Via Bayer AG

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Genome editing: Europe can embrace innovation while assuring safety

Bayer calls on the College of Commissioners for a cross-functional platform where parties can discuss a way forward for genome editing.

It has been a year since the European Court of Justice issued a judgement that triggered grave concerns in the scientific community: ruling that plants developed through targeted mutagenesis, a form of genome editing, should be subject to the same strict EU laws that apply to genetically modified (transgenic) crops.

Europe’s top court underlined that it would be up to policymakers to create a regulatory framework that specifically addresses this topic. A year later, the opportunity for the newly elected leaders in the European Commission and European Parliament will be to create a supportive policy and regulatory framework that foster scientific advancement on products that benefit society, while ensuring a high safety standard for human health and the environment.

Genome editing could be the next epoch-defining advancement — the printing press of the 21st Century.

History provides us with many examples of what can happen when decisionmakers ignore innovation, rather than embrace its potential to benefit society.

The Ottoman Empire, the dominant political power straddling Europe and Western Asia for more than 300 years, barred the introduction of the printing press in the 16th Century, trying to hold on to its monopoly on distributing information. This unwillingness to enable access to a technology that could exponentially improve people’s lives was an important cause of its downfall.

The printing press of the 21st Century

When it comes to world-changing innovation, many believe that genome editing could be the next epoch-defining advancement — the printing press of the 21st Century.

By enabling human health researchers to efficiently and precisely alter faulty genes, there is a certain optimism that genome-editing tools like CRISPR/Cas will be able to treat — and potentially cure — a wide range of serious diseases caused by DNA mutations, from sickle cell anemia  to genetic blood disorders and even cancer.

Kemal Malik, Board member and head of Innovation at Bayer AG

As with any new technology, there will always be risks and benefits.  Part of the public debate around genome editing, however, must include discussion around ethical questions that will arise from these new tools.

For example, while there can be important therapeutic choices to cure illnesses by altering non-inheritable genes, there are major implications and ethical concerns introduced by altering human DNA that can pass from generation-to-generation. Bayer believes the line should be drawn at making any changes to hereditary genes and joins the call for a scientific moratorium on such work.

DNA changes in humans that are not inherited by the next generation can be ethically accepted, if it cures serious diseases. We therefore favor a transparent and balanced societal debate that takes into account the different ethical aspects of genome editing used in human genetics.

We therefore favor a transparent and balanced societal debate that takes into account the different ethical aspects of genome editing used in human genetics.

Genome editing also offers a great potential for agriculture. Using the same tools, plant breeders can more precisely and efficiently develop improved crops that help farmers grow more with fewer resources, including less nitrogen fertilizer, pesticides, land and water. It can be used to develop food products with improved nutritional value, alleviate food allergies and curb global food waste.

In fact, genome editing is a much more precise and efficient way to reach the results one might achieve through historical methods of breeding. If the resulting plants are indistinguishable from traditional breeding, they should be considered equally safe.

In the public debate, the EU must avoid a repetition of the GM debate of 20 years ago, but discuss the new tools on genome editing by their new merits.

The way forward

Having learned about the need to reconsider well-entrenched ways of thinking from past debates on the regulation of new technologies, we support initiatives that advance a broad stakeholder and societal debate on the future use of genome editing in Europe.

Rather than watching other regions pass by, Europe should use its knowledge on combining innovation with social progress and deploy new technology to the benefit of its society.

Bayer, along with leading scientists, asks for an EU-wide regulatory approach to genome-edited plants that considers not only the technical process of breeding and development, but, more importantly, the end product of that process too.

Our company is engaging with relevant stakeholders in the EU and around the world to establish a process for sharing information about genome-edited products in the market, and to assure the safe, transparent and responsible use of the techniques in agriculture.

Bayer calls on the EU’s new commissioners to form and steer an inter-institutional, cross functional platform where stakeholders and civil society can discuss how to introduce innovation with proportionate and science-based regulation in Europe.

The development of new breeding technologies should be guided by key principles, particularly:

  • Safety, ensuring the highest level for consumers and the environment, focused on the specific risk by product.
  • Transparency measures that earn society’s trust, including those that help consumers identify and choose food based on sustainable methods and benefits.
  • Sustainability, where every innovation, including genome editing, should be considered for the improvements they can bring towards more sustainable practices.

The Ottoman Empire, one of the wealthiest states of its time, watched other countries overtake it and eventually lost the ability to determine its own fate. Rather than watching other regions pass by, Europe should use its knowledge on combining innovation with social progress and deploy new technology to the benefit of its society.

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