To enhance the participants ability to handle the ethical and legal issues in Antiretroviral Therapy (ART).
To enable participants appreciate their legal and ethical obligations in providing ART.
UNIT 1: The Linkages between HIV and AIDS, Human Rights and Public Health.
UNIT 2: Legal and Ethical issues in HIV and AIDS.
UNIT 3:Legal and Ethical issues in ART .
UNIT 4:Legal and Ethical issues in ART in special circumstances.
U NIT 5 : T he R ole of the Medical P racti ti oner .
The L inkages between HIV and AIDS, H uman Rights and P ublic Health.
As the HIV and AIDS pandemic continues to ravage humankind, a number of issues have come up engendering many difficult questions relating to the linkage between the law and human rights and the strategies and policies put in place to combat the scourge.
The protection of Human rights is essential to safeguard human dignity in the context of HIV and AIDS and to ensure an effective, rights based response to HIV and AIDS .
Public health interests do not conflict with human rights .
HUMAN RIGHTS PRINCIPLES RELEVANT TO HIV and AIDS
The right to non-discrimination, equal protection and equality before the law.
The right to life.
The right to the highest attainable standard of physical and mental health.
The right to work.
The right to liberty and security of the person.
The right to freedom of movement.
The right to seek and enjoy asylum.
The right to privacy.
The right to freedom of opinion and expression and the right to freely receive and impart information.
The right to freedom of association.
The right to marry and found a family.
The right to equal access to education.
the right to an adequate standard of living.
The right to social security , assistance and welfare.
The right to share in scientific advancement and it’s benefits.
The right to participate in public and cultural life.
The right to be free from the torture and cruel, inhuman or degrading treatment or punishment.
Enjoyment of these rights under the UDHR and the Kenyan Constitution is made subject to the rights of others, to public interest , morality, public order and the general welfare of a democratic society.
Some of the rights are absolute while others are derogable.
HIV and AIDS initiatives work best where there is a supportive legal and ethical environment which is protective to human rights.
Where such legal framework exists there have been tangible gains to public health in AIDS control and management programmes.
Legal and Ethical issues in HIV and AIDS .
Various ethical and legal controversies have arisen with regard to the myriad of legal issues that arise in relation to HIV and AIDS.
EXAMPLES OF LEGAL AND ETHICAL ISSUES.
Testing for HIV and the debate on whether or not it should be voluntary or mandatory.
Confidentiality of HIV test results with ethical dilemmas on the Doctor/patient relationship,employer/employee situation,partner notification to mention but a few.
Discrimination of people living with HIV and AIDS in employment and in the provision of services.
Criminalisation of what is popularly referred to as deliberate infection with HIV.
Harmful cultural practices, such as wife inheritance, polygamy, arranged marriages and domestic violence raise myriad legal questions.
Ethics of research.
THE LEGAL FRAMEWORK IN KENYA.
Amendment of the Public Health Act in 1987 to make HIV a notifiable disease .
No other legislation that directly addresses HIV and AIDS except the HIV and AIDS Prevention and Control Bill.
General reliance placed on policy and national guidelines e.g
( i)Sessional paper no. 4 of 1997 which is a policy paper.
Home based care .
Blood donation and sero- surveillance
Kenya National Clinical Manual for ARV providers .
OTHER SOURCES OF HIV and AIDS LAW.
The Constitution –which contains a bill of rights
Relevant statutes e.g the Public Health Act.
The Medical Practitioners and Dentists Act.
The clinical officers Act (CAP 260)
Pharmacy and poisons Act (CAP 244)
The Narcotics and Psychotropic Drugs Act
The Industrial Property Act.
International guidelines and relevant codes of ethics .
GUIDELINES ON LEGAL AND ETHICAL ISSUES
In absence of codified law, reliance is placed on various international guidelines, policy statements in sessional paper no. 4 of 1997, recommendations of the Government task force on legal issues relating to HIV and AIDS and the HIV and AIDS Prevention and Control Bill 2002.
Some of the guidelines that are relevant to ART and with which those engaged in administration of ART must be familiar with include:
HIV and AIDS, Non-discrimination and equality before the law.
Testing for HIV.
Indirect testing-screening of Blood,semen and body parts donated.
Anonymous and unlinked testing of populations and groups.
Pre-Natal Testing and Testing of Newborns.
HIV and AIDS privacy and confidentiality.
There are numerous legal and ethical issues raised by HIV and AIDS.
Minimal legislation has been enacted to address these legal and ethical issues.
Much reliance has been placed on policy and guideline documents which are not legally binding.
Legal and Ethical issues in ART .
THE LEGAL AND ETHICAL ASPECTS OF ART.
The broad and ethical issues that arise in ART are those of availability, affordability and accessibility.
Intense debate on the best way to deal with the scarcity of ARV treatment.
Arguments have been put forward either supporting equitable distribution of drugs or distribution of drugs on ability to pay principle.
Some of the arguments include:
The principle of justice:- whose basis is that no individual should be deprived of access to affordable and effective treatment, because of inability to pay.
The greatest good to the greatest number:- those interventions that can save most lives have a stronger ethical claim than those that will benefit fewer individuals.
All or none:- Health care that is not available to all should not be available to any.
Let those who can pay obtain treatment.
Whether the government should intervene to ensure provisions of care meets currently accepted standards.
Whether physicians should permitted to dispense such drugs.
The Pharmacy and Poisons Act Cap 244 of the laws of Kenya. Has a role to play in availability of ARVs with regard to the aspects of fast tracking procedure for registering essential medicines.
Access to ARV drugs is still and issue in this country.
Industrial Property Act has been enacted to make provision for parallel importation and compulsory licensing, though the latter have not been implemented by the government.
Government through NASCOP collaborates with NGO’s to make provision of ARVs to district hospitals.
Attempts have also been made to train health care providers to administer the ARVs.
Legal and Ethical issues in ART in special circumstances .
More complex issues in ART arise from special groups including :
Victims of rape.
Street people and minors.
LEGAL AND ETHICAL ISSUES WITH REGARD TO HEALTH CARE WORKERS
Do they need to know the HIV status of their patients and vice versa?
Do they need post exposure prophylaxis?
How does one deal with issues of consent and confidentiality of HIV results in these special circumstances?
Do health care workers require protective gear at the workplace?
Health care workers need not know the HIV status of their patients.
They must adopt the safety measures provided by universal standards.
No legal justification for the patient to know the HIV status of the Health care provider.
Health care workers need post exposure prophylaxis as it would encourage them to care for patients with HIV and AIDS.
The employer is under an obligation to provide suitable working conditions and equipment to its employees as required by the law.
LEGAL AND ETHICAL ISSUES WITH REGARD TO VICTIMS OF RAPE
How does one get to know the HIV status of the rapist?
Is there a legal basis for testing the victim
Should ARVs be administered as a matter of routine?
Victims of rape should benefit from ARV prophylaxis designed to reduce risk of infection.
The victim should not be tested without her consent.
LEGAL AND ETHICAL ISSUES WITH REGARD TO UNBORN BABY AND MTCT
Is there need for routine and administration of ARVs?
What is the legal position on the testing of pregnant women.
Do we need the consent of the partner for administration of ARVs on pregnant women?
How about the partner who is exposed to HIV infection if infected does he need ARV?
Do we stop ARV after delivery?
There is need to administer ARVs to unborn children as it significantly reduces the rate of transmission from parent to child.
A partner needs to be consulted but the final decision to use ARVs should be made by the patient.
Spouses who are affected by the virus equally need ART but after the relevant procedures have been complied with.
LEGAL AND ETHICAL ISSUES WITH REGARD TO MINORS
Whose responsibility is it to provide ARVs to minors and ensure safe administration of the same?
Is the duty of the parents or the duty of the government?
Who should give consent for the treatment?
Children’s rights to confidentiality and privacy in regard to HIV status should be recognised .
In getting consent, legal guardians should pay due regard to the child’s view especially if child is a mature minor.
The HIV and AIDS Prevention and Control Bill, obligates the government to provide ART to minors.
THE ROLE OF THE MEDICAL PRACTI TI ONER .
To ensure protection of human rights in the process of testing care and treatment by among other things facilitating counselling and maintaining confidentiality of HIV results.
To create awareness both of preventive measures and of human rights of individuals especially by providing information that would enable the grant of informed consent.
To prevent the harmful effects of adherence.
To observe the ethics of medical practice.
To be cognisant of the legal and ethical procedures expected of them in ART including referral of rape victims to the police.
To refer patients who raise legal issues with regard to the aspects of inheritance of property and succession matters, to legal officers or human rights organizations.
What happens when the patient is unable to pay his medical bills, is there any legal redress against the health care provider if he refers him to another institution?
What happens when a medical practitioner prescribes, ART which turns out to be unavailable in the chemist. Accordingly the pharmacist calls the medical practioner to ask for a substitute drug and the medical practitioner changes the prescription orally.
Issue of liability arises where the patient reacts adversely to the new drug prescribed.
Although the prescription is by the medical practioner the liability would fall on the pharmacist.