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Medical Guidelines Vs Regulation: Cracking Down

Medical Guidelines Vs Regulation: Cracking Down
IVF babies at a fertility clinic. The ICMR has issued closure notice to the Ahalya IVF clinic/Photo: UNI
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Above: IVF babies at a fertility clinic. The ICMR has issued closure notice to the Ahalya IVF clinic/Photo: UNI

With the ICMR pulling up clinics allowing geriatric pregnancies using ART, doctors need to question their own role towards patients in the absence of a law in this regard


By Dr KK Aggarwal

All medical marvels may not be legal. A case in point is that of 74-year-old Erramatti Mangayamma who delivered twins on September 5 using Assisted Reproductive Technique (ART). Now the Indian Council of Medical Research (ICMR) has issued a notice of closure to Guntur-based Ahalya IVF clinic where Mangayamma was treated.

Terming it an unethical practice, the ICMR has asked the clinic to explain why it performed IVF on a senior citizen, thereby risking her life. If the reply is not satisfactory, its licence may be cancelled. ICMR’s 2017 guidelines cap the age limit for ART at 45 for women and 50 for men. The Assisted Reproductive Technologies (Regulation) Bill, which is yet to be passed by Parliament, also caps the age limit at 45 for women to undergo IVF.

Yet, despite these guidelines, regulation has often been a problem. Mangayamma is not the first case of geriatric pregnancy. In 2016, 70-year-old Daljinder Kaur of Haryana delivered a baby boy following the same procedure. It is obvious that hospitals and clinics are giving guidelines the go-by in their chase of lucre. ICMR expects ART clinics to self-regulate and follow the best practices in the absence of a law.

In the medical profession, the need to self-regulate is vital and critical. There was a time when only the Hippocratic Oath was enough. Then came the Medical Council of India Oath in 2002 when it was felt that an ethical framework needs to be rolled out for the medical profession. In 2009 came stringent punishments for violation of some medical ethics. The same year, the Consumer Protection Act was made applicable to the medical profession. And now, more and more cases of criminal offences are being applied to medical cases. These episodes then blow up with violence being perpetrated on doctors and leading to an erosion of trust between the patient and medical practitioners.

Self-regulation, based on guidelines made by the collective medical society and represented by a medical association, is the best answer in most cases. If the medical profession does not self-regulate, the government will be forced to bring in regulations and this will invariably involve criminal prosecution.

In the absence of any law at present, the following processes should be followed: self-regulation, taking experts’ opinions, seeking medical association consensus and following standard treatment and textbook guidelines.

In the medical profession, regulations are needed in public interest. They are primarily concerned with enabling patients to get access to high-quality, safe and effective medical care and avoiding access to products that are unsafe. When appropriately implemented, regulation ensures public health benefits and the safety of patients, healthcare workers and the community.

World Health Organisation has a mandate in this regard, which is outlined in the World Health Assembly Resolution 60.29, “to encourage member states to draw up national or regional guidelines for good manufacturing and regulatory practices, to establish surveillance systems and other measures to ensure the quality, safety and efficacy of medical devices (and medical care) and, where appropriate, to participate in international harmonisation”.

Clinicians need to follow up-to-date clinical practice guidelines about the care of patients with specific conditions. This includes a systematic review of research evidence for the targeted condition and recommendations about patient management based on evidence and value judgements that should be explicitly identified as such.

Guidelines are only suggestions for care. There will always be individual patients who should be managed differently for various reasons—biologic differences (e.g., rates of drug metabolism, strength of immune response or genetics), comorbidities (presence of one or more additional conditions co-occurring), availability of resources, cultural preferences and patient preferences.

Credible guidelines involve development by a panel representing a full range of expertise, an unbiased systematic review of the evidence, grading the strength of the evidence and recommendation, incorporation of multiple factors, including feasibility, harm, costs and patient preferences and a process for ongoing review and updating. Adherence to guidelines has not automatically been equated with reasonable practice and the courts are unlikely to follow the standards enunciated in clinical guidelines without critically evaluating their authority, flexibility and scope of application.

Any treatment which does not fall into available guidelines may seem like experimentation and need informed consent and entry in the clinical trial registry. Informed consent in such situations will include disclosure of facts about the available guidelines and why they were not followed.

If a case is part of a research protocol, it should follow Medical Council of India (MCI) ethics regulation 7.22 on research which says: “Clinical drug trials or other research involving patients or volunteers as per the guidelines of ICMR can be undertaken, provided ethical considerations are borne in mind. Violation of existing ICMR guidelines in this regard shall constitute misconduct. Consent taken from the patient for trial of drug or therapy which is not as per the guidelines shall also be construed as misconduct.”

In the present case of geriatric pregnancy, if it comes before the MCI, it would have a dialogue not only with the doctor but also the patient. It will examine the informed consent in detail. As per MCI ethics regulations, it is true that a patient has the right to choose the treatment and the doctor. He or she also has the right to privacy and confidentiality.

The MCI’s ethics regulation 7.11 may also examine why this case was made a subject of media exposure. If the media publicity was done for self-gratification, it may amount to professional misconduct on the part of the treating doctors. There is no reason why the patient herself would have approached the media in this case. Doctors have a responsibility towards the health of their patients and should not gamble with it either for money or publicity.

—The writer is President, Confederation of Medical Associations of Asia and Oceania and Heart Care Foundation of India

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