The Supreme Court on Friday agreed to examine a plea seeking a direction to Centre for formulating a Uniform Code of Pharmaceutical Marketing Practices to curb unethical practices of Pharma companies and ensure an effective monitoring mechanism, transparency, accountability as well as consequences of violations. A bench of Justices DY Chandrachud and Surya Kant issued notice to the Centre seeking its response in six weeks saying it wants to know what the government has to say on this issue. At the outset, senior advocate Sanjay Parikh, appearing for petitioner ‘Federation of Medical and Sales Representatives Association of India’, said that this is an important issue in the public interest and there is a recent judgement by this court which said that both bribe-giver or bribe-taker both are prohibited. He said that Pharmaceutical companies are saying that they are not liable as the bribe-takers are the doctors and in foreign countries, they have legislation to curb these unethical marketing practices.
Parikh said that the government should look into it and the code should be made statutory in nature as “we all know what happened with Remdesivir injections and other drugs of those combinations”. The bench said can this not be worked out by making a representation to the government. Parikh said that they have already done this and have been pursuing it with the government since 2009 and till the government comes out with the code, this court may lay down some guidelines. The plea filed through advocate Aparna Bhat sought direction that till an effective law is enacted as prayed, this 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 proper and reasonable modifications/additions, which should be followed by all the authorities/courts under Articles 32, 141, 142 and 144 of the Constitution. The plea added that 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”, it added.
The plea said that though termed as ‘sales promotion,’ in fact, direct or indirect advantages are offered to doctors (as gifts and entertainment, sponsored foreign trips, hospitality, and other benefits) in exchange for an increase in drug sales. It said that unethical drug promotion can adversely influence doctors’ prescription attitudes and harm human health by over-use/ over-prescription of drugs, prescription of higher doses of drugs than necessary, prescription of drugs for a longer period than necessary, prescription of the higher number of drugs than necessary and prescription of an irrational combination of drugs. It said that the pharmaceutical companies use high-pressure promotion practices to lure physicians to prescribe irrational combination drugs to generate massive sales. “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”, it said. The plea said that since 2005, the Petitioners have been seeking effective prevention and control of unethical marketing practices in the pharma industry by way of an enforceable Code of Ethical Marketing, through regular interaction with the Centre. “Petitioners seek enforcement of the fundamental right to health enshrined in the Right to Life under Article 21 of the Constitution of India in view of the ever-increasing instances of unethical marketing practices by Pharmaceutical Companies in their dealings with healthcare professionals resulting in the prescription of excessive and/or irrational drugs and a push for high-cost and/or over-priced brands, which are practices that directly affect citizens’ health, violating their rights under Article 21 of Constitution”, it said.
The plea said that there are abundant examples that show how corruption in the pharmaceutical sector endangers positive health outcomes and puts patients’ health at risk. “As violations of this kind have become a recurring phenomenon and are progressively becoming more pervasive, the Petitioners pray that a Statutory Code of ethical marketing for the pharmaceutical industry, with penal consequences, be established to curb such practices for the enforcement of the Fundamental Right to Health of the people of India. Due to the voluntary nature of the existing Code, unethical practices continue to increase and have also surfaced during the COVID-19 times”, it added. It said that no enforceable law exists which regulates the promotion of drugs by pharmaceutical companies vis-à-vis healthcare professionals, and therefore unethical practices continue unfettered.
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