11 Fees chargeable by the European
Food Safety Authority
| (32001)
14198/10
COM(10) 496
| Commission Report on the advisability and feasibility of presenting a legislative proposal enabling the EFSA to receive fees
|
| Legal base | —
|
| Document originated | 23 September 2010
|
| Deposited in Parliament | 4 October 2010
|
| Department | Food Standards Agency
|
| Basis of consideration | EM of 28 October 2010
|
| Previous Committee Report | None
|
| To be discussed in Council | No date set
|
| Committee's assessment | Politically important
|
| Committee's decision | Cleared
|
Background
11.1 In establishing the European Food Safety Authority (EFSA),
Regulation (EC) No 178/2002[23]
also required the Commission to publish within three years a report
on the feasibility and advisability of putting forward a legislative
proposal which would enable the Authority to charge fees for services
rendered. The Commission has now sought to fulfil that remit in
the current document, which has been prepared in the light of
comments made on an earlier consultation paper.
The current document
11.2 In presenting its report, the Commission says that this
has been based on a longer period than originally envisaged because
initially the EFSA was still in its developmental phase, and it
was important to take into account its experience over a longer
period, particularly in the light of new challenges over recent
years (including a significant increase in the work involved in
processing applications for product authorisations). The Commission
then looks in turn at the advisability and feasibility of establishing
a fee system.
ADVISABILITY
11.3 The Commission notes that the majority of Member States
are not in principle against charging fees to applicants, on the
grounds that this could achieve more secure funding, a more professional
service, increased cooperation between the Authority and national
agencies, a reduction in authorisation delays, and a greater harmonisation
of various agency procedures at European level. However, there
is also recognition that the establishment of a fee system in
the case of the EFSA would be complex, and of the consequent need
to identify the conditions and specific cases where this might
be done. On the other hand, the Commission says that most industry
stakeholders have reservations, arising from concerns that
fees could damage both the Authority's actual and perceived independence;
that the EFSA was established to protect public health, and that
its financing is therefore a public responsibility, where any
shortfall should not be met by funding from private industry;
and that the burden imposed by fees would be contrary to the Lisbon
agenda and detrimental to innovation. The EFSA itself has
not taken a view either for or against fees, commenting only that
funding may not be an issue, provided a number of conditions are
met, particularly as regards its independence and accountability.
11.4 In presenting its own views, the Commission
says that, as effective and transparent mechanisms are in place,
it does not believe that the establishment of fees would diminish
the EFSA's independence, or the perception of it, suggesting that
this has not proved to be the case with either the European Medicines
Agency or the European Chemicals Agency. It adds that most the
EFSA's tasks are of general interest and financed by the public
budget,[24] and that
only those related to the assessment of authorisation dossiers,
where private interest would be served, could be subject to fees,
though it points out that the distinction between general and
private interest is not always straightforward. Finally, the Commission
says that its commitment to the better regulation approach means
that fees would not be established without a meaningful cost-benefit
ratio having been established after a full analysis.
FEASIBILITY
11.5 The Commission notes that two main concerns
have been raised — the difficulty of identifying beneficiaries,
and the extent to which a fee system might lead to instabilities
in the EFSA's budget.
Identification of beneficiaries
The Commission says that the main problem identified
by Member States and stakeholders is the extent to which authorisation
procedures for certain foods are aimed mainly at giving general
approvals for the benefit of all operators, and rarely protect
proprietary data or offer exclusivity to the applicant, as compared
with the arrangements for medicinal products. This means that
it would be difficult to identify beneficiaries, and that it would
be unfair to make an applicant pay a fee for a generic authorisation
in cases which benefit the whole sector. The Commission adds that
it recognises the difficulty of identifying beneficiaries in the
food and feed sectors, and that the impact of fees would therefore
give rise to difficulties not encountered for medicines and chemicals.
However, it suggests that a sector-by-sector approach might be
adopted, in that specific authorisation holders can be identified
in the areas such as genetically modified food and feed, pesticides,
flavourings and additives, nutritional and health claims, and
novel foods.
EFSA budgetary stability
The Commission says that Member States have pointed
out that fees may not always guarantee a stable annual budget
for the EFSA as the number of dossiers for assessment can vary
from year to year, and that the introduction of a fee system may
provide grounds for reducing public funding, possibly leading
to a decrease in the Authority's budget. However, it suggests
that it should be possible to guarantee a number of fixed costs
by public funding in order to stabilise the budget, though it
also recognises that, as the establishment of fees can only be
based on a stable workload, this issue needs to be explored further.
POSSIBLE OPTIONS
11.6 The Commission says that four possible options
have emerged from the comments it has received. These are
- a flat rate fee for all applicants
for authorisation;
- graduated fees for all applicants for authorisation;
- graduated fees for all applicants who are authorisation
holders;
- maintaining the existing system without fees.
It says that, although this is not an exhaustive
list, it provides a good basis for further work, in which it proposes
to look at the costs of the services which could be subject to
fees (and to refine these further); to examine the relationship
with the national fees which EU legislation permits for plant
protection products; and to consider whether any special arrangements
are needed for small and medium sized enterprises (SMEs).
11.7 At this stage, the Commission says that
it is not possible to draw any definitive conclusions without
further consideration being given to the various issues which
arise, including the preparation of an impact assessment. However,
it suggests that consideration should in any case be given to
the option of graduated fees for applicants who are already authorisation
holders, and to the introduction of fees for the authorisation
of genetically modified organisms, feed additives, claims, novel
foods, active substances used in plant protection products, and
smoke flavourings.
The Government's view
11.8 In her Explanatory Memorandum of 28 October
2010, the Parliamentary Under-Secretary of State (Public Health)
at the Department of Health (Anne Milton) says that the UK can
see merit in the EFSA charging for some of its work on authorisations,
for example where an application is specific to commercial products
or companies, and believes that it would in those cases be appropriate
for fees to be set at a European level (for example by a central
authorisation body, as in the case of medicines). However, she
adds that fees should be set for work exclusive to the EFSA's
role, and should not duplicate charges for work already charged
by national authorities, as for example in the case of plant protection
products.
11.9 The Minister also says that, in response
to the Commission's earlier consultation, the UK flagged the need
to consider how to deal with charges for the approval of generic
products for use by more than one person or business, and also
noted the need for clarity on how fees would be introduced and
how the money raised by them would be used by the EFSA. She stresses
that it is important that any fee system did not stifle innovation
and growth or have a disproportionate impact of on small and medium
sized enterprises, but notes that the report takes account of
these concerns, which will be explored further in the proposed
impact assessment.
Conclusion
11.10 This document simply identifies the
extent to which it would be advisable and feasible for the European
Food Safety Authority to charge fees for some of the work it carries
out, and this issue will be the subject of further work by the
Commission, including the preparation of an impact assessment
of the various options which have been identified. In view of
this, we see no need to withhold clearance, but, as any measures
which might arise from this report could have implications for
an important area of activity, both economically and as regards
food safety, we think it right to draw it to the attention of
the House.
23 OJ No. L.31, 1.2.02, p.1. Back
24
Such tasks account for 69% of the EFSA's budget. Back
|
