Public Health And The Dimension Of Commercial Interest - Ethical Dimension Of Pharmacy
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Category: General Law
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PUBLIC HEALTH AND THE DIMENSION OF
COMMERCIAL INTEREST: ETHICAL DIMENSION OF
PHARMACY
Aina Singh Dhurve1 & Kamal Nayan Singh2
INTRODUCTION
Pharmacy is the science that directly relates with the wellbeing of humans and it also works on the principle of Profit, so there is always a point where commercial interest conflict with the professional integrity and public health. In the world of modern science where profits based environment where the industry operates between the dilemma of financial gain and professional conduct and welfare of individuals. The essence of pharmacy, as it is considered as both science and profession based on well-being of human not solely depend upon the profits, which focuses on the compassion, fairness and accountability. Institute of Pharmacy is not only vested with the dispensing of medicine also vested with the interest of safeguarding the lives as well, rational use of drugs and preventing the harm of humans.
Pharmacy is also considered as course of action which strictly adhere to the moral duties and its accountability towards the client. These principles bind this profession towards the best interest of patient, uphold truth in communication to maintain the medical environment. Ethical practice in pharmacy ensures that commercial motives never overthrown the fundamental responsibility of protecting and promoting public health. However, significantly increasing commercialization of the healthcare sector manifested through overpricing, misleading advertising, and aggressive marketing of the lifesaving drugs which also poses severe ethical challenges before the law. The tussle between profits and patient’s welfare is ultimate dilemma as access to essential medicine is human right and right of justice.
There is very long tussle between commercial profit and human welfare creates challenge and to counter these there is exhaustive legal and judicial framework regulates the profession of 1 “M Pharm, Department of Pharmacology, School of Pharmacy, Parul University, Vadodara, Gujrat, 391760”.
pharmacy, there are various legislation such as the Drug ( Price Control) Order, 2013, The Essential Commodities Act 1955, and the Consumer Protection Act 2019, which ensures and regulates the healthcare accessible and affordable to poor, and to effectively safeguards these rights Indian Judiciary through various landmark judgement and pronouncement which upheld the ethics and welfare of human remains the utmost priority which is based on the commodity based on the trust of Public. Thus these principle of welfare must be in accordance with the commercial interest but surely avoid the over pricing and also ensures the they should act as trader and to protect the human health and dignity.
Moral Duties, Professional Standards, and Pharmacist Accountability In the era of modernization pharmacy should upholds moral principle and duty to prioritize the welfare of patient, ensure effective medication after protecting the privacy of elders, and strictly adhere to professional conduct which is primarily based on honesty and continuous learning which includes various responsibilities so the much as clinical decisions, ethical conduct, and compliance to the regulation. Pharmacist must address and assess errors rightly and ensures the transparency between care of patient and legal obligation based on the healthy environment of trust, care and patient oriented responsibility.
1. Moral Duties of Pharmacists – Advanced distributive services are undoubtedly
valuable to humans; yet they can never replace or change the importance of professional judgment which defines a true profession. Such values as compassion, faithfulness, and fairness define the very essence of pharmaceutical care; as this concept matures, practitioners will identify other associated virtues and values. “By not reflecting upon the human values associated with pharmacy as a practice, pharmacists may weaken the fundamental moral underpinnings of pharmacy as a profession”3. And also “Pharmacists are also given the responsibility to help people to maintain good health, to avoid ill health and, where medication is appropriate, to promote the rational use of medicines and to assist patients to acquire, and gain 3 “R. A. Buerki & L. D. Vottero, Ethical Responsibility in Pharmacy Practice, 2nd ed. (American Institute of the History of Pharmacy, 2002)”.
maximum therapeutic benefit from, their medicines. The role of the pharmacist is continuing to develop”4.
2. Professional Standards in Pharmacy – “The practice of pharmacy and, indeed, all
healing professions is an intensely personal, peculiarly human activity that has been traditionally guided by such basic human values as compassion, dignity, justice, and truth. Although human values are more commonly associated with such humanistic disciplines as philosophy and religion, health professionals are beginning to realize that the success of their medical interventions with their patients depends as much upon interpersonal, value-based relationships as it does upon technical competence”.
3. Pharmacist Accountability - “Pharmacists should communicate to patients and to
prescribers the results of their efforts to help patients make the best use of medicines and new models of pharmacist accountability for the outcomes of medicine use should be developed, existing pharmacy laws and regulations should be reviewed and enhanced with the goal of fostering an appropriate level of pharmacist autonomy and accountability”5. Successful practitioner efforts to transform pharmacy practice from a supply function to a “clinical function should be celebrated and publicised within the profession”6. Pharmacy is a profession rooted its essence in “moral duties, professional standards, and accountability”. Pharmacists act must be based on “compassion, fairness, and faithfulness, prioritizing patient welfare, promoting health, and ensuring rational medication use”.
Pharmacy Professional standards emphasize ethical value relationship which is built on trust, dignity, justice, and truth, shows effective care depends on humanistic approach. Profit vs. Patient Welfare: Ethical challenges in pricing, marketing, and access to essential medicines. There is very big logical conflict between profit and welfare of public at large is significant challenges in the industry, Pharmaceutical companies mostly generates profit by high and over 4 “International Pharmaceutical Federation (FIP), Statement of Professional Standards: Codes of Ethics for Pharmacists (2004)”.
pricing and also based on aggressive marketing over welfare which essentially restrict the essential medicine and to maintain the valance between profitability with ethical responsibility is significant and it is to be ensured with equitable healthcare and protection of rights of patient. Misleading Advertising and Ethical Breaches – Misleading, false and aggressive ads in healthcare which potentially to be false in many cases, makes it a serious ethical violation that compromises safety of patient and public trust. When pharmaceutical companies increase benefits and conceal the risks factors, the consequences extend beyond financial fraud endangering lives. This issue signifies the urgent need for transparency, accountability, and ethical responsibility in medical marketing. “Misleading advertising is one of the most egregious ethical issues in the marketing of medical products.
This process involves the dissemination of promotional content that key lifesaving drugs which misrepresents the efficacy, safety, or purpose of such medicines and products, which is potentially leading to harm the patient. One of the prominent case is of the pain medication named as OxyContin, which is produced by Purdue Pharma company and for years, Purdue Pharma represented in the public OxyContin as having a low risk of addiction, despite having contrary evidence. This false, misrepresented and misleading advertising contributed to the opioid crisis in the United States of America, where millions of public individual became addicted to opioids, which leads to significant morbidity and mortality in the country.
The case of OxyContin highlights and shows that how misrepresenting advertising can erode patient trust and harm the life of patients in healthcare systems, which lead to significant health crises, and result in significant legal and financial penalties and repercussion for the companies involved. The OxyContin case exemplifies and shows that there will be devastating outcomes of unethical marketing practices in medicine because this profession directly relates with the life of individuals. “Misleading advertising not only raises the crisis of public health but also ends the moral principles of healthcare system which is upholding truth and integrity in medical promotion is essential to protect patients, maintain trust, and prevent future ethical and societal harm”7.
Ethical Tension in Pricing and Access - The ethical conflict between profit and patient welfare is significant in healthcare, as financial motives can compromise access to essential medicines. “The ethical tension between maximizing profit and ensuring patient health is 7 “Okeleke, P. A. , Babatunde, S. O. , & Ijomah, T. I. (2022). The Ethical Implications and Economic Impact of Marketing Medical Products: Balancing Profit and Patient Well-being. International Journal of Management & Entrepreneurship Research, 4(12), 709–728”.
another critical issue in the marketing of medical products and Pharmaceutical companies and medical device manufacturers operate within a for-profit framework, which naturally prioritizes financial gain and however, this profit motive can conflict with the ethical imperative to prioritize patient well-being, for instance, the case of Martin Shkreli, former CEO of Turing Pharmaceuticals, who infamously raised the price of the life-saving drug Daraprim by over 5,000%, illustrates the potential for profit-driven decisions to jeopardize patient access to essential medications and this decision was widely criticized as prioritizing financial gain over patient needs, as it placed the drug out of reach for many who depended on it for survival.
” 8 Cases like Martin Shkreli’s Daraprim shows how price hike highlight that prioritizing profit over patient needs risks ethical breaches and endangers the life of vulnerable patients. Influence of Marketing on Healthcare Providers - “The influence of marketing on healthcare professionals has been documented in various contexts, including the overprescription of antibiotics and the preference for brand-name drugs over more costeffective generic alternatives. The ethical concern here is that marketing practices may compromise the objectivity of healthcare providers, leading to decisions that are not necessarily in line with evidence-based medicine. This can result in suboptimal patient care, unnecessary healthcare costs, and the potential for adverse drug reactions due to inappropriate prescribing.
”9 Ethical Tensions in Regenerative and Aesthetic Medicine - In regenerative medicine, high demand, lucrative cash-pay treatments, and limited regulation arise the ethical tensions, where financial motives may outweigh patient welfare and professional responsibilities. “In aesthetic and regenerative medicine, the potential for such conflicts is amplified by the lucrative nature of these practices. Aesthetic medicine has become ‘big business, driven by commercial interests and proactive marketing’ as noted by the Nuffield Council on Bioethics. Regenerative medicine, too, is a burgeoning industry; over 1,400 businesses were operating roughly 2,754 clinics selling stem cell treatments as of 2021. Many of these interventions are cash-pay services outside the realm of insurance reimbursement or rigorous regulation. The combination 8 “Okeleke, P. A. , Babatunde, S. O. , & Ijomah, T. I.
(2022). The Ethical Implications and Economic Impact of Marketing Medical Products: Balancing Profit and Patient Well-being. International Journal of Management & Entrepreneurship Research, 4(12), 709–728”.
of high patient demand, out-of-pocket payment, and variable oversight creates an environment where financial motives could overshadow ethical obligations. ”10 Profit vs. Patient Welfare - In regenerative and essential medicine such as PCM etc. available at high demand, lucrative cash-pay treatments, and very limited regulation raises ethical tensions, where financial motives may ignore patient welfare and professional responsibilities imposed on them. “The healthcare industry must balance the pursuit of profit with the responsibility to prioritize patient safety and public health. Ensuring that marketing practices are aligned with these ethical imperatives is essential for maintaining public trust in the healthcare system and protecting patient well-being. ”11 Legal and Judicial Framework Related to Consumer Protection Ensuring Ethical Conduct.
Drugs (Prices Control) Order, 2013 (DPCO) The Drugs (Prices Control) Order, 2013 – This order has been issued under Section 3 of the Essential Commodities Act, 1955 which control and regulate the pricing of drugs, it is the framework that regulates and control the pricing of medicines in India. The National Pharmaceutical Pricing Authority (NPPA), established in 1997, and the authority is empowered under Paragraphs 312, Paragraph 413, and Paragraph 2014 of the DPCO to fix, revise, and monitor the prices of essential drugs listed in the Schedule-I (National List of Essential Medicines). Under Paragraph 4, “the ceiling price is calculated based on the simple average of prices of all brands having at least 1% market share. Paragraph 11 15 “prohibits any manufacturer from selling a ‘scheduled formulation’ at a price higher than the one fixed by the NPPA, ensuring affordability and access”.
If a manufacturer charges above this limit, Paragraph
1316 mandates “recovery of the overcharged amount with interest”. Furthermore, Paragraph
10 “Ghalamghash, R. (2025). Patients vs. Profits: Ethical Tensions in Aesthetic and Regenerative Medicine. International Journal of Scientific Research and Management (IJSRM), 13(05), 2179–2192”.
1417 requires “manufacturers to print the maximum retail price (MRP) inclusive of all taxes on
the label, promoting transparency and consumer awareness”. Paragraph 2018 empowers NPPA to “monitor even non-scheduled drugs to prevent unreasonable price hikes”. Ethically, the DPCO upholds and protect the principle of “distributive justice” which ensures that lifesaving drugs are accessible irrespective of economic class. It also in accordance with Article 2119 of the Constitution of India, which guarantees the “right to life”, encompassing “access to essential medicines”. By restricting profiteering and restricting the overpricing, the DPCO balances profitability with public welfare. Thus, it functions not only as a pricing control authority but also as instrument safeguarding the ethical duty of the pharmaceutical industry toward “patient welfare and social responsibility”. 2.
Essential Commodities Act, 1955 – “The Essential Commodities Act, 1955”, provides the foundation for government involvement in the production and supply of critical goods, which includes medicines. Under Section 2A20, the “Central Government may declare any commodity as essential in the public interest” and “once declared, the government can regulate its supply, distribution, and trade”. Section 321 of the Act “authorizes the central government to issue control orders for regulating or prohibiting production, storage, distribution, and pricing of essential commodities”. Under Section 3(2)(c)22 of the Act, “specific power is granted to fix maximum prices to prevent unfair profiteering and black marketing”.
In the period of health emergencies, such as epidemics or shortages, the government can invoke the powers to fix prices of essential drugs or oxygen cylinders and to prevent hoarding or shortage. Violations of the provisions of the Act attract severe penalties under Section 723, which prescribes “imprisonment and fines for contravention of any order made under Section 3”. The Act also empowers authorities to “cease the stock and prosecute offenders to deter unethical trade practices”. From an ethical point of view, the Act emphasizes “social equity and moral accountability, ensuring essential goods are not exploited for commercial gain”. By treating certain specific medicines as essential public goods, it enhances and protected human welfare
17 “Under para 14 of the Drugs (Prices Control) Order, 2013”
18 “Under para 20 of the Drugs (Prices Control) Order, 2013”
above market liberty, fulfilling the responsibility of state under Indian constitution under Directive Principles of State Policy to secure the health of its citizens balancing with overpricing. Therefore, the Act acts as a regulatory shield and also as ethical protection, protecting consumers from higher pricing and ensuring equitable access during public health crises. 3. Consumer Protection Act, 2019 - The Consumer Protection Act, 2019 which replaces the 1986 Act to provide a modern and efficient framework for the protection of consumer rights, explicitly covering healthcare consumers. Under Section 2(7)24, a “consumer” is defined as “any person who buys goods or hires services for consideration” which includes “patients purchasing medicines or availing medical treatment”.
Section 2(47)25 defines unfair trade practices, which includes “misleading advertisements, overpricing, or concealment of material facts about cost or quality”. Section 2(9)26 enshrines six consumer rights including the “right to be protected against unfair practices, the right to be informed, and the right to seek redressal”. The act establishes three tier grievance redress system of Consumer Dispute Redressal Commission at district, state and national level and under various provisions allowing the patient to file the complaint against professional and hospitals as well for overpricing and forgery of billing. Section 1827 which empowers CCPA to investigate and penalize for the offence of misleading advertisement and overpricing.
Section 2128 of the acts empowers the CCPA to order to the Companies or Industries regarding the discontinuation of deceptive ads and may impose fine up to 10 Lakhs Rupees to establishes the transparency in the healthcare industry. Legal framework of India related to ethical and pricing related issue in the pharma sector includes a strong combination of economic and ethical responsibility. Statutory provisions such as Drug (Price Control) Order, 2013 is there to protect and safeguard the consumer from high pricing of companies and industry by empowering the NPPA to cap the price of essential medicine. The Essential Commodity Act 1955, ensures and protect the human and ensures the
24 Essential Commodities Act, 1955, s. 2”.
there is availability of essential drug and medicine at affordable rates specially when there is any urgent or emergent situation like epidemic and pandemic and to protect the consumer, Consumer Protection Act 2019 empowers he patient that is customer to act as the sound and informed consumer and protect themselves from over pricing and deceptive ads. All the statutes ethical legal and sound legal framework that upholds the principle of equity, justice and good concise. And all these laws reaffirms that health care industry should not only focus on the profits but also have to protect the life of humans. Landmark Judgments Related to Overpricing and Ethical Conduct The Indian judiciary has played a significant role in ensuring that healthcare should be based on morality, while a professional service, remains grounded in “ethics, accountability, and fairness”.
Over these years, Indian Courts have delivered various landmark judgments that define and interprets the boundaries of “ethical conduct, pricing transparency, and consumer protection” in the field of medicine. This was laid down in the landmark ruling of Indian Medical Association v. V. P. Shantha & Others29, where the Supreme Court observed that “medical services fall under the purview of the Consumer Protection Act, 1986” and the Court declared that “doctors, hospitals, and nursing homes providing services for consideration are liable for deficiencies, overcharging, or unethical conduct”. This judgment gives new dimension of healthcare law by “empowering patients as consumers and mandating fairness and transparency in medical services”.
This judgement also emphasized on that healthcare cannot be treated as commerce and that ethical responsibility and it is integral to the profession of pharmacy. This principle of ethical responsibility was further interpreted and enforced in the landmark ruloling of “Spring Meadows Hospital v. Harjol Ahluwalia”30, where the Supreme Court upheld that compensation for negligent act and overpricing of medicines, pointing out that hospitals are not only responsible for their acts of staff but also for maintaining fair pricing and proper standards of care towards the patient. The Hon’ble Supreme Court further reiterated that patient welfare and safety are of most importance and need to be protected in every possible manner, and unethical billing or negligent behavior violates both legal and moral duties owned by the companies. In the case of “V. Kishan Rao v. Nikhil Super Speciality
29 (1995) 6 SCC 651”.
Hospital”31, Hon’ble Court observed that even specialized hospitals are accountable and under jurisdiction of the consumer law and cannot escape from their liability by citing complex medical procedures and legal lacunas the court further observed that the patients has right to affordable, transparent, and quality care while state has duty to protecting it, pointing out that the exploitation by overcharging the medicines and drugs in the guise of specialized treatment breaches ethical obligations owned by hospitals and pharma companies. The ethical dimension of drug pricing was addressed in the landmark case of Union of India v. Cynamide India Ltd. 32, a related to the Drugs (Prices Control) Order, 1979.
The Supreme Court in this case observed that drug price fixation is not merely an “administrative function but a measure of social control to prevent profiteering and ensure equitable access”. The Court further emphasized that drug manufacturers hold a “public duty to act within reasonable pricing norms, reinforcing that access to essential medicines is a matter of public welfare, not private profit”. Similarly, in the landmark case Hindustan Antibiotics Ltd. v. Workmen33, the Hon’ble Court observed and recognized the “importance of balancing industrial profits with the public’s right to affordable medicine”. This judgment highlighted that the “pharmaceutical industry has a social obligation to maintain fair pricing structures consistent with national health interests, a concept that underpins later laws like the Drugs (Prices Control) Order, 2013”. In Parmanand Katara v.
Union of India34, the Court extended the scope of fundamental right to life under Article 21 of the Constitution and states that the right to health as part of it. The court further observed ruled that “every doctor, whether in government or private service, has an ethical and legal duty to provide immediate medical aid to preserve life, irrespective of ability to pay”. This case also established that “monetary considerations must never override medical ethics or human compassion”. The Supreme Court observed the similar view and deepened this principle in Paschim Banga Khet Mazdoor Samity v.
State of West Bengal35, Hon’ble Court observed that “failure of state hospitals to provide timely treatment violated the right to life” and the Court directed the state to improve “healthcare accessibility and affordability, affirming that economic constraints cannot justify denial of medical care, thus
31 (2010) 5 SCC 513”.
32 AIR 1987 SC 1802”:
connecting affordability with constitutional morality”. Finally, in the case of Kusum Sharma v. Batra Hospital & Medical Research Centre36, the Supreme Court laid down guiding principles for “medical negligence, emphasizing transparency, competence, and ethical standards in practice”. The Court also observed that “while doctors are not insurers of successful outcomes, they are duty-bound to act with honesty, integrity, and fairness”. Collectively, these eight judgments have built enhances the jurisprudence that integrates law, ethics, and patient rights. Hon’ble Court observed that affirm that the right to health under Article 21 includes “access to affordable and ethical medical treatment”. The Hon’ble courts have repeatedly observed that profit must not precede patient welfare.
CONCLUSION
The ethical world of pharmacy underlines the balance between commercial profit and patient welfare, which reminding all stakeholders that healthcare is a moral principle, not merely a market transaction based on profits. Pharmacists in the world of medicine, as vital healthcare professionals, bear a moral and professional obligation towards the patient to ensure the rational use of medicines, uphold transparency between them, and act with honesty, and accountability towards the patients. Ethical pharmacy practice goes beyond dispensing the medicines but also it embodies “trust, fairness, and integrity”, which forms the foundation of a just and fair healthcare system. The laws and key framework in India, enforced and protecting weaker section of society.
Various laws such as “Drugs (Prices Control) Order, 2013, the Essential Commodities Act, 1955, and the Consumer Protection Act, 2019”, which mandates and strengthen the ethical commitment by “regulating pricing, preventing exploitation, and protecting consumer rights”. And also, the governance of “ethics, law, and justice ensures” that the pharmacy and pharmaceutical industry and this profession remains focused on public welfare than commercialization in India.
36 “MANU/SC/0098/2010”.