THE RULE OF LAW
MEDICAL LAW

INFORMED CONSENT - THE CONVENTION FOR THE PROTECTION OF HUMAN RIGHTS ANDDIGNITY OF THE HUMAN BEING WITH REGARD TO THE APPLICATION OF BIOLOGY AND
MEDICINE: CONVENTION ON HUMAN RIGHTS AND BIOMEDICINEArticle 7 of the International Covenant on Civil and Political Rights (1966) is enshrined inArticle 5 of the Convention for the Protection of Human Rights and Dignity of the Human Being
with regard to the Application of Biology and Medicine: Convention on Human Rights andBiomedicine (ETS No 164) (1997), Oviedo, Spain (the "Oviedo Convention"). The OviedoConvention is a legally binding international legal instrument on the protection of humanrights in the medical field. It sets out fundamental principles applicable to daily medical
practice and is regarded as such in the European Treaty on patient's rights. Chapter II Consent, Article 5 - General Rule states:"Chapter II – Consent
Article 5 – General rule
An intervention in the health field may only be carried out after the person
concerned has given free and informed consent to it.
This person shall beforehand be given appropriate information as to the purpose
and nature of the intervention as well as on its consequences and risks.
The person concerned may freely withdraw consent at any time."(emphasis added)
https://rm.coe.int/168007cf98

MEDICAL LAW (1)CONSENT IN MEDICAL TREATMENT
THE RIGHT to accept or refuse medical treatment and or medical procedures.
THE RIGHT TO BODILY INTEGRITY includes the long-established common law right of theindividual to choose to accept or refuse medical treatment or interventions, as confirmed in
the case of Re T (Adult - Refusal of Treatment (1993) Fam 95 at 107, Lord Donaldson stated:"An adult patient who...suffers from no mental incapacity has an absolute right tochoose whether to consent to medical treatment, to refuse it or to choose one
rather than another of the treatments being offered. This right of choice is not limited
to decisions which others might regard as sensible. It exists notwithstanding that thereasons for making the choice are rational, irrational, known, unknown or even nonexistent.
This position reflects the value that society places on personal autonomy in matters of
medical treatment and the very long established right of the patient to choose toaccept or refuse medical treatment from his or her own doctor (voluntas aegroti
suprema lex- Over his or her own body and mind, the individual is sovereign)(John Stuart Mill, On Liberty, 1859.).";-https://www.globalhealthrights.org/wp-content/uploads/2013/03/EWCA-1992-In-re-Tadult-refusal-of-medical-treatment.pdfand
The law of Negligence applies with respect to a breach of the Right to bodily integrity Informed consent - freely given - must be obtained prior to medical procedures and or
medical treatments and or participation in a live human experimentThe law of negligence is engaged when a person's physical and psychiatric integrity isbreached. In UK case law, in the judgement in the Supreme Court decision in the case ofMontgomery v Lanarkshire Health Board [2015] UKSC 11 Lady Hale stated inter alia:"It is now well recognised that the interest which the law of negligence protects is aperson's interest in their own physical and psychiatric integrity, an important featureof which is their autonomy, their freedom to decide what shall and shall not be donewith their body.
An adult person of sound mind is entitled to decide which, if any, of the available
forms of treatment to undergo, and her consent must be obtained before treatment
interfering with her bodily integrity is undertaken.""..it could now be stated with a reasonable degree of confidence that the need for
informed consent was firmly part of English law." https://www.supremecourt.uk/cases/docs/uksc-2013-0136-judgment.pdf
https://www.supremecourt.uk/cases/uksc-2013-0136.html

MEDICAL LAW (2)THE LEGAL DUTY TO OBTAIN INFORMED CONSENT BY BEFORE TREATMENT WITH BODILYINTEGRITY IS UNDERTAKEN
In the Supreme Court judgment in the UK case of Montgomery v Lanarkshire Health Board[2015] UKSC 11 (the "Montgomery case") was cited in the UK High Court (Queen's Bench) caseof Thefaut v Johnston 2017] EWHC 497 (QB) in the Judgment of the court at paras [52] and[53] entitled "Informed consent", which states, inter alia:"52.

In Montgomery v Lanarkshire Health Board [2015] UKSC 11("Montgomery") in the joint judgment of Lord Reed and Lord
Kerr (with whom Lord Neuberger, Lord Clarke, Lord Wilson andLord Hodge agreed) it was stated at paragraphs [87]...":"87. An adult person of sound mind is entitled to decide
which, if any, of the available forms of treatment toundergo, and her consent must be obtained before
treatment interfering with her bodily integrity isundertaken." ; (emphasis added)

MEDICAL LAW (3)INFORMATION ON ADVERSE EFFECTS
The legal Duty of Care to ensure the patient is aware of any Material Risks involved in any
medical treatment and of any reasonable alternative or variant treatments - the test ofMateriality of Risks
In the UK case of Montgomery v Lanarkshire Health Board [2015] UKSC 11 in the Judgment ofLord Reed and Lord Kerr (with whom Lord Neuberger, Lord Clarke, Lord Wilson and Lord Hodgeagreed) it was stated at paragraphs [87], inter alia:"87. (cont.) The doctor is therefore under a duty to takereasonable care to ensure that the patient is aware ofany material risks involved in any recommended
treatment, and of any reasonable alternative or variant
treatments.
The test of materiality is whether, in the circumstancesof the particular case, a reasonable person in thepatient's position would be likely to attach
significance to the risk, or the doctor is or should
reasonably be aware that the particular patient would
be likely to attach significance to it."In the UK case of Thefault v Johnson, at paragraph [53] and [56]of the judgment, the court
clarifies how "Materiality" of risks is measured.
53.
"...."Materiality" is measured according to that which thepatient would attach significance to, i.e. in the context of thedecision to be taken."; and56.
Paragraph [89] suggests that the subjective element could
extend quite far.....:"89. Three further points should be made. First, it follows fromthis approach that the assessment of whether a risk ismaterial cannot be reduced to percentages. The
significance of a given risk is likely to reflect a variety offactors besides its magnitude: for example, the nature of the risk, the effectwhich its occurrence would have upon the life of the patient, the importanceto the patient of the benefits sought to be achieved by the treatment, thealternatives available, and the risks involved in those alternatives.
The assessment is therefore fact-sensitive, and sensitive also to thecharacteristics of the patient." (emphasis added)

MEDICAL LAW (4)THE REQUIREMENT TO ENSURE THAT "ADEQUATE TIME AND SPACE" IS PROVIDED TO THE
INDIVIDUAL TO HAVE A "DIALOGUE" REGARDING THE MATERIAL RISKS INVOLVED AND THE
NEED TO "DE-JARGONISE COMMUNICATIONS"In the UK case of Thefaut v Johnston 2017] EWHC 497 (QB) in the Judgment of the court atparas [58] and [59] under the sub heading "Informed consent", the Judgment states, inter alia:"58. Paragraph [90] of Montgomery is significant in shedding light onthe modus operandi of communication. Two points emerge.
First the centrality of "dialogue" is stressed. ....The issue is not so much themeans of communication but its adequacy. Mr Peacock used the apt expression"adequate time and space" to describe the characteristics of a "dialogue"that satisfied the test in law.;
59.
The second point arising from paragraph [90] is the need tode-jargonise communications to ensure that the message isconveyed in a comprehensible manner....this can include
caution in the use of percentages. There is the risk that they canconvey false degrees of certainty where, in truth, none reallyexists. ... Paragraph [90] states:"90. Secondly, the doctor's advisory role involves dialogue,
the aim of which is to ensure that the patientunderstands the seriousness of her condition, and theanticipated benefits and risks of the proposed
treatment and any reasonable alternatives, so that
she is then in a position to make an informed
decision. This role will only be performed effectively if
the information provided is comprehensible.
The doctor's duty is not therefore fulfilled bybombarding the patient with technical informationwhich she cannot reasonably be expected to grasp, letalone by routinely demanding her signature on aconsent form." (emphasis added)
https://www.bailii.org/ew/cases/EWHC/QB/2017/497.html#para58
https://www.bailii.org/ew/cases/EWHC/QB/2017/497.html#para59

MEDICAL LAW (5)NHS CONSTITUTION
The NHS Constitution for England (last updated 2015) states under the heading "Respect,consent and confidentiality" that every person has the right to:"(a)be treated with dignity and respect, in accordance with their
human rights;(b)accept or refuse treatment that is offered, and not be given
any physical examination or treatment unless they havegiven valid consent;(c)be given information about the test and treatment options
available, what they involve and their risks and benefits;(d)be involved in planning and making decisions about their healthand care with their care provider or providers." (emphasis added)
https://www.gov.uk/government/publications/the-nhs-constitution-for-england/the-nhsconstitution-for-englandMEDICAL LAW (6)THE GENERAL MEDICAL COUNCIL
Doctors are expected to keep up to date with and practise in line with GMC guidance andthe law
The General Medical Council's (the "GMC") factsheet entitled "Key legislation and case law
relating to decision making and consent", states that
"This factsheet sets out some of the key legislation and case law relating to medical
decision making and consent in the UK. It is not intended to be a comprehensive list,
nor is it a substitute for independent, up-to-date legal advice.
We expect doctors to keep up to date with and practise in line with our guidance andthe law."(emphasis added)
https://www.gmc-uk.org/-/media/documents/factsheet---key-legislation-and-case-lawrelating-to-decision-making-and-consent-84176182.pdf
The right to refuse medical treatment includes the right to refuse life-saving treatment as per
the UK Court of Protection's decision in the case of King's College NHS Foundation Trust v C[2015] EWCOP 80 in which the Judgment states, inter alia:"A capacious individual is entitled to decide whether or not to accept medicaltreatment. The right to refuse treatment extends to declining treatment thatwould, if administered, save the life of the patient."
https://www.familylawweek.co.uk/site.aspx?i=ed151871
The GMC factsheet cites the following in relation to the case of King's College NHS Foundation
Trust v C [2015] EWCOP 80:"Assessing a patient’s capacity when they make a decision that is considered unwise:
The Court of Protection held the following.
A person with capacity is entitled to decide whether or not toaccept
medicaltreatment. The right to refuse treatment extends todeclining treatment thatwould save the life of the patient.
A person must not be judged to lack capacity to make a decision solely because they
make a decision that is considered to be unwise."https://www.gmc-uk.org/-/media/documents/factsheet---key-legislation-and-case-lawrelating-to-decision-making-and-consent-84176182.pdf

MEDICAL LAW (7)CAPACITY TO INFORMED CONSENTThe Mental Capacity Act 2005 - the legal framework for assessing an individual's mental
capacity to provide informed consent to medical treatment
The GMC factsheet cites the following in relation to the law applicable to individual's aged 16
and over and their individual capacity to consent to medical treatment in England and Wales
as follows:"Mental Capacity Act 2005
This Act provides a legal framework for making decisions on behalf of people
aged 16 or over who lack capacity to make decisions themselves. It clarifies:-who can make decisions, including decisions about medical care andtreatment, for people who are unable to decide for themselves-how those decisions should be made.

Doctors and other healthcare professionals must refer to the Mental Capacity Act Codeof Practice, which explains how the Act should work on a daily basis and sets out thesteps that those using and interpreting it should follow when:-assessing a person’s capacity-

reaching a decision in the best interests of a person who does not havecapacity."

https://www.gmc-uk.org/-/media/documents/factsheet---key-legislation-and-case-lawrelating-to-decision-making-and-consent-84176182.pdf
https://www.legislation.gov.uk/ukpga/2005/9/contents
https://www.gov.uk/government/publications/mental-capacity-act-code-of-practicehttps://www.bma.org.uk/advice-and-support/ethics/adults-who-lack-capacity/mentalcapacity-act-toolkitPatients lacking capacity but who previously objected to vaccination could not be forcibly
treated with a COVID-19 vaccine
In a recent ruling by the Court of Protection, SS v Richmond [2021] EWCOP 31, it was foundthat a dementia patient who lacked capacity but who previously objected to vaccination could
not be forcibly treated with a COVID-19 vaccine.

-https://www.courtofprotectionhub.uk/cases/ss-v-london-borough-of-richmond-uponthames-anor-2021-ewcop-31
https://www.bailii.org/ew/cases/EWCOP/2021/31.html

MEDICAL LAW (8)THE IMPOSITION OF MEDICAL TREATMENT WITHOUT CONSENT CONSTITUTES AN
INTERFERENCE WITH ARTICLE 8 OF THE EUROPEAN CONVENTION ON HUMAN RIGHTS
The case law of the European Court of Human Rights establishes that the provision of medicaltreatment without consent constitutes an interference with article 8 of the European
Convention on Human Rights ("the ECHR"). The imposition of medical treatment without theconsent of a mentally competent patient, would interfere with a person's physical and or
mental integrity in a manner capable of engaging the rights protected under article 8 (1) ofthe Convention as held in the case of Pretty v United Kingdom (2002) 35 EHRR 1 (EctHR), in
which the court held, inter alia:"the imposition of medical treatment, without the consent of a mentally competent
adult patient, would interfere with a person's physical integrity in a manner capableof engaging the rights protected under article 8 (1) of the Convention [the ECHR]."(emphasis added)
https://www.globalhealthrights.org/wp-content/uploads/2013/10/ECtHR-2002-Pretty-vUnited-Kingdom.pdf
https://www.echr.coe.int/Documents/Guide_Art_8_ENG.pdf