Breaking News: Link 121

Breaking News Links, as part of the research project GESPAM (Geopolitica, Salute Pubblica e Accesso alle Medicine/Geopolitics, Public Health and Access to Medicines), aim to focus on the latest challenges by trade and governments rules to equitable access to health in resource-limited settings


Breaking News 121

Pope Francis: Europe’s idea has been replaced by bureaucracy

EU congratulates Nobel Prize winner Malala Yousafzai

As US Trade Representative Arrives in Delhi, MSF Urges India to Stand Strong Against Attack on Affordable Medicines

The Transatlantic Trade and Investment Partnership and the NHS: Separating myth from fact 

Solutions to improve access to medicines and biomedical innovation through EU trade and R&D policy 

Extension of the 2013 MPP-ViiV Healthcare Licence for Abacavir (Statement) 

Access to Medicine Index Applauds the Medicines Patent Pool for High Standard Licences  

Ebola outbreak can be ended in 2015: UN’s Ban Ki-moon 

How the EU is working together with partners to fight Ebola 

Strengthening the Malaria Treatment Arsenal for Children in Africa  

Artesunate-Mefloquine Fixed-Dose Combination (ASMQ FDC) Proves Safe and Efficacious to Treat Children in Africa with Malaria 

DNDi Latin America Receives FINEP Innovation Award in Social Technology    

ACP-EU JOINT PARLIAMENTARY ASSEMBLY 28th SESSION: 1-3 December 2014 Strasbourg (France)

What is the Future for Community Health Workers?

Civil society, a neglected resource in realising the right to health for all

Maps Tell Powerful StoriesAbout Children, Neighborhoods, and Possible Policy Solutions

5 lessons about unleashing the potential of pro-poor health innovation

Beyond GDP indicators: To what end? 

Low-Income African Countries Get Go-Ahead for Green Energy, Climate Resilience and Forest Management 

A changing climate landscape? 

The Future of the Planet and the Irresponsibility of Governments 

Protecting Profits over People

Rwanda Launches Land Information Portal 

World AIDS Day 2014: UNAIDS Shifts Its Emphasis toward Reducing New Infections 

Vaccino anti-Aids, l’Istituto superiore di Sanità ferma l’operazione Vaxxit 

Adaptive Engagement: China’s Approach to Southern Africa 












Fighting for Hepatitis C Treatment Access: We Cannot Repeat the Mistakes of the HIV Epidemic

Hepatitis C virus (HCV) infection can be cured now thanks to highly effective oral direct-acting antivirals (DAAs). But it remains only a distant dream for most who need it worldwide. We must fight HCV DAA bank-busting price tags, and the intellectual property regime and the industry behind it, that collude to undermine public health

Fighting for Hepatitis C Treatment Access: We Cannot Repeat the Mistakes of the HIV Epidemic

Karyn Kaplan_photo

by Karyn Kaplan*

                          International Hepatitis/HIV Policy and Advocacy Director, Treatment Action Group (TAG)

Over the past year, news headlines across the globe heralded the arrival of a cure for hepatitis C virus (HCV), which kills 500,000 people each year (more than 185 million are estimated to be infected). The advent of oral direct-acting antivirals (DAAs) that are more effective, simpler to administer, easier to tolerate, and are taken for a shorter duration than previous standard of care has led experts to predict the potential of global HCV eradication. But as new DAAs pour onto the market, questions about access, particularly in low- and middle-income countries (LMICs), loom large.

 Gilead’€™s Sovaldi (sofosbuvir), one of the first DAAs to receive regulatory approval in the US and Europe, is considered the backbone of the new HCV standard of care. Sovaldi is priced at US$84,000 for a three-month course. Harvoni, Gilead’€™s combination therapy, a once-a-day pill approved for HCV genotype 1, costs US$94,500 for the same duration. For people in LMICs, home to 85% of people with HCV and the majority of the world’€™s poor -€“ more than a billion living on less than US$1.25/day, according to the World Bank – €“this extortionate pricing is tantamount to a death sentence.

Even high-income countries in Europe, and the US, and Australia, have balked at DAA high pricing. In the US, Medicaid (a federal program that pays for medical services for low-income citizens) has rationed and outright denied these new medications to patients due to their high price tag. States such as New York, California, and Illinois are basing treatment eligibility on cost considerations, not medical criteria.

 In November 2014, hepatitis C activists in New York State traveled to Albany, the state capitol, to protest restrictions to HCV DAAs that include:

 -Requiring patients to wait until they demonstrate late-stage disease progression before they can have treatment

-Denying HIV/HCV-coinfected patients treatment if, in the past 6 months, they have had detectable HIV RNA viral load

-Requiring that patients demonstrate “€œno high-risk behavior (recurring alcohol use, intravenous drug use, etc.).”

 Approaches that limit rather than expand access are increasingly common, in the US, Europe and Australia where DAAs are on the market but too expensive for national and local healthcare programs. The result is disastrous for people living with chronic HCV, which, untreated, causes serious liver disease including cirrhosis and liver cancer, and death. “€œWe don’€™t make HIV-positive people in New York wait for treatment until they have AIDS, we don’€™t tell people who eat meat that they can’€™t be treated for heart disease, and so we shouldn’€™t withhold HCV treatment from people who need it. New York should not backslide into unethical cost-cutting,”€ pointed out Tracy Swan, Treatment Action Group (TAG) Hepatitis/HIV Project Director and participant in the protests.

 For people in LMICs, prospects for accessing new DAAs are even more dismal. DAA producers like Gilead and Bristol-Myers Squibb (BMS) have not registered their drugs in most of these countries. Their recently announced global access plans reflect a greater interest in emerging market profit-seeking than expanding access to treatment in developing countries, which is their stated goal.

Gilead’€™s voluntary license to 7 Indian generic companies, publicized in September 2014, allows sales of cheaper generic versions of their DAAs in only 91 countries (at time of announcement). Gilead excludes 73 million people with HCV from the deal, including 30 million in China, and other high-prevalence countries like Brazil, Russia, Thailand, Ukraine and the US, where need is greatest; while “€œbeefing up”€ the scope of their license with many low-prevalence small island nations. BMS’€™ plan (“€œbusiness as usual,”€ according to Médecins Sans Frontières) covers just 90 countries, similarly denying affordable access to nearly half of the world’s people with HCV.


Source: Gilead’€™s License on Hepatitis C drugs, Sofosbuvir and Ledipasvir: a Fool’s Bargain. Available at:

The global HIV/AIDS treatment access movement demonstrated the critical role of competition among generic drug makers to help drive down the price of treatment. The price of standard HIV medications dropped by 99 percent as a result. Also, communities of people living with HIV/AIDS and allies advocated to their governments to utilize legal safeguards in international trade agreements and domestic law, including compulsory licensing and patent opposition, so locally produced or imported generic versions of antiretroviral therapy (ART) could be made available. Without widespread access to generic ART, millions of lives would have been lost.

Andrew Hill and colleagues have shown the minimum cost to produce HCV DAAs generically is only a fraction of their market price. Combination treatment, including genotype testing and treatment monitoring (and providing for a 4% profit margin) could cost just US$177-444.

Governments have an obligation to promote the highest attainable standard of physical and mental health for its people. According to the World Health Organization (WHO), every United Nations Member State has ratified at least one international human rights treaty recognizing the right to health. Therefore, governments –regardless of resources –must make progress toward fulfilling this right. The UN and multilateral funding agencies such as the Global Fund to Fight AIDS, Tuberculosis and Malaria (GFATM), have an instrumental role to play in helping to increase the capacity of governments to successfully address HCV.

 In May 2014, the World Health Assembly, the policymaking body of the World Health Organization (WHO), unanimously passed a resolution calling for stepped-up action on viral hepatitis from the WHO Director-General and Member States. The WHO issued their first-ever HCV treatment guidelines, to encourage countries develop plans and programs. These are significant advances, pushed for by activists on the ground who are engaged in raising awareness, building treatment demand, and advocating for political will in the countries where they live. Yet, the potential impact of WHA and WHO action is greatly diminished if the medications remain priced too high and generic versions of oral DAAs blocked for decades by patents granted to originator companies. UN agencies need to do more – in particular, to address the devastating price and patent barriers erected by the pharmaceutical industry.

In July 2012, a global coalition of HCV community advocates **– people with HCV, people with HIV/HCV, and people who inject drugs– and their allies -€“ issued the Washington Call, a platform of principles and demands including to the pharmaceutical industry to drop the price of HCV diagnostics and medications; donors to support community mobilization and treatment literacy; and political leaders to mobilize resources. Since then, the coalition has launched global advocacy campaigns, held community capacity-building workshops, organized meetings with Pharma and high-level policymakers, and used direct action demonstrations and other strategies to increase access to HCV treatment and care. Yet the cure remains out of reach for most people who need it now, and all stakeholders need to do more.

It would be unethical and unforgivable to allow the lessons of the HIV epidemic, such as promoting urgent access to affordable generic medications to meet the scale of the treatment need, to go unheeded. HCV can be cured, now. But it remains only a distant dream for most who need it. We must fight HCV DAA bank-busting price tags, and the intellectual property regime and the industry behind it, that collude to undermine public health.


*Karyn Kaplan is the Director of International Hepatitis/HIV Policy and Advocacy at Treatment Action Group (TAG) in New York. She is the co-founder of Thai AIDS Treatment Action Group (TTAG), and worked on HIV and human rights with grassroots communities in Thailand for 20 years. She is the recent recipient of a Health GAP Global Health Justice award. 

**For further information on the global coalition and its campaigns and publications, as well as how to get involved, please visit, or contact the author at





Breaking News: Link 120

Breaking News Links, as part of the research project GESPAM (Geopolitica, Salute Pubblica e Accesso alle Medicine/Geopolitics, Public Health and Access to Medicines), aim to focus on latest challenges by trade and governments rules to equitable access to health in resource-limited settings


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Governance for Health in a Changing World, 10-11 November 2014, DurhamUniversity 

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What Factors Might Have Led to the Emergence of Ebola in West Africa?

After Ebola: Five Lessons for Outbreak Response  

Commission launches transparency initiative for TTIP and lobbying  

Stop TTIP Take Action Initiative  

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G-20 Leaders Unveil National Growth Strategies, Eyeing US$2 Trillion Boost  

Erik Solheim: ‘If the UK can commit 0.7% of GDP to development, so can France’ 

2014 Access to Medicine Index – More being done, but progress is uneven 

Index: Pharma Industry Improves On Access To Medicines, Needs Work On Ethics, Patent Disclosure

KEI comment on the new Tufts Study on Drug Development Costs 

R&D cost estimates – MSF response to Tufts CSDD study on cost to develop a new drug 

Sovaldi, Harvoni, And Why It’s Different This Time 

Health Affairs 2014 vol 33, issue 10: Specialty Pharmaceutical Spending & Policy  

US IP Industry Meeting With Indian Judges A “Ruse”, Activists Say 

 “A better pill to swallow” – Interview Paul Newton and Raffaella Ravinetto 


GM Food and the precautionary principle  

Stop trying to save the world: Big ideas are destroying international development

International development is broken — here are 2 ways to fix it

How technology is checking health corruption in India  

Why India, not China, is a better investment partner for Africa  






Post-Trial Access to Communities: The Case of Haematological Malignancies

The issue of post-trial equitable access to essential medicines for treating non-communicable diseases (NCDs) in low and middle-income countries is raising increasing concerns. This article suggests some short-term measures to fill in the relevant gaps

 Post-Trial Access to Communities : The Case of Haematological Malignancies

 by Raffaella Ravinetto*

Head of Clinical Trials Unit, Antwerp Institute of Tropical Medicine


The issue of access to medicines in Middle and Low Income Countries (LMICs) has often been investigated from the perspective of transmissible diseases, such as HIV/AIDS, malaria, tuberculosis, and of transmissible tropical diseases. However, non-communicable diseases (NCDs) are more and more prevalent in LMICs: according to the WHO, 80% of deaths from NCDs now occur in LMICs. Inevitably, the issue of access to essential medicines for treating them is raising increasing concerns. A few countries like India and Indonesia have issued compulsory licenses to improve access to some life-saving cancer drugs. According to Bollyky (2013) the controversy over patented medicines for NCDs and their affordability in developing countries is comparable to the one prompted, more than one decade ago, by antiretroviral drugs, and addressing this new access-crisis will require a transformation in global health (1).

As a first step of a broader investigation, and as an attempt to contribute to the ongoing debate, we explored the model of hematological malignancies, and we illustrated our findings in a Comment which has been recently published in the Lancet Hematology (2). We chose this therapeutic field for different reasons. First, new and innovative medicines today allow to cure hematological malignancies in an important group of patients. Second, the high price of these medicines makes them hardly accessible in LMICs, including Middle Income Countries (MICs) like South Africa (3). Third, clinical trials for marketing authorization purposes are often carried out in MICs: our preliminary analysis concerning twelve haematological drugs recommended by international guidelines and/or under development shows that thirty % of phase 3, interventional, commercial trials registered in, involved sites in MICs, where the  likelihood that the medicine will be accessible to all is poor, due to pricing issues.

This raises, in addition to the general access issues, the specific issue of post-trial access to the general population in the countries where the trials took place. According to the main international ethical guidelines (4-6), the obtainement of scientific results in a vulnerable group should be linked to health benefits for that population, so that conducting a clinical research in a MIC where all or a part of the population cannot benefit from the study finding is unethical, and even exploitative.

In practice, looking at the clinical development plan adds a layer of complexity -and of ethical challenges- to the problem of access to medicines. In our paper, we suggest some short-term measures for achieving an  equitable distribution of the burdens and benefits of clinical research. First, regulatory agencies should require an “€œethical clause”€ binding the marketing authorization holders to offer innovative, patented drugs at tiered prices in all MICs where trials are conducted. Second, physicians and patients in MICs, hopefully joined in this effort by peers in high income countries, should lobby for a “juxtum pretium” for patented, life-saving drugs tested in trials in their countries.

The mobilization of patients, physicians and civil society has played a major role in the effort to fill the gaps in access to life-saving therapies for HIV/AIDS, and this lesson should now be retaken to correct the unequal distribution of  burdens and benefits in globalized  clinical research, and more generally to fill in the unacceptable gap in access to life-saving therapies for non-communicable diseases.



1) Bollyky TJ. Access to Drugs for Treatment of Non-Communicable Diseases. PloS Med 10 (7): e1001485. doi: 10.1371/journal.pmed.1001485.

2) Ravinetto R, Guenzi PD, Massat P, Gaidano G. Globalisation of clinical trials and ethics of benefit sharing. Lancet Haematology (2014); 1: e54-e56. Accessible upon registration at

3) Experts in Chronic Myeloid Leukemia. The price of drugs for chronic myeloid leukemia (CML) is a reflection of the unsustainable prices of cancer drugs: from the perspective of a large group of CML experts. Blood 2013; 121:4439-42

4) World Medical Association. Declaration of Helsinki: Ethical Principles for Medical Research Involving Human Subjects. JAMA 2013;310: 2191–4

5) The Belmont Report. Ethical Principles and Guidelines for the Protection of Human Subjects of Research. The National Commission for the Protection of Human Subjects of Biomedical and Behavioural Research, 1979.

6) International Ethical Guidelines for Biomedical Research Involving Human Subjects, Council for International Organizations of Medical Sciences (CIOMS) in collaboration with the WHO. CIOMS 2002, Geneva.


*Raffaella Ravinetto holds a Pharmacy Degree from the University of Torino and a Postgraduate Diploma in Tropical Medicine from the Antwerp Institute of Tropical Medicine.   

After a seven-year experience as a Clinical Research Scientist in the private pharmaceutical sector, she worked in emergency and development programs in the Balkans and in Africa. In 2002, she joined Médecins Sans Frontières (MSF), where she followed various dossiers on access to essential medicines and quality of medicines, while performing regular field assessments. She currently works at the Antwerp Institute of Tropical Medicine, as head of the Clinical Trials Unit, coordinator of the Switching the Poles Clinical Research Network and promoter of Quamed (a Network promoting evidence-based strategies for universal access to quality medicines). She was president of the Italian branch of MSF (2007-2011).   

Her main areas of interest include North-South collaborative clinical research, research ethics (particularly in relation to resource-constrained settings) and access to health. 

Breaking News: Link 119

Breaking News Links, as part of the research project GESPAM (Geopolitica, Salute Pubblica e Accesso alle Medicine/Geopolitics, Public Health and Access to Medicines), aim to focus on latest challenges by trade and governments rules to equitable access to health in resource-limited settings 


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IFPMA: What health partnerships do?


Time for the EU to take an active stance to promote child health

Child Mortality Gap Narrows in Developing Countries 

The future of the fight against malaria 

WHO In Race To Find Promising Ebola Treatments As Many Products Ruled Out  

First trials for Ebola treatments to start at MSF sites in December 

What Would It Really Take to Halt Ebola and Prevent Future Epidemics? 

WIPO’s Assistance To Developing Countries: Taking Forward The Unfinished Reform Agenda  

MEPs pave the way for European Year for Development 2015 


Guide to EuropeAid funding instruments 2014–2020

A Complex Thing! Are measures of complexity an end in themselves to address extreme poverty? 

The case for including migration in the post-2015 agenda 

Geopolitics, Security and Energy Transition: A Greens/EFA conference in Istanbul     

G20 summit: Can they ignore climate change?   

We must manage global warming risks by cutting carbon pollution, top scientists conclude  

How to Tell If the G-20 Is Still Serious about Tax and Corruption 

G-20 Brisbane Showing Cracks in Infrastructure Agenda 

US Should Not Oppose China-led Development Bank, Analysts Say 






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Latest News Links is part of the research project GESPAM (Geopolitica, Salute Pubblica e Accesso alle Medicine/Geopolitics, Public Health and Access to Medicines), which aims to focus on real-time news and the best options for use of trade and government rules related to public health by resource-limited countries



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Antiviral Therapy Supplement on HIV challenges

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The Ultimate Global Antipoverty Program 




People’s Health Before Corporate Profits: U-Turn for Governance in a Changing World

Unbiased solutions for global health depend on political will to improve equity, coherence, coordination, collaboration, transparency and accountability both at domestic and international level. Unfortunately, governments’€™ directions in the most affluent countries run contrary to these principles while turning intellectual property agendas into policies which protect monopolistic interests at the expense of equitable access to care and lifesaving treatments in resource-limited settings. As such, prospects for equity in health only hinge on non-stop, multi-sector engagement worldwide to pressure governments into doing U-Turn changes by common measures on shared agenda

People’s Health Before Corporate Profits: U-Turn for Governance in a Changing World

by  Daniele Dionisio*

Member, European Parliament Working Group on Innovation, Access to Medicines and Poverty-Related Diseases


Worsening Health Inequity 

At a time when the low- and middle-income countries (LMICs) have been cut off from access to medicines for years, the most affluent countries wobble under the burden of new medicines huge costs that are beyond the grasp of their public health systems. Meanwhile, the worldwide rise of non-communicable diseases (NCDs) is  of special concern for the resource-limited countries still tackling the ongoing business of communicable diseases.  

The US$ 2 billion gap between the resources needed to adequately respond to the global TB epidemic and the funding currently provided by countries and donors still persists. This occurs even as 75 percent of the estimated 150-€“180 million people infected with hepatitis C live in LMICs where about 7 million people still do not have access to anti-retroviral medicines.

From bad to worse, since the incentives of current patent system are driven by profits, where short-term maximization of returns to shareholders is prioritized, the lower-income countries lacking profitable pharmaceutical markets are all the more discriminated.

Overall, this represents the failure of the current policies for global health as revealed at least by the scandalous  absence of a treatment for the deadly Ebola virus. 

In today’€™s world landscape, which is torn by dis-alignment, litigations and frictions among the involved parties, the root causes of health inequities are to be found in weaknesses in political domains at the supranational level. As reported, these include: democratic deficit, weak accountability, institutional stickiness, missing institutions and restricted policy space for health.  

This context entails that unbiased solutions for global health only hinge on political will to improve equity, coherence, coordination, collaboration, transparency and accountability both at domestic and international level. 

Unfortunately, the current governments’€™ directions and trade agreements, largely by the European Union (EU) and the United States (US), run contrary to these principles while turning intellectual property (IP) agendas into policies which protect monopolistic interests at the expense of equitable access to care and lifesaving treatments in resource-limited settings. 

Concern refers to still underway international negotiations, such as the Trans-Pacific Partnership (or TPP), the EU-India and EU-Thailand deals, and the Transatlantic Trade and Investment Partnership (or TTIP), at a time when an already signed Canada-EU Trade Agreement  and a recent EU custom regulation have incurred relevant criticism.

Not to mention that the government of Canada recently killed a bill on access to medicines for developing countries.

These cases just represent the tip of the iceberg for the underhanded tactics to ensure that developing countries adopt clauses that go beyond the full extension they had a right to under the World Trade Organization (WTO) Trade-Related Aspects of Intellectual Property Rights Agreement (TRIPS). TRIPS-plus measures would include: making it easier to patent new forms of old medicines that offer no added therapeutic efficacy for patients (“€œevergreening”€ rules); restricting “€œpre-grant opposition,”€ which allows a patent to be challenged before it is being granted; allowing customs officials to impound shipments of drugs on mere suspicion of IP infringement, including “€œin transit”€ products that are legal in origin and destination countries; expanding data exclusivity beyond WTO’€™s request for data protection against unfair commercial use only; extending patent lengths beyond 20-year TRIPS requirements; and restricting countries’€™ ability to use to the full the public health flexibilities recognized in the TRIPS agreement, including compulsory licenses and patent exceptions.

This comes as no surprise now that, coupling with the lack of transparency of a closed-doors TPP round in October, a leaked document – a revised copy of IP chapter from the secret TPP negotiations dated May 2014 – also disclosed US-Japan TRIPS-plus positions, with Australia backing “€œevergreening”€ rules.

These circumstances add concern that, like the Canada-EU deal, terms encompassing an investor state dispute settlement (ISDS) provision could end up in the final TPP text (as feared for other, including TTIP, in progress deals). ISDS would enable foreign investors from TPP states to sue the governments who sign up to it if those governments act in a way that harms their interests. 

As such, ISDS provision links in with a WTO non-violation nullification of benefits (or NV) clause that could be used if a WTO member deems that another member’€™s actions caused an unexpected loss of benefits, even if there is no violation of a WTO agreement. Developing countries are wary of NV provision while the moratorium on its use  under TRIPS continues to be renewed at WTO Ministerial Conferences. 

The non-transparent dynamics bound up with ISDS and NV terms compound fear that its allowance would be something that ultimately backs the developed economies rather than making headway on the right to health in resource-limited countries. Hence, it was not by chance that at June 2014 TRIPS Council Meeting  the US put forward a text arguing in favour of NV complaints under TRIPS.

Should NV and ISDS provisions be allowed, WTO and TPP member states might face pressures to reverse already enacted policies or measures under the threat of legal complaints on the grounds of a loss of expected benefit to the patent holders or foreign investors. These complaints could be used to threaten members’€™ use of flexibilities laid down in the TRIPS agreement also as regards access to medicines. 

Governments’€™ moves to obtain lower cost generic versions and cut extortionate prices of new medicines (such as antiviral, anticancer innovative combination treatments) could be argued indeed to make pointless or erode the expectations of the patent owners. Relevant risk sectors also include tariffs on medicines, as would be the case should a country that has agreed to reduce tariffs on an imported product later subsidise home manufacturing of the same medicine. A complaint against this country would be allowed to re-establish the conditions of competition in the original transaction.

Additionally, the sectors relevant to packaging and labelling requirements, and to IP protection enforcement measures, may also result as risk target areas, since they might affect the patent holders’€™ access to the market of medicines.

Under these circumstances, a claim could easily be lodged against a government for nullifying or eroding benefits by applying IP protection rules or packaging and labelling models that, despite full alignment with TRIPS requirements, are deemed to be insufficiently stringent or fraudulent.

These strategies add to the current breakthrough of multinational drug corporations in the middle-income country markets including through takeovers and buyouts of local companies.

Reportedly, this links in with US relentless pressure on India to open to more direct foreign investment and to further liberalize the Indian economy to make it easier for multinational corporations to operate there under TRIPS-plus IP measures.  As such, the newly  launched “€œIPR Think Tank to Draft National IPR Policy“€ in India could disappointingly converge on this.

These concerns add to criticism incurred by seven Indian manufacturers as regards pacts recently inked with Gilead for reverse engineering hepatitis C innovative regimens. With a limited territory covered, these pacts raise doubts about the coherence of Indian counterparts at a time when there are no relevant patents in India, several pre-grant oppositions have been filed and unrestrained competition by compulsory licences could have been pursued.  

Feeding  the conflicting issues above is a strategy by some pharmaceutical companies to undermine efforts of the South African government to amend its IP laws, increase affordability of medicines and brighten the future of healthcare in South Africa. Revealed through a leaked document bluntly titled, “€œCampaign to Prevent Damage to Innovation from the Proposed Draft National IP Policy in South Africa”€, this campaign fully backs the business interests while trying to sell the idea that stronger IP protections are essential to foreign investment, innovation, and achievement of public health goals. As such, the campaign refrain papers over evidence that heightened IP rights, instead of leading to greater innovation and affordable prices, make consumers captive to Big Pharma’€™s extortionate pricing.

Taken together, all insights above are an indication that, under EU and US governments’€™ complicity, corporate profits now outweigh any commitment to the global human rights.  

Worse, the current supranational policies have critically impaired access to food in the resource-limited settings, with a deeply negative impact on health. Over the last 20-30 years, the World Bank and the International Monetary Fund (IMF), and more recently the WTO, have forced countries to decrease investment in food production and to reduce support for peasant and small farmers. Under neo-liberal policies, state-managed food reserves have been considered too expensive and governments have failed to protect farmers and consumers against sudden price fluctuations, while being forced to “€œliberalise”€ their agricultural markets through reducing import duties and accepting imports for at least 5% of their internal consumption even if they did not need it. As such, the critics argue that the neo-liberal policies have destroyed the capacities of countries to feed themselves.  

This occurs even as land grabbing and evictions as part of neo-colonialism policies, including for biofuel agribusiness, are on the rise in Africa and elsewhere under national governments complacency and a widespread corruption.

Meanwhile, more coherence with Lisbon Treaty commitment to “€œhigh level of human health protection in all policies”€ should have been displayed by the EU as regards the Economic Partnership Agreements (EPAs*) negotiated with the African, Caribbean and Pacific (ACP) countries, that were flaunted to promote sustainable development and growth, poverty reduction, better governance and the gradual integration of ACP countries into the world economy. 

These insights add to criticism that the EU is becoming more protectionist in agriculture, trade and aid areas, at a time when substantial reform of EU’€™s agricultural subsidies has been  called for.

*EPAs are reciprocal, but asymmetric trade agreements, where the EU, as one regional block, provides full duty free and quota free market access to EPA countries and/or regions and where ACP countries/regions, commit to open at least 75% of their markets to the EU. As of 1 October 2014, EPAs have been concluded by 28 countries of the EU with 49 ACP countries, covering over 900 million people, on 4 continents. 

And there is more.

The World Health Organization (WHO) performances, including its Medicines Pre-qualification Programme, are suffering  from funding shortages and inadequate collaboration by member governments, at a time when an alarm bell is ringing over the fact that the majority of medicines granted marketing authorisation has no added therapeutic value compared to medicines already on the market. In some cases the new medicine even did more harm than good. 

Not to mention that dis-alignment by member governments accounts for the exceedingly slow pace of the WHO Member State Mechanism on SSFFCs (Substandard/Spurious/Falsely-labelled/Falsified/Counterfeit medical products) since it was established in May 2012. This is disappointing now that the poor legislative and regulatory framework monitoring the quality, sale and transit of medicines in the developing countries, coupled with the scarcity of human and financial resources and a lack of political will, still allows the trade in counterfeit and substandard medicines to boom.

These circumstances add to the critical shortage of health care professionals that limits the access to care to billions of individuals in resource-limited settings. One third of the world’€™s population -€“ over 2 billion people -€“ do not have regular access to the essential medicines that they need.  

Meanwhile, the real impact on global health and development is pending as regards the BRICS (Brazil, Russia, India, China, South Africa) countries and other fast-growth Next Eleven or N-11 (Bangladesh, Egypt, Indonesia, Iran, Mexico, Nigeria, Pakistan, the Philippines, Turkey, South Korea, Vietnam) economies.

The BRICS emphasize “€œSouth-South”€ cooperation through commitment to collaborate with each other on health, and have already contributed to global health through financing, capacity building, dramatically improved access to affordable medicines, and development of new tools and strategies.

Although the BRICS have their own motives, including economics and politics, for engaging in international assistance, the increased investments in health innovation and the production of low-cost medicines, diagnostics and vaccines by the BRICS will expectedly continue to provide benefits to developing countries. 

Relevantly, it is big news that at the BRICS summit in Brazil last July the BRICS established their New Development Bank, which has long-term implications for global order and development.    

Common Health Agenda, Nothing Less

What expectations on the whole background above? Hopes that a comprehensive global health goal could be reached soon are hardly credible with the load of unresolved issues still on the table. As reported  “€œ…Achieving health equity is not just a matter of coming up with technical solutions and providing the means to finance them. We have to consider the political landscape and rectify the dysfunctions in global governance that undermine health”… 

Admittedly, governments in the most advanced countries look like they wouldn’€™t be ready to embark on the gaps highlighted here as an opportunity for national security and profitable return on their disbursements instead of just a heavy burden in times of economic slump. Rather, they seem to be captive to their eagerly profit-hungry corporate holdings in a vicious circle of mutually reinforcing political and commercial interests over public health concerns.

As such, prospects for equity in health only hinge on non-stop, multi-sector engagement worldwide to pressure governments into doing U-Turn changes by common measures on shared agenda that include:

Rejecting pressures towards adopting heightened IPRs and strengthened enforcement mechanisms as the keys to foreign investments and innovation 

As reported, “…inclusive evidence typically shows that most low- and middle-income countries do not benefit economically from IP maximization since they are net importers of IP goods and since the path to technological development is ordinarily through copying and incremental innovation-development tools that are severely undermined by IP monopoly rights and their related restrictive licensing agreements”…

Rejecting World Bank income classification to measure a country’s capacity to afford high-priced medicines

As argued, …..the World Bank classification dates back to the 1980s and only measures a country’s per-capita average of total income. However, the map of poverty has changed since the 1980s. Today, the majority of the world’s poor no longer live in poor countries, but rather in places where there is greater wealth along with higher inequality.

Relevantly, MSF contends  that….the US Medicaid-defined poverty line ($21.50/person per day) would be a far more reliable tool to estimate how many millions will live below it once countries cross the high-income threshold. As regards TPP countries, MSF highlights that “…In eight of the 12 TPP countries for which there is data, more than a quarter of a billion people will live below the U.S. Medicaid line when their country is classified as high income. By the time Malaysia and Mexico reach high income designation, more than 80 percent of their populations will still fall below this poverty line. Among current high-income TPP countries, the percentage of the population under this poverty line ranges widely, going as high as 69 percent in Chile”€.

Rejecting  privatization policies, including by publicly funded insurance packages using networks of private providers 

As reported, ….while reinforcing the notion that healthcare is a commodity and not a basic human right, this approach, proposed by the World Bank and their allies, has several problems and side effects: fragmentation of care, higher cost, precedence of procedures over preventive medicine and further dismantling of the public healthcare system. At the same time, insurance packages divert attention and funds from a more comprehensive approach directed at modifying the root causes of disease, through socioeconomic interventions aimed at increasing equity.  

Inherently, as per a report from the Philippines, “…the current privatization policies of the Philippine government do not provide an answer to the enormous health needs. Despite the name of the Philippine “€œUniversal Health Care”€ program that claims to “€œbring equity and access to critical health services to poor Philippinos”€,  commercialisation of health services will do exactly the opposite. Unfortunately, the European Commission is supportive of these policies and formerly approved a contribution of euros 33 million in support of the Health Sector Reform Agenda of the Philippine government”….  

Rejecting closed doors negotiations since they blur transparency

Banning the non-violation nullification of benefits ( NV) clause under TRIPS 

Banning TRIPS-plus clauses, including investor state dispute settlement (ISDS) provisions, that could negatively affect health and worsen inequalities in access to care and treatments 

Withdrawing pressures on LMICs to jeopardize the use of TRIPS safeguards and flexibilities relevant to the price of medicines

Pushing for open knowledge and new approaches to  pharmaceutical innovation that do not rely on the patent system and de-link  the costs of R&D from the price of medicines

Promoting technology transfer with least-developed countries without exporting excessive IP standards through assistance programs

Backing generic competition as the most effective way to lower medicine prices in a sustainable way

Backing governments that make use of  TRIPS safeguards and flexibilities to protect and promote public health

Linking  together patent offices and legislators worldwide to develop evidence-based reforms of the patent regime of medicines

 As reported, “…[I]f countries set higher standards for incremental innovation patenting, and permit citizen or third-party review of patents before and after examination, then we will likely see increased generic competition in the …, new combination therapies, and lower … prices. In the longer term, higher inventiveness standards will help clear the patent thicket to allow new products to develop, and push industry towards genuine innovations”….

Calling on companies to join the Medicines Patent Pool  

Actively supporting partnership agendas (as per DNDI and GAVI examples among others) that are devoted to the development of new medicines and vaccines for neglected diseases that disproportionately affect poor population settings

Ensuring that the Global Fund to Fight AIDS, Tuberculosis and Malaria continues to use generic medicines and support UNITAID work to make quality medicines and diagnostics available and affordable   

Ensuring that revenues from a Financial Transaction Tax (FTT), whose approval is in progress in Europe, will substantially be committed to development and for the fight against health scourges, diseases of the poor and pandemics

FTT revenues would be a resource for the EU to channel towards the WHO and Global Fund needs. An FTT would be instrumental to the spirit and resolutions of latest WHO Assemblies. Hence, it should be up to the EU to push that non-discriminatory access to health and lifesaving medicines becomes a substantial objective for FTT revenues.

Ensuring that leading institutions and organisations enhance working with health ministries to strengthen national systems, invest in infrastructures, improve transparency and accountability, and boost needs-driven rather than market-driven rules

 This would mean giving up “€œclosed doors”€ negotiations and adopting multi-sector participatory models for decisions affecting national health, growth, employment and budgets.

Ensuring that international agreements include clauses whereby donors must strengthen WHO-aligned quality clauses in tender transactions with non-governmental organisations, while purchasers must insist that manufacturers and distributors supply medicines that meet WHO requirements, and governments must authorise export only of products meeting WHO quality, efficacy and safety standards

Ensuring that research and innovation for health is linked to improving economic prosperity and is critical to eradicating poverty (since poor health and disability contribute substantially to poverty) 

Ensuring that indicators for R&D for health tools that primarily affect LMICs address a comprehensive set of outcomes including financing needs, infrastructure and human resources needs, enabling policies, necessary partnerships, capacity strengthening, and access requirements 

Ensuring that any research and innovation indicators measuring progress against the goals and targets outlined in the post-2015 agenda* also increase accountability of researchers, governments, and funders, and inform research processes 

Ultimately, the success or failure of the post-2015 agenda relies just as much on how the goals and targets are implemented as it does on how progress will be measured 

*In support of the inclusion of research and innovation for health in the post-2015 agenda, over 150 organizations and individuals recently signed a petition to United Nations (UN) Secretary General Ban Ki-moon and Member States urging the UN to keep the research, development, and delivery of new and improved health tools for diseases and conditions impacting LMICs at the heart of the post-2015 development agenda  

Seeking  synergies among global level institutions to address global health challenges, support stronger leadership by the WHO to improve global health, enhance dialogue and joint action with key players, including UN agencies involved in global health, international financing institutions, regional organisations, regional health networks, and countries, in order to coordinate actions, advance in the achievement of commitments, and avoid overlapping and fragmentation 

Seeking synergies for equitable health access with fast growing, including BRICS and N-11, middle-income country economies 

Pushing for a complementary relationship, rather than a conflicting one, between World Bank, IMF and the New BRICS Development Bank as regards the development and health needs of marginalized population settings in LMICs

Pushing for full exemption of out-of-pocket expenses for the poor; poor-friendly pathways towards universal health coverage; heavy taxation on tobacco and other harmful substances; and reduction or elimination of agricultural export subsidies and energy subsidies on air-polluting fuels 

Opposing land grabbing, deforestation  and state-managed food reserve dismantling policies 

Reversing “€œBrain Drain”€, health worker shortage by a transformation of the present training approach, as to adapt curricula to local needs, promote strategies to retain expert faculty staff, expose trainees to community needs during training, promote multi-sector approach to education reforms, and strengthen links between the educational and health care delivery system. Western academic institutions’ role is to facilitate the process 

Asking for the European Medicines Agency (EMA) to be financed only through EU budget as per application fees channeled to the European Commission 

This would improve transparency and accountability.

Asking for anti-counterfeit laws and law enforcement policies not to substitute for effective national regulatory frameworks

Asking for organizations with potential conflicts of interests and IP perspectives to issue statements eschewing the use of IP law to counter generic medicines

Asking for investment in technologies to detect “€œbad medicines”€ to be followed up with provisions to increase public awareness and incident reporting, along with regulations on medicine quality that include definitions as per shared WHO terms  



*Daniele Dionisio is a member of the European Parliament Working Group on Innovation, Access to Medicines and Poverty-Related Diseases. He is an advisor for “€œMedicines for the Developing Countries”€ for the Italian Society for Infectious and Tropical Diseases (SIMIT), and former director of the Infectious Disease Division at the Pistoia City Hospital (Italy). He may be reached at

Chagas in a Non-Endemic Area: First Level Health Care. Lights and Shadows

This work deals with the experience carried out by the Secretariat of Health and Social Medicine of the Municipality of La Plata and Mundo Sano Foundation from July 2010 to December 2013 at school institutions of the Buenos Aires province and primary health care centers of the municipality (CAPS). They are aimed at implementing a pilot trial to address the situation of people affected by Chagas disease from a comprehensive perspective, carrying out early diagnosis and timely treatment in a specific non-endemic geographic area of La Plata city, in the Buenos Aires province

Chagas in a Non-Endemic Area: First Level Health Care. Lights and Shadows

Mabel Lenardòn*, Patricio Orsini*; Marina Chopita*, Pedro Ramos*, Ana Paula Da Cruz*, Florencia Suárez Crivaro*, Sonia Tarragona**, Patricia Le Moal*, Belén Osaeta*, Jaime Henen*, Ana C. Pereiro**

*Secretariat of Health and Social Medicine of the Municipality of La Plata 

**Mundo Sano Foundation



Chagas Disease (CD) is named after Carlos Ribeiro Justiniano Chagas, a Brazilian physician that discovered it in 1909. The parasite causing the disease is Tripanosoma cruzi, which nests in several tissues and produces irreversible heart damage in 30% of chronic patients, and neurological  and digestive injuries in 10 % of the cases. 1 

In endemic areas, the most frequent form of transmission is vector-borne, through the bite of hematophagous insects called “€œvinchucas”€. Likewise, there is evidence in the region of transmission through the intake of contaminated food and drinks. 2 

There are three forms of transmission that are not related to any geographical area, namely: through transfusions, organ transplantation, and congenitally (mother to child). The first two are currently not frequent due to the presence of strict controls at blood banks. However, the congenital form (mother to child) constitutes a serious problem since it is the main form of transmission of the disease in non-endemic areas. As a result of migrations, women infected spread the infection to other areas congenitally, and what is even more worrying is that it is the least perceptible form to perpetuate the disease. 36        

In the most usual forms of transmission, which are vector-borne and congenital, children are the most exposed, which makes CD a relevant pediatric issue for the countries in the region. 7-8   For this reason, the aim of this document is to present the results of a pilot program for detection and treatment of people affected by CD, especially school children and pregnant women in a semi-rural non-endemic area of the Buenos Aires province so as to assess the need to expand the test to cover all the district with a program with characteristics that are similar to those developed at the pilot trial, and, at the same time,  analyze the operating capacity of the Primary Health Care Centers (CAPS) for this pathology.

Current State of Chagas Disease

Chagas Disease is characteristic of Latin America and according to recent PAHO estimates, in the Americas there are approximately 100 million people at risk, over 8 million people infected and approximately 56,000 new cases every year, who become infected through different forms of transmission. Around 12,000 people die of Chagas disease annually. 9

In Argentina, a prevalence rate at 4.1 is estimated for the general population, with over 1,600,000 infected people and variable regional percentages. The population exposed in endemic areas amounts to 7,300,000 people. 10-11    

Even though significant progress has been made regarding control of vector transmission in the Americas, the lack of actions prolonged along time, aimed at eradicating Chagas disease from the endemic areas, has given rise to a continuous prevalence of this disease, whereas migrant phenomena have been the factor giving rise to its geographical expansion into urban areas, thus becoming a public health concern in nations where vector transmission has not been documented yet. 

The Chagas disease figures available at present show a serious public health problem, although its magnitude is even greater due to the presence of important under-reporting of the number of cases. The reasons lying beneath said under-reporting can be found in the fact that in many places, the disease must not be compulsorily reported, or that only severe cases are reported, even when there are sub-clinical acute cases. Apart from that, since it presents no symptoms, the disease remains unnoticed by the people affected, who consequently do not seek for assistance; besides, detection demands the active search for positive cases, which is not frequent in most of the countries affected.

Justification of the Intervention

Approximately 750, 000 children are annually born in Argentina, 12 figure that makes us infer that the health system each year hosts between 34,000 and 45,000 pregnant women infected by Tripanosoma cruzi (according to estimated prevalence rates) and from 1,700 to 2,200 newborns with congenital Chagas disease.13  Currently, only 30% of these cases are diagnosed, which means that there will be thousands of children that will develop the disease during adulthood and, if they are girls, they will be likely to continue transmitting the infection to their own children if not timely treated. 

Unfortunately, if diagnosis is made during pregnancy, the mother cannot be treated since the drugs available are contraindicated during the gestation period. Neither is there any efficient way to perform diagnosis of fetal infection during the intrauterine period, so the most adequate procedure at this stage consists of early diagnosis of newborns followed by specific treatment with beznidazole or nifurtimox, the only two drugs currently available for treatment of the disease. 14

Early detection of positive cases does not only bring about social and health benefits, but also economic ones. 

Care of People Affected

Certainly, there are many reasons that can justify why this pathology had for so long been part of the list of neglected diseases. Without trying to go deeply into each of them, we will try to describe those that, to our belief, can explain most of the veil of neglect that covered Chagas disease for so long.

During the 70s, 80s and part of the 90s, Chagas disease occupied a limited space in physicians’€™ training curricula -€”pre-graduate reference books, mainly American and Spanish, did not develop the issue extensively- €”and specific treatments, particularly in the chronic phase, were challenged. All these factors together triggered a clear delay in diagnosis and treatment of the people affected, most of whom were under-diagnosed and/or disheartened to follow parasiticide treatments. 

The lack of training and information of health teams could have had an influence on some of the behaviors observed such as that of considering Chagas a disease related to rurality and with no effective treatment, which discourages the implementation of mechanisms tending to start actions for primary, secondary and even tertiary prevention of the disease. 

Devoting the health space to the exclusive care of the complications brought about by Chagas disease is to condemn many individuals to miss the opportunity to have timely treatment and lead a plentiful life. 

The lack of symptoms for several years and even decades demands a proactive health system that can find outside the hospital sphere -€”the paradigm of the environment where the process health-disease takes place- €”those people who do not have the need to seek medical consultation. It is for that reason that it is necessary to implement epidemiological research as well as training and updating activities intended for the members of the primary health care teams, who are the access to the health care system, both strategies with different degrees of implementation. 

The characteristics of the Argentine health system could also have had a negative influence on the comprehensive health care sometimes demanded by these patients, since there are multiple administrative areas that coexist in the same territory (provincial hospital-municipal CAPS and national institutions) which are not always integrated. 

Relegating Chagas disease patients to exclusive treatment at the third level of care in order to receive treatment by specialist’€™s means, in many cases, imposing a barrier to access to the system since said treatment, for multiple reasons, is hard to be provided to people who have low resources and live in distant geographic regions. 

Currently, there is consensus regarding the fact that patients with this disease can and must be followed at the first level of care, leaving the levels of increasing complexity to those who show moderate and/or severe complications. The present work offers a strategy (pilot trial), among many likely ones, to start these actions. 15-16    


In order to develop intervention models, the principles of stability, sustainability, scalability and replicability are taken into account. This means that our projects are permanent and sustainable along time, which means that they can be started in a reduced geographic area or with a small group of people (depending on the approach) so that once tested, they can be improved, expanded and replicated in another area or in other groups.

The first step is to perform a diagnosis of the situation that shows the state of affairs, then design and plan the most adequate type of intervention in this case, create strategic partnerships and working teams, manage the project with the local actors (community participation is key to the successful achievement of the projects) and finally, the processes and results are assessed and the necessary adjustments made. 

In this pilot trial, a program for public health intervention was designed to perform diagnosis of Chagas disease on a school population in certain areas of La Plata district, Buenos Aires province. In order to detect positive Chagas Disease cases in an infant population and start timely treatment, the choice of the school environment as a recommended geographic area to develop these actions seems adequate, due to, among other reasons, the high level of schooling usually presented by the first level of education and the lower need of time and resources posed by this option. Likewise, the Primary Health Care Centers were used as the environment for detection, diagnosis and treatment of congenital Chagas disease, especially to attract the group of pregnant women there.

Selection of the area of intervention

The choice of province and area of work were based on the analysis of relevant variables to identify the population at potential risk and in terms of opportunity and access. 

The analysis of the relevant variables consisted in surveying data produced by the Populational Censuses, the Permanent Household Survey (EPH after its name in Spanish) and the General Directorate of Migrations in relation to the 2004-2012 series of settlements issued by the National Directorate of Migrations and the analysis of domestic migrations on 2001 census data.  The 24 regions of the Greater Buenos Aires area first, and then the Autonomous City of Buenos Aires are coincidentally presented there as the greatest jurisdictions that welcome domestic and foreign migrants coming from regions where CD is a public health issue (Bolivia, Paraguay, etc.). 17-18 

Graph 1. Relevant variables used for selecting the intervention area

1Lenardon 1BIsLenardon

Source: Own elaboration based on the National Directorate of Migrations (2004-2012)

Given that the overall surface of the Buenos Aires province is over 300,000 km2, delimiting a geographic area was key to start the activities. To that aim, special attention was put on the following:

1. Data provided by professionals of the Urban and Rural Zoonosis Directorate of Buenos Aires province

2. The domiciles of the 181 women with positive serology for Chagas, who had given birth during the month of September 2008 and who were surveyed for perinatal risk factors as carried out by the Directorate of Maternity and Infancy of the Ministry of Health of the Buenos Aires province 19 and

3. Criteria of opportunity such as the willingness of the different districts to perform the assessment, distance to urban centers and health equipment and infrastructure available.

Finally, an area of land intervention in La Plata city, encompassing 190 km2, as well as an area for sanitary work encompassing 20 km2 were delimited.

Development of the Pilot Trial

The target population was selected pursuant to Section 4 of Law 26,281 -€”the new Law on Chagas Disease passed in 2007- €”which prioritizes school-age children and pregnant women and their children. 

In order to carry out the activities of the pilot trial, a framework agreement was signed between the participating parties, the Secretariat of Health and Social Medicine of the Municipality of La Plata and Mundo Sano Foundation, and plans were made to perform interventions in the three schools located in semi-rural areas, and in three CAPS in their vicinity. 

This first trial made it possible to establish a connection between the teams of professionals, the school community and the parents of the children attending those schools, as well as to test the design of the work. To that aim, a risk survey was outlined and delivered onto the school institutions, which evaluated the risk to suffer the disease as a consequence of the location where the mother and child had been born, of the blood transfusions received, and the positive serology for Chagas disease tested during pregnancy. All the variables were given the same relevance so as to determine the potential risk.

The scheme of activities contemplated the following steps: 

1. Request an authorization to school supervisors and, once obtained, hold a meeting with the school authorities and teachers to explain to them the relevance of the work carried out, as well as the requisites needed to have said work accomplished,

2. Organize informative meetings with parents to explain the reach of the disease and the importance of early detection,

3. Deliver a risk survey and informed consents, 

4. Assess the results,

5. Make appointments to see the children detected at risk and have their venous blood samples taken,

6. Refer the samples to the central laboratory to have them processed,

7. Make individual appointments with the parents of children with positive serological tests to explain to them the consequences of CD, inform them that the treatment is free of charge and introduce them to the health professional that will do a follow-up of the patient at the CAPS

8. Likewise, the need to assess other next of kin of those affected is communicated to them, and if they result positive, the same treatment and follow-up process will be carried out.

Once the pilot trial is finished, the necessary adjustments were made and work continued at other schools located on the perimeter mentioned, incorporating the survey and informed consent to the Program of Health at Schools (Programa de Sanidad Escolar-€”PROSANE), in force in the district.

At the same time, routine and systematic inclusion of Chagas disease serology was reinforced for all pregnant women at the CAPS, and members of the health team were trained in Chagas disease diagnosis and treatment. Likewise, women who resulted positive in their serology were called to be controlled and treated after delivery; family planning counseling was provided before starting parisiticide treatment; all the children whose mothers were serologically positive were called to be tested; Chagas patients were performed complete check-ups and medical records were drawn; parasiticide treatment was prescribed for those patients that needed it, and informative meetings on Chagas Disease were held at the CAPS.

Both children older than 10 months of age and women of childbearing age were diagnosed by means of two serological determinations in venous blood: ELISA and HAI (indirect hemagglutination) and assessed prior to the beginning of treatment with hemogram, transaminase and urea.

All patients were administered 5 mg/kg/day of benznidazole, 400 mg maximum a day. At the beginning of the treatment, a pillbox with the two doses needed to complete the weekly treatment, a follow-up sheet to tick the dose taken, instructions with sanitary and diet tips to follow during treatment, details of the likely presence of adverse effects and what to do when said events take place were provided to the patients. In the case of those patients whose domicile was located far from the health care center and/or those who presented with previous allergy backgrounds were prescribed anthihistaminics, with the indication of the doses to be taken if necessary before attending the health care center for evaluation and control.

All patients were called for weekly appointments during the first month for supervision of the drug taken and to have it replaced, and to detect likely adverse effects as well. During the second month the interviews were made fortnightly. The design contemplated active domicile search on the part of the health agents and/or social workers of the patients that did not attend the appointment with the physician. Patients older than 21 years of age with no demonstrated pathology or incipient cardiopathy were given information on the levels of evidence and recommendation on how to receive treatment, as well as the results of preliminary studies regarding the benefits of the parasitic drug on reduction of the progression of the disease, so that they could opt whether to be treated or not. 20-21    

In the case of people older than 50 years of age, such as the national standards in force state, it was decided not to start any treatment as a result of the lack of evidence of therapeutical effects and a greater likelihood to present complications with the specific medication.


During the development of the pilot trial, until late 2013, a populational group considered at potential high risk of infection was assessed. Said group was constituted by 456 people: 129 children -€”between 2 and 15 years of age- €”and 329 adults. Of them, 181 presented positive serology for CD and received treatment.

The number of people diagnosed and treated increased at an annual rate as the working methodology was consolidated. This evolution can be observed in the graph, where, between the years 2011 and 2012 it rose by 25%, and for the year 2013 the annual rise regarding the previous year was 82%.


Source: Own elaboration

Most of the people diagnosed and treated were adult women who accounted for 78% of the total figure (144 women), 10% corresponded to adult men (18 men), and the children younger than 15 years of age were 12% with a similar distribution by sex. 

The preponderance of females over males can be accounted for by the working methodology used, where focus was made on the survey on pregnant women, with gynecologists and obstetricians being in charge of diagnosis and therapeutic treatment.

Regarding treatment, all the patients opted to receive the parasiticide medication and none of them failed to have the controls made. Only three people older than 40 years of age (1.5%) had to interrupt the treatment since on two occasions they were undergoing a pruritic maculopapular rash that was quickly reversed with antihistaminics. They accomplished less than 30 days of medication treatment. These episodes took place at the beginning of the program of activities. In later years, only 35 patients (19.33%) presented with minor or moderate skin reactions that quickly reversed and did not represent a cause for interruption of the medication treatment. 

No person under treatment did present severe skin reactions that demanded referral to higher complexity health centers and/or admission to hospital, neither did they present any of the other likely complications described. 

All the people older than 15 years of age (160) were requested to have an ECG and cardiology control made. A total figure of forty-two (26.26%) people did not have these tests performed since they said they could not attend due to work commitments and since they lived in remote areas.

Limitations and Lessons Learned

The pilot trial became highly relevant in order to establish adjustments to the initial project. Both the risk survey and the informed consent revealed the need to incorporate to the final design complementary actions to be implemented due to the finding of a high number of parents with low levels of education. 

Schools became the proper place to capture a high number of school-children in the short term and to guide parents; however, access to these facilities demanded strong articulation efforts beforehand. 

Given the reach that prevention can have in this environment, it is important to re-think and strengthen the necessary bond between health and education areas to make prevention smoother.

Design in the sanitary environment contemplated a working modality that would prevent patients from being unnecessarily referred to the greater urban centers, given the distance to and from there and the difficulty in having regular public transport available. In order to do this, it was necessary to join the efforts of an important number of professionals (nurses, biochemists, obstetricians, pediatricians, health agents, social workers, midwives, social communicators, drivers and staff), whose commitment and dedication grew as time went by, driven by the results obtained. 

When the CAPS’s resolution capacity was exceeded, patients were referred to levels of greater complexity, though attendance there was lower than that to the CAPS. One example of this was a cardiology consultation made, which had to be referred to greater complexity levels since there was no electrocardiograph and/or cardiologist available at the first level of care. The following are some of the reasons that account for a smaller attendance to other centers: distance, lack of public transport, and the type of daily job that leave workers little margin of free time to make consultations. It is also worth mentioning that in many health centers that are not integrated into this project, patients were given contradictory messages on the need to carry out parasitic idée treatment, or the practices they had been requested at the CAPS were rejected. It is for those reasons that, in many cases, patients opted not to continue demanding for treatment. 

The therapeutically strategy established -€”similar to DOT, directly observed therapy- €”enabled health teams and patients to have an important tool available when they needed to make early supervision, detection and treatment of outcomes of adverse reactions. When these appeared, they were minor or moderate and ceased with oral antihistaminic medication.

While this project was being implemented, benznidazole production and supply were interrupted, which obviously delayed both the development of the project and the speed to capture and treat patients, facts that were reversed when supply was re-started.

Initially, and resulting from the methodology for patient selection, the adult population was exclusively female. During the last year, some men started to make spontaneous consultations to be diagnosed and treated, although the figure is low in relation to women’s. 

While training the health teams, it was observed that even though Chagas disease is well known, the therapeutic experience is null and the initial fears of the apparent adverse effects caused by the drugs are relatively high. The strategies adopted (directly observed treatment, the possibility of permanent telephone communication of the physician in charge of the treatment with national specialist on the issue, and the availability of the drugs to control likely complications) were important at the beginning until the team achieved therapeutic experience. It is highly probable that allocation of more teaching hours devoted to diagnosis and treatment of Chagas disease within physicians’ training curricula will help generate greater commitment on the part of the health teams to these issues.


Being able to diagnose and treat newborns and children, as well as women at childbearing age when they have not shown any manifestations of the disease yet should be a priority within the health environments, especially for those in charge of health policy making and management, considering the results of said actions and their cost-benefit.

This work makes it possible to observe how active policies and an adequate epidemiological assessment can generate important findings in a relatively small and unthought-of area, and deploy prevention and cure actions.

It also expresses clearly the need to strengthen the first level of care to face this issue and the need to generate patient-centered models of management of chronic pathologies that can help overcome the barriers to access to a health system, usually suffered by the people affected who live in remote areas.


The authors would like to thank Dr. Héctor Freilij for the training offered to our professionals, his valuable contributions, and the enthusiasm he transmitted carrying out his work; and Dr. Gustavo Mari­n for having driven us to start the activities in the La Plata district



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6– Kirchhoff, Louis V. ; Pearson, Richard D (2007): “€œThe emergence of Chagas disease in the United States and Canada”€, Current Infectious Disease Reports, Vol. 9,Nº5, Sep 2007.

7– Altcheh J (2013): Enfermedad de Chagas en la Infancia. Presented at the Discussion Workshop “€œChagas: enfermedad atendida”€ (Chagas: a disease cared for) Fundacion Mundo Sano, Buenos Aires, 3 June 2013.

8– Zaidenberg, M (2009) “€œChagas en ninos. El desafi­o de los ultimos tiempos”€ (Chagas in children. The Challenger of recent times€) presented at the 12th International Symposium of Epidemiological Control of vector-borne diseases. Fundacion Mundo Sano, Buenos Aires, 4 September, 2009.

9– PAHO Webpage

10-PAHO (2006): “€œEstimacion cuantitativa de la enfermedad de Chagas en las Americas”€. Montevideo, Uruguay. OPS/HDM/CD/425-06; 2006. p. 1-28.

11-PAHO- Mundo Sano (2007): La enfermedad de Chagas a la puerta de los 100 anos del conocimiento de una endemia americana ancestral. OPS/CD/426-06 Mundo Sano. July 2007. Argentina

12-2011 Vital Statistics. Directorate of Health Statistics and Information. Ministerio de Salud de la Nacion. Available at

13-Chuit, R, Segura, EL (2012). “€œEl control de la enfermedad de Chagas en Argentina. Sus resultados”€. Rev. Fed. Arg. Cardiol 2012;41(3):151-155  

14-Ministerio de Salud de la Nacion (2010). Gui­a de diagnostico y tratamiento. Informacion para los equipos de salud. Direccion de Epidemiologi­a. Programa Nacional de Chagas. Available at

15-OPS (2012) II Reunion Sudamericana de Iniciativas Subregionales de Prevencion, Control y Atencion de la Enfermedad de Chagas. OPS, August 2012.

16-Ministerio de Salud de la Nacion (2010). Gui­a de diagnostico y tratamiento. Informacion para los equipos de salud. Direccion de Epidemiologi­a. Programa Nacional de Chagas. Available at

17-Estadi­sticas. Direccion Nacional de Migraciones Ministerio del Interior y Transporte

18-Pizzolitto, G; Porto, A; (2006): “€œDistribucion de la poblacion y migraciones internas en Argentina: sus determinantes individuales y regionales”€. Universidad Nacional de La Plata; Facultad de Ciencia Economicas. December 2006

19-“€œEncuesta Perinatal 2008: Resultados en Hospitales Publicos de la Provincia de Buenos Aires y Ciudad Autonoma de Buenos Aires.” Page 66. Available at

20-Sosa Estani, S; Segura, E; Colantonio, L (2012): “€œTherapy of Chagas Disease: Implications for Levels of Prevention”€. J Trop Med. 2012; 2012: 292138

21-Viotti, R; Vigliano, C; Lococo, B; Bertocchi, G; Petti, M; Alvarez, MG; Postan, M; and Armenti, A (2006): “€œLong-Term Cardiac Outcomes of Treating Chronic Chagas Disease with Benznidazole versus No Treatment A Nonrandomized Trial”€ ;Ann Intern Med. 2006;144:724-734.

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Latest News Links is part of the research project GESPAM (Geopolitica, Salute Pubblica e Accesso alle Medicine/Geopolitics, Public Health and Access to Medicines), which aims to focus on real-time news and the best options for use of trade and government rules related to public health by resource-limited countries


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