Ethical Issues in Health Research in Developing Countries

June 2, 2005

RRT in Thailand’s “30-RRT in Thailand’s “30-Baht” Health Insurance Baht” Health Insurance Scheme:Scheme:

Ethical Dimensions of Ethical Dimensions of the Choice of Optionsthe Choice of Options

Daniel Wikler, Ph.D.Dan Brock, Ph.D.Harvard University

Ole F. Norheim, M.D., Ph.D.University of Bergen

Tessa Tan Torres, M.D.World Health Organization

Ethical Dimensions of Health Resource Allocation

WHO’s normative work on health resource allocation develops strategies and tools, such as cost-effectiveness analysis, for member states

Health resource allocation should be both efficient and fair. In recent years, WHO has given increasing attention to methods for assessing and ensuring fairness and other ethically- and socially-sensitive attributes.

The RRT Dilemma in Thailand’s UC

Though RRT is expensive, its omission from UC coverage is open to challenge on ethical grounds because– CSMBS and SSS do cover RRT

But SSS is a contributory scheme and CSMBS is part of the compensation package for employees

– ESRD, a lethal condition that can occur at any point in the lifespan, is treatable. Most patients do not have to die, if resources are made available.

Consultation Process

Two years’ data collection and analysis by MOPH

Involvement of three professional bioethicists with academic and WHO experience

Analysis of issues conducted in tandem with creation of WHO manual on ethical dimensions of health resource allocation

Meetings with stakeholders in Thailand

Overview: Key questions

Who will be covered? What will be offered to them? Will patients face discontinuation of care? Who will pay? Who should decide? Should the criteria be

public?

Provisional Criterion: KT eligibility

1. RRT (PD or HD) is offered only to those who are eligible for KT (age 60 cut-off; no serious co-morbidity, contraindications for transplantation)

2. No-discontinuation pledge

3. Vigorous, sustained effort to increase KT

Remarks on Provisional Criterion: Ethics

Offers some priority to the young, yielding more equal opportunity to live a normal lifespan

– Priority to the young is limited by the requirement that candidates for KT not have co-morbidities

No-discontinuation pledge is perceived as ethical and minimizes desperate fund-raising efforts that impoverish families of patients

KT’s good outcomes and low post-operative cost makes this criterion more cost-effective, achieving added efficiency in addition to fairness.

Remarks on Provisional Criterion: Ethics

No-discontinuation pledge means that some who are rejected due to age will be much younger than some who continue to receive RRT

The % of KT-eligible patients who will receive organs is tiny today and will never be more than 20%. The possibility of KT is irrelevant to 80%-95% of patients and should not be the basis of a life-or-death decision.

Option #1: Full Coverage + co-pay

1. Everyone covered by UC will be offered RRT

2. No patient will face discontinuation of care

3. Two sub-options:#1A. No co-payment (not financially feasible)

#1B. Co-payment will be required from all except the poorest

Remarks on Option #1: Ethics

Most popular with almost all stakeholders High cost to NHSO for Option 1A High risk of chronically underfunded, low-

quality program

Option #2: Priority to the young

1. RRT provided to every patient in need, up to an age cut-off (e.g. 60, 65, or 70---the average Thai life expectancy).

2. The age-cut off will be determined by fiscal constraints.

3. Transition to co-pay after the age cut-off.

Remarks on Option #2: Ethics

Age is the sole criterion for selection Emphasis on age offers each person the maximum

chance to reach an average lifespan Age is one of the selection principles most widely

endorsed by stakeholders This option offers nothing to those in need whose

kidneys fail after the age cut-off Necessity for discontinuation after age cut off

– Resources constraint – Savings will enable new enrolees to initiate RRT

Option #3: Individualized Selection

1. Fiscal constraints determine the number of patients who can be offered RRT.

2. Selection of patients is by provincial panels using national multiple, unranked criteria, e.g.

1. Age (priority for the youngest)2. Income (priority for the poorest)3. Having young dependents4. Productivity5. Medical conditions

3. No discontinuation

Remarks on Option 3: Ethics

Non-health-related criteria consider patients for their usefulness rather than as ends in themselves

Selection panels must apply diverse, unranked, incommensurable criteria

Possible wide variation between provinces in patterns of selection---“horizontal” inequity

Unpredictable; little accountability; arbitrary? No-discontinuation pledge means that some who are

denied care due to age will be much younger than some who are given RRT at UC expense.

Potential for “nepotism” or jumping the queue

Remarks on Option 3: Policy

This system may provoke migration of patients between provinces---self-defeating and burdensome

Difficult to implement

Option #4: Benefit for all with priority to young

1. UC offers RRT to every patient in need, but the entitlements are limited.

2. The number of years of RRT provided depends on age. Younger patients get more.

3. Every patient is entitled to at least one year.

4. Transition to co-payment after the age cut-off is reached or the brief entitlement expires.

Remarks on Option #4: Ethics

Serves two goals: – Priority to the young, increasing the chance to

approach the average lifespan– Treating people as equals: everyone gets

something, no one is shut out Lack of a no-discontinuation pledge is

perceived as a problem. But that pledge would require that some be shut out from the beginning.

Remarks on Option #4: Policy

What should the age priority and the number of guaranteed years be? How should this be decided, since many different combinations will be equally consistent with the fiscal constraint?

The lack of a no-discontinuation pledge will be seen as an ethical problem by some people

The other options are easier for the public to understand.

Remarks on Option 4: Policy

This would function better if there were informal means to favor patients with better health outcomes

This option may provoke less political resistance than other options, yet it obeys the fiscal constraint.

Cross-cutting issues:Human Rights and Constitutionality

Will the rule for selection be challenged on constitutional grounds?

Do “A right to health” and “Nondiscrimination” rule out any RRT option that provides care to some but not to all?

Are Options 1 and 4 less vulnerable to legal challenge?

Cross-cutting Issues:PD and KT

Should coverage be limited to PD as long as this is a medically-suitable alternative to HD?– PD is potentially cheaper and can be provided in

rural areas– But strong advocacy and support would be needed

Cost can be reduced by increasing KT. But this would require significant changes in harvesting practices, incentives, and possibly laws.– “Presumed consent”? Non-related living donors?

Cross-cutting issues:When to impose a co-pay

– Should some co-payment---to offset costs, not to control demand--- begin as soon as RRT is initiated?

– Should co-payment be offered to patients whose need for RRT occurs after the age cut-off?

Cross-cutting Issues:Co-pays and financial devastation

Co-pays may place a very high burden on patients and their families, resulting in some cases in impoverishment and debt in multiple households

Co-pay is not imposed to control demand, but to offset cost to MOPH; but its contribution is slight.

Cross-cutting Issue:Discontinuing immunosuppresion

Should age-related limits on entitlements for HD apply also to immunosuppressive drugs for KT recipients who continue to need them?

Cross-cutting Issues: Relaxing the age-related limits on entitlement

The choice of age-related limits on entitlements in these options is determined by the fiscal constraint.

If more funds become available, the age-related limits can be relaxed. Ultimately they might be abolished.

Younger patients on RRT today may find that the age-related limits been relaxed by the time that they reach the age of today’s limits.