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.