The Surrogacy (Regulation) Bill, 2016 was introduced in Lok Sabha on November 21, 2016 and is listed for passage this week.  The Bill regulates altruistic surrogacy and prohibits commercial surrogacy.  We present a brief overview of the Bill and some issues that may need to be considered:

How is surrogacy regulated under the Bill?

The Bill defines surrogacy as a practice where a woman gives birth to a child for an eligible couple and agrees to hand over the child after the birth to them.  The Bill allows altruistic surrogacy which involves a surrogacy arrangement where the monetary reward only involves medical expenses and insurance coverage for the surrogate mother.  Commercial surrogacy is prohibited under the Bill.  This type of surrogacy includes a monetary benefit or reward (in cash or kind) that exceeds basic medical expenses and insurance for the surrogate mother.

What is the eligibility criteria for couples intending to commission surrogacy?

In order to be eligible, the couple intending to commission a surrogacy arrangement must be a close relative of the surrogate mother.  In addition, the couple has to prove that they fulfil all of the following conditions:

  • They are Indian citizens who have been married for at least five years;
  • They are in the age group of 23-50 years (female partner) and 26-55 years (male partner);
  • A medical certificate stating that either or both partners are infertile;
  • They do not have any surviving child (whether biological, adopted or surrogate), except if the surviving child is mentally or physically challenged or suffers from a fatal illness;
  • A court order concerning the parentage and custody of the child to be born through surrogacy;
  • Insurance coverage for the surrogate mother.

Additional eligibility conditions that the intending couple need to meet may be specified by regulations. It could be argued that the qualifying conditions for surrogacy should be specified in the Bill and not be delegated to regulations.

Who is a close relative under the Bill?

The Bill does not define the term close relative.

Who is eligible to be a surrogate mother?

The surrogate mother, apart from proving that she is a close relative of the couple intending the surrogacy, also has to prove all the following conditions:

  • She was or is married and has a child of her own;
  • She is 25 to 35 years old;
  • She has not been a surrogate mother before;
  • She possesses a medical certificate of her fitness for surrogacy.

What will be the legal status of a surrogate child?

The Bill states that any child born out of a surrogacy procedure shall be the biological child of the intending couple and will be entitled to all rights and privileges that are available to a natural child.

What is the process for commissioning a surrogacy?

The intending couple and the surrogate mother can undergo a surrogacy procedure only at surrogacy clinics that are registered with the government.  To initiate the procedure, the couple and the surrogate mother need to possess certificates to prove that there are eligible.  These certificates will be granted by a government authority if the couple and the surrogate mother fulfill all the conditions mentioned above.  The Bill does not specify a time period within which the authority needs to grant the certificates.  Further, the Bill does not specify a review or appeal procedure in case the application for the certificates is rejected.

What is the penalty for engaging in commercial surrogacy under the Bill?

The Bill specifies that any person who takes the aid of a doctor or a surrogacy clinic in order to conduct commercial surrogacy will be punishable with imprisonment for a minimum term of five years and a fine that may extend to five lakh rupees.

Offences such as (i) undertaking or advertising commercial surrogacy; (ii) exploiting or abandoning the surrogate mother or child; and (iii) selling or importing human embryo or gametes for surrogacy will attract a minimum penalty of 10 years and a fine up to 10 lakh rupees.

[This post has been co – authored by Nivedita Rao]

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:

  • The Under-Graduate Medical Education Board (UGMEB) and the Post-Graduate Medical Education Board (PGMEB): These two bodies will be responsible for formulating standards, curriculum, guidelines for medical education, and granting recognition to medical qualifications at the under-graduate and post-graduate levels respectively.
  • The Medical Assessment and Rating Board: The Board will have the power to levy monetary penalties on institutions which fail to maintain the minimum standards as laid down by the UGMEB and the PGMEB.  It will also grant permissions for establishing new medical colleges, starting postgraduate courses, and increasing the number of seats in a medical college.
  • The Ethics and Medical Registration Board: This Board will maintain a National Register of all the licensed medical practitioners in the country, and also regulate professional and medical conduct.  Only those included in the Register will be allowed to practice as doctors.  The Board will also maintain a register of all licensed community health providers in the country.

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.