Climate Change Is Having a Major Impact on Global Health


Warming temperatures are exposing more people to heat waves and increasing the risk of disease spread

Prolonged and deadly heat waves are becoming more common, leaving millions at risk. Credit: Matteo Colombo 

A devastating heat wave swept across Europe in 2003, killing tens of thousands of people, scientists estimate. Many were elderly, with limited mobility, and some already suffered from chronic diseases. But climate change is making such extreme weather more common—and the effects will not be limited to the old and sick. Warming temperatures do not only threaten lives directly. They also cause billions of hours of lost labor, enhance conditions for the spread of infectious diseases and reduce crop yields, according to a recent report.

The report, published last December in the Lancet, represents the latest findings of the Lancet Countdown—a coalition of international research organizations collaborating with the World Health Organization and the World Meteorological Organization. The group tracks the health impacts of—and government responses to—climate change.

“It affects everyone around the world—every single person, every single population. No country is immune,” says Nick Watts, executive director of the Lancet Countdown and one of many co-authors of the report. “We’ve been seeing these impacts for some time now.”

Credit: Amanada Montañez; Source: “The 2018 Report of the Lancet Countdown on Health and Climate Change: Shaping the Health of Nations for Centuries to Come,” by Nick Watts et al., in Lancet, Vol. 392; December 8, 2018

The report found that millions of people worldwide are vulnerable to heat-related disease and death and that populations in Europe and the eastern Mediterranean are especially susceptible—most likely because they have more elderly people living in urban areas. Adults older than 65 are particularly at risk, as are those with chronic illnesses such as heart disease or diabetes. Places where humans tend to live are exposed to an average temperature change that is more than twice the global average—0.8 versus 0.3 degree Celsius (graphic). There were 157 million more “heat wave exposure events” (one heat wave experienced by one person) in 2017 than in 2000. Compared with 1986 to 2005, each person was exposed to, on average, 1.4 more days of heat wave per year from 2000 to 2017. That may not seem like a lot, but as Watts notes, “someone who is 75 and suffers from kidney disease can probably survive three to four days of heat wave but not five or six.”

Sweltering temperatures also affect productivity. A staggering 153 billion hours of labor—80 percent of them in agriculture—were lost to excessive heat in 2017, the new report found, with the most vulnerable areas being in India, Southeast Asia, sub-Saharan Africa and South America. The first stage of heat’s impact is discomfort, says report co-author Tord Kjellstrom, director of the Health and Environment International Trust in New Zealand and a consultant on environmental and occupational health. But there comes a point at which it is simply too hot for the body to function. For example, sweating heavily without replenishing water can result in chronic kidney disease, Kjellstrom notes. News reports have documented farm workers in Central America dying from kidney problems after years of working in the hot fields. Richer countries such as the U.S. may avoid the worst effects because of better access to drinking water and, in the case of indoor work, air-conditioning. But these solutions can be expensive, Kjellstrom says.

Then there are indirect effects. For example, warmer temperatures have increased the geographical ranges of organisms that spread dengue fever, malaria and cholera. The “vectorial capacity”—a measure of how easily a disease carrier can transmit a pathogen—of dengue virus, which is spread by the Aedes aegypti and Aedes albopictus mosquitoes, reached a record high in 2016. The percentage of coastline suitable for bacteria in the Vibrio genus (which includes the species that causes cholera) increased from the 1980s to the 2010s in the Baltic region and northeastern U.S. by 24 and 27 percent, respectively. In Africa’s highlands, environmental suitability for the malaria-causing Plasmodium falciparum parasite increased by nearly 21 percent from the 1950s to the 2010s.

Climate change also threatens food security. Our planet still produces more than enough food for the world, but 30 countries have seen crop yields decline as a result of extreme weather, the report found.

“Overall, the report does suggest very serious concerns about the way in which climate change is evolving and its potential implications for human health,” says Andy Haines, a professor of environmental change and public health at the London School of Hygiene & Tropical Medicine, who was not involved in the 2018 report but has co-authored previous Lancet Countdown assessments. “One of the problems is that we don’t have enough data on the actual impacts, particularly in the low-income countries,” which will likely be most affected, he says.

The report did find some bright spots: in 2015, 30 of 40 countries surveyed by the WHO reported having climate change health adaptation plans, and 65 percent of cities have undertaken (or are undertaking) risk assessments that address threats to public health infrastructure. But worldwide spending on health adaptation is still under 5 percent of all climate adaptation spending. And funding has not matched that pledged in the Paris Agreement, the global climate accord that is set to take effect in 2020.

Among the biggest steps countries can take to mitigate these health effects are phasing out coal-fired power and shifting to greener forms of transportation, Watts says. Electric vehicles are making inroads in places, he notes—and “active” transport, such as walking or cycling, is also important. Tallying up the costs of climate change, Watts says, makes it clear that “our response or lack of response is going to determine our health over the next century.”

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Bill Gates Thinks Cancer Therapies Could Serve a Much Wider Purpose


IN BRIEF

During a recent keynote address, Bill Gates advocated the creation of a bridge between the private sector and global health, nothing that research conducted by the former could help treat the problems of the latter.

A WIN-WIN SCENARIO

Bill Gates has high hopes for the future of cancer research, and not just in the battle for which it’s intended. The philanthropist thinks the same therapies researchers are developing to fight cancer could one day be used to “control all infectious diseases.”

Gates made the claim during his keynote address at J.P. Morgan’s Annual Healthcare Conference in San Francisco. He told the audience that the immunotherapy used to treat cancer patients in the world’s more prosperous nations could eventually be used to control infectious diseases such as HIV, TB, and malaria in its poorest.

Unfortunately, according to Gates, the pharmaceutical and biotech companies conducting this research may not see any incentive to pursue such applications, but they should.

“[I]n health — as in many other aspects of life — the free market tends to work well for people who can pay…and not so well for people who can’t,” said Gates. “But over the last decade, our experience has shown that we can stretch the reach of market forces so the private sector’s most exciting innovations also benefit people with the most urgent needs.”

Gates told the audience that the private sector can benefit from achieving breakthroughs in global health, noting that developing economies are growing much faster than developed ones. Additionally, he believes the Gates Foundation can help mitigate any risk to the private sector by providing “more predictability” and by investing in companies with the technologies that could be useful for global health.

BEYOND CANCER

In 2016, an estimated 445,000 people died from malaria, 1 million from HIV-related illness, and 1.7 million from TB (including 0.4 million with HIV). If cancer treatments could prevent the spread of these diseases and help treat those already infected, we could see a significant decline in these figures.

But cancer research is just the start. As Gates said in his keynote, research to treat other health problems of “rich-world markets” could help doctors address the problems of poorer ones.

For example, research into neurodegenerative diseases such as Alzheimer’s could be useful for those trying to treat the hundreds of millions of children with cognitive development issues due to growing up in poverty. Meanwhile, researchers in Africa and South Asia attempting to address undernutrition may glean valuable insights from obesity research.

By creating a bridge between the private health sector in developed nations and the global health community, we can ensure that all the world’s citizens have access to the best treatment options available. As Gates concluded in his keynote, reaching this goal of health equity in our lifetime isn’t just a possibility — it’s an imperative.

Generic drugs: Review and experiences from South India


Abstract

The cost of pharmaceuticals, as a percentage of total healthcare spending, has been rising worldwide. This has resulted in strained national budgets and a high proportion of people without access to essential medications. Though India has become a global hub of generic drug manufacturing, the expected benefits of cheaper drugs are not translating into savings for ordinary people. This is in part due to the rise of branded generics, which are marketed at a price point close to the innovator brands. Unbranded generic medicines are not finding their way into prescriptions due to issues of confidence and perception, though they are proven to be much cheaper and comparable in efficacy to branded medicines. The drug inventory of unbranded generic manufacturers fares reasonably when reviewed using the World Health Organization-Health Action International (WHO-HAI) tool for analysing drug availability. Also, unbranded generic medicines are much cheaper when compared to the most selling brands and they can bring down the treatment costs in primary care and family practice. We share our experience in running a community pharmacy for an urban health center in the Pathanamthitta district of Kerala State, which is run solely on generic medicines. The drug availability at the community pharmacy was 73.3% when analyzed using WHO-HAI tool and the savings for the final consumers were up to 93.1%, when compared with most-selling brand of the same formulation.

Keywords: Drug availability, drug industry/legislation and jurisprudence, drugs, economic competition, essential medicines, generic*, generic medicines, global health, India, patents as topic/legislation and jurisprudence*, poverty, unbranded generics

Introduction

The World Health Organization (WHO) estimates that almost 30% of the world population lacks access to essential medicines and that the figure will rise to more than 50% in some countries of Africa and Asia.[1] The cost of the pharmaceuticals is the main factor that hampers access to medicines and the governments in poor countries seem to be doing very little to counter this problem. The public sector availability of essential medicines was less than 50% in most of the countries of Africa and Asia.[2] This is appalling in the face of increases in healthcare expenditure in most of the developing nations, mostly financed through secured loans by international development banks and consortia.

The situation in India is not very different than that of other developing nations. Healthcare expenditures have been growing in India, both in real terms and also when considered as a proportion of the Gross Domestic Product (GDP).[3] However, even with this recent increase in healthcare spending, India’s expenditure on health is nowhere near that of OECD (Organisation for Economic Cooperation and Development) nations.[4] The total public spending on healthcare in India accounted for only around 1.2% of GDP in 2012, with the per-capita spending on health around USD 160. This is a miniscule amount when compared against the OECD per-capita healthcare spending of USD 3,484 in 2012.[3,4] This shows that the healthcare spending in the country is set to rise further in the coming years and the healthcare industry is all set for a boom time.

The cost of medicines and pharmaceuticals as a percentage of total healthcare spending has also been rising worldwide.[5] It is the fastest-growing item in the healthcare budgets worldwide and it varies between 20-60% in various healthcare budgets of countries.[6] By 2020, the prescription drug market in United States of America is set to grow to USD 700 billion (B) and China will be USD 260 B.[5] Though no credible predictions about the Indian pharmaceutical industry are available, it is quite safe to assume that Indian pharmaceutical industry will also grow manifold. The growth of the pharmaceutical market worldwide and its increased share in total healthcare spending will reignite the age-old debate on how to balance the cost of innovation in drug research and universal access to the fruits of that research.[7]

Rise of Generics

The role of generic medicines in reducing the healthcare expenditure has been recognised for a long time. Multiple studies have proven that saving through substitution of originator brands by cheaper generic medicines, savings in the range of 10-90% can be achieved.[8] Most national governments have been encouraging the use of generic medicines worldwide and many healthcare systems have policies of substituting expensive branded original medications with generic medicines.[9] In the United States, generic substitution (GS) is an accepted practice and at the end of 2012, almost 80% of all the prescriptions were of generic medications. This has resulted in a substantial moderation of expenditure growth in widely used drugs and significant savings to the economy.[6] In the United Kingdom, GS is now a standard practice in hospitals operated by the National Health Service (NHS) and medical schools have included generic prescribing as a part of their medical training.[10]

In India, the procurement price of essential medicines is generally lower than the mean International Reference Pricing (IRP) but availability of these drugs in the public sector has always been a problem. The exorbitant cost of some of the commonly used medications in private pharmacies makes it inaccessible to majority of the poor.[11] Also, the difference between procurement prices and retail prices in case of some of the generic medicines, were as high as 28 times, which shows a very high margin of profit-taking in view of limited price control mechanisms.[11] It is in this light, that the government revised the National Pharmaceutical Pricing Policy in 2012. It gave methods to calculate ceiling prices for drugs which are under the National List of Essential Medicines (NLEM) which was modified in 2011. It gave a formula for deciding the ceiling prices for drugs under NLEM, using a market-based pricing (MBP) method, taking into account the prices of all manufacturers having a market share of more than 1% nationally.[12] The Drug Price Control Order of 2013 was a follow-up to the National Pharmaceutical Pricing Policy and gave the price ceiling for 348 drugs and over 600 formulations. However, the action was considered inadequate by many activists lobbying for cheaper drugs and they termed it as a sell-out to international pharmaceutical companies.[13]

Indian Pharmaceutical Industry

The multiplicity of brands and manufacturers makes it difficult to decipher the actual market dynamics and the structural issues in the Indian pharmaceutical industry. The complexity of the market and the intensity of the competition between companies in India have made the country a hub for manufacture of generic medicines, earning a sobriquet “pharmacy of the developing world.”[14] This, along with a favorable governmental stance has made India a powerhouse in this field, bringing it into direct confrontation with certain developed nations where most of the big multinational pharmaceutical companies are located[14] There have been many instances when the Indian Patents Office and the Supreme Court of India effectively used certain flexibilities of the Trade Related Aspects of Intellectual Property Rights (TRIPS) agreement of the World Trade Organization and also the safeguards embedded in the Indian Patents Act. The compulsory licensing of Sorafenib, a drug used in treatment of advanced liver and renal cancer and the rejection of patent application for Imatinib, a drug used in the treatment of leukaemia, were considered as landmark decisions by many state and non-state organizations involved in pharmaceutical sector.[15,16]

Considering the Indian scenario, we can divide the brands into innovator brands (IB), most-selling generics (MSG), and least-priced generics (LPG).[17] The IBs will be at the highest price point, followed by MSGs and LPGs. A new category of generic drugs known as unbranded generics (UB) are also coming into the market now. These drugs are usually manufactured by not-for-profit organizations or are subsidised by certain non-governmental organizations (NGO).[18] Though the price points of these different categories of drugs are different, their efficacies are comparable. This fact has been proved by multiple studies all over the world and it belittles the reasoning which goes behind differential pricing of the same drug.[19,20] Even though it has been proved that there is not much difference in efficacy between the above categories of drugs, physicians tend to prescribe drugs manufactured by highly-reputed companies. Their trust is often misplaced as most of these leading companies market drugs manufactured by less-known manufacturers.[18]

A Model Community Pharmacy: Experiences from South India

Pushpagiri Medical College, which is a teaching hospital in Kerala state of India partnered with a social organization, Bodhana Social Service Society, involved in poverty alleviation and income generation programmes, to start an urban health center with an objective to improve patient accessibility to cost-effective medical care. The urban health center serves a population of 10,000, spread over 5 municipal wards of Tiruvalla municipality and was intended as a model for cost-effective primary care. A comprehensive population survey was carried out before the start of the project and the health center started functioning in September 2014. As a part of the initiative, a community pharmacy was opened to stock unbranded generic drugs manufactured by two non-governmental organizations. Low-Cost Standard Therapeutics (LOCOST), Baroda and Comprehensive Medical Supplies India (CMSI), Chennai were the two NGOs providing us with the drugs which were needed at the community pharmacy.[21,22] The drugs were provided to us at a nominal cost, after we provided an undertaking that the Pushpagiri Medical College is a charitable institution with no intention of making profits. Also, the physicians working at the health center made a collective decision to prescribe all the drugs generically and the pharmacist was advised to dispense the cheapest generic brand.

The drug inventory available with these not-for-profit manufacturers were fairly comprehensive when reviewed using the World Health Organization-Health Action International (WHO-HAI) tool for quantifying availability of essential medicines.[23] The WHO-HAI tool is a validated method for measuring availability of drugs in a health system and includes 30 core medicines: 14 essential medicines for global burden of disease and 16 medicines specific to the WHO region [Table 1].[24]

Table 1

Drug inventory of LOCOST, Baroda and CMSI, Chennai: Review using WHO-HAI tool for WHO South East Asian Region

The WHO-HAI tool showed a drug availability of 73.3% for LOCOST, Baroda and 43.3% for CMSI, Chennai. This is much better when compared to drug inventory in public hospitals in other parts of India, assessed using the same methodology.[11] There are a multitude of companies and NGOs manufacturing UB medicines and the drug inventory of a health system can be made comprehensive through a mixed purchase model where procurement is done from multiple vendors.[23]

Similarly, unbranded generic drugs offered significant savings to the health system in terms of costs involved for procurement. When reviewed against the MSBs, UB medicines were costing only a fraction of the maximum retail price (MRP) of MSPs [Table 2].

Table 2

Comparison of drug prices of most-selling brands and their generic counterparts: drugs identified by WHO-HAI tool for WHO South East Asian Region[17,25]

The community pharmacy has been in operation since September 2014, and stocks over 120 formulations manufactured by unbranded generic manufacturers. In addition, it also supplies LSG to augment the drug inventory of the pharmacy. There is a family physician and a general practitioner who run the center, apart from regular specialist visits from Pushpagiri Medical College Hospital. The urban health center has an outpatient load of 20-25 patients a day within 6 months of starting operations. The staff from the center is providing services to 3 old-age homes and a few surrounding schools and the drugs from the community pharmacy is being used for free supply during the medical camps conducted by the department of community medicine.

The patients and the physicians have responded positively to this novel initiative and the general acceptability has been found to be high, though objective studies to assess the same are yet to be done. Some physicians have suggested replicating this model in other similar health initiatives also. The financial sustainability of the model is still unproven, and the urban health center along with the community pharmacy is being sustained with large subsidies provided by Pushpagiri Medical College and Bodhana Social Service Society. The cost of setting-up such a facility was around INR 500,000, which includes the furniture, basic medical equipment, basic lab accessories, and first round of procurement for the community pharmacy and is exclusive of the capital expenditure on the building. The average monthly expenditure in running the health center, has been around INR 150,000 a month, including salaries, cost of consumables and medicines and exclusive of building rent and depreciation. The income earned by the center is around INR 40,000, and there is an excess of expenditure over income to the range of more than INR 100,000 a month, which is subsidised by Pushpagiri Medical College and Bodhana Social Service Society. Both the organizations are charitable societies run by a prominent religious group and the subsidies are meant to further their commitment to social causes.

The community pharmacy concept faced the following key challenges:

  • Absence of intermediaries for drug procurement results in inordinate delays in transit, mainly on account of the tardy services rendered by private logistics companies
  • Advance payment in full has to be remitted to the bank accounts of these NGOs for supply of drugs, which goes against the standard practice of procurement followed in hospitals. This has been an issue with the internal audit department
  • The difference between procurement price and the MRP is minimal and this is causing worries of long-term financial sustainability of the community pharmacy model
  • Packaging of the drugs is unattractive in some cases, resulting in difficulty to convince patients about the efficacy of the drug
  • We have faced difficulty in convincing some of the specialist doctors on the quality of the drug, despite providing ample literature proving the efficacy of unbranded generic drugs.

The Way Forward

Many studies have revealed apprehensions among physicians in prescribing UB medicines to their patients. Most of these apprehensions are related to quality of the product and the fear of losing patients.[26] Along with these unfounded concerns, poor patient acceptability due to various issues like poor packaging, lack of brand promotion initiatives, etc., are affecting the extend of penetration of UB drugs in the country, even though India is becoming a lifeline for all developing countries in the supply of generic medicines.[27] The government and the policy makers in India and other similar developing countries should focus on building the confidence of physicians and the patients regarding unbranded generic medications. The demand side management should include a multifaceted approach in which issues of different stakeholders are addressed and affirmative actions taken in favour of unbranded generic medicine manufacturers.[27] Another important issue is concerning the inherent deficiencies and implementation status of the Drug Price Control Order of 2013. The said order has been criticised extensively for being myopic in its approach, as the number of formulations included is less than 20% of the whole pharmaceutical market. Also, it gave ample space for pharmaceutical companies to tweak their marketing strategies by focussing on formulations and dosages not covered by the Drug Price Control Order. It also leaves out the important area of fixed-dose combinations (FDCs), a potential loop-hole for the pharmaceutical companies to exploit fully. It is indeed distressing to note that more than 90% of the diabetic drug market is out of the purview of this order.[13] The policy makers in the country needs to get a realisation that the share of drugs in out-of-pocket expenditure (OPP) is around 80% in India and a tighter regulatory framework is needed to protect the consumers against exploitation.[28]

In the future, we intend to do a study on the perception about generic drugs, among the treating physicians and the patients who form the clientele of the community pharmacy. This can help us to understand the issues which affect the actual stakeholders and find means to improve the acceptability and penetration of generic medicines. Also, after the yearly financial audit, we plan to do a cost-benefit analysis to objectively analyse the efficacy of the model in monetary terms.

References

1. The World Medicines Situation 2011. The World Health Organisation. [Last accessed on 2015 Mar 2]. Available from: http://apps.who.int/medicinedocs/documents/s18772en/s18772en.pdf .
2. Cameron A, Ewen M, Ross-Degnan D, Ball D, Laing R. Medicine prices, availability, and affordability in 36 developing and middle-income countries: A secondary analysis. Lancet. 2009;373:240–9. [PubMed]
3. Health Expenditure, Total (% of GDP) | Data | Table. [Last accessed on 2015 Mar 2]. Available from: http://data.worldbank.org/indicator/SH.XPD.TOTL.ZS .
4. Microsoft Word-Briefing-Note-INDIA-2014-doc-Briefing-Note-INDIA-2014.pdf. [Last accessed on 2015 Mar 2]. Available from: http://www.oecd.org/els/health-systems/Briefing-Note-INDIA-2014.pdf .
5. Daemmrich A, Mohanty A. Healthcare reform in the United States and China: Pharmaceutical market implications. J Pharm Policy Pract. 2014;7:9. [PMC free article] [PubMed]
6. Hoffman JM, Li E, Doloresco F, Matusiak L, Hunkler RJ, Shah ND, et al. Projecting future drug expenditures–2012. Am J Health Syst Pharm. 2012;69:405–21. [PubMed]
7. Sax P. Spending on medicines in Israel in an international context. Isr Med Assoc J. 2005;7:286–91.[PubMed]
8. Cameron A, Mantel-Teeuwisse AK, Leufkens HG, Laing RO. Switching from originator brand medicines to generic equivalents in selected developing countries: How much could be saved? Value Health. 2012;15:664–73. [PubMed]
9. Hassali MA, Alrasheedy AA, McLachlan A, Nguyen TA, Al-Tamimi SK, Ibrahim MI, et al. The experiences of implementing generic medicine policy in eight countries: A review and recommendations for a successful promotion of generic medicine use. Saudi Pharm. 2014;22:491–503. [PMC free article][PubMed]
10. Duerden MG, Hughes DA. Generic and therapeutic substitutions in the UK: Are they a good thing? Br J Clin Pharmacol. 2010;70:335–41. [PMC free article] [PubMed]
11. Kotwani A, Ewen M, Dey D, Iyer S, Lakshmi PK, Patel A, et al. Prices and availability of common medicines at six sites in India using a standard methodology. Indian J Med Res. 2007;125:645–54.[PubMed]
12. Copy of f1.pdf – NPPPNotification.pdf [Internet] [Cited 2015 Mar 2, Last accessed on 2015 Mar 2]. Available from: http://www.nppaindia.nic.in/NPPPNotification.pdf .
13. Paying the Price – The Hindu. [Last accessed on 2015 Mar 2]. Available from: http://www.thehindu.com/opinion/op-ed/paying-the-price/article4912732.ece .
14. Kapczynski A. Engineered in India–patent law 2.0. N Engl J Med. 2013;369:497–9. [PubMed]
15. Bhaumik S. India’s rejection of Novartis’s patent is but a small step in the right direction. BMJ. 2013;346:f2412. [PubMed]
16. Lancet Oncology. Is India ready to lead the battle for fair access to medicines? Lancet Oncol. 2013;14:437. [PubMed]
17. Bhargava A, Kalantri SP. The crisis in access to essential medicines in India: Key issues which call for action. Indian J Med Ethics. 2013;10:86–95. [PubMed]
18. Amit G, Rosen A, Wagshal AB, Bonneh DY, Liss T, Grosbard A, et al. Efficacy of substituting innovator propafenone for its generic formulation in patients with atrial fibrillation. Am J Cardiol. 2004;93:1558–60. [PubMed]
19. Kesselheim AS, Stedman MR, Bubrick EJ, Gagne JJ, Misono AS, Lee JL, et al. Seizure outcomes following the use of generic versus brand-name antiepileptic drugs: A systematic review and meta-analysis. Drugs. 2010;70:605–21. [PMC free article] [PubMed]
20. Asia Pacific Ecumenical News-News. [Last accessed on 2015 Mar 2]. Available from: http://apenews.org/newsread.asp?nid=163 .
21. LOCOST: Medicines within the Common Man’s Reach | The Alternative. [Last accessed on 2015 Mar 2]. Available from: http://www.thealternative.in/business/locost- affordable-medicine-drugscommon-man-reach .
22. Where Are We Now: Assessing the Price, Availability and Affordability of Essential Medicines in Delhi as India Plans Free Medicine for All. [Last accessed on 2015 Mar 2]. Available from: http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3733775 . [PMC free article] [PubMed]
23. Madden JM, Meza E, Ewen M, Laing RO, Stephens P, Ross-Degnan D. Measuring medicine prices in Peru: Validation of key aspects of WHO/HAI survey methodology. Rev Panam Salud Publica. 2010;27:291–9. [PubMed]
24. Drug Price List. List of Generic Names in Alphabetical Order. [Last accessed on 2015 Mar 2]. Available from: http://www.medindia.net/drug-price .
25. Generic Index | DrugsUpdate India. [Last accessed on 2015 Mar 2]. Available from: http://www.drugsupdate.com/generic/listing .
26. Waning B, Diedrichsen E, Moon S. A lifeline to treatment: The role of Indian generic manufacturers in supplying antiretroviral medicines to developing countries. J Int AIDS Soc. 2010;13:35. [PMC free article][PubMed]
27. Shrank WH, Choudhry NK, Liberman JN, Brennan TA. The use of generic drugs in prevention of chronic disease is far more cost-effective than thought, and may save money. Health Aff (Millwood) 2011;30:1351–7. [PubMed]
28. Thakkar KB, Billa G. Light at the end of the tunnel: The Great Indian Pharmacoeconomics story. Front Pharmacol. 2013;4:153. [PMC free article] [PubMed]
Source:www.ncbi.nlm.nih.gov

Is the global health community prepared for future pandemics? A need for solidarity, resources and strong governance


In the wake of recent outbreaks of Zika, Ebola and the MERS-CoV viruses, many are asking: how prepared is the global public health community to deal with future emerging pandemics? Collective action at national, regional and global levels is the best way forward.

In the wake of recent outbreaks of Zika, Ebola and the MERS-CoV viruses, and with trust in global institutions at an all-time low, many are asking: how prepared is the global public health community to deal with future emerging pandemics? A recent report by the Commission on the Global Health Risk Framework, convened by the US National Academy of Medicine, stated that “we are underinvested and underprepared” (GHRF Commission, 2016). What needs to be done? Our experience so far shows that collective action at national, regional and global levels, backed by strong political will and sufficient resources, is the best way to enhance pandemic preparedness and deal with what is not just a health, but a much wider global security issue.First, any effective global response to pandemics will be only as effective as national preparedness, as “the best way to prevent the global spread of diseases is to detect and contain them while they are still local” (Rodier et al, 2007). The Ebola crisis in West Africa demonstrated the dire consequences of fragile health systems unprepared to deal with a massive epidemic. National preparedness is based on the capacities for surveillance, rapid diagnosis, case management, a trained health workforce and surge capacity within the health infrastructure to deal with large numbers of affected persons. WHO’s International Health Regulations (IHR), which covers surveillance, monitoring, containment and core capacity building, serves as a guide for countries to strengthen their national health infrastructure and pandemic preparedness. Within a larger context, the strengthening of health systems through provision of universal health care is necessary to achieve the Sustainable Development Goals (SDGs) (Touraine et al, 2014), and pandemic preparedness must be seen as a part of the overall health infrastructure in a holistic and integrated manner.

Unfortunately, many developing countries are not sufficiently prepared to deal with an emerging pandemic owing to limited resources, competing priorities and lack of political commitment. An ongoing concern, for example, is the weak and patchy implementation of the IHR, which would better prepare these countries for dealing with pandemics (Lancet, 2014). To underline this urgent need to upgrade public health infrastructure and capabilities of low- and middle-income countries, a recent report proposed spending US$3.4 billion/year to improve global resources for pandemic preparedness and responses (GHRF Commission, 2016).

Second, better regional preparedness will facilitate early warning of potential pandemics and improve international coordination of collective actions for its containment. Effective regional cooperation requires a platform for dialogue and action based on solidarity, trust and goodwill, and, most importantly, a commitment to sharing information rapidly and openly. In South-East Asia, for example, ASEAN (Association of Southeast Asian Nations) provides a high-level political and strategic platform for coordinated action, which is supported by regional surveillance initiatives, such as the Mekong Basin Disease Surveillance network. Elsewhere, plans by the European CDC and the African Union to create an African CDC are similarly important initiatives.

There are other strong arguments in favour of regional responses over a more slowly evolving global response. Countries in the region are in closer contact with each other, understand each other and are in a better position to quickly render assistance in the spirit of “helping neighbours”. While efficient regional responses remain a laudable goal, the approach has been dogged by the fairly low profile of health issues in most developing countries, which has, in turn, resulted in a lack of commitment, expertise and resources.

Third, in the face of a potential global spread of a pandemic, global responses must continue to play a central role. WHO’s GOARN (Global Outbreak and Alert Response Network) remains at the centre of global coordination efforts but, of course, relies on efficient, accurate and rapid reporting from affected countries. At a higher policy level, WHO continues to be the major international public health agency with a mandate to declare a Public Health Emergency of International Concern (PHEIC), which it has done three times in relation to pandemic influenza, the resurgence of polio and Ebola. Besides alerting the world to a potential pandemic, a PHEIC declaration raises global awareness, facilitates coordinated action and, importantly, helps to mobilize resources to mitigate the impacts of a pandemic. At the front lines, global responses by international NGO’s such as Doctors Without Borders (MSF) and the International Red Cross have also been critical in dealing with rapidly deteriorating situations, such as with Ebola in West Africa.

But, as with national and regional preparedness, the recent pandemics have highlighted shortcomings of the global responses. There has been strong criticism, for example, of WHO’s inadequate response to the Ebola crisis. An independent expert panel concluded that the organization was slow in recognizing the severity of the situation and did not issue a PHEIC until 5–6 months after the problem began to emerge as a serious threat (Maurice, 2015). The panel also determined that WHO did not have the capacity “to deliver a full emergency public health response” against a severe epidemic outbreak.

However, there are things what WHO can and cannot do. The WHO is not an organization, which can, in 48–72 h, mobilize 100 doctors, 100 nurses and 100 tons of equipment and then transport them to crisis hotspots around the world. Despite the fact that one of its core functions is “to provide technical support to Member States”, it is not an emergency response organization and it is not equipped to do so. What it can, and perhaps should have done, was to be a information clearing house to more rapidly alert the world of the impending emergency. The delay was partly attributed to WHO’s organizational structure and delays in information flows between its regional offices and its headquarters in Geneva (Maurice, 2015). MSF, on the other hand, responded heroically on the front lines but was soon overwhelmed by the sheer magnitude of the Ebola outbreak. WHO has borne the brunt of the criticisms, but questions have also been raised about the role of other entities during the Ebola crisis, including the World Bank, the governments of the affected countries, NGOs and other humanitarian groups, and the African Union. In addition, bilateral government responses from the militaries and agencies of the USA, the UK and France were instrumental in helping to deal with the Ebola crisis, but such responses have important diplomatic and political repercussions, which require more analysis and dialogue.

The expert panel report recommended many remedial actions for WHO to be better prepared in the future, such as forming a new Centre for Emergency Preparedness and Response (Maurice, 2015). Beyond these recommendations, another key question that is being asked by many is “what new structures beyond WHO and MSF might be needed to efficiently and effectively address emerging pandemics at the global level?”

Before addressing the issue of creating new global structures, we should clarify some of the criteria and requirements needed for a more effective global public health response to future pandemics. Four are proposed: (i) reforming, consolidating and strengthening key WHO functions; (ii) providing significant and sustainable resources to rapidly responding to outbreaks: suggestions have been made, for example, for a contingency fund of US$100 million to be established at WHO and a much larger Pandemic Emergency Facility to be set up between WHO and the World Bank; (iii) high-level political commitment and mechanisms to ensure rapid and coordinated global action, perhaps through the imprimatur of the UN Security Council which declared a resolution on Ebola (Gostin & Friedman, 2014); and (iv) the need for a more multi-sectoral approach. For instance, in lieu of the fact that many emerging diseases have animal origins, organizations involved in animal health should also participate, through a “One Health” approach, in joint monitoring and surveillance efforts (McCloskey et al, 2014).

Are such new structures really needed to fulfil these roles efficiently and globally? While it may be attractive in the current atmosphere of disappointment with global institutions to propose a new “Global Fund for Health” (Ooms & Hammonds, 2014), this decision should not be taken lightly. There are already many entities and the creation of new structures has huge implications with regard to the risk of fragmentation of efforts, governance, resources and political issues, which extend well beyond health. Prudence dictates that strengthening existing structures and mechanisms, based on the lessons learned from recent pandemics, would be a better strategy. To give the needed effort the necessary political boost, it has been suggested that a high-level summit meeting should be convened, ideally by a respected third party outside of the United Nations, which will allow all interested parties to objectively compare their diagnoses of what is needed, and suggest solutions for enhancing preparedness (Garrett, 2015). Such an opportunity may occur in May 2016 during the G-7 Summit at Ise-Shima in Japan where outbreak preparedness is likely to be on the agenda as part of the broader theme of human security.

In conclusion, global preparedness for future pandemics must be considered at three closely inter-connected levels: national, regional and global. Strong national public health infrastructures, effective coordination, solidarity, goodwill, trust, sufficient resources, and a strong emphasis on decisive, collective and rapid action are the foundations for a better global response system to deal with future pandemics. It will also be important to manage the tensions that exist between national sovereignty and the importance of international collective action. The time to act is now or “there is genuine danger that financial commitments from the G-7 nations, disease surveillance promises made by 194 nations, and essential improvements needed in the global governance of outbreaks will all simply fade off into the sunset of forgotten urgency”

Methodological and Policy Limitations of Quantifying the Saving of Lives: A Case Study of the Global Fund’s Approach.


Summary Points

·         A recent trend in global health has been a growing emphasis on assessing the effectiveness and impact of specific health interventions.

·         For example, it has been estimated that 8.7 million lives were saved between 2002 and mid-2012 by “Global Fund–supported programmes” (as distinct from The Global Fund alone) through antiretroviral therapy (ART); directly observed tuberculosis treatment, short course (DOTS); and distribution of insecticide-treated mosquito nets (ITNs).

·         This paper assesses the methods used by The Global Fund to quantify “lives saved,” highlights the uncertainty associated with the figures calculated, and suggests that the methods are likely to overestimate the number of “lives saved.”

·         The paper also discusses how the attribution of “lives saved” to specific programmes or actors might negatively affect the overall governance and management of health systems, and how a narrow focus on just ART, DOTS, and ITNs could neglect other interventions and reinforce vertical programmes.

·         Furthermore, the attribution of “lives saved” to Global Fund–supported programmes is potentially misleading, because such programmes include an unstated degree of financial support from recipient governments and other donors.

Discussion

This paper argues that the number of “lives saved” that are attributed to Global Fund–supported programmes is not as certain as has been suggested by The Global Fund, and is likely to be an overestimate. Furthermore, estimating the “lives saved” by Global Fund–supported programmes is confusing and potentially misleading, because such programmes include a considerable but unstated amount of financial support from other sources. Finally, a number of potentially negative policy effects are associated with the selective impact estimation of downstream clinical interventions.

While this paper focuses on The Global Fund, the issues raised here apply to other global health partnerships and international donor agencies that are increasingly under pressure to quantify the health impact of their investments. The methods for estimating and attributing “lives saved,” and the consequences of doing so, should be questioned and subjected to critical debate.

In the case of The Global Fund, for a start, greater clarity and explanation about the assumptions and generalisations of the methods are required; this should include publication of uncertainty ranges and of disaggregated estimates of “lives saved” for each of the three interventions and for each year. The Global Fund should also conduct and publish sensitivity analyses, particularly in relation to treatment effectiveness, and publish estimates of “lives saved” through DOTS based on alternative counterfactual scenarios.

If the health impact of ART, DOTS, and ITNs is to be estimated in the form of “lives saved,” we argue that this should not be done as an exercise focused on individual external agencies, but rather on the collective contributions of governments and development partners within countries. This would confer a number of benefits. First, the monitoring of service delivery outputs and the estimation of their health impact would be linked to an assessment of the performance of national health systems (a more appropriate unit for assessment) and the degree to which development partners are working in harmonisation with each other and in alignment with ministries of health and their national plans and priorities. This would help shift more attention towards the strengthening of integrated national plans and information systems.

Second, holistic assessments of service delivery results and health improvement at the country level would allow for a context-based analysis of performance, including assessments of efficiency and equity. This would be aided by cross-country comparisons that would reveal variations in effectiveness (and efficiency) of ART, DOTS, and ITNs that arise from differences in, amongst other things, access to health care, quality of care and treatment adherence, and population coverage of nonclinical determinants of health such as access to clean water and nutrition. By describing this variation, policy attention can be directed not just at the delivery of selected clinical interventions, but also at the social, economic, and environmental conditions that influence the degree to which those interventions are effective. This stands in marked contrast to a modelling approach that assumes standardised levels of effectiveness across countries or regions.

Third, estimates of “lives saved” at the country level might be more valid and less uncertain because they would be derived from more appropriate and country-specific modelling assumptions, and because it would motivate countries to improve the quality of their data. In addition, it could stimulate other actors within countries, such as parliamentary health committees, universities, and local nongovernmental organizations, to develop the capacity to scrutinise the performance of the health system. While many countries produce annual health reports, health needs assessments, and national health plans, which provide some description of progress in the health sector, they are often incomplete or weak. Subnational analyses are frequently absent or superficial; and the fragmented and piecemeal nature of reporting systems, encouraged by vertical and donor-driven DAH, still undermines the development of coherent planning, budgeting, management, and information systems.

While an estimate of “lives saved” by ART, DOTS, and ITNs at country level would still be limited by its narrow focus on three interventions, it would provide a platform for monitoring and evaluating other aspects of HIV, TB, and malaria programmes and be more easily incorporated into a national system of data collection and evaluation that takes into account a wider package of health systems inputs, processes, and outputs, enabling policy makers and planners to consider the importance of investments that do not have a measurable or immediate mortality impact.

If individual external agencies need to estimate their specific contribution to “lives saved,” this could be done more simply by apportioning a share of a country’s estimated number of lives saved on the basis of their proportional financial contribution to THE or total HIV/AIDS, TB, and malaria programme financing. This would provide a more meaningful assessment of the contribution of individual agencies, avoid double-counting in reported estimates of “lives saved” by external agencies, and incentivise external agencies to promote coherent national health planning and reporting.

Many of these recommendations  are applicable to external agencies in general. However, since 2012, The Global Fund has been providing more active support for detailed national evaluations of programme performance and impact, and more accurate measures of disease incidence, prevalence, mortality, and morbidity in 20 to 25 “high-impact” countries. This provides it with an opportunity to shift emphasis away from estimating “lives saved” by individual interventions and donor-supported programmes, towards an assessment of health systems performance and impact that incorporates all major actors, programmes, and interventions, and a fuller assessment of the contribution of social, economic, and other upstream determinants of health.

Source:PLOS

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