Issue Type: Biomedical Research

Humane Society International

Liver chip aav expression
Emulate

In 2021, the number of animals used for research testing in South Korea reached a record high of 4.8 million. This trend of increased animal testing in South Korea cuts against the global trend of development and adoption of innovative, non-animal approaches—the New Approach Methodologies. Despite its current reliance on animals, South Korea is actively involved in the pursuit of innovative approaches including organ-on-a-chip technology, organoids and computer-based modelling. However, wider adoption of NAMs is slow and could be accelerated through stronger harmonization of efforts involving regulatory authorities and other stakeholders.

To provide the legislative support needed to advance the use of of NAMs, HSI/Korea has been working with lawmakers, researchers, and industries to pass the PAAM Act. This bill, the Act on the Promotion of Development, Dissemination and Use of Alternative to Animal Testing Methods, was introduced in 2020 at Korea’s National Assembly by Assemblymember Ms. In-soon Nam.

As a part of ongoing efforts to raise stakeholder awareness around the PAAM Act and the need for wider adoption of NAMs, HSI/Korea’s director of government affairs, Borami Seo, spoke to Dr. Lorna Ewart, chief scientific officer at Emulate, Inc. Emulate produces human cell-based technologies that recreate human biology, Organ-Chips, also known as microphysiological systems. We asked Dr. Ewart to explain how these technologies can shift the paradigm of health research toward more human-predictive methods.

HSI: For those readers who are unfamiliar with organ-on-a-chip technology, could you briefly explain what it is?

Lorna Ewart: OOC is an in vitro model that allows cells to exist and function as if they were in the human body. We believe that if the cells are in an environment familiar to them, they will function like they would in the human body. Therefore, the data we generate from these models, can be translated into whole human body response, increasing the translational value of the data.

HSI: OOC is still a new technology. What are the challenges that you have been facing?

Lorna Ewart: At Emulate, we see five major challenges. One, scientists need to be convinced that the microfluidic platform is robust and reliable. Now that we can show this, the next challenge is sourcing good quality human cells. Cell quality is a challenge for the industry at large, but it is important because good cells make good models, and this equals good data. The third challenge is ensuring that we reduce the complexity of operation. We want to make it as easy as possible for scientists to work with our instruments to generate data. The next challenge would be answering the question, “Why bother using organ-chips when there are other methods?” We need to demonstrate the value of data generated using OOC. Lastly, there are many organizations developing OOC models. Engineers are building diverse microfluidics platforms or designing different chips. Many people in this field believe that having different types, shapes and sizes of instruments or chips is slowing the field down. Therefore, there are many discussions around the standardization of the technology which will accelerate adoption and ultimately commercialization of OOC, but standardization too soon may reduce overall innovation.

HSI: What are the prospects of OOC? How far has the commercialization process come?

Lorna Ewart: At Emulate, we work with academic researchers, scientists in the pharmaceutical industry, and government agencies, predominantly the US Food and Drug Administration. Those scientists are either using models that we have developed or we train them to build their own models. Emulate currently has validated workflows and applications for five major organs: the liver, the colon intestine, the duodenum intestine, the brain and the kidney. However, our customers have built over 70 various combinations of models and applications.

In terms of commercialization, Emulate began to be commercially active in 2018. We sell the Human Emulate System, which includes the chips, the microfluidic instrument, software and accessories needed for scientists to use OOC in their research. If researchers want, they can also buy cells from Emulate, which we call a “Biokit,” across the five organ models we are building. Or customers can buy chips that are compatible with the microfluidic instrument and build models using their own cells. We also perform fee-for-service studies where customers ask us to perform the experiment on their behalf, often involving one of their assets.

HSI: For regulatory adoption, standardization seems to be the next step. How does it work with regulators?

Lorna Ewart: The US and EU regulatory authorities welcome the fact that OOC platforms represent a credible approach to animal models. They are specifically interested to learn if these new models can provide data that closely resemble human responses and that they are reproducible and reliable.

Regulatory authorities want to understand the relevance of the data that OOC can provide. This is because they are primarily interested in safety data generated from OOC. The regulator’s role in progressing candidate drugs into clinical trials relies on demonstrating that it is safe for humans. In subsequent phases of clinical development, efficacy is of paramount importance. Models that show a high degree of human relevance will give the regulators greater confidence to progress the candidate drug into the clinic. We should also remember that regulators also want confidence in drug efficacy and OOC can also be used for this purpose and may also reduce the use of animals.

HSI: Can you give us an example where OOC is used to generate safety data and show its value?

Lorna Ewart: According to current regulatory guidelines, candidate drugs are required to be tested in two animal species, typically a rat and dog, when considering small molecules.

In November 2019, Emulate published in Science Translational Medicine, describing the simultaneous development of rat, dog, and human Liver-Chips. We demonstrated that species chips were able to reproduce species-specific toxicity, importantly highlighting where chips could highlight toxicities that were not relevant to human, therefore enabling a candidate drug to progress but equally showing that toxicity detected in human Liver-Chips should be considered very carefully before progressing to a clinical trial. Regulatory authorities are very interested in understanding how this technology can be used to generate more human-relevant data like this.

To my knowledge, there has been no declaration of any pharmaceutical companies stating the use of OOC instead of animal models for safety testing. But I believe it will happen.

HSI: How is OOC replacing animal testing?

Lorna Ewart: I see that OOC has a role in each of the categories of the 3Rs: Replacement, Reduction and Refinement.

Reduction is probably the first example where OOC will impact. Emulate recently completed the single largest Organ-Chip study to date where we evaluated the performance of the human Liver-Chip across 27 small molecules that had been in the clinic. Liver-Chip was able to detect 9 out of 10 drugs that resulted in clinical hepatotoxicity. As such, we propose that scientists should adopt this model and use it before dose range finding studies in animals. By doing this, scientists can identify hepatoxic drug candidates earlier in their screening cascades. They would therefore not need to perform the in vivo study for this candidate, thus reducing the number of animals used. Ultimately, as more organ chip models show a high predictive value for clinical outcome, conversations about the steps towards replacement of animals can begin.

Refinement may be a little harder to demonstrate but it is possible to use OOC to understand the exposure ranges and therefore avoid exposing animals to unnecessarily high doses of the candidate drug.

HSI: Do you see researchers moving away from animal testing? What’s your perspective on this?

Lorna Ewart: I sense that there is growing momentum in the field of animal model alternatives. I believe we are in very exciting times, perhaps at the tip of the iceberg with growing voices from younger scientific generations questioning the validity of animal testing, especially as technology continues to advance.

Governments can also play a major role. Korea’s PAAM Act will help accelerate the acceptance and use of NAMs. Discussions in the European Union are also pushing scientists to think differently. It’s not going to happen just through one organization, one scientist alone. It’s partnership work.

HSI: Regarding the role of government, do you have any suggestions how Korean government can encourage the OOC field and move towards non-animal approaches?

Lorna Ewart: Firstly, the technology has huge potential, but the field needs further investment to continue to improve it and realize its full value. If the Korean government can consider targeted investment towards non-animal alternatives such as human relevant models, it would drive the field forward.

Additionally, government can also proactively encourage the use of new technologies especially when it comes to developing pharmaceutical products. This can be done by positively choosing to use alternatives rather than accepting the traditional norm of animal testing.

HSI: Regarding Korea’s PAAM Act, how do you think it will contribute to advancing science communities?

Lorna Ewart: Researchers will be able to use the best tools available to them, instead of being limited by animal models, which are known to have translational issues. By reducing our global reliance on non-human testing methods and instead leveraging human biology for human drug development, we anticipate the combination of human biology and technology to usher in a new era in human health.

Reference in this article to any specific brand, trade, firm or corporation name is for the information of the public only, and does not constitute or imply endorsement by Humane Society International or its affiliates of any specific company or its products or services, and should not be construed as or relied upon, under any circumstances, by implication or otherwise, as investment advice. The views and opinions expressed in the article do not necessarily state or accurately reflect those of Humane Society International or its affiliates.

Humane Society International

sirius_r/iStockphoto

SEOUL, South Korea—Humane Society International/Korea welcomes the introduction of the Act on the Vitalization of Development, Dissemination, and Use of Alternatives to Animal Testing Methods (VAAM Act). Assembly member Jeoung Ae Han and 12 other National Assembly members introduced the measure on December 23rd.

In an era with so many questions arising around the scientific validity of animal testing carried out in relation to food, pharmaceutical and chemical safety, there are also increasing efforts to develop and standardize alternatives to animal testing approaches.

The VAAM Act was introduced to emphasize the urgency of passing a bill introduced in December 2020, that supports non-animal technology development and adoptionAssembly member In-Soon Nam introduced the earlier bill, the Act on the Promotion of Development, Dissemination and Use of Alternatives to Animal Testing Methods (PAAM Act).

Assembly member Han explained the aim of the new bill: “There needs to be a legislative system to actively share research information and support for alternatives to animal testing using innovative approaches by cross-ministerial authorities. We need to improve public health with advanced science, following global examples.”

As HSI/Korea director of government affairs, Borami Seo observed, “There are challenges in using internationally recognised alternative methods in Korea due to different guidelines provided by various ministries. It is important that our central ministries come together to support non-animal approaches with strategic plans from development to implementation. Assemblymember Nam’s December, 2020 was a first step. Together, the VAAM Act. and  PAAM Act will serve to prioritize the importance of human biology-based methods without using animals. That’s great for people and animals.”

ENDS

Media contact: Borami Seo bseo@hsi.org

Bill 70/2014, backed by Humane Society International, passed a plenary session vote in the Senate, advancing bill to final legislative step

Humane Society International

HSI

BRASILIA—After nearly a decade in the National Congress, Bill 70/2014, which aims to enact a federal ban on animal testing for cosmetics in Brazil, passed the Senate today. The amended bill, which represents the collaborative work of Humane Society International and the Brazilian Association of the Personal Hygiene, Perfumery and Cosmetics Industry, garnered the support of Sen. Alessandro Vieira, Sen.  Eliziane Gama andSen.  Nelsinho Trad. The Liberte-se da Crueldade Brazil campaign, launched in 2012, led by Humane Society International in Brazil in partnership with the NGO Te Protejo, handed in more than 1.6 million signatures to the President of the Senate demonstrating citizen support to encourage the swift vote of this bill, which has been dwelling in Congress for nearly a decade.

Humane Society International in cooperation with the Brazilian Association of the Personal Hygiene, Perfumery and Cosmetics Industry strengthened the bill language to reflect international best practices in non-animal testing methods. Stakeholders achieved a consensus, highlighting that cosmetics animal testing on products and their ingredients was unnecessary, leading to the unanimous vote of the amended bill, marking a significant milestone for animals used in laboratories in Brazil.

Antoniana Ottoni, public affairs specialist from HSI, said: ‘We’ve achieved a significant milestone today. After nearly a decade in Congress, we were finally able to pass this in the Federal Senate. We are very pleased to see this bill moving once again. This was a joint effort between Humane Society International, the Brazilian Association of the Personal Hygiene, Perfumery and Cosmetics Industry and the politicians who have supported this issue. We thank the president of the Senate for championing this bill, along with all senators who continue to reinforce this issue in Congress. We look forward to working with all stakeholders to move the bill swiftly through the final legislative stage to become law.”

Senator Nelsinho Trad said: “It is our duty to protect animals. I am happy to endorse this matter and with the movement of the Federal Senate in favor of the cause. Now, we urge colleagues in the Chamber of Deputies to analyze the substitutive text and approve it as soon as possible.”

The next step for this project to become a federal law will be a debate and vote in the Chamber of Deputies, which could make Brazil the 43rd country to ban animal testing for cosmetics.

Facts:

  • Animal testing for cosmetics can  subject rabbits, guinea pigs and mice to eye/skin irritation, eye/skin corrosion, acute toxicity (LD50), and other tests s without pain relief. Consequences of this type of experimentation are permanent skin injuries, blindness, eye irritation, stress, intoxication and death.
  • Worldwide, there are already 42 countries that have banned animal testing for cosmetic purposes, including India, Norway, Switzerland, South Korea, Australia, Colombia, Mexico and those belonging to the European Union. At the national level, the Federal District and 13 states in Brazil have legislated through state laws to end these practices: São Paulo, Rio de Janeiro, Mato Grosso do Sul, Minas Gerais, Amazonas, Pará, Santa Catarina, Paraná, Pernambuco, Espírito Santo, Acre and Paraíba. However, Bill 70/2014 seeks to ban experimentation on animals for cosmetics at the federal level, thus including all states in the country.
  • More than 2,000 “cruelty-free” beauty brands are available worldwide. These companies produce safe products by using ingredients that have a history of safe use along with modern reliability assessment tools without the need for animals. HSI recommends reviewing the list of brands free of animal testing in Te Protejo Brasil.

ENDS

Media Contact: Antoniana Ottoni: +556181403636; aottoni@hsi.org

Humane Society International / Global

HSI

SEOUL—Humane Society International/Korea has won an “Outstanding Contribution to Society” award, given by the Korean Society for Alternative to Animal Experiments.

The award is sponsored by KSAAE every year to recognize individual academics and institutions and entities that contribute to the promotion of alternative approaches to animal testing. The award ceremony was held at the 3rd Asia Congress for Alternatives to Animal Experiments in Korea. Congress participants, along with representatives from South Korea, Japan, China, India, Europe, and USA joined in congratulating HSI/Korea on receiving the award.

HSI/Korea has been active in public awareness and legislative campaigns focusing on the chemical toxicity, medical and biologicals fields to remove obsolete animal tests and promote non-animal methods using state-of-the-art technologies. Even as interest in adopting human-biology relevant approaches increases worldwide, regulatory acceptance and use of such human-predictive methods remain slow in Korea.

HSI/Korea, director, government affairs Borami Seo said “We are thrilled to receive this “Outstanding Contribution to Society” award. HSI/Korea would like to share this honor with the many parties who supported our mission to promote animal testing replacement for better science. Right now, there is a bill, the Act on the Promotion of Development, Dissemination and Use of Alternatives to Animal Testing Methods in the national assembly and we urge the government to support this measure in the interest of Korean scientific communities and public health.”

ENDS

Media Contact: Borami Seo: bseo@hsi.org

Humane Society International

guinea pig being injected
Guinea pigs, rabbits, mice, birds and other animals were used in testing by the thousands. 

Brazil’s Ministry of Agriculture (MAPA) has introduced a new regulation making it possible for companies to forego two obsolete and scientifically unnecessary animal tests for quality control of veterinary biological products such as vaccines. The move has been welcomed by Humane Society International, which has been working in Brazil and across the globe with regulatory authorities and industry stakeholders to eliminate and replace obsolete animal testing from regulations for both human and veterinary biological products, promoting a global regulatory alignment in the way non-animal tests are accepted and implemented.

The animal tests impacted by the new Brazilian regulation – the Target and Laboratory Animal Batch Safety Tests – were developed nearly a century ago, consumed vast numbers of mice, guinea pigs, birds and larger animals, and are now widely regarded as unnecessary for assuring the safety of veterinary biologicals. Following a comprehensive scientific review, Brazil has decided to join the United States, Europe, Japan and other major economies in allowing companies to waive these tests.

Antoniana Ottoni, federal affairs specialist for Humane Society International in Brazil, said, “This welcome regulatory reform is a true win-win-win – sparing animals needless suffering and death, reducing costs and bureaucracy for companies and authorities, while ensuring a high standard of quality and safety for veterinary medicines in Brazil. We are grateful to colleagues in our Agriculture Ministry for their collaboration and willingness to break from a century old tradition in favour of alignment with the growing international scientific and regulatory consensus.”

Marcos Vinícius Santana Leandro, auditor and General Coordinator of Veterinary Products in MAPA’s Department of Animal Health said, “The Ministry of Agriculture, Supply and Livestock took the decision to install an official process for waiving animal tests for quality control for veterinary products, aware that the safety of these products can be achieved by improving the manufacturing process, which have come a long way over the past few decades, introducing strict controls over starting materials and the development of Good Manufacturing Practices (GMP), quality assurance and control, and pharmacovigilance systems. These advances have contributed to the creation of a safe environment in which waiving these tests has become a viable and safe possibility. In addition, it will enable the regulatory harmonization necessary to reduce bureaucracy in the registration of health veterinary products of extreme relevance to animal health and the development in our country.”

The new MAPA regulation is available here.

Fans can vote online to help Save Ralph win internet’s top honor

Humane Society International

HSI

WASHINGTON, DC—Humane Society International announced today that Save Ralph has been nominated for best Public Service & Activism video in the 26th Annual Webby Awards. Hailed as the “Internet’s highest honor” by The New York Times, The Webby Awards, presented by the International Academy of Digital Arts and Sciences, is the leading international awards organization honoring excellence on the Internet.

Save Ralph is a stop-motion animation short film produced in several languages by Humane Society International (HSI) in support of its global campaign to end cosmetic testing on animals. Written and directed by Spencer Susser and produced by Jeff Vespa in partnership with HSI and the Arch Model studio of puppet maker Andy Gent, the film features HSI’s campaign spokesbunny Ralph, as he goes through his daily routine as a “tester” in a lab. HSI’s #SaveRalph campaign tackles the disturbing issue of animal testing in an original and unexpected way—using the story of one bunny to shine a light on the plight of countless rabbits and other animals suffering in laboratories around the world, engaging viewers to help ban animal testing for cosmetics. The English-language film features a star-studded cast including Oscar winner Taika Waititi as Ralph, along with Ricky Gervais, Zac Efron, Olivia Munn, Pom Klementieff and Tricia Helfer. Save Ralph was also produced in French, Portuguese, Spanish and Vietnamese, and subtitled in multiple other languages, to support HSI’s efforts to reach hearts and minds of consumers and lawmakers in Canada, Brazil, Chile, Mexico, Southeast Asia and beyond.

“Nominees like Save Ralph are setting the standard for innovation and creativity on the Internet,” said Claire Graves, president of The Webby Awards. “It is an incredible achievement to be selected among the best from the 13,500 entries we received this year.”

“We are absolutely thrilled that Save Ralph is being recognized by the Webby Awards. This nomination provides a fantastic opportunity for Ralph to continue shining a global spotlight on the cruelty of cosmetic testing on animals to a new audience and the need to ban this practice around the world,” said Donna Gadomski, Save Ralph executive producer and HSI senior director of external affairs.

“Save Ralph has had a tremendous impact on Humane Society International’s efforts to end cosmetic testing on animals globally since its premiere last April,” said Troy Seidle, Save Ralph executive producer and HSI vice president of research and toxicology. “This film has motivated millions of people around the world to sign HSI’s petition to outlaw this cruel and obsolete practice, propelling Mexico to become the first North American country to ban cosmetic testing on animals, and is helping advance our legislative efforts in several other countries. We’re excited that the Webby recognition may help continue this momentum.”

As a nominee, Save Ralph is also eligible to win a Webby People’s Voice Award, which is voted online by fans across the globe. From now until April 21st, Save Ralph fans can cast their votes at Webby Awards People’s Voice .

Winners will be announced on Tuesday, April 26, 2022, and honored in a star-studded show at Cipriani Wall Street. Winners will have an opportunity to deliver one of The Webby Awards’ famous 5-Word Speeches. Past 5-Word Speeches include: Steve Wilhite’s “It’s Pronounced “Jif” not ‘Gif’; NASA’s “Houston We Have A Webby”; and Solange’s “I Got Five On It.”

ENDS

Media contact: Cassie Bodin-Duval, international coordinator in media relations: cbodinduval@hsi.org

Humane Society International is pleased by changes in national regulations to minimize animal use in school supplies safety assessment

Humane Society International

mustafagull/iStock.com 

RIO DE JANEIRO—Humane Society International is excited to announce that animal-free safety assessment of school supplies is now possible in Brazil. Previously, rats and rabbits were routinely used to test paints, glues and other school supplies. HSI worked together with Brazilian stakeholders to change the requirements for school supplies safety, avoiding the use of many animals.

Although several non-animal methods have been accepted in Brazil since 2014, due to lack of clarity animals are still routinely used. Non-animal assessment of school supplies first required changing the Brazilian National Standards Association (ABNT) norm for school articles safety to allow assessment of the product based on existing information on its ingredients. Another important change is the requirement that animals are used only as a last resort and only when technical justifications are present. These unprecedented changes have been codified in ABNT NBR 15236:2021, published on Sept. 9.

The second required change was for the registering authority to refer to this new norm, which was published on Oct. 8 in the Inmetro Ordinance number 423. This makes the ABNT 15236:2021 the mandatory requirement for toxicological safety assessment and school supplies compliance in Brazil.

These regulatory changes are the result of a joint effort and HSI appreciates the discussions involving different stakeholders and the important support provided by the National Council for the Control of Animal Experimentation (CONCEA).

“These apparently simple changes ensure child safety while avoiding the unjustifiable use of many animals in safety assessment of school supplies in Brazil,” said Dr Bianca Marigliani, HSI’s science advisor. “These changes also set the precedent for the kind of regulatory clarity that is needed to finally implement non-animal methods in chemical safety assessment in Brazil and bring us closer to regulatory harmonization with other countries.”

ENDS

Media Contact: Bianca Marigliani: bmarigliani@hsi.org; +55 11 97635-6068

Additional Information:

According to Brazilian regulations, all school supplies with more than 3 grams of paints, glues, gouaches, watercolors and powered material per unit of use must have their safety confirmed regarding acute oral toxicity. Those susceptible to skin contact must also have their safety confirmed for skin irritation. According to the previous version of the ABNT 15236 (Amendment 1, published in May, 2020), acute oral toxicity and skin irritation could be assessed by in vivo or in vitro methods, which means the laboratories were free to choose between testing on living animals or using alternative methods, in these cases, cell cultures. In addition, in Brazil safety testing has traditionally been performed on finished products, which is expensive, time consuming and has significant limitations, mostly counting on animal testing.

The Research and Toxicology Department of HSI in Brazil identified that ABNT Brazilian Norm 15236:2020 was in disagreement with:

  • the Three Rs principle, which stands for reduction, refinement and replacement of animal use;
  • the Environmental Crimes Law (Law number 605/1998), which considers it a crime to use living animals for scientific purposes when there are alternatives; and
  • the Normative Resolution number 18 of the CONCEA, which recognized alternative methods for different endpoints, including an alternative (non-animal) method for skin irritation, and with a five-year deadline for mandatory replacement of the animal method, ended in September, 2019.

Aware of the possibility of an unjustified and wrongful use of animals for conformity assessment of school supplies, HSI managed to engage CONCEA and ABNT on the discussion to change the ABNT 15236 norm. ABNT organized a series of online meetings with HSI and CONCEA members, representatives of laboratories and school supplies industries and other stakeholders to discuss HSI suggestions for changing the ABNT requirements for safety assessment of school supplies. After two rounds of public consultation, HSI’s suggestions were accepted and ABNT standard 15236:2021 was published on Sept. 9, 2021.

The main changes by endpoint are the following:

  • for both acute oral toxicity and skin irritation, the ingredient-based safety assessment is the recommended strategy.
  • for acute oral toxicity, in vitro methods can be used if it is not possible to perform ingredient-based safety assessment, and in vivo methods are only allowed as a last resort and when there is technical justification (e.g. sample incompatibility with the in vitro test).
  • for skin irritation, an integrated approach on testing and assessment (IATA) must be followed, if new tests are needed, in vitro methods can be used, and in vivo methods are only allowed as a last resort and when there is technical justification.

The ABNT 15236:2021 is now cited by the consolidated version of the Inmetro Ordinance number 423, which determines the requirements for conformity assessment of school supplies. This makes the ABNT 15236:2021 the mandatory requirement for toxicological safety assessment and school supplies compliance in Brazil. The changes made to the ABNT 15236 ensure child safety while guaranteeing the use of animals as the very last resort, which can prevent the unjustifiable use of many animals in the safety assessment of school supplies.

Scientists, industry leaders and other specialists discussed why an Action Plan for the active phase-out of the use of animals in experiments is needed and provided examples of existing tools and procedures, which could be soon implemented by the European Commission

Humane Society International / Europe

Luchschen/istock

BRUSSELS— The Intergroup on the Welfare and Conservation of Animals organised an extraordinary meeting on Accelerating the transition to animal-free innovation, in partnership with Eurogroup for Animals and Humane Society International/Europe.

This special session featured a roundtable panel debate on the opportunities opened up by the European Parliament’s recently adopted resolution on an action plan to transition to animal-free innovation “with the aim of driving the active phase-out by reducing, refining and replacing procedures on live animals for scientific and regulatory purposes.”

The idea of phasing out animals used in laboratories is not new and was mentioned in Directive 2010/63 on the protection of animals used for scientific purposes. With that resolution in September, though, the EP recognised that an active, coordinated approach for reduction and, ultimately, the full replacement of animals has not been achieved. By requiring an EU-wide action plan with an ambitious timetable and list of milestones, the EP is aiming to actively drive the phase-out of animals used for all scientific purposes.

Kirsty Reid, Director of Science Policy at the European Federation of Pharmaceutical Industries and Associations, stressed the need for stronger collaboration and mentioned the existing good collaboration between industry and civil society, like the partnership with Humane Society International on the deletion of an obsolete animal-based safety test for some pharmaceutical products. She underscored her belief that government agencies and regulators must place more trust into innovative methods.    

One of the core ideas of the resolution is to promote new technologies capable of replacing animal models by providing data that are more relevant to human biology than animals. One of these technologies is organs-on-chips.

Thibault Honegger, CEO of The Neuro Engineering Technologies Research Institute, explained why organs-on-chips are so often described as a game-changing technology capable of better mimicking aspects of human biology than animals or simpler in vitro models. Honegger provided examples of organs-on-chips being used right now, like the Parkinson’s chip device and the one used to develop an anti-pain treatment, which are already having a direct impact on human health, in a way that could not have been achieved using animals. From his point of view, what the EC needs to include in the Action Plan is a global approach covering the entire production chain, and the enhancement of biobanks and cells databases, along with a dedicated stakeholders’ task force as in the US.

Another point underlined by the EP resolution centers on education in non-animal methods. There is little point in having the most advanced technologies in the world if very few people know how to use them. Prof. Beatriz Silva Lima, Dean of the Faculty of Pharmacy at the University of Lisbon, suggested that the EU, in order to foster the knowledge and use of new advanced non-animal methods in academic research, should make these methods more available to researchers because at the moment animal testing is still cheaper. So, even if there are different new advanced technologies (e.g. organoids and organs on chips), they are sometimes not affordable. Prof. Silva Lima also highlighted the need to facilitate access to human tissues and cells to foster the speedier development of human-focused models.  

Prof. Ingrid Visseren-Hamakers from the Radboud University shared her view that the European Commission, in order to ensure that this plan delivers significant reductions of animal use, improves health research and produces economic benefits, must link the Action Plan to other policy areas. Animal-free science is part of a larger set of trends including a shift in attitudes towards nonhuman animals. The EU Green Deal asks that we protect human health and the environment and to be able to do that we need new science, human-relevant science and transformative change. If we transform our society, for example using less chemicals and pesticides, changing our diets and moving towards a preventive curative system, we would need less animal testing and could proceed with the implementation of laws and policy that support a shift to non-animal methodologies.

Anja Hazekamp, President of the Intergroup, concluded by informing the audience that the Intergroup will now request a meeting with the European Commission to share the conclusions of the event and discuss views on the Parliament’s call for an Action Plan. 

ENDS 

Notes 

Agenda Accelerating the transition to animal-free innovation: Measures for an action plan to phase-out experiments on animals 

Israeli scientists recently developed a cancer drug without any animal tests by using chips with human kidney, liver and heart cells.  

‘Organs-on-chips’ represent a new market sector growing quickly at a rate of 28% per year, which means that the market size will be multiplied by 7 by 2030 according to projections.  

Contacts:

Agnese Marcon, Communications Manager, Eurogroup for Animals 

a.marcon@eurogroupforanimals.org 

+32 (0) 456 078 038 

Yavor Gechev, Communications Director, Humane Society International/Europe 

ygechev@hsi.org 

+359 (0) 88 946 8098 

Humane Society International

Bliznetsov/iStock.com

SEOUL, SOUTH KOREA—The National Assembly and Humane Society International/Korea have organized a biomedical research multi-stakeholder forum called Alternatives to Animal Testing with Scientific Approaches.

Co-hosting the event are the chair of National Assembly’s Health and Welfare Committee Minseok Kim, National Assembly members In-soon Nam and Hyun-young Shin, and the National Assembly Animal Welfare Forum. The forum is sponsored by the Ministry of Food and Drug Safety and the Osong Medical Innovation Foundation.

Prior to the forum discussion, the skin irritation test that was recently accepted by the Organisation for Economic Co-operation and Development will be showcased. This new method was developed using the model KeraSkinTM, funded by the Ministry of Food and Drug Safety’s Korea Center for the Validation of Alternative Methods. Kyung-Min Lim at Ehwa Womans University and the company Biosolution led this project. Now that the method is recognized as an international standard, it can be used for regulatory testing on cosmetics, industrial chemicals or biomedical devices.

Alternatives to Animal Testing with Scientific Approaches will be attended by representatives from Biosolution, BioToxtech, Korea Institute of Chemical Technology, Ministry of Food and Drug Safety, Nexel, Humane Society International/Korea and Bundang Seoul National University Hospital. Participants will share opinions on the current challenges, barriers in promoting alternatives to animal testing and what should change to move towards non-animal approaches.

In South Korea, while there are alternatives available, animal testing is still frequently used as the first option in research and toxicology. This is due to the lack of awareness and dissemination of new methods and has resulted in the widespread notion that alternatives are expensive or non-existent. This unfortunately discourages companies from proactively using newer, non-animal testing methods.

Committee Chair Minseok Kim said: “Animal testing replacement is relatively a new subject for health research in South Korea. However, as the technology advances and the general public is increasingly aware of animal welfare concerns, Korea is in a very good position to lead the health research and development that can mimic human responses rather than relying on animal models. I look forward to hearing from industries how we, lawmakers, can support the effort.”

Assembly member Nam said: “While there are research efforts to replace animal testing, we need a system where these research results can be disseminated, and industries are encouraged to practice them. Today’s dialogue is to understand the perspectives from relevant stakeholders in support of the bill, Act on the Promotion of Development, Dissemination and Use of Alternatives to Animal Testing Methods, also known as the PAAM Act. Feedback from industries is valuable to continue inclusive dialogue in advancing the current research and development based on humane approaches.”

Borami Seo, interim executive director and senior policy manager for HSI/Korea, said: “HSI/Korea has been pointing out the problems surrounding the absence of strategic development and dissemination plans in Korea. While Korea is renowned for its advanced technology, conventional animal testing approaches continue to be preferred despite growing concerns about their scientific and ethical limitations. We hope to see more stakeholders come together and join the conversation for the protection of humans and animals while embracing emerging technologies that can better predict human biology.”

Forum details:

Date: September 2

Location: Biosolution head office, Seoul, South Korea

Chairperson: Borami Seo, Humane Society International/Korea

Agenda:

  • Welcome speech
  • National Assembly In-soon Nam
  • Presentation: OECD validated 3D reconstructed human skin model showcase
  • Panel discussion: Views on challenges and solutions to support alternative approaches to animal testing

Moderator:

Kyungmin Lim, College of Pharmacy, Ehwa Womans University

Panelists:

  • Choongseong Han, NEXEL
  • Jung seon Lee, Biosolution
  • Cheol-Beom Park, BioToxtech
  • Sejoong Kim, Bundang Seoul University Hospital, 3D Motive project
  • Myung Ae Bae, Korea Research Institute of Chemical Technology
  • Ja-young Jung, Ministry of Food and Drug Safety
  • Borami Seo, Humane Society International/Korea

Campaign launched in support of act to promote alternatives to animal testing

Humane Society International

Multiart/iStock.com

SEOUL—Animal protection organization Humane Society International/Korea (HSI/Korea), cosmetics brand Lush Korea and civic group People for Non-human Rights (PNR) have teamed up for laboratory animals by launching a petition to support the Act on the Promotion of Development, Dissemination and Use of Alternatives to Animal Testing Methods (PAAM Act).

According to a report on animal testing statistics published by the Animal and Plant Quarantine Agency, the number of animals used for testing in South Korea was 4,141,433 in 2020. This figure is a 43.8% increase compared to five years ago, when 2,878,907 animals were subjected to testing in 2016. While animal testing is increasing, there is an effort to replace animal testing and introduce scientifically sound alternatives. In Europe and the United States, pharmaceutical companies are already starting to use organoids and organ-on-a-chip models. These technologies can emulate human physiology and are used to test substances instead of animal experiments.

The PAAM Act petition campaign aims to raise public awareness about the importance of promoting alternatives to animal testing both to reduce cruelty to animals and to improve human health. Citizens will be encouraged to participate in signing the petition that urges central government and lawmakers to pass the bill.

PAAM Act was introduced to the National Assembly in December 2020 and is sponsored by assembly member In-soon Nam. The bill is focused on supporting development of new methods that can mimic human biology or using computer-based approaches while moving away from relying on animal models. It also provides a legal ground for collaboration among central authorities to disseminate these developed methods through harmonized planning.

Along with the launch of the petition page, a mini webinar titled ‘Let’s learn about animal testing and alternatives’ will be released through Lush Korea’s YouTube channel in September. The webinar will feature HSI/Korea, Lush Korea, PNR and Jae-Sung Kwon, an assistant professor at the College of Dentistry at Younsei University. The panelists will discuss the status of animal testing, developing replacement approaches and why the PAAM Act is important.

Borami Seo, interim executive director and senior policy manager for HSI/Korea, said: “The PAAM Act took three years of preparation including consulting with relevant institutions and experts. The bill is important in that it stipulates unprecedented, but much needed, initiatives to bring central governments together to put Korea on track for the progress in health research based on more effective, science sounding approaches than animal testing.”

Won Jung Park, ethics director for Lush Korea said: “Considering an increasing interest in ethical consumerism in the 4th industrial revolution era where modern technologies are emerging, PAAM Act is what we need now. Lush Korea has long been supporting work around animal testing replacement. I hope that this PAAM Act petition campaign will contribute to speedy passage of the bill and bring an end to cruel and unnecessary animal testing.”

Anyone can show their support for the PAAM Act petition campaign by visiting Lush Korea stores or lush.co.kr/animalfreetesting.

ENDS

Media Contact: Borami Seo: bseo@hsi.org

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