In the aftermath of the nuclear leaks in Japan, there have been concerns regarding the safety of nuclear power plants around the world. There are some proposals to change the regulatory framework in India to ensure the safety of these plants. We examine some of the issues in the current structure. Which body looks at safety issues regarding nuclear power plants in the country? The apex institution tasked to look at issues regarding nuclear safety is the Atomic Energy Regulatory Board. The AERB was set up in 1983 to carry out regulatory and safety functions regarding nuclear and radiation facilities. The agency has to give clearances for establishing nuclear power plants and facilities. It issues clearances for nuclear power projects in stages after safety reviews. The safety of setting up a nuclear plant in any given area is also assessed by the AERB. For example, it would have looked into the safety of setting up a nuclear power project in Jaitapur in Maharashtra. AERB also reviews the safety mechanisms within existing nuclear plants and facilities. To do this, it requires nuclear facilities to report their compliance with safety regulations, and also makes periodic inspections. Under the recently passed Civil Liability for Nuclear Damage Act, 2010 the AERB is also the authority responsible for notifying when a nuclear incident takes place. Mechanisms for assessing and claiming compensation by victims will be initiated only after the nuclear incident is notified. Why is the Atomic Energy Regulatory Board in the news? Prime Minister Manmohan Singh announced on March 29, 2011, "We will strengthen the Atomic Energy Regulatory Board and make it a truly autonomous and independent regulatory authority." This announcement came in the backdrop of the continuing crisis and high radiation levels at the Fukusima nuclear plant in Japan. News reports opined that the lack of proper autonomy of Japan's nuclear regulator curbed its effectiveness. Japan's ministry of economy, trade and industry regulates the nuclear power industry, and also promotes nuclear technology. These two aims work at cross-purposes. India's regulatory structure is similar to Japan in some respects. What measures has the AERB taken post the Fukushima nuclear incident in Japan? Following the nuclear incident in Japan, a high-level committee under the chairmanship of a former AERB chairman has been set up to review the safety of Indian nuclear power plants. The committee shall assess the capability of Indian nuclear power plants to withstand earthquakes, tsunamis, cyclones, floods, etc. The committee will review the adequacy of provisions for ensuring safety in case of such events. Is there any issue in the current regulatory structure? The AERB is a regulatory body, which derives administrative and financial support from the Department of Atomic Energy. It reports to the secreatry, DAE. The DAE is also involved in the promotion of nuclear energy, and is also responsible for the functioning of the Nuclear Power Corporation of India Limited, which operates most nuclear power plants in the country. The DAE is thus responsible both for nuclear safety (through the AERB), as well as the operation of nuclear power plants (through NPCIL). This could be seen as a conflict of interest. How does the system of independent regulators differ from this? The telecom sector provides an example of an independent regulator. The Telecom Regulatory Authority of India does not report to the Department of Telecommunications. The DoT is responsible for policy matters related to telecommunications, promoting private investment in telecom, and also has a stake in BSNL. Had TRAI reported to the DoT, there would have been a conflict of interest within the DoT. What will the proposed legislation change? Recent news reports have stated that a bill to create an independent regulatory body will be introduced in Parliament soon. Though there is no draft bill available publicly, news reports state that an independent Nuclear Regulatory Authority of India will be created by the bill, and the authority will subsume the AERB within it. This post first appeared as an article on rediff.com and can be accessed here.
Today, the National Medical Commission Bill, 2019 was passed by Lok Sabha. It seeks to regulate medical education and practice in India. In 2017, a similar Bill had been introduced in Lok Sabha. It was examined by the Standing Committee on Health and Family Welfare, which recommended several changes to the Bill. However, the 2017 Bill lapsed with the dissolution of the 16th Lok Sabha. In this post, we analyse the 2019 Bill.
How is medical education and practice regulated currently?
The Medical Council of India (MCI) is responsible for regulating medical education and practice. Over the years, there have been several issues with the functioning of the MCI with respect to its regulatory role, composition, allegations of corruption, and lack of accountability. For example, MCI is an elected body where its members are elected by medical practitioners themselves, i.e., the regulator is elected by the regulated. Experts have recommended nomination based constitution of the MCI instead of election, and separating the regulation of medical education and medical practice. They suggested that legislative changes should be brought in to overhaul the functioning of the MCI.
To meet this objective, the Bill repeals the Indian Medical Council Act, 1956 and dissolves the current MCI.
The 2019 Bill sets up the National Medical Commission (NMC) as an umbrella regulatory body with certain other bodies under it. The NMC will subsume the MCI and will regulate medical education and practice in India. Under the Bill, states will establish their respective State Medical Councils within three years. These Councils will have a role similar to the NMC, at the state level.
Functions of the NMC include: (i) laying down policies for regulating medical institutions and medical professionals, (ii) assessing the requirements of human resources and infrastructure in healthcare, (iii) ensuring compliance by the State Medical Councils with the regulations made under the Bill, and (iv) framing guidelines for determination of fee for up to 50% of the seats in the private medical institutions.
Who will be a part of the NMC?
The Bill replaces the MCI with the NMC, whose members will be nominated. The NMC will consist of 25 members, including: (i) Director Generals of the Directorate General of Health Services and the Indian Council of Medical Research, (ii) Director of any of the AIIMS, (iii) five members (part-time) to be elected by the registered medical practitioners, and (iv) six members appointed on rotational basis from amongst the nominees of the states in the Medical Advisory Council.
Of these 25 members, at least 15 (60%) are medical practitioners. The MCI has been noted to be non-diverse and consists mostly of doctors who look out for their own self-interest over public interest. In order to reduce the monopoly of doctors, it has been recommended by experts that the MCI should include diverse stakeholders such as public health experts, social scientists, and health economists. For example, in the United Kingdom, the General Medical Council which is responsible for regulating medical education and practice consists of 12 medical practitioners and 12 lay members (such as community health members, administrators from local government).
What are the regulatory bodies being set up under the NMC?
The Bill sets up four autonomous boards under the supervision of the NMC. Each board will consist of a President and four members (of which two members will be part-time), appointed by the central government (on the recommendation of a search committee). These bodies are:
How is the Bill changing the eligibility guidelines for doctors to practice medicine?
There will be a uniform National Eligibility-cum-Entrance Test for admission to under-graduate and post-graduate super-speciality medical education in all medical institutions regulated under the Bill. Further, the Bill introduces a common final year undergraduate examination called the National Exit Test for students graduating from medical institutions to obtain the license for practice. This test will also serve as the basis for admission into post-graduate courses at medical institutions under this Bill. Foreign medical practitioners may be permitted temporary registration to practice in India.
However, the Bill does not specify the validity period of this license to practice. In other countries such as the United Kingdom and Australia, a license to practice needs to be periodically renewed. For example, in the UK the license has to be renewed every five years, and in Australia it has to renewed annually.
How will the issues of medical misconduct be addressed?
The State Medical Council will receive complaints relating to professional or ethical misconduct against a registered medical practitioner. If the medical practitioner is aggrieved of a decision of the State Medical Council, he may appeal to the Ethics and Medical Registration Board. If the medical practitioner is aggrieved of the decision of the Board, he can approach the NMC to appeal against the decision. It is unclear why the NMC is an appellate authority with regard to matters related to professional or ethical misconduct of medical practitioners.
It may be argued that disputes related to ethics and misconduct in medical practice may require judicial expertise. For example, in the UK, the regulator for medical education and practice – the General Medical Council (GMC) receives complaints with regard to ethical misconduct and is required to do an initial documentary investigation in the matter and then forwards the complaint to a Tribunal. This Tribunal is a judicial body independent of the GMC. The adjudication decision and final disciplinary action is decided by the Tribunal.
How does the Bill regulate community health providers?
As of January 2018, the doctor to population ratio in India was 1:1655 compared to the World Health Organisation standard of 1:1000. To fill in the gaps of availability of medical professionals, the Bill provides for the NMC to grant limited license to certain mid-level practitioners called community health providers, connected with the modern medical profession to practice medicine. These mid-level medical practitioners may prescribe specified medicines in primary and preventive healthcare. However, in any other cases, these practitioners may only prescribe medicine under the supervision of a registered medical practitioner.
This is similar to other countries where medical professionals other than doctors are allowed to prescribe allopathic medicine. For example, Nurse Practitioners in the USA provide a full range of primary, acute, and specialty health care services, including ordering and performing diagnostic tests, and prescribing medications. For this purpose, Nurse Practitioners must complete a master's or doctoral degree program, advanced clinical training, and obtain a national certification.
