Showing posts with label equitable access. Show all posts
Showing posts with label equitable access. Show all posts

Sunday, March 6, 2011

Health Reform: Understanding the Social Dynamics of Health equity & costs, Government’s role, Public response and responsibility


Health Reform: Understanding the Social Dynamics of Health equity & costs, Government’s role, Public response and responsibility
Dr David KL Quek, drquek@gmail.com

“Those whose perspective is limited are likely to err in judgment, taking wrong turns, making bad judgments, and inflicting harm on others… Narrow-minded thinking undermines dynamism and prosperity… The ancient saying that goes, literally, ‘The thinking of a wise sage turns thrice a day,’ is meant to say that the sage is always receptive to new ways of thinking—that is, ready to learn new lessons and see by fresh perspectives. It behooves us to avoid rigid ways of thinking.” ~ Konosuke Matshushita (Founder of Panasonic)[1]
“In every country, regardless of its economic position, the future is likely to include severe pressure to increase value for money in health care. Governments will need to respond intelligently, or face public/voter acrimony, a loss of solidarity underpinning health care, and avoidable ill health, that in turn damages economic prospects. Given the great difficulty of examining the impact of different, often diffuse policies, the necessarily limited evidence base, and the length of time needed to develop policies and implement them, decisions as to the best approaches to reform may be necessarily based more on pragmatism, experience, instinct, and ideology than evidence. Pooling international experience here will be crucial and may help to short cut years of otherwise well-intended but ineffective reform.”
~ Jennifer Dixon and Vidhya Alakeson, Nuffield Trust[2]

Health—an indispensable social structure
Most people accept that health is a human right. Everyone expects that whenever anyone falls ill or suffers an injury, he or she is entitled to some form of treatment, especially first aid or resuscitation, even lifesaving surgery. The question of costs is usually not considered upfront, and is regarded distasteful if broached or worse, demanded!
It has become an accepted custom that society finds some mechanism to pay for such a system of entitlement. It would appear socially unacceptable even reprehensible, if a patient presents to any health facility and be turned away because of inability to pay for the service, worse if the injury or ailment appears life threatening!
However, despite this expectation, it has always been known that if one goes to a public sector health facility, some degree of waiting and queuing is in order. And unless this is grossly or unbearably prolonged, most patients would accept such a mechanism of service, given the constraints of reality—people sort of know that there is some need or basis for prioritizing, for triaging, for rationing; although sometimes this sequence of events may be broken and loudly complained about.
Historically however, healthcare has had a checkered and less salubrious past. Even as recently as the last 18th-19th century, most people could not afford ‘professional’ medical care. Medicine though long in history, was still at its infant magical if wondrous best, with more diagnostic physician prowess than actual lifesaving therapies or cures.
Clever prognostication or dubious amelioration of pain and suffering appeared to be the usual outcome of then medical encounters. Poor houses were aplenty where quasi-scientific medicine was practiced. The hapless ill and the poor were often tested upon for case studies or for much needed experience building for younger aspiring doctors/surgeons. Many ordinary people had even less rights than perhaps even a domestic pet or a draft horse.
More than anything else, public health measures such as sanitation and sewage reforms ultimately changed the dire consequences of the squalid ghettoes, tenements and working and living conditions for the indigent. Doctors then only performed house calls or carried out highly dubious surgeries, bloodletting, leaching, cupping, blistering, etc. for a fee, or for some barter exchange of goods or services. Wandering ‘surgeons’ and stone-cutting, cataract-extracting barbers were the lesser peripatetic tradesmen who thrived on providing some painful ‘cures’.
The poor really did not have any assured access to any doctor. At best they availed themselves only to traditional ‘snake-oil’ health restoratives and old wives’ tales of magical panaceas and ‘cure-alls’. Social conscience did not really pervade the 19th century until enlightenment gradually resulted in wider egalitarian spread of ideas, humanising man as man and not man as indentured serfs or slaves!
However, over time most countries of the world have accepted the moral imperative that attaining the best possible standards of health is an inalienable moral and legal right.[3]


Health as a Human right
It was the ‘British laws’ in 1802 that led the way in establishing that ‘health’ was a civil right and expected public goods, triggered by the dreadful health conditions and threats among the destitute of the Industrial Revolution.
In 1925, Chile became the first enlightened nation ever to incorporate the right to health into its constitution. Surprisingly, despite its capitalistic bent, 72% of Americans strongly believe that health care should be considered a human right, in a poll undertaken in 2007. However, this is not enshrined in its constitution or laws.[4] Therefore, America remains ambiguous about labeling health as a human right. While the United States is a signatory to ICESCR (International Covenant on Economic, Social, and Cultural Rights), it has yet to ratify this key treaty, unlike the other 160 nations.
A recent paper exhorts for a more enlightened premise for American healthcare: “It is an assertion of the responsibility of governments to strive for ‘the highest attainable standard of physical and mental health.’ It is an asseveration that governments will respect, protect, and fulfill the right to health by ensuring the availability, accessibility, acceptability, and quality of the care required. It is an averment that governments will honor the tenets of accurate information, nondiscrimination and equality, and participation. It is an avouchment that governments will address the ‘underlying determinants of health’ such as sound housing, clean water, and adequate nutrition, especially as these determinants apply to the needs of poor and other marginalized populations.” [5]
These days more than 100 countries boast a commitment to the right to health or health care in their national constitutions.[6]
Thus aligning oneself with such social scruples as ‘health for all’ is a fairly modern societal phenomenon. We all believe that attaining health is a rightful and timely human development goal for everyone.
Sadly however, healthcare equity appears once again to be overshadowed and challenged by a rising consumerist-capitalist mindset. Many people increasingly deem self-preservation as their overriding personal philosophies of self-interest and self-advancement. There are mounting qualms of yielding too much perceived individual sacrifices, and diminution of individual space and choice, in deference for the avouched ‘greater good’ for more people or others…
Simply put, every man wants only to pay for those things or services, that he can afford for himself and perhaps for his immediate family: he is less willing, even unwilling to contribute to the benefit of others, unless forced upon him to do so by certain laws or authority, i.e. an overarching hegemon, a Leviathan.
Of course, many of our more socialist-minded colleagues might take exception to such a deconstruction of our healthcare dilemma or such a cold depiction of our self-interested persona. Perhaps in reality there might be more selfless religious practitioners, altruistic persons than they have been given credit for. Many do believe that healthcare is an irrevocable human right—that governments of all nations have a duty to provide adequate allocations to ensure such a nonnegotiable social prerogative!
My personal social perspective is generally altruistic, but also realistically sober. I have always enunciated such a stand, that man needs to be more humane, more human—this is ideally, politically correct. Pragmatically however, rising costs and competing demands have made such a commitment extremely difficult to follow-through, for many a people eking out a living! Hence, I also understand that more and more people are drifting toward a less charitable self-serving mindset… notwithstanding the fact that we continue to constantly remind ourselves, and others, of society’s inherent goodness—that we must be greater than our sum of individual identities and self-interests.
But I have been accused of being too preachy, too idealistic, too goody two shoes, which often rankle many who simply wish to be left alone to their own devices… Many would simply switch off, rather than to be bothered by conscience-disturbing ‘noises’ or moralizing sound bytes!

Health vs. Competing Public Goods & Services—Reality of Rationing Care
Our complex society however, ensures that we have even more convoluted contending requirements or partisan needs. The harsh reality is that healthcare is simply just one of the many competing public goods that most governments have to juggle with, particularly with finite yet gradually diminishing fiscal resources. Everyone is always trying to appease and accommodate disparate if expedient and politically-correct rival demands. There is no right or wrong in this, certainly no one model that encapsulates the best approach.
Thus, there will always be some degree of healthcare rationing or compromise.[7] Some have argued however, that governments which undercapitalized their health system tends to get away by under-servicing and under-provisioning, thereby justifying the very limited services available to their charges because of this low or under-allocation of funds.
Lack of supply side services would invariably lead to greater delays and queues. This in turn, directly or conveniently discourages public demand due to enforced wait times: for some, inability to wait leads to resorting to private care; or for others without means, stoically resigning to the fate of waiting in lines—the ultimate unvarnished truth of the powerless…
Fewer people are willing to pay for others who have not seen fit through their own personal efforts or capacities to help look after themselves, their families and their own socioeconomic interests. Everyone is expected to make reasonable contributions toward covering such eventualities. ‘Fend for yourselves’, everyone seems to imply. Certainly not everyone can.
Because, there would certainly be those who are genuinely destitute or disadvantaged—they cannot afford to contribute beyond their ‘poverty’ level. Disposable income is already very marginal among the poor in most countries. Health just does not figure high up in their hierarchy of immediate personal or family needs! Sadly, in many parts of the world including developed nations, this group of the poor and the marginalized is growing.
In the USA alone nearly 50 million people are uninsured.[8] They are thus exposed to the extreme whims and the flawed quality of erratic health care, mostly via emergency department visits with no long-term follow-through solutions to their more chronic ailments! Thus, health outcomes remain substandard and below that achievable by those who have insurance or means.
For the poor, most people expect the government to take care of this, in as unobtrusive a manner as possible, preferably without jarring our own comfort zones and our conscience. We expect the government to provide these social safety nets, at bare minimum encroachment on others, certainly not to reduce the expected benefits for ourselves. Certainly this is the overriding version of the American psyche, which threatens to miscarry the Obamacare health reform—notwithstanding the sporadic clanging discordant sound bites from the “Michael Moore”s of alternate views.
Many Americans and I dare say even Malaysians, are simply not prepared to spend any more to help others, merely because the latter cannot afford to do so for themselves. Modern society is more self-centred and less altruistic. Paradoxically however, the latter characteristic is demanded of medical professionals, and perhaps also of the governing authorities, which should somehow provide the necessary facilities and source the appropriate funds!
The difficulty in offering any modicum of healthcare service is that this is an ill-defined bottomless pit. What and how much healthcare can be provided as universal coverage for all? What constitute indisputably as necessary services? How do we determine unavoidable variations of coverage? What about less evidence-based, more questionable or very marginal benefits of some care options? How does one define what constitutes emergency care or barest basics medical care, fully accessible to everyone? Or should every conceivable healthcare service be made freely available to just everyone?
The complexity is trying to agree on the minimum basket of healthcare services that everyone is entitled to, without undue strains as to costs. We expect this would be provided as an inclusive basket of rights, through prudent payroll or government tax revenue allocations, and hopefully not through another reimbursement mechanism or another additional levy, social health insurance, whatever, etc. Remember, most Malaysians are already against any idea of a GST type of taxation, which penalizes the poor more than the rich…
Where can we keep a lid on expectations to whatever comprehensive medical care possible? If someone has say, a cancer—how does one define how far to go with investigations, surgery, treatment and even access to experimental if marginally beneficial drugs, which cost astronomical sums? How much is a human life worth to keep sustaining or prolonging—a few years, a few weeks, or days?
What about a debilitating stroke or heart disease? Who should provide for some or all of the possible therapeutic modalities? Already many people baulk at having to take a polypharmacy of medications to reduce risk factors and improve function and survival. Does age or mental capacity or terminally-ill status, factor into this equation to provide or deny some of these quasi-beneficial treatments?
Costs can run into a significant portion of anyone’s wages, so who should subsidize, or should this be provided as a privilege, without copayment, etc? This is indeed the crux of why a collective social health insurance is so useful and a fairer mode of community-distributed risk sharing, why we should urge everyone to buy-in. Major catastrophic illness can and has bankrupted many people before and would do so again in the future, unless hedged by some form of community risk sharing.
Yet the converse is also alarming: the uninsured have poorer control of their diabetes, high blood cholesterol levels or achieving blood pressure goals. Not surprisingly, many uninsured in America are also those who have badly managed risk factors and therefore more inclined to suffer more complications and suffer poorer health outcomes![9]
Catastrophic illness and end of life care is frightfully expensive and accounts for as much as 60 to 95% of all lifetime healthcare costs![10] Would this economic consideration be different or the same for say a young person vs. an elderly dying? Whose life is worth more and who less? Can we play God? Should we? Would such huge costs be better applied for more life promoting health care for many more people? Would the rights of the many subsume to or override that of one special case?

Socioeconomic Realities & Essential Government Role
When it comes to health care, economic and social realities dictate that some form of rationing always have to be put up with. There is usually some agreed upon basket of health and medical services, which would form the bare minimum basis of access for all. It is rare that every possible test, medication or care is readily or fully accessible to everyone, on demand, or even when in need.
No health system in the world can provide every possible healthcare service on demand to everyone, without some constraints or queues. But for those who are able or willing, private purchase of such services is often expedited without delays and upon demand. This approach is impossible without free market mechanisms to private care access, but this is way too expensive for just about every person!
No system can survive without government intervention and contribution of government tax revenue allocations. But even this is proving to be too much for most modern budgetary prudence. Demand nearly always outstrips supply. There is always that moral hazard of everyone who is ill to demand and to expect to be tested and treated—early, quickly and comprehensively—often over-utilising scarce or limited facilities and costly resources.
Thus, there is growing need for citizen education, input, contribution and empowerment too—there needs to be buying in by citizens. More and more health authorities now recognize that some form of co-payment or premium payments toward some form of social health insurance, is needed. This is crucial so that everyone then has a responsibility in knowing that because they are contributing to this finite fund, they have a joint duty to use this fund prudently and responsibly, and with collective social conscience.
It is important that every citizen recognize that health is an essential social service which although usually provided for or ‘guaranteed’ by government, is not a given.
Many lesser-endowed countries usually do not apply sufficient attention or resources to this sector, which is why poorer economies have citizens who have poorer sanitation, more communicable diseases, have shorter life expectancies. They generally lack access to even basic healthcare services, suffer high maternal and child mortalities, and most need to pay extraordinary out-of-pocket expenses to buy even a small modicum of medical services.
But enlightened governments usually allocate sufficient resources to health as a critical social service, which is provided through tax revenues or specially apportioned allocations or levies. However, there must be true accountability and transparency as to the use of such funds so that people can feel satisfied that there is as little wastage and leakage from administrative or improper practices. Otherwise, this will prove to be very unpopular and many among the citizens would resist such an extra form of GST-like taxation.
If everyone understands this social need for such a contribution, then it would be easier to discuss the harder options more sanguinely. It is critical to explain that there is no such thing as a ‘free lunch’ in healthcare, because demand for health services will almost always exceed any country’s finite resources.
But unfortunately for many Malaysians, there have been confusing stands made by the authorities: on the one hand pledging free healthcare for the needy, while on the other, also asking the rest of the public to pay more. The government appears to be flip-flopping, making reassuring sporadic pronouncements of free or almost free healthcare services, especially during political posturing, while also warning about subsidy removals, when in more sober moments of tackling budget deficits!

Greater Government allocation for Healthcare Critical
Of course, this is not to deny the fact that our very poor citizens need to be protected—that we need a more robust structure of social safety nets. But apparently we do have a large segment of our population whose family income is less than RM2000 per month, which would place them in the “poverty” level, even if not defined as hard core poor. There is an estimated 40% of the working population under this category! This is indeed a huge burden!
Because of this, most civil society advocates have urged our government for larger allocations for healthcare, up from the current 2.1% to at least 4 to 5% of the GDP. This might help boost private enterprise contribution by a similar margin, whose current contribution amounts to only 2.7% of the GDP.[11],[12] So do we have the political will to do this well and fairly? Instead of the usually paltry RM12 to 13 billion a year, an allocation of some RM25 to 30 billion would certainly help boost the coffers for much needed restructuring efforts, catering to the poorest and the needy.
Importantly, how do we allocate these much-needed funds more openly, more prudently, so that citizen misgivings and resistance can be allayed? This will be the true test of the government’s sincerity and commitment to good governance in the delivery of such dutiful intrinsic public goods and services!
We have to move away from entitling concessionaires or special interest groups or companies to handle some of these critical services. Special negotiated contracts should be done away with; they reek of too much cronyism and rent-seeking patronage, which not only have become despised buzzwords, but also increase costs without the attendant benefits of cost-effectiveness. This results in unnecessary leakages and decreased productivity.
Transparent and prudent allocation of funds would encourage our citizens to accept greater contribution towards some collective sharing of healthcare costs and community-rated insurance, when they know their money and tax contribution is well spent.
The MMA urges the government to set up a more structured healthcare social safety net system, which must include such crucial need-based Medicaid, Medicare and CHIP (for children). This social construct already available in many developed nations, would be that crown in the accepted array of government sponsored public goods, funded from tax allocations. Such subsidised care would exempt these poorer or retired (noneconomic-wage earning) groups from contributing to the planned SHI. With this in place, we can then calculate more accurately how much each paying citizen can contribute, as painlessly as possible!
The most important part of any health reform is the appropriate and frugal utilization of this finite health fund, the actual structure of the services, which should not marginalize or sideline any stakeholder. Most importantly our public and our patients should not suffer the worse for it due to disruptions caused by inept, technical or corrupt glitches!

Dialogue & Consultation with Civil Society Vital
Medical doctors should be at the forefront of such changes and must be allowed the greatest feedback and consultation, as they are the ones on the ground running. They have enough clinical experiences, albeit not the technical knowledge about macroeconomic costs and personnel requirements, etc. of how to exactly do what is right or practical.
It is true that doctors would have their vested interests, but collectively doctors have always been greater than their individual selves. Most medical groups would always tend toward the greater public good, while subsuming their own self-interests.
However, most doctors just do not have the expertise, energy or time to study these restructuring plans in detail or minutiae. Sadly, we do not even have any comprehensive documents to review or study, for helping to streamline or improve some of these plans and programmes. This contrasts starkly with the nearly 100 odd publications and technical details made available on the new ‘Liberalising the NHS’ reforms, first mooted last year! [13],[14]
But as interested professionals with responsibilities, the MMA must rise to the occasion and immerse itself into this process, and our members must be more ready to participate in this ongoing dialogue. Otherwise, we would truly be marginalized and left on the wayside!
Sadly too there has been a desperate dearth of research and publications (whether for discourse or debate) on many of these absolutely necessary health policy issues. Our Universities must do more to encourage more academic as well as research-based practical, economic and policy health studies, so that we can have clearer definable information about ‘real’ data from the ground, which can help create better systems.
Physicians must take the lead; we cannot afford to be apathetic and adopt a ‘couldn’t care less’ attitude! Neither would it do, to simply complain on the sidelines—we must get involved and participate by coming forwards to be engaged in the process and in helping to steer the direction of healthcare transformation. Griping and hoping that interested physicians out there and ‘others’ would do the job for them, is just what is wrong with the process these days. More must come forward to actively take part, and play a more critical helpful role.
Medical professionals must take part in understanding and studying these consequences of changing health care across the globe, and particularly in this country. We just have to! No one else would understand the healthcare scenario better, if we allow the powers that be a free rein at structural reforms, which could impact the profession, our patients and the public, radically and irreversibly!
But recognizing these physician-led social duties and responsibilities is not new. In the 1930s just after the Great Depression, the Committee on the Costs of Medical Care, chaired by Stanford University president, Dr. Ray Lyman Wilbur, recommended that “Medical service should be more largely furnished by groups of physicians and related practitioners, so organized as to maintain high standards of care and to retain the personal relations between patients and physicians.”[15]
So, it is this constantly shifting dynamic of balancing demand with need and supply at the best cost-efficiency that most nations try to achieve a modicum of equilibrium. Otherwise, these nations face runaway healthcare costs and fractured disruption or meltdown of their health services!
The leadership of the American College of Cardiology recently urged physicians and public policy makers to work together when enacting any major changes in health care reform, especially when it comes to point-of-care professionalism where standards and quality of patient care must not be compromised, in the continued search to contain healthcare costs:
   “The right amount of care and how best to deliver it is uncertain. Medical care is a point-of-care interaction between the patient and a clinician. It is a blend of the observations, fears, and concerns of the patient balanced by the expertise and experience of the clinician. This joint decision-making is a balance of the art and science of medicine. At its best, it is exceptional. At its worst, it can include inappropriate care because of knowledge-based deficiencies or even personal financial gain. In truth, it is easier to identify blatant overuse than errors of omission… The goal for the best health care, however, is not harmonization of a utilization map but deciding the right amount of care at the right time.”[16]
But more than 20 years on, the dynamics have changed tremendously—we have seen the establishment of even more private hospitals and clinics, which have grown to absorb some 62% of the outpatient clinic consultations of the Malaysian public, some 65 million patient visits out of more than 100 million such outpatient encounters. But because of higher cost considerations, hospital use in the private sector only cater to some 30% of the population, with 70% still overcrowding the heavily subsidized (less than 2% of the hospital cost is reimbursed by the patients) public hospitals.[17]
Hence, there is widening discrepancy in access and use of these health services, which lead to greater delay and longer queues for those who cannot afford the private sector. The public hospital sector with its constantly short staffing problems continues to look after the rest of the 75% who need hospitalization for more difficult surgeries and therapies.
Can we now suddenly merge and integrate these two systems, private and public seamlessly, without adequate comprehensive planning and exchanges of ideas and details, about how best to bring this about without upsetting the current system and endangering this working if imperfect system?
Mustn’t we be more involved in this national dialogue to truly improve the system together, and not in fits and stutters, and certainly not in possibly disruptive experimentations…?




[1]Konosuke Matshushita, The Path, McGraw-Hill, New York, 1968.
[2] Jennifer Dixon, Vidhya Alakeson. Reforming health care: why we need to learn from international experience. The Nuffield Trust Briefing, September 2010.
[3] United Nations, Economic and Social Council. Substantive Issues Arising in the Implementation of the International Covenant on Economic, Social and Cultural Rights (ICESCR): General Comment No. 14: The Right to the Highest Attainable Standard of Health. http://www.unhchr.ch/tbs/doc.nsf/%28symbol%29/E.C.12.2000.4.En. Accessed November 22, 2010.
[4] The Opportunity Agenda. Human rights in the US: opinion research with advocates, journalists, and the general public. August 2007 http://opportunityagenda.org/files/field_file/Human%20Rights%20Report%20-%202007%20public%20opinion.pdf. Accessed November 22, 2010.
[5] Eric A. Friedman, Eli Y. Adashi. The Right to Health as the Unheralded Narrative of Health Care Reform. JAMA, December 15, 2010: 304(23): 2639-2640.
[6] Kinney ED, Clark BA. Provisions for health and health care in the constitutions of the countries of the world. Cornell Int Law J. 2004;37:285-355.

[7] Donald W Light, The real ethics of rationing. BMJ 1997;315:112-115 (12 July)

[8] Matthew Buettgens, Bowen Garrett, and John Holahan. Why the Individual Mandate Matters. Timely Analysis of Immediate Health Policy Issues. December 2010. Urban Institute. Robert Wood Johnson Foundation. http://www.rwjf.org/files/research/71601.pdf (Accessed 3 Feb 2011); pg 3.
[9] Schober SE, Makuc DM, Zhang C, Kennedy-Stephenson J, Burt V. Health insurance affects diagnosis and control of hypercholesterolemia and hypertension among adults aged 20–64: United States, 2005–2008. NCHS Data Brief, no 57. Hyattsville, MD: National Center for Health Statistics. 2011.
[10] Mike Mitka. Hospitalizations for Extreme Conditions Mean Extreme Expenses, Study Verifies. JAMA, December 15, 2010—304(23): 2579-2580
[11] David KL Quek. Budget 2010: What’s in it for Health Care?
[12] Ministry of Finance, Government of Malaysia. National Budget 2010

[13] Depart of Health Services, UK. Liberating the NHS: Legislative framework and next steps. 15 December 2010. http://www.dh.gov.uk/en/Healthcare/LiberatingtheNHS/index.htm (Accessed 20 Jan 2011)

[14] British Medical Association. NHS reform consultations, responses and briefings. 19 January 2011 http://www.bma.org.uk/healthcare_policy/nhs_white_paper/consultationpaperswp.jsp (Accessed 26 Jan 2011)

[15] Falk IS, Rorem CR, 1. Ring MD. The costs of medical care: a summary of investigations on the economic aspects of the prevention
and care of illness. Chicago: University of Chicago Press 1933:515-93.
[16] James T. Dove, W. Douglas Weaver, Jack Lewin, Health Care Delivery System Reform—Accountable Care Organizations. J Am Coll Cardiol 2009;54:985–8.
[17] Dato’ Dr Maimunah bt A Hamid, Deputy Director General of Health (Research and Technical Support). 1Care for 1Malaysia:
Restructuring The Malaysian Health System.
Presented at the 10th Malaysia Health Plan Conference on 2 February 2010

Friday, April 2, 2010

Equitable Access to Pandemic Flu Vaccines -- Prof Chan Chee Khoon

Equitable Access to Pandemic Flu Vaccines[1]
 
Chan Chee Khoon
Center for Policy Research & International Studies
Universiti Sains Malaysia
 
Donor Leverage for Access to Avian Flu Vaccines
In late 2006, the Indonesian government made a controversial decision to withhold its H5N1 avian flu virus samples from WHO’s collaborating centers as leverage for a new global mechanism for virus sharing that had better terms for developing countries. 
 
In breaking with the existing practice of freely sending flu virus samples to these laboratories, Indonesia expressed dissatisfaction with a system which obliged WHO member states to share virus samples with WHO’s collaborating centers, but which lacked mechanisms for equitable sharing of benefits, most importantly, affordable vaccines developed from these viral source materials.
 
The Indonesian decision, invoking provisions in the Convention on Biological Diversity (1992) for sovereign rights over biological resources, aroused indignation and accusations of irresponsibility which endangered global health.  There were however also expressions of support and sympathy, including an editorial from The Lancet:
 
To protect the global population, 6.2 billion doses of pandemic vaccine will be needed, but current manufacturing capacity can only produce 500 million doses.  Indonesia fears that vaccines produced from their viruses via the WHO system will not be affordable to them… In November 2004, a WHO consultation reached the depressing conclusion that most developing countries would have no access to vaccine during the first wave of a pandemic and possibly throughout its duration… The fairest way forward would be for WHO to seek an international agreement that would ensure that developing countries have equal access to a pandemic vaccine, at an affordable price.  Such a move would demonstrate global solidarity in preparing for the next pandemic (Lancet editorial, February 17, 2007).
 
On March 29, 2007, immediately following an interim agreement for Indonesia to resume sending flu virus samples to WHO, health ministers of eighteen Asia-Pacific countries issued a Jakarta Declaration which called upon WHO “to convene the necessary meetings, initiate the critical processes and obtain the essential commitment of all stakeholders to establish the mechanisms for more open virus and information sharing and accessibility to avian influenza and other potential pandemic influenza vaccines for developing countries”.  These concerns were tabled at the 60th World Health Assembly in Geneva (May 14–23, 2007) as part of a resolution calling for new mechanisms for virus sharing and for more equitable access to vaccines developed from these viral source materials. 
 
In the course of the deliberations, it emerged that WHO had not abided by the terms of the 2005 WHO guidelines[2] on sharing of viruses which required the consent of donor countries before WHO’s collaborating centers could pass on the viruses (other than the vaccine strains) to third parties such as vaccine manufacturers.  While discouraging the use of material transfer agreements (MTAs) at the point when donor countries transferred their virus samples to WHO, WHO’s collaborating centers nonetheless resorted to MTAs when they transferred to third parties vaccine strains containing parts of the viruses supplied by developing countries such as Indonesia, Vietnam and China.  Indeed WHO’s collaborating centers themselves, as well as third parties, had sought patents covering parts of the source viruses used in developing vaccines and diagnostics[3].  Possibly the most contentious item on the health assembly’s agenda in 2007, the issue of virus sharing and access to avian flu vaccines remained unresolved until the final hours of the assembly when a resolution was adopted mandating WHO to establish an international stockpile of vaccines for H5N1 or other influenza viruses of pandemic potential, and also to draft new terms of reference for the sharing of influenza viruses[4].
 
The Indonesian government’s stance was notable on four counts:
 
  • it called into question a system that had worked satisfactorily in routinely transferring viruses to manufacturers which produced seasonal flu vaccines for markets in affluent countries, but whose (pre-)pandemic flu vaccines were beyond the reach of poorer communities
  • it was explicitly a critique of WHO’s balance of pragmatism which it felt was overly accommodative of corporate priorities and structural inequities, to the detriment of the health and wellbeing of underserved communities among its member states
  • it was an exercise of leverage by a source country of biological materials seeking to redress the inequities of access to what may be vitally important health inputs (avian flu vaccines) developed from these source materials
  • it was seeking equitable benefits from commercial developers not just for its nationals but for other communities as well who were likely to be sidelined by commercially-driven product development and distribution.
 
Global Health Security, or Global Public Health?
In April 2003, as the SARS pandemic was unfolding, Ilona Kickbusch, Professor of Global Health at Yale University’s School of Public Health lamented the weak enforcement mandate of international agencies such as the WHO for securing the cooperation of member states in safeguarding global health.  In parallel with “an incentive system for countries who act as responsible global citizens”, she issued an accompanying call “to explore sanctions by the UN Security Council, the WTO and the IMF for countries that do not adhere to global health transparency and their obligations under the IHR” [5]. 
 
Similar sentiments, couched in terms of health security and health policing, had been expressed about Indonesia’s refusal to dispatch H5N1 virus samples to the WHO’s collaborating centers.  In a strongly-worded op-ed in the Washington Post (August 10, 2008), Richard Holbrooke and Laurie Garrett castigated Indonesia’s “dangerous folly” as “morally reprehensible” actions of a recalcitrant state which jeopardized global health security (perhaps calling for humanitarian intervention?):
 
Here's a concept you’ve probably never heard of: “viral sovereignty.” This extremely dangerous idea comes to us courtesy of Indonesia's minister of health, Siti Fadilah Supari, who asserts that deadly viruses are the sovereign property of individual nations - even though they cross borders and could pose a pandemic threat to all the peoples of the world… Disturbingly, the notion has morphed into a global movement, fueled by self-destructive, anti-Western sentiments. In May, Indian Health Minister A. Ramadoss endorsed the concept in a dispute with Bangladesh. The Non-Aligned Movement - a 112-nation organization that is a survivor of the Cold War era - has agreed to consider formally endorsing the concept of “viral sovereignty” at its November meeting… Political leaders around the world should take note - and take very strong action.
 
A year later in July 2009, as the H1N1 pandemic was unfolding amidst efforts to boost vaccine production, along with widespread concerns over supply limitations and distribution, Garrett belatedly acknowledged the essential point about “viral sovereignty”, that it was above all an exercise of sovereign leverage for more equitable access to lifesaving vaccines in a pandemic situation:
 
The Minister of Health of Indonesia, Dr. Siti Supari, has insisted for several years that it is not the duty of her country to share samples of H5N1 bird flu viruses.  Supari’s position all along has been that the drug companies will turn these viruses into vaccines, and then charge so much for their products that the poor countries will never be able to afford the life-saving products. What we now see unfolding with the H1N1 vaccine scenario would seem to validate her argument… when a pandemic comes, the rich world takes everything and saves itself (ScienceInsider, July 28, 2009).
 
Despite appeals to humanitarian solidarity[6] and to enlightened self interest[7], almost all of the first billion doses of H1N1 vaccine produced in 2009 were allotted to 12 wealthy nations which had made advance orders.  Sanofi Pasteur and GlaxoSmithKline pledged 120 million doses to the WHO for distribution to poor countries, but even those pledges could only be fulfilled months after the pandemic had waned.  
 
In Mexico, the epicenter of the H1N1 pandemic where health authorities had promptly shared its viruses with WHO’s Global Influenza Surveillance Network (GISN), Health Secretary Jose Angel Cordova revealed that “we had to wait in the second line to buy the vaccine, because obviously the first shipments were for the countries that make the vaccine”[8].  With no domestic production capacity at the time, Mexican officials had ordered 30 million doses of the vaccine from Sanofi Pasteur and GlaxoSmithKline, most of which could be delivered only in February or March 2010.  Under the circumstances, they made an arrangement to borrow 5 million doses from Canada, as the pandemic waned in the northern hemisphere.
 
Access to Pandemic H1N1 Vaccines:  A Worrisome Preview
As it turned out, the H1N1 pandemic peaked in October-November 2009 in the northern hemisphere, and it furthermore remained mild, more comparable in severity to the 1957 and 1968 pandemics than to the feared 1918 pandemic. 
 
Many nations cut back on their vaccine orders, others attempted to sell off excess stock or pending deliveries as the threat perception receded and skepticism about the vaccines’ safety resurfaced among the general public.  France, for example, had ordered 94 million doses for its 65 million people and eventually tried to sell off 50 million doses of excess inventory.  In Britain, the government negotiated to reduce prior contracts for 90 million doses.  The United States had contracts to buy 251 million doses from five companies.  It reduced by 22 million doses an order of 36 million from CSL Ltd., an Australian manufacturer that fell behind on deliveries, while retaining the other orders.  As of early February 2010, only about 62 million doses had been administered to US residents.  There had been earlier controversies over the reluctance of US health authorities to deploy adjuvanted vaccines, i.e. vaccines with booster additives which could have doubled the available doses at a time when vaccine demand greatly exceeded vaccine supply.
 
In September 2009, President Obama’s administration had brokered an agreement with eight other wealthy nations (Australia, Brazil, France, Italy, New Zealand, Norway, Switzerland, and the United Kingdom) to donate ten percent of their vaccine supplies to WHO for use in poor countries, on top of the pledges by Sanofi Pasteur and GlaxoSmithKline. (Eventually, two additional countries and four more manufacturers came on board, raising the total pledges to 180 million doses of vaccine).
 
As of early February 2010 however, only two of the 95 countries listed by WHO as having no independent means of obtaining flu vaccines - Azerbaijan and Mongolia - had received any.  WHO had earlier planned to deliver vaccines to 14 of these countries by then, and even then shipments were adequate to protect only 2 percent of the countries’ populations.  Pledges and exhortations aside, few were really surprised that when faced with perceived national emergencies, countries that could afford vaccines prioritized their own nationals first, and only when the worst had passed, transferred their leftovers to the poor using the WHO as a clearinghouse.
 
In the wake of the mild pandemic, WHO’s alert system for influenza pandemics also came under scrutiny.  Under WHO’s six-stage approach, the highest (pandemic) stage is declared when a new flu strain that spreads easily among humans and causes serious illness, shows evidence of sustained community level spread in at least two regions of the world.  The system however focuses more on transmissibility, while lacking an index of virulence or lethality.  This causes confusion among people who equate “pandemic” with a high death rate, usually measured by the “case-fatality ratio” (CFR, the ratio of deaths to infections).  In truth, the CFR is an unstable parameter in the early stages of a novel outbreak, since it is usually the fatalities and severe cases that come to early attention, thus inflating the CFR as an artifact of underreported mild or asymptomatic infections.
 
There were also allegations of scaremongering by parties with vested interests in vaccine manufacture and sales, squandering of scarce health resources and diversion of attention from more urgent priorities in global health.  Prior to the H1N1 pandemic, some researchers had already begun to question the efficacy of seasonal flu vaccines (Jackson 2005, Jefferson 2006).
 
In any case, whether one felt cheated by or relieved at the mild course of the pandemic, it provided a valuable preview of likely scenarios for vaccine supply and timely access, in the event of a more virulent pandemic.  For developing countries, this dress rehearsal was uncomfortably close to the scenarios anticipated by Dr Siti Fadhilah Supari, the Third World Network, and others. 
 
Resolution WHA60.28 in 2007 (“Pandemic Influenza Preparedness: Sharing of Influenza Viruses and Access to Vaccines and Other Benefits”) was notable in declaring for the first time, at the highest levels of representative global health diplomacy, that affordable access to the benefits of virus sharing in such forms as vaccines, medicines, and diagnostics was the equitable quid pro quo of global virus sharing arrangements for pandemic alert and response. 
 
Indeed the WHO Intergovernmental Meeting (IGM) on Pandemic Influenza Preparedness, a process mandated by WHA60.28, included by consensus the following paragraph in its draft framework for reforming the GISN[9]: 
 
Recognise that member states have a commitment to share on an equal footing H5N1 and other influenza viruses of human pandemic potential and the benefits considering these as equally important parts of the collective action for global public health.
 
In the absence of reciprocal benefits, the International Health Regulations (2005) in particular, which impose mandatory disease reporting obligations on signatory member states, could reduce poorer front-line states to the role of pandemic “canaries” in an early warning system for emergent flu pandemics.


[1] Paper presented at the Conference on Strengthening Health and Non-Health Response Systems in Asia: A Sustained Approach for Responding to Global Infectious Disease Crises (co-organized by Nanyang Technological University and the World Health Organization, 18-19 March 2010, Singapore )
[2] Avian and pandemic influenza: developments, response and follow-up, and application of the International Health Regulations (2005) - Best practice for sharing influenza viruses and sequence data.  EB120/INF.DOC./3 (WHO Executive Board, 120th session), 11 January 2007.  Geneva ; World Health Organisation.
[3] TWN Information Service on Health Issues, 22 May 2007. http://www.twnside.org.sg/title2/health.info/twninfohealth090.htm  (accessed on May 23, 2007).
[4] Pandemic influenza preparedness: sharing of influenza viruses and access to vaccines and other benefits.  Resolution WHA60.28, adopted at the 60th World Health Assembly ( Geneva , 23 May 2007) http://www.who.int/gb/ebwha/pdf_files/WHA60/A60_R28-en.pdf  (accessed on May 29, 2007)
[5] SARS: Wake-Up Call for a Strong Global Health Policy.  Yale Global Online, 25 April 2003.
[6] Yamada Tadataka (Gates Foundation): “Pandemic vaccines allocated to developing nations should become available in the same time frame as vaccines for developed nations”.
[7] Ruth Levine (Center for Global Development): “If your neighbor’s house is on fire, would you hoard all the water while you waited for the flames to come your way?”
[8] Associated Press, January 12, 2010 
[9] “Pandemic Influenza Preparedness Framework for the Sharing of Influenza Viruses and Access to Vaccines and Other Benefits”, IGM session, 8-13 December 2009


****************************
CHAN Chee Khoon, ScD
Professor (Health & Social Policy)
Center for Policy Research & International Studies
Universiti Sains Malaysia
11800 Penang, Malaysia
tel : + 60 4 6534537
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