Ladies and gentlemen,
It is a great pleasure to join you today.
I am delighted that Wageningen University and Keystone Policy Centre have brought this year’s CRISPR conversation to Europe.
This event is called ‘conversations’, so I guess we all agree that we need a debate. Especially when it’s about technology that excites and terrifies in equal measure.
It is described – depending on what you read – as transformative and magical, scary and controversial, life-enhancing and life-threatening.
It’s been associated with unicorns and dinosaurs, referred to as “playing God”.
It’s no wonder the public isn’t sure what to make of it.
And one of the many things I’ve learned as European Commissioner is the more complex the subject, the more polarised the debate, and the greater the need to talk about it.
I hope this is the first of many CRISPR conversations we’ll have in Europe.
Everyone here knows gene editing is a big deal.
I’ve just come from a conference where I spoke about the enormous threat of antimicrobial resistance, and the need to develop alternative tools and therapies.
CRISPR is one example.
It offers huge potential to reduce resistance levels and prolong the life of existing antibiotics.
It can also make us more resistant to disease.
It can cure or prevent genetic or life limiting conditions in a single treatment rather than lifelong therapy.
As a former cardiac surgeon, I was very excited to read about the possibility of a gene editing vaccine to protect against heart disease.
On the other side of my Commission portfolio, I deal with the food chain and food safety.
And here too, new breeding techniques can help us tackle some profound challenges such as food security, fod intolerances, or climate change.
Examples include low-gluten, non-transgenic wheat has been developed through gene editing by Instituto de Agricultura Sostenible (Institute for Sustainable Agriculture), in Spain and University of Minnesota, in USA. This wheat could be used to produce low-gluten foodstuff.
Or potatoes with a non-browning trait and producing less asparagine have been developed through gene editing. These potatoes provide the potential for the formation of acrylamide to be reduced by 60-70% when potatoes are baked, fried or roasted at high temperatures. (This could completely ‘save’ Belgium fries)
Some excellent examples are also described in Mies Loogman’s book on Genetic Modification & Sustainable agriculture.
All in all, gene editing techniques can be used to improve crop resistance, herd health, food quality, diets and nutrition.
In short, it offers a potential answer to many important questions.
The trouble is, it also raises quite a few:
- Is it safe and ethical?
- Is it socially acceptable?
- Where do we set the limits?
- How will it impact on society and the economy?
These questions are key and they need to be answered if Europe wants to move forward and be part of progress in technology.
As regards to legislation, in the EU, gene editing is covered by several key pieces:
- the rules for advanced therapy medicinal products,
- the framework for tissues and cells
- and finally, the rules for genetically modified organisms.
For advanced therapy products, the rules are well adapted to support responsible use of technologies like CRISPR.
They give a high level of patient protection and the flexibility to accommodate scientific developments. Both of these aspects must remain highly valued.
To accommodate scientific progress responsibly, we can take inspiration from Francis Collins, who discovered the genes associated with a number of diseases and led the Human Genome Project. Whilst undertaking this project, he also explored and raised the associated ethical dilemmas, concluding that the gene related science was ethical when used responsibly.
The European Medicines Agency assesses the products and develops appropriate scientific guidelines.
It actively engages with developers, scientists, patients and other international regulators to keep the conversation moving.
We know how powerful these therapies are from those that already have an EU marketing authorisation.
Many clinical trials are also showing promising results.
Yet the clock is ticking for patients and techniques such as CRISPR can speed up the process.
It can make production faster and cheaper, more affordable and accessible.
Improved nucleuses can also lead to increased safety.
At the same time, there are scientific unknowns.
We need to be careful about the off-target effects of these tools.
For example, the risk of cancer linked to CRISPR CAS9 technology which is currently being analysed.
Let me also mention here that we are working with Member States on applying GMO rules to clinical trials with gene therapy medicinal products.
Last July, we published a first set of measures for this and we will continue to discuss more initiatives to support the process.
The EU’s framework for tissues and cells is also designed to provide a high level of patient protection and safety. Every year, it ensures the safety and quality of over 700 000 cycles of in vitro fertilisation – IVF – within the EU.
Once a Member State decides a technique is allowed within IVF, the technique needs to be organised within the boundaries of this EU framework. Amongst others, this includes rules on process authorisations, facilities, staff and quality measures in the IVF laboratory, as well as rules on reporting outcome and events at the clinic.
Within IVF – the CRISPR technique offers the potential to prevent devastating genetic diseases being passed down to children.
For example, haemophilia and cystic fibrosis.
That said, a highly innovative technique like CRISPR still has a lot of unknowns and safety and ethical concerns.
Like all gene editing techniques, CRISPR therefore needs to be used responsibly.
This was underlined last November when Chinese researchers announced the birth of twins whose DNA structure had been altered with CRISPR-Cas to prevent them from contracting HIV.
In the EU, modification of the human germ-line is banned.
This was done against scientists’ call for a moratorium on applying this technique to the germ-line of embryos, and without engaging with the relevant authorities.
Quite rightly, it provoked strong reactions and I am pleased no similar applications have been reported in the EU.
It underlined the fact that society feels very strongly that scientific progress needs to go hand in hand with good governance.
The Commission is currently evaluating the EU’s framework for tissues and cells to check whether it remains fit-for-purpose and can support advanced techniques. This evaluation has highlighted some challenges – in particular keeping up with the fast-moving world of biotechnology.
EU countries are however preparing to authorise highly innovative processes in IVF.
And several national authorities are currently developing a common approach for such authorisations within an EU-funded action. This will help ensure that future innovative techniques do meet the EU safety and quality requirements.
These authorities do this by working closely with scientific bodies such as the European Society for Human Reproduction and Embryology.
Such collaboration between authorities and scientist is key, to allow for responsible progress.
Broadly speaking, gene editing in the medical field is much more accepted in the EU than it is in the agri-food sector.
On gene therapies, citizens are more measured, while on genetically modified food, they tend to be more risk averse.
This creates additional challenges.
You will all know that last year the EU Court of Justice ruled that the EU’s legislation on GMOs must apply to all organisms obtained via new techniques of gene editing.
It means they must be authorised before they are released into the environment, and traced and labelled on the market to support consumer information and freedom of choice.
In a part of the world where GMO often meets with O-M-G, this decision has intensified the interest of stakeholders and the debate on the subject.
Following the Court ruling, the Commission has taken a number of steps with the Member States to ensure the rules are properly implemented.
We have discussed it with Member State experts and asked them to feed back on the challenges and solutions.
We asked the European Network of GMO Laboratories to look at possibilities to detect plants grown from new techniques of gene editing.
It recently confirmed that developing methods to achieve this might be challenging.
The Commission has also asked the European Food Safety Authority to assess the current guidance for risk assessment.
This is to check it is adequate to evaluate products of gene editing.
At the same time, we have been looking at other topics of general interest beyond the pure science of these technologies.
This is an important part of the bigger picture.
The European Group on Ethics gives the Commission high quality, independent advice on the ethical aspects of science and new technologies.
The Commission has asked the Group to assess the ethics of applying gene editing to animals and in the context of biodiversity and ecosystems.
These initiatives aim to gather expert views from across the board to ensure all relevant information is considered.
As the current Commission approaches the end of its mandate I’m often asked: what next?
Are there going to be changes to the EU’s GMO framework or challenges to the Court’s ruling?
The answer is, I don’t know and I don’t want to speculate.
The current Commission certainly won’t present any further policy initiatives in this area.
That is a decision – and a challenge - for my successor.
Allow me to use this slide from Bohanec’s book on GMOs that I read with great interest.
I think it is self-explanatory - no one died from a GMO and gene editing has important potential to make our societies and systems more resilient and sustainable. However, these benefits, especially in the food area, are often omitted, misunderstood, or not even considered.
I have already expressed myself on this subject a number of times: I believe in science and I know that here I am talking to a like-minded audience.
I regret that these techniques are not used to its full potential.
And it’s not seen as a necessity in the same way that medical progress is.
Of course, rapid developments in science and technology need careful consideration and there should be an adequate legal framework.
New therapies, techniques and products already are an important reality.
They may also become a necessity.
We need to ensure Europe is attractive to the scientists and researchers working on them.
I know many scientists believe that products obtained through new breeding techniques should not be subject to the GMO rules.
They stress the current situation means research is moving away from the EU.
Again, I personally share these concerns.
This means we are losing innovations to foreign countries, and required to later buy them from abroad. If this trend continues, we may become a museum of ancient agriculture.
I would like to give you an example. Before their accession to the EU, Romania cultivated GM soya. After the accession, this was banned. Some people call this situation ‘new Luddism’, I would probably use a stronger word
At a Citizens’ Dialogue last autumn, I was very clear: we need to support investment in innovation and new technologies.
If we don’t, we will miss out.
We will fall behind our competitors, and lose our talented researchers.
Last week, I also spoke to food journalists about the risk of “demonising” the processes. We need to keep up and move forward.
These are very relevant challenges.
But it must be translated into recognised benefits for EU society – particularly in the food area – to carry public support.
Throughout my time in office, I’ve said time and again, we need to speak to citizens about science, about technologies and about risk, using their language, and include them in our collective journey.
Our conversation on these topics needs to continue with open debate and open minds.
Ladies and gentlemen,
To conclude, I come back to the CRISPR references I made at the start.
Our conversation needs to focus on the facts, not the myths, and it must be open and transparent.
I am a strong supporter of science and a science-based policy.
But I am also a great believer in the power of communication to build understanding and break down barriers.
CRISPR is complex and highly scientific but it’s no longer a novelty.
It’s something to be used appropriately, but it’s not something to be afraid of.
We have a duty to discuss it and engage in public debate.
The questions shouldn’t be whether CRISPR can be used to breed unicorns or bring back dinosaurs.
The question should be how we can use CRISPR responsibly to answer some of the most challenging questions humanity faces.
This is the future.