Download UK and EU Implementation of the Nagoya Protocol

UK and EU Implementation of the
Nagoya Protocol
Prepared for
RSC IP Case Law Symposium
Dr Darren Smyth
y
20th November 2014
eip.com
Background - I
• 1992 - Convention on Biological Diversity signed at the Rio Earth Summit
• Only non-Parties of CBD are Andorra, Holy See, South Sudan … and …
United States of America
• 2010 - The Nagoya Protocol on “Access to Genetic Resources and the Fair
and Equitable Sharing of Benefits Arising from their Utilization” is signed
• 50 ratifications required for Protocol to enter into Force
Background - II
• October 2012 - A draft Regulation related to Nagoya is proposed by The
European Commission (in addition to a ratifying Regulation)
• Parliament reviewed in four committees,, all of whose rapporteurs
pp
were
Greens
• Parliament voted in favour of radically amended draft, including
retrospective effect
• 6 December 2013 - Following Trilogue between Commission, Parliament
and Council
Council, compromise draft issued
• 22 January 2014 Trilogue text approved by Environment Committee
Background - III
• 16 April 2014 Regulation (EU) 511/2014 for compliance measures is
adopted, and enters into force 9 June 2014
• 14 Julyy 2014 – Uruguay
g y becomes the 50th state to Ratifyy Nagoya
g y protocol
p
• 12 October 2014 – Protocol comes into Force, 90 days after 50th
ratification
• 12 October 2015 – Articles 4, 7 and 9 of EU 511/2014 will come into force
 User compliance and due diligence
 Monitoring of user compliance
 User compliance checks
Nagoya Provisions
• Nagoya Protocol itself founded on principles of:
―Prior informed consent of Party (=country) before access to genetic
resource is permitted (Article 6)
―Fair and equitable sharing with Party of benefits arising from utilisation
of ggenetic resources on mutuallyy agreed
g
terms (Article
(
5; examples
p of
benefits in Annex)
―Applies also to associated traditional knowledge (Article 7)
• These are not further elaborated in the Regulation; instead a “due
diligence” obligation is created
Due diligence – Regulation Article 4
Users (=researchers) required to exercise “due
due diligence
diligence” to ascertain that
genetic resources have been accessed in accordance with ABS/regulatory
requirements; and keep for 20 years after end of utilisation “Internationally
recognised
i d certificate
tifi t off compliance”
li
” [[cff P
Protocol
t lA
Artt 6(3)(
6(3)(e)]
)] or
information/documents concerning:
• Date and place of access
• Description of genetic resource utilised
• Direct source of genetic resource and subsequent users
• Access and Benefit Sharing (ABS) agreements, access permits, mutually
agreed terms including benefit-sharing,
benefit sharing, and any rights or obligations
related to ABS
Declaration – Regulation Article 7
•
Users (=researchers) required to declare “due
due diligence
diligence” exercised on
receipt of research funding
•
At final stage of development of product
product, compliance must also be
declared AND the corresponding documents submitted to competent
authority
•
Proposal by Parliament to require similar declaration in patent
applications was removed at Trilogue
Due diligence process
As imagined by Defra
Due diligence – Penalties
• Rules on penalties left to Member States of EU
• Penalties are required (Article 11) in relation to compliance with Articles
4 to 7 of Regulation
g
and required
q
to be “effective,, proportionate
p p
and
dissuasive”
• UK proposals include a mix of civil and criminal sanctions, ranging from
Compliance Notices, to imprisonment for up to 2 years or Variable
Monetary Penalties (up to £250,000)
Due diligence - Problems I
• Nagoya drafted envisioning access to genetic resources that have
associated traditional knowledge, and especially higher organisms;
relates to “Bioprospecting” and to combat “Biopiracy”
• But the actual provisions of Nagoya, and the Regulation, cover ALL nonhuman genetic resources
• For ALL genetic resources, European researchers will have to keep
documentary evidence EITHER of Art. 4 due diligence OR that not
required (eg resource was accessed before Regulation came into force; or
resource is of human origin)
• Additional burden that is NOT carried by eg US researchers
Due diligence - Problems II
• Special provisions for pathogens relating to public health emergency; due
diligence obligations to be complied with by either 1 month of the health
threat being terminated, or within 3 months of commencement of
research
h (“
(“utilisation”)
tili ti ”) – otherwise
th
i research
h mustt b
be tterminated.
i t d
• This seems strict for an emergency situation – perhaps a drafting error?
Nagoya in the UK
•
The National Measurement Office appointed as ‘Competent
Competent Authority’
Authority
•
An executive agency for ensuring “fair and accurate measurements
are available and used for transactions
transactions”
•
Will be responsible for carrying out enforcement of Nagoya in the UK –
inspections of compliance and due diligence, as well as raising awareness
and improving understanding of Nagoya obligations
•
Also
so carry
ca y out functions
u ct o s ass
assigned
g ed to member
e be states, suc
such as verifying
e y g
applications for ‘register collection status’ (part of EU regulation)
•
Defra ((specifically,
p
y, Julian Jackson)) will be the National Focal Point –
resource for answering questions, dissemination of information on
procedures etc.
Supporting Due Diligence
•
Guidance will (eventually) be published by the National Measurements
Office – will set out procedures for civil sanctions, and what would merit
criminal action
•
EU regulations include two provisions to assist users:
•
g
(EU
( Reg,
g, Art. 8)) – assessment of user due
‘Best Practice Recognition’
diligence compliance procedures by EU. If EU decide that following
the user’s procedure would comply with due diligence obligations,
the user may qualify for a lower frequency of compliance checks
•
Registered Collections (EU Reg, Art. 5) – a collection which can
demonstrate it has all the necessary documentation: anyone who
accesses that collection will be deemed to have already carried out
due diligence – significant reduction of burden on user
Access and Benefit-Sharing Clearing-House (ABS-CH)
•
The ABS-CH
ABS CH is “is
is a platform for exchanging information on ABS and a key
tool for facilitating the implementation of the Nagoya Protocol”
•
Informs user on countries’
countries legislative measures
measures, competent national
authorities etc.
•
Should eventually have provisions for enhancing legal certainty and
transparency for procedures of access
•
Will also include internationally recognised certificates of compliance (eg
(eg.
recognised Best Practice procedures in EU)
•
https://absch.cbd.int/
•
Not quite ready yet though…
ABS Agreements - Problems
Inherent problems with system envisaged by Nagoya:
• If consent and ABS agreement is required before access, no guarantee
that anything
y
g useful will be discovered,, so time and resource will have
been wasted on negotiating ABS agreement
• Particularly relevant in pharmaceutical research where the useful drug
molecule hit rate is relatively low; but applies in research generally
• From perspective of Party holding genetic resources, entering into ABS
creates expectation of value; if the accessing company then says use has
led to nothing of value, this assertion (while often true) likely to lead to
suspicion
It could have been worse - I
Many demands of European Parliament were refused
refused, eg:
•
Mandatory disclosure of origin in patents (although perhaps only delayed
– treaty currently in negotiation at WIPO)
•
Expansion of “use” (=research according to Nagoya) to “utilisation as well
as subsequent applications and commercialisation”
commercialisation (much broader)
•
Expansion of scope from “genetic resources” to “derivatives” - “a naturally
occurring biochemical compound resulting from the genetic expression or
metabolism of biological or genetic resources, even if it does not contain
functional units of heredity” – i.e. anything derived from any organism
It could have been worse - II
Also demand for retrospective effect was refused – Parliament proposal was
that for genetic resources or derivatives already accessed, any future use or
commercialisation would require:
•
ABS agreement already in place; OR
•
If no existing applicable agreement
agreement, negotiation of new agreement with
country of origin; OR
•
If country of origin cannot be ascertained, provide benefit sharing with a
“Union benefit-sharing fund” (to be set up)
This devastatingg proposal
p p
was rejected
j
in the Trilogue
g
Recent Developments
Meeting in Pyeongchang:
•
•
CBD COP 12
– biennial Conference of the Parties to the CBD
•
NG COP/MOP 1 – fi
firstt C
Conference
f
off th
the P
Parties
ti and
dM
Meeting
ti off th
the
Parties to the Nagoya Protocol
NG COP/MOP 1 Chair:
Ch i YYoon SSeong-kyu,
k National
N ti
l IInstitute
tit t off Ecology,
E l
South Korea
Recent Developments
Meeting in Pyeongchang:
•
CBD COP 12
– biennial Conference of the Parties to the CBD
•
NG COP/MOP 1 – fi
firstt C
Conference
f
off th
the P
Parties
ti and
dM
Meeting
ti off th
the
Parties to the Nagoya Protocol
•
NG COP/MOP 1 Chair:
Ch i YYoon SSeong-kyu,
k National
N ti
l IInstitute
tit t off Ecology,
E l
South Korea
•
NG COP/MOP 1 Chair: Ham Pande (representing Prakash Javadekar),
Javadekar)
Ministry of Environment, India
(South Korea isn’t
isn t actually a party to Nagoya Protocol…)
Protocol )
Recent Developments
Meeting in Pyeongchang:
•
•
CBD COP 12
– biennial Conference of the Parties to the CBD
•
NG COP/MOP 1 – fi
firstt C
Conference
f
off th
the P
Parties
ti and
dM
Meeting
ti off th
the
Parties to the Nagoya Protocol
A lot
l t off talk
t lk about
b t ‘P
‘Pyeongchang
h
roadmap”
d
”
Recent Developments
Meeting in Pyeongchang:
•
CBD COP 12
– biennial Conference of the Parties to the CBD
•
NG COP/MOP 1 – fi
firstt C
Conference
f
off th
the P
Parties
ti and
dM
Meeting
ti off th
the
Parties to the Nagoya Protocol
•
A lot
l t off talk
t lk about
b t ‘P
‘Pyeongchang
h
roadmap”
d
”
•
The CBD proposal appears more confusing
Recent Developments
Meeting in Pyeongchang:
•
CBD COP 12
– biennial Conference of the Parties to the CBD
•
NG COP/MOP 1 – fi
firstt C
Conference
f
off th
the P
Parties
ti and
dM
Meeting
ti off th
the
Parties to the Nagoya Protocol
•
A lot
l t off talk
t lk about
b t ‘P
‘Pyeongchang
h
roadmap”
d
”
•
Actual content is not finalised, but won’t affect Nagoya implementation
directly – focussed on wider CBD “Aichi
Aichi Biodiversity Targets
Targets”
Aichi Biodiversity Targets
20 defined targets,
targets which fall within 5 ‘strategic
strategic goals’:
goals :
•
Address the underlying causes of biodiversity loss by mainstreaming
biodiversity across government and society
•
Reduce the direct pressures on biodiversity and promote sustainable use
•
To improve the status of biodiversity by safeguarding ecosystems, species
and genetic diversity
•
Enhance the benefits to all from biodiversity and ecosystem services
•
Enhance implementation through participatory planning, knowledge
management and capacity building
WIPO Intergovernmental Committee
•
In parallel with Nagoya – ‘WIPO
WIPO IGC on Intellectual Property and Genetic
Resources, Traditional Knowledge and Folklore’ (both WIPO and CBD are
UN entities)
•
Draft articles have not been finalised, but should be published soon
(WIPO mandate refers to finalising the texts within the 2014/15
bi
biennium)
i )
•
Proposed policies (from WIPO/GRTKF/IC/28/4) would require an
applicant to disclose the origin of genetic resources or traditional
knowledge where the invention directly derives from these components
What do we need to do now?
•
Ensure researchers are prepared – due diligence paperwork
•
Be able to provide evidence that resources were accessed pre-Nagoya
•
Have an understanding of access and benefit sharing agreements
•
Be aware of ((eventual)) UK implementation,
p
, and its associated p
penalties
•
Keep up to date with Nagoya ‘Access and Benefit-Sharing Clearing-House’
(ABS-CH) – “a key tool for facilitating the implementation of the Nagoya
Protocol, by enhancing legal certainty and transparency”
•
Follow ‘WIPO IGC on Intellectual Property and Genetic Resources,
Traditional Knowledge and Folklore’ decisions
Conclusion
•
“Bioprospecting”
Bioprospecting , “biopiracy”
biopiracy and “misappropriation
misappropriation of genetic
resources” difficult to define, and probably all less prevalent than alleged
by proponents of Nagoya
•
Many examples of alleged misbehaviour do not withstand close scrutiny
•
EU Regulation will create burden of maintaining documentation
•
Places US researchers at an advantage
•
But it could have been worse…
•
…and perhaps still could get worse