EU companies must get ready for ‘bio-piracy’ law now

By Annie Harrison-Dunn contact

- Last updated on GMT

Will new regulations mark an end to colonial-style R&D?
Will new regulations mark an end to colonial-style R&D?

Related tags: European union

Global and EU regulation aims to stop companies using indigenous bio knowledge and material to make profits without filtering any of the benefits back.

The Union for Ethical BioTrade (UEBT) said the enforcement of the Nagoya Protocol last October, a UN agreement of about 55 countries, was a positive step towards this.

In the making since the 90s, the protocol needed 50 states for it to come into force. 

The Protocol introduced ABS – Access to Genetic Resources and the Fair and Equitable Sharing of Benefits Arising from their Utilisation – and basically meant countries had the right to regulate access to non-human genetic resources in their territories. This covered sectors including agriculture, biotechnology, health, cosmetics and food.

This effort was matched in the EU with regulation (511/2014​) requiring companies to prove it had biodiversity research permits as part of the market approval process for natural ingredients.

The main obligations around due diligence of this EU regulation were delayed until October 2015 while stakeholder meetings took place to gather more information and form secondary legislation as well as guidance for companies on which activities would actually be covered. National movement has already been seen however.

Maria Julia Oliva, UEBT’s senior coordinator for policy and technical support, said companies should be planning now for when the regulation is actually enforced in October.

She said this was part of a process that would help incentivise biodiversity and ensure fair R&D at the point of access in the country and commercialisation elsewhere.

“In order to give biodiversity-rich countries and communities living near biodiversity an incentive for sustainable use, you have to make sure they also benefit from the value of biodiversity.

“If the benefits are being harnessed by a researchers and companies that are very far away from these deserts or tropics etc. and there are no benefits flowing back, then there is very little incentive to conserve that biodiversity.”

What are these regulations responding to?

Oliva gave the example of the neem​ tree in India. In 2005 the EU Parliament's Green Party, India-based Research Foundation for Science, Technology and Ecology (RFSTE) and the International Federation of Organic Agriculture Movements (IFOAM) won a ten-year patent battle.

The European Patent Office (EPO) granted the US Department of Agriculture and multinational WR Grace a patent for an anti-fungal pesticide product using neem​ to in 1995, but the Indian government argued this was bio-piracy of traditional Indian knowledge.

Another example might be hoodia – a type of cactus traditionally used by South African San Bushmen to suppress appetite and thirst when crossing the dessert and since used as a weight-loss ingredient.

South Africa’s Council for Scientific and Industrial Research (CSIR) along with partner companies tried to patent the plant. Eventually a benefit sharing agreement based on revenue was settled with the community. 

So what do all of these pieces of paper mean?

Many countries already have their own ABS protocols. What the Nagoya agreement means is that foreign companies using bio material and/or knowledge in those countries have to abide by those national rules.

What the EU regulation is likely to mean once it comes into full swing in October this year is that European companies will be asked at various check point stages – such as funding requests and marketing authorisation – for proof of due diligence and accordance to those relevant laws like permission for access from the country and the nominated stakeholder, for example a landowner.

She said countries like France may add further check points such as patent application.

This all means companies will be obliged to keep better records of where the ingredient ready for commercialisation came from and whether the appropriate people were remunerated for that traditional knowhow or bio resource.

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This ‘benefit sharing’ differed according to country and could be mutually negotiated. This could mean paying into a national pot, paying individuals, communities or institutions, intellectual property rights, scholarship agreements, technology transfer or data sharing.

The knowledge point of course was much more complicated to prove and settle.

“Traditional knowledge is a very tricky because it’s not clear exactly what type of use [of knowledge] needs permission and what is just general background research.

“For that reason there is a lot of anecdotal evidence that companies have moved away from working with ingredients that have traditional knowledge. Or really selecting cases where the traditional knowledge is held by a particular group or group of communities and they can make sure there is legal certainty about securing authorisation.”

Oliva said this would increase traceability since companies would be forced to know where the ingredients came from, even if through a supplier, and whether the access and benefit requirements of the origin country had been respected.

From fear to pragmatism

The EU regulation will not be retrospective but will apply to access to bio resources after both countries signed up to the Nagoya Protocol.

Under theNagoya Protocol, companies will now be able to check on a central system whether a permit has been granted for a particular bio material.

Oliva said this was part of a movement from fear of misappropriation of bio resources towards a more transparent and practical system that can facilitate R&D for the companies “who want to do things right” ​and in turn valorise biodiversity for the country.

In the EU the check points will be established by national authorities that will be responsible for monitoring.

In the UK this has been handled by the Department for Environment, Food and Rural Affairs (DEFRA), with fines of up to £250,000 and a maximum of two years in prison established for the most severe cases of non-compliance.

France is currently passing its own rules, with it and Denmark said to be considering hefty fines also.   

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