Sol-Gel Announces Positive Top-Line Results from Epsolay® Phase 3 Program in Papulopustular Rosacea

  • All primary and secondary endpoints achieved in both Phase 3 clinical trials
  • Rapid efficacy demonstrated, with statistical significance reached as early as Week 2 compared with vehicle
  • Favorable safety and tolerability profile, similar to vehicle
  • Conference call and webcast today at 8:30 AM ET

NESS ZIONA, Israel, July 08, 2019 (GLOBE NEWSWIRE) — Sol–Gel Technologies, Ltd. (NASDAQ: SLGL) ("Sol–Gel" or the "Company"), today announced positive results from its Phase 3 program evaluating Epsolay microencapsulated benzoyl peroxide cream, 5%, made with the Company's proprietary microencapsulation technology, for the treatment of papulopustular rosacea. In two 12–week clinical studies, SGT 54–01 and SGT 54–02, Epsolay demonstrated statistically significant improvement in both co–primary endpoints of (1) the number of patients achieving "clear" or "almost clear" in the Investigator Global Assessment (IGA) and (2) absolute mean reduction from baseline in inflammatory lesion count. In an additional analysis, Epsolay demonstrated rapid efficacy achieving statistically significant improvements on both co–primary endpoints compared with vehicle as early as Week 2. Epsolay demonstrated a favorable safety and tolerability profile similar to vehicle.

James J. Leyden, M.D., dermatologist and Emeritus Professor CE of Dermatology at the University of Pennsylvania commented on the results, "It's exciting that Epsolay delivered outstanding and rapid efficacy with a microencapsulated benzoyl peroxide without irritating the sensitive skin of rosacea patients. These findings are extremely positive and, if Epsolay is approved, it has the potential to represent a significant advance in the treatment of papulopustular rosacea."

Epsolay is the first in a pipeline of dermatologic product candidates in development using Sol–Gel's proprietary microencapsulation technology. This platform was designed to enable drug substances to be entrapped in porous silica microcapsules in order to address the limitations of topical drug delivery by stabilizing active drug ingredients, extending drug delivery time and reducing potential irritation caused by direct application to the skin. In the fourth quarter of 2019, top–line Phase 3 results are expected for TWIN, the Company's investigational fixed–dose combination of microencapsulated benzoyl peroxide and microencapsulated tretinoin being studied for acne vulgaris.

"While we expected to see strong efficacy and tolerability with Epsolay, the rapid efficacy was a standout in our Phase 3 studies," said Dr. Alon Seri–Levy, Chief Executive Officer of Sol–Gel. "It's very difficult for patients of any dermatological disease, let alone rosacea, to wait months for a positive clinical result. That a quarter of Epsolay patients in both trials reached their treatment goals within a month, when the efficacy of existing topical products can be quite slow, is clinically meaningful and illustrates a clear unmet need within a rapidly growing marketplace."

SGT 54–01 and SGT 54–02 Trial Design

To assess the efficacy and safety of Epsolay in moderate–to–severe papulopustular rosacea, 733 patients aged 18 and older were enrolled in two identical, double–blind, vehicle–controlled Phase 3 clinical trials at 54 sites across the U.S. Patients were randomized at a 2:1 ratio to be treated once–daily with either Epsolay (n=493) or vehicle cream (n=240) for 12 weeks. After the initiation of treatment, clinical and safety evaluations were performed at Weeks 2, 4, 6, 8 and 12. The primary efficacy endpoints for both trials were success in IGA score at Week 12, defined as "clear" (0) or almost clear" (1) on a scale of 0 to 4, and a reduction in absolute mean inflammatory lesion count at week 12.

Baseline Papulopustular Rosacea Severity

In study SGT 54–01, patients in the Epsolay and vehicle treatment groups had a baseline mean inflammatory lesion count of 25.7 and 26.3, respectively. The proportion of patients with "moderate" (3) or "severe" (4) IGA in the Epsolay treatment group was 86.4% and 13.6%, respectively, and 88.1% and 11.9%, respectively, in the vehicle treatment group.

In study SGT 54–02, patients in Epsolay and vehicle treatment groups had a baseline mean inflammatory lesion count of 29.8 and 27.5, respectively. The proportion of patients with "moderate" (3) or "severe" (4) IGA in the Epsolay treatment group was 90.8% and 9.2%, respectively, and 91.8% and 8.2%, respectively, in the vehicle treatment group.

Primary Endpoint Results (intention–to–treat population)

SGT 54–01 SGT 54–02
Epsolay
N=243
Vehicle
N=118
p–value Epsolay
N=250
Vehicle
N=122
p–value
Proportion of patients achieving "clear" or "almost clear" at Week 12 43.5 % 16.1 % <0.001 50.1 % 25.9 <0.001
Absolute mean change in inflammatory lesion count from baseline at week 12 –17.4 –9.5 <0.001 –20.3 –13.3 <0.001

Secondary Endpoint Results (intention–to–treat population)

SGT 54–01 SGT 54–02
Epsolay Vehicle p–value Epsolay Vehicle p–value
Proportion of patients achieving "clear" or "almost clear" at Week 4 25.4 % 6.5 % <0.001 26.1 % 14.1 % 0.009
Absolute mean change in inflammatory lesion count from baseline at Week 4 –14.6 –8.7 <0.001 –16.7 –10.5 <0.001
Proportion of patients achieving "clear" or "almost clear" at Week 8 39.6 % 15.8 % <0.001 44.0 % 26.0 % 0.006
Absolute mean change in inflammatory lesion count from baseline at Week 8 –16.8 –10.6 <0.001 –20.0 –12.4 <0.001

Exploratory Endpoint Results (intention–to–treat population)

SGT 54–01 SGT 54–02
Epsolay Vehicle p–value Epsolay Vehicle p–value
Proportion of patients achieving "clear" or "almost clear" at Week 2 9.5 % 3.1 % 0.009 13.2 % 5.5 % 0.017
Absolute mean change in inflammatory lesion count from baseline at Week 2 –10.5 –5.5 <0.001 –13.0 –8.0 <0.001

Safety and Tolerability

Epsolay appeared to be generally safe and well–tolerated with a low rate of cutaneous side effects (e.g., dryness, scaling, itching and burning/stinging) comparable to vehicle. Adverse events were primarily mild to moderate in severity with the most frequently reported adverse events across both studies being application site erythema and application site pain reported by less than 3.4% of subjects. There was no treatment–related serious adverse events, with a combined total of 2 unrelated serious adverse events (1 Epsolay, 1 vehicle) reported across both trials. A combined total of 11 subjects (9 Epsolay, 2 vehicle) discontinued treatment due to an adverse event across both trials.

Preliminary Financial Results for the Second Quarter Ended June 30, 2019

The Company estimates its revenue for the second quarter of 2019 attributable to sales of its partnered generic product, acyclovir cream, 5%, with Perrigo to be approximately $7.0 million. To date, this is the only generic acyclovir cream available on the U.S. market. As of June 30, 2019, the Company's cash, cash equivalents, deposits and marketable securities is expected to be approximately $49.8 million, excluding the approximate $7.0 million in revenue from acyclovir cream, 5%, in the second quarter of 2019. Based on current assumptions, the Company expects its existing cash resources will enable funding of operational and capital expenditure requirements through the third quarter of 2020.

The estimates above represent the most current information available to the Company's management and do not present all necessary information for an understanding of the Company's financial condition as of and the results of operations for the quarter ended June 30, 2019. The Company is currently preparing its financial results for the three months ended June 30, 2019. The Company's actual results may differ materially from these estimates. The company plans to release final second quarter financial results on August 8, 2019.

Conference Call and Live Webcast (with slides) @ 8:30 AM Eastern Time
U.S. toll free: 877–282–0504
International: 270–215–9895
Passcode: 2570059
Webcast: https://edge.media–server.com/mmc/p/3ukswwiw

The webcast can be accessed live on the Events & Presentations section of the Company's website at http://ir.sol–gel.com. It will be archived for 30 days following the call.

About Epsolay

Benzoyl peroxide has not been approved by the FDA for the treatment of rosacea and may cause significant skin irritation in rosacea patients. Epsolay is an innovative topical cream containing microencapsulated benzoyl peroxide, 5%, in development for the treatment of papulopustular rosacea. Epsolay utilizes a patented technology process to encapsulate benzoyl peroxide within silica microcapsules to create a barrier between the medication and the skin. The slow migration of medication from the microcapsules delivers treatment doses onto the skin, while the barrier reduces the ability of benzoyl peroxide to induce the strong oxidation process that can result in significant skin irritation, such as erythema, burning and stinging. Silica is chemically inert, photochemically and physically stable, and is safely used in topical products. If approved, Epsolay has the potential to be the first FDA–approved single–active benzoyl peroxide prescription drug product.

About Papulopustular Rosacea

Papulopustular rosacea is a chronic and recurrent inflammatory skin disorder that affects nearly 5 million Americans.1 The condition is common, especially in fair–skinned people of Celtic and northern European heritage. Onset is usually after age 30 and typically begins as flushing and subtle redness on the cheeks, nose, chin or forehead. If left untreated, rosacea can slowly worsen over time. As the condition progresses the redness becomes more persistent, blood vessels become visible and pimples often appear. Other symptoms may include burning, stinging, dry skin, plaques and skin thickening.

About Sol–Gel Technologies

Sol–Gel is a clinical–stage dermatology company focused on identifying, developing and commercializing branded and generic topical drug products for the treatment of skin diseases. Sol–Gel's current product candidate pipeline consists of late–stage branded product candidates that leverage our proprietary, silica–based microencapsulation technology platform, and several generic product candidates across multiple indications.

Forward–Looking Statements

This press release contains "forward–looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. All statements contained in this press release that do not relate to matters of historical fact should be considered forward–looking statements. These forward–looking statements include information about possible or assumed future results of our business, financial condition, results of operations, liquidity, plans and objectives. In some cases, you can identify forward–looking statements by terminology such as "believe," "may," "estimate," "continue," "anticipate," "intend," "should," "plan," "expect," "predict," "potential," or the negative of these terms or other similar expressions. Forward–looking statements are based on information we have when those statements are made or our management's current expectation, and are subject to risks and uncertainties that could cause actual performance or results to differ materially from those expressed in or suggested by the forward–looking statements. Important factors that could cause such differences include, but are not limited to: (i) the adequacy of our financial and other resources, particularly in light of our history of recurring losses and the uncertainty regarding the adequacy of our liquidity to pursue our complete business objectives; (ii) our ability to complete the development of our product candidates; (iii) our ability to find suitable co–development partners; (iv) our ability to obtain and maintain regulatory approvals for our product candidates in our target markets and the possibility of adverse regulatory or legal actions relating to our product candidates even if regulatory approval is obtained; (v) our ability to commercialize our pharmaceutical product candidates; (vi) our ability to obtain and maintain adequate protection of our intellectual property; (vii) our ability to manufacture our product candidates in commercial quantities, at an adequate quality or at an acceptable cost; (viii) our ability to establish adequate sales, marketing and distribution channels; (ix) acceptance of our product candidates by healthcare professionals and patients; (x) the possibility that we may face third–party claims of intellectual property infringement; (xi) the timing and results of clinical trials that we may conduct or that our competitors and others may conduct relating to our or their products; (xii) intense competition in our industry, with competitors having substantially greater financial, technological, research and development, regulatory and clinical, manufacturing, marketing and sales, distribution and personnel resources than we do; (xiii) potential product liability claims; (xiv) potential adverse federal, state and local government regulation in the United States, Europe or Israel; and (xv) loss or retirement of key executives and research scientists. These and other important factors discussed in the Company's Annual Report on Form 20–F filed with the Securities and Exchange Commission ("SEC") on March 21, 2019 and our other reports filed with the SEC could cause actual results to differ materially from those indicated by the forward–looking statements made in this press release. Any such forward–looking statements represent management's estimates as of the date of this press release. Except as required by law, we undertake no obligation to update publicly any forward–looking statements after the date of this press release to conform these statements to changes in our expectations.

For further information:
Sol–Gel Contact:
Gilad Mamlok
Chief Financial Officer
+972–8–9313433

U.S. Investor Contact:
Chiara Russo
Solebury Trout
+1–617–221–9197
crusso@soleburytrout.com
Media Contact:
Stephanie Bukantz
Chamberlain Healthcare PR
+973–477–1814
Stephanie.bukantz@syneoshealth.com

Source: Sol–Gel Technologies Ltd.


1 Data on file, Sol–Gel

Solar Collectors and Solidarity Change Lives in Argentina

Volunteers install a solar water heater, made from recycled materials, with a 90-litre tank on the roof of a modest home in the Argentine municipality of Pilar, 50 km north of Buenos Aires. This unique thermal generation system was designed by Brazilian engineer José Alano, who did not patent it in order to facilitate its free use. Credit: Daniel Gutman/IPS

Volunteers install a solar water heater, made from recycled materials, with a 90-litre tank on the roof of a modest home in the Argentine municipality of Pilar, 50 km north of Buenos Aires. This unique thermal generation system was designed by Brazilian engineer José Alano, who did not patent it in order to facilitate its free use. Credit: Daniel Gutman/IPS

By Daniel Gutman
PILAR, Argentina, Jul 8 2019 – “This is the best thing ever invented for the poor,” says Emanuel del Monte, pointing to a tank covered in black tarps protruding from the roof of his house. It forms part of a system built mostly from waste materials, which heats water through solar energy and is improving lives in Argentina.

Thanks to him, hundreds of families in three poor neighbourhoods on the outskirts of the Argentine capital now have hot water for bathing. They used to heat water in pots but had abandoned the practice in recent years because of the high costs of cooking gas.

Del Monte, 32, his wife and five children live in an unpainted cinder-block house with a half-built brick perimeter wall in the neighborhood of Pinazo, Pilar municipality, about 50 km north of Buenos Aires.”When they first tell you about it, you don’t understand what they’re talking about. Then you realize it’s an opportunity you can’t miss out on because it changes your life.” – Verónica González

Pinazo is a community of about 5,000 people that reflects the social deterioration in the 24 municipalities surrounding Buenos Aires, which together with the capital account for more than 13 million of the country’s 44 million inhabitants.

Neighbourhoods on the outskirts of the capital are home to 130,000 of the 200,000 people who lost their jobs in 2018 in this South American country, where the economy is in a deep crisis and poverty has climbed to 36 percent of the population, according to official figures.

The paved streets of Pinazo are lined with houses with roof tiles and gardens, run-down but clearly middle-class.

But if you turn down the dirt side streets, many of the homes are shacks made of boards, corrugated metal and even pieces of tarp, between empty dirt lots where cats, dogs and chickens wander about.

On some Saturdays, however, things get busy on several of the empty lots: dozens of volunteers, mostly young people, work for hours building solar heaters, together with many local residents.

The volunteers gather early on one side of the freeway from Buenos Aires and come to the neighbourhood together, in cars and trucks loaded with huge bags full of plastic bottles, cans, cardboard boxes, old mattresses and tarps.

Mariana Alio and her husband, Emanuel del Monte, stand in front of their house in Pinazo, a poor neighbourhood in the municipality of Pilar, in Greater Buenos Aires. On the roof they have a solar water heater, covered with mattresses and tarps that keep it warm, which provides them with hot water for bathing – a luxury their family had to do without because of the high cost of the cooking gas they used to heat water in pots. Credit: Daniel Gutman/IPS

Mariana Alio and her husband, Emanuel del Monte, stand in front of their house in Pinazo, a poor neighbourhood in the municipality of Pilar, in Greater Buenos Aires. On the roof they have a solar water heater, covered with mattresses and tarps that keep it warm, which provides them with hot water for bathing – a luxury their family had to do without because of the high cost of the cooking gas they used to heat water in pots. Credit: Daniel Gutman/IPS

In addition, local residents at the site gather useful waste products, which they used to burn or throw into the polluted stream that gives its name to the neighborhood, since there is no garbage collection system.

Convened by the non-governmental organisation Sumando Energías, the volunteers say their goodbyes just before sunset, after building and installing on the roofs of up to four houses solar energy collectors and 90-litre thermal tanks, which keep the water warm because they are covered with mattresses and tarps.

“Each collector is made with 264 plastic bottles, 180 cans and 110 cardboard boxes. Most of the materials we use are reused,” Pablo Castaño, 32, who founded Sumando Energías in 2014, tells IPS as he walks around, supervising the work of the volunteers.

“I am convinced that sustainability is the only way to improve things for the poor. Social and economic solutions go hand in hand with environmental solutions,” says Castaño.

The head of Sumando Energías says he came into contact with the conditions in low-income areas while volunteering for another NGO, Techo (Roofs), dedicated to providing decent housing in slums, and became interested in renewable energy while studying to become an industrial engineer.

Castaño was born and raised in the southern province of Río Negro, near Vaca Muerta, the giant unconventional oil and gas field that the government is counting on to give a boost to Argentina’s declining economy. But he argues that “it is not the burning of fossil fuels that is going to save us.”

The solar collectors consist of 12 parallel two-metre-long PVC tubes covered with cans that absorb heat from the sun and heat the water inside the pipe. They are then wrapped in plastic bottles and cardboard.

Young volunteers from Sumando Energías build solar collectors in the Pinazo neighborhood. The NGO trains them in the development of clean energies that provide social, environmental and economic solutions in poor neighbourhoods in Argentina. Credit: Daniel Gutman/IPS

Young volunteers from Sumando Energías build solar collectors in the Pinazo neighborhood. The NGO trains them in the development of clean energies that provide social, environmental and economic solutions in poor neighbourhoods in Argentina. Credit: Daniel Gutman/IPS

“That’s how we generate the greenhouse effect that keeps the temperature up. The next step is to set up a closed circuit between the pipes and the tank, which is placed on top, as hot water becomes dense and tends to rise. After about 60 round-trip cycles, the water is hot, between 40 and 65 degrees (Celsius),” says Lucía López Alonso, one of the volunteers.

“What is generated is not electricity, but solar thermal energy,” she tells IPS.

Emanuel del Monte’s wife, Mariana Alio, who works at a greengrocer’s, says their family used to heat up water in pots using cooking gas, for bathing, but economic difficulties forced them to only use gas for cooking.

“Some people in the neighbourhood still think I’m crazy when I tell them that I now have hot water from a system built using waste products,” says Del Monte, who recently lost his job as a maintenance worker in Escobar, a municipality near Pilar, and today does odd jobs, mowing lawns or as a handyman.

In both Pilar and Escobar, slums exist side by side with summer homes and gated communities – some of them wealthy and all of them surrounded by walls and fences and protected by private security guards – where slum-dwellers can find casual work.

“(José) Alano didn’t patent it in order for his design to be used freely. We also follow his philosophy and uploaded the solar collector manual to our Facebook page, so anyone can access it,” Castaño explains.

In four years, Sumando Energías has built and installed 174 solar collectors in neighbourhoods on the outskirts of Buenos Aires.

In the poor neighbourhood of Pinazo, on the outskirts of the Argentine capital, young volunteers cover a 90-litre thermal tank with a layer of foam recycled from old mattresses, which helps keep water heated by a solar collector - also made with old plastic bottles and cans - warm. Credit: Daniel Gutman/IPS

In the poor neighbourhood of Pinazo, on the outskirts of the Argentine capital, young volunteers cover a 90-litre thermal tank with a layer of foam recycled from old mattresses, which helps keep water heated by a solar collector – also made with old plastic bottles and cans – warm. Credit: Daniel Gutman/IPS

Castaño explains that the system for making solar collectors with reused materials was designed in 2002 in Brazil by retired mechanic José Alano, who promoted it in the south of his country.

The activist says the units have a useful life of 10 years or more, but points out that they last longer because they do not have mechanical parts. In addition, the plastic bottles can be easily replaced when they eventually darken and no longer perform their function of maintaining heat.

The aim of the initiative is not only to provide a solution for poor families but also to pass on know-how about renewable energy to the volunteers, who donate 1,500 pesos (about 33 dollars), which are used to cover the cost of the materials.

“We also receive some donations from companies, but we don’t accept any from companies linked to the fossil fuel business,” says Castaño.

Sumando Energías is now working on prototypes of solar cookers that will allow families like those living in the Pinazo neighbourhood, most of whom depend on the informal labour market, to cut their dependence on cooking gas cylinders, which cost 10 dollars to refill.

“Many of us here have had 25-litre electric water heaters, but they tend to burn out because the electric power source is unreliable,” says Verónica González, a 34-year-old local resident who lives with her mother, three daughters and a niece, as she cuts plastic bottles alongside the volunteers.

Her family is among the latest to benefit from the solar heaters designed by Alano. “When they first tell you about it, you don’t understand what they’re talking about. Then you realize it’s an opportunity you can’t miss out on because it changes your life,” she tells IPS.

Climate Change Victims: What Will You Do Next?

Professor Joshua Castellino is Executive Director of the UK-based Minority Rights Group International

By Joshua Castellino
LONDON, Jul 8 2019 – Contemporary politics generates a lot of noise and smoke, with little attention devoted to understanding, analysing and fixing the causes of the noise and smoke. The global public discourse is dominated by statements made by politicians and aspirants to power, designed to shock, awe and draw support.

But the statements are rarely about real underpinning threats facing society: not on climate change, and not on the urgent need to generate employment in the face of increased mechanization.

Anger and resentment at the loss of jobs on account of shifts in manufacturing are dismissed as a design fault to be overcome through simple solutions: building walls, departing clubs like the EU, increasing tariffs on ‘foreign produce’ and keeping migrants out since they are apparently responsible for the failure of the economy to generate employment.

Irresponsible as that simplistic politics might be, it pales in comparison to how climate change is treated. The sheer abdication of governance is appalling and shameful, calling into question the essence of why governments are needed at critical times in human history.

While scientists have produced compelling evidence for decades, the recent impact of climate change is difficult to refute for even the least educated person. When Greta Thunberg called for urgent action she received adulation and patronage in equal measure, but none have yet been able to respond with the urgent action she called for.

Many in government around the world appear to accept the realities of climate justice, but see it as an issue for the future – unlikely to affect their time driven mandate of adhering to power.

In its Key Trends Report 2019, focussing on climate justice, Minority Rights Group (MRG) provides evidence of the impact of climate change on the most vulnerable communities in society.

The overarching facts on climate change are not new: Lake Chad, a key water body in Africa has shrunk by 90 per cent since the 1960s, while the Arctic is currently warming twice as fast as anywhere else on earth. These stark facts, in the public realm for long, have not yet focussed on the impact on people.

The push for Canadian indigenous communities to leave their ancestral lands in the face of climate impact is mirrored by those in the Pacific in Tuvalu and Kiribati.

The degradation of forests around key water towers in Kenya, and their occupation for commercial use, impacts their traditional custodians, depriving them of their homes, and disrupting the flow of water across Africa, into the Nile and onwards into the Mediterranean.

As the desert eats into Chad, pastoralists face a heightened crisis, stimulating migrant flows into Europe, while Nigeria is heading in a similar direction with tensions rising as pastoralists, faced with shrinking grazing areas, make incursions into others’ territories.

Pastoralists and sedentary communities are also building up to a stand-off in Morocco as competition for land and water becomes acute.

The continued exploitation of natural wealth in the form of oil and gas by wealthy companies, despite stark warnings about the carbon economy, are creating devastating immediate consequences for the communities cursed with living in proximity to these.

This is as true in Kenya as in Ecuador, Thailand and Russia. In every case communities are forced to contend with pollution, dereliction of their environment, impact on their livelihoods and the eventual loss of their homes. That they were not consulted in any of the processes is a given, only exacerbated by the shocking governance failures over what ought to happen to them.

A new theme is also emerging that treats indigenous communities and forest dwellers in particular as inconvenient nuisances that through their very existence negatively impact the push towards climate conservation.

This phenomenon pits environmentalists against super marginalized communities, who appear to be considered as collateral for the few pitiful moves being made in the name of environmental protection. The argument being made appears to posit communities that have lived in a sustainable and traditional manner for centuries being tagged with responsibility for environmental damage.

This deeply flawed argument goes against all evidence, making scapegoats out of subsistence driven communities, for activities that have been sustainable for centuries and create an overall negative carbon footprint.

It also facilitates the biggest polluters and corporate actors, who continue to reserve the right to make profits out of natural wealth in conjunction with governments, that no matter what property regime is used, do not belong to them.

Alongside each of these relatively ‘new’ phenomena, lies the time-honed discrimination that has erected structures over centuries that seek to maintain the hegemony of a small privileged elite in each society.

Thus, the plight of Black Americans in New Orleans affected by Hurricane Katrina lies in stark contrast to the urgent action taken in the face of the flooding experienced by Manhattan as a result of Hurricane Sandy.

The Valladolid Controversy of 1550 was the first publicized debate concerning the rights of colonized peoples. Bartolomé de Las Casas argued that native Americans were human despite their ‘unchristian’ customs, while Juan Ginés de Sepúlveda believed they were barbarians rather than human, and therefore had to be suppressed. The dispute may seem like a historical footnote that captured the fatal attraction and insecurity towards Otherness.

Yet in this the most recent crisis facing humanity its echoes are alive and well. Climate change affects us all, of that there is little doubt. At what point this becomes survival critical for you is merely a reflection of the accident of birth.

Wealth and proximity to power may keep you insulated a while longer. Indigenous peoples and minorities the world over on the other hand, have continued to be treated as objects whose consent to anything is irrelevant and unnecessary, and therefore they form the frontline to the crisis.

Sane, scientifically validated well-informed voices have called for urgent action. MRG’s Key Trends Report of 2019 provides evidence of the current impact of climate injustice on communities. If governments continue to abdicate responsibility to solving this problem, we need to sweep them away and bring in others who can respond to this need.

Each of us have a responsibility to hold our governments to account for issues that matter, while not being drawn into meaningless games that maintain the power of the few over the many. If climate change is not highest on your agenda it ought to be, and you must act politically and responsibly to make sure your voice counts.

If not for the indigenous and minority communities now, then for yourself and your own loved ones tomorrow.

Climate Change Deniers Violate Human Rights

Cooking with a biogas stove, photo: Sven Torfinn

By Eco Matser
AMSTERDAM, Jul 8 2019 – Whoever still thinks climate change is purely an environmental issue, threatening only nature, needs to think again. Climate change is also essentially a human issue because of its devastating effect on human life – and rights. It exacerbates existing inequalities, undermines democracy and threatens development at large. Likewise, by far the greatest burden will fall on those already in poverty, while the rich will be able to buy their way out of rising heat and hunger.

Human rights and climate change

The latest report on climate change and poverty by the UN Special Rapporteur on extreme poverty and human rights puts it bluntly: “climate change threatens the full enjoyment of a wide range of rights,” – from the right to land, resources and food, to the right to good health. It will spark conflicts and aggravate all current forms of insecurity.

Equally important will be the impact on democracy. As the UN report outlines, governments struggle to get support for (the costs of) action to combat climate change and the major socio-economic transformations this requires. “In such a setting, civil and political rights will be highly vulnerable.”

We at Hivos, and a number of organizations and individuals with us, have long warned about the terrible impact climate change can have on development and how it so unfairly affects people living in poverty. For years, we have been calling for an integrated approach to combatting climate change that benefits both the environment and development goals. Here’s why:

 

Exacerbating poverty and inequality

People in poverty are far more vulnerable to climate shocks because they have fewer resources available to adapt or make themselves resilient. Hence, they are driven deeper into poverty. For example, farmers risk losing their income due to drought or other extreme weather, and (fishing) communities living in coastal areas will have to flee rising sea levels.

Eco Matser, Hivos global Climate Change / Energy and Development Coordinator

Eco Matser, Hivos global Climate Change / Energy and Development Coordinator

Apart from increasing inequalities between rich and poor, climate change is also causing a growing divide between ethnicities, the sexes, generations and communities (Amnesty International). Areas inhabited largely by migrants and ethnic or racial minorities are more exposed to problems like industrial pollution, overcrowding, food insecurity, landslides, and the impacts of resource extraction; women and girls are disproportionately affected across the board; (indoor) air pollution is particularly harmful to children and the elderly; and the lands of indigenous people are more vulnerable to changing weather patterns.

 

Reduced productivity

And there is the threat to all our economies. At present, heat stress already causes loss of productivity. This will rise to 2 percent of working hours by 2030 even if we manage to maintain the global temperature increase below 1.5°C, estimates Moustapha Kamal Gueye, Coordinator of the ILO’s Green Jobs Program.

 

The risk of “climate apartheid”

The UN report also cites what is possibly the most disturbing risk of all. A new era of “climate apartheid” where the wealthy pay to escape rising temperatures, hunger, and conflict while the rest of the world is left to suffer. “Perversely, the richest who have the greatest capacity to adapt and are responsible for and have benefitted from the vast majority of greenhouse gas emissions, will be the best placed to cope with climate change, while the poorest, who have contributed the least to emissions and have the least capacity to react, will be the most harmed,” the report states.

 

A just transition

For all these reasons, mitigating climate change is an urgent human rights obligation. But it also provides a huge opportunity to enhance these rights. The transition to a low carbon economy would actually strengthen workers’ and women’s rights and reduce the divide between individuals and between communities.

Providing access to clean and affordable energy resources will increase the (economic) wellbeing of people currently living in poverty. Replacing firewood with “clean” solar, biogas or electric cooking equipment not only reduces carbon emissions but provides much healthier conditions for women and children. The same goes for the energy needs of (remote) off-grid rural communities, which can be much easier met by wind and solar energy sources that in turn do not harm the environment. In fact, it is estimated that the renewable energy sector alone will create 18 million new jobs – also for the underprivileged.

 

Making the right link

Linkages made by some human rights organizations have referred to specific issues like the “right to food” or the “land rights” of indigenous peoples. But they barely ever make the connection between climate change and human rights writ large. This is we so warmly welcome the UN report on climate change and poverty.

Governments and the private sector have equally failed to integrate the two. In the Paris Agreement, governments committed to reduce greenhouse gas emissions and support climate vulnerable countries to adapt to irreversible consequences. But missing is the fact that people have the right to be protected against climate change. That there needs to be a just transition, ensuring gender equality, and minority and indigenous rights, while reducing economic and social inequalities. And that the implementation should be transparent and participatory, in accordance with the right to information.

The private sector also has a huge role to play. Fossil fuel companies in particular must take responsibility for the negative climate effects they cause and transition to renewable energy, phasing out fossil fuel exploration and use.

 

Climate change policies must be human rights policies

In conclusion, integrating human rights into climate change policies will simply improve and expand their effectiveness. As the UN report states, “This crisis [climate change] should be a catalyst for states to fulfil long ignored and overlooked economic and social rights, including to social security and access to food, healthcare, shelter, and decent work.”

This opinion piece was originally published here

Sustainable Development Needs a Hardware Update

By Jens Martens
BONN, Jul 8 2019 – When UN Member States adopted the 2030 Agenda and its SDGs in September 2015, they signalled with the title Transforming our World that ‘business as usual’ is no longer an option and fundamental changes in politics and society are necessary.

Four years later they have to admit that they are off-track to achieve the SDGs. The global civil society report Spotlight on Sustainable Development 2019 shows that in many areas there is no progress at all, and in some even regression.

Destructive production and consumption patterns have further accelerated global warming, increased the number of extreme weather events, created plastic waste dumps even in the most isolated places of the planet, and dramatically increased the loss of biodiversity.

Fiscal and regulatory policies (or the lack of) have not prevented the accelerated accumulation and concentration of wealth but have only made them possible, and thus exacerbated social and economic inequalities.

Systemic discrimination keeps women out of positions of power, disproportionately burdens them with domestic and care-giving labour and remunerates their formal employment less than it does that of men.

Total global military expenditure reached the historic high of US$ 1.822 trillion in 2018. In contrast, net ODA by members of the OECD Development Assistance Committee (DAC) was only US$ 153.0 billion in 2018, thus less than one tenth of global military spending.

Most governments have failed to turn the proclaimed transformational vision of the 2030 Agenda into real transformational policies. Even worse, national chauvinism and authoritarianism are on the rise in a growing number of countries, seriously undermining the social fabric, and the spirit and goals of the 2030 Agenda.

… but there are signs of change

Despite these gloomy perspectives, there are signs of push-back. In response to the failure or inaction of governments, social movements have emerged worldwide, many with young people and women in the lead.

They do not just challenge bad or inefficient government policies. What they have in common is their fundamental critic of underlying social structures, power relations and governance arrangements.

Thus, the implementation of the 2030 Agenda is not just a matter of better policies. The current problems of growing inequalities and unsustainable production and consumption patterns are deeply connected with power hierarchies, institutions, culture and politics. Hence, policy reform is necessary but not sufficient. Meaningfully, tackling the obstacles and contradictions in the implementation of the 2030 Agenda and the SDGs requires more holistic and more sweeping shifts in how and where power is vested, including through institutional, legal, social, economic and political commitments to realizing human rights.

In other words, a simple software update (of policies, norms and standards) is not enough – we have to revisit and reshape the hardware of sustainable development (i.e. governance and institutions at all levels).

Strengthening bottom-up governance

Re-visiting the hardware of sustainable development has to start at the local and national level. While most governance discourses emphasize the democratic deficit, gaps and fragmentation in global governance, the major challenge for more effective governance at the global level is the lack of coherence at the national level. Therefore, it is necessary to strengthen bottom-up governance.

Bottom-up governance refers not only to the direction of influence from the local to the global. It also calls for more governance space to be retained at local and sub-national levels.

It enables, for instance, indigenous peoples, small farmers and peasant communities to exercise their rights in retaining their seeds, growing nutritious foods without genetically modified organisms, and accessing medicines without paying unaffordable prices set by transnational companies and protected by intellectual property rights.

The same is true for universal access rights to social protection. Social protection needs to be owned and governed by sub-national and national governments with fiscal space created in national budgets.

Universal, free access to essential public services are the foundation blocks of the SDGs and at the core of local governments’ commitment to the 2030 Agenda.

However, the privatization of public infrastructure and services and various forms of public-private partnerships (PPPs) often have had devastating impacts on service accessibility, quality and affordability.

Responding to these experiences, counter-movements emerged in many parts of the world. Over the past 15 years there has been a significant rise in the number of cities and communities that have taken privatized services back into public hands.

Achieving the SDGs will not happen without an enabling environment at international level. But what we often see is a disabling environment that makes it difficult to raise the urgently needed domestic resources.

Local and national (fiscal) policy space is often limited by external interventions. The International Monetary Fund (IMF) plays a central role in this regard. In many countries, for instance Egypt and Brazil, IMF recommendations and loan conditionalities have led to deepening of social and economic inequalities and threats to human rights.

No policy coherence without governance coherence

In endorsing the 2030 Agenda governments committed to enhancing policy coherence for sustainable development (SDG target 17.14) and to respect each country’s policy space (SDG target 17.15).

The achievement of these targets is constantly undermined by the inherently asymmetric nature of the global governance system with the IMF and World Bank dominating discourse and policies. Thus, policy coherence will not be possible without overcoming governance incoherence.

The current system of global (economic) governance is marked by systematic asymmetry. The most striking example is the asymmetry between human rights and investor rights.

Today’s trade and investment agreements give transnational corporations far-reaching special rights and access to a parallel justice system to enforce them, the Investor-State Dispute Settlement (ISDS) system.

Removing the ability of investors to sue States in the ISDS system and similar rules in investment and trade agreements would be a first step in reducing the systematic asymmetry in global governance. It would also be a step towards governance coherence for sustainable development.

Overcoming the weakness of the HLPF

Enhancing governance coherence also means that the relevant UN bodies, particularly the High-level Political Forum (HLPF), must be strengthened and no longer de facto be subordinated to the international financial institutions and informal clubs like the G20.

Governments established the HLPF as a universal body and gave it a central role in overseeing a network of follow-up and review processes at the global level.

But compared to other policy arenas, such as the Security Council or the Human Rights Council, the HLPF remained weak.

The SDG Summit in September 2019 and the HLPF review process to take place in 2019-2020 are opportunities to reposition the HLPF more firmly in the General Assembly machinery, similar to the direction taken by the Member States for the Human Rights Council (HRC) in 2005.

With an agenda of equal importance and intimately connected to those of the HRC, the General Assembly should transform the HLPF to a Sustainable Development Council, supported with complementary machinery at regional and thematic levels.

But the claim to make the UN system ‘fit for purpose’ requires more than upgrading the HLPF and its related fora.

Democratic governance requires democratic funding

Adequate funding at all levels is a fundamental prerequisite to improve the governance of SDG implementation. At the global level this requires the provision of predictable and reliable funding to the UN system.

Governments should reverse the trend towards voluntary, non-core and earmarked contributions as well as the increasing reliance on philanthropic funding. Democratic governance requires democratic funding instead of unpredictable support from private foundations of wealthy individuals.

Parallel to the global level the widening of the public governance space requires, among other things, changes in fiscal policies at national level. This includes, for example, taxing the extraction and consumption of non-renewable resources, and adopting forms of progressive taxation that prioritize the rights and welfare of poor and low-income people (e.g., by emphasizing taxation of wealth and assets).

Fiscal policy space can be further broadened by the elimination of corporate tax incentives and the phasing out of harmful subsidies, particularly in the areas of industrial agriculture and fishing, fossil fuel and nuclear energy.

Instead of engaging in a new arms race, governments should reduce military spending and reallocate the resource savings, inter alia, for civil conflict prevention and peacebuilding.

But as the massive protests by the yellow vests movement in France against rising fuel prices just recently demonstrated, interdependencies between environmental and social policy goals and targets require particular attention. Many environmental policy instruments have regressive effects on income distribution.

But if priorities are properly defined and interdependencies effectively anticipated, fiscal policies can become a powerful instrument to reduce socioeconomic inequalities, eliminate discrimination and promote the transition to sustainable production and consumption patterns.

Revitalizing global norm-setting – rejecting corporate voluntarism

Enhancing governance coherence requires providing the institutions responsible for the implementation of the 2030 Agenda and the SDGs not only with the necessary financial resources but also with effective political and legal instruments.

At global level this requires changing the current course of relying on non-binding instruments and corporate voluntarism. This is particularly relevant in areas where significant governance and regulatory gaps exist.

The currently discussed post-2020 global biodiversity framework should include binding targets and implementation commitments for State Parties, in accordance with the principle of common but differentiated responsibilities.

With regard to the governance of the oceans, there is currently no mechanism that coordinates the different legal frameworks, making it difficult to effectively address conflicts of interest. This is particularly relevant with regard to deep sea mining. To overcome these governance gaps may require even a new UN body on Oceans.

There is also a need for a legally binding agreement to tackle plastic pollution. Many civil society organizations and legal experts call for a new global Convention on Plastic Pollution with a mandate to manage the lifecycle of plastics, including production and waste prevention.

Governance and regulatory gaps exist as well in the global digital economy. Self-regulation of internet companies will not work, and regulation through e-commerce trade agreements will not work either.

The Internet Governance Forum (IGF) of the UN has the potential to advance in this arena, but it lacks authority and does not have the mandate to make any rules.

Corporate social responsibility initiatives, such as the UN Global Compact, and voluntary guidelines, such as the UN Guiding Principles on Business and Human Rights (UNGP) have particularly failed to hold corporations systematically and effectively accountable for human rights violations.

The Human Rights Council took a milestone decision in establishing an intergovernmental working group to elaborate a legally binding instrument (or ‘treaty’) to regulate the activities of transnational corporations and other business enterprises.

This ‘treaty process’ offers the historic opportunity for governments to demonstrate that they put human rights over the interests of big business.

UN2020 – democratic global governance at the crossroads

Scientists warn that the world is moving fast towards tipping points with regard to climate change and the loss of biodiversity, that is, thresholds that when exceeded can lead to irreversible changes in the state of the global ecosystem.

Similarly, the system of global governance is facing tipping points that, when transgressed, lead to irreversible changes. Multilateralism is in crisis.

But, as medical doctors tell us, a crisis points to a moment during a serious illness when there is the possibility of suddenly getting either worse or better.

There is still the danger of exacerbating authoritarianism and national chauvinism, and of not only shrinking but vanishing space for civil society organizations in many countries.

But there is also a rapidly growing global movement for change, a movement that takes the commitment of the 2030 Agenda to “work in a spirit of global solidarity” seriously.

The year 2020 with its official occasions, particularly the 75th anniversary of the United Nations, provides an important opportunity to translate the calls of the emerging global movements for social and environmental justice into political steps towards a new democratic multilateralism.