16 Sharing of benefits from genetic sources
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14641/12
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COM(12) 576
(b)
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14728/12
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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; QMV; consent
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| Department | Environment, Food and Rural Affairs
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| Basis of consideration | Minister's letter of 12 February 2014
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| Previous Committee Reports | HC 86-xviii (2012-13), chapter 4 (31 October 2012), HC 83-xix (2013-14), chapter 1 (30 October 2013) and HC-xxiii (2013-14), chapter 6 (4 December 2013)
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| Discussion in Council | See para 16.13 below
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| Committee's assessment | Legally and politically important
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| Committee's decision | Cleared
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Background
16.1 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.
16.2 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.
16.3 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.
16.4 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.
16.5 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.
16.6 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.
16.7 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.
16.8 We subsequently 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 concluded
that a final Regulation, which reflected 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.
16.9 As regards the position of the European Parliament,
the Minister highlighted its continuing wish to prohibit the use
of illegally acquired genetic resources (which the UK believed
is unacceptable as it would impact adversely on the research industry
in Europe), and that the Parliament still wanted to see the retroactive
application of the Regulation to previously-accessed genetic resources
(which would significantly increase its costs and complexity).
He said that the UK had been 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 added that Member States had been
working hard to find additional flexibility in order to reach
a compromise agreement with the Parliament, but that the Lithuanian
Presidency's mandate was clear that it could only agree a final
Regulation on behalf of the Member States if that did not impose
unreasonable costs on users and regulators alike.
16.10 In view of this, he asked if we would now consider
clearing the document from scrutiny so that discussions could
move freely, adding that the trilogue negotiations were on-going,
and that the European Parliament had faced increasing pressure
from Member States and other stakeholders to take account of the
concerns expressed. He remained hopeful that a final agreement
could be reached, but added that this would largely depend on
the flexibility of the European Parliament, given the known strong
positions of Member States on these key issues.
16.11 We said that, whilst we were grateful to the
Minister for this update, and noted the mandate which the Council
had given the Presidency for the trilogue discussions, we hesitated
to clear the document, whilst those discussions had still to be
completed. Having said that, we did not want to prevent the Government
from supporting a satisfactory deal if one was on offer, and we
said that we would therefore 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.
Minister's letter of 12 February 2014
16.12 We have now received from the Minister a further
letter of 12 February 2014, in which he says that the relevant
European Parliament Committee has recently approved a text reflecting
the agreement reached in trilogue, which conforms with the UK's
negotiating aims. In particular, although Member States had to
agree to the inclusion of a definition of illegal use and a bolstered
requirement for meeting due diligence standards, any retrospective
application of the proposed Regulation has been removed, as has
the prohibition on the use of illegally-accessed genetic resources,
and the UK's subsidiarity concerns have been met by the removal
of the power for the Commission to de-register registered collections
without first receiving a request from the relevant Member States.
As a consequence, the Minister says that he is confident that
the additional burden on UK businesses and researchers will now
be minimal,
16.13 The Minister says that the text is expected
to be voted upon shortly by the European Parliament plenary, following
which it will be adopted by the Council, and then signed, with
publication in the Official Journal expected in June 2014.
Conclusion
16.14 We are grateful to the Minister for this
update, and we are now content to clear both these documents.
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