Position Statements
The executive members of Society for Indian Academy of Medical Genetics approved this document on 21 November 2018 Correspondence to: info@iamg.in
Background:
Recent advances in genetics and genomic technologies have enabled prevention, diagnosis and improvements in health of general public. However currently all the health insurance providers exclude genetic conditions, birth defects, congenital disorders and congenital anomalies from the purview of coverage. The Society for Indian Academy of Medical Genetics strongly believes that an individual's genetic information should not be used for discrimination from health insurance coverage or discrimination in employment.
Present status:
The Insurance Act, 1938, envisaged the establishment of the Insurance Regulatory Development Authority (IRDA) for regulating the insurance sector in India. The guidelines issued by IRDA on February 20, 2013, excluded conditions like pregnancy, infertility, congenital and genetic conditions, but did not define 'genetic' conditions (1). Following this, the insurance companies in India amended the terms of their policies and excluded 'genetic conditions' from insurance coverage. On July 29, 2016, IRDA issued a new guideline for standardization of insurance in health care in India, in which, 'genetic condition' was not mentioned and only 'congenital anomalies' were mentioned (2). On February 26, 2018, Delhi High court held that 'genetic disorder' was a vague term and should not be used to exclude insurance claims and directed the IRDA to re-look at their exclusionary clauses to prevent rejection of claims by insurance companies on the basis of genetic status of individuals (3). On March 19, 2018, IRDA issued a notification directing all insurance companies not to include 'genetic diseases' as one of their exclusion criteria in all health insurance policies (4). The Honorable Supreme Court of India has stayed the operation judgment of the Delhi High Court on August 27, 2018 (5).
The Universal Declaration of Human Rights (6), 1948 states, "Everyone has a right to a standard of living adequate for the health and well-being of himself and his family, including food, clothing, housing and medical care, and necessary social services, and the right to security in the vent of unemployment, sickness, disability, widowhood, old age, or other lack of livelihood in circumstances beyond his control". The European Convention on Human Rights & Biomedicine does not allow discrimination of any kind on the basis of genetic heritage and permits genetic testing for the purposes of health or for scientific research only and not for insurance purposes. Predictive genetic testing should not be done for insurance purposes (7). Many European countries like Austria, Belgium, Switzerland, Denmark and Portugal have made legislations for use and regulation of genetic data (3). Several countries across the world have enacted laws in respect of genetic discrimination by insurance corporations. The Genetic Non-discrimination Act, 2008, in United States of America, bars the use of genetic information in health, education and employment and prohibits charging of higher premium based on the genetic predisposition of an individual for developing a disease in future (8).
Article 14 of the Constitution of India prohibits discrimination of any kind, which includes discrimination based on genetic heritage of an individual (9). The Right to Health is a Fundamental Right, as an integral part of Article 21 (10) and Right to Healthcare is also a Fundamental Right and the right to avail an insurance is an integral part of Right to Healthcare. Hence it is unconstitutional to discriminate individuals based on their genetic status.
Society for Indian Academy of Medical Genetics position on discrimination against individuals with genetic conditions: Genetic and genomic information of an individual should not be used for discrimination against health insurance and employment. Any such discrimination would amount to misuse of such information.
Explanation:
1. Genetic and genomic information: This means history, clinical evaluation, imaging or medical tests that provide genetic information or reveal the genetic constitution of an individual. Genetic constitution of an individual is determined at the time of conception and well before birth of an individual. They can be revealed by several means: clinical evaluation, family history, analysis of pedigree, blood/urine or any other laboratory tests, imaging (CT scan, MRI, and ultrasonography), genetic/genomic tests (Sanger sequencing, next generation sequencing or any other traditional or specialized genetic tests) and participation in genetic research. Genetic information of an individual aids healthcare of an individual.
2. Discrimination in health insurance: This includes levying additional premiums, asking for genetic/genomic information of an individual, refusing health insurance, refusing claims based on genetic and genomic information and refusing renewals.
3. Discrimination in employment: Employers cannot discriminate in appointment, remuneration, promotion and provision of medical facilities based on genetic and genomic information.
References:
https://indiankanoon.org/doc/60279502/
https://www.irdai.gov.in/ADMINCMS/cms/Uploadedfiles/Guidelines%20on%20Standardization%20in%20Health%20Insurance%202016.pdf
- M/S United India Insurance ... vs Jai Parkash Tayal on 26 February, 2018. RFA 610/2016 & CM Nos.45832/2017
https://www.livelaw.in/irdai-directs-insurance-companies-stop-excluding-genetic-disorders-new-health-insurance-policies-cites-delhi-hc-judgment-read-notification/(Ref: IRDAI/HLT/REG/CIR/046/03/2018)
http://www.indiaenvironmentportal.org.in/content/458245/order-of-the-supreme-court-of-india-regarding-the-right-of-insurers-to-reject-claims-on-genetic-disorders-clause-27082018/
Universal Declaration of Human Rights, UN (December 10, 1948)
European Convention on Human Rights & Biomedicine, Oviedo (1997)
Genetic Non-discrimination Act of USA (2008)
Article 14 in The Constitution Of India 1949
Article 21 in The Constitution Of India 1949
Background:
With rapid technological advances, genomic testing has become widely available and affordable to the public. 'Direct-to-consumer genetic testing (DTC-GT)' refers to genomic/genetic testing offered to consumers by commercial service providers without the supervision and guidance of a health care professional, predominantly for the purpose of finding their ethnic origins, paternity, genomic variants that might affect disease pre-disposition, life style, or disease status, and management. Due to wider access to online advertisements and publicity gimmicks evoking the curiosity of consumers, there has been a rise in the demand and uptake of DTC-GT in India. The Society for Indian Academy of Medical Genetics (SIAMG) believes that DTC-GT without involving a health care professional causes more harm than good and the society strongly discourages the use of DTC-GT in any circumstance.
Present status:
No strict regulations for DTC-GT services exist in India. Currently, worldwide more than 300 commercial organisations offer DTC-GT and information is easily available over the internet (organisations' websites or e-commerce websites) with unmoderated access, with or without the intermediation of a healthcare professional. These commercial organizations often make exaggerated claims and promises on benefits of these services by providing scientifically unproven information.
Society for Indian Academy of Medical Genetics position on direct-to-consumer genetic testing has discussed this issue among its executive committee members and has resolved that:
The SIAMG does not endorse DCT-GT and strongly dissuades the use of over-the-counter DTC-GT for healthcare purposes (for the diagnosis, predisposition testing, carrier testing and management) or in any other form of service delivery (paternity testing, ethnic origin, predisposition to life style disorders, pharmacogenomics etc.) without a healthcare professional and/ or pre and post-test genetic counseling. SIAMG condemns the use of DTC-GT for testing of minors for carrier or disease predisposition testing.
Explanation:
1. Genetic tests and interpretation of their results are complex and are associated with ethical, social and legal issues. Any form of genetic testing should be undertaken for an appropriate medical indication under a certified genetic healthcare professional after appropriate pre-test counselling and informed consent. Post-test counseling should be provided while providing the results back.
2. The clinical utility and validity of DTC-GT are questionable as they emphasize only on the genetic variants, totally disregarding the clinical signs/ symptoms, medical and family history, effects of environment, and lifestyle of the consumers. In India, there are no quality assurance guidelines for most of the genetic assays and pathogenicity prediction of the detected genetic variants and hence clinical implications of DTC-GT are extremely doubtful.
3. There is a huge scope for misinterpretation of the genetic results as neither the commercial organizations nor consumers understand the complexity of genomic assays in the absence of health care professionals. They may fail to realize that the genetic test performed may not be able to provide an etiological diagnosis for condition in question. Moreover, this might lead to a sense of false assurance, if genetic test has not detected any clinically relevant variant. DTC-GT may also generate undue anxiety if result is positive, as there is no healthcare professional to explain the implication of the results.
4. The consumers may not completely understand the utility, implications and actionability of the detected genetic variants and thus may receive inappropriate medical advice which may cause immense psychological distress and discrimination. Such unsupervised and unwarranted testing can cause a huge burden on the healthcare system and genetic counsellors, who will be requested to interpret the complex genetic results.
5. Concerns over consumer data storage, privacy and sharing also exist
6. Predictive testing in minors raises many ethical, legal and social concerns.
References:
Farkas DH, Holland CA. Direct-to-consumer genetic testing: two sides of the coin. J Mol Diagn 2009; 11: 263-5.
Phillips AM. Data on Direct-to-Consumer Genetic Testing and DNA testing companies. DOI: 10.5281/zenodo.1183565. https://zenodo. org/record/1183565#.XM1YeegzY2w
Ramos E, Weissman SM. The dawn of consumerdirected testing. Am J Med Genet C Semin Med Genet 2018; 178: 89-97.
Scott Roberts J, Ostergren J. Direct-to-Consumer Genetic Testing and Personal Genomics Services: A Review of Recent Empirical Studies. Curr Genet Med Rep 2013; 1: 182-200.
Su P. Direct-to-consumer genetic testing: a comprehensive view. Yale J Biol Med 2013; 86: 359-365.
- https://www.healio.com/gastroenterology/oncology/news/online/%7B3839aa60-4115-4298-94fd-8dd35927079d%7D/dtc-genetic-testingincreased-uptake-requires-expert-guidance
Drafted by Dr Dhanya Lakshmi N1 and Urja Asher2 on behalf of Society of Indian Academy of Medical Genetics (SIAMG)
1Associate professor, 2MSc Genetic counselling, Department of Medical Genetics, Kasturba Medical College, Manipal, India The executive committee of SIAMG approved this statement on 10 August 2019
