The protests against the nuclear power plant at Kudankulam have intensified over the recent weeks. The Kudankulam plant is expected to provide 2 GW of electricity annually. However, activists concerned about the risks of nuclear energy are demanding that the plant be shut down. The safety of nuclear power plants is a technical matter. In this blog post we discuss the present mechanism to regulate nuclear energy and the legislative proposals to amend this mechanism. Atomic materials and atomic energy are governed by the Atomic Energy Act, 1962. The Act empowers the central government to produce, develop and use atomic energy. At present, nuclear safety is regulated by the Atomic Energy Regulatory Board (AERB). Some of the drawbacks of the present mechanism are discussed below. Key issues under the present nuclear safety regulatory mechanism The AERB is not empowered to operate as an independent operator. The AERB was established by the government through a notification and not through an Act of Parliament. Its powers and functions are therefore amendable by the Department of Atomic Energy through executive orders. The parliamentary oversight exercised upon such executive action is lower than the parliamentary oversight over statutes. [1. The executive action or the Rules are in force from the date of their notification. They are to be tabled before Parliament mandatorily. However, an executive action is discussed and put to vote in Parliament only if an objection is raised by a Member of Parliament. The executive orders may be reviewed by the committee on sub-ordinate legislation. However, this committee has to oversee a large volume of rules and regulations. For instance, there were 1264 statutory notifications that were tabled before the Rajya Sabha in 2011-12.] Furthermore, the Atomic Energy Commission that sets out the atomic energy policy, and oversees the functioning of the AERB, is headed by the Secretary, Department of Atomic Energy. This raises a conflict of interest, as the Department exercises administrative control over NPCIL that operates nuclear power plants. It is pertinent to note that various committee reports, including a CAG Report in 2011, had highlighted the drawbacks in the present regulatory mechanisms and recommended the establishment of a statutory regulator. A summary of the Report may be accessed here. Proposed mechanism Following the Fukushima nuclear incident in 2011, the Nuclear Safety Regulatory Authority Bill, 2011 was introduced in Parliament to replace the AERB. The Bill establishes the Nuclear Safety Regulatory Authority (NSRA) to regulate nuclear safety, and a Nuclear Safety Council to oversee nuclear safety policies that the NSRA issues. Under the Bill, all activities related to nuclear power and nuclear materials may only be carried out under a licence issued by the NSRA. Extent of powers and independence of the NSRA The Bill establishes the NSRA as a statutory authority that is empowered to issue nuclear safety policies and regulations. The Nuclear Safety Council established under the Bill to oversee these policies includes the Secretary, Department of Atomic Energy. The conflict of interest that exists under the present mechanism may thus continue under the proposed regulatory system. The Bill provides that members of the NSRA can be removed by an order of the central government without a judicial inquiry. This may affect the independence of the members of the NSRA. This process is at variance with enactments that establish other regulatory authorities such as TRAI and the Competition Commission of India. These enactments require a judicial inquiry prior to the removal of a member if it is alleged that he has acquired interest that is prejudicial to the functions of the authority. The proposed legislation also empowers the government to exclude strategic facilities from the ambit of the NSRA. The government can decide whether these facilities should be brought under the jurisdiction of another regulatory authority. These and other issues arising from the Bill are discussed 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.
