Pre-Printed & Fixed Forms To Record Patients’ Consent Amounts To ‘Unfair Trade Practices’ : Remarked NCDRC

    The apex consumer commission, NCDRC, has called for a fixed format for obtaining consent or undertaking in medical procedures and termed pre-printed forms as an “unfair trade practice” within the meaning of section 2(1)(r) of Consumer Protection Act, 1986, saying that the pre- printed forms fits in any procedure, doctor or patient thus setting a case of administrative arbitrariness.

    Meaning of Unfair Trade Practices

    The order of the National Consumer Disputes Redressal Commission (NCDRC) came after hearing a medical negligence case involving RG Stone Urology and Leprosy Hospital in Delhi. While dismissing the complaint of any medical negligence or deficiency in service by the hospital and terming it as “frivolous, bereft of merit and ill-conceived”, the two-member bench of the commission comprising Dr S M Kantikar and Dinesh Singh took note of the peculiarity of the ‘informed consent’ form and meaning of unfair trade practices under Consumer Protection Act.

    The reason of the dispute was that, a 65 years old patient with pain in abdomen had rushed to a private hospital in Delhi and underwent a surgery. The surgery caused some complications and patient alleged medical negligence by the hospital and doctors who treated him. He approached State Consumer Commission which rejected the complaint on ground of pecuniary jurisdiction.

    NCDRC view on unfair trade practices and ‘informed consent’

    On approaching the NCDRC , commission found that the consent obtained by the hospital was “informed consent”.

    Though the allegations of medical negligence were rejected, the Commission observed that it cannot ignore the security and threat of pre- printed forms for recording informed consent which amounts to unfair trade practices, the Commission held that,

    “However, we cannot ignore the peculiarity of the ‘informed consent’ in the instant case which needs prompt and proper rectification. It is pertinent to note that a pre-printed form-‘informed consent cum undertaking having blank spaces for limited selective handwritten entries and for signatures. Such consent form fits into any procedure , any doctor , and every patient. Thus, it will take shape of informed consent if someone after filling up the blank spaces in handwriting and affixing the signatures of the patient. This is administrative arbitrariness and deceptive.”

    Finally, the commission imposed penalty on hospital directing them to deposit Rs. 10 lakh in the Consumer Legal Aid Fund of NCDRC within a month.