Could HIV be the Youngest Disease to be Eliminated? The Experience of Ethiopia

Excellent partnership between the government, key stakeholders, and the community has helped Ethiopia rise to the tectonic challenge of HIV. Since 1990, more than 90% reduction in new HIV infection has been recorded. Survival of HIV-positive individuals has substantially improved. At present, about 70% of HIV-positive people in the country know their status and 65% are on treatment

Taye Balcha

by Taye Tolera Balcha, MD, MPH, PhD

Director General, Armauer Hansen Institute (AHRI)

Could HIV be the Youngest Disease to be Eliminated? The Experience of Ethiopia

 

About 100 million people live in Ethiopia. Of these, three-quarters of a million are HIV-positive. National HIV prevalence among pregnant women showed significant decline, from 5.3% in 2005 to less than 1% today. Implementation of combination of interventions at community and health facility levels is the driving force for this unprecedented drop. Even now, there is a wide variation in HIV prevalence between different geographies and population groups in the country. Regions like Gambella and population groups including female sex workers have substantially higher rate of the disease than the rest of the regions and population groups in the country, respectively. Further, some diseases are traditionally used as surrogate markers of HIV infection. About 10% of tuberculosis patients nationwide, for instance, are HIV-positive. While the major behavioral driver of the epidemic is unsafe sexual practice, young women and girls are excessively affected.

What worked well in Ethiopia?

A combination of tailored HIV prevention strategies were implemented among diverse population groups. Early on, regular sessions of community conversations were conducted at each village in the country. The core messages in the late 90s and early 2000s were HIV prevention, voluntary counseling and testing, and fighting stigma and discrimination among positives. As treatment was practically out of reach, clinicians were able to treat only few opportunistic infections as the disease progresses ensuing mostly death.

Concurrent with major global advances in the field of HIV, however, HIV messages in Ethiopia showed significant evolution. The Health Extension Workers (HEWs), anchored within each community since 2004, repurposed the messages adding the newfound benefits of getting tested and linkage to care and treatment for positives. This was a monumental development in the field which turned HIV from a capital punishment to a chronic disease. It not only dented the upward spiral of the pandemic, but assured citizens that HIV was no more considered a national anxiety.

While the development of HIV treatment was a game changer in its own right, we are far from ending AIDS for good. Recently, an organized community movement, Health Development Army (HDA), took charge of their own health, fighting public health threats including HIV. Several communities in the country established Community Care Coalition (CCC) as a mechanism for nutritional and other support for HIV-positive members of their communities. CCC is a component of broader Solidarity Fund established by HDAs aiming at covering everyone in the community with available health and related interventions.

Since community systems are not robust in urban settings, health facilities play crucial role in HIV prevention and early care and treatment. Also, the roles of HIV-positive individuals and associations in HIV prevention, care and treatment is much more amplified in urban settings. Matching an accelerated industrialization, development projects are heavily engaged in HIV prevention and treatment efforts targeting their workforce. In this regard, a dynamic partnership between the health sector and an array of sectors engaged in development has been proved vital to intercept HIV transmission and provide treatment for positives, and as a consequence minimize productivity loss due to the disease.

HIV care and treatment

Like several other low-income countries, Ethiopia scaled up antiretroviral treatment (ART) in 2005. In 2006, the access to treatment was further expanded involving hundreds of health centres mainly staffed by non-physician clinicians. Concurrently, Ethiopia rolled out coordination and networking mechanisms for HIV treatment monitoring laboratory facilities to track disease progression and response to treatment. Free diagnosis and treatment of all HIV-associated conditions was included in the essential health service package of the country to ensure unhindered access to comprehensive services to everyone in need.

To maximize healthy and productive retention in care and treatment, the health sector established sustained partnership with HIV-positive individuals and associations. Associations of HIV-positive individuals have been in charge of treatment adherence counseling, early tracing and encouraging re-engagement into care and treatment in cases of loss to follow up. Similar efforts have been made to bridge the chasm in recommendations by modern providers and religious platforms and traditional healers. The health sector has been effective in convincing major religions in the country that medical and spiritual treatments are not incompatible. The case of co-administering HIV medicines and Holy Water is seen as one of the most successful strategies for treatment adherence and retention in care in the country. Holy Water is considered ‘a cure for major diseases’ among followers of the major religious denomination in Ethiopia.

Achievements to date and new initiatives

Since 1990, more than 90% reduction in new HIV infection has been recorded. Survival of HIV-positive individuals has substantially improved. At present, about 70% of HIV-positive people in the country know their status and 65% are on treatment. Globally, 60% of HIV-positive individuals know their status and 46% of positives receive treatment.

The UNAIDS three 90s (identifying 90% of HIV-positives, linking 90% of the positives to treatment and viral suppression in 90% of those on treatment) by 2020 and the global commitment to end AIDS by 2030 has spurred the progress. Coherent with these global commitments, there are several revitalization efforts dealing with both prevention and treatment. With determined focus to end AIDS as public health threat in 2030, the health sector has intensified inter-sectoral collaboration, mayoral forums and expanded media campaign.  In partnership with key stakeholders, the Ministry of Health recently launched HIV Catch up Campaign to accelerate testing the right people and link all positives to treatment. A total of 178 towns and cities have been selected for targeted testing and treatment strategies including rights-based partnership with index cases.

Other potentially game changing initiatives include instituting regular surveillance targeting workforce of large development projects to tailor prevention efforts, to understand active transmission dynamics and promote early and sustained treatment for positives. Ethiopia has also adopted the new paradigm of treating all HIV-positive people. Further, a new national compassionate and respectful care initiative will minimize stigma and discrimination and boost retention on treatment.

Conclusion

Excellent partnership between the government, key stakeholders particularly the US President’s Emergency Plan for AIDS Relief and the Global Fund, and the community has helped the country rise to the tectonic challenge of HIV. The Ethiopian experience shows that we have to accelerate our efforts to end AIDS for good. Although we might be far from new discoveries like HIV vaccine or cure, it is possible that the battle against AIDS could be won using the weapons we have. It is also possible that HIV could be the youngest disease to be eliminated in the history of humankind.

 

 

Kenya in a Bad Shape about Open Defecation Free Goal

Even though the national law establishes the right to “reasonable standards of sanitation”, some Kenyan people are denied them. Especially in rural areas, the worst-off people face poor living conditions due to open defecation. The Government is implementing a four year strategy to fight against this scourge, but corruption, misappropriation and mismanagement risk to frustrate the efforts

Pietro_picture-150x150

by Pietro Dionisio

Degree in Political Science, International Relations

Cesare Alfieri School, University of Florence, Italy

Kenya in a Bad Shape about Open Defecation Free Goal

 

The Kenyan Constitution Article 43 (b) declares sanitation as a basic human right and guarantees the right of every person to “reasonable standards of sanitation.”

Despite the law, open defecation is an issue in the Country, where almost 50% of rural people still lack access to basic sanitation. Admittedly, access to sanitation has shown only a slight increase from  1990 (25%) to 2013 (32%). To make things even worse, most facilities (72%) only consist of pit latrines providing insufficient levels of safety, hygiene and privacy.

People cannot bear that situation any longer. What’s more, this context has a huge economic impact since Kenya loses KES 57 billion annually due to poor sanitation.

It has been estimated that in the Country an average 14% of total population usually practice open defecation, though the real rate could be higher.Relevantly, there are massive inequalities among counties. While in some of them the rate is about 75% of local population, in Turkana county it peaks beyond 82%.

Typically, open defecation is bound up with poverty:  more than 60% of the poorest wealth quintile practice it as against less than 1% in the wealthiest quintiles. As such, it comes as no surprise that access to sanitation facilities is higher in the lower poverty gap index counties, as compared with those counties with a higher poverty gap index.

These circumstances entail deep consequences on people’s (especially children) health. As such, it is not by chance that 35% of children in Kenya suffer from moderate to severe stunting. Childhood stunting, which can affect both educational and long-term productivity outcomes, has been linked, in fact, to poor sanitation and open defecation. Not to mention that, as a consequence of the lack of access to water and sanitation, diarrhea is second to pneumonia as a cause of death in children under five.

Adding to the burden of sickness and death, inadequate sanitation threatens to contaminate Kenya’s water sources and undermine human dignity. Access to safe water supplies throughout Kenya is only 59% currently. And while rural areas are those more plagued, cities are not performing much better. In fact, rapid urbanization has not been followed by a parallel growth of water and sanitation services. Some 15 million city dwellers lack access to a piped water supply or sanitation services, and this number continues to rise. In poor urban zones, less than 20% of the population have access to sanitation, and 80% of facilities are shallow pit latrines that add to the environment pollution while coupling with only 12% estimated sewerage coverage and a barely 5% effectively treated national sewerage.

Against this backdrop, the Kenyan Government just implemented the National Open Defecation Free Kenya 2020 Campaign Framework 2016-2020 as an attempt to make the Country open defecation free by 2020 and achieve the Sustainable Development Goal (SDG) N. 6.

So compounded, the Campaign aligns with the “Kenya Environmental Sanitation and Hygiene Policy (KESHP)2016-2030” and the “Kenya Environmental Sanitation and Hygiene Strategic Framework (KESSF) 2016-2020” respectively.

The overall campaign goal is to eradicate open defecation and declare all counties and Kenya Open Defecation Free by the end of 2020. The specific objectives of the campaign are to:

  • Develop capacities of key Community-Led Total Sanitation (CLTS) stakeholders in all 47 counties by 2017.
  • Develop an effective Planning, Monitoring Evaluation and Research Unit (PM&ER) system for more effective evidence-based approaches to the campaign targets.
  • Mobilize partners and the media to support the campaign goals.
  • Facilitate and assist county governments in achieving their respective Open Defecation Free sub counties, wards and villages targets.
  • Engage and enable the private sector to respond effectively to the demand created for sanitation materials and products.
  • Mobilize and allocate adequate resources to enable county governments to achieve their Open Defecation Free sub counties, wards and villages targets.

To implement the “National Open Defecation Free Kenya 2020 Campaign” over the next four years, both national and county governments will require a large outlay of financial resources. The overall investment required over the next four years (2016/17-2019/20) to achieve 100% Open Defecation Free by 2020 across all the 47 counties in Kenya is estimated at KES 41.6 billion. Because of limited resources, earmarking of money should align as much as possible with the national and counties’ priorities. As such, an efficient monitoring and evaluation system should be put in place to improve the already working one.

Relevantly, it is fundamental to concretely fight against corruption and misappropriation. In the  Transparency International’s 2015 Corruption Perception Index, Kenya was listed as one of the world’s most corrupt countries, ranking 139 out of 168.

The strategy set in motion by the Kenyan government is deeply based on funding from international agencies and organizations including, among others, the World Bank, UNICEF, and AMREF. The Government should consider these funds as a starting point and use them just to implement the strategy and make it sustainable in the long run. Unfortunately, it looks like this wouldn’t be the case due to corruption, misappropriation, and mismanagement, among other bad habits.

These habits should be given up in order not to lose an opportunity to improve sanitation and make the Country free from open defecation. It makes no matter should that happen in 2020 or later, provided a step by step, policy by policy gradual improvement becomes visible. Not for money or as a clue for developed countries that their money is spent well, but for Kenyan people deserving wealthy living conditions.

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Advocacy for Health and Social Justice Works: the Case of the Transatlantic Trade and Investment Partnership (TTIP)

The recognition that the TTIP prioritized the “right to profit” of transnational corporations over the “right to health” of citizens deeply affected people’s sense of justice. It is exactly for this reason that it triggered such widespread civic protest that has been decisive in stopping the fast-track approval of the TTIP 

 signed_roberto_de-vogli

 by Roberto De Vogli*, PhD, MPH1 2 3

1 Department of Public Health Sciences, School of Medicine, University of California, Davis, US

2 Department of Epidemiology and Public Health, Division of Population Health, University College London, London, UK

3 Department of Psychology, University of Padova, Padova, Italy

Advocacy for Health and Social Justice Works: the Case of the Transatlantic Trade and Investment Partnership (TTIP)

 

The Transatlantic Trade and Investment Partnership (TTIP) is a moribund treaty. The largest ever free trade agreement, designed to influence countries that account for 50% of global Gross Domestic Product (GDP) (1), has received a series of lethal blows from a critical mass of organised civic society organisations and advocates. The agreement may not be dead yet, but it is severely wounded. It was supposed to be signed this year, but France, through its Minister for Foreign Trade, Matthias Fekl, has already demanded an end to TTIP talks (2). Without the French support, the deal is not going very far, actually nowhere; and the chances that it will be approved in the future are rather slim.

But make no mistake: major lobbyists of the TTIP, such as those large transnational corporations (TNCs) that have proposed the treaty to the EU and USA, will not concede an easy defeat. In fact, they are already working hard to find new ways to move the trade agenda forward. For example, another treaty, similarly dangerous for our health, has been recently approved: the Comprehensive Economic and Trade Agreement, or CETA (3) Yet, there is little doubt that the political efforts of protest movements have been decisive in stopping the fast-track approval of the TTIP. Civic society made a difference and, to some extent, the protest against the treaty has already partially succeeded.

What caused this preliminary success? What accounts for incapability of the EU and US to approve the TTIP on time? Not many years ago, the first acts of protests against the TTIP were largely ignored. The early pioneers of the campaign were easily dismissed as lunatics, or radicals. Now, only a few have audacity to openly support the treaty. The belief that the TTIP will produce significant economic benefits and that the income generated by the TTIP will trickle down to the general population (4) is not taken very seriously. The public is instead convinced more than ever that the TTIP is a dangerous policy for people’s health. In a recent review of the literature, we showed that the trade deal is likely to have a series of negative health consequences including the underutilization of needed healthcare services and medications especially among vulnerable populations such as low-income communities and people with multiple chronic diseases. In the same review, we also indicated that the TTIP is likely to generate a negative impact on regulations aimed at reducing cigarette smoking, alcohol consumption, diet- and agriculture-related diseases. The treaty is also very dangerous because it can impair international environmental agreements on climate change that has been recognised as the major threat to global health of the century. (5)

The publication of evidence on the potential health effects of the TTIP in academic journals, and the wide dissemination of the same results through social media, newspapers, and other outlets, was certainly important, but not crucial. Very often, scientific evidence is ignored and political decisions are taken on the basis of collective emotions about a topic. What persuaded governments to withdraw support from the TTIP was not the science on its negative impact on health probably. Rather, it was the active involvement of civic society and the massive protests of non-governmental organizations and activists that reduced the political desirability of the trade deal. The relentless advocacy work performed by the alliance of organizations such as those under the ban STOP TTIP European Initiative Against TTIP and CETA (6), the massive demonstrations against the treaty throughout Europe involving up to 250,000 people (7) and the collection of over 3.4 million signatures demanding the abandonment of the treaty were impressive demonstration of people’s power by any standards. (8)

What mobilized the most these protest movements? It is difficult to establish a single cause for there is no quantitative data to rely on. Yet, a plausible culprit seems the widespread recognition of the potential injustices promoted by the TTIP. People are particularly outraged, and for very good reasons, about the TTIP’s Investor to State Dispute Settlement (ISDS) arbitration system, a mechanism that allows TNCs to sue governments when a policy or law reduces the value of their investment. It is especially through the ISDS that the TTIP has finally been recognized for what it is: not a free trade agreement, but an investor protection treaty.

It is no coincidence that the treaty was made in secret and supposed to be approved relatively quickly among closed doors. About 92% of consultation meetings for the TTIP have been carried out with private companies or their representatives with no involvement of civic society. (9) It was only thanks to organizations such as Wikileaks (10) and Greenpeace (11) that we are all aware of the details of the treaty. Clearly, the recognition that the TTIP prioritized the “right to profit” of TNCs over the “right to health” of citizens deeply affected people’s sense of justice. It is exactly for this reason that it triggered such widespread civic protest.

The story of the temporary defeat of the TTIP contributes to our understanding of what needs to be done in order to build effective, successful public health movements. It shows that, in order to mobilize people around health issues, it is key to address their sense of justice and injustice. In a time where there is widespread hopelessness about so many intractable problems, from climate change to rising income inequality, this story provides a ray of hope for the future of public health. Those who do not bother engaging in advocacy work because they feel hopeless and believe that large TNCs are just too powerful to be defeated have been, at least in this case, proven wrong. Indeed, they have been proven wrong multiple times as lessons about success stories in reducing cigarette smoking and car accidents have shown us. This story adds to the literature and shows one more time that public health advocacy works, especially when it addresses problems of social injustice at the same time. (12)

 

References

  1. Transatlantic Trade and Investment Partnership. The Economic Analysis Explained. Brussels: European Commission, Centre for Economic Policy Research, 2013.
  2. https://www.theguardian.com/business/2016/aug/30/france-demands-end-to-ttip-trade-talks-matthias-fekl
  3. http://www.epsu.org/sites/default/files/article/files/Health-social-Services%20in%20CETA-TTIP%20Executive%20summary_2016.04_EN.pdf
  4. Raza W, Grumiller J, Taylor L, Tröster B, von Arnim R. ASSESS TTIP: Assessing the Claimed Benefits of the Transatlantic Trade and Investment Partnership. Final Report. Vienna: Austrian Foundation for Development Research, 2014.
  5. De Vogli R and Renzetti N. The Potential Impact of the Transatlantic Trade and Investment Parternship (TTIP) on Public Health? Epidemiol & Prev 2016;40(2).
  6. https://stop-ttip.org
  7. https://www.theguardian.com/world/2015/oct/10/berlin-anti-ttip-trade-deal-rally-hundreds-thousands-protesters
  8. http://www.independent.co.uk/news/business/ttip-three-million-people-sign-petition-to-scrap-controversial-trade-deal-a6680411.html
  9. Corporate Europe Observatory. Who lobbies most on TTIP? Available: http://corporateeurope.org/international-trade/2014/07/who-lobbies-most-ttip Accessed: February 19, 2014.
  10. Public Citizen. The Trans-Atlantic “Free Trade” Agreement (TAFTA). U.S. and European Corporations’ Latest Venue to Attack Consumer and Environmental Safeguards? 2015.
  11. https://www.theguardian.com/business/2016/may/01/leaked-ttip-documents-cast-doubt-on-eu-us-trade-deal
  12. Gielen A, Green L. The Impact of Policy, Environmental and Educational Interventions: A Synthesis of the Evidence from Two Public Health Success Stories. Health Education & Behavior 2015;42(1S)20S-34S.

 

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*Correspondence to: Roberto De Vogli, Department of Public Health Sciences, School of Medicine, Department of Public Health Sciences, University of California, Davis. One Shields Ave. Med Sci 1-C Build. Davis, CA 95616 email: rdevogli@ucdavis.edu

 

 

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WHO Makes Headway in Hepatitis C Treatment Access Campaign

It is morally mandatory to ensure that lifesaving direct-acting antivirals for hepatitis C treatment become accessible to all those who need them. This requires commitment and coordination by all interested parties to overcome barriers to access

MINOLTA DIGITAL CAMERA

by Daniele Dionisio*

Policies for Equitable Access to Health (PEAH)

WHO Makes Headway in Hepatitis C Treatment Access Campaign

 

A leading cause of liver cancer and cirrhosis, chronic infection by hepatitis C virus (HCV) affects more than 80 million people worldwide, 85% of whom live in low (13%) and middle (72%) income countries. Around 15% of Egypt’s population, for example, is infected – one of the world’s highest prevalence rate – while it is estimated that 12 million people in India have hepatitis C.

Nearly 700 000 people are killed by hepatitis C yearly, where preventive vaccines are lacking.

And this occurs at a time when at least 1.2 million people in Japan and three million Americans suffer from hepatitis C, while the infection is a major European public-health challenge (between 0.4% and 3.5% of the population in different EU Member States), as the most common single cause of liver transplantation.

The field of HCV therapeutics made dramatic headway in 2013 with the introduction of a new class of medicines called direct-acting antivirals (DAAs). By directly blocking essential steps for HCV to replicate, they have shown convincing efficacy, mainly when used in combination (functional cure rates in excess of 90% after 12 week treatment), with a good safety profile.

Now it is morally mandatory to ensure that these lifesaving treatments become accessible to all those who need them. This requires commitment and coordination by all interested parties to overcome barriers to access. Indeed, access to these regimens is a problem of global concern since these drugs were introduced at exorbitant prices making the scale-up of treatments a hard task for healthcare systems throughout the world.

Fortunately, the situation is evolving and a new WHO Global Report on Access to Hepatitis C Treatment: Focus on Overcoming Barriers, released on 27 October 2016 shows how political will, civil society advocacy and pricing negotiations are helping address the scourge of hepatitis C.

As declared …The report provides the information that countries and health authorities need to identify the appropriate HCV treatment, and procure it at affordable prices. The report uses the experience of several pioneering countries to demonstrate how barriers to treatment access can be overcome. It also provides information on the production of new hepatitis C drugs and generic versions worldwide, including where the drugs are registered, where the drugs are patented and where not, and what opportunities countries have under the license agreements that were signed by some companies as well as current pricing of all recommended DAAs, including by generic companies all over the world….

The Report embodies the WHO commitment to make DAAs available at all times, in adequate amounts, and at affordable prices for the health systems and communities. It takes into account that in May 2016, at the World Health Assembly, 194 countries adopted the first-ever Global Health Sector Strategy on Viral Hepatitis, agreeing on the target to treat 80% of people in need by 2030. As such, the Report aligns with the 2016 WHO guidelines recommending the use of DAAs as part of their inclusion on WHO Essential Medicines List in April 2015.

So compounded, the Report follows in the wake of a resolution on hepatitis unanimously adopted by member states at the WHO General Assembly in May 2014. Among other things, the resolution urged member states …(12) to consider, as necessary, national legislative mechanisms for the use of the flexibilities contained in the Agreement on Trade-Related Aspects of Intellectual Property Rights in order to promote access to specific pharmaceutical products;…

The resolution also requested the Director General ….(9) to support Member States with technical assistance in the use of trade-related aspects of intellectual property rights (TRIPS) flexibilities when needed, in accordance with the [WHO] global strategy and plan of action on public health, innovation and intellectual property;…

As the Report maintains, over one million people in low- and middle-income countries have been treated with DAAs to date. This result was achieved by price negotiations and, mostly, competition from generic equivalents through voluntary licensing (VL) agreements (a flexibility provision in WTO’s TRIPS Agreement) for local production. The sharpest price cuts have been registered in countries, including India, home to several competitor firms.

The Report highlights that in 2015, 275 000 people in low- and middle-income countries had benefited from DAA-based hepatitis C regimens. In Egypt, 170 000 people were treated with DAAs in 2015, and 500 000 more people received DAA treatment between January and September 2016. This was made possible as the price for a 28-day supply of one of the DAAs, sofosbuvir, dropped from US$ 300 in 2014 to US$ 51 in 2016.

As treatment is expanded, high quality of supply becomes crucial. Relevantly, the Report stresses that while the WHO prequalified, as of 14 October 2016, the first brand DAA – daclatasvir-, none of the currently rolled out generic DAAs are prequalified or have passed regulatory authority approval. Things should reverse soon, however, since a number of generic and brand products have entered the WHO Prequalification Programme.

Regrettably, though WHO is backed by a number of leading partner organizations worldwide, including the Medicines Patent Pool Initiative and DNDi charity among others, a major concerted effort is needed.

Concern arises from evidence that while the amount of new infections exceeds by far the number of patients enjoying treatment on an annual basis, DAA prices remain very high in most affluent countries. These circumstances have led to treatment rationing, including in the European Union.

To make things even worse, some middle-income countries excluded from generic formulations and VL agreements are still paying extortionate prices. Just for example, the price for a three-month treatment of sofosbuvir and daclatasvir fluctuates from US$9 400 in Brazil to US$79 900 in Romania.

Admittedly, negotiations have ignored many middle-income countries with large populations and disease burden because they were judged by industry to be profitable markets, even though resident people with chronic hepatitis C often come from poor and marginalized communities with little ability to pay for expensive medicines. As reported, Thailand (0.9 million), Brazil (1.9 million) and China (8.9 million), whose markets are home to well-off elites who can afford out-of-pocket spending (at least 800 million people in China), were excluded from VL agreements.

This is without prejudice to the awareness that a number of constraints basically limit the VL model because the originators actually hold control over the whole chain of steps, including narrowing permission for export to the extent that they like. As contended by Médecins Sans Frontières, “…VL agreements often provide generics firms with access only to those markets which a multinational company does not want to or cannot exploit through ”monopolistic” marketing, distribution and sales….”

In the face of this, compulsory licensing (CL), another TRIPS-based flexibility provision, would be a more reliable mechanism for maximizing the affordability by allowing generic companies to produce the patented product, use the patented process without the consent of the patent holder, and sell affordable versions without any limitation by the innovator firms.

To conclude, what else is required against the landscape outlined above to achieve, as envisaged by WHO, “…a world where viral hepatitis transmission is halted and everyone living with viral hepatitis has access to safe, affordable and effective prevention, care and treatment services” ?

Filling the gaps highlighted here is a matter of priority and a way for WHO member states to consolidate the WHO leadership in global health. To this aim, they should secure the Organization more financial support and alignment now that WHO performances, including its Medicines Prequalification Programme, suffer from funding shortages and inadequate collaboration by member governments.

Additionally, non-stop, coordinated pressure by stakeholders, civil society and organizations worldwide is needed to induce industries to perform better in terms of corporate social responsibility, coherence, accountability and transparency.

While helping identify shared priorities, this strategy would avoid overlapping and ensure that innovative medicines for hepatitis C are delivered without restrictions and in a fast, equitable manner.

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*article originally published in Intellectual Property Watch 

http://www.ip-watch.org/2016/11/07/makes-headway-hepatitis-c-treatment-access-campaign/

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 “Medicines 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). Dionisio is Head of the research project PEAH – Policies for Equitable Access to Health. He may be reached at d.dionisio@tiscali.it http://www.peah.it/ https://twitter.com/DanieleDionisio

 

 

 

 

 

 

 

 

 

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The High Level Panel Report: to gather dust or create real change on access to live saving medicines?

The report by the United Nations (UN) High-Level Panel (HLP) on Access to Medicines went public on 14 September. Concerted efforts are now needed for the UN system and member states to adopt and implement the HLP recommendations. Otherwise the report will simply end up gathering dust on some shelves in a UN office

MohgaKamalYanni

by Mohga Kamal-Yanni

Senior Health and HIV Policy Advisor, Oxfam GB

Editor Global Health Check

The High Level Panel Report: to gather dust or create real change on access to live saving medicines?

cross-posting from http://www.globalhealthcheck.org/?p=1923

 

Maid-cleaning-books

There is hardly a day that goes by without some headline about a highly priced medicine that is beyond the means of those who need it. For decades, access to medicines was automatically associated with problems in poor countries. However, it has now become clear that the high price of medicines is crippling healthcare systems everywhere in the world. Patients’ stories from South Africa to Sweden and from Colombia to the UK tell the difficult reality of people’s struggle to get access to life-saving medicines.

For example, the price of effective medicines to treat Hepatitis C can be over $100,000 per patient. The Dutch government’s submission to the High Level Panel states that “We have an estimated 20,000 patients with this disease. Such costs make our healthcare unaffordable. If we continue in this way, it will become nearly impossible to reimburse patients for these medications”.

SOVALDI

The prices of cancer medicines are beyond the reach of many patients who need them especially in developing countries.

donna MOHGA

 

“I was diagnosed with breast cancer in 2013. My insurance refused to cover my Herceptin treatment because of the high price. Now the cancer has spread all over my body. I need Herceptin so that I can live and bring up my two boys”.
“Tobeka Daki from South Africa”

While the high medicine prices is one side of the access problem, the Ebola crisis highlighted the other side: lack of innovation for public health needs. The current global system relies on intellectual property (IP) rules that create monopolies in order for pharmaceutical companies to generate profits and thus to finance research and development (R&D). Where companies see they can make money, they even invent new disease’ names for medical conditions to market their medicines – as in the latest case of opioid-induced constipation. In that case, clinicians who found a way to ease the suffering of the dying got investors to bring a drug to market only when a broader market was identified – the opioid dependence that has reached crisis levels in the United States. But where there is no profit, such as in the case of Ebola, there is no investment from companies.

In December 2015, the UN Secretary General established a High Level Panel (HLP) to “recommend solutions for remedying the policy incoherence between the justifiable rights of inventors, international human rights law, trade rules and public health in the context of health technologies.” The HLP is a unique opportunity to advance access to health technologies for several reasons. The HLP acknowledges the potential conflict of interest between the human right to health and IP rules. Moreover, unlike other initiatives that have tended to focus on neglected diseases, the HLP tackles all health technologies for all diseases in all countries.

The HLP published its report in September 2016, which includes recommendations that represent positive steps to advance access to medicines [1]. On the innovation side, the report recommends that the UN Secretary General start a process for UN member states to negotiate a binding R&D convention that delinks the cost – and hence financing – of R&D from the price of the final product. This is a critically important initiative. The pharmaceutical industry justifies the ever increasing prices of medicines by citing the high cost of their R&D even though all information related to those costs is shrouded in secrecy. The industry also fails to recognize the important role of public financing for R&D. The HLP report calls for increased public financing through domestic resources as well as innovative sources like the financial transaction tax. However, increasing public financing for R&D is not enough unless there are binding agreements for affordable prices of the resulting products.

Nearly all issues related to medicines are shrouded in secrecy. Therefore, it is important that the HLP report recommends transparency of information involving R&D costs, medicine pricing, patent status and clinical trials, as well as negotiation of Free Trade Agreements (FTAs).

On the access side, the report recognises the political and commercial pressures that countries face when they try to use the flexibilities enshrined in the World Trade Organization’s (WTO) Trade Related Aspects on Intellectual Property Rights (TRIPS) Agreement, which allows governments to adopt specific policies to protect public health. Free Trade Agreements (FTAs) include measures that actually restrict governments’ ability to adopt pro-health policies. While the report recommended that countries register any pressure they face at the WTO, and countries to conduct impact assessment on potential effect of FTA measures on access to medicines, it fell short of proposing an immediate ban on excessive IP protections in FTAs.

Unfortunately, the US government and pharmaceutical companies started attacking the report even before it was published. The unholy alliance between rich country governments and the pharmaceutical industry employs extensive resources and pressures to stop the development or promotion of alternatives to the current IP system to finance R&D, which is based on conferring monopoly power to extract the highest profit from the end product. But this system is failing patients around the world. Now is the time for change, for a system that places the human right to health as the determinant of the R&D agenda and enables affordable pricing of products.

Good recommendations require active engagement that leads to action if they are to bring about beneficial change. Concerted efforts are now needed for the UN system and member states to adopt and implement the HLP recommendations. Otherwise the report will simply end up gathering dust on some shelves in a UN office. It is now in the hands of the UN Secretary General to move this process forward. His action would be a valuable parting gift to the world as he leaves office at the end of this year, a critical step toward ensuring access to medicines for all so no one is left behind.

 

[1] These recommendations have limitations, which are explained in the Commentary included in the report’ Annex, by three panel members, including Winnie Byanyima, Executive Director of Oxfam International.

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Related articles:

Access to Medicines Report, green light to action International Health Policies 03/10/2016

Lessons from the Ebola crisis Future Virology (2015) 10(5), 473–476

Alleged R&D Costs: Not a Transparent Driver of Drug Prices Intellectual Property Watch 04/03/2016 

 

 

Domestic Policies for Trade to Uphold the Right to Health

This article turns the spotlight on national policies needed to counterbalance the ominous prospects for health bound up with international trade agreements

MINOLTA DIGITAL CAMERA

by Daniele Dionisio*

Policies for Equitable Access to Health (PEAH)

Domestic  Policies for Trade to Uphold the Right to Health

 

At a time when governments in the most affluent countries are turning their agendas into monopolistic interest-friendly policies, international trade agreements such as TTIP, TPP, CETA and TISA, among others, are incurring criticism for the effects these agreements will have on access to health services for the public health.

These cases represent just the tip of the iceberg of the tactics employed to ensure that developing countries adopt measures  which  go beyond the full extensions they had a right to under the World Trade Organization (WTO) Trade-Related Aspects of Intellectual Property Rights Agreement (TRIPS).

These measures, collectively termed TRIPS-plus, would include making it easier to patent new forms of old medicines that offer no added therapeutic benefit for patients (the so-called ‘ever-greening’); restricting ‘pre-grant opposition’, which allows a patent to be challenged before it is being granted; enforcing intellectual property (IP) beyond what TRIPS requires; allowing customs officials to impound shipments of drugs on mere suspicion of IP infringement, including ‘in 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 preventing drug regulatory authorities from approving new drugs if they might infringe existing patents.

TRIPS-plus measures add to the impending threat of investor state dispute settlement (ISDS) provisions with regards to access to medicines.  Indeed, most currently-being negotiated or finalized trade agreements are feared to introduce ISDS clauses whereby many forms of government regulations, including price cuts of medicines that do not conflict with the TRIPS agreement, could be sued by the patent owners for alleged discriminatory practices.

ISDS risk sectors encompass tariffs on medicines, as would be the case should a country that has agreed to reduce tariffs on an imported product later subsidize home manufacturing of the same medicine. A complaint against this country under an ISDS system 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 ISDS 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.

Against the backdrop mentioned above, which policies should be pursued at a national level to curb the negative public health impact of international trade and investments agreements?  A timely answer entails referring to the recommendations laid down on the 14th of September by the United Nations High Level Panel on Access to Medicines  in their final report. The Panel was established in November 2015 and tasked with reviewing and weighing proposals and making recommendations for ending the misalignment among the right to health, and trade rules and the patent system, as the main barrier to the equitable access to health priorities.

The Panel’s recommendations take place under the UN 2030 Agenda perspective consisting of 17 Sustainable Development Goals (SDGs) and 169 targets. In this scheme, the health goal ranks high as an overarching aim amidst the other 16 SDGs. It includes nine targets: three related to the Millennium Development Goals (MDGs), three to non-communicable diseases and injuries, and three cross-cutting or focusing on systems encompassing universal health coverage, universal access to sexual and reproductive health care services, and also to reduced hazards from air, water and soil pollution. Furthermore, the health goal strictly entwines with a number of the other 16 goals. For example, health is a contributor to (and a beneficiary from) poverty reduction, hunger relief and improved nutrition, safer cities, lower inequality, sustainable consumption, affordable and clean energy, toxic chemicals management, clean water and sanitation, and to the efforts to combat climate change and safeguard aquatic and terrestrial ecosystems as well.

Overall, at a time when the SDGs focus on universal access to medicines and services for different health targets, trade agreements are undermining access to these very medicines. Now, what can be done about it, particularly at the level of national or state governance?

  • Rejecting pressures towards adopting heightened IP rights and strengthened enforcement mechanisms as the keys to foreign investments and innovation. Reportedly, 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 the 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.
  • Banning TRIPS-plus clauses, including ISDS provisions, since they jeopardize the right to health and make inequalities in access to care and treatments even worse.
  • 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 end 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. This would include asking for organizations with potential conflicts of interests and IP perspectives to issue statements eschewing the use of IP law to counter generic medicines.
  • Linking together patent offices and legislators to develop evidence-based reforms of the patent regime of medicines.As contended, If 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….market, 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.
  • Ensuring that governments and leading institutions boost transparency and needs-driven rather than market-driven rules. This would mean giving up closed doors negotiations, while working with health ministries and multi-sector counterparts for decisions affecting national health, growth, employment and budgets.
  • Pushing for country-governments’ leadership to implement a coordinated response to fight corruption, while refraining from being caught with corporate holdings in a circle of mutually reinforcing political and commercial interests over public health concerns.
  • Asking for anti-counterfeit laws and law enforcement policies not to substitute for effective national regulatory provisions.
  • Ensuring that international agreements include clauses whereby donors must strengthen WHO-aligned quality clauses in tender transactions with non-governmental organizations, while purchasers must insist that manufacturers and distributors supply medicines that meet WHO requirements, and governments must authorize export only of products meeting WHO quality, efficacy and safety standards.

 

As arguedAchieving 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

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*article originally published in IHP – International Health Policies 

http://www.internationalhealthpolicies.org/domestic-policies-for-trade-to-uphold-the-right-to-health/ 

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 “Medicines 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). Dionisio is Head of the research project PEAH – Policies for Equitable Access to  Health.

d.dionisio@tiscali.it http://www.peah.it/ https://twitter.com/DanieleDionisio

 

 

 

Breaking News: Link 213

Breaking News Links, as part of the research project PEAH (Policies for Equitable Access to Health), aim to focus on the latest challenges by trade and governments rules to equitable access to health in resource-limited settings

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Breaking News: Link 213

 

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