6 Sharing of benefits from genetic sources
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(34301)
14641/12
+ ADDs 1-3
COM(12) 576
(b)
(34317)
14728/12
+ ADD 1
COM(12) 577
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Draft Regulation on Access to Genetic Resources and the Fair and Equitable Sharing of Benefits Arising from their Utilisation in the Union
Draft Council Decision on the conclusion of the Nagoya Protocol on Access to Genetic Resources and the Fair and Equitable Sharing of Benefits Arising from their Utilisation to the Convention on Biological Diversity
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| Legal base | (a) Article 192(1) TFEU; co-decision; QMV
(b) Articles 192(1) and 218(6) TFEU; consent; QMV
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| Department | Environment, Food and Rural Affairs
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| Basis of consideration
| Minister's letter of 29 November 2013
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| Previous Committee Reports
| HC 86-xviii (2012-13), chapter 4 (31 October 2012) and HC 83-xix (2013-14), chapter 1 (30 October 2013)
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| Discussion in Council
| Not applicable |
| Committee's assessment
| Legally and politically important
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| Committee's decision
| Not cleared, but waiver granted under paragraph (3)(b) of the Scrutiny Reserve Resolution (see para 6.11); further information requested.
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Background
6.1 Genetic resources have a wide range of users
and resultant benefits, and the Convention on Biological Diversity
(CBD) provides the main international framework for their equitable
sharing. However, it does not specify how this should be achieved
in practice, and the Nagoya Protocol to the Convention therefore
seeks to establish more predictable conditions for access and
ensuring that only legally acquired sources are used. It requires
all parties to take measures regarding user compliance, but they
are free to decide whether to regulate access: however, if they
do so, they must implement the detailed provisions set out in
the Protocol.
6.2 As we first noted in our Report of 31 October
2012, the Protocol is a mixed agreement with shared competence,
and has been signed by the EU and 24 Member States. These two
documents comprise (a), a draft Regulation implementing those
provisions falling within EU competence, and (b), a draft Council
Decision, enabling the EU to ratify the Protocol, once the Regulation
has been adopted. More specifically, the draft Regulation sets
out minimum due diligence measures, which all users in the EU
would have to exercise to establish that genetic resources are
accessed legally, and the benefits fairly and equitably shared;
require all users to transfer relevant information to subsequent
users; and oblige users to declare at the point of commercialisation
that they have complied with their due diligence obligation. The
proposal would also require the Commission to establish an EU
Register of Trusted Collections comprising only fully documented
samples of genetic resources, and Member States would have to
verify whether a collection meets the necessary requirements,
whilst users acquiring a genetic resource from it would be considered
to have exercised due diligence.
6.3 We also noted that the Government welcomed the
draft Council Decision (except insofar as it would require the
EU and Member States to ratify simultaneously), but had drawn
attention to a number of preliminary concerns over the draft Regulation,
including the possibility that certain of the measures might not
be in accordance with the principle of subsidiarity. We were told
that a full analysis would be undertaken ahead of the deadline
in the Subsidiarity Protocol for raising any objection with the
Commission, and that, although the Government had yet to complete
a detailed Impact Assessment, it would undertake this for any
final Regulation. In the meantime, an initial analysis of the
financial considerations suggested that there would be minimal
costs for Government and for users.
6.4 We commented that there appeared to be more to
the proposed Regulation than met the eye, and, in noting that
the Government would be undertaking a full analysis of the subsidiarity
implications, we stressed the importance of our receiving this
in good time to allow the preparation of a draft Reasoned Opinion,
if that was seen to be required. Pending this, and the Government's
detailed Impact Assessment, we said that we were holding both
documents under scrutiny.
Subsequent developments
6.5 We next reported to the House on 30 October 2013,
when we drew attention to the unsatisfactory way in which the
Government had handled the subsidiarity issue. We also recorded
that there had been no developments on the draft Directive, and
that, although some Member States preferred a ban on the use of
illegally acquired genetic resources, rather than the due diligence
approach proposed by the Commission (and favoured by the UK),
discussions in the Council on the draft Regulation appeared to
be moving in a sensible direction. However, the UK remained concerned
by the views under consideration by the European Parliament, which
favoured a prohibition-based approach, had proposed additional
information requirements on users, and would apply the Regulation
retroactively to genetic resources accessed before it entered
into force. The UK was also seeking to remove a Commission suggestion
that matters relating to traditional knowledge should be addressed
by the Regulation, and concerns remained that the proposed scheme
for 'Trusted' or Registered Collections would give the Commission
unnecessarily broad powers to remove individual collections without
reference to Member States.
6.6 However, we went on to note that, although the
European Parliament's plenary session on 16 September 2013 had
adopted most of the amendments which cut across the Government's
position, the UK's concerns were shared by the Commission and
the majority of Member States, and had been reflected in the Presidency's
mandate for the trilogue negotiations, which were expected to
begin on 16 October and to be finalised before the end of the
year. In view of this, the Government expressed the hope that
we would be able to clear the draft Regulation.
6.7 We commented that, although we were pleased to
note that the discussions within the Council had been satisfactory
from the UK's point of view, there still appeared to be a number
of uncertainties surrounding the position of the European Parliament,
and that we had yet to receive the promised impact assessment.
In view of this, we said that we would like to have this further
information before we could consider clearing either of these
documents.
Minister's letter of 29 November 2013
6.8 We have now received a further letter of 29 November
2013 from the Parliamentary Under-Secretary at the Department
for Environment, Food and Rural Affairs (Lord de Mauley), enclosing
a very comprehensive 'checklist' impact assessment, looking at
the costs to users which will accrue from the different obligations
of the Nagoya Protocol and the Regulation. It concludes that a
final Regulation, which reflects the Commission's original proposal
whilst taking account of the views of Member States, would deliver
significant benefits for UK users of genetic resources, not least
compared with the approach favoured by the European Parliament,
and would in particular help them adapt to the changes to the
research landscape which will result from the coming into force
of the Nagoya Protocol.
6.9 As regards the position of the European Parliament,
the Minister highlights its continuing wish to prohibit the use
of illegally acquired genetic resources (which the UK believes
is unacceptable as it would impact adversely on the research industry
in Europe), and that the Parliament still wants to see the retroactive
application of the Regulation to previously-accessed genetic resources
(which would significantly increase its costs and complexity).
He says that the UK found itself very firmly supported in its
opposition to these and some other elements of the Parliament's
proposals, both by Member States within the Council, by the Commission,
and by UK and EU stakeholders. He adds that Member States have
been working hard to find additional flexibility in order to reach
a compromise agreement with the Parliament, but that the Lithuanian
Presidency's mandate is clear that it can only agree a final Regulation
on behalf of the Member States if that does not impose unreasonable
costs on users and regulators alike.
6.10 In view of this, he asks if we would now consider
clearing the document from scrutiny so that discussions can move
freely, adding that the trilogue negotiations are on-going, and
that the European Parliament has faced increasing pressure from
Member States and other stakeholders to take account of the concerns
expressed. He remains hopeful that a final agreement can be reached,
but adds that this will largely depend on the flexibility of the
European Parliament, given the known strong positions of Member
States on these key issues.
Conclusion
6.11 We are grateful to the Minister for this
update, and for the very comprehensive impact assessment checklist
he has provided, which demonstrates the significant benefits (and
low costs) which would arise from the adoption of a proposal in
the form supported by the UK and the other Member States, as opposed
to that still preferred by the European Parliament. This of course
highlights the need to head off the European Parliament's amendments,
and, whilst we note the mandate which the Council has given the
Presidency for the trilogue discussions, we hesitate to clear
the document, whilst those discussions have still to be completed.
Having said that, we would not want to prevent the Government
from supporting a satisfactory deal if one is on offer at the
end of the day, and we would therefore be prepared to grant a
waiver under paragraph 3(b) of the Scrutiny Reserve Resolution,
subject to the proviso that we would like to be kept informed
of subsequent developments.
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