Nagoya Protocol: searching for living gold

Like gold panners they traverse the world, sifting through matter in the hope of striking lucky and finding immeasurable riches. Yet bioprospectors are more likely to be holding pipettes and sample tubes than metal detectors and pans. Bioprospecting involves searching for elements of the biological world that have potential commercial or scientific value.

The concept of bioprospecting and the issues it raises are not new, but rapid technological advances have brought them to the fore. In October 2014, the Nagoya Protocol of the Convention on Biological Diversity (CBD) came into force with the aim of sharing the benefits of biological wealth. However, the project is still far from completion, critics warn of its flaws and the list of ratifying countries has many gaps, including the US.

So does Nagoya represent an overdue and desperately needed step in the right direction, or more red tape and unattainable expectations?

Harvesting the fruits of evolution

Evolution has led to an immense body of diversity as organisms have adapted to live in almost every type of environmental. The value of the natural world as a resource for humans has long been recognised, yet the potential to ‘mine’ this resource is now greater than ever. Developments in molecular biology and computing power have been key.

In recent years the speed of DNA sequencing has soared, just as the cost has plummeted. So accessible is DNA sequence information that scientists now face a new problem—making sense of the huge amount of data available. In the context of bioprospecting, raw sequence per se is not of particular use without knowing which parts of it constitute genes, what proteins the genes encode and what functions they perform. The challenge is to ‘annotate’ the sequence.

Even after locating a gene and identifying it as being of potential value, considerable further work may be required to engineer the protein produced by the gene into a more useful form. Producing a drug ready for sale will add further years to the process. The end result will be a combination of millions of years of evolution and the ingenuity of biochemists.

Whose work is it anyway?

It is the fusion of nature and human effort inherent in bioprospecting that presents a problem. On the one hand the fruits of bioprospecting are, by definition, naturally derived. It seems wrong for commercial entities to take all the profits, leaving the source countries, and indigenous communities who have known about and used the resource for generations with nothing.

On the other hand the burden of risk sits squarely on the shoulders of those undertaking the research. The research requires huge amounts of time, effort and money, and of all the resources investigated only a tiny fraction will be found to be of value. As ever, striking the right balance is difficult, especially where the aim is to achieve international consensus.

A legal solution?

In 1992, growing public and political interest in biodiversity culminated in the global CBD, forged with three aims in mind: conserving biodiversity, using biological resources sustainably and, of particular relevance to the issue of bioprospecting, sharing the benefits arising from the use of genetic resources fairly. Dealing with the third of these aims, the Nagoya Protocol was formulated in 2010 to provide specific mechanisms for implementing change, coupled with binding obligations.

In a world divided by inequality, some of the richest, untapped pools of biodiversity lie in the poorest and least developed regions. Without an enforceable set of rules, there is a risk that increased interest in bioprospecting will lead to profits for the nations and companies with the most advanced bioprospecting abilities, and not for the countries from which the resources are derived.

The Nagoya Protocol reinforces the idea that countries have ownership over genetic resources and that they should receive a share of any benefits that flow from them. A further key principle is that indigenous and local communities will often be in possession of traditional knowledge related to genetic resources. Where such knowledge is utilised for commercial gain, the relevant local communities should benefit.

October 2014 was a significant month for the protocol. With the threshold of 50 ratifying states having been reached in July, Nagoya came into force 90 days later, on October 12. This was in time for the 12th meeting of the governing body of the CBD, meaning that the first meeting of the parties to the protocol could be held concurrently with the main CBD proceedings in Pyeongchang, South Korea.

Over the week of October 13 to 17, working groups grappled with issues fundamental to the protocol, eventually reaching decisions that were successfully adopted by consensus.

Several of the decisions made are of particular importance. Agreement was reached on a way forward for the setting up of an access and benefit-sharing clearing house, designed to allow the global exchange of information (for example, rights over genetic resources, obligations of users and national focal points of contact), and thereby help parties to implement the protocol. Similarly, the decision concerning compliance and enforcement also represents a key first step for ensuring the protocol is functional.

"The Nagoya Protocol reinforces the idea that countries have ownership over genetic resources and that they should receive a share of any benefits that flow from them."

However, there is no hiding that these achievements are the start of a long journey. Although contracts between resource users and providers will be central to Nagoya, the process of collating and sharing model contractual clauses is still in its early stages. Similarly, among the most significant unanswered questions surrounding implementation is how to deal with situations where genetic resources are found in more than one country, or are tied to traditional knowledge of more than one community.

In such circumstances, will multilateral agreements be required? The ‘decision’ reached on this issue was for further investigation and discussion—both subject to the availability of funds—to take place. Answers and agreement are probably some way off.

Gaps in the ‘global’ consensus

Not everyone has faith in Nagoya. The Pyeongchang meeting ended with a plea for further countries to ratify the protocol. Brazil, one of the richest nations in the world with respect to biodiversity, has yet to go through the ratification process. The US, too, is noticeably absent from the list of countries that have ratified the CBD (and, until this changes, is prevented from ratifying Nagoya, which supplements the CBD).

However, the US government still adheres to the principle of national sovereignty over resources and of sharing the benefits of bioprospecting. Dr David Newman, chief of the natural products branch of the US National Cancer Institute (NCI), outlines to LSIPR the system of ‘source country commitment’ in operation.

“Anyone who licenses an NCI patent,” Newman explains via email, “must come to an agreement with the country of origin within one year or the licence is pulled.”

Opponents of the new protocol argue that extra burdens will be imposed upon researchers, thereby hindering scientific progress, and that the US—operating outside the protocol—will have an advantage over the rest of the world. Yet Newman sees the protocol as an attempt to streamline the administrative complexities left in the wake of the CBD.

One of the principles of Nagoya is that there would be identifiable people in the governments with whom one could deal.

“I still have grey hair and ulcers from trying to find these in many countries,” says Newman. With ‘national focal points’ designated and identified on the clearing house system, the hope is that the communication process will be simplified.

There is also a concern that Nagoya will build up developing nations’ expectations, only leading to disappointment and mistrust when the anticipated profits fail to materialise. Newman cites the myth “where any discovery of a molecule that stopped a cancer cell in vitro was considered to be worth billions of dollars”, adding that the problem still remains to an extent. Only a tiny proportion of compounds screened reach the drug stage and maintaining realism in the expectations of resource-rich countries will be a major challenge of Nagoya’s implementation.

Important first strides on a long and difficult path

It has taken considerable time and effort to progress from the adoption of the CBD in 1992 to the Nagoya Protocol in 2010 and, in 2014, its coming into force. Undoubtedly progress has been made but fundamental questions remain and, given the number of parties involved in the negotiations, solutions will likely not come quickly.

Among the 20 Aichi biodiversity targets, formulated as part of the UN Strategic Plan for Biodiversity 2011–2020, target 16 is that the Nagoya Protocol is in force and operational. As pointed out in the closing speech at the Nagoya party meeting, the parties have “achieved the first part”.

The second part—bringing Nagoya into operation, and doing so by 2015—still represents a major challenge. The challenge though, is a worthwhile one: if implemented carefully, the principles underlying Nagoya have the potential to ensure that source countries and communities receive a fair share of the profits derived from their genetic resources.

Charles Brabin has a D.Phil. in Genetics and is a non-practising barrister. He can be contacted at: charles.brabin@magd.oxon.org