SC Issues Notice In Plea For Direction To Frame Uniform Code Of Pharmaceutical Marketing Practices To Regulate Unethical Practices by Pharma Companies

The bench of Justices DY Chandrachud and Surya Kant was hearing the writ petition by the FEDERATION OF MEDICAL & SALES REPRESENTATIVES ASSOCIATION OF INDIA which further seeks a direction that till an effective law is enacted as prayed above, the Court may lay down the guidelines to control and regulate unethical marketing practices by pharmaceutical companies, or in the alternative, make the existing Code binding with such modifications/additions as the Court may find proper and reasonable, which should be followed by all the authorities/courts under Articles 32, 141, 142 and 144 of the Constitution.

The profession of pharmaceuticals/ medicine is widely acknowledged as a noble one. Apart from being a source of livelihood, it contains inherent elements of sacrifice and service towards the ailing humanity. In manufacturing, selling, distributing and marketing medical substances, which include potent drugs, a pharmaceutical company enjoys great power over people and must conversely be charged with strict accountability of doing its utmost to safeguard the health and lives of people. Given the highly pernicious influence and power of the pharmaceutical industry over medicines, which are a social good because of their significance for individual lives, not only the production, sale and distribution of medicines but also the marketing thereof, including both direct advertising and indirect promotion, become important public issues. The government has a critical role in ensuring that these aspects are effectively regulated so that the health of people is not adversely affected due to considerations of profiteering. In Union of India & Anr. vs. Cynamide India & Anr. 1987 SCR (2) 841 this Court observed:

"2. Profiteering, by itself, is evil. Profiteering in the scarce resources of the community, much needed life-sustaining foodstuffs and life- saving drugs is diabolic. It is a menace which has to be fettered and curbed."", it has been submitted.

"A study of Indian regulatory regime governing the pharmaceutical sector reveals the lacuna in law. The manufacture, sale and distribution of drugs is regulated inter alia by the 'Drugs and Cosmetics Act of 1940' and rules made thereunder. Direct-to-consumer advertising is regulated under several enactments. However, no enforceable law exists which regulates the promotion of drugs by pharmaceutical companies vis-à-vis healthcare professionals, and therefore unethical practices continue unfettered. The Indian Medical Council (Professional conduct, Etiquette and Ethics) Regulations of 2002 prescribe a Code of conduct for doctors in their relationship with pharmaceutical and allied health sector industry, and prohibit acceptance of gifts and entertainment, travel facilities, hospitality, cash or monetary grants by medical practitioners from Pharmaceutical companies. This Code is enforceable against doctors, however, does not apply to drug companies, leading to anomalous situations where doctors' licenses are cancelled for misconduct which is actuated, encouraged, aided and abetted by pharma companies. The pharma companies go scot- free. By contrast, numerous countries across the world, including the United States, France, Germany, Hungary, Italy, U.K., Venezuela, Argentine, Russia, China, Hong Kong, Singapore, Australia, South Korea, Philippines, Malaysia and Taiwan, have enacted stringent laws to curb corruption in the pharmaceutical sector, in one or both of the two ways, viz., by enacting:

(a) general laws to prevent & control bribery in the private sector, and/or (b) special laws/provisions to prevent and control pharma corruption. These laws have been effectively enforced in several countries around the world where stringent criminal sanctions and hefty fines have been levied against pharma companies that were found to have paid kickbacks or other advantages to healthcare professionals to promote sales of their products. A few of the instances are briefly mentioned below:

(a) 1996- doctors sentenced in Germany in the heart valve scandal (b) 2009-Johnson & Johnson paid USD 2.2 billion to U.S. authorities

(c) 2013-Pfizer paid USD 2.3 billion to settle civil and criminal allegations (d)2014-GSK paid ¥ 3 billion in fine, 4 executives sentenced to jail in China

(e) 2018-Pfizer paid USD 23.85 Million in the U.S. for paying kickbacks", it is advanced.

"In India, pharmaceutical companies spend enormous amounts of money in sales promotion to influence doctors to generate maximum prescriptions thereby increasing drug-sales. One study noted that Top 7 pharma companies together had spent Rs. 34,186.95 Crores in Marketing Spend in 8 years making drugs expensive. Sales Promotion expenses constitute 20% of the cost of drugs thereby taking the drugs further away from the reach of the common man. Though termed as 'sales promotion,' these are, in fact, direct or indirect advantages offered to doctors (as gifts and entertainment, sponsored foreign trips, hospitality and other benefits) in exchange for increase in drug-sales. There are several ways in which unethical drug promotion can adversely influence doctors' prescription attitudes and harm human health, including the following:

(a) Over-use/ over-prescription of drugs: The many ways in which drugs may be overprescribed, in excess of therapeutic need (all of which are harmful for human health) include:

a. Prescription of higher doses of drugs than necessary

b. Prescription of drugs for a longer period than necessary c. Prescription of higher number of drugs than necessary

(b) Prescription of irrational combination of drugs:

Pharmaceutical companies use high pressure promotion practices to lure physicians to prescribe irrational combination drugs to generate massive sales. Irrational combinations of drugs mix antimicrobials and other medicines, where one or more of the ingredients is usually unnecessary. These drugs are usually without approval in medical texts and are potentially injurious to health. Hundreds of these combinations have been banned by the Government of India on several occasions, however, drug companies have managed to continue flooding the Indian pharmaceutical markets with combination drugs. Aside from various other ill-effects such as adverse drug reactions, protracted illnesses and death, this kind of misuse has led to the emergence of a life-threatening phenomenon, namely, antibiotic resistance. The insurgence of 'super bug' (bacterium that has become resistant to antibiotics) has become a serious concern since no antibiotics will work on it due to over-use and repeated use of antibiotics for prolonged periods. India is one of the worst affected nations by antimicrobial resistance (AMR) due to unfettered and ever-rising sales of antibiotics in India", the petition points out.

"Pursuant to the public criticism in the media, articles by experts and demands of expert associations (including the petitioners), the Respondent No. 1 initiated a move in 2009 to have a discussion with stakeholders to develop a mechanism to regulate unethical pharmaceutical marketing practices. As a result, a voluntary 'Uniform Code of Pharmaceutical Marketing Practices' was introduced in 2015. The petitioners herein gave many suggestions to the DoP to improve the Code by including penalty clauses and giving it a statutory backing. On different occasions the Government of India acknowledged that the menace of corruption existed in the industry and needed to be curbed. The Government also agreed that the voluntary Code was not working and needed to be statutorily enforced. These occasions included:

(a) Circular(s) issued by the Government of India

(b) Statement of Hon'ble Minister during visit to the Netherlands

(c) Meetings between the Government and Pharmaceutical associations (d) In response to letter(s) of Petitioners and Member of Rajya Sabha (e) Annual Report 2017-18 of the Government of India

In 2017, the Respondent No. 1 sent a proposed draft Drugs (Control Marketing) Order – 2017 under section 3 of the Essential Commodities Act, 1955 to the Ministry of Law, Department of Legal Affairs, however, for reasons best known to the Ministry of Law, the same was not enacted. Thus, the Code which exists today remains voluntary in nature, thereby making its implementation impossible. Predictably, the menace of pharma corruption has not been arrested. On the contrary, ample evidence exists which not only proves that the menace of unethical promotion practices affects human health adversely but also that it is progressively becoming more pervasive and increasing at an alarming rate, including:

(a) books and journals written by healthcare experts

(b) testimonies of doctors and other healthcare professionals

(c) studies containing interviews with medical representatives

(d) international research reports and studies

(e) Views of international health organisations

(f) articles and news-reports in local and international publications", it is urged.

"These also prove that a Voluntary Code has not worked in India. Petitioners submit that it is high time that the lacuna in ensuring the Right to Health is urgently filled up by an appropriate legislation and till such legislation comes, by appropriate directions issued by this Hon'ble Court under Article 32 read with Articles 141, 142 and 144 of the Constitution. The reasons are several (detailed grounds stated in the Petition are not repeated herein): Firstly, this Hon'ble Court has held in a catena of judgments that the Right to Health is a facet of the right to life in Article 21 of the Constitution guaranteed to the people of India. Unregulated corruption in the pharmaceutical sector endangers positive health outcomes and puts the health of individuals at risk as well as society at large resulting in violation of Article 21 of the Constitution. Ample evidence exists which proves that over-prescription of drugs and irrational combination of drugs are injurious to health and prolonged use may lead to drug resistance, protracted illness and death. Secondly, (a) India ratified the International Covenant on Economic, and Cultural Rights (ICESCR). Article 12 of the ICESCR obligates States to take action to protect every individual's right to the highest standard of health which includes ensuring that a proper legislative framework is provided to protect the right to health. (b) India also ratified the UN Convention against Corruption in May, 2011 according to which laws against corruption in the private sector ought to have been brought into the municipal law by the Parliament. It is trite law that International Commitments and Conventions which promote and elucidate the content of Fundamental Rights and Right to Life ought to be considered as part of the Fundamental Rights. Thus, there is an obligation on the Parliament to enact a law to regulate unethical practices by pharma companies which affect the Right to Health of the people of India. Thirdly, abundant evidence exists, both nationally and internationally, which proves that voluntary pharma codes have not worked. International experience confirms that the only way to curb this menace is by enacting and enforcing stringent laws with statutory force behind them. Having acknowledged that the voluntary code was not working and in the absence of any evidence to suggest that the Government's earlier conclusions were wrong, the recent and unexpected change of mind of the Government of India is beyond any reason or rationale", it is submitted.

The petition continues to aver, "Fourthly, if unfettered 'promotion' of drugs by pharmaceutical companies is allowed to continue, the day is not far when India will become the hub of adverse drug reactions, drug/ antimicrobial resistance, protracted illnesses and deaths. Evidence already exists that India is the world's top consumer of antibiotics and a hotbed for drug evading bacteria, leading to global concerns India could be undermining global efforts to limit antimicrobial resistance. Dozens of unapproved and sometimes risky formulations have been found on the India market.

Fifthly, if no enforceable law is enacted to curb unethical sales promotion practices by drug manufacturers, a grossly anomalous situation (which exists today) will continue where no action is taken against a recalcitrant drug Company for the same misconduct for which doctors are severely punished, even while the misconduct was caused, encouraged, aided and abetted by the drug company which goes scot-free.

Lastly, the Supreme Court is the protector of right to life and social and economic justice enshrined in the Indian Constitution and its preamble. This court has frowned upon the practice of profiteering in connection with life-saving drugs as 'diabolical', as it runs counter to the promise of social and economic justice under the Constitution, especially in the field of medicine which is held to be a 'noble profession'. It is urged that the Hon'ble court intervene to ensure that proper measures, curative and preventive, are taken for safeguarding the health of the people of India since no nation can develop without ensuring that its population stays healthy."

The petition has been drawn by Advocate Surabhi Agarwal and filed through Advocate Aparna Bhat