Health activists raise doubts on pharma associations self-monitoring the code
The notification of the Uniform Code for Pharmaceutical Marketing Practices (UCPMP) 2024 on March 12 has been welcomed by major pharma associations, while health activists allege it is a “whitewash.”
The notification directs all associations to constitute an Ethics Committee for Pharmaceutical Marketing Practices (ECPMP), set up a dedicated UCPMP portal on their website, and take further necessary steps towards implementation of the Code.
In an official statement, Anil Matai, Director General, Organisation of Pharmaceutical Producers of India, (OPPI) commends the Department of Pharmaceuticals for taking a pivotal step toward fostering transparency and ethical practices within the pharmaceutical industry. He mentions that OPPI member companies follow the stringent OPPI Code of Pharmaceutical Practices 2019 (OPPI Code) which is based on the International Federation of Pharmaceutical Manufacturers and Associations (IFPMA) Code.
As per the OPPI statement, “this new code signifies a shared commitment to ensuring that interactions between pharmaceutical companies and healthcare professionals are conducted in an ethical and transparent manner with a focus on advancing patient care. Aligning with stringent ethical norms and enabling engagement with healthcare professionals, will not only uphold public trust but also foster a culture of responsible collaboration aimed at enhancing medical knowledge and improving patient outcomes. Moreover, the emphasis on informational and educational items, with a capped value, represents a balanced approach that prioritises knowledge dissemination and enhancement. OPPI looks forward to the development of well-defined guidelines for engagements such as Continuing Medical Education and conferences as the guidelines would underscore the importance of transparent collaboration between the industry and HCPs for the betterment of patient care.”
Sudarshan Jain, Secretary General, Indian Pharmaceutical Alliance (IPA ) points out that the Notification of UCPMP 2024 establishes a framework for communication claims, educational activities, samples, and other market initiatives within the knowledge-driven pharmaceutical industry. “It clearly lays down what activities are permissible and outlines a complaint procedure involving both industry associations and the Department of Pharmaceuticals. Indeed, it is a step forward towards industry advancement, prioritising superior patient care and adhering to established norms.”
Dr Viranchi Shah, National President, Indian Drug Manufacturers’ Associaton (IDMA) also welcomes the UCPMP, calling it a “balanced order that ensures that there is a healthy and ethical engagement between pharmaceutical industry and medical professionals, which is very important in the interest of patient. It also brings clarity in the domain, of what is acceptable and what is not. It carries a deterrence by way of actions against marketers who are found to be engaging into unacceptable practices. IDMA has always been in favor of ethical marketing practices.”
However, Dr Ravi Wankhedkar, health activist asks if the new UCPMP is just a “whitewash”, as it expects pharma associations to themselves monitor the code. “How can accused be the judge themselves?” He reasons that there should have been a statutory legal regulatory body to control and enforce this code compulsorily, drawing a comparison to the role of state medical councils or the National Medical Commission or the Bar Council or Advt Council etc. Or else cancel all councils and let peer associations monitor us, is his contention.
Shah of IDMA reiterates that, “In IDMA’s opinion it is a powerful and mandatory order. The code has two levels of actions. The first level is by the associations and includes financial penalties, public announcements, asking the involved entities to issue corrective statements in the media and others. At the second level it also has provisions for legal actions by government bodies. Hence it is a powerful way of dealing with companies engaging in unethical practices. The view that associations are equated to accused, in IDMA’s opinion, is not well founded.”
Industry experts however opine that legal action by government bodies is sure to be challenged by pharma companies.
Malini Aisola, co-convenor of All India Drug Action Network (AIDAN), agrees that it is an eyewash. “There is intentional misleading that the code is mandatory whereas it actually continues the problematic system where industry bodies are expected to act against unethical practices. A clear example highlighting the conflicts of interest is the sham investigation conducted by IPA into Micro Labs.”
“The new UCPMP legitimises many unethical practices that are rampant and prevalent as the primary means of providing inducements to the medical fraternity,” she said.
For instance, the Code permits pharma companies to engage healthcare professionals in consultant-advisory capacity provided it is for ”bona-fide research services, under a consultancy agreement involving a consultancy fee or an honorarium-based payment, subject to the relevant provisions of the Income-Tax Act, 1961.’ This is followed by a stricture that such engagements should ensure the “patient interest is not compromised and integrity of the healthcare professional is maintained…” Aisola points out that this is meaningless without specific mechanisms to protect patient interests such as requiring public disclosure of the contracts.
Similarly, section 8.2 and 8.3 prohibit pharma companies and their representatives from making travel and hospitality arrangements for doctors or their family members, ‘unless the person is a speaker for a CME or a CPD Program.’ Aisola points out that this is a loophole that is widely utilised.
Aisola alleges that pharma companies have found many sophisticated ways to circumvent ethical norms which have become more subtle and difficult to trace. Many doctors receive sizable fees for being on scientific advisory committees of pharma and medical device companies. Yet others are serve as investigators in clinical trials. While many payments are accompanied by legal contracts, the new UCPMP does not have any requirement for public disclosures of payments to doctors for research support.
She also points out that there is no provision for anonymous complaints so it would be impossible for whistleblowers to file complaints. The fee of also Rs. 1000 is an unnecessary deterrent and barrier given that hardly any complaints were received in over a decade under the UCPMP 2015.
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