Consumer Protection Flashcards
who might we need protecting from?
Ourselves:
Society:
Commercial Interests:
The nation state:
What are the accepted norms that define us?
An Individuals identity
The information that defines them:
Personal data – information identifying a person
Personal sensitive data – information about an individual including health records
The information that defines the individual in the context of health?
Their characteristics – age gender, social and behavioural metrics
These are biochemical, physiological and genetic
The results of tests that describes them
Their health and wellbeing past and present
the right of the individual to preotection is define by their…
Human rights
what does the UN declaration of human rights 1948 say?
Article 1: “All human beings are born free and equal in dignity and rights.”
Atricle 2: “without distinction of any kind, such as race, colour, sex,” …., “national or social origin,” …. “or other status. “
Article 7: “All are equal before the law and are entitled without any discrimination to equal protection of the law”
Article 25: “Everyone has the right to a standard of living adequate for the health and well-being of himself and of his family” including “medical care and necessary social services”
Why might we need protecting in the context of genetic testing
Quality, validity and utility:
Unregulated, inappropriate claims for testing
Unvalidated and low quality of test or service
Low or no utility
Legality:
Test that contravenes legal and social norms
Pre-implantation selection or selective abortion
Eugenics in all but name
Psychological and social harm:
Access to support and follow up
Discrimination:
In the work place
In society
In healthcare
What is discrimination?
Degrading treatment and inequality of rights of an individual or group
chamber defintion of discrimination
Chambers dictionary: unfair treatment of a person, racial group, minority, etc; action based on prejudice
insureres defintion of discrimination
Insurers: rational vs irrational discrimination – rational personal predictive risk assessment based on risk an individual brings to the pool
lawyers definition of discrimination
Lawers: legal vs illegal discrimination
patients definition of discrimination?
Patients: differential negative treatments of an individual based on their current, past health or their future health risk (genetic makeup?)
what is genetic discrimination?
Different groups or people have different perspectives, this potentially leads conflicting views of acceptability
These views are often influenced by socioeconomic deprivation, lack of national resources, immigration and globalisation
Conflict potentially leads to shifting norms of acceptability restricted access exclusion from healthcare, insurance, housing, reproductive freedom etc
evidence of genetic discrimination
1998 uk study Low et al:
Of members of support groups for patients with genetic disease
33% encountered problems obtaining health insurance
5% of the general public surveyed had similar difficulty
13% of individuals with no actual genetic risk reported genetic discrimination by insurers
2000 us study cancer genetecists, Matloff et al:
68% stated they would not bill insurance companies for genetic testing for fear of discrimination
26% reported the use of an alias when requesting testing
2013 international review Joly et al:
48% of studies had some empirical evidence of rare discrimination
42% of studies reported genetic discrimination that gave serious grounds for concern
explain regulation
Primary purpose is to provide a framework which
secures the individuals and societies rights and best interests.
Secondary purpose to provide public confidence through openness and transparency
what is regulation driven by?
Regulation is driven by Biomedical ethics or Bioethics
what are the european regulations?
European legislation forms the minimum legislative framework
In Vitro Diagnostic Device Directive (IVDD 1998)
IVDD enforced by the UK Medicines and Healthcare Products Regulatory Agency (MHRA) individual countries legislate on top of this framework few regulate beyond this
Regulates test methods and equipment - not whether conclusions or medical advice drawn from the results benefit the consumer
Applies to commercial genetic tests for health purposes only
explain uk voluntary regulation?
Clinical Pathology Accreditation UK Ltd scheme and other voluntary schemes
ensures regular inspection and quality of laboratory service
does not apply to the clinical efficacy or interpretation of the results, similar to CLIA in US
UK Genetic Testing Network
advisory organisation that provides commissioning support to the NHS and DH for NHS patients in the UK
promotes quality & equality of access
regulation by bioethical consent
Council of Europe Convention on Human Rights and Biomedicine (1997, 2008)
International agreement on Bioethics
legally binding to signatories, requiring parliamentary ratification
Applies to tests for “health purposes” includes specifically genetic tests & services
Requires these are of appropriate quality, validity, and utility
Doesn’t apply to DTC testing this currently escapes “for health purposes”?
Human rights and privacy in europe: genetic exceptionalism
Is a Life time risk of cardiovascular disease determined by blood pressure & cholesterol different in its privacy from the same predictive risk accorded by a genetic factor?
Is the risk of cancer predicted by life style different from SNP(s) predisposing to cancer?
Is a family history of dementia different from correlative genetic risk of dementia?
The genome tends to be treated differently from other personal risk factors – this is debatable and controversial
define genetic exeptionalism
: the concept that genetic data/information is somehow relates to identity and is more private
