An interview with Heather Wallace, PhD, FRCPath, FBTS, FRSC, FRSB, FBPhS, European Registered Toxicologist, University of Aberdeen, United Kingdom, Immediate Past President of the British Toxicological Society, and President-Elect of EUROTOX. She is a Professor of Biochemical Pharmacology and Toxicology, School of Medicine, Medical Sciences and Nutrition.
M: Hi Professor Wallace, thank you for being willing to participate to this interview.
In the United States, we have heard quite a bit of buzz about Brexit. However, most of it surrounded the fact that it would be horrible for science. Needless to say, that as scientists we are all a little bit perplexed by what this means for the science of toxicology. From safety and regulatory toxicology in the chemical and pharmaceutical industries, to fundamental research in academia, we look forward to understanding what this means.
First, can you tell us more about what is “Brexit” exactly? When will it come into full effect?
H: Brexit is short hand for “British exit” that entails Britain leaving the European Union (EU). This historic vote took place on 23 June 2016 and the result was 51.9% in favor of leaving the EU. This involves disentangling all aspects of the government of the UK from the EU and will be a very complex and involved process. At the moment, the UK government is preparing for Brexit but the leaving date has not yet been agreed. The UK has to trigger Article 50 of the Treaty of Lisbon that became law in 2009. Essentially, once Article 50 has been invoked then the clock will start ticking for the full exit of the UK from the EU. The whole process of exiting is predicted to be 2 years although it may be longer.
M: Let’s try to understand the regulatory implications… the EU has been leading the front on so many fields of chemical legislation: First, REACH has been a game changer in toxicology and safety evaluation of chemicals by requiring data and democratizing the accessibility to the data. What are your thoughts with respect to chemical regulation?
H: REACH is a major issue. Any exports from the UK to the EU still will be governed by REACH. Under the regulations, there is a legal entity responsible for REACH registration or re-registration of chemicals known as an Only Representative (OR). Anyone out with the EU must have an appointed OR. Currently, an OR has to be within the European Economic Area (EEA). When the UK withdraws from the EU, smaller companies and consultants in the UK will no longer be able to undertake REACH registration for exports from a UK-based company. This will clearly create many problems and undoubtedly increase the costs for smaller businesses.
M: Similarly, in 2009, the EU cosmetic regulation prohibited animal tests for cosmetic ingredients. Do you think that the UK will return to conducting such tests and/or that it will delay progress in the development of alternatives approaches?
H: The UK is a leading voice in the regulatory field and is a strong supporter of the 3Rs—replacement, refinement, and reduction of animal tests. It will continue to promote the development of the best approach to safety testing of all chemicals.
M: Finally, the obvious outstanding question is what will be the implications in the pharmaceutical industry? Will the UK remain aligned with the ICH guidelines/EMA regulations?
H: This is one of the areas where the scientific community will be pressing the UK government very hard to retain harmonization of the regulatory framework that already exists in the current EU. This framework has been developed carefully over time and offers best practice across Europe currently. The UK is highly regarded in terms of the quality and transparency of its regulation.
M: Now let’s address the environment: There was a recent article in the Guardian stating that Brexit would adversely impact the air pollution crisis, and EU regulations have driven improvements in water quality throughout Europe. Will Brexit result in a worsening of the UK environmental standards?
H: Personally, I do not see the UK backtracking on any legislation that improves the environment. The UK has always supported improvements to the environment.
M: Last but not least, and more closely related to you, what about the impact on the toxicological research that is conducted in academia? What will be the repercussion on funding? On progress?
H: There are three main areas of concern here: funding, free movement of scientists and students, and retention of the current workforce. The EU through a range of funding instruments have supported scientific and clinical research for many years. The current framework is Horizon 2020. Within these instruments, the UK has consistently “punched above its weight” and UK researchers have been heavily involved in the programs and indeed have led many of the framework projects. Loss of access to this funding stream is of great concern. The UK Treasury recently announced that it will underwrite funding for approved Horizon 2020 projects, which is good news. However, what will happen in the future is very unclear and uncertain.
Within the UK toxicology is an international business with many EU nationals working in universities and in the pharmaceutical, chemical, and biotechnology industries. Our success depends on the free movement of these scientists and clinicians and, most importantly, on the nurturing of EU exchange students who are funded through a variety of schemes (ERASMUS, Marie Sklodowska-Curie) available within the EU.
Retaining our talented workforce needs to be a key goal in all the Brexit negotiations and that can only be done by creating an environment that is supportive and collaborative within our universities and industries.
M: Any final thoughts for your colleagues from the other side of the pond?
H: All of this will be challenging and at present the biggest issue is the uncertainty around almost everything. Once Article 50 has been triggered and the negotiations start in earnest, we might then have a clearer picture of what will be to come.
M: Thank you so much for taking the time to answer our questions. Your insight is truly appreciated and I wish you, and all of UK’s toxicologists, the best through these uncertain times.