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.

————————————————————————–

*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

 

 

 

 

 

 

 

 

 

Breaking News: Link 214

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

DSCN1778

Breaking News: Link 214

 

Day One And Beyond: What Trump’s Election Means For The ACA 

Philanthropy in the Age of Trump: Six Predictions 

The 2016 Election Reveals The Differences On Health Care Are Deeper Than Ever 

As America votes, climate delegates hold their breath in Marrakech 

Bridges Special Update #1 | As Paris Agreement Goes Live, Focus Shifts to Implementation 

A Trump presidency may threaten UN funding, climate deal 

Trump victory plunges climate conference into uncertainty 

Climate change solutions for the poorest countries 

Future of food security depends on irrigation methods that adapt to climate change – UN agency 

Amazonians call on leaders to heed link between land rights and climate change 

WIPO Evaluates Its Role in Achieving the Sustainable Development Goals 

What a Big Bank is Doing to Light Up Poor Countries 

People’s Health Movement – North America: Montréal Assembly 15 – 8 – 2016 

Sustainable Development Goals and Global Health Education 

WHO Makes Headway In Hepatitis C Treatment Access Campaign 

Importation of generic hepatitis C therapies: bridging the gap between price and access in high-income countries 

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

Access to Medicines Report, green light to action 

WTO Members Discuss UN High-Level Report On Medicines Access That WHO Declined To Discuss 

Two Generics Companies Apply For First WHO Prequalification Of Novel Antiretroviral 

Which pharmaceutical companies have the most essential medicines and vaccines?

The Lancet: Essential medicines for universal health coverage 

Overcoming challenges to a TB epidemic 

Silence marks Ebola milestone, but scars remain 

How Relevant Is Sexual Transmission of Zika Virus? 

Proposal By WHO To Increase Country Contributions Receives Mixed Reactions 

East African Nations Agree Declaration Promoting Regional Pharma Sector Investment 

Indian Generic Pharma Warns Against Government Caving To US Pressure On Data Exclusivity 

India Patent Office denies patent for prostate cancer drug sold under brand name Xtandi, generic name enzalutamide 

Human Rights Reader 399 

Towards Equity in Service Provision for Gay Men and Other Men Who Have Sex with Men in Repressive Contexts 

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.

——————————————–

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

————————————————————————–

*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

DSCN1778

Breaking News: Link 213

 

WHO: public health round-up 

Margaret Chan attempts one last WHO funding boost  

EU, Canada sign historic trade deal amid protests 

EU signs Canada trade pact, rejects ‘post-truth’ critics 

US doubtful that CETA momentum will speed up TTIP talks 

First Hundred Days for Global Health 

China will need to be more transparent to achieve its development goals 

World Bank appoints Kristalina Georgieva as chief executive 

We need a dose of global collaboration to fight Zika 

Microcephaly in north-east Brazil: a retrospective study on neonates born between 2012 and 2015 

Inequalities in full immunization coverage: trends in low- and middle income countries 

The U.S. Is Standing in the Way of Cheaper Drugs for the Poor 

Public referendum on drug prices in the US: will it bring relief? 

The Cost Of A Cure: Revisiting Medicare Part D And Hepatitis C Drugs 

What Should We Make of a Pharma Giant’s New Plans for Global Health Giving? 

Plenary 2 Of ISPOR 19th Annual European Congress Focuses On Differential Pricing Of Medicines In Europe: Impact on Access, Innovation, and Affordability 

2016 Access to Medicine Index – to be published 14 November 

Global implementation of PrEP as part of combination HIV prevention – Unsolved challenges 

New handbook for dengue outbreak contingency planning 

Dengue Contingency Planning: From Research to Policy and Practice 

Drug-resistant TB rates in west Africa much higher than previously thought 

WHO global database for active TB drug safety monitoring and management

How a cash-strapped UN is struggling to solve the cholera epidemic in Haiti 

As Haiti Struggles to Recover From Disaster (Again), Who’s Helping? 

New York City’s Trans Fat Restrictions Ten Years Later 

Neoliberalism is creating loneliness. That’s what’s wrenching society apart 

Ushering In The New Era Of Health Equity 

Can microloans lift women out of poverty? 

Not good enough: What philanthropy can do to fix social services 

UNPO Newsletter: October 2016 edition 

Investing in Human Resources via Education Is Essential to Improving Access to Surgical and Anesthetic Care Across the Globe 

A Medical Provider’s Perspective on Treating Undocumented U.S. Immigrants 

Research on community-based health workers is needed to achieve the sustainable development goals 

Paris climate pact enters into force, focus shifts to action 

WHO: Ambient air pollution, a global assessment of exposure and burden of disease 

Breaking News: Link 212

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

DSCN1778

Breaking News: Link 212

 

Global Goals can ‘propel us toward a better future for all on a healthy planet,’ Ban says on UN Day 

Ready for a paradigm shift in global health? 

EPWG statement supporting recommendations of the UN High-Level Panel on Access to Medicines report 

Choosing trade over aid 

Domestic Policies for Trade to Uphold the Right to Health 

Canada cautious on CETA deal breakthrough 

Ceta debacle heralds a period of disintegration for the EU 

US, India Trade Ministers Agree List Of IP Enforcement Actions For India, USTR Says 

The role of trade policy reform in advancing the 2030 Agenda 

Histories of medical lobbying 

Social Science Insights To Advance A Culture Of Health 

Human Rights Reader 398 

India’s war on the sex selection drugs linked to stillbirths 

Persons with disabilities must benefit from — and contribute to — development, says UN expert 

6 tips for designing programs to better serve girls 

The FDA’s Controversial Duchenne Drug Approval And The Moral Impulse To Rescue 

The Health Care Payment Learning And Action Network: Supporting Effective Action On Alternative Payment Models 

Between Quick Wins And Long Roads Ahead On Antimicrobial Resistance 

Global report on access to hepatitis C treatment – Focus on overcoming barriers 

Over 1 million treated with highly effective hepatitis C medicines 

Knowledge for Change: webinar series to educate on relevant topics within viral hepatitis 

Gates Foundation shapes investments to ‘accelerate to zero’ on malaria 

47th Union World Conference on Lung Health: Even “free” TB treatment can come with catastrophic costs 

Global health experts call on India for greater efforts to deal with TB  

A water-chilled coolbox gets vaccines on tap to the world’s poorest 

Mosquitos to be infected with bacteria in fight against Zika virus 

Follow the Numbers: A Deep-Pocketed Funder Brings More Data to NGOs in Africa 

Sofia seeks to headquarter European Medicines Agency 

The Guardian view on climate change: good news – but not yet good enough 

Deal struck for world’s biggest marine reserve in Antarctica

Factors Influencing Access to Health Care in South Africa

South Africa has a lot of improvements to make in terms of population’s physical accessibility, financial protection and acceptability of the current public health care system. The National Health Insurance offers hope to the disadvantaged but it will not be ready anytime soon leaving the current health care arrangements with their own vulnerability needing continued revamping. The government may need to stop being reactive but proactive in addressing the inequality that is fuelling the lack of access for a majority of the population

  Plaxcedes

 by Plaxcedes Chiwire

Deputy Director, Strategic Planning Unit (Health Economist) at Western Cape Department of Health, South Africa 

Factors Influencing Access to Health Care in South Africa

                                  

  

Introduction

The World Health Organisation constitution articulates ‘the highest standard attainable standard of health as a fundamental right of every human being’, with the right to health including access to timely, acceptable, and affordable health care of appropriate quality (United Nations High Commissioner for Human Rights; World Health Organisation, 2008). The WHO further state that the right to health is a fundamental part of our human rights and of our understanding of life in dignity. The 1948 Universal Declaration of Human Rights article 25 also mentions health as part of the right to an adequate standard of living (United Nations, 1948). The 1966 International Covenant on Economic, Social and Cultural Rights recognised the right to health as a human right (United Nations High Commissioner for Human Rights, 1996).

Three sections in the South African constitution provide for the right to health care services. These provisions include reproductive health, emergency services, basic health care for children and medical services for detained individuals and prisoners (South African National Constitutional Assembly, 1996).  However, being afforded the right to something does not necessarily translate into getting the service, more so the quality of care. The International Bill of Rights, of which most national constitutions are based on, awards human beings the most incredible freedoms. But on analysis on whether the implementation of these rights has undertaken, most countries fail the test dismally, including the health sectors in most of these countries. Despite some shortcomings South Africa has invested a lot into making sure that these rights are upheld.

The South African legislative framework supports the quest for universal health coverage, or to be less ambitious, that of purely quality health care for all citizens. Universal Health Care is a proponent of the World Health Organisation (WHO), which was the driving force into achieving the Millennium Development Goals (MDGs) by 2015. It has found a place within the expanded agenda of the Sustainable Development Goals (SDGs), the successor to the MDGs, after most nations failed to achieve the MDGs, South Africa included (Statistics South Africa, 2015). Target 3.8 of the SDGs alludes to achieving universal health coverage, with the inclusion of access to quality essential health care services, medicines and vaccines for all. The issue of access is however, silently alluded to in all the SDG 3 goals. Improved access is the key to unlocking any successful implementation, and achievement of the intended outcomes for SDG 3. The WHO describes access to health care as having physical accessibility to health services, financial affordability influenced by the household and the financial systems within the country and acceptability by the patients of the services provided to them (Evans, Hsu, & Boerma, 2013).

Provision of easy access to health care falls short in many aspects. The National Development Plan reiterates that poor implementation of policies is a problem and there is need to hold people accountable and allowing innovation if government is to succeed in any type of service provision (South African Department of the Presidency: National Planning Commission, 2012).  The adoption of National Health Insurance by the South African government is a way forward in advancing universal health care. Several factors should be considered when wanting to attain an equitable access to care. It is not only the health centres that allow for patient access, but interactions amongst a broader socio-economic determinants and outcomes. Examples include demography, health seeking behaviour of individuals, burden of disease, geographical set up of the towns and rural areas, income, education, infrastructure and the economics shifts. Inequality is a major aspect in access to care and is measured mostly using income as proxy.

Population

Statistics South Africa (2016) estimated the 2016 mid-year population to be about 55.9 million, an increase from about 50.6 million in 2011. The public health sector is currently drowning under increased burden of disease and the government acknowledges the need to re-engineer primary health care. Increased migration has also contributed to the overburdened health system. A dissection of the current situation already shows an adult population riddled with a high burden of diseases, namely HIV/AIDs, tuberculosis (TB), non-communicable diseases and injuries (Statistics South Africa, 2016). The ageing of the population noted in some parts of the country also has an impact on disease burden, especially the non-communicable disease which affects the older population.

The HIV/AIDS prevalence of the total population for 2016 was estimated to be 12,7% and18,9% for those aged 15-49. The infant mortality rate for 2016 was projected to be 33,7 per 1 000 live births whilst life expectancy was 59.7 for males and 65.1 for females (Statistics South Africa, 2016).

Equity

If there is to be equitable  quality health care in the country, efficient measures need to be put in place which includes further strengthening of health and wellness promotion programmes as  preventative measures. The number of people on social grants increased from about 2.5 million to about 16.6 million between 1997 and 2015, an increase of 564%. The dependency level is becoming shockingly high and needs to be managed very carefully. The Gini co-efficient, a measure of income inequality, has not changed that much, with a slight increase from 0.6 to 0.679 between 1995 and 2009, then slightly declined to 0.63 in 2010 (World Bank, Development Research Group, 2016). This reflects high levels of inequality which have been attributed on the high unemployment rate i.e. 26.7% ending June 2016 (Statistics South Africa, 2016). Private medical aid caters for only 16% of the population and the rest are the responsibility of the government (South African Department of Health, 2015).

Financing and financial protection

South Africa has been experiencing a low growth in Gross Domestic Product (GDP) since 2015. The government has been forced to seriously consider cost containment measures, asking all departments to cut expenditure for the Medium Term Expenditure Framework (MTEF) period 2016/17 to 2018/19. South Africa’s credit rating as at June 2016 was Baa2 with negative outlook. This is one level above junk status and there is a possibility of a downgrade if the economic growth continues to be 0.1% in 2016 and 1.0% in 2017 as projected by the International Monetary Fund. The government health expenditure/GDP is estimated to be 4.2% and 4.1% for the private/GDP, totalling 8.3% above the required WHO recommendation (South African Department of Health, 2015). The incremental increase in the government’s health budget cannot sustain the substantial demand in health services. However, health outcomes remain poor, characterised by drug stock outs, long waiting hours, lack of cleanliness and safety problems amongst a multitude.

Jumare et al cites Berman (1995) as having concluded that the only way out for middle income countries, South Africa included was to reduce the growth in the health budget and focus on cost containment (Jumare, Ogujiuba, & Stiegler, 2013). This assertion seems to be the status quo for the government as a whole. The strategy was however criticised for being anti-poor and was likely to cause a diversion from neglected groups who so need easy and affordable access to health care. The only way to avoid this pathway is by continued ring-fencing of certain budgets an example being the Conditional Grant for HIV/AIDS, which will allow for free anti-retroviral treatment.

Continued no-fee service for maternal and child health care (MCHC) is another way to ensure consistent access. Gilson and Schneider note the increase in utilisation of services after the introduction of free MCHC and the failure to translate to a reduction in maternal and child mortality rates or increased hospital deliveries (Gilson & Schneider, 2006). The country still grapples with late bookers for Basic Antenatal Care (BANC), which is a risk for increased maternal and antenatal mortality. Free user fees, even for a few services is, however, a catch 22 situation. The numbers of people falling into the debt trap has risen resulting in the portion of the population that could afford medical aid narrowing. There is a possibility the 16% covered in 2015 would be much lower by the end of 2016 owing to the current economic hardships. The National Health Insurance (NHI) white paper (released 10 December 2015) notes the spending by the 83 medical aid schemes to be six times higher than Organisation for Economic Co-operation and Development (OECD).  This means the public sector will have to cater for new clients and this will result in huge service and financial pressures. How then does the government balance their health account without asking the public to pay just a little bit extra?

Increased taxation, debt and general budget support from donors seem to be the only sustainable solution in the long term. With the NHI White Paper currently being commented on, it waits to be seen how the financial arrangements will pan out. Clarity on the provider mechanisms and the role of the provinces in procuring services are not clear. Developed countries have institutions in place managing value-based reimbursement/fee for value structures, a step ahead of value based care/fee for service. Money is a major factor in deciding whether to seek health care or self-medicate. The following section looks at factors influencing these decisions.

Health Seeking Behaviour

Despite the heavy efforts by the national and provincial departments of health to promote access to treatment, individual’s health seeking behaviours is the major factor influencing access to health care. Health seeking behaviours are influenced by education levels, cultural beliefs, gender, financial strain or personal perception of health centres. The health care environment has become more consumer driven and several options of where to seek care are available, making it more important to have personal-centred services in order to attain increased patient satisfaction from the system and continued use of the facilities/services.

A study in the North West provinces refutes this assertion, noting that urban counterparts rated their health much better in comparison to rural counterparts (Van der Hoeven, Kruger, & Greeff, 2012). Both agreed to availability of care though the quality of care was below expected standards, with staff failing to deliver on the patient’s requests. Adequately equipped facilities tend to be a pull factor while the opposite pushes patients away. Continued strengthening of the service delivery platform and quality improvement in the public health sector should take priority, which it currently does if the public perceptions are to be reversed. Operation Phakisa Ideal Clinic is a government initiative meant to ensure all clinics are up to the gold standard. It is an online tool which all clinics are evaluated against different criterion and the information is available to the public.

In the same study, economic circumstances were poorer for rural community members in terms of not only affordability of health care but also transportation money needed to seek treatment (Van der Hoeven, Kruger, & Greeff, 2012). Ultimately, socio-economic factors such as income exacerbate the morbidity and mortality amongst the poor. South African children are 10 times likely to die from diarrhoea if they come from poverty stricken household in comparison to those who are better off (Chola, Michalow, Tugendhaft, & Hofman, 2015).

Traditional healers become the go to doctors. Some are bogus whilst some have their capabilities to treat other ailments. They have been crucial in the fight against HIV/AIDS and TB. The Department of Health (DoH) established the Traditional Healers Bill, to

“provide for a regulatory framework to ensure the efficacy, safety and quality of traditional health care services to provide for the management and control over the registration, training and conduct of practitioners, students and specified categories in the traditional health practitioners profession and to provide for matters connected therewith”. (Ministry of Health, 2003)

MacKian (2014) reiterates the need to design health service delivery strategies in a way sensitive to the local dynamics of the community (MacKian, 2004). The community information systems which are aligned to mostly the Home and Community Based Care (HCBC) platform of the government departments is one way to strengthen the health promotion. Children have been reported to die at home from diarrhoea due to the parent’s lack of knowledge and information on the diseases and what steps to take for treatment (Mulaudzi, Phiri, Mmamakwa, & Mataboge, 2016). The redesign of the HCBC service platform creates the potential for capacity development; enabling a more responsive health system that pro-actively engages households on matters that impact on wellness. The Community Health Workers (CHWs), under this platform have been applauded for increasing the adherence in HIV and TB treatment, child and maternal programmes through their home support visits. However, the HCBC in the country faces its own challenges of under paid community health care workers resulting in high turnovers. In provinces such as the Western Cape, the Non-Governmental organisations are contracted by the DoH to run the programme. However, in areas like Gauteng, the DoH has faced court action. The CHWs demanded to be recognised as government workers with permanent employment contracts, a demand with far reaching consequences in terms of budgets especially in a fiscal constrained environment.

The DoH came with policies on integration of TB/HIV treatment in the primary health care (PHC) services, decentralization of the management of multi-drug resistant (MDR) TB from specialized to lower levels of care and strengthening community-based care. The main purpose is to try and deal with the vertical organisation of services likely to weaken the system as patients are required to make separate visits for different ailments. The integration not only has helped in improving health outcomes, but has an added advantage to those seeking treatment. Not only do they get treatment in one place, but they save in terms of travelling, food and time costs. There is general consensus that once the economic and financial costs are taken care of, an individual’s chances of seeking treatment increase. However, a point of contention that has affected patients’ access to treatment has been the separate treatment rooms and or patient folders for those with HIV/AIDS (Zwarenstein, et al., 2011). Stigma is still very rife. Patients fear being betrayed by the folder colour or the designated room for HIV patients, resulting in either changing the centre of treatment or ultimately defaulting. The issue of human rights versus operational design to streamline processes as part of lean management comes into question. Would we rather prioritise human rights over running a centre at optimal efficiency?

Despite the formation of adherence groups, TB remains the main cause of death, dating back to 2009 (12%) (Soul City and SA National Department of Health, 2015) increasing to 21,8% in 2014 (Statistics South Africa, 2015). The Western Cape has the highest number of TB infections in South Africa. South Africa as a whole has records 1% of the total population as being infected by TB. Co-existence of TB and HIV/AIDS has also increased the number of TB infections. WHO estimates the percentage to be between 60 and 73 (Soul City and SA National Department of Health, 2015). High defaulting rates (6.2% in 2013) have resulted in the continued spread of TB despite the high cure rates.

Infrastructure, Water and Sanitation

Housing and infrastructure has contributed immensely to lack of access in health care. The link between poor housing infrastructure and poor health status is pronounced in the South African context. Lack of access to proper housing has inevitably resulted in factor contributing to lack of access to health care. The pre-apartheid era detected who could access what forms of houses due to the economic and political conditions. Such conditions widened the gap between the poor and the rich, leaving more indigent households dependent on the state for provision of housing, water and sanitation. The existence of huge informal settlement in the country, has the government grappling to provide “better housing”, by upgrading 750 000 households by 2019 within informal settlements. The National Department of Human Settlements’ main aim is to provide households, “with secure tenure and access to basic services, such as water and sanitation,” (South Africa’s National Treasury, 2016).  In 2011, access to piped water (inside the yard) was at 73.4% and increase from 69.4% in 2007 (Statistics South Africa, 2016). MDG 7[1] target of 74.7% had been surpassed by the year 2012. Improved access to sanitation had been achieved with 75% of the population (Chola, Michalow, Tugendhaft, & Hofman, 2015).

 

Plaxcedes image


Figure
1: Built Environment Factors Affecting Public Health

Source: Adapted from Srinivasan, O’Fallon & Deary 2003

 

The government’s continued efforts to bring water to the doorsteps of every household is commendable as a way to circumvent water-related diseases such as diarrhoea which have found a place on the South African Health calendar i.e. from November to May (Western Cape Government, 2016). Diarrhoea is the second leading cause of death in children under 5, accounting for 14.9% in 2014 (Statistics South Africa, 2015). With all the efforts, climate change has had its own unforeseen impact. In 2015, the Southern African region started experiencing a prolonged drought and water access was disrupted, even to those with household tapes thereby increasing the likelihood of diseases like diarrhoea. The public health sector needs to be ready at any point time cease to focus on a particular season.

Several studies allude to poor and inadequate housing leading to a multitude of health problems, namely asthma, depression air pollution, obesity, substance abuse and aggressive behaviour, an ingredient for non-accidental injuries (Srinivasan, O’Fallon, & Dearry, 2003). By extension, the access to health is diminished. A major cause for concern is the increase in TB related infections and deaths within South Africa.

Distance

Spatial planning in the urban and rural areas is far from similar. In areas like the Eastern Cape where the rural area is not well developed, health centres are very far from each other, so are the referral centres. It is difficult to get an ambulance to a place on time due to the geographical terrain. The distance decay further complicates the issue of bringing health care to the rural population. There are huge disparities in the urban and rural population. Performance indicators are therefore structured differently, an example being the response rate for urban ambulances which is measured with a 15 minute target whilst in rural areas it is a 40 minute target.  A few seconds can determine life or death. Forty minutes is just too long. The same applies to other provinces rural areas.  Distances between clinics and hospitals leave much to be desired. Though in the urban areas, the 2km rule between health centres has been well pronounced during urban planning, access to those centres is still poor and lack of finances, specifically transport money, is mostly to blame. In the urban area, studies show that 2/3 of South Africans reside less than 2km from the health centres, 90% reside within a 7 km range (McLaren, Ardington, & Leibbrandt, 2014).

Despite having a social security in place, offered through the South Africa Social Security Agency (SASSA) grants and Unemployment Insurance Fund (UIF) for those unemployed, the amounts are menial and cannot cover transport costs. In most cases resources are shifted from household use to transportation when client is already in an emergency situation, affecting their health outcomes in a negative way.

Related to housing and infrastructure within the informal settlements, is the lack of clear transport routes and street names, easily identifiable. In most provinces, the Emergency Medical Services’ (EMS) response rates have been lowered by poor performance in the informal dwellings. The situation has becoming dire with some residents believing the response times are only poor in the informal areas because of racial or class disparities and this has resulted in attacks against the EMS support services. In the Western Cape, gang violence (Etheridge, 2016), criminal elements have been noted as a factor due to the targeting of Mobile Data Terminal (MDT) devices installed in ambulances (Medical Brief, 2016) resulting in attacks on the EMS staff. While the major concern is a life being lost if an ambulance arrives late, it is now clear that lives can be lost for those responding to emergency calls. It makes one wonder whether the “urban penalty” (Kearns, 1988) actually exists in South Africa. The penalty assumed urban areas were associated with poor health than rural areas due to poor sanitation and housing, overcrowding and other social ills in comparison to rural areas which are in essence more spacious.

Conclusion

South Africa, may be a leading economy in Africa, but it has a lot of improvements to make in terms of population’s physical accessibility, financial protection and acceptability of the current public health care system. The NHI offers hope to the disadvantaged but it will not be ready anytime soon leaving the current health care arrangements with their own vulnerability needing continued revamping. The government may need to stop being reactive but proactive in addressing the inequality that is fuelling the lack of access for a majority of the population.

 

References

Chola, L., Michalow, J., Tugendhaft, A., & Hofman, K. (2015, April 17). Reducing diarrhoea deaths in South Africa: costs and effects of scaling up essential interventions to prevent and treat diarrhoea in under-five children. BMC Public Health, 15-394. doi:10.1186/s12889-015-1689-2

Etheridge, J. (2016, 9 14). News24. Retrieved 10 10, 2016, from News24: http://www.news24.com/SouthAfrica/News/concern-as-another-ambulance-is-attacked-in-cape-town-20160912

Evans, D. B., Hsu, J., & Boerma, T. (2013). Universal health coverage and universal access. Retrieved from Bulletin of the World Health Organization : http://www.who.int/bulletin/volumes/91/8/13-125450/en/

Gilson, L., & Schneider, H. (2006). The impact of free maternal health care in South Africa. In M. Berer, & R. T. Sundari, Safe Motherhood Initiatives: Critical Issues. Oxford: Blackwell Science, for Reproductive Health Matters. Retrieved from https://www.gov.uk/dfid-research-outputs/the-impact-of-free-maternal-health-care-in-south-africa

International Monetary Fund . (2016, July). World Economic Outlook Update . (IMF, Producer) Retrieved 10 13, 2016, from https://www.imf.org/external/pubs/ft/weo/2016/update/02/

Jumare, F., Ogujiuba, K., & Stiegler, N. (2013, July). Health Sector Reforms: Implications for Maternal and Child Healthcare in South Africa. Mediterranean Journal of Social Sciences, 4. doi:Doi:10.5901/mjss.2013.v4n6p593

Kearns, G. (1988). The urban penalty and the population history of England. In A. Brandstrom, & L. Tedebrand, Society, Health and Population During the Demographic Transition (pp. 213–236). Stockholm: Almqvist and Wiksell International.

MacKian, S. (2004). A review of health seeking behaviour:problems and prospects. Manchester : University of Manchester.

McLaren, Z., Ardington, C., & Leibbrandt, M. (2014, 10 20). Distance decay and persistent health care disparities in South Africa. BMC Health Services Research, 14:541. doi:DOI: 10.1186/s12913-014-0541-1

Medical Brief. (2016, August 10). Paramedics demand protection against violent attacks. Retrieved from Medical Brief: http://www.medicalbrief.co.za/archives/paramedics-demand-protection-violent-attacks/

Ministry of Health. (2003). Traditional Health Practitioners’ Bill. Pretoria: Ministry of Health .

Mulaudzi, F. M., Phiri, S., Mmamakwa, D. M., & Mataboge, P. (2016, May 6). Challenges experienced by South Africa in attaining Millennium Development Goals 4, 5 and 6. African Journal of Primary Health Care & Family Medicine, 2(26).

Soul City and SA National Department of Health. (2015). Literature Review of TB in South Africa. Pretoria: Soul City.

South African Department of Health. (2015). National Health Insuarance in South Africa: White Paper. Pretoria: National Department of Health .

South African Department of the Presidency: National Planning Commission. (2012). National Development Plan 2030. Pretoria: Department of the Presidency.

South African National Constitutional Assembly. (1996, May 8). Department of Justice. Retrieved October 16, 2016, from Legislation: http://www.justice.gov.za/legislation/constitution/saconstitution-web-eng.pdf

South African National Department of Health . (2016, 10 5). Essential Drugs Programme (EDP). Retrieved from http://www.health.gov.za: http://www.health.gov.za/index.php/essential-drugs-programme-edp

South Africa’s National Treasury. (2016). National Department of Human Settlements 2016/17 Budget. Pretoria: National Treasury.

Srinivasan, S., O’Fallon, L., & Dearry, A. (2003). Creating healthy communities, healthy homes, healthy people: initiating a research agenda on the built environment and public health. American Journal of Public Health, 93(9), 1446–1450.

Statistics South Africa. (2015). Millennium Development Goals: Country report 2015. Pretoria: Statistics South Africa.

Statistics South Africa. (2015). Mortality and causes of death in South Africa,2014: Findings from death notification. Pretoria: Statistics South Africa .

Statistics South Africa. (2015). Mortality and causes of death in South Africa,2014: Findings from death notification. Pretoria: Statistics South Africa.

Statistics South Africa. (2016). Mid-year population estimates. Pretoria: Statistics South Africa .

Statistics South Africa. (2016, 10 11). Statistics South Africa Website. Retrieved from Statistics South Africa: http://www.statssa.gov.za

United Nations. (1948). United Nations Universal Declaration of Human Rights 1948. Geneva: United Nations .

United Nations High Commissioner for Human Rights . (1996). International Covenant on Economic, Social and Cultural Rights. Geneva: OHCHR.

United Nations High Commissioner for Human Rights; World Health Organisation. (2008). The Rights to Health Fact Sheet no. 31. Geneva: United Nations.

Van der Hoeven, M., Kruger, A., & Greeff, M. (2012, June). Differences in health care seeking behaviour between rural and urban communities in South Africa. International Journal for Equity in Health, 11(31). doi:10.1186/1475-9276-11-31

Western Cape Government. (2016, 10 11). News and Speeches News and Speeches Archive. Retrieved from Western Cape Government: https://www.westerncape.gov.za/news/diarrhoea-season-here

World Bank, Development Research Group. (2016). Retrieved October 5, 2016, from World Bank Gini Index: http://data.worldbank.org/indicator/SI.POV.GINI?locations=ZA

Zwarenstein, M., Fairall, L., Lombard, C., Mayers, P., Bheekie, A., English, R., . . . Bateman, E. (2011, April 21). Outreach education for integration of HIV/AIDS care, antiretroviral treatment, and tuberculosis care in primary care clinics in South Africa: PALSA PLUS pragmatic cluster randomised trial. British Medical Journal, 342-2022. doi:10.1136/bmj.d2022

 

[1] Halve, by 2015, the proportion of people without sustainable access to safe drinking water and basic sanitation

Breaking News: Link 211

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

DSCN1778

Breaking News: Link 211

 

India’s States Increase Health Spending, But Will They Spend Effectively? 

EU-Africa talks pose larger questions on aid and security 

Africa’s population boom fuelling ‘unstoppable’ migration to Europe 

The Culture Of Health Action Framework And Systems Science: Opportunities And Challenges 

PHM Europe meeting London, 9 October 2016 

In the Breast Cancer Fight, New Donor Attention to Race and Inequity 

‘Massive scale-up’ needed if global targets on tuberculosis are to be met – top UN health official 

World Health Organization warns that global tuberculosis fight is billions of dollars behind 

WHO: Global Tuberculosis Report 2016 

Why Is The News About TB So Bad? 

Why is multidrug-resistant TB a health security threat? 

A Winning TB Surveillance Strategy for Ukraine 

How the world is slowly winning the war against malaria 

UNICEF: Vaccine price drop will save millions of child lives 

UNICEF Tender Allows Gavi To Supply Vaccines For Millions Of Children 

Nearly 100 Organisations Press For Better Medicines Access In Asian Region RCEP Agreement 

An open letter to the sixteen governments negotiating the Regional Comprehensive Economic Partnership (RCEP) 

Eli Lilly Commits To Healthcare For 30 Million People In Middle-Income Countries And US By 2030 

55 Civil Society Groups Ask US Government To Allow Export Of Affordable Version Of Prostate Cancer Drug Xtandi 

This is how Modi government aims to meet UN development goals 

Bitter Harvest: Cassava and Konzo, the Crippling Disease 

Clean air for livable cities 

A Global Green Funder Tries its Hand at Community-Level Climate Justice 

Climate change could drive 122M more people into extreme poverty by 2030 

How to find a resilient solution to extreme poverty 

Eradicating poverty — a lofty ideal or achievable goal? 

World Food Program USA and Cargill partner to strengthen local food security 

The world’s future hinges on supporting 10-year-old girls, says UN 

The US presidential: Threatening future to health 

Clinton and Trump: A tale of two foundations 

Talking Disputes Philip Morris v. Uruguay AN ICTSD/WTI ADVISORS EVENT – 27 October 2016 

17 October 2016: USTR Ambassador Michael Froman’s reflections on the United Nations High-Level Panel on Access to Medicines

Breaking News: Link 210

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

DSCN1778

Breaking News: Link 210

 

WHO: Public Health round-up 

WHO urges global action to curtail consumption and health impacts of sugary drinks

Taxing sugary drinks can curb global epidemic of obesity and diabetes — UN health agency   

Global health leaders identify top priority for next WHO chief 

World Health Summit focuses on improving global health infrastructures 

Healthcare innovations won’t cure global health inequality – political action 

Ban announces launch of new partnership platform to support financing for Sustainable Development Goals 

What Bipartisan Opportunities Will The Next Congress And President Have To Improve Health Policy? 

How international financial institutions and donors influence economic policies in developing countries 

Africa Has a Brain Drain Problem. This Funder Aims to Change That 

The Medicines Patent Pool Expands its Expert Advisory Group (EAG) to Include Leaders with Expertise in Hepatitis C and Tuberculosis 

The Medicines Patent Pool Announces MedsPaL: Its New Medicines Patents & Licences Database 

UPDATED: Gilead’s Sovaldi takes a patent hit in Europe, hiking risk of early generics 

Partial Revocation Of EPO Patent On Sofosbuvir, Key For Hepatitis C 

Essential medicines for cancer: WHO recommendations and national priorities 

Negotiating prices of drugs for rare diseases 

Tackling menstrual health taboo in Uganda 

Neonatal mortality within 24 hours of birth in six low- and lower-middle-income countries 

9 ways funding for the global HIV response could go further 

Distinguishing between Zika and Spondweni viruses 

Modeling The Economic Burden Of Adult Vaccine-Preventable Diseases In The United States 

‘Mental Health First Aid’ for All Is a Goal of Annual Observance 

Hurricane Matthew: Haiti needs vaccines to stop deadly cholera spreading 

EU, US negotiators officially drop aim of concluding TTIP in 2016 

China-Africa cooperation model needs to evolve 

Climate change, food, water and population health in China 

Trade Measures to Combat IUU Fishing: Comparative Analysis of Unilateral and Multilateral Approaches  

Environmental taxation and EU environmental policies 

A CONVERSATION WITH… ETHAN NADELMANN Drug Policy Alliance 

Human Rights Reader 397 

Italy lashes out at EU states for not taking in refugees 

Access to Medicines Report, Green Light to Action

The much-anticipated report by the United Nations (UN) High Level Panel on Access to Medicines went public on 14 September. Hopes that its forward-looking recommendations could speedily succeed are threatened, however, by the load of conflicting issues still on the table worldwide

MINOLTA DIGITAL CAMERA

by Daniele Dionisio*

Policies for Equitable Access to Health (PEAH)

Access to Medicines Report, Green Light to Action

 

The United Nations High Level Panel on Access to Medicines was established in November 2015 and tasked with reviewing and weighing proposals and making recommendations for ending the misalignment among the right to health, trade rules and the patent system, as the main barrier to the equitable access to health priorities.

The much-anticipated report by the Panel finally went public on 14 September. Its well-grounded recommendations and requests to the interested parties make it a cornerstone for all relevant decisions to the fair access to treatments and care not just at a poor country level. Admittedly, access to medicines is a problem of global concern at a time when extortionate drug prices are laming healthcare systems throughout the world.

Relevantly, the Panel calls for WTO members to comply with and globally implement the WTO Doha Declaration on TRIPS (WTO Agreement on Trade-Related Aspects of Intellectual Property Rights) and public health. This includes facilitating the issuance of compulsory licences, rejecting the so-called ever-greening of patents and restricting patents to genuine inventions only.

The report says that “Governments and the private sector must refrain from explicit or implicit threats, tactics or strategies that undermine the right of WTO Members to use TRIPS flexibilities.” It maintains that “Instances of undue political and commercial pressure should be reported to by the WTO Secretariat during the Trade Policy Review of Members.” As per its terms, “WTO Members must register complaints against undue political and economic pressure which includes taking punitive measures against offending WTO Members.”

Coherently, the report calls on governments engaged in international trade and investment negotiations to ensure that these do not include clauses contrary to their obligations to the right to health. The public health impact of the agreements should, instead, be carefully weighed throughout the negotiations and made publicly available.

The Panel insists that the UN agencies (UNCTAD, UNDP, WHO, WIPO among others) should mutually collaborate at their best, including with the WTO and all relevant bodies, to support governments to introduce public health-friendly patentability standards.

As the Panel stresses, “universities and research institutions that receive public funding must prioritize public health objectives over financial returns in their patenting and licensing practices.” That includes the use of non-exclusive licences while giving up intellectual property (IP) rights and joining public sector patent pools and other mechanisms equipped for the maximization of innovation and access.

Relevantly, governments are asked to enhance their levels of investment in health technology innovation to meet neglected needs.

Moreover, the report calls for all the relevant parties to “test and implement new and additional models for financing and rewarding public health research and development (R&D), such as the transaction taxes and other innovative financing mechanisms.”

What’s more, the Panel urges to begin negotiations at the WHO for a binding research and development treaty up to delinking R&D costs from the end prices of medicines. The treaty “should focus on public health needs, including but not limited to, innovation for neglected tropical diseases and antimicrobial resistance and must complement existing mechanisms.”

Furthermore, the Panel contends that “Governments should strengthen national level policy and institutional coherence between trade and intellectual property, the right to health and public health objectives by establishing national inter-ministerial bodies to coordinate laws, policies and practices that may impact on health technology innovation and access.”

Meanwhile, the United Nations Secretary-General is asked to set up an independent review body tasked with assessing progress on health technology innovation and access, while monitoring the challenges and advances on innovation and the enjoyment of technologies for health under the UN 2030 Agenda perspective. Membership should encompass representatives from governments, the UN and multilateral organisations, civil society, universities, and the private sector.

The UN Secretary-General is also requested to establish an inter-agency taskforce on health technology innovation and access working “toward increasing coherence among United Nations entities and relevant multilateral organizations like the WTO.”

The report contends that “Governments should require manufacturers and distributors of health technologies to disclose to drug regulatory and procurement authorities information pertaining to:

(1) the costs of R&D, production, marketing and distribution of health technology being procured or given marketing approval with each expense category separated; and

(2) any public funding received in the development of the health technology, including tax credits, subsidies and grants.”

Relevantly, the WHO is invited to establish and keep up with an “accessible international database of prices of patented and generic medicines and biosimilars in the private and public sectors of all countries where they are registered.” At the same time, governments are asked to establish, preserve and update publicly accessible databases with patent information status and relevant figures to drugs and vaccines.

Falling Short of Expectations?

It is strict duty for the UN system to work with governments to ensure the report’s recommendations are carried into effect with no delay. Unfortunately, since the Panel asks all counterparts to act in unison toward the best collaboration, coherence, accountability and transparency, the percentage of success is unpredictable at the moment.

Admittedly, in today’s global landscape, which is torn by misalignment, litigations and frictions among the involved parties, governments look like they wouldn’t be ready to embark on these recommendations as an opportunity to advance public health over political and commercial interests.

From bad to worse, the current governments’ directions and trade agreements, largely by the European Union (EU) and the United States (US), run contrary to the Panel’s principles while turning IP agendas into policies that protect monopolistic interests at the expense of equitable access to care and lifesaving treatments in resource-limited settings.

Just for example, the Panel’s request for transparency in costs to help curb extortionate drug prices looks like a difficult task now that pharma companies and their allies are lobbying policy decision makers  to scupper any rules that would force them to disclose the real R&D costs and profits of their medicines and the rationale for charging what they do.

As such, it comes as no surprise that the report was opposed by the US Chamber of Commerce and the pharmaceutical industry.

These circumstances bode ill at a time when the US administration is lobbied by the pharmaceutical corporations, the European authorities are doing almost nothing to check the tide of ‘me-too’ drugs, and the European Medicines Agency keeps testing new medicines only in terms of safety and efficacy compared with a ‘pretend’ drug.

To conclude, what expectations for the world landscape mentioned above? Hopes that comprehensive, non-discriminatory health goals could speedily be reached are threatened by the load of conflicting issues still on the table.  As argued, “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…”

All things taken together, the Panel’s report recommendations look like a hard bet. Yet, they matter against all the odds as an overarching voice hammering the point that prospects for global health goals only depend on non-stop, multi-sector engagement worldwide to pressure governments into making “U-turn” changes by common measures on a shared agenda.

 

————————————————————————–

*article originally published in IHP – International Health Policies  http://www.internationalhealthpolicies.org/access-to-medicines-report-green-light-to-action/

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