The National Health Act 2014 in Clinical Practice Overview

The 

National Health Act 2014

 in

clinical practice: The Known, the

Unknown and the Cryptic

Adegboyega Ogunwale

, 

MB, BS (IL), PGD

(Statistics), FWACP, LLM (Med. Law & Ethics)

Introduction

•

A landmark event occurred in Nigeria on Friday,

31

st

 October, 2014 when the much publicized

National Health Act received Presidential assent

under the hand of 

Dr. Goodluck Ebele Jonathan,

GCFR

•

Even Mr President (as he then was) and the

Nigeria that he superintended have always been

a brilliant mix of the known, the unknown and

the cryptic indeed. To say anything further will

certainly be scandalous!

•

Anyway, we got a good Act which can be better

and some day, could be best.

The National Health Act

•

Title: ‘An Act to Provide A Framework for the

Regulation, Development and Management of a

National Health System and Set Standards for

Rendering Services in the Federation, And Other

Matters Connected Therewith, 2014.

•

History outline:

–

First reading: Tuesday, 2

nd

 October, 2012

–

Second Reading: Wednesday, 12

th

 December, 2012

–

Third Reading & Passage: Wed., 19

th

 Feb., 2014

–

Presidential Assent: October 31, 2014

3

The National Health Act 2

•

Arrangement:

–

Part I: Responsibility for health and Eligibility for

health Services and establishment of National

Health System (Nigerian NHS!)

–

Part II: Health Establishments and Technologies

–

Part III: Rights and Obligations of Users and

Healthcare Personnel

–

Part IV: National Health Research and Information

System

–

Part V: Human Resources for Health

4

The National Health Act 3

–

Part VI: Control of Use of Blood, Blood products,

Tissue and Gametes in Humans

–

Part VII: Regulations and Miscellaneous Provisions

5

Areas of focus in clinical practice

•

Main sections of emphasis:

–

Sections 20-30

•

Other relevant sections:

–

Section 38

–

Section 40

–

Section 43

–

Section 45: 

Industrial dispute in the health sector

–

Section 48

Emergency treatment under the Act

•

Covered in section 20

–

“A health care provider, health worker or health

establishment shall not refuse a person emergency

medical treatment for 

any reason

whatsoever

”(emphasis mine)

–

Contravention: guilty of an offence; fine of N100,000

or six months’ imprisonment or both

•

Cryptic

 OR 

unknown

:

–

s. 64 defines “reasonable cause” as any extenuating

circumstance which prevents the healthcare provider,

etc. from providing emergency medical treatment

•

Does compliance with s. 20 differentiate

private

 from 

public

 health establishments?

No. So, who bears the cost of mandatory

treatment on emergency basis in private Hs?

•

Note: s. 48(1)(b): consent may be 

waived

 for

medical investigations and treatment in

emergency cases although this relates directly

to removal of tissue, blood or blood products

from living persons – extent of application??

Rights of users and providers of

healthcare

•

Covered in section 21

•

Human rights: apply to both users and

providers

•

Ethical duty to protect the rights of patients

–

Autonomy

–

Beneficence

–

Non-maleficence

–

Justice: in the distributive sense

Do patients have rights?

•

Patients are primarily human beings before they become ill.

•

This shared humanity makes it clear that they have rights.

•

International declarations and conventions indicate this

position:

–

WHO Constitution

–

WHO Declaration of Alma-Ata

–

Universal Declaration of Human Rights (1948), African Charter,

Nigerian Constitution (1999 as amended)

–

International Covenant on Civil and Political Rights and the

International Covenant on Economic, Social and Cultural Rights

(1966)

–

UN Convention on the Rights of the Child (1989)

–

UNESCO Universal Declaration on the Human Genome and

Human Rights (1997)

–

UNESCO Universal Declaration on Bioethics and Human Rights

10

Do patients have rights? 2

•

A summary of rights in healthcare (Mason & Laurie, 2013):

–

Right to be respected and treated with dignity

–

Right to the highest attainable standard of physical and mental

health and associated right to healthcare

–

Right to consent and to refuse consent to medical intervention

–

Right not to be subjected to medical or scientific

experimentation without consent

–

Right to equality under the law

–

Right to protection against arbitrary interference with privacy or

with the family

–

Right to enjoy the benefits of scientific progress and its

application

–

The protection of the rights of vulnerable persons

11

Do patients have rights? 3

•

The EU Charter of patients’ rights (2002) provides 14

key rights in the healthcare 

context:

12

Do healthcare providers have rights?

•

Section 21:

–

Right to protection from injury or damage to the

person and property of healthcare personnel

–

Right to protection from disease transmission e.g.

Ebola and the need for PPE + other protective steps

–

Right to refuse treatment of physically or verbally

abusive service user or user who sexually harasses

provider; may report such user to appropriate

authorities

–

Conscientious objection e.g. to assume care of JWs

who may not cooperate with treatments such as BT

PART A, Section 9, MDCN Code of Ethics

(2004

)

Indemnity of staff

•

Section 22

•

Applies only when staff is not found negligent

•

Unknown

: this law is silent as to what

happens if healthcare provider found

negligent 

while following institutional policy

•

Cryptic

: Raises the need for proper indemnity

insurance for key healthcare professionals

Healthcare user’s consent

•

Covered under section 23

•

Emphasis appears to be on ‘full information’ or

disclosure to patient

•

Voluntariness and capacity not adequately

addressed (Compare with instruments such as

Nuremberg Code (1949

), 

Declaration of Helsinki

(as amended, 2013)

, the UK 

MCA (2005)

•

Where does this law stand on the matter of

substituted judgment? Will it be proxy consent or

best interest?

Incompetent adults

•

s. 26(2)(b)(ii): consent for disclosure of

confidential material may be provided by

‘guardian’ or ‘representative’

•

s. 64 (interpretations): for patients incapable of

taking decisions, “user” (i.e. proxy for the patient)

includes: SPOUSE or in the absence of the

spouse, PARENT, GRANDPARENT, ADULT CHILD

(NOT LESS THAN 18), BROTHER, SISTER OR

ANOTHER PERSON AUTHORISED BY LAW TO ACT

ON BEHALF OF THE PATIENT (no particular order

defined).

Consent and children

•

s. 64: when user is ‘below the age of majority’,

consent may be provided by proxy who may

be patient’s parent or guardian or another

person authorised by law to act on behalf of

the child. What is this age: 

16, or 18?

•

Where does this law stand in the arena of

“Gillick competence”? Is there a direct

translocation of English Jurisprudence into

Nigeria in this matter? MDCN (2004) seems to

believe so (s. 39, pp. 49-50!)

Informed consent: relevant case law

•

Okonkwo v. MDPDT (Court of Appeal, Lagos;

June, 1999

)

–

Ob/Gyn charged with causing death (by

negligence) of a 29 year old female with Anaemia,

a member of the Jehovah’s Witnesses; she refused

blood and was referred to Okonkwo (also a JW).

He kept her in his clinic for 4 days (without blood

transfusion) and she died. He was ready to give

blood (pt refused); he gave other treatments

–

MDPDT verdict – guilty and was suspended from

medical practice for 6 months

19

•

Allowing the appeal: The court held:-

–

“If a patient refuses to give informed

consent, the law is that the medical

practitioner will not proceed to administer

the medical treatment. Otherwise, the

practitioner will be liable for assault or

other forms of trespass to the person and

for any other mental or physical injury or

damage which may occur”

20

•

“Having regard to sections 35(1) (freedom of

thought, conscience, religion) and 36(1)

(freedom to hold opinions) of the Constitution

of the Federal Republic of Nigeria (1979) and

other personal rights of the individual, 

an

adult of sound mind has a right to choose

what medical treatment made available to

him subject to and when to refuse

”

•

“The courts should not allow medical opinion

of what is best for the patient to over-ride the

patient’s right to decide for himself…”

21

•

Justice Benjamin Cardozo in 

Schloendorff v.

Society of New York Hospital

, 211 N.Y. 125, 105

N.E. 92 (1914) held:

–

“Every human being of adult years and sound mind

has a right to determine what shall be done with his

own body; and a surgeon who performs an operation

without his patient's consent commits an assault for

which he is liable in damages. This is true except in

cases of emergency where the patient is unconscious

and where it is necessary to operate before consent

can be obtained”.

22

–

Williamson v East London and City Health

Authority (1998) 41 BMLR 85

: 

plaintiff consented

to removal and replacement of a leaking breast

implant. Doc found a more serious condition

during surgery and conducted mastectomy. Doc

found liable for causing injury; 20,000 pounds

awarded

23

•

Consent for minors:

–

For those minors that lack mental capacity, consent

should be sought from parents (

see Glass v United

Kingdom (2004) 39 EHRR 341

)

–

Minors that are ‘emancipated’ or mature, having

mental capacity can provide consent on their own

(

Gillick v West Norfolk and Wisbech Area Health

Authority and another [1986] 1 AC 112

)

•

Consent for those with mental disorders

rendering them incompetent:

–

Find out if they have executed powers of attorney; if

so, consult relevant attorney.

–

If not, treatment should be carried out based on the

‘best interests’ principle

24

•

When adults refuse consent to treatment:

–

Wishes of patient to be respected even if it will

lead to death

•

Re T (adult ) (refusal of medical treatment) [1992] 4 All

ER 649

: pregnant JW who refused blood transfusion.

Decision to transfuse was only justifiable because she

was found to lack mental capacity

•

Re C (adult: refusal of medical treatment) [1994] 1 All

ER 819

: 68 yr old schizophrenic prisoner who refused

amputation despite life-threatening gangrene. Court

found him capable to refuse and amputation was not

done.

25

•

Level of information to be disclosed for consent to be

‘informed’:

–

This should follow a ‘prudent patient’ standard. What

amount of information would a reasonable person wish to

have? Take into account, the patient’s concerns (

Reibl v

Hughes (1980) 114 DLR (3d) 1)

.

–

The General Medical Council (UK) offers this guidance: “

In

deciding how much information to share with your

patients you should take account of their wishes. The

information you share should be in proportion to the

nature of their condition, the complexity of the proposed

investigation or treatment, and the seriousness of any

potential side effects, complications or other risks

”

26

Health Records

•

Section 24-25: creation of health records

•

Records must be kept for ‘every user’

•

This suggests that documentation of every

clinical transaction is key

•

Avoid ‘corridor consulting’

Confidentiality

•

Section 26 covers this important medico-legal

issue

•

Cryptic

: What are the grounds for derogation

from this responsibility?

–

Public health: What if the ‘public’ is not public in

the real sense but a single potential victim clearly

identified?

Medical Confidentiality

•

Legal and ethical duty

•

Legal duty:

–

Both under statute(s) and common law

•

Common law: contract, equity and tort

•

Current statute: NHA (2014)

•

Ethical premise:

–

Basic ethical principles

–

Hippocratic oath

–

Other declarations

–

Code of medical ethics (MDCN, 2004; 2008)

29

Common law duty of Confidentiality

•

Developed through cases in which patients

sued physicians for alleged disclosure of

confidential information 

without

justification

(Mae, 2004)

1.

Contract: implied contractual duty of

confidentiality in a consultation encourages

patients to disclose sensitive information; no

fear of disclosure without consent 

(see Parry

Jones v Law Society (1969) Ch 1 at 7

30

Common law duty of Confidentiality 2

2.

Equity: patient relies in good faith on the

physician to keep “secret” secret.

3.

Tort: there is a general duty on the physician

not to cause forseeable harm to another

through disclosure of confidential material

[Furniss v Fitchett (1958) NZLR 396]

31

Furniss v Fitchett (1958) NZLR 396]

•

Mr. & Mrs. Furniss were both patients of Dr. Fitchett.

•

Mrs. seemed to exhibit paranoia towards Mr. and

confided in Dr. Fitchett.

•

The paranoid symptoms led to marital disharmony.

•

Mr. contacted solicitor and asked dr. for a medical

report on his wife.

•

Dr. issued medical report [without patient’s consent]

indicating that wife could be mentally ill; report came

up during separation proceedings in court.

•

Mrs. Sued doctor and the doctor was liable for

breach of confidentiality and harm to patient.

32

Confidentiality and professional

conduct

•

Nature of the obligation of confidentiality: Court of

Appeal in 

A-G v Guardian Newspapers Ltd [1990] AC 109

, it

was upheld that there was a public interest in a

legally enforceable protection of confidences

received under a notice of confidentiality. This is

applicable to all confidential material.

•

Hunter v Mann ([1974) QB 767 at 772

: “…the doctor is

under a duty not to [voluntarily] disclose, without

the consent of the patient, information which he, the

doctor, has gained in his professional capacity”

33

Confidentiality as per the Code of Medical

Ethics in Nigeria

•

Features as rule 44 under Part D: Improper

relationship with colleagues or patients.

•

Salient points:

–

Information about the patient during the course

of 

patient-doctor relationship

 constitutes a 

secret

and such 

must in no way be divulged by him to a

third party

 (not very practical in a teaching

hospital!)

34

–

Medical records to be kept away from any person

who is not a member of the profession

[contentions: no reference to nurses, medical

records staff, social workers, occupational

therapists, etc. who may be clinical staff but 

not

members of the profession

]

–

The ethic covers 

criminal abortion

, venereal

disease, 

attempted suicide

, concealed birth, and

drug dependence.

–

Reasons for disclosure of information (not

necessarily breach!): education, research

monitoring, public health surveillance, clinical

audit, administration and planning.

35

Steps to take before disclosure of

Confidential information

•

Seek patient’s consent: 

whenever possible

,

whether or not you judge

 that the patient can

be identified from the disclosure. 

“Volenti non

fit injuria”

•

Maintain data anonymity: “cryptic utilization”

of clinical material for teaching or publication

in 

professional journals

;

•

Keep disclosures to the 

minimum necessary

:

“need to know basis”

36

Limits to Confidentiality: the “proper”

breach

•

Disease notification: no consent of patient

needed

•

Clear advice to patients on the breach which

will attend medical exams for employment,

insurance, security or determination of legal

competence

•

“discretionary” breach of confidentiality to

protect the patient or the community from

imminent

 danger

37

Limits to Confidentiality: the “proper”

breach 2

•

Disclosure of information on legal “minor” to parents

or guardians: take note of “Gillick” competence

which is recognized by council in relation to consent

(MDCN, 2004; 

Gillick v West Norfolk and Wisbech Area Health

Authority and another [1986] 1 AC 112

).

•

Disclosure during court proceedings (strictly under

protest – “testimonial privilege): 

subpoena duces

tecum and subpoena ad testificandum

•

When the patient sues/accuses the doctor in his

professional capacity

38

Practical Dilemmas w.r.t Confidentiality

•

Consent to publish

•

Patient’s best interests

•

The doctor balancing “private interest” with “public

good”

•

Confidentiality in HIV infection: stigma, sexual

connotation of the disease, association with drug

addiction; not yet a notifiable disease

•

Confidentiality within the family

•

Confidentiality and death – details on death

certificate?

39

Relevant Case 1

•

W v Egdell [1990] 1 All ER 835:

–

A patient in a secure hospital sought a review of

his case in order to obtain transfer to another a

regional hospital.

–

His lawyers obtained a report from an

independent psychiatrist – report unfavourable

and was not tendered; application was aborted. Pt

however due for routine review of detention

order.

40

Relevant Case 1 cont’d

–

Doctor sent separate report to the Medical

director of the hospital and the home office.

–

Sued for breach of confidentiality

–

Trial judge and Appeal court found for the

defendant: disclosure was in public interest –

patient had committed multiple homicides in the

past.

41

Relevant Case 2

•

Case Note 210870 [2010] NZ Priv Cmr 24

:

–

A medical centre disclosed health information to a

patient’s former partner.

–

Both partners (X & Y) were both patients of the facility

who were involved in court proceedings after the

breakdown of their relationship.

–

X visited centre with her new partner and asked for the

family file. Centre mistakenly thought her new partner was

Y and disclosed sensitive information about Y’s anxiety

disorder.

–

X used this information against him in the family court

42

Relevant Case 2 cont’d

–

Medical centre was investigated by the Privacy

Commissioner and they were liable.

–

Remedies: centre apologised, agreed to pay

compensation and to provide Y and his children

with free medical services for a set time.

43

Relevant Case 3

•

Director of Human Rights Proceedings v

Henderson [2011] NZHRRT 1

–

General practitioner disclosed information about a

patient who was on a methadone programme

(drug abuse treatment) to a senior nurse at

patient’s place of work.

–

He believed pt had displayed drug-seeking

behaviour, had previous convictions for drug

offences and was mistrusted by police.

44

Relevant Case 3

–

Tribunal found that with the information available

to the doctor at the material time, he did have

reasonable grounds to regard a threat that was

imminent and that disclosure to someone

responsible would respond to and mitigate the

threat.

–

Tribunal found his disclosure justified and he was

not liable for breach of the Health Information

Privacy Code.

45

Tarasoff 1: A confidentiality dilemma

•

Tarasoff v Regents of University of California,

551 P 2d 334 (Cal, 1976)

–

Prosenjit Poddar, a student at University of

California was in psychotherapy and he told his

therapist that he intended to kill a young lady,

Tatiana Tarasoff who had rejected his advances.

–

Therapist informed campus police but Poddar

denied the threat during interview. Nothing else

was done

–

Poddar left therapy and two months later,

murdered Tatiana Tarasoff

46

Tarasoff 1: A confidentiality dilemma 2

–

Victim’s family sued the university which was

running the clinic

–

The Californian Supreme Court ruled that the

therapist had a “duty to warn” the intended victim

and established a doctrine that justified breach of

confidentiality in exceptional circumstances

–

A similar scenario involving HIV transmission may

be found in 

Reisner v Regents of the University of

California (1995) 37 Cal Rptr 2d 518.

47

Access to records

•

Covered under sections 27-29

•

Protection of health records (s. 29)

•

s. 27: disclosure of record to other healthcare

provider or health establishment when it is in

the interest of the patient

•

s. 28: use of records for treatment,

teaching/research and the conditions to be

applied

•

s. 29: Protection of health records by setting

up ‘control measures to prevent unauthorised

access to the records and to the storage

facility in which, or system by which, records

are kept’

•

Offences

 under s. 29: failure in protecting

records, falsification of records, unauthorised

creation, modification, destruction or copying,

unauthorised data linkage, unauthorised

electronic connection to electronic data,

unauthorised modification of electronic data

–

Penalty: punishable by two year imprisonment or

a fine of N250,000.00 or both

•

The 

Cryptic

:

–

The need for professionalism and data security

–

The merits and demerits of electronic records

•

The 

Unknown

–

Do patients have a right to their own records? s.

27 may be invoked since it grants access to ‘any

other person’, etc. as is necessary…in the best

interest of the user (i.e. patient).

–

Compare: WHO/MNH/MND/95.4; BMA 2008;

Department of Health, 2008.

Access to Records: exemplary law

•

This should state that individuals have a right

to apply for access to health information

about them.

•

It should allude to relevant legislative

measures or instruments that support this

right of access.

•

Define health records and state prerequisites

for the granting of the application as well as

fees (DoH, 2010).

Electronic Health Records: a note

•

A necessary component in the 21

st

 Century

•

Advantages (Ogundipe, 2011):

–

Less space consumed

–

 Improved cost-effectiveness

–

Variable of ‘poor handwriting’ removed

–

Improved quality of archived data: prevention of

undue degradation

–

Ease of data retrieval for patient care and research

•

Ethical challenges/disadvantages

–

Unauthorised access by criminal infiltration of

database via the internet or intranet (breach of

confidentiality of a wider scope and resultant

injury to a large number of data subjects at the

same time)

–

Non-existent legal framework in respect of

electronic data for the Nigerian health sector

Beyond Codes and frameworks: The

Freedom of Information Act (2011)

•

s. 15(1)(i) of the FOI Act provides exemption

of personal information from disclosure under

the Act; applications for patients’ records 

shall

be denied

–

“Files and personal information maintained with

respect to 

clients

, 

patients

, residents, students, or

any other individuals receiving social, 

medical

,

educational, vocational, financial supervisory or

custodial care or services directly or indirectly

from public institutions..”

•

Furthermore, s. 17 states explicitly:

“A public institution 

may deny

 an application

for information that is subject to the following

privileges:

a)

Legal practitioner-client privilege

b)

Health Worker-client privilege

c)

Journalism confidentiality privilege

d)

Any other professional privileges conferred by

the Act

Complaints Procedure

•

Covered in Section 30

•

Procedure established by relevant authority (minister or

commissioner) and should be followed by complainant

•

The 

cryptic

:

–

voluntary self-regulation despite prescribed standards

(complaint to be directed to head of the health estab???)

–

Abuse of process is quite likely:

•

No laid down procedure for external oversight of internal complaints

procedure

•

Estab may assume ‘jurisdiction’ over the complaint when not

appropriate

•

Any sanctions for failure to address complaints in a just and timely

manner?

Regulation of Assisted Reproduction:

The Nigerian Situation

58

Afr J Reprod Health, 2011, 15(3):73-80

Regulation of IVF under the Act: s. 50

•

No clear regulation yet!

•

Only prohibition of reproductive and therapeutic

cloning

–

S. 50: (1) A person shall not:- (a) manipulate any

genetic material, including genetic material of human

gametes, zygotes or embryos; or (b) engage in any

activity including nuclear transfer or embryo splitting

for the purpose of the cloning of human being; (c)

import or export human zygotes or embryos.

–

Contravention: Five year imprisonment without

option of fine.

59

•

No direct help may be sought from provisions

related to ‘tissue’ because of s. 64

(interpretations under the act):

–

‘tissue’ means human tissue, and includes flesh,

bone, a gland, an organ, skin, bone marrow or

body fluid, but excludes blood or a gamete.

–

However, tissue does not specifically exclude

‘zygote’, ‘embryo’ – what is the implication of this

gap?

60

Other important areas

•

S. 38: All private health care providers to establish

and maintain health information system as part

of the national health information system; failure

to comply = N100,000 fine or six months

imprisonment or both.

•

s. 43: Minister to make ‘regulations’ regarding the

creation of new categories of healthcare

personnel to be educated or trained in

conjunction with the appropriate authority e.g. Is

this a time for Certified Nursing Assistants instead

of ‘auxiliary nurses’?

Other important areas 2

•

S. 45: health services to be classified as

essential service and subject to the provisions

of the relevant law.

•

Industrial disputes to be taken seriously; total

disruption of health services in public

institutions to be avoided; reasonable

measures to be taken by Minister to ensure

return to normalcy 

within 14 days

.

Recommendations

•

Amendments must focus on:

–

Improved interpretation of ambiguous terms

–

Improved scope

–

Improved statement of reasonable exceptions or

exemptions

–

Clearer statement on oversight over complaints

procedure

•

The need for Code of Practice – allows for more

explicit understanding of provisions and their

required practical action steps.

Conclusion

•

The National Health Act 2014 is a commendable

legislative initiative in the effort to regulate healthcare

delivery in Nigeria.

•

Despite its relatively comprehensive outlook, it suffers

from some important deficiencies in scope,

interpretations and in terms of applicability in actual

practice.

•

Lessons learnt from day to day physician-patient

interactions are bound to provide the fundamental

insights required for the refining amendments to the

Act which must come with time.

“For time, that curious teacher of the ages, will

prove the known, give form to the unknown,

and expose the cryptic; in the light of time, all

shall be known”

- Anonymous

66

“There is a tide in the affairs of men which

taken at the flood, leads on to fortune;

Omitted, all the voyage of their life is bound in

shallows and in miseries. On such a full sea are

we now afloat, And we must take the current

when it serves or lose our ventures”

-

Shakespeare in 

Julius Caesar

Let us seize the moment provided by this law to do our

own best for humanity!

Thank you very much!!!