Major success in the USA: new drugs no longer have to be tested on animals for approval

7 February 2023

DAAE

For the first time in more than 80 years, a change in U.S. law will allow new drugs to be tested using modern, animal-free, human-based methods.

Eurogroup for Animals welcomes this huge step forward and calls on the EU to follow suit by developing and implementing a strategy for human-relevant drug development without animal testing.

The new law, signed by U.S. President Joe Biden at the end of December 2022, allows the U.S. Food and Drug Administration (FDA) to approve new drugs without requiring animal data. Previously, pharmaceutical companies were required by law to test the safety and efficacy of their drug candidates in multiple animal studies, including toxicity tests on one rodent species such as a mouse or rat, and one nonrodent species such as a monkey or dog, before testing the drug candidates in human clinical trials.

A large amount of data clearly demonstrates the failure of the outdated system based on animal testing. On average, 92% of drug candidates that successfully pass all animal tests are later abandoned during human clinical trials, mainly because they do not work or cause significant side effects.”

Dr. Dilyana Filipova, scientist at Doctors Against Animal Experiments

Thanks to the new law, modern, human-relevant approaches, such as human mini-organs (“organoids”), organ-on-a-chip and computer-based methods can now be used for regulatory purposes in the U.S. instead of standard animal test methods. Many non-animal methods have already been shown to be more accurate and reliable than animal testing. For example, a recent study used a human-liver-chip to demonstrate the toxicity of several liver-damaging compounds, whereas previous animal tests had incorrectly classified the same compounds as harmless.

Such examples show the potential of this legislative change to not only save countless animals from barbaric testing and a cruel death, but also to ensure better safety for patient.”

Dr. Dilyana Filipova, scientist at Doctors Against Animal Experiments

However, animal testing is not banned under the new law and is still allowed as a possible testing approach. Nevertheless, it is a huge step forward that pharmaceutical companies will no longer be legally obliged to conduct animal tests, and will be free to use accurate, human-relevant, non-animal methods.

While the U.S. is introducing this modern, forward-looking legislation, some animal testing is still required by law  for drug approval in the EU.

Europe must follow the example of the U.S. as soon as possible, and end the use of animals in drug testing. If we want to develop better therapies and not fall behind in the global drug market, we should also rely on the most modern, successful and reliable human-based methods and not on pointless animal testing.”

Dr. Dilyana Filipova, scientist at Doctors Against Animal Experiments

Read more at source

Doctors Against Animal Experiments

Regards Mark

Proposal to alter Food and Drugs Act could see animal-tested products outlawed in Canada

Canada could ban testing of cosmetics on animals, a move which some animal rights activists say makes them “very hopeful” for the future.

“There’s a lot of support from this across parties,” said Camille Labchuk, executive director of the organization Animal Justice.

The ban aims to change the Food and Drugs Act to outlaw the sale of cosmetics that were tested on animals or contain animal-tested ingredients. These include products such as make-up, nail polish and perfume.

Read more:

Canada trails other nations on banning animal-tested cosmetics. A new plan aims to change that | CBC Radio

Regards Mark

26 January 2023

Signed, sealed, and delivered! The “Save Cruelty Free Cosmetics – Commit to a Europe Without Animal Testing” European citizens’ initiative (ECI) has smashed the requirement of gathering 1 million validated signatures, reaching over 1.2 million statements of support from European citizens.

The European Commission must now meet with campaigners and address citizens’ concerns. As over 10 million animals suffer in experiments in the EU every year and new non-animal technologies are being developed faster than ever before, the time for change is now.  

The days of forcing cosmetics ingredients down the throats of defenceless animals, intentionally infecting them with debilitating diseases, or drilling holes into their skulls must end – a radical rethink at the EU level is needed to support the transition.”

Sabrina Engel, chair of the ECI’s organising committee, PETA Germany

This European citizens’ initiative powerfully backs up the demand of the European Parliament to phase out animal testing for good. With the voice of the citizens added to the chorus, the Commission cannot ignore the loud calls to accelerate the transition to non-animal science.”

Tilly Metz, MEP, Greens–European Free Alliance

With the threat that the chemicals strategy poses to animals in laboratories, this ECI could not be timelier. From today, no additional animal tests should be requested to fill information gaps about chemicals. We need to move to safer and more humane safety assessments of chemicals.”

Sirpa Pietikäinen, MEP, European People’s Party

The message from citizens has never been clearer or more aligned with the voices of scientists, industry, NGOs, and politicians. Everyone understands that a plan to phase out animal experiments is a win-win situation for humans, other animals, and the environment. Now, the Commission should listen to citizens and finally make it happen.”

Anja Hazekamp, MEP, the Left

European citizens have been asking for cruelty-free cosmetics for a long time. This European citizens’ initiative is another reminder to the Commission that EU citizens will not stand by while loopholes in legislation are not closed to end all animal tests on cosmetics.”

Niels Fuglsang, Progressive Alliance of Socialists and Democrats

The ECI’s three critical asks call for robust implementation of the EU ban on animal testing for cosmetics ingredients, a full transition to non-animal methods for chemical safety tests, and committing to a plan to phase out all experiments on animals. 

The ECI was launched in August 2021 by Cruelty Free Europe, Eurogroup for Animals, the European Coalition to End Animal Experiments, Humane Society International/Europe, and PETA, with the support of global beauty and personal-care companies The Body Shop, Dove. It has since been actively promoted by companies such as Lush and a coalition of groups and campaigners from every corner of Europe. Hundreds of celebrities also supported the campaign, including Sir Paul McCartney, Ricky Gervais, Finnish heavy metal band Lordi, Italian singer Red Canzian, French journalist Hugo Clément, and actor Evanna Lynch. 

No other ECI has ever received this level of support across so many different countries. To be successful, an ECI has to collect at least 1 million validated signatures and has to meet a minimum target across at least seven different EU countries. This ECI passed the minimum target in 22 different countries, demonstrating pan-European support for ending animal testing.   

Regards Mark

Animal Testing Is Still Required for Drugs and Certain Cosmetics — What Are the Pros and Cons?

Whether it’s done for cosmetics, medication, or anything in between, animal testing is a cruel practice, and one that animals can never consent to.

However, testing on animals is required for all new medications used in the U.S., and is still required in China’s cosmetics industry in many instances.

Keep reading for a look into the pros and cons of animal testing, aka vivisection, both in the pharmaceutical industry and the cosmetics industry.

Animal Testing Is Still Required for Drugs and Certain Cosmetics — What Are the Pros and Cons? (msn.com)

Regards Mark

Elon Musk’s Neuralink investigated over killing of 1,500 animals in botched tests:

Musk’s Neuralink investigated over killing 1,500 animals in botched tests (msn.com)

Regards Mark

From Eurogroup foor Animals.

EPAA Conference 2022 “Accelerating the Transition to Animal-Free, Sustainable Innovation”

23 November 2022

This year’s European Partnership for Alternative Approaches to Animal Testing (EPAA) Annual Conference gathered members from the European Commission, the European Parliament, regulatory authorities, industry, academia, and NGOs to discuss the challenges that still need to be addressed to make animal-free sustainable innovation a reality within the EU.

MEP Tilly Metz opened the conference by stressing that what is needed is not less testing, but different and more effective testing using new approach methodologies (NAMs), as well as a better coordinated cross-sectoral EU approach.

The Directorate-General for Research and Innovation made it clear that the Commission is committed to work towards the phasing out of animals in science, and announced an European roadmap aiming to fully replace animals in chemical safety assessments. The Joint Research Centre also expressed the need to develop a NAM-based classification system to better demonstrate the safe use of chemicals and ensure a higher level of protection. 

EPAA’s achievements in 2022, including the development and promotion of non-animal strategies to replace animal-based tests, as well as their aspiring plans for 2023 to increase the use of NAMs for regulatory safety testing, demonstrate EPAA’s strong engagement to accelerate the replacement of animal testing by innovative non-animal approaches.

The industry, represented by Cefic and Unilever, shared its intentions to continue its efforts to implement the use of NAMs, and ensure the protection of people using the best (non-animal) science available. As Carl Westmoreland summed up, “there isn’t a lack of tools, just a lack of experience with using them to make decisions”. The European Medical Agency also indicated that it is open to discuss NAMs and 3R testing approaches for human and veterinary medicinal product applications, and presented the ambitious and promising work plan of its new working party focused on fostering the 3Rs.  

Finally, Emily McIvor summarised the successes achieved over the past years in accelerating the transition to non-animal science, including the European Parliament’s Resolution to ‘Accelerate a Transition to Innovation without the use of Animals in Research, Regulatory Testing and Education’, the launch of the €400 million PARC project to establish a centre of excellence for the transition to Next Generation Risk Assessment, and the successful European Citizens Initiative (ECI) Save Cruelty Free Cosmetics – Commit to a Europe without Animal Testing which collected over 1,4 million signatures. 

In this regard, Eurogroup for Animals recently published a position paper which reflects some of the key elements needed in a EU wide strategy for the transition to non-animal science. 

Key elements of a strategy to transition to non-animal science

Key elements of a strategy to transition to non-animal science | Eurogroup for Animals

Regards Mark