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Journal of Postgraduate Medicine, Vol. 56, No. 1, January-March, 2010, pp. 1-2 Editorial A new challenge for Indian physicians and healthcare industry: Decoding the MCI code of professional conduct Bhatt A Clininvent Research Pvt. Ltd., A-103, Everest Chambers, Marol Naka, Andheri - Kurla Road, Andheri (E), Mumbai 400 059, India. Correspondence Address: Clininvent Research Pvt. Ltd., A-103, Everest Chambers, Marol Naka, Andheri - Kurla Road, Andheri (E), Mumbai 400 059, India. arunbhatt@clininvent.com Code Number: jp10001 PMID: 20393240 DOI: 10.4103/0022-3859.62415 The physician-industry relationship has been a subject of considerable focus in recent years. [1] In a survey of 3167 American physicians published in 2007, Campbell et al., reported that 94% of respondents had some type of relationship with the pharmaceutical industry. [1] The relationships included: providing food at the workplace (83%); doling out drug samples (78%); reimbursement for costs associated with professional meetings or continuing medical education (35%), and payments for consulting, giving lectures, or enrolling patients in trials (28%). The findings of such surveys have highlighted the need to reflect on the implications of wide-ranging financial ties between the physicians and the pharmaceutical industry. There are growing concerns that these highly prevalent physician-industry relationships may unduly influence professional judgments involving the primary interests and goals of medicine. Spurred on by such concerns, in 2009, the Institute of Medicine, USA published an exhaustive report focusing on the conflict of interest in medical research, education, and practice. [2] The report concluded that such conflicts of interest threaten the integrity of scientific investigations, the objectivity of professional education, the quality of patient care, and the public′s trust in medicine. [2] The report recommended many voluntary and regulatory measures to strengthen protections against financial conflicts of interest in medicine without hindering patient care or the advancement of medical knowledge. [2] It recommended several actions to improve disclosure of financial ties between the medical community and industry, limit company payments and gifts, and remove industry influence on medical education and on the development of practice guidelines. Several Indian authors have discussed the impact of industry practices on physician practice behaviors. [3],[4],[5],[6],[7],[8] The articles have emphasized the need for the industry, doctors and medical institutions to adopt ethical practices in the interactions with each other. The Indian pharmaceutical industry associations-Indian Drug Manufacturers′ Association (IDMA) and Organization of Pharmaceutical Producers of India (OPPI) - have their own codes of Pharmaceutical Marketing Practices, which focus on ethical promotion of medicines to healthcare professionals. [9],[10] In 2009, the Department of Pharmaceuticals, Government of India urged the IDMA and OPPI to develop a Uniform Code of Pharmaceutical Marketing Practices. As these codes do not set limits on spending and adherence is voluntary, this move was criticized. The media felt that this step would not be able to curb inducement provided to physicians and called for an effective legal mechanism that required companies to disclose payments or gifts to physicians above a particular value. [11] Dr Verma, in his 2004 editorial, had also recommended that Medical Council of India (MCI) should discourage physician-industry interaction by incorporating a specific code of ethics. [8] The recent December 2009 amendment of the MCI Code of Ethics Regulations seems to be the Indian government′s response to these demands from the medical profession and media. The MCI has amended the Indian Medical Council (Professional Conduct, Etiquette and Ethics) Regulations, 2002 and has added a new clause 6.8 in the Chapter 6 on Unethical Acts. [12] This clause describes the Code of conduct for doctors and professional association of doctors in their relationship with pharmaceutical and allied health sector industry. The code prohibits a medical practitioner from receiving a) any gift b) any travel facility for self and family members for vacation or for attending conferences, seminars, workshops, CME program, etc as a delegate c) any hospitality like hotel accommodation for self and family members under any pretext or d) any cash or monetary grants for individual purpose in individual capacity under any pretext from the industry. [12] The code recommends that a medical practitioner can conduct research projects funded by the industry. [12] However, he/she has to ensure that such projects have regulatory permission, ethics committee approval, and fulfill all the legal requirements prescribed for medical research. Funding for medical research can only be received through approved institutions. The source and amount of funding should be publicly disclosed when the study begins. The physician should provide proper care and facilities to human volunteers. The doctor should also avoid conduct of undue animal experimentations. However, if these are necessary, then they should be done in a scientific and a humane way. The medical practitioner should ensure that the research agreement has a clause giving him freedom to publish the results of the research. The code advises that a medical practitioner should not compromise his/her own professional autonomy and/or the autonomy and freedom of the medical institution in interactions with the industry. [12] A medical practitioner can work for the drug industry as consultants, researchers, advisors or in any other professional capacity. However, he has to maintain professional integrity and freedom. He has to ensure that his patient′s interests are not compromised in any way and such affiliations are fully transparent and within the law. The code forbids a medical practitioner from endorsing any drug or product publicly. Any study conducted on any product should be presented to appropriate scientific bodies or published in appropriate scientific journals. The provisions of the MCI Code seem to fulfill the need for a legal mechanism. However, the code has been criticized, as it did not prescribe any penalty for the doctors who violate the provisions. In response, MCI has suggested various degrees of punishments for doctors who accept gifts worth Rs.1000 from any pharmaceutical or allied healthcare company. The punishments range from censure (for accepting gifts valued between Rs.1,000 and Rs.5,000) to removal from the Indian or State Medical Registry for more than one year (for accepting gifts worth more than Rs.1,00,000). [13] However, there are still questions about the process of monitoring, and complaints. Besides, the code does not have any actions for the industry. In the US, nine states have laws or resolutions which affect pharmaceutical marketing. [14] New York state is considering a law which proposes to fine pharma companies that violate the law between $15,000 and $250,000 per violation, and healthcare professionals between $5,000 and $10,000 per violation. [15] The New York state Department of Health would be responsible for enforcement, but would rely on complaints to identify violators. Recently, the MCI has requested the Union Health Ministry to amend the Drugs and Cosmetics Act to bring the pharmaceutical companies under the ambit of the law in making them punishable for rolling out freebies to the doctors for promoting their medicines. [16] As the MCI does not have jurisdiction over the industry, it would be desirable for the government to consider steps to monitor the marketing activities of the healthcare industry. The provisions for medical research are in accordance with the responsibilities of clinical trial investigators in the regulations and guidelines laid down by Central Drugs Standard Control Organization (CDSCO) - Schedule Y and Indian Good Clinical Practice (GCP). [17],[18] However, the term "approved institution" is ambiguous. If it means a public or private medical college/hospital, then the physician in private practice cannot conduct clinical research. However, as per Indian GCP, an institution means any public or private medical facility where a clinical study is conducted. [17] Schedule Y also refers to medical college, hospital or other facility where the clinical trial will be conducted as an institution. [18] Also, CDSCO clinical trial permission uses the term institution/centre in the approval letter. Considering these, it appears that an individual medical practitioner in private practice can conduct a clinical trial. However, the MCI needs to clarify this and also suggest a mechanism for public disclosure of funding. The recommendations regarding a medical practitioner′s autonomy, freedom and integrity reinforce the important principles of professional autonomy. But the term "consultant/advisor" is ambiguous. This provision can be misused for paying fees to a private medical practitioner by appointing him/her as a consultant/advisor. However, if it is meant to cover medical practitioners working as fulltime medical advisors in pharma industry, it will support the medical advisors working in pharma industry in withstanding pressures of marketing departments and in exercising their professional autonomy. The MCI Code is a step in the right direction and can achieve the objectives of curtailing the unethical aspects of the physician-industry interaction practices. The objectives of the code can be served only if the MCI provides explanatory notes for ambiguous provisions and creates a robust mechanism for monitoring and implementation. Also, this MCI effort needs to be supported by other stakeholders - state and central government, professional medical associations and healthcare industry. References
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