Willemien Wieland: ‘Cooperation is crucial to the transition to entirely animal-free testing’
Willemien Wieland is a regulatory toxicologist and regulatory affairs manager at Charles River in Den Bosch. TPI asked her five questions by email.
How did you become involved in the Transition Programme for Innovation without the use of animals (TPI)?
My day-to-day work as a toxicologist at Charles Rivers revolves around the safe use of (chemical) substances, for example in the workplace, but also in the home. Some of the information about possible effects of substances can come from animal testing. We try to determine these effects as much as possible using animal-free methods.
Imagine that we want to find out whether a substance is harmful to the skin. In nine out of 10 cases, we can do so without animal testing. However, we must know for sure that the alternative test is reliable; namely, the result predicts what will happen if the substance actually comes in contact with human skin.
Since many alternatives are still being developed as far as determining the reliability of the predictive value of the result is concerned, animal testing is still needed. Generally speaking, governments do not take any risks when it comes to safety. There are strict requirements for the way in which safety can be determined. The question is whether some tests that do not involve animals already meet these strict requirements. We must continue to engage in dialogue on this topic.
Besides being a toxicologist, I am the secretary of Charles River Den Bosch's Animal Ethics Committee (DEC). The Central Authority for Scientific Procedures on Animals (CCD) uses the DEC’s recommendations to decide whether a company will obtain a permit for animal testing, for example. For each application we check whether the social benefit of the animal test outweighs the potential animal suffering and whether an animal test is truly necessary. If it does not, or if there are suitable alternatives available that cause less discomfort to the animals, then the company will not obtain a permit. Once a permit has been obtained, the government will continue to monitor correct implementation.
What do you consider a desirable and realistic goal for TPI, and why?
Making our society ‘animal-free’ is no simple process. Especially if we want to simultaneously guarantee the safety of people and the environment and to keep developing new medicines. Ideally, TPI brings together parties who are involved in animal testing and the development and application of alternatives to animal testing. It offers a platform where experts can collaborate.
However, I believe the goal should not only be sharing existing knowledge. We also need to create wide-ranging awareness about the purposes for which we currently use animal testing. We can subsequently formulate common action points: where can the number of animal tests (or the number of animals used in animal testing) be reduced in the short term and what knowledge and development is needed for this? To me, this is how we can use knowledge, time and financial resources efficiently. Ideally, new insights and a broad support base also ensure that animal testing is no longer regarded as the standard for the most reliable results, for example within the framework of legislation and regulations, and that legislators accept the results obtained from alternatives sooner.
From your position at Charles River, where do you see the most important opportunities for TPI?
TPI could encourage assessors to clarify which alternatives to animal testing they accept for which substances, within the framework of laws and regulations. Clarity ensures that companies run a lower risk if they use such an alternative test strategy, which makes them more inclined to do so.
I also hope that TPI is able to initiate international cooperation. Alternatives to animal testing stand the best chances when people consider them an international priority.
What do you consider the biggest difficulties facing TPI? What can be done about it?
In many cases, laws and regulations currently require animal testing to assess the safety of substances. The sector therefore has no choice but to use animal testing in those cases. This situation is partly due to the fact that we simply do not have enough knowledge to predict the potentially harmful effects of substances on the human body. Take for example a complex biological process such as a pregnancy; how can we simulate that process using cultured cells? As long as we do not have a proper model to do so, without animal testing we cannot estimate whether pregnant women can continue to use a medicine at no risk to their unborn child.
Not only medicines but also chemicals used in industrial applications, such as in paint, are tested, for instance to determine if they have potentially harmful effects when people are continually exposed to them. There are various agencies that assess the safety of these substances, but they do not all agree on the acceptance of alternative methods. For example, REACH, the regulation for industrial chemicals in Europe, allows the read-across approach. Using this approach, you predict properties of a substance by looking at the data for substances that have a similar chemical structure and properties. However, the evaluating agencies, which in this case is the European Chemical Agency (ECHA), can also reject this approach because they do not fully trust the outcome. That means additional work is required, sometimes using animal testing. It is therefore not always clear in advance whether agencies will accept alternatives to animal testing, and which alternatives they will accept. The sooner that clarity is provided, the sooner a company like Charles River can validate and offer alternatives. Moreover, the debate about reducing animal testing is extremely multifaceted. Someone who conducts fundamental brain research requires a completely different approach than someone who wants to know if a substance can trigger allergic reactions. Researchers on the university side often have no idea what the business sector is doing and what they are using animal testing for – and this also applies vice-versa, too, of course.
That is why we need to combine scientific knowledge and experience with alternative methods in order to move forward towards non-animal innovation. Sharing is not always possible, unfortunately. Parties have a diversity of interests: perhaps a research group wants to publish a new idea, or there is a possibility to apply a new method commercially. We need to find solutions for this.
Given the current situation, I am convinced that replacing animal testing will be a challenging task. Huge investments will be needed because we still lack a lot of knowledge to make the transition to entirely animal-free research. Cooperation is absolutely vital to making this transition.
What role do you envision for Charles River and yourself in realising opportunities and removing obstacles?
Charles River has a wealth of knowledge and experience with animal testing. We are working hard on alternatives to animal testing, such as the previously mentioned read-across approach, and on various in vitro (such as tests using cultured cells) and in chemico models (such as testing chemicals to predict the reactivity of a substance). We also use computers to predict potential effects according to chemical structure (Quantitative Structure Activity Relationship, QSAR). We share this knowledge as much as possible. For instance, our employees give presentations on new insights and they publish articles in professional journals about animal testing and the application of alternatives.
Charles River also actively seeks contact with governments and other assessors to promote the acceptance of alternatives and to share our experience with alternatives. In addition, the company plays a role in the validation of new alternative test methods; after all, the value of an alternative test must be proven before it can be implemented on a large scale and deemed acceptable by the assessment bodies. Moreover, it is important to realise that every organisation – including Charles River – learns more every day; tomorrow we will be a step further than today.
Within TPI, I see a role for myself to get other participants acquainted with laws and regulations for animal testing and with all the requirements that planned new alternative testing methods must meet. So that together we can continue to make progress towards minimising the use of laboratory animals.