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Covid-19 vaccines for very young children

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Dr B.J.C.Perera 

MBBS(Cey), DCH(Cey), DCH(Eng), MD(Paed), MRCP(UK), FRCP(Edin), FRCP(Lon), FRCPCH(UK), FSLCPaed, FCCP, Hony FRCPCH(UK), Hony. FCGP(SL) 

Specialist Consultant Paediatrician and Honorary Senior Fellow, Postgraduate Institute of Medicine, University of Colombo, Sri Lanka.

In any immunisation programme against an infective disease, the aim is to vaccinate as many of the susceptible population as possible. That is a fundamental principle in epidemiology. There is absolutely no question in the minds of the experts that in the case of the raging COVID-19 pandemic that is causing havoc right round the globe now, there is universal susceptibility of all humans of all nations, all populations and all social groups of the people of planet earth to this miserable blight. There are no worthwhile differences in the ethnic groups, age categories and socio-economic assemblies in their actual propensity for contracting the disease. The virus will get in and infect anyone anywhere. There are only differences in the severity of the illness and the tendency to die from the disease in certain well-understood categories or age groups of people.

It is a well-recognised fact that the coronavirus disease may be quite asymptomatic in a vast proportion of affected youngsters of all age groups, ranging from very young pre-schoolers to adolescents and even young adults. In another significant though rather small proportion of children and young people, the symptoms are quite mild. Only in a very small minority, perhaps as low as 1 to 2 percent of affected children, is the disease is of such severity as to need intensive treatment. In the United States of America, a proportion varying from 0.01% to 1.9% of all affected children needed hospitalisation. Their death rates in children in different states has varied between zero to about 0.25% of all deaths in all age groups from COVID-19. However, this has varied somewhat in different countries due to individual susceptibilities, coexistent other diseases and of course the ‘variants of concern’ such as the Delta strain, as described by the World Health Organisation (WHO).

With all this in mind, one might wonder as to why experts are advocating vaccination of children against COVID-19. After all, it does not seem to be as much of a major problem in children as it is in adults and the elderly. In addition, up to now, there have been only scarce amounts of data regarding the safety and effectiveness of the vaccines in children and it was difficult to arrive at a definitive conclusions regarding the requirements to vaccinate children and young people.

There is no question as to the need to vaccinate susceptible children, such as those who have co-morbid diseases, as they are more likely to get severe complications and die from the disease. Yet for all that, what about the need to vaccinate the other healthy children? In answer to that, there are a few other observations that need to be addressed. Children are more susceptible to catch the disease by virtue of the surroundings that they have to be kept in the classrooms of schools, the risks of catching the disease during travel to school in crowded public or private transport vehicles as well as the inevitable congregations of significant numbers of them in schools and playing fields. Those children who contract the virus can spread the disease even if they are asymptomatic. One must also remember that children and young people form a significant proportion of the population of any country and to arrive at the 70% coverage of the population as the Gold Standard for herd immunity, it is necessary to think of vaccinating them as well.

We, in this emerald isle, have now vaccinated children with comorbidities which make them that much more vulnerable and susceptible to die. Currently children over 15 years and up to 19 years are being vaccinated with the Pfizer vaccine with the trade name “Comirnaty”. As this vaccine is licensed for Emergency Authorisation Usage in children over the age of 12 years, it is most likely that Sri Lankan children from 12 to 15 years may also be vaccinated soon. That decision will be made after careful consideration of several medical details. In contrast to the Pfizer Comirnaty vaccine, the Oxford AstraZenica vaccine is currently licensed to be used only in persons above the age of 18 years. Results of some on-going research trials in the usage of that vaccine in those under 18 years of age are awaited.

The burning question in medical circles at present is what about children under the age of 12 years. Should they be vaccinated? A few weeks ago, closer to a month or so, Pfizer Inc., submitted the data of their clinical trials on the efficacy and safety of their Pfizer Comirnaty vaccine directly to the United States Food and Drug Authority (FDA) for licensing its usage for children over five years of age. They submitted the data before they were peer-reviewed and published in any research journal. That modus operandi came under some flak as the company has a previous history of concerns being expressed in medical circles as a company that uses ‘aggressive pharmaceutical marketing’ and was also alleged to have been involved in several other ethical misdemeanours (https://en.wikipedia.org/wiki/Pfizer).

However, in this instance, Pfizer appears to stand vindicated because the results of the study have now been published in the reputed New England Journal of Medicine on 09th November 2021. It is an on-going research study in children over six months of age, going up to 11 years of age. The paper presents very convincing data in children over five years of age going up to 11 years. The company has not provided analytical data for children under five years of age. The entire project consists of an Open-Label Phase 1 dose-finding study, together with on-going Phase 2 and 3 randomised placebo-controlled studies.

In the Phase 2–3 trial, participants were randomly assigned in a 2:1 ratio to receive two doses 21 days apart of either the Pfizer BNT162b2 Comirnaty vaccine at the dose level of 10-μg, identified during the open-label Phase 1 study, or placebo, respectively. Immune responses 1 month after the second dose of the vaccine were immunologically bridged and compared to those in 16-to-25-year-olds from the pivotal trial of two 30-μg doses of BNT162b2. Vaccine efficacy against Covid-19 at seven days or more after the second dose was assessed. They also looked at the adverse effects profile and the researchers found no significant incidence of any serious side-effects of the vaccine, including even the rare myocarditis and pericarditis.

Based on the results, the researchers concluded that “A Covid-19 vaccination regimen consisting of two 10-μg doses of BNT162b2 administered 21 days apart was found to be safe, immunogenic, and efficacious in children five to 11 years of age”. It must be noted that the dose used is one third of the 30-μg dose used for adults and the elderly. In addition, one may speculate that Pfizer had decided to present the data directly to the FDA before the paper was published in a journal because of the unavoidable delay in publishing the accepted articles in scientific medical journals. One could now well understand that as a reason for the pathway that Pfizer Inc., had elected to take in the very recent past.

Taking into account all this information, the local experts in the medical field will have to make appropriate decisions regarding COVID-19 vaccination in children under the age of 15 years. It will necessarily involve serious consideration being given to many complex aspects of the entire scenario. It would indeed be a daunting task for the decision-makers, very specially the Sri Lanka College of Paediatricians, which is the premier academic organisation principally involved in child healthcare. However, it must be unequivocally stated that a prerequisite for such decisions would be the mandatory licensing of any vaccine against COVID-19 by internationally recognised licensing authorities for the under 12-year age group.



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Singarasa Case should guide GoSL’s Geneva policy

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BY Dharshan Weerasekera

In 2005, the Sri Lankan Supreme Court ruled in the seminal case Singarasa v. Attorney General (SC/SPLA/182/99) that the U.N. Human Rights Commission (the predecessor of today’s U.N. Human Rights Council) did not have jurisdiction, within Sri Lanka, to make recommendations on behalf of the petitioner. In doing so, the court decided that Sri Lanka’s accession to the optional protocol to the International Covenant on Civil and Political Rights (ICCPR) in 1997 had been done in a manner contrary to the Constitution, and hence illegal.

This case has invaluable lessons to teach in regard to the present government’s ‘Geneva Policy.’ By ‘Geneva Policy,’ I mean the government’s stance to the UNHRC’s follow-up resolutions to Sri Lanka’s unilateral withdrawal, in March 2020, from the co-sponsorship of Resolution 30/1 of October 2015. In response, the Council adopted Resolution Resolution than 30/1. Among other things, it establishes an evidence-gathering mechanism to collect evidence of war crimes and other crimes against Sri Lankans.

Meanwhile, in September 2022, the High Commissioner released a report on Sri Lanka’s progress in implementing the recommendations of Resolution 46/1. The government has officially rejected both, Resolution 46/1 and the High Commissioner’s report, on grounds that they were done without Sri Lanka’s consent and, therefore, contrary to the founding principles of the Council. (See A/HRC/51/G/1, paras 1.1, 1.2). However, the Foreign Ministry, in its response, lists various things that the government is doing to comply with Resolution 46/1.

I argue that the government, continuing to comply with the Resolution while, at the same time, rejecting it in principle, without first obtaining a definitive interpretation of the relevant legal position, from an international forum, or even the Sri Lankan Supreme Court, creates a dangerous precedent. Given the fact that state practice is one of the sources of customary international law, the government’s conduct has the potential to do irreparable harm to the long-term interests of the country.

Unfortunately, there is little, or no, discussion of these issues in local newspapers, and academic journals, and it is in the public interest to start one. In this article, I shall discuss: i) the facts and reasoning of the Singarasa judgment, ii) the High Commissioner’s report and the government’s reply, iii) assess of the government’s position, and draw the relevant conclusions.

The Singarasa case

In 1991, the High Court of Colombo convicted Singarasa of five charges, under the Prevention of Terrorism Act. The charges dealt with alleged attempts by Singarasa, and others, to attack the Army camps,in Jaffna and its suburbs. Singarasa appealed against the conviction to the Court of Appeal and then the Supreme Court. He also complained to the U.N. Human Rights Commission. The HRC could entertain petitions under the Optional Protocol to ICCPR. Sri Lanka had ratified the ICCPR, in 1980, and acceded to the protocol, in 1997. The HRC said that, Sri Lanka was under obligation to release Singarasa.

The main issue, in this case, is whether Sri Lanka’s accession to the ICCPR, and the related protocol, gives a right to an international body to intervene in the domestic sphere to determine Singarasa’s fate. The court answers ‘no,’ because of the following reasons. The court starts with the premise that the authority for the President to enter into international agreements comes from Article 33(f) of the Constitution. Article 33(f) states: “To do all such acts as, not being inconsistent with the provisions of the Constitution…he is required or authorized to do.” It follows that the President cannot agree to anything inconsistent with the Constitution.

The court then assesses the signing of the ICCPR, in 1980, and the subsequent accession to the optional protocol, in 1997, separately. The court points out that the ICCPR requires that the respective signatories adopt domestic legislation to implement the provisions of the covenant. This does not conflict with our Constitution and hence is lawful.

However, when acceding to the optional protocol, the government had issued a declaration that envisioned that the rights of Sri Lankan citizens could be adjudicated in tribunals, and forums, outside this country. The court points out that the institutions, through which Sri Lankans can vindicate their rights, within this country, are exhaustively set out in Article 105 of the Constitution, and the HRC is not one of them. Therefore, the court deems the accession to the optional protocol illegal. The court states:

“Where the President enters into a treaty or accedes to a covenant the content of which is inconsistent with the provisions of the Constitution or written law it would be a transgression of the limitation in Article 33 (f) and ultra vires—such acts of the President would not bind the Republic qua State.” (p. 11)

The High Commissioner’s report and the Government’s reply

The most disturbing aspect of the High Commissioner’s report is its description of the progress made by the impugned evidence-gathering mechanism. It states: “OHCHR continues to develop the information and evidence repository using an e-discovery platform….OHCHR commenced identifying material held by other actors and engaging with information providers. To date, the databases of two organisations have been migrated into the repository, and negotiations with other information providers are ongoing.” ((A/HRC/51/5, 4th October 2022, para 54.)

The report also details what the OHCHR plans to do with this information. It says: “To develop possible strategies for future accountability processes, the project team started mapping potential accountability process at international level, including through consultations with relevant stakeholders, in particular national authorities, victims and civil society organisations.” (para 56.)

In sum, it is clear that a vast operation is underway, not just to collect evidence against Sri Lanka but to set the groundwork to help prosecute Sri Lankans before various national and international forums. To the best of my knowledge, the founding statutes of the UNHRC, as well as the OHCHR, do not give enforcement capabilities to these institutions to prosecute or assist in the prosecution of people for violations of human rights and other offences.

Their respective mandates to protect and promote human rights are to be carried out with the consent of all nations concerned and in a spirit of “cooperation and constructive international dialogue.” Therefore, through the impugned mechanism the OHCHR has now arguably expanded its mandate to include an enforcement component, seemingly without any debate or discussion of the matter before the Council.

To turn to the government’s response, in the introductory paragraphs of the said document, the government rejects both resolution 46/1 as well as the High Commissioner’s report on grounds that they violate the UN’s founding principles. However, for much of the remainder of the report (which runs to 16 pages) the government enumerates the various things it has been doing to implement various provisions of the resolutions. For instance, the government discusses the work being done under the Office on Missing Persons, Office for Reparations, and so on.

On the OMP, the report states inter alia: “The OMP conducted panels of inquiries as part of the verification process. More than 89% of persons (1207 of 1370 applicants invited for inquiries) met with members of the panel and their testimonials were recorded.” (A/HRC/51/G/1, 9th September 2022, para 46)

Meanwhile, on the Office for Reparations, the report says, “The office processed 5964 claims for payment, by the end of 2021, and paid a sum of Rs. 399.8 million in settlement, out of the allocated sum of Rs. 800 million….Upto the end of 2022, the OR received Rs. 226 million to pay compensation and 2097 claims were settled utilizing Rs. 153 million.” (para 56)

In sum, even though the government has nominally rejected resolution 46/1 and by extension resolution 30/1 as well, the government is expending great energy, including enormous sums of money, to comply with various provisions of those resolutions.

Assessment of the policy

The Singarasa case establishes that the President, when conducting foreign policy, is exercising the power conferred under Article 33 (f) of the Constitution. One cannot suppose that it is consistent with the Constitution to comply with the provisions of a resolution that the Government itself considers to be in violation of the founding principles of the UNHRC.

Admittedly, a resolution of the UNHRC does not rise to the level of a treaty or covenant. However, there should now be a serious debate in this country about whether the reasoning above should apply to such resolutions which continue to target Sri Lanka on the world stage.

Furthermore, if, as I have suggested, the OHCHR has expanded its mandate by exploiting the provisions of Resolution 46/1 to acquire capabilities that were never envisioned in the relevant founding statutes, permitting such conduct to continue has the potential to set precedents in customary international law, with grave consequences for Sri Lanka, as well as other nations.

Therefore, Sri Lankan citizens are entitled to know the legal basis for the government’s continued compliance with provisions of Resolution 46/1, while nominally rejecting the Resolution. The only institution that can provide a legal opinion binding on the government is the Supreme Court. The President has the capacity, under Article 129 of the Constitution, to request an advisory opinion of the Supreme Court on any matter of public importance.

In these circumstances, it is incumbent on the government to seek an advisory opinion as to whether it is lawful for the government to continue complying with provisions of Resolution 46/1 unless and until the UNHRC clarifies its position in regard to the impugned mechanism.

Conclusion

It is in the interest of all Sri Lankans to keep a close eye on what the government is presently doing in Geneva. There is a famous legal maxim that says, “The laws assist the vigilant, not the sleepy.” Ultimately, it is the Sri Lankan people who will pay the price for any mistakes or missteps that successive governments make in regard to their “Geneva Policy.’

(The writer is an Attorney-at-Law)

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Human Papillomavirus vaccine: one that can prevent a cancer

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This article has been written as a fervent plea to the parents of little girls of the eligible age group. Please make sure that your precious daughters get this vaccine. It will be an investment for their happiness in the future.

By Dr B. J. C. Perera

All vaccines by definition are substances that are used to stimulate immunity against a particular infectious disease or a specific causative organism. Such vaccines are used to prevent the occurrence of the said diseases in humans and animals. Several vaccines have been introduced to combat such infectious diseases over the last few decades. In some countries, the use of some of these vaccines has led to the elimination of dreaded diseases like Diphtheria, Tetanus, Whooping Cough or Pertussis, Polio, Measles, German Measles or Rubella, just to name a few.

Sri Lanka has a very efficient and inherently equitable system that looks after the Expanded Programme of Immunisation (EPI) for children and young people. In general, we have been extremely successful in this programme and can boast of over 90 per cent coverage for the vaccination of all children. We have successfully eliminated polio, the last case being confirmed as far back as 1993, and we are free of diphtheria, tetanus, measles and German measles or rubella. The success of the EPI is due to many factors that include government commitment, the unstinted dedication of parents, the promotion of the programme through all media channels and the dedicated work of all grades of healthcare personnel. The very high literacy rate of the populace of our country enables all information regarding vaccination to be most conveniently conveyed to the population. Sri Lanka has been hailed as a country that has achieved so much in this field, but with so few resources. It has been cited as a model to the entire Asian region as well as even the world.

In addition to their undoubted effectiveness in protecting against infective microorganisms, some of these vaccines have other bonus effects. At least two of the vaccines in use today have telling effects in preventing certain cancers. One is the Hepatitis B vaccine. It provides protection against liver cancer. The other is the more recent Human Papillomavirus vaccine (HPV vaccine) which protects females against cancer of the neck of the womb, which is also referred to as the cervix of the womb. That disease is generally referred to as Cervical Cancer.

The Human Papillomavirus (HPV) is sexually transmitted and most people become infected sometime during their lifetime. In the majority, it is soon after becoming sexually active. Most infections are asymptomatic and usually clear up spontaneously, accounting for remission in 90% within two years. Only 10% of persistent HPV infections with certain genotypes of HPV can persist and progress to changes in the cervix. If infection from cancer-causing HPV types persists over 10-15 years, women can go on to develop precancerous lesions that, if left untreated, develop into cervical cancer. This process takes an average of 20-30 years from infection to the development of cervical cancer.

In 1995, Dr Anne Szarewski, a renowned researcher from the United Kingdom, led a team who outlined the role of human papillomavirus in uterine cervical cancer detection and screening. Then the researchers began work on an HPV vaccine. Szarewski was also a chief investigator, principal investigator and author of key HPV vaccine trials and publications, who helped to develop the bivalent HPV vaccine. The word bivalent is used to indicate that it contains two strains of HPV. HPV infections are very common, often with minimal symptoms, but high-risk HPV strains can go on to cause other medical conditions, particularly cervical cancer.

In 2006, the first vaccine for Human Papillomavirus (HPV) to be used globally was approved. HPV vaccination has now gone on to become a key part of the effort to eliminate cervical cancer. According to the available research results, HPV vaccination could reduce the lifetime risk of cervical cancer by 35–80%; the rather wide range being due to several studies with different methods. The vaccine was initially promptly snapped up in the West, especially in the Scandinavian countries. In Sweden, the coverage of the vaccine is over 80 per cent. However, according to the data put out by the World Health Organization (WHO) in November 2022, the human papillomavirus vaccine against cervical cancer has been introduced in just 41 per cent of low-income countries, even though they represent much of the disease burden, compared to 83% of high-income countries. We have a set of 10-year data on the benefits of the vaccine and in certain Western countries, a significant drop in the morbidity and mortality rates of cervical cancer is already evident.

In Sri Lanka, the National Vaccine Summit in January 2015 recommended the usage of the HPV vaccine and the government introduced it in 2017 for girls within the age range of 10 to 13 years. That age group was decided on the premise that to get the best results, we need to introduce the vaccine before sexual activity starts. The vaccine was to be administered to the selected age groups in the schools free of charge and in the fee-levying private sector. To date, the vaccine is not available through the Immunisation Clinics of the Provinces and the MOH Clinics.

NOW HERE IS THE REAL CRUX OF THE MATTER. For a variety of reasons, the coverage of the HPV vaccine in the entire cohort of eligible girls in Sri Lanka is somewhere between 30 and 40 per cent. This is woefully inadequate coverage to get the best possible results, especially when looked upon in the light of over 90 per cent coverage of the other vaccines in the National Expanded Programme of Immunisation. Cervical cancer ranks among the five commonest cancers in women in Sri Lanka. HPV vaccine is just one of two vaccines that can prevent cancers. All children have had the Hepatitis B vaccine which protects against liver cancer, as it is given through the National Programme of Immunisation. But, and this is a BIG BUT, the only other vaccine, the HPV vaccine that can prevent cervical cancer, shows a rather low uptake.

We do need to escalate the uptake rate of the HPV vaccine to at least around 80 per cent to get reasonable benefits in the reduction of the morbidity and mortality that is currently seen in cervical cancer. I think we have to admit that due to very many reasons, the message has not gone through to the general population in the country. When inquiries are made from the mothers of eligible girls, the vast majority of them are not even aware of the existence of this vaccine and more importantly, the future beneficial potential of this endeavour. The age group selected is a rather tricky cohort. They get upset at the drop of a hat. The last thing they want is an injection. They will run away, as fast as possible, to avoid it. Some are so frightened that it is not uncommon to see them faint even at the sight of the syringe and the needle. One way of getting the cooperation of these little girls is to allow either the mother or the father to be present to hold her hand most reassuringly when the vaccine is administered. An additional initiative would be to make it widely available through the Immunisation Clinics for it to be administered to all those who have missed it when it was given in the school. This is particularly important as the vaccine is quite expensive when administered in the private sector.

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Latest position on debt restructuring process

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By Jayampathy Molligoda

According to the announcement made by the Managing Director of the IMF Kristalina Georgieva, the IMF Executive board meeting will be held on 20 March to consider and hopefully approve the EFF arrangement for Sri Lanka. In the meantime, the Ministry of Finance and the Central Bank in consultation with IMF have finalised the latest position of Sri Lanka’s Public Debt as at end 2022 just prior to commencement of debt restructuring negotiations with creditors. Having perused the document uploaded to the Ministry of Finance (MOF website) recently, which is a comprehensive summary of debt stock as at end 2022, I have tabulated the summary of the main facts and figures (See Table). As can be seen, the total public debt stock has skyrocketed to US $ 83.6 billion, which includes total foreign debt of US$ 45.6 billion and the local debt of 38 billion in US $ equivalent. The total debt as a % of GDP as stated in the above MOF doc is 128%. The public debt is expected be reduced to 100% of GDP in order to ensure debt sustainability in line with IMF supported program parameters coupled with ‘comparability of treatment principle’ whilst ensuring equitable burden sharing for all restructured debt.

However, I have my doubts about GDP computation here. As per the MOF doc page 1, the Nominal GDP was stated as Rs. 23.7 trillion for the year 2022. The $ exchange rate used for conversion as Rs.363.10 clearly indicating that it is the year end figure, they have taken the year end Exchange rate of Rs 363.10 per US$. It is pertinent to ask the question as to why ‘year- end exchange rate’ figure to convert our annual GDP in rupee to US dollars? It should have been the ‘average exchange rate’ as in the past so many years computed by CBSL. As a result, the GDP (in US$ terms) works out to US$ 65.2 billion only. That’s why the total public debt stock of US$ 83.6 billion works out to 128% of GDP – my initial query is; why did they take year-end figure of Rs363.10 instead of taking the average exchange rate?

Besides, the real critical issue is how to reduce the debt stock to a level of 100% of GDP in the context of declining GDP (- 7.8% in 2022) and on the other hand, our debt stock is on the rise. More importantly, if we take the total ‘multilateral debt’ out, then the foreign debt is US $ 34 billion only, which includes ISBs and bilateral loans. Assuming a higher ‘haircut’ of 33% for foreign debt is agreed upon, it works out to 11 billion thus reducing the total public debt to 73 billion only.

In this regard, The President in his latest open letter dated 14 March ‘23 to Sri Lanka’s official Bilateral creditors has clearly indicated that there will be equitable treatment of burden sharing in respect of all creditors (except IMF/WB/ADB) Quote; ” ..we reiterate our commitment to a comparable treatment of all our external creditors with a view to ensuring all round equitable burden sharing for all restructured debt. To that end, we will not conclude debt treatment agreements with any official bilateral creditor or any commercial creditors or any group of such creditors on terms more favourable than those agreed. …To this end we also confirm that we have not and we will not make any side agreements with any creditor aimed at reducing the debt treatment impact on that creditor.”

In the circumstances, my own view is we are reluctantly compelled to restructure local debt i.e.; TBs and, it is inevitable that the local debt of USD equivalent of 38 billion would also need to be taken into consideration for debt restructuring – otherwise there is no way of reducing the total public debt stock to the level that is required as per IMF conditions. This would create a serious issue for our ‘finance system stability’ and all our commercial banks will be in trouble. Further the deposit holders including pension funds are badly affected. The temperature of social unrest is brought closer to the boiling point.

As stated in the global research article by Jonathan Manz recently, former Chief Economist and Senior Vice President of the World Bank, and Nobel Prize winner, Joseph Stiglitz, has slammed the IMF for unleashing riots on nations the IMF is dealing with; he has pointed out that the riots are written into the IMF plan to force nations to agree with the average 111 conditions laid down by the IMF and they destroy a country’s democracy and independence. He has been a critique of IMF causing great damage to countries through the economic policies it has prescribed countries to follow in order to qualify for IMF loans. However, neither Stiglitz nor any other eminent economist has yet to come out with a practical and alternative policy framework to overcome the most serious economic and financial crisis faced in the 75 years of Sri Lanka’s independence.

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