Open Forum on Agricultural Biotechnology (OFAB) In Africa

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23 Οκτ 2013 (πριν από 3 χρόνια και 8 μήνες)

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1

Open Forum on Agricultural Biotechnology (OFAB) In Africa

Pu
blic
policy for biotechnology: international lessons from
European
experience

By Mark Cantley, Brussels and Lancaster


Introduction


I’d like to start by expressing my thanks to the African Agricu
lture Technology Foundation for
inviting me to this
international
occasion.

The AATF is playing an important role in opening
windows to international collaboration,
in

promoting collaboration between public and private
sectors, and
in

promoting the transfe
r of new scientific knowledge into technologies appropriate for
the national situations in Africa



all of these activities directly relevant to this Forum on
Biotechnology
.

I note that it has recently been accorded host

country

status here in Kenya.


I un
derstand that you had hoped that Dr Norman Borlaug
, the “Father of the Green Revolution”,

might have been able to grace this occasion with his presence.

That certainly would have been
wonderfully appropriate, although sadly for Africa, the major impact of
the Green Revolution has
so far been on wheat and rice.

You may have noticed that a few days ago at CIMMYT, the
International
Maize and Wheat Improvement Center
, Dr Borlaug was awarded India’s highest
honour


the Padma Vibhushan.

In his remarks on accepti
ng this award, he recalled the early days
of the Green Revolution in India and Pakistan


and the opposition and difficulties which he faced,
not least from government bureaucrats.

Some things don’t change.

He also commented in passing
on some of the oppos
ition to modern biotechnology
;


Western blockades of safe GM crops impede
its acceptance in most poor, food
-
insecure countries."


It reminds me of the French remark, “
plus ça change, plus c’est la mê
me chose”


the more things
seem to change, the more the
y remain the same.

And having wrestled with opposition to
biotechnology in international bureaucracies for the past 20 years of my career, I can sadly confirm
the truth of Borlaug’s observations.

But in addressing this Forum, I have to ask myself, rather t
han
repeating what you already know, what value can I add, what can I offer you
.

I shall try to present
some lessons from history, from European policy struggles with biotechnology, and from my own
experience.

I’ll try to
be
accurate in my facts


but the
opinions expressed will certainly be
personal.


The AATF represents an important initiative for bringing an international perspective to bear on
the
challenges facing agriculture in sub
-
Saharan Africa
.

I was interested to read the draft report

on
biotechno
logy

released earlier this year by NEPAD, the New Economic Partnership for Africa’s
Development
.

Their High
-
Level Panel on Modern Biotechnology met here in Nairobi in July, and I
noted with pleasure that Dr Mpoko Bokanga, Executive Director of the AATF, is

a member of the
Panel.

The report is entitled, “
Freedom to Innovate:

Biotechnology in Africa’s Development
”.

It
is an excellent report, an important report


and it addresses some policy issues

which are fraught
with difficult
ies


difficulties which I sh
ould also like to address in my own remarks today.

Hence
the title of my talk;

“Public Policy for Biotechnology:

International Lessons from European
Experience”.

And I don’t want to waste your time going over matters with which you are already
familiar.



2

We must recognise that


around the world


we are always engaged in societal learning processes.

Different countries are at different points on the

learning curve

.

That phrase, “the learning
curve”, is too simplistic a model, a metaphor, for the complex
ities of societal learning processes.
For countries

differ profoundly in their histori
cal experience, their

cultures,
their
geography,
climate,
and
natural resource endowments …
, in short, in the challenges and opportunities which
they face, and in the pot
ential strengths which they can bring to bear on meeting these.

It is not jus
t

a game of “Follow my leader”, but a more complex process of learning from one another, of inter
-
dependencies, but also of needs for independent and nationally specific action.


The Lisbon objective


a competitive, knowledge
-
based economy


In the European Union, our heads of government of the Member States hold regular meetings.

In
March 2000,

meeting in Lisbon,

they adopted as a strategic objective that the EU by 2010 should
bec
ome “the most competitive knowledge
-
based economy in the world”.

That was surely a bold
and ambitious objective;

but “a man’s reach should exceed his grasp”


it represented an aspiration,
which has not lost relevance over the past 6 years
.

It is an as
pira
tion of
particular relevance to the
life sciences and biotechnology.

For over recent decades, we have witnessed a massive surge of
new knowledge and understanding about the structure and functioning of all living entities.

I should
say, a massive
and conti
nuing

surge


for there is no indication of any slowing down i
n that
process.

We might note, for example,

that the US National Institutes for Health a couple of years
ago published a Request for Applications for grants to support new technologies

to reduc
e

the cost
of
genome
sequencing by 2 orders of magnitude within 5 years


and by at lea
s
t 4 orders of
magnitude within 10.

That would bring us towards the target of “the $1000 genome”


whether we
speak of man, his domesticated animals, his cultivated crops
, or the pathogens which attack these.

From the technology side, there is every indication that these targets are achievable.


Such availability of information will have many implications for the way we pursue biological
research, and for its practical app
lications.

It has consequences which policy
-
makers cannot, and
should not, ignore.

Not every country can build sophisticated infrastructure and finance the latest
equipment;

but these matters can be managed on an international scale


and infrastructure ca
n
include access to facilities elsewhere as well as construction of national facilities.

Electronic
communication, software and databases have indeed brought us all closer to McLuhan’s “global
electronic village”.


The continuing rapid progress of the tech
nologies is well illustrated by Rob Carlson’s graph, which
shows that also in biology, there operates something like the famous


and so far accurate


“Moore’s Law” for memory chips.


The central role of knowledge


I referred earlier to the new report fr
om the NEPAD Panel on Biotechnology.

Their report
repeatedly refers to the role of the new knowledge, access to it, use of it
. They write,




“One of the major changes in recent development thinking is the realization that what
separates developed and less d
eveloped countries is not just a gap in resources, but a gap in
knowledge.”



“Technological innovation is … a product of a society’s proclivity to encourage, foster and
invest in learning in the most comprehensive sense.”



“Governance structures may need to
be realigned to reflect a society’s willingness to
explore new forms of knowledge.”

3


These are conclusions no less applicable to the policies of the European Union, and which are
reflected in the “Lisbon objective”.

O
ur political leaders
have

emphasis
ed th
e need to

shift to a

Knowledge
-
based economy
”.

The reasons for this are clear, not least in terms of the
need to
move

our economic activities

towards sustainability
, and the need to reduce our “ecological
footprint”, to reduce and reverse the currently un
sustainable activities of our agriculture, our
industry, and our domestic habits.


The shift to a

K
nowledge
-
B
ased
E
conomy”

is a shift in which the life sciences and biotechnology
have been playing a significant role, and that role c
an greatl
y increase as
a result of the new
knowledge and techniques which are becoming available.

In the European Union, as they start their
7
th

multi
-
year “
Framework Programme” o
f

research and technological development,
the life
sciences and biotechnology are defining thematic
priorities oriented by the concept of a

Knowledge
-
Based Bio
-
Economy
”.


Following the statement of
the Lisbon objective

in the year 2000, the President of the European
Commission, at that date
Romano Prodi

(who is now Prime Minister of Italy)
,
met with

sev
eral of
his Commissioners



the Commissioners responsible for Agriculture, Environment, Industry,
Research,

Health and Consumer Protection,
and Trade


and asked them to prepare a European
S
trategy for the Life Sciences and Biotechnology, for the coming de
cade.

The preparation of that
strategy was a major undertaking

over the following year
, inviting widespread
public
consultation,
and submissions of advice and opinions from a wide range of parties and individuals.

Finally, the
strategy document was publish
ed in February 2002.


That strategy document remains today the basis for coordination of the Commission’s proposals
relating to the life sciences and biotechnology


at least, in principle.

As to the practice


well, I’ll
come to that in a moment.

The orig
inal document, like many documents written by multiple
authors,
by various

departments each with its own agenda and objectives, is in some degree
schizophrenic.

Som
e

chapters are drafted by those in research and industry who are cl
early
enthusiastic about
the pot
ential of the new knowledge and technologies.

Other chapters are drafted
by departments with regulatory responsibilities, who are convinced that to restore and maintain
public confidence, it is essential to have a clear, strong, regulatory framework

governing the new
technologies and the products resulting from their application.


The report is also in two parts:

the first half is a more political statement
about the importance of
the life sciences and biotechnology, and of their various applications
, emphasising the many
dimensions of a strategy.

The second half is more operational, translating the political objectives
into a 30
-
point “Action Plan”


each “Action” summarised in a half
-
page box, listing the key
activities, the targ
ets, and the organis
ations resp
onsible.

Many of the boxes
include among the
responsibles, “the European Commission”;

but like any national government, the Commission has
many departments


many “Directorates
-
General”, each headed by a different Commission
e
r


individuals effe
ctively of ministerial status.

So the various tasks to be undertaken in
implementation of the strategy are immediately translated into responsibilities of individual
departments, and individual Commissioners.


In order

to ensure coordination, there
is a Bi
otechnology Steering Committee, chaired by the
Secretary
-
General, the most senior official in the Commission;

and this committee brings together
not only staff from the various services involved, but from the Cab
inets of the several
Commission
ers
, represen
ting the political level
.

So, in principle, there is coordination.

In practice,
each department pursues its own agenda, and as everybody is very busy, nobody really has much
4

time to devote to such “horizontal” activities.

As it is often brutally expressed,

“You don’t get
promoted for being f
riendly with other Ministries”.

Only if there is a strong, sustained drive from
the top


from the Chief Executive in a company, or in a government, from the Prime Minister, can
you expect serious implementation of a coo
rdinated strategy.


Managing dynamic complexity


I go into these details, because although my recent experience has been largely with the European
Commission, the same problems arise in principle with every national administration


every
country has Minis
ters of Agriculture, Environment, Industry,

Health,

Research, Trade and so on.

In
federal countries it becomes more complex


i
n Austra
lia, for example, the federal official
responsible for authorisation of genetically modified crops has given the “Green l
ight” for gm
canola


but the governments of all the states most concerned have decided far various reasons


political, economic or whatever


to maintain moratoria for the time being.


In fact there are at least five levels on which regulatory and/or leg
islative instruments can affect the
“freedom to operate” of biotechnology companies.

Each level can be quickly introduced and
illustrated by some current or recent dispute:




Global



almost every agency of the United Nations has some interest in biotechnol
ogy,
and there are global instruments such as the WTO agreements, the Codex Alimentarius
Commission (defining standards which are the basis for international trade in foodstuffs),
the Convention on Biological Diversity, the Cartagena Protocol;



Multinationa
l



as in the European Union, or other regional groupings which have
committed themselves to common rules governing research, manufacture and trade using
certain products and technologies;



National
, as determined by national elected parliaments and governm
ents;



Regional
, as within federal countries in which legislative and regulatory powers are divided
between the federal government and the regions


the example of gm canola in Australia
has been mentioned;



Local
, as is illustrated by the current battle in
California, where some counties have
legislated on agricultural biotechnology, and a bill recently debated in the State legislature
seeks to prevent such county
-
leve
l action There are 58 counties in California


such local
rules
would oblig
e

industry to ad
apt its products and marketing to a proliferation of
different local regimes


with corresponding
consequences such as
discouraging
technological innovation, and increasing costs and prices
to the final consumer
, for no gain
in safety or environmental prot
ection.


Thus any national administration faces at least two dimensions of complexity:

firstly, to ensure
coordination between the policies pursued by the many Ministries with interests in biotechnology;

and secondly, to recognise that the national level i
s just one of the many levels at which there are
pressures, constraints, agreements and rules governing what may be done.


In Europe, in spite of the strategy, which is basically positive about biotechnology, we have
finished up
with the most stringent reg
ulatory framework in the world


and some of the members
of the European Parliament think this is something of which we should be proud.

Here is a
summary list of the
main
current regulations bearing on the use of modern biotechnology and its
products

(“GM
Os” = genetically modified organisms):


5



Directive
90/219
,
on
contained use

of
gm

micro
-
organisms
for research and industrial
purposes

(
subsequently amended by 98/81)
;



Directive
90/220
,
on
the
deliberate release

into the environment of
GMOs;
(subsequently
r
eplaced by 2001/18


see below);



Directive
90/679
,

on
safety of workers

vis
-
à
-
vis biological agents (
replaced since
November 2000 by Directive 2000/54)
;



Regulation

258/97
,

on

novel foods

and novel food ingredients
;



Directive 98/44, on the
protection of bio
technological inventions
;



Directive 2001/18,
on the
deliberate release

into the environment of
GMOs

and repealing
Directive 90/220
;



Regulation (EC) No 1946/
2003 on
transboundary movements

of GMOs (giving effect in
European law to the requirements of the Ca
rtagena Protocol on Biosafety);



Regulation 1829/2003, on

gm food and feed
;
(su



Regulation 1830/2003, on
the
traceability and labelling

of
GMOs

and the traceability of

food and feed products produced from
GMOs;



Directive 2004/35 on
environmental liability

wi
th regard to the prevention and remedying
of environmental damage
(com
ing

into effect in 2007).


Currently applicable legislation in the EU, such as the Regulations and Directives cited above, can
be accessed in all EU official languages at the Eurlex webs
ite,
http://europa.eu.int/eur
-
lex/en/index.html
.

The progress of legislative proposals under discussion (and related documents)
can be followed via the PreLex site, at <http://europa.eu.int/prelex
/apcnet.cfm?CL=en>.



Well, I have fought for 20 years against over
-
regulation of modern biotechnology, with little
success;

it is a cancer, which unfortunately shows signs of spreading across much of the world.

It
damages competitiveness, of course;

but m
ore importantly, it does nothing to safeguard health or
the environment


indeed what is worse is that it impedes the development and diffusion of
products, services and technologies for which there is already desperate need in many countries


and these n
eeds can only increase over the coming decades as we see population increase from 6 to
8 billion, and we have to feed this expanded population from the same cultivated area or less, while
seeking simultaneously to stop and reverse the current unsustainable

and environmentally
damaging practices.

So, how did we get int
o

this foolish and dangerous situation
, of needless over
-
regulation
?

And how do other countries and regions avoid it?


We need at this point to review some history


for as was observed by
the
philosopher George
Santayana
, “Those who do not learn from history are condemned to repeat it.”

Modern
biotechnology is usually defined in terms of the use of recombinant DNA techniques, which were
first published 33 years ago


in 1973.

33 years


a third

of a century … let me split that between
the first thirteen years, up to 1986, and then consider what has changed during the past 20 years


before drawing some lessons for the future.


Precaution



the early years


The
re is much reference to the use of a

precautionary approach
in managing

the conjectural risks of
a new technology.

In fact the best case study
of the application of the precautionary approach to

modern biotechnology was one
initiated

by the action of the interested scientists themselves.

Fol
lowing the first scientific papers on recombinant DNA, in 1973, concerns were expressed about
possible new risks associated w
ith the new organisms being cre
ated.


6

In response to these concerns, scientific leaders wr
o
te to the US National Academy of Science
s,
which set up a committee to look into the possible risks.

The committee

of eminent scientists was
chaired by Paul Berg.

T
hey reported very publicly, by
drafting

their conclusions and
recommendations in the form of a letter,
sent to both
Science

and
Natu
re
, and published
in both
journals

in July 1974.

That letter admitted the uncertainties;

recommended that
certain specific
types of experiment should not be conducted, thus launching a sort of moratorium, while further
research was undertaken;

and suggeste
d that there be an international conference to discuss further
the possible risks and ways of managing them.

The whole matter was thus conducted with the
greatest transparency;

and the conclusion after several further years of research, experience and
disc
ussion in many countries, was that the new technologies would not in practice gi
ve rise to
problems or risks any different from those already

routinely

encountered and managed in the
various sectors of application of the life sciences.


In the United State
s, that conclusion was published finally in 1984, and confirmed in 1986
.

I
n

principle

it

remains the basis of US policy today.

In the European Union, we originally proposed
stringent legislation, but in response to the evolution of the debate, we reduced t
hat to a
Recommendation of the Council of Ministers, in 1982, that governments should not control it
strictly, but should maintain systems of

national

registration and oversight … just in case.


The debate was also conducted internationally, in pa
rticular

through the Paris
-
based Organisation
for Economic Cooperation and Development, the OECD.

They published in 1986 a Council
Recommendation, which noted in passing that “there is no scientific basis for legislation specific to
the use of recombinant DNA molec
ules”;

and that OECD “Blue Book” remains a widely
-
quoted
reference document in the context of discussions on modern biotechnology
1
.


So during those early years, the thirteen years from 1973 to 1986, there was a high
-
profile,
international debate, against
a background of continuing and very successful scientific research,
and gradual progress towards the first practical and commercial applications.

It seems to have been
a successful demonstration of the rational application of the precautionary approach;

a
dynamic and
practical method of managing the uncertainties of innovation


of striking a balance between
unknown risks, and the risks of stifling valuable innovations.


The changes of the past 20 years


Things have changed quite a lot in the subsequent 20
years, but it is useful as we face the
challenges of today and the next ten or twenty years to have some sense of perspective, some sense
of the historical context of today’s policy debates.

How can we summarise the key developments?


The technology has be
en driven forward, predominantly by the private sector, in various sectors
and applications.

In pharmaceuticals, safer vaccines have been developed, and developed faster, as
a result of the new knowledge and techniques.

Scarce and expensive molecules such
as insulin and
the interferons have become affordably available.

The human genome has been sequence
d
, as have
the genomes of many important viral and bacterial pathogens


opening up new avenues for
prophylaxis and therapy.

Many of our major unresolved pro
blems, of human or animal health, or in
the diseases of our crops, result from genetic disease, viral attack, or cancers


all of which have in
common that they are disorders of the genetic machinery.

Today, we are acquiring the tools to see



1

“Recombinant DNA Safety Considerations:

Safety considerations for industrial, agricultural and environmental
applications of

organisms derived by recombinant DNA techniques”, OECD, Paris, 1986

7

what is going
on, at molecular level


and thus to develop molecular level responses to these age
-
old scourges.


In agriculture

also there have been major successes.

A
s the first genetically modified crops have
been introduced, we have seen their very rapid take
-
up arou
nd the world, without problems to
health or environment, and with very substantial reductions in use of pesticides.

The
Bacillus
thuringiensis

is familiar to organic farmers for use as a pesticidal spray;

scientists have identified
the specific molecules a
nd mechanisms involved, and have used modern biotechnology to insert the
gene for some of the Bt endotoxins into crop plants su
c
h as corn and cotton.

Their success is
reflected in the
rapid uptake of such varieties in
Argentina,
China and the US among othe
r
countries;

and is also reflected in a massive reduction in the spraying of chemical pesticides on
these crops


amounting in total to some 6% of the previous quantity of pesticides being employed
.


Unfortunately, we have seen some less promising developm
ents in the public policy debates and
actions.

There has been, and there continues, a fundamental debate about the novelty of modern
biotechnology.

Of course, every applicant for a patent stresses the novelty of his invention


if you
have designed better
brakes for a car, you may try to get a patent


but this does not mean that you
are fundamentally redesigning the automobile.

So in modern biotechnology, there are a stream of
new inventions proclaiming their novelty


but there is also a strong argument t
hat the latest
inventions are essentially part of a continuing scientific tradition that can be traced back decades
and even centuries


to Gregor Mendel establishing the concept of the discrete gene;

to Anton Van
Leeuwenhoek through his microscope discove
ring the existence of cells, and of microbial life


and
further back, if yo
u wish to pursue
the story.


Mo
dern agriculture, today’s vaccines, many of the products and services which we take for granted,
are the fruits of these past scientific discoveries,

and of the practical steps which gradually brought
them into application, and through trial and error over many years


and through the pressures of
competitive behaviour by compa
n
ies


have progressively improved their performance and safety.

These proce
sses continue


the same generic processes, producing and refining or rejecting a
continuing stream of potential new inventions, products, services.

Under the eye of history, there is
a continuum of discovery, invention, innovation


and some countries see
m to ha
ve become better
at encouraging these processes than others.


In Europe, over the past twenty years, we have seen some high
-
profile events

which have damaged
the public’s

confidence in science, in government, in industry, and in scientific advice to

governments.

The sad result is an over
-
regulated situation which has deterred research or driven it
out of Europe;

deterred innovation and investment, and caused difficulties with trading partners.

As
Europe is the largest agricultural importer in the wor
ld, this regulatory situation is exported to all
the countries that wish to send agricultural exports to Europe.


This aspect is a major danger for developing countries who need to improve the performance of
their agriculture, while improving the conservat
ion of their environment and their health standards.

An important example is the “Golden Rice” which has been developed by scientists in Europe.

They have incorporated in rice the genes coding for the precursor of Vitamin A.

Vitamin A
deficiency is a major

problem in many poor countries, and causes several hundred thousand cases
of childhood blindness every year.

This excellent initiative


which was co
-
financed by the Swiss
government, the Rockefeller Foundation, and the European Commission


has been atta
cked by
Greenpeace, because it uses the genetic modification technology against which they have been
campaigning for many years.

I find this sort of behaviour profoundly unethical;

and in response
8

would like to quote a key sentence from the report of the N
uffield Council on Bioethics, relating to
gm crops in developing countries:



the Council concluded that there is a moral imperative to make GM crops readily and economically
available to people in developing countries who want them.




Legislation

is adop
ted nationally, but as the examples illustrate, can have global adverse
consequences.


On sovereignty

and the international dimensions


Sovereignty is always a sensitive topic, usually addressed with political rhetoric of pretence and
self
-
delusion.

The re
ality is of inter
-
dependence and constraint.

We all have strong interests in
international collaboration, for many reasons:




The diversity and affordable prices of the goods in our shops;



The markets to which we can send our exports;



The expertise in many
areas which we can derive from abroad


managerial, scientific,
technological, in many sectors of public service and private industry.


But our international interdependence is double
-
edged.

We are constrained by the international
agreements to which our g
overnments


often for excellent reasons


commit us.

The agreements of
the World Trade Organisation are far from perfect, but they amount to a substantial expansion of
opportunities and a package of benefits for producers and consumers throughout the worl
d.

They
have direct relevance to some of the issues which bear strongly on public policy for biotechnology.

They do not dictate the level of risk which individual societies choose, the balance between caution
in the face of innovation, and the desire to be
nefit from innovation.

But they impose requirements
that national legislation be non
-
discriminatory
as between domestic production and imports.


They do not preclude a precautionary approach, as is reflected in this paragraph from Article 5 of
the Sanitary

and Phyto
-
Sanitary agreement:



In cases where relevant scientific evidence is insufficient, a Member may
provisionally adopt sanitary or phytosanitary measures on the basis of available
pertinent information, including that from the relevant internationa
l organizations
as well as from sanitary or phytosanitary measures applied by other Members. In
such circumstances, Members shall seek to obtain the additional information
necessary for a more objective assessment of risk and review the sanitary or
phytosa
nitary measure accordingly within a reasonable period of time.

[
Article 5,
para 7, of SPS agreement
]



But they constrain the application of such cautionary approaches, not only to be non
-
discriminatory, but to be limited to the least restrictive possible
approach in order to maintain
the
desired level of protection:



when establishing or maintaining sanitary or phytosanitary measures to achieve the
appropriate level of sanitary or phytosanitary protection, Members shall ensure that
such measures are not m
ore trade
-
restrictive than required to achieve their
appropriate level of sanitary or phytosanitary protection, taking into account
technical and economic feasibility. [
Article 5, para 6 of the SPS agreement
]



9

The World Trade agreements are significant, b
ecause they have an effective Complaints Procedure,
with enforcement of sanctions, and even the largest players such as the USA and the European
Union have lost cases and had to change their laws or procedures.

This happened earlier this year
with the US c
omplaint against the European Commission for undue delay in their authorisation
procedures.

The WTO refers for expertise on standards to other international bodies, in particular
so far as concerns food, to the Codex Alimentarius Commission.

Codex has also

been active in
considering standards relating to trade in p
roducts of modern biotechnology.

It has established an
ad hoc Intergovernmental Task Force on F
oods derived from
Biotechnology, which will be holding
its sixth session later this year, considering

a range of papers on various topics.

More at the stage of “Work in progress” is the Carta
gena P
rotocol on Biosafety, created under the
aegis of the Convention on Biological Diversity.

Indeed, it represents in some senses a “Hijacking”
of the CBD, for ther
e is no evidence to indicate that trade in
“living modified organisms”, to use the
CBD phrase, has any impact on the loss of biodiversity.

Rather, it seems to have been used, in
opportunist fashion, by those responsible for environment policy in national a
dministrations, as
another stick with which to beat modern biotechnology

-

another means with which to limit and
penalise its use
.

Discussions are working through the articles of the Convention, addressing
procedures for such matters as advance informed ag
reement, liability, and environmental impact.

The Convention has been
ratified

by
188

countries
, the Cartagena Protocol by 134



but not by
some of the largest agricultural exporters, in particular the USA.


“Soft” risks


with hard consequences


As
ide fro
m these international instruments, in principle legally binding, but slow and uncertain in
application, there
are
some much more immediate international links and impacts.

First, there are
trading links:

the threat of losing export markets can be a major c
onstraint of governments, and of
legislatures,
and this threat is
much more immediate and effective than some long
-
term notion of
possible violation of an international agreement.

M
arket positions can be destroyed very rapidly by
fears, scares, public perc
eptions and opinions


whether or not scientifically well
-
based.

Such
perceptions can be swiftly influenced by communications and rumours


and these are readily
generated by groups hostile to modern biotechnology.

The more extreme and sensational the
accu
sation, the more readily it will be taken up by the media and the more rapidly it will spread
around the world.

The non
-
governmental organisations, less constrained than companies, have
swiftly learned how best to use the web to spread their campaigning me
ssages.

In the age of the
Internet, campaigning organisations can swiftly mobilise an appearance of public concern, and
campaigns of letter
-
writing to political leaders, or can organise consumer boycotts of targeted
goods in the shops.

They survive on visi
bility, which leads to membership and subscriptions


and
these pressures are as likely to lead to bias as any concern of companies for profits
,

or
of
scientists
for reputation.


We have had to learn


sometimes the hard way


that there are new kinds of r
isk.

We are familiar
with the idea of possible risks to health, or to the environment, and such risks are amenable to
scientific analysis, through research, and as practical experience accumulates.

This is familiar
ground, for both the producers, and the i
nsurers.

But there has developed in recent years a third sort
of risk, which I would describe, for lack of a better term, as “Soft risk”.

By this I mean the sort of
political, reputational risk that can destroy the acceptability of products and technologie
s.

If
strongly
-
organised non
-
governmental organisations target a company, or its products and
technologies, it can have major effect.

“Soft” risks can have h
ard consequences.


10

Closely related


for public opinion matters to politicians


are the risks that

can be created by
legislative fiat, regulatory decision, and court judgements


all of them highly subject to public
opinion.


Modern biotechnology has suffered greatly from this sort of risk


and the b
a
ttles are continuing.


Such cases illustrate a perv
ersion of the regulatory process.

They waste resources, political,
administrative, and scientific, diverting them from the pursuit of real problems to the management
of trivialities.

They thus have the perverse effect of damaging the interests and policy o
bjectives
which they pretend to protect.


Continuing and future challenges to policy
-
makers


Such battles are happening at present, over coexistence and thresholds
.

As gm technology provides
improved varieties of more and more crops, and are adopted in mor
e and more countries, it will be
necessary to find pragmatic arrangements for coexistence of conventional, organic and gm crops.

This should not be a major difficulty


agriculture, and the high quality seed industry, have been
coping with this sort oif pr
oblem for many decades, even centuries.

In Europe, we grow high erucic
acid rapeseed for its use as an industrial oil;

and we grow “00” rapeseed, with very low content of
erucic acid, because
this acid

is toxic to mammals.

The different varieties are kept
apart by rules on
separation distances, and by carefully directing the different varieties to the appropriate marketing
channels.


However, this sort of pragmatic technical matter can be inflated into a big political issue if we use
slogans such as “absolu
te purity”, “zero contamination” and the like, and set thresholds for the
presence of unauthorised gm materials at such low levels as to be almost unattainable.

Then when
the presence o
f

gm material is detected, a great campaign can be launched about “cont
amination”.


A good current example is the fuss over some unauthorised long
-
grain gm rice that has been
detected in US rice exports.

Under political pressures for grand
-
sounding but simplistic solutions,
the Europeans adopted legislation implying “zero tol
erance” for presence of unauthorised gm
material.

Some gm grains of LL601 have been detected in US rice


at about 6 grains per 10,000.

Because of the “zero tolerance” issue, a matter that is essentially a non
-
problem becomes infl
a
ted
into an international

trade dispute;

the NGOs can accuse companies of carelessness and
governments as incompetent;

and can pretend that they are contributing to the protection of the
consumer and the defence of the environment.

Similar difficulties are arising in Japan and Sou
th
Korea.

All around the world, politicians are running scared of the adverse publicity which they
might attract if they annoy campaigning NGOs.


If we allow our legislators to be pressured into adopting silly laws, unrelated to scientific evidence
or real

safety issues, then we shall suffer such consequences.

Similar issues are going to arise
around environmental liability.

If we do not adopt realistic and practicable thresholds for the
presence of impurities in seeds or in commodity crops, then any detect
able traces of unauthorised
materials becomes another basis for a high profile political dispute.


In
the European

legislation for environmental liability, Directive 2004/35, we had great difficulty in
defining “environmental damage”, given the wide range
of natural variation, from day to day,
season to season and year to year;

or “damage to biological diversity”.

We sought initially to
impose obligatory insurance against environmental damage on the users of supposedly dangerous
technologies.

The insurance
industry replied that they were, of course, happy to expand their
11

business


but they could not find serious scientists capable of defining or measuring
“environmental damage”.


It is possible to participate in a major way in international trade, while mai
ntaining autonomy over
national regulatory decisions.

Argentina has recently appointed Moisés Burachik, General
Coordinator in their Biotechnology Office,

to review its regulations relating to gm crops.

As he has
explained in recent correspondence
2
, he has

been asked to:



prepare a proposal for a change in our

regulations for gm crops. The idea is that there

is

already enough evidence on the safety which will allow us to reduce thestringe
ncy of the
present regulations.


My task is to prepare a proposal whi
ch will remove requirements which are

what we now call
"over
-
regulatory", and
we
will certainly appreciate all

contributions you

would care to make
to my task.


Our regulation can be described as too precautio
nary
, but rational. We

don't accept studies
wit
h less than p
ee
r
-
reviewed paper quality. And

yet, we ask for interactions in stacked events, even if the genes are

widely unrelated, and this sort of thing.



Such are some of the public policy challenges from which no government can escape today.

In the
r
eport of the NEPAD Panel on Biotechnology,
the authors write that, “regulatory agencies
may
have to reconsider how their technology policies hinder or facilitate the learn
ing process”, and this
is clearly the sentiment underlying this action of the Argenti
ne government, to revise their
regulations.


I have no doubt that these and other diverse national challenges face many African governments,
and I look forward to hearing more about these challenges during the course of this Forum.


Conclusions


From the e
xamples and the experience I have discussed, I have tried to summarise a few lessons
which may be relevant to other countries.




A
coordinated national strategy

can be a powerful instrument for advancing a country’s
interests in the use of modern biotechnol
ogy


but its establishment and effective
implementation requires strong and continuing commitment from the political leadership.



Don’t be trapped

into using a vocabulary and following an agenda which has been dictated
by other parties, for other purposes



there are many “siren voices”
.



Don’t ignore

others’ mistakes
,
and don’t

repeat them


learn

from them
.



Look at the experiences, the successes and failures
, of other countries;

but in deciding
which are relevant to your situation,
de
fine your own needs an
d priorities.



Use international collaboration to
expand your opportunities, not to constrain them
.



Maintain adaptive capability
, a dynamic policy stance which can be readily updated.

Note
that this may be difficult to do within an international collaborati
on, where decision
-
making
is typically slow.

Therefore such agreements should allow flexibility for adaptation at
national level.




2

AgBioChatter, 31 August 2006