Published 2018-06-26

This post is also available in Swedish

Key decisions on plant-breeding rules expected shortly

Many issues about which regulations exist regarding plant breeding are either difficult to interpret or unclear. In October, the European Court of Justice must make an important ruling on whether crops modified with CRISPR-Cas technology should be classified as GMOs.

Until the 1960s plant breeding was, in principle, unregulated. This is no longer true. Today, instead, we have a hotchpotch of rules that are often hard to interpret and sometimes contradictory.

This applies particularly to the application of patent rights regarding plants, but also to legislation on genetically modified organisms (GMOs), as well as to various international conventions. Common to all is that they affect the prospects of plant breeding.

To clarify what rules exist and describe their practical implications for plant breeders, the Royal Swedish Academy of Agriculture and Forestry (KSLA) and the Swedish Seed Association held a seminar in mid-May. Their hope was that they would also be able to present important news during the meeting. This did not happen.

‘We had hoped that, by now, we would have received notification from the European Court of Justice about which rules are to apply to CRISPR-edited plants. Unfortunately, no such announcement has been made,’ said Dennis Eriksson in his talk.

Eriksson is active in Mistra Biotech, but has also worked at the European Plant Science Organisation (EPSO) in Brussels as a Mistra Fellow. EPSO is an independent organisation that collaborates on plant breeding issues with research institutes and universities in more than 30 countries.

One of his conclusions is that policy cannot keep up with today’s rapid development.

What is new is that several genetically modified (GM) crops are now on their way onto the market. Currently, however, they are not classified as GM crops because they are edited with CRISPR-Cas technology, one implication being that they contain no new DNA.

To clarify what is happening, in October 2016, nine French organisations asked the European Court of Justice (ECJ) which rules were to apply. Their primary explicit purpose was to get these crops classified as GMOs and thus subject to the EU’s strict genetic engineering directives.

Since then, the ECJ has processed the question, but not yet announced which rules apply. Now, however, the issue is becoming urgent. Under EU regulations, the Court must decide within two years, so it now has only a few months to make its decision.

Eriksson emphasised the Swedish position: that the starting point should be the risk to human and animal health, not the technology itself. Several of the other seminar speakers agreed, and thought the only reasonable way forward was technology-neutral legislation.

Another discussion point during the seminar was the future significance of the Nagoya Protocol, a 2014 international agreement on genetic resources and associated traditional knowledge. Read more about the Protocol in the fact box below.

Several attendees considered this an important agreement. The problem is that few people know what it means and who is affected.

Jens Sundström of the Swedish University of Agricultural Sciences (SLU) is critical of the Protocol and said that he had asked 100 researchers at SLU what they knew about the Nagoya Protocol. The finding was that hardly any understood its implications.

‘Many people think they’re not affected, but that’s wrong. We also think the Protocol should be cancelled, since there’s a contradiction between the aspiration of the research, to spread knowledge, and the Protocol’s aim of locking in and creating property rights around this knowledge.’

Other storm clouds discussed were the likely consequences of Brexit. Anxiety is primarily based on the fact that the British in many cases share the Swedish view on issues relating to plant breeding and GMOs.

‘Plant breeding has a long tradition of cooperation, and of being promoted by public funding. But in recent decades, patents have become increasingly dominant for companies active in the sector. The big ones have therefore engaged many lawyers to protect their own company’s interests,’ said Bo Gertsson, Breeding & Technology manager at the agricultural cooperative Lantmännen.

Despite the delayed notification of which rules will apply in the future, there was some hope for the future, especially among those who want to use CRISPR-Cas technology for faster, safer plant breeding.

‘We have no clear indicators of what the Court of Justice’s rulings will be, so we can only wait. Hopefully, they’ll reach a decision faster than the European Commission. There, we’ve been waiting for ten years now,’ were Eriksson’s somewhat wry final words.

 

Facts — the Nagoya Protocol

The Nagoya Protocol is an international agreement on genetic resources and associated traditional knowledge that governs how genetic resources are collected and used in research and product development, and how benefits from their use are distributed.

The Nagoya Protocol, which entered into force on 12 October 2014, provides a legal framework for ‘fair and equitable sharing of benefits arising from the utilization of genetic resources’. The aim is to create greater legal security for both the country providing these resources and their users.

Genetic resources may be plants, animals, or parts of them, such as seeds, spores, plant parts, sperm, yeast cells, viruses and bacteria.

Common to these resources is their important and growing role in several economic sectors, such as food production and forestry, as well as in development of pharmaceuticals, cosmetics and biobased energy sources.

Protecting the traditional knowledge of indigenous peoples and local communities, with their traditional way of life, is also important, because it can yield clues to scientific discoveries.

Traditional knowledge includes innovations and customary practices for conserving and making sustainable use of biodiversity. In many cases, this knowledge has passed down through the generations by word of mouth, and may be found in stories, legends, folklore, rituals, songs and laws.

National legislation in various countries diverges when it comes to how ‘traditional knowledge’ is defined. It is therefore important for users who are uncertain whether their research includes traditional knowledge to make contact with the country from which genetic resources and associated traditional knowledge are derived.

Links:

The Swedish Environmental Protection Agency has extensive information on the Nagoya Protocol on its website.

See a podcast of the whole seminar (in Swedish) here.

Text: Per Westergård