A dose of regulation
GS Paper 2: Government policies and intervention
Important for
Prelims exam: Provision of UCPMP
Mains exam: Unethical practices in Medical field and its impact on society
Context
Micro Labs has been accused of paying doctors approximately 1,000 crore rupees as bribe to prescribe Dolo-650(Paracetamol tablets) for Covid-19 patients, registering sales that were significantly higher than those of competing products in the market.
Is there any code which restrict these unfair practices
• The Government has put in place a Uniform Code for Pharmaceutical Marketing Practices (UCPMP) for Pharmaceutical companies, which is in operation since 01.01.2015, to prevent unethical practices by the pharmaceutical companies.
• This code governs the conduct of pharmaceutical companies in their marketing practices, duly covering the various aspects such as medical representatives, textual and audio-visual promotional materials, samples, gifts, etc.
• The code establishes relationship with healthcare professionals, wherein the provisions related to travel facilities, hospitality and cash or monetary grants to physicians or their families have been elaborated
• The code also details
o the mode of operation of the code,
o responsibilities of the Pharmaceutical Associations in constituting the Ethics Committee for Pharmaceutical Marketing Practices (ECPMP) for handling the complaints and Apex Ethics Committee for Pharmaceutical Marketing Practices (AECPMP) for review,
o procedure of lodging a complaint, procedure of handling of complaints by the Pharmaceutical Associations and various penalty provisions.
• This code, however, has been vastly undermined by the fact that it is voluntary in nature.
Need of a code
• This is an unexceptionable case in as much as the nexus between doctors and pharma companies is a well-known secret.
• In its most common and harmless form it consists of sending doctors and practitioners branded stationery, calendars, or desk knick-knacks to keep their products on top of the mind in a crowded market.
• This is especially important in a market such as India, where many essential drugs are placed under price control.
• The more serious examples of this nexus are when doctors are offered paid-for junkets to attend medical conferences, or given fees to act as lead investigators on clinical trials or in endorsing key research papers.
• It has been suggested that under the statutory code, all pharma companies disclose payments made to doctors or their associations, directly or indirectly.
• This is a sensible suggestion on the face of it but it is an open question whether the conversion of a voluntary code into a statutory one will change the situation appreciably, even if the penalties imposed are severe.
What needs to be done to make it effective
• This is a sensible suggestion on the face of it but it is an open question whether the conversion of a voluntary code into a statutory one will change the situation appreciably, even if the penalties imposed are severe.
• For a code to be effective, several conditions have to be met.
o These egregious practices occur all over the world, not just in India.
o But a combination of stronger regulation and robust whistleblower policies in developed nations has ensured that these practices come to light from time to time.
o In India, whistleblower protections remain weak on account of the inefficiencies of the judicial system. But another uniquely Indian administrative problem of overlapping jurisdictions is also likely to hamper the effectiveness of a UCPMP.
Tussle for control
• The ambit of the UCPMP is currently the focus of a tussle between the Department of Pharmaceuticals, which comes within the purview of the Ministry of Chemicals and Fertilisers, and the Ministry of Health.
• Ministry of Health has been pushing for the UCPMP to be brought under the impending Drugs, Medical Devices and Cosmetics Act, but the Department of Pharmaceuticals is unwilling to forfeit its control of this large and fast-growing industry.
Diagnosing Ethical Practices
• Talks around developing UCPMP began around 2005.
• Stakeholder meetings with civil society, drug firms, etc happened.
• In 2015, UCPMP was adopted as a voluntary code to keep unethical practices at bay.
• Pharma associations responsible for ensuring this is followed by their members.
• DoP has said in 2020 that there is no provision for it to directly deal with complaints.
• SC now hearing plea to direct Centre to make UCPMP mandatory.
Way forward
• Govt needs to make UCPMP mandatory and legally binding, which codifies the dos and don’ts for promoting drugs to pharma companies, the roles played by medical representatives, etc.
• The Supreme Court is currently hearing a plea to make the Uniform Code for Pharmaceutical Marketing Practices (UCPMP) a statutory requirement.
o SC needs to hear this on a fast track basis so that it could be given statutory backing.
• Ethical marketing and promotion should be brought within the ambit of the new Drugs, Medical Devices, and Cosmetics Act.[/fusion_text][/fusion_builder_column][/fusion_builder_row][/fusion_builder_container]