MASTER CLASS IV Convention Centre, Lavale

NAME OF THE SPEAKER: Dr. Sanjay Gupte DESIGNATION: Past President, FOGSI TOPIC: Special Laws and Legal Framework

SUMMARY Dr. Gupte talked about 4 laws – PCPNDT Act – Transplantation of Human Organs Act 1994 – Surrogacy and its Ethics – Maharashtra Clinical Establishment Act He discussed the various acts describing their contents, legalities, penalties in them.

PCPNDT Act In this act he gave an insight about the various diagnostic tests which can be performed and the various legalities that are involved. In this act he stressed upon the various consequences that a person can face if he performs a sex determination test. He also mentioned about the precautions and the duties which an obstetrician doctor should take while treating a pregnant lady.

He defined terminologies like genetic clinic, Genetic Counseling Centre, Genetic Laboratory, Pre-natal diagnostic procedures, Prenatal diagnostic test. He also spoke about who has the authority to open these centers and perform these tests in those centers. He then mentioned about the terms and conditions which are required for the registration of the clinic or the centers and the consequences that the practitioner will have to face incase he violates the Act.

He also mentioned the list of indications for USG during pregnancy. He mentioned about some of the offences which come under this act like disclosing of the gender of the child, an ayurvedic doctor prescribing medicine that will help the female patient to get a male child etc. He gave an insight about the code of conduct that will apply incase any pregnant lady confirms about the female fetus to another doctor He concluded this act by mentioning about the checklist under PCPNDT Act.

Transplantation of Human Organs Act 1994 In this act he gave a brief idea about the organ transplantation and what includes in organ transplantation like the consent letter of the patient and donor, health status of both, certificate of registration of the institute and the various ethical issues involved in it. He also included the role of medical council is essential for practicing the organ transplantation procedure legally.

The Act defines two categories of donors. – First, it permits a near relative, defined as a patient’s spouse, parents, siblings, and children, to donate a kidney to the patient. – Secondly, live donors who are not near relatives but are willing to donate kidneys to the recipient due to attachment or any other reasons are permitted to do so, provided that the transplantations have the approval of the Authorization Committee, established under the Act

Authority for the removal of human organs: Any donor may, in such manner and subject to such conditions as may be prescribed, authorize the removal, before his death, of any human organ of his body for therapeutic purposes. If any donor had, in writing and in the presence of two or more witnesses (at least one of whom is a near relative of such person), unequivocally authorized at any time before his death. Any human organ is to be removed from the body of a person in the event of his brain-stem death, no such removal shall be undertaken unless such death is certified

He talked about the preservation of the human organs that can be used further for the transplantation purpose. He mentioned about the various Restrictions on removal and transplantation of human organs. The certificate of registration is necessary for every institution which is conducting human organ transplantation

The ethics of transplantation can be expressed in three requirements: – Medical integrity – Scientific validity – Consent To conclude this act he emphasized on the importance of the ethical issues and the control of illegal trade of organ transplantation.

Surrogacy and its ethics Here he briefed about what is surrogation and the two types of surrogation which can be performed i.e. gestational surrogacy and traditional surrogacy. He spoke about the rights of the surrogate mother and the commissioning parents. He also mentioned about the legal contract which is to be signed between the commission parents and the surrogate mother. He also briefed about malpractices which are going on these days thereby violating the Act.

He then spoke about The Legal Scenario in India. Commercial surrogacy has been legal in India since 2002 and recently there has been a sharp increase in the frequency of commercial surrogacy arrangement. People from western countries are flocking to India to get a baby of their own genes. To deal with legal pre-requisites for a commercial surrogacy, there is no uniform law in India.

Various indications of the surrogacy law are After hysterectomy o for cancer o For post partum hemorrhage o for menorrhagia Congenital absence of the uterus Repeated failure of IVF Recurrent miscarriage Severe medical conditions incompatible with pregnancy

He mentioned about the Responsibility of childrearing, financial transactions, surrogate mother criteria. He briefed about the commercialization of surrogacy and The ART center should not advertise its surrogacy services in any way. He talked about all the risks involved in being a surrogate as well as the tests and about the availability of the surrogates

He then talked about Right of the child to information about donors or surrogates. In conclusion he said: – In the present day scenario of ART, it would be unethical to prohibit surrogacy and deny a sect of women their right to become a mom. – Laws should provide a helping hand in regulating and monitoring surrogacy to prevent the exploitation of poor surrogate women by ART centers and to ensure the smooth handing over of the baby from the gestational surrogate to the commissioning couple.

Maharashtra Clinical Establishment Act It is still a proposed draft of the bill 2014 in the State of Maharashtra. The benefit of this Act if it comes into force will be that. All the government departments will also be included apart from the private institutions. Patients will also be given the right. Council will also be under this Act. Appellate authority for clinical establishment. And the various penalties that will adhere with it for violating the terms of this act.

Powers of State Council under this act Classify the clinical establishments into different categories; Develop the templates for developing minimum standards and minimum standards of clinical establishments by appointing different committees and their periodic review; Determine within a period of two years from its establishment, the first set of standards for ensuring proper healthcare by the clinical establishments Safeguard the interests of patients and health care providers alike.

Conditions and Authority for Registration Local registering authority 1. For Municipal corporation area Medical Officer Health of Municipal Corporation – Chairman Deputy Medical Officer Health of Municipal Corporation – Member Secretary. Medical officer delegated this subject appointed by Chairman – Member 2. For Municipality area Civil Surgeon – Chairman Additional Civil Surgeon – Member Secretary Medical officer delegated this subject appointed by Chairman - Member

He mentioned about the Procedure for provisional and permanent registration Rules under this act 1. The State Government may, by notification, make rules for carrying out all or any of the provisions of this Act. 2. In particular and without prejudice to the generality of the foregoing power, such rules may provide for all or any of the following matters, namely: o Allowances for the members of the State Council under sub-section (4) of section 3;

o Consultative process to be followed for determining standards and classification of clinical establishments under section 7; o The procedure under which the powers of the local registration authority may be exercised for the purpose of provisional registration of clinical establishment o The minimum standards of facilities and services under clause (i) of section 12; To conclude he talked about the rights and the responsibilities of the patient that will encompass with the constitution of this act.

Report Prepared By: Akhila Nayak Anisha Mehta Ebrahim Khan Nikhil Dhorepatil Shirin Khan Swati Sonik Yogita Patil (MBA –HHM )