By Jeremiah Norris
In global health, there is no other percentage that has so captured the public imagination and dominated media coverage than the relationship of national health expenditures to Gross Domestic Product (GDP). In the US, the current figure is 18% of GDP. When published, this percentage ignites a perception that often takes on the value of reality. It is followed by hand-wringing comments in the press and among policy-makers that we spend more than double what other developed countries do and get less in return. This assumes that there is an equivalency within the various components which comprise GDP from developed countries with socialized medicine when compared to a capitalist system. Moreover, the expenditure rate is seen as a resource flow which dissipates into a dark hole in space, notwithstanding the fact that health care itself is a central contributor to the economy, particularly on employment, even in recessionary times.
The US Government’s Bureau of Economic Analysis (BEA) defines GDP as “the output of goods and services produced by labor and property located in the United States. As long as these are supplied by US residents, they may be located either in the US or abroad.”
That is the accepted definition of GDP. But it doesn’t mean that health expenditures within a socialist economy where it is funded through general taxation is measured by the same yardstick as those in the US where it is financed by an equal percentage of public-private sources and delivered almost exclusively through private provision.
These are some items counted towards US GDP but not in socialized medicine countries:
- the cost of mal-practice insurance and awards to plaintiffs;
- the accelerated depreciation on 5-year schedules of plant and equipment;
- health care employer and employee payroll contributions to Social Security, Medicare, 401 (k) retirement plans, and Workmen’s Compensation Insurance;
- and, in most developed countries, capital investments are publicly funded and accounted for through ministries of public works; in the US these same investments are charged against GDP for health.
Canada has a single payer system. When an annual national health budget is passed, it is then divided among the provinces according to population. They can consume the amounts specified in their budget allocations—and then no more. Yet, Canadians spend more on health care than what is accounted for in their national budget. In 2012, more than 40,000 Canadians sought specialty care in U. S. institutions, where their expenditures were charged against US GDP and deducted from Canada’s.
The capital assets in hospitals and medical equipment in the EU are publicly owned, thus there is no need to apply for tax relief on depreciated values. This is a substantial sum in the US as “almost one-third of health care spending pays for hospital services”. EU health care cadres pay one tax into the Treasury for all social services, obviating payroll taxes as in the US for, pension, Social Security, Workmen’s Compensation and Medicare.
Over the past five years, health care jobs in the US have outpaced employment trends overall. They account for one out of every six jobs created by 2012. As jobs disappeared during the Great Recession, health care companies continued hiring. They “added 428,000 jobs throughout the 18-month recession from December 2007 until June 2009 and have continued to grow at a steady rate since the end of the recession.”
The percentage of health care expenditures is lower in “all other developed countries [which] rely on a large degree of direct government intervention and rate-setting to achieve lower-priced medical treatment for all citizens”. For instance, on pharmaceuticals, France and Italy directly regulate prices at launch and subsequent rate of price increases. Germany, the Netherlands, and Denmark operate reference price systems of reimbursement and thereby exert strong pressure on prices charged by manufacturers. The UK operates a system of profit regulation that constrains prices to yield no more than a target overall rate of return on capital. One effect of this regulatory environment is that one of its a major producers maintains a paper registration of corporate ownership on the London stock exchange, but conducts its main manufacturing operations in the US where it can price products on the open market. The Canadian government monitors price levels at launch and rates of increase to assure they are “reasonable”. If US pharmaceutical producers want to be in these markets, then they have to lower their prices and conform to EU regulations, though the same product is available in US markets, often at double the price. Regulated prices in the EU translate into lower health care expenditures relative to GDP; in effect, they also mean that US citizens are subsidizing health care for their counter-parts in the EU.
To change this perception we have to change the reality. Objective-based research is needed on the relationship of GDP and health care spending since policy-makers allocate resources on the basis of comparisons between developed countries. The measurement has to be of like-things to like-things. There can be little doubt that it isn’t equivalent to compare socialist economies with capitalist economies. On one simple indicator, if EU countries permitted market pricing of drug products, then their ratio of health care expenditures to GDP would be far higher than presently reported in the 8-10% range.
By Jeremiah Norris
The upward thrust of events that have shaped healthcare in America since 1900 when national health expenditures were unknown to 18% of GDP in 2013 constitutes a study often lost in the mist of time, and one that is illustrative of the long road to the Affordable Care Act of 2010 (ACA). The 18% is seen as expenditure within a seamless, integrated ‘system’, rather than the amorphous components which comprise a public-private cottage industry. At the advent of the 20th Century, population was 76m with a life expectancy of 47 years. Health insurance wasn’t available, nor published reports on health expenditures until the mid 1950s. Now, we have 317m with a life expectancy of 78.2 years, and 84% is covered by health insurance.
The beginnings of organized medicine weren’t in place until the Flexner Report of 1910, funded by Carnegie Foundation. The Report served as the catalyst for establishing a standard curriculum in medical schools, their accreditation, and the licensing and certification of practitioners. Up until that point, there were proprietary medical schools, mainly operated as private businesses. Approximately one-third of them closed in the decade following publication of this Report. From 1910 – 1928, the Rockefeller Foundation funded a momentum for change through the reorganization of medical education within twenty-four universities.
Since then, the major drivers on the upward expenditure curve have been government initiatives. During the Great Depression of the 1930s, patients had difficulty paying hospitals for services. The government stepped in, offered community hospitals non-profit status in return for a fixed percentage of their income over expenses to cover uncompensated care. This was the birth of Blue Cross-Blue Shield Association.
In the late 1950s, the government established wage and price controls in private businesses. It then permitted employers to substitute health insurance as a covered benefit in lieu of wage increases.
In 1965, the Congress passed Medicare, which provided healthcare for those aged 65+. In 1972, legislation authorized the End Stage Renal Disease Program under Medicare. It now covers 90% of all US citizens with severe chronic kidney disease, regardless of age. In 1997, the Congress added a new component, the Program of All-Inclusive Care for the Elderly. It provides comprehensive care for individuals age 55 and older who are sufficiently frail to be categorized as “nursing home eligible” by their state’s Medicaid program. Disability insurance was added in the 1970s for those under age 65, some as infants. In 2006, the Prescription Drug Benefits Program was added.
In 1966, the Congress enacted Medicaid, a program for the provision of health services to the poor. States provide up to one half of the funding. Those with disabilities who do not have a work record and receive Supplemental Security Income (SSI), are enrolled into Medicaid as a mechanism to provide them with health insurance. Medicaid payments currently assist nearly 60% of all nursing home residents and about 37% of all childbirths in the US. The federal government pays on average 57% of Medicaid expenses.
In 1997, the Children’s Health Insurance Program (CHIP) was enacted by the Congress as a partnership between federal and state governments. It is administered by HHS and provides matching funds to states for health insurance to families with incomes that are modest but too high to qualify for Medicaid.
In 1960, Congress enacted the Federal Employees Health Benefit Program (FEHB). The government contributes 72% of the premium of all plans offered to active and retired federal employees. FEHB is administered by the US Office of Personnel Management.
The Military Health System is under the US Department of Defense, while the Veterans Administration is a separate Cabinet post. They provide healthcare to active duty, retired military personnel, dependents, and veterans from all service branches.
The Indian Health Services was established in 1955, and is operated through HHS. In 2011, its budget was $4.3 billion, covering 2,700 nurses, 900 physicians, 400 engineers, 500 pharmacists and 300 dentists. Other health professionals bring total staffing to more than 15,000. Indians are also eligible to apply for health care provided by Medicaid.
For the period 2013-2022, these health spending differences per enrollee can be seen in 2013 and 2022:
Medicare spending per enrollee $11,829 $16,914
Medicaid spending per enrollee $7,784 $10,777
CHIP $2,187 $3,115
Employer-sponsored Private Health Ins. $5,435 $8,204
Other Private Health Insurance $2,434 $5,587
A central premise of ACA is that it will bend the cost curve downward on national health expenditures. Excepting Medicaid, the other programs mentioned will be outside of ACA’s specific domain, though they cover some 100m people. For those enrolled into Medicaid, the Federal government will pay States its full costs for the first three years, and 95% thereafter. There will be no deductibles. This will accelerate the present differential between government and private spending, assuring that the HHS’s actuary prediction of health expenditures rising to 20% of GDP by 2022 will be realized.
by Jeremiah Norris
Advocates of Universal Health Coverage (UHC) believe that the key to success can be seen in the World Bank’s new vision as stated by its President in his address to the World Health Assembly in May 2013. He said: “We must be the generation that delivers universal health coverage … warning that UHC could become a toothless slogan”.
Senior policy-makers at the Bank, and its sister organization, the IMF, should take this warning seriously. In 1999, the Bank conducted an audit of 107 of its health projects, finding: 1) “the Bank does not adequately assess borrower capacity to implement planned project activities; 2) notably lacking is an adequate assessment on demand for health services; 3) we know little about what the Bank has ‘bought’ with its investments”.
In 2009, it conducted another internal audit based on corrective measures it had set in place, finding: one-third of World Bank health, nutrition and population program loans met with unsatisfactory outcomes. The Bank spent $17 billion on these initiatives.
Subsequently, the Guardian Weekly drilled deeper into the Bank’s audit, determining that: “despite the Bank’s raison d’être to end poverty, that was the specific objective of only 6% of projects and a secondary objective of 7%. Even when this was a stated objective, there was little monitoring of outcomes. Where it was done, few projects had achieved that goal … and much of the spending aids [the] richest 20% of people”.
The Bank conducts annual reviews through its Independent Evaluation Group (IEG). In a 2006 evaluation of a subsample of 25 Bank-assisted countries for which outcomes had been assessed, “only 11 reduced the incidence of poverty between 1990s and the early 2000s, while poverty either stagnated or increased in the remaining 14 countries”.
In 2007, the IMF published a report on health aid and infant mortality. It found that “despite the vast empirical literature considering the effect of foreign aid on growth, there is little systematic empirical evidence on how overall aid affects health, and none (to our knowledge) on how health aid affects health”.
The Bank’s funding is directed mainly to the public health sector of developing countries. Here, it is burdened by high transaction costs, lack of ownership, and interest payments. It competes with private resource flows, often without these operational liabilities. Official Development Assistance (ODA was once the dominate form of assistance to developing countries. But today, according to Hudson’s Index of Global Philanthropy and Remittances, “Nearly 80% of all DAC donors’ total economic engagement with the developing world is through private financial flows.”
An October report by the Bank on global remittances has estimated that they are “expected to reach $414 billion in 2013, and $540 billion by 2015”. These flows often are used to purchase health and educational benefits. Sooner or later, every remitted hard currency ends up in a country’s central bank where it is used to purchase goods and services which can only be procured through the use of scarce foreign exchange.
In the post-colonial world of the early 1960s, most countries emerging into independence had virtually no private health sectors. In that environment, it was perfectly logical for the World Bank to lend into their public sectors. That world has changed dramatically. For instance, in the largest countries, private expenditures on health as a percent of total expenditures on health show that it is 69% in Bangladesh; 81% in Cambodia; 64% in China; 76% in India; 65% in Indonesia; 55% in Mexico; 75% in Nigeria; 73% in Pakistan; 62% in South Africa; 70% in Uganda; and 73% in Viet Nam.
The successful implementation of UHC is dependent upon: “1) removal of direct out-of-pocket payments); 2) [a migration from] employment-based and contributory insurance models … to the public health sector; and 3) financial support through general government revenues”. Given the choice between low cost private resources for healthcare and heavily burdened ODA for UHC, it shouldn’t be surprising that ministries of finance would choose a resource flow which would provide them with increased levels of foreign exchange at least cost to their societies, while at the same time improving their international credit ratings for borrowing.
The Bank’s president is prescient in his caution that UHC could end up as a slogan. Yet, when used in his new vision To End Extreme Poverty by 2035 during the Bank’s Annual Meeting in October, it indemnifies donors from performance accountability. Who could be against such a laudable goal! When cast against an ocean of inconsequential Bank and IMF audits and their leadership in debt forgiveness of $93 billion for 40 poor countries through the Jubilee Program—the same countries which would be the main subjects of UHC, an embrace of these concepts by the Bank can be seen as a continuous tight grip on slogans in a retracing search for yesterday’s icebergs.
By Jeremiah Norris
At Alma Ata, Kazakhstan, in 1977, WHO was charged with a new program initiative, “Health for All by the Year 2000” (HFA). Broadly, its aims were to “bring health within reach of everyone in a given country. By ‘health’, it is meant a personal state of well being, not just the availability of health services. [it implies] A state of health that enables a person to lead a socially and economically productive life.”
Subsequently, bilateral and multilateral agencies, as well as numerous non-governmental organizations, supported its goals and funded them extensively from that date through 2000 with billions of donor dollars. In 2001, WHO published “Macroeconomics and Health: Investing in Health for Economic Development” (MH). It was written by an impressive list of Commissioners, headed by Prof. Jeffery Sachs, then with HarvardUniversity, and funded at $2.5 million by WHO. The basic thrust of this new initiative is a formulaic expression: “expanding coverage for essential health services to the world’s poor through scaling up resources, poverty would be reduced, economic development accelerated, and global security advanced. This could save at least 8 million lives each year by the end of the decade, and assuming that each DALY saved “gives an economic benefit of 1 year’s per capita income of a projected $535 in 2015, the direct economic benefit … would be $186 billion per year, and plausibly several times more”.
A critical component of HFA was Multisectoral Planning, in which WHO would engage all line ministries in its global effort. It re-emerged in MH as a recommendation for the formation of National Macroeconomic Commissions, co-chaired by ministries of finance and health. There isn’t any public record of these Commissions having been formed. MH is completely absent of any references to HFA in the main text, in Appendix I listing the Commissioners; their Biographical Sketches; or Reports and Working Papers; or Appendix 2; or References; or even in the Glossary!
It calculated an economic benefit for the 8 million lives saved annually by essential health interventions. The Commissioners walked away from the downstream implications by making an assumption that those saved would go on to a life of suspended animation, free of noncommunicable diseases (NCD) and the costs associated with them. Once a child makes it beyond age 5, the unerring arrow of a costly NCD morbidity will strike somewhere along life’s path. Not much else in healthcare is certain. This is.
WHO never published a final report on HFA. This would have generated a wealth of ‘lessons learned’. Applied to the Commissioners 2001 work, this valuable resource could have substantially grounded its proposal in a legitimacy otherwise difficult to obtain.
Notwithstanding the lack of progress on these two initiatives, the 2005 World Health Assembly resolution and the 2012 UN General Assembly resolution supported the concept of Universal Health Coverage (UHC). Proponents of this concept believe that universal health coverage means “that people should have access to all the services they need, of good quality, without suffering financial hardship when paying for them”.
A key financial barrier to this coverage is co-payments by patients. At the 66th World Health Assembly in May 2013, the President of the World Bank said: “anyone who has provided health care to poor people knows that even tiny out-of-pocket charges can drastically reduce their use of needed services. This is both unjust and unnecessary”.
His statement was in contravention to the Bank’s report of 20 years ago, titled: “Investing in Health”. It proposed the implementation of user fees, a policy which was adopted by many Member States. It is also contrary to WHO’s ranking of Members on healthcare. In every category, “Singapore is either the very best in the world or near the very top. Its out-of-pocket healthcare costs are the highest in the world”.
The predominant form of health financing in most developing countries is in their private sectors. Out-of-pocket payments include co-payments for those covered by health insurance plans, government retirees under medical care through social security-type systems (it is 65% of total public health expenditures in Bolivia), and private health plans. Their removal under UHC would require approval from ministries of finance, causing them to impose additional sources of funding for public health via new taxes.
Alongside these two global initiatives, other programs were launched independent of direct WHO management. Two of the largest are PEPFAR (the President’s Emergency Plan for HIV/AIDS, TB and Malaria) launched in 2003 with a $15 billion grant from the U. S. It was renewed in 2008 with an additional grant of $53 billion. It works closely with the Global Fund to Fight HIV, TB and Malaria, “which in its recent replenishment was able to obtain $18.9 billion in new pledges”. Together, these two organizations expect to have 10 million AIDS patients under ARV treatment by the end of 2013. For the first time in the global fight against AIDS, the number of new infections has declined.
Rather than leading the way forward on global health, the two WHO initiatives followed past remedies: pour in money and stir. Money was used as a product for consumption when experience informed PEPFAR and the Global Fund that it needed to be used as a medium with a command power to create something of value between partners.
Fire in the Blood, a film by Punjabi-Irish writer-director Dylan Mohan Gray was first released at the Sundance Film Festival in January 2013. Since then, it made blood boil on at least several continents. In Global Health Check February 2013, Araddhya Mehtta blogs that the documentary film covering Africa before HIV/AIDs mass treatment programs got underway “tells a harrowing story of inhumanity and heroism” and details how “millions upon millions of people, primarily in Africa were left to die horrible, painful deaths, while the drugs which could have saved them were being safely and cheaply produced and distributed just a short airplane ride away.”
She goes on to tell how the film accuses multinational drug companies and Western Governments of collaborating “to keep low-cost generic AIDS drugs out of the hardest hit countries.” According to Mehtta, film director Gray described the story as a “real-life David vs. Goliath tale, full of incredibly interesting, daring, courageous mavericks, who took on the world’s most powerful companies and governments to do what virtually everyone else at the time said was impossible (i.e. mass treatment of HIV/AIDS in Africa), and against all odds they won…”
Mehtta and Gray fail to mention some pertinent facts that present an altogether different picture.
First, the global health community and the Clinton Administration throughout the 1990s did not fund any HIV/AIDS overseas treatment programs. They advocated only preventive programs, such as testing, counseling, and condoms. The notion that Africans would agree to testing for the HIV/AIDS virus with the associated stigma and no available treatment was always puzzling to me. President Thabo Mbeke in South Africa was in denial of the entire AIDS epidemic. According to Roy Caroll, “He questions the link between viruses and AIDS, and believes that the correlation between poverty and the AIDS rate in Africa was a challenge to the viral theory of AIDS.” So it’s hard to see who the real “courageous mavericks” were in the 1990s and early 2000s.
It wasn’t until George W. Bush came into office and completely reversed the U.S. Government position against treating AIDS that the global health community changed its tune. President Bush ushered in treatment and created the well-known PEPFAR program in early 2003 which combined prevention and treatment for the first time for patients in poor countries hardest hit by AIDS. Only then, in December of 2003, did the WHO initiate its own program which included treatment for the first time.
Secondly, for Mehtta to proclaim, without any examination of the evidence, that there were “safely and cheaply produced” drugs just a short airplane ride away is misleading. She seems to be referring to Indian companies that were producing knock-off HIV/AIDS drugs for export. It’s safe to say that the drugs were cheap, but not that they were safe since India requires no bioequivalence testing on drugs for export. The chickens came home to roost in May of 2004 when the WHO recalled 36 Indian drugs from the market and mainly in Africa because the Indian companies could not provide proof of bioequivalence. And, while India was the epi-center of low cost production of ARVs, it had as difficult a time of providing treatment to its own patients as to those in the global arena. In October 2006, the International Treatment Preparedness Coalition criticized India for having 785,000 patients eligible for ARV treatment while only 6% of them were receiving it.
What Mehtta and the film do not acknowledge is the role of the U.S. Government’s FDA, which in May 2004, in an effort to increase AIDS drugs for poor countries, offered to accept any ARV drug file for review from companies in any country that wanted FDA certification to confirm that their drugs were valid ARV generics. In turn, U.S. companies, also wanting to increase AIDS drugs for poor countries, did not challenge the Indian companies for violating their patents. This made it possible for the U.S. Government to purchase these drugs and expand distribution even though the price differentials between the Indian and U.S. ARVs were not that significant.
This successful and innovative program between the U.S. Government and companies resulted in the number of AIDS patients being treated increasing from 400,000 in 2004 to more than 8 million patients by the end of 2012. Eighty percent of these patients were receiving Indian drugs, but this time, they were drugs that had been tested for safety and efficacy. And finally, even before President Bush allowed treatment of AIDS patients in U.S. programs, and the global health community followed suit, U.S. companies spun into action with multi-country and single country HIV/AIDS programs for vulnerable populations overseas. From 2000 through 2011, companies donated some $76 billion in drugs – often ARVs, and $9 billion in cash donations including capacity building and physical infrastructure. These contributions are greater than the combined health budgets of the World Bank, WHO, and USAID over the same time period.
The story of HIV/AIDS deserves a better documentary than Fire in the Blood if we are to ever learn from our mistakes for future pandemics. Yes, the story of HIV/AIDS is a sad story of unnecessary human suffering, but the film is missing the chapter on how global health experts endorsed only preventive programs without treatment for over a decade. Yes, ARVs were blocked from reaching Africa but primarily by health policy makers, not in a conspiracy of governments and companies. Yes, it did take some courageous mavericks to set it right, but not the ones generally mentioned, rather President Bush, the U.S. FDA, Dr. Paul Farmer who was the first to demonstrate that AIDS treatment could work in resource-constrained environments, and NGOs that stood their ground on the importance of both prevention and treatment. Documentary filmmakers should at least provide a balanced story and “do no harm” when they turn their cameras to life and death matters.
On May 26, 2012 the World Health Assembly (WHA) adopted a resolution calling for an inter-governmental meeting to examine the proposals made in April by the Consultative Expert Working Group on Research and Development: Financing and Coordination (CEWG) to initiate a Global R&D Convention. It called for “open approaches to R&D, pooled funds, direct grants to companies in developing countries, prizes for milestones and end products, and patent pools”. The main recommendation of the CEWG was, however, more far-reaching: “to start multilateral negotiations for the possible adoption of a binding convention on health R&D”.
The concept of a Global Convention rests on three main premises:
- 1) “the current R&D model, based on patents and market-oriented research, fails to generate new health technologies to face global challenges arising from existing health needs, particularly in developing countries;
- 2) it is necessary to secure product access and affordability by delinking R&D costs from the prices of products; and
- 3) voluntary financing cannot be the main or unique source of funding—a better, more sustainable and predictable financing model is needed”.
In April 2012, Medecins sans Frontiers (MSF) stated: “the current R&D system is driven by market forces, not health needs, and relies overwhelmingly on the patent system to recoup costs by via high prices”.
How relevant are these premises to issues to the the Millennium Development Goals (MDGs)? In both cases, WHO was designated by the UN as the operative agency in September of that year.
Ten years ago, researchers showed that “from 1975-1999, only 1.3 percent of new drugs and medicines were developed for neglected tropical diseases and tuberculosis despite the fact that these diseases accounted for 12 percent of the global burden of disease”.
Yet, when adopting the eight MDGs in September 2000, WHO dismissed both neglected tropical diseases and TB. In Goal #6, the only one with a specific disease target, it read: “Combat HIV/AIDS, Malaria and other diseases”. The urgency now being expressed in the high burden of tropical diseases by the CEWG was curiously absent in 2000 when WHO relegated them to a global potpourri of ‘other diseases’.
Is the low percentage of new drugs and medicines as important a factor in subsequent access and affordability, or is the number of drugs that actually came on the market in this period to diminish tropical diseases more important? Let’s look at a few examples.
In 1978, an R&D company introduced Ivermectin to combat an age old scourge: onchocerciasis or river blindness. It made this therapy available at no cost into perpetuity. This disease is the world’s second leading cause of infectious blinding, leading to reduced agricultural output. A World Bank evaluation looked at riverine communities that had left the land due to endemic blindness. Once this disease “was controlled, 25 million hectares of land were returned to agricultural production, enough to feed 18 million people”.
In the 1980s, USAID sponsored a program to introduce Oral Hydration Salts (ORS) as the treatment of choice for diarrheal disease. The product was developed by an R&D company, and considered by some to be “possibly the most important advance of this century”.
Although the R&D companies patented their respective therapies, neither enforced them when other non-R&D companies massively produced these products. Today, ORS is the preferred treatment for diarrheal diseases, saving the lives of millions of poor children.
In 1987, when the global AIDS epidemic was beginning its ascendancy and no interventions were in sight, one R&D company developed the first therapy for effective treatment: AZT. This sparked a revolution in product innovation by others: today MSF records that there are 26 different therapeutic classes of ARVs, all of them covered by extant patents. Most are being produced by Indian firms as generics without fear of legal challenge from their right-holders. MSF has designated India as “pharmacy to the developing world”. (9) WHO records in 2012 more than 8 million AIDS patients under life-extending ARV treatment, up from less than 50,000 in 2003.
In 2006, the Congressional Budget Office published a study on average costs and times to successfully develop a new molecular entity. “In 2000, the total cost was $802 million, with an average time of 11.8 years to bring a product to market”. By 2012, that average costs has risen to $1.3 billion and the time to 12+ years.
All new drugs that reach the market after FDA approval don’t necessarily find a market. In 2006, one R&D company introduced a new inhaler for asthmatics. By 2011, it had to conclude there was no market for it, writing down $2.3 billion in losses. An R&D Convention would most certainly produce some losers; how would they be covered?
The first order of business for the CEWG should be: in a global health community increasingly focused on evidence-based programming, can the concept for an R&D Convention be sustained by its founding premises?
If these answers can provide confidence to continue with the concept, then advocates need to propose a new regulatory agency with extraterritorial enforcement authorities. It would have to address this question: is there a scientific justification for the retention of FDA/EMEA pharmaceutical quality requirements more stringent than those of the proposed R&D Convention? Investors, public and private, would want assurances of this nature before they expend untold billions in the absence of a proof of concept.