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Thursday, 12 December 2013

EU Implementation of the Nagoya Protocol - Heading to Catastrophe or Catastrophe averted?

I am a biopiracy denier. I did not know that I was a denier. Tim Roberts, the beloved former president of the Chartered Institute of Patent Attorneys kindly informed me of the fact at the CIPA Congress recently. On the other hand I already knew that I was the human amanuensis of a fictional feline so on top of that being a biopiracy denier is maybe not all that bad. 

What is this rubbish I hear you cry. Well, the thing is that the Nagoya Protocol is currently on its way into being enacted into European Union legislation. And the European Parliament has taken a relatively sensible proposal from the Commission and attempted to turn it into a nightmare.


The more neutral term for "biopiracy" is "bioprospecting". Indeed, at the CIPA Congress, "biopiracy" was raised as an example of a term (like "troll") that has little clear and unambiguous semantic meaning, and serves mainly to indicate the disapproving attitude of the person using the term. Even the term "bioprospecting" seems to this Kat  to have an unfortunate negative connotations of a "Wild West" attitude anchored in the 19th century Gold Rush fevers.


Oh and I probably have to clarify that by "denier" I mean "one who denies", not something to do with the fineness of the mesh of stockings.


But I digress. Let me first take a step back.

Once upon a time there was the Convention on Biological Diversity. This Convention stated that countries had sovereignty over the genetic resources found in their territory.  This principle appears in Article 15:

Recognizing the sovereign rights of States over their natural resources, the authority to determine access to genetic resources rests with the national governments and is subject to national legislation.
Previously unknown title of this picture:
The IPKat's cousin caught in the rain
while engaged in a spot of biopiracy
Actually this Kat finds that idea quite questionable, but let's let that go for now.  (Well, we kind of have to, since the CBD has been signed and ratified by squillions of countries so that the principles articulated therein are now widely accepted.)  On second thoughts, before we let it go, I do want to note that the concept of national ownership of genetic resources reached its appalling culmination in the announcement by the government of Indonesia invoking "viral sovereignty" in order to deny access to a new strain of avian influenza (H5N1) virus that was first detected in that country (see "Haggling over viruses: the downside risks of securitizing infectious disease" by Stefan Elbe Health Policy Plan. (2010) 25 (6): 476-485.; and this Washington Post article). This Kat fails to see that such an attitude assists either the country concerned or the wider world.  Ho hum, I am digressing again.

The problem with the CBD was that such sovereignty was really rather theoretical. Having sovereignty in principle is no good if you can't do anything about it or with it. So the good diplomats and negotiators of the world got together in Nagoya & signed the Protocol.  You can read the text here.

Now the Protocol makes sense only if you believe that such a thing as biopiracy exists to a non-negligible degree. That is, that you believe that companies regularly go off to developing countries that are rich in natural resources, extract from them samples, take those samples in order to develop valuable medicines and other products, without compensating the countries from which the samples came. "But surely," I hear you cry, "if there is a treaty designed to prevent this, then surely it must be a problem". Well, you would think so, wouldn't you? But when you come to look for the evidence that is put forward in support of this proposition, it all looks rather thin. 

Recently an anonymous commentator on the blog stated that this activity happens all the time. When I challenged to support this allegation then answer came there none. 

The European Commission in their proposal for a Regulation to implement the Nagoya protocol states


26% of all new approved drugs over the last 30 years are either natural products or have been derived from a natural product.
But "Natural Product" has a broad range of meanings, much broader than anything that could possibly be considered biopiracy, and the paper cited (Newman and Cragg (2012), "Natural Products as Sources of New Drugs over the 30 Years from 1981 to 2010". Journal of Natural Products, 75(3), pp 311–335) does not seem to go into details about what kind of sources are implicated.  This Kat was recently referred to a paper ("Biological Diversity in the Patent System" by Paul Oldham, Stephen Hall, Oscar Forero) on biological diversity in the patent system, and came across some interesting findings.  The paper reports that, of plants referred to in the patent collections searched:
The top ranking species are: Aloe vera for dermatological disorders and antineoplastic agents; Ginkgo biloba for nervous system disorders; Taxus brevifolia (Pacific yew) for antineoplastic agents; Cannabis sativa (cannabis) for nervous system disorders; Camellia sinensis (tea) for antineoplastic agents and anti-infectives; Panax ginseng for a range of agents including antineoplastic agents; Vitis vinifera (grape vine) for dermatological disorders; Momordica charantia (Bitter melon) for antineoplastic agents and hyperglycaemia;  Curcuma longa (turmeric) for antineoplastic and dermatological disorders;Glycyrrhiza glabra (Liquorice) for dermatological disorders; Glycine max (soybean) for urinary system disorders; Centella asiatica (Indian pennywort) for dermatological and anorexiant/anti-obesity agents; Hypericum perforatum (St. Johns wort) for antidepressants and anxiolytics;Camptotheca acuminata (the Chinese happy tree or cancer tree) for antineoplastic, antiviral and anti-parasitic agents; Zea mays (maize), in connection with anti-infectives, andRosmarinus officinalis (rosemary) for dermatological disorders.
and then goes on to say:
As the lists of species presented above reveal, the bulk of patent activity is concentrated around a small number of well-known and cosmopolitan species. 
Anyway back to the Protocol, notwithstanding the paucity of evidence for biopiracy as an actual, as opposed to theoretical, problem. What it says relatively simply is that if a genetic resource is taken from its country of origin, then, if the country so requires, the researcher must enter into an access and benefit sharing agreement, in order to share the fruits of any benefit that comes out of research into that resource.  So the key planks of the Nagoya Protocol are to put into place enforceable mechanisms to ensure that taking of a genetic resource from its country of origin is only done with the Prior Informed Consent (PIC - see Article 6 of the Protocol) of that country and, if required, also entering in Access and Benefit Sharing arrangements with the country (ABS - see Article 5 of the Protocol).  In order to implement this, the Commission Proposal for a Regulation proposed (at Article 4):
Users shall exercise due diligence to ascertain that genetic resources and traditional knowledge associated with genetic resources used were accessed in accordance with applicable access and benefit-sharing legislation or regulatory requirements and that, where relevant, benefits are fairly and equitably shared upon mutually agreed terms. Users shall seek, keep, and transfer to subsequent users information relevant for access and benefit-sharing.
Now of course, I am hoist with my own petard.  if I say that this never happens to any financially significant extent, then surely they can be no harm in the legislation.  And, indeed, this Kat would have had no real problem with the proposal as put forward by the Commission.  Because the draft Regulation stated (at Article 2):
This Regulation applies to genetic resources over which states exercise sovereign rights and to traditional knowledge associated with genetic resources that are accessed after the entry into force of the Nagoya Protocol for the Union. It also applies to the benefits arising from the use of such genetic resources and to traditional knowledge associated with genetic resources.
So this meant that in future researchers would have to get prior informed consent and enter into an ABS to take genetic resources from other countries. Well, what is the harm in that?  Actually probably nothing, and there could well be some advantages.  And we might even overlook the absence of anything resembling, errr, evidence to support the proposal for new legislation.  (You see, this Kat has spent too long in the company of the Katonomist.)

But then the European Parliament got their hands on the draft Regulation.  As they would, being the Parliament and everything.  They added "or utilised" into Article 2 above after "accessed" and also the following wording "as well as subsequent applications and commercialisation." at the end.  This would make the Regulation retrospective.  They also expanded the meaning of "genetic resource" to include "derivatives", meaning "product of genetic expression", i.e. any part of any organism.  So everything that anyone had already, that had come from another country, would potentially have immediately become considered biopirated.  Use would have become illegal (oh yes, they beefed up the "illegal" part as well).  (You can see the full reports here, as well as the link at the beginning of this paragraph to the pdf report of the Committee on the Environment, Public Health and Food Safety.)

Incidentally, the meaning of "use" was unclear, because although in the original proposal it was clear that "use" meant "research"; after Parliament's amendments it sometimes meant "commercialisation" as well, making even more people potentially retrospectively deemed biopirates.

Somebody possessing such contaminated material would, as Parliament envisaged, have to either revert to the country of origin (if known) to negotiate a benefit sharing agreement, or, if the country of origin is not known, pay to a [European] "Union benefit sharing fund".

Any such retroactivity and expansion of the scope of the proposed Regulation would severely hamper research in Europe, and impose a bureaucratic burden far out of all proportion to any supposed harm that may have occurred in the past, or indeed benefit that could accrue in the future.  While the scope of such expanded legislation might not affect the Kat using the herbs and spices in his kitchen, it is not at all fanciful that it would impact upon a farmer growing any crop that is not indigenous (even if it is one grown here for decades already.)

It was actually at this point that this Kat noticed all this, upon reading (you know who you are who alerted this moggy - thank you) that the European Parliament had voted in First Reading to include these amendments to the original proposal, thereby changing the scope of the proposed changes beyond recognition. (see for example here.)  He has been meaning to write about it for some time, but has been spurred into action by Merpel informing him that a revised proposal is expected out soon, following negotiations between Council, Commission and Parliament.  He will of course write about that as soon as news emerges, but wants to let his dear readers have time to digest the background and issues first.  It is a lot to digest in one go, and surprisingly little has been circulating on the issue since the Parliament vote.

Tim Roberts of course saw the problems of inappropriate implementation (and even appropriate implementation) of the Nagoya Protocol back in 2011 from attending meetings of the Intergovernmental Committee on GeneticResources, Traditional Knowledge and Folklore (IGC-GRTKF) and wrote a lovely paper on it here, which is an excellent introduction to the issues.

When an entirely new piece of legislation is introduced, imposing additional requirements on the public, particularly if any of those requirements are retrospective in effect, then it is of course essential that the legislation be clear. The Commission proposal was generally clear (and of course it was not retrospective). The Parliament amendments, by contrast, were rather a mess (like Paris), not least because of the ambiguity over the meaning of "use". The usual effect of unclear legislation is that people who are unsure as to what they may legitimately do err on the side of caution and do nothing. Thus the expected effect of the proposed regulation as amended by Parliament would be to create large bureaucratic hurdles, stifle research and commercialisation of technology (including agriculture), without clearly producing significant benefits for the intended beneficiaries (developing countries). 


And don't get me started on Traditional Knowledge (TK). No, really. Do not let me embark on the topic. It is also addressed in the Nagoya Protocol.  But this post is long enough with too much material already, so I will leave that aspect to a later piece.

Merpel notes that the fact that the Rapporteur for the main European Parliament reporting Committee responsible for the legislation (Environment, Public Health and Food Safety) is a member of The Greens group within the EP is entirely unrelated to the unjustified expansion of the scope of the proposed legislation.  It is also of course completely coincidental that the Rapporteurs for the Committees that gave opinions (Development, Agriculture and Rural Development, and Fisheries) are also Greens.  Merpel is also sure that that the fact that the UK government department under whose jurisdiction these negotiations fall is DEFRA is no cause for concern at all. 

12 comments:

Norman said...

The Intellectual Property Institute of Canada (the Canadian IP practitioners’ professional association) has raised similar concerns in its submissions regarding Canada’s possible signature of the Nagoya Protocol. The IPIC submission is a public document, and (with permission) I have uploaded a copy of it: http://bit.ly/1e7Qbdg

IPIC’s main concerns are that both the scope of the right and the remedy are unclear and potentially very broad. I should emphasize at the outset that IPIC’s concerns, and certainly my own, do not relate to the sharing per se, but rather that it will be very difficult to determine ex ante whether sharing is required. The basic problem is that innovators will have to track their sources of knowledge, not just their sources of physical material. Because of the nature of the transmission of knowledge, there is considerable potential for inadvertent triggering of the requirement to share. This example is provided by IPIC:

For example, suppose an anthropologist visits an indigenous tribe somewhere and is told that a certain plant, e.g. a particular species of yew, is used to treat a particular disease. The anthropologist reports this in an anthropology paper. Indirectly, this information (derived from the genetic resource) becomes known to a Canadian company. Because of the nature of transmission of knowledge, the Canadian company may not be aware of the anthropology paper itself and consequently may not be aware that the ultimate source was traditional knowledge. The Canadian company investigates a different species of yew that is native to Canada, and isolates a therapeutically important compound and patents and commercializes a derivative of that compound. After the world-wide success of the compound, the anthropologist becomes aware of the drug, and that it is based on yew, and makes the connection to her paper. It is subsequently established that the ultimate source of the biotech firm’s information that yew might be useful in the treatment of the disease is indeed the indigenous tribe. Could the tribe then have a claim to share in the profits, the terms being imposed ex post?

Anonymous said...

Here's an interesting further spanner to throw in the works... The Nagoya Protocol assumes that the State has sovereign rights over their natural resources. However in some countries, there are questions about whether the State has authority to determine access to genetic resources or to enact national legislation in relation to them.

For example in New Zealand some Maori believe that the traditional knowledge of their people is the property of the "Crown" to use and benefit from.

This introduces another layer of complexity for any legislation and accession to international treaties.

Guess that's why you said you'd leave the traditional knowledge aspect for another day.

Graham Dutfield said...

I detect a whiff of scornfulness in this particular Katpost. I do accept that most of what is said about biopiracy is exaggerated and unsupported by the evidence. There is in fact published corroborating evidence that it goes on. But to suggest it is some kind of "global pandemic", as some NGOs have done, is absurd, as is the presumption that much economic value is extracted in this way by the high tech industries. But note that the food, beverages and cosmetics sectors may be a very different story, though.

About Indonesia, for what it's worth I was contacted out of the blue in the late noughties by somebody at the World Bank referring to Indonesia's refusal to hand over samples and asking whether I could come up with any legal arguments on the basis of the Biodiversity Convention for requiring Indonesia to hand them over under international law. I said there were no such arguments, and that while Indonesia's stance was unfortunate the country's position on the matter was understandable. My conviction does not of course require me to accept the validity of every single concern expressed at the time by people in the Indonesian government. I suggested that the best contribution the Bank could make would be to bring together the disputing parties, sponsor a reasoned debate, and facilitate a deal as soon as possible that provided Indonesia and other developing countries with certain assurances. I never heard back from my correspondent.

Personally I have some problems with the ABS concept as set out in the CBD and Nagoya Protocol and feel it is unlikely to be workable. Moreover, the EC is unlikely to come up with anything sensible. This draft certainly isn't very good.

As a supporter of indigenous peoples in my view what they really need are supportive local and national governments giving them sufficient autonomy to make decisions on matters affecting them rather than bureaucratic, vague and unworkable international legal instruments (and national laws). Much traditional knowledge has value but that value, while genuine, is limited in the life science industries context. So I do not see how any regulatory or legal regime can create international markets for TK transactions. Besides indigenous peoples have their own customary norms about knowledge access and exchange, and while often keen to engage in commercial activity tend to be uncomfortable with our intellectual property norms. Understandably they also lack confidence in licensing and contractual arrangement that are part of the stock in trade of commercial outfits (and lawyers).

The value of traditional knowledge is primarily local and is worth protecting for that reason.

Graham Dutfield

Tim Roberts said...

"The value of traditional knowledge is primarily local is worth protecting for that reason"

For that reason it's worth conserving, agreed. But if by 'protecting' you mean stopping other people using it - or knowing it? - that's less clear.

Dr No said...

What does this mean for companies working in the medical field. For example, if vaccines for bird flu or SARS are developed from viruses isolated and sequenced in other countries, how would this play out? What about those who are using clinical isolates from different member states, is there any impact?

Tim Roberts said...

Dr No, undoubtedly there is an impact. Before you start work on a new flu vaccine you may need permission from the 'country of origin' and to enter into an Access and Benefit Sharing agreement with it. A 'country of origin' is one which possesses the genetic resource (the flu virus) in 'in situ conditions' (which presumably means in some local human being that has the disease). If there is more than one such, you might need to work out which country had it first, but more likely any one will do. Or you might wait until a visitor returns home from the afflicted area, and get samples from him (assuming that his returning home in possession of the virus without permission from the country where he caught it is not illegal).
When you say 'different member states', are you talking about Nagoya members, or EU members? Most of the EU are not planning to assert their genetic resouce rights (rumoured exceptions may be Spain and Denmark). As regards Nagoya, isolates from different countries may be the same, or essentially the same, or significantly different. Nagoya is not (I think) clear about genus and species. Safer not to work with any samples from countries you don't have an agreement with?

Graham Dutfield said...

I think I need to clarify my earlier comment. Yes, by saying "protecting", "conservation" was very much on my mind. But not some kind of ex situ conservation done by others. It should be noted that customary norms regulating use are likely to exist. These may effect the freedoms of others to use this knowledge. This may not be tantamount to "stopping" use by others but rather that the use is conditional. So conservation at the local level and protection may be two sides of the same coin. Needless to say perhaps, not all young indigenous people have much time for "the wisdom of the elders". But many do too.

Also, there are provisions in Nagoya that require benefits to be shared with holders of traditional knowledge. The problem of course is that the circumstances in which such outcomes will ensure are likely to be rare.

About influenza viruses I'm not sure anybody needs to worry about Nagoya. At least, that is my hope. The WHO did negotiate the so-called Pandemic Influenza Preparedness Framework for the Sharing of Influenza Viruses and Access to Vaccines and Other Benefits. It's available from the WHO website. I expect this now forms the rules of engagement for viral sample sharing. I haven't read it thoroughly but according to my superficial reading it's pretty sensible.

I haven't responded to Dr No as I have with Tim and Darren as I'm not keen to engage with anonymous people.

Simon Taor said...

Like Darren, I could also call myself a biopiracy denier. I find the concept of a country having rights in the plants that just happen to grow there (in many cases but for the wind, they could grow elsewhere) more than a little strange.

Tim, if a pharma company must enter into an Access and Benefit Sharing agreement with a 'country of origin' of a flu virus before working on a vaccine, then is it not right and fair that the 'country of origin' take some responsibility for the flu virus? Do these genetic resource rights not come with genetic resource responsibilities?

If I owned a dog that attacked a stranger in the park, I would be held accountable for my dog’s actions. If a flu virus is the genetic resource of a country, should that country be held accountable for the damage caused by the virus?

I think few people (me included) would think that a country should be held accountable for the damage caused by a virus that just happened to mutate there. But then again, before I read about Nagoya, I would have imagined that few people would think that a country has any ownership rights over the genetic material that just happens to grow there at the moment.

Anonymous said...

"come with genetic resource responsibilities?"

You really do want blood from a stone, don't you?

Simon Taor said...

If you are going to be facetious, I may as well join in:

If I took some hemp netting from your country to mine, and then found within the hemp a compound with a useful medicinal purpose, would your country expect to receive money for old rope?

Anonymous said...

Simon,

You are going to have to try harder to be facetious.

If you discover something in the rope, then it is no longer merely old rope.

It's now "New and Improved" old rope.

Dr Abeba Gebreselassie said...

I am writing this to indicate you to an example on a different form of bio-piracy. I have done a case study on access to and benefit sharing from Ethiopian plants : Teff and Vernonia. Two European based companies signed material transfer agreement with the government of Ethiopia. The terms of the agreement sounds good, but the companies never complied with the terms of the agreement. The British company which signed the MTA on vernonia claims to be bankrupt. However, in reality the company is doing its business. The Dutch company has taken out a patent, and three plant variety rights based on the teff it accessed from Ethiopia. Hence, even if it may be difficult to find bio-piracy in its strict meaning, unless the company that took the plant come up with an outstanding product, which may attract the media,it will be difficult to trace which plant is from where. I have done a legal study on the above two Ethiopian cases , and if you are interested in it, you can read my book : "The Sustainability of Plants and Plant Intellectual Property Rights" : http://www.isbs.com/partnumber.asp?cid=28604&pnid=374851

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