramatically speeds up this process.

The Way Ahead

1. There is a need for a mandatory code for identifying and penalizing unethical promotion on the part of pharma companies. 
2. Mandated disclosure by Pharmaceutical companies of the expenditure incurred on drug promotion
3. Ghost writing in promotion of pharma products to attract disqualification of the author and penalty on the company
4. Vetting of drug related material in Continuing Medical Education 

Health care isn’t just another consumer product. It is more than that. The Hippocratic ideals of putting patients first are ingrained in our culture and reflected in the regulation of medical licenses and malpractice law. But although Hippocratic ideals have long been the basis of expectations for medical professionals, they haven’t yet been formally applied to health care companies. This is a major shortcoming in an era when the actions of large health systems, pharmaceutical companies, device companies, and insurance companies can have even greater effects on patients than the actions of individual clinicians.

Connecting the Dots:

1. Ethical practice can be enforced only through peer pressure. Legislation is no solution to the malady. Discuss.
2. Explain the potential and problems being faced by pharmaceuticals industry in India. What is the socio-economic significance of this industry? How IPR issues have posed a serious threat to this sector?
3. Do you think drug pricing policy in India needs an overhaul? Examine.
4. You are the head of the Ethics Committee on Genetic Engineering. Your job is to examine the ethical dimensions in the field of genetic engineering. One day you receive an application for ethical clearance from a big pharma company which is planning to launch the technology of embryonic gene editing. This technology shall help expecting parents to have children with desired traits and qualities. Moreover, it shall also reduce the risk of chronic diseases in the lifecycle of the newly born.

You get a felling that allowing this technology will create a controversy. A section in the society feels that it would be immoral to interfere with God’s creation. Moreover, such decision would also leave the poor and marginalised sections deprived of the fruits of the new technology as it is highly expensive. On the other hand, the scientific community backing this technology believes that such a ground breaking success should not be wasted on moral or ethical grounds. It has always been in the nature of human beings to innovate and invent, thereby, improving the quality of life. Gene editing would be immensely beneficial for humanity as it would open endless possibilities for improving human life and alleviate their sufferings.

What decision would you take in this regard? Substantiate your view point with suitable reasoning. (250 Words) (20) (Refer Solution)