‘International cooperation is key to achieving progress’

What is your opinion on animal testing?

Animal testing is currently still indispensable if you wish to market safe and effective medicines. Dutch ambitions are high, but the Netherlands cannot go it alone. What is necessary above all else is large-scale global cooperation. If you go too fast as a country, this will have adverse effects.

Which adverse effects are you talking about?

An outflow of the research capacity; scientists who would rather do their work elsewhere on earth, maybe somewhere where you would prefer animal testing was not done.

A strong reduction is possible in the Netherlands, but only if you can get all research centres to agree. The energy transition is also facing its own obstacles. So, in a similar fashion, this transition also won’t be smooth sailing.

Which steps are already possible?

I believe in rewarding good behaviour instead of punishing bad behaviour. Banning animal testing seems like a bad idea to me. You can achieve more by promoting other methods and creating added value in this way. The point is that there should be advantages and that researchers should not have to be scared that a journal will still require animal testing.

A lot of expertise is present in the Netherlands. There are countless groups working on models to replace animal testing. All this know how can be showcased and distributed in an even better way. We can play a prominent role. If you truly want a transition to animal-free research then that involves more than ‘we can make good models’.

Which role does the Medicines Evaluation Board have to play in this?

In addition to assessing the efficacy, safety and quality of medicines, the MEB also conducts a lot of research. For example, we look at how we can make the system in regards to regulations as efficient as possible. We confer with other parties to see which guidelines include animal testing, how consistently they are applied, and whether or not there are conditions under which we would not be required to ask for certain studies involving animal testing. My colleague Peter Theunissen, for example, is the Dutch representative in EMA’s 3R working group and is very active in efforts to effect a reduction in the use of laboratory animals.

Is reducing animal testing as much as possible an ethical principle?

We are concerned with the scientific necessity of studies. If there is no such necessity, then the research in question is not ethical by definition. And that means that you do not need animal testing in every study, even if you think it is necessary. You have to look very critically at what is truly necessary. If animal testing is not directly necessary then this needs to be said, even though the guideline requires its use.

How do you encourage the industry to go along with this?

Officially, via scientific recommendations. Companies have a development plan that leads to questions, such as: do you approve of this package of studies? If we believe things can be done differently then we will make suggestions based on science. Often companies will implement these recommendations.

But they are already doing a lot of their own accord. Major companies, with a lot of capacity, will often come up with plans to avoid conducting certain studies and we then often agree with these decisions. But we also see that companies come up with studies that we do not believe are necessary. When this happens, we talk to them about it.

We also speak at conferences and meetings about our views on animal testing with all the relevant groups. We focus on ensuring a dialogue. It is clear that understanding each other continues to be vital in our ability to take steps.

This movement is definitely happening in the pharmaceutical industry. The ICH (International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use, ed.) emphasises reducing animal testing in the development of new guidelines or adjustments to international guidelines. Major steps have also been taken in the area of accepting alternative methods.

Sometimes a method is never validated and included in regulations. Is this something you recognise?

The validation problem is mainly an issue in the world of chemicals, and not so much in pharmaceutical research. New methods have to be qualified. This means we want to understand the context in which the method will be used and whether or not the method does what it claims. That is a less stringent form compared to a formal validation. This means that it is easier to research alternative methods for pharmaceutical research, because when the context of use of a method is accepted and the method is deemed fit for purpose after a positive evaluation by the EMA, then it can, in principle, be used.

The problem is that, despite all the developed assays, no safety assays have been qualified for use yet, whereas companies have been using those assays for years. The only thing you can do is focus on improving the connections between the industry and academic centres, or managing this on a European level. Then you can answer questions in a much more coordinated manner. For example: for which human-centric endpoints would it be interesting to qualify an animal-free method at this time?

What is the role of the EMA?

The EMA has published a regulatory science agenda, which includes a considerable innovation in animal experiments and 3R aspects component. On behalf of the 3R working group, Peter Theunissen is responsible for directing the development of new guidelines that help businesses design the qualification of their animal-free methods. And in the EMA’s Non-Clinical Working Party, we are working on the development of new international guidelines surrounding the use of laboratory animals, improved scientific safeguarding of responsible animal testing in those guidelines, and maximising the use of data from this type of research.

When it comes to the development of NAMs (New Approach Methodologies, ed.) you need to know who the end user will be from the beginning of the process. This also means being absolutely certain about whether or not this end user is interested in both the model and qualifying it together. Otherwise it will not work.

So a lot of work still needs to be done on animal-free innovations.

That is correct, and the 3R philosophy will remain very important in this. Some queries can still only be solved with the use of animal testing, but there are often also very good scientific arguments against it. In terms of regulations, much can still be achieved. In regards to NAMs, I see that many of these innovations are in different stages of development. From toddler, to adolescent, to adult. But oftentimes, we are not even aware of what already exists.

Within TPI, we may have thought too easily about these types of developments. The idea was, we’ll begin and the rest will follow. You may be ambitious and enthusiastic, but it is not that simple. Until now, TPI has focused on the Netherlands too much. If you want to take big steps, you cannot do this without the international context.

Steps need to be taken to achieve an animal-free future, which requires an international multi-year plan. This means that, as the Netherlands, we need to find partners to cooperate with for the next 15 to 20 years.

Additional relevant perspectives can be found in our Stories column.