1. Improving quality of life for humans and animals
In 2016, the Netherlands National Committee for the protection of animals used for scientific purposes (NCad) published a recommendation to transition to research without the use of animal experiments. It called for a gradual reduction and planned exit by 2025, particularly for animal experiments in the context of regulatory safety testing, i.e. safety tests required by law for chemical, foodstuffs, ingredients, pesticides and medical devices and vaccines. In the aftermath of its publication, the recommendation by the NCad was repeatedly cited as a“masterplan” to stop animal experiments in the Netherlands –wrongly, as has emerged.
2. Making sure animals are handled responsibly
The Animal Welfare Charter of Interpharma was launched ten years ago. With the signing of the charter, the research-based pharmaceutical companies in Switzerland underlined their ethical responsibility in animal experiments both at home and abroad. The guiding principles of the charter are the 3Rs – Refine, Reduce and Replace – committing the industry to replace as many animal experiments as possible with alternative methods, to reduce the number of laboratory animals used and to refine the methods so that any stress or constraint is kept to a minimum. When the industry launched the charter in 2010, Christine Egerszegi-Obrist, former member of the Council of States and President of the 3Rs Research Foundation Switzerland, saw this step as an acknowledgement of the efforts and the ambition to establish high standards in animal experiments worldwide as far as possible. She confirmed that, for the industry, it was not about following the minimum legal requirements, but about leading on the world stage by example.
3. Tasks and aims of the Swiss 3Rs Competence Centre (3RCC)
Promotion of high-quality research for the benefit of animals through financial support for outstanding scientific projects in the field of the 3Rs
Development of an educational strategy for the 3Rs, adapted to different levels and professional groups
Establishment of a network and a communication platform for stakeholders and interested parties with up-to-date information on the principles of the 3Rs and alternative methods
5. Involvement of academic institutions –working together internationally
The pharma industry’s Animal Welfare Charter set milestones that academic researchers also saw as pointing the way ahead. The charter substantially influenced the wording of the principles and objectives of the Basel Declaration – a call by academic institutions for more trust, transparency and communication in animal research. The Basel Declaration was adopted on 29 November 2010 during the first Basel conference “Research at a crossroads”. Like the Declaration of Helsinki, which sets out the ethical principles for clinical research in humans, the Basel Declaration Society aims to help ensure that ethical principles such as the 3Rs are applied worldwide in research involving animal experiments. The Basel Declaration was initially signed by more than 60 academic researchers from Switzerland, the UK, France and Sweden. In the meantime, more than 4700 representatives of academic research from 65 countries have signed up to it. Together, the Animal Welfare Charter and the Basel Declaration lay down an important marker for the promotion of laboratory animal welfare in industrial and academic biomedical research. The international spread of commitments by industry and academics is particularly important because in many other countries around the world, unlike in Switzerland and Europe, research in animals is inadequately regulated by law and, in some cases, not regulated at all.
5. Dialogue with interest groups and the public
With the charter, the annual Animal Welfare Report – which documents the numerous projects and initiatives to improve animal welfare in research – and engagement in the framework of the competence centre 3RCC, research-based pharmaceutical companies in Switzerland have opened themselves to dialogue with the public and stakeholders. For example, the regular exchange of views between representatives of Swiss Animal Protection (SAP) and industry has been firmly established since 2011. Transparent communications and the education of cross-disciplinary working groups and networks signal the common will of all actors and supports the process for continual and sustainable improvement in the situation of laboratory animals.
6. Promising alternatives
What do the next ten years of the Animal Welfare Charter promise? New digital technologies have huge potential for the further reduction, refinement and replacement of animal experiments. It is already possible to investigate a lot of questions concerning new active substances today using computer-based simulation models. Likewise promising are in vitro methods such as organ-on-a-chip technology, in which miniature organs are artificially recreated from stem cells and placed on a small chip to model the inner workings of the human body. With the aid of these chips, drug candidates can be tested for efficacy and toxicity at an early stage. The technology is still in its infancy, so it is only possible at present to bring four or five organs together on one chip – a fraction of the human body. In order for this approach to be used in the future as an alternative in drug development, further progress therefore needs to be made in digital technologies. But the research interest is considerable. The search for alternative methods is worthwhile not only for the welfare of laboratory animals, but also for the companies, because these alternatives are usually less cost-intensive and easier to standardize than animal models. Increasingly innovative digital systems are also being used in the housing of laboratory animals to improve the welfare of the animals and at the same time to deliver more comprehensive and more conclusive data for the researchers. Even though animal experiments will not be replaced in the foreseeable future, these offer good prospects for animal welfare and scientific progress.
7. Excursus: Interview with Dr. Birgit Ledermann
Why did research-based pharmaceutical companies in Switzerland decide ten years ago to sign Interpharma’s Animal Welfare Charter?
The use of animals in research is a very emotional issue. Many people criticize research with animals, but at the same time want certainty that new medicines meet the highest standards of quality, efficacy and safety. While it is customary for pharmaceutical companies to introduce internal standards for animal research in line with the relevant national standards and other norms, the unique thing about Interpharma’s charter is that these standards were mutually agreed throughout the industry in the whole of Switzerland. The ten articles of the Animal Welfare Charter were developed after the establishment of four key elements: a) an open and constructive dialogue between stakeholders, b) the promotion of general and vocational training, c) the promotion of all aspects of the 3Rs and d) testing and certification. The commitments of the charter apply to Interpharma member companies and to all external research and development partners. This is especially important because animal welfare standards vary from country to country, and the charter guarantees identical high standards regardless of where the research with animals takes place.
What has been the biggest personal highlight or most positive development for you in the last ten years regarding the charter?
One of the most important highlights for me is the open and constructive dialogue between stakeholders. Interpharma has cultivated a regular, constructive dialogue with the Swiss Animal Protection (SAP) organization and the University of Zurich for many years. This dialogue has led to a mutual understanding between the organizations involved. A further highlight of Interpharma are the joint audits of our external partners. These joint efforts help us improve to animal welfare and ensure that the 3Rs (reduction of animal numbers, refinement of animal experiments and replacement of animal experiments with alternative methods) are applied by our partners. The audits reduce the workload and the amount of time required both for member companies and for external partners and are therefore highly appreciated.
How important is the charter internationally?
The charter has attracted international attention, because the pharma industry in Switzerland has harmonized its animal welfare standards and conducted joint audits for the first time. The charter and the concept of joint audits serve as an example, and both have been presented at various conferences and meetings in various countries in recent years.
“We must intensify our dialogue with the public.”
What challenges do you see for the next ten years of the charter?
Biomedical research, including in the pharmaceutical industry, is meeting with ever greater resistance to the use of animals in research. While we have broadened our internal dialogue on the need for the use of animals in the discovery and validation of new medicines, we need to step up our dialogue with external stakeholders, especially with the public. We must speak more often and more openly about the importance of this research, explaining that animals may only be used in research if there are no recognized alternatives, and also about the stringent legal standards and the engagement of people who work with the animals. In addition, we need to keep promoting the implementation of the 3Rs – reduction, refinement and replacement of animal research. Application of the 3Rs reduces not only the number of animals used in research, but also the variability of the data and thereby also improves the quality of the research with animals. Interpharma provides financial support to the Swiss 3Rs Competence Centre and is represented on its management boards. A further objective is to continue our joint audits for the assessment of our external partners.
Is it realistic or conceivable that drug development could one day do without animal experiments altogether?
Although the pharmaceutical industry is making huge efforts to replace the use of animals in research with alternative methods where possible, the development of new and safe medicines without the use of animals will not be possible within the foreseeable future.