European Parliament resolution on the Commission communication to the Council and the European Parliament on availability of veterinary medicinal products (COM(2000) 806 — C5-0105/2001 — 2001/2054(COS))
Date: 2001-05-03
Institutions: Committee on the Environment, Climate and Food Safety, European Parliament
Subjects: consumer protection, foodstuff, market approval, veterinary drug

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10.
Calls for continued and increased efforts to restore the environment in the most contaminated
regions, utilising the information and expertise of the IAEA and other bodies, and urges the G7 and the
EU to give more consideration to management of the whole contaminated environment, especially forests
and bodies of water, because of the interaction between them and agricultural land;

11.
Based on new scientific evidence suggesting doubts about aspects of the radiation risk model, par-
ticularly as regards the effects of the Chernobyl fall-out, requests the Commission to arrange an epidemi-
ological study of the effects of Chernobyl throughout Europe as a whole; also calls on the IAEA and
Unscear, as well as the ICRP and Euratom, to re-examine the risk model;

Believes that closer cooperation and dialogue between the Ukrainian Parliament and the European

12.
Parliament on energy-related matters is essential;

13.
Instructs its President to forward this resolution to the Council, the Commission, the Presidents and
Parliaments of the Ukraine, Belarus and Russia, the Secretary-General of the UN, the IAEA, the WHO, the
Unscear and the ICRP.

12. Veterinary medicinal products

A5-0119/2001

European Parliament resolution on the Commission communication to the Council and the Euro-
pean Parliament on availability of veterinary medicinal products (COM(2000) 806 (cid:129) C5-0105/2001
(cid:129) 2001/2054(COS))

The European Parliament,

(cid:129) having regard to the communication from the Commission (COM(2000) 806 (cid:129) C5-0105/2001),

(cid:129) having regard to Council Directive 81/851/EEC of 28 September 1981 on the approximation of the

laws of the Member States relating to veterinary medicinal products (1),

(cid:129) having regard to Council Regulation (EEC) No 2377/90 of 26 June 1990 laying down a Community
procedure for the establishment of maximum residue limits of veterinary medicinal products in food-
stuffs of animal origin (2),

(cid:129) having regard to Commission Decision 2000/68/EC of 22 December 1999 amending Commission
Decision 93/623/EEC and establishing the identification of equidae for breeding and production (3),

(cid:129) having regard to the Note for Guidance of the Committee for Veterinary Medicinal Products (CVMP)
of the European Agency for the Evaluation of Medicinal Products on the risk analysis approach for
residues of veterinary medicinal products in food of animal origin (EMEA/CVMP/187/00-FINAL),

(cid:129) having regard to the formal noting by the Commission at a meeting of the Council on 14 December
1999 (Council ref. 14171/99) that Member States need not withdraw certain drugs pending the adop-
tion of legislative proposals,

(cid:129) having regard to Rule 47(1) of its Rules of Procedure,

(cid:129) having regard to the report of the Committee on the Environment, Public Health and Consumer Policy

(A5-0119/2001),

(1) OJ L 317, 6.11.1981, p. 1.
(2) OJ L 224, 18.8.1990, p. 1.
(3) OJ L 23, 28.1.2000, p. 72.

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A. whereas the crisis on the availability of veterinary medicines has resulted from the withdrawal, since
1 January 2000, of marketing authorisations for all existing veterinary products containing substances
for which no maximum residue limits (MRLs) have been established,

B. whereas the lack of medicines in the veterinary sector has serious consequences for animal health and

welfare, with unacceptable situations caused especially by unavailability of local anaesthetics,

C. whereas many products with a well established use have been withdrawn from the market because the
data required to renew their marketing authorisation were not generated and it included such data for
the establishment of MRLs,

D. whereas, due to the existing legal provisions and product specific characteristics, there is a lack of
economic interest in carrying out necessary research and development on veterinary medicines for
certain species such as sheep and horses, and other, minor species, such as goats, turkeys, rabbits or
bees,

E. whereas the Commission has announced on several occasions that one of its objectives is to improve
the level of animal health, in particular by increasing the number of medicinal products available,

F. whereas the CVMP concluded that specific MRLs for specific target species may not be necessary to
ensure the protection of the health of the consumer against possible harmful effects resulting from the
ingestion of residues and that MRLs can be extrapolated between species,

G. whereas analytical methods are already available for those substances on which the MRL extrapolation

will be based,

H. whereas specific measures must be implemented for horses, as the general measures contemplated for

the other species cannot address the problem of equine medicines,

I. whereas Commission Decision 2000/68/EC recognises that treatment of horses may require the
administration of medicinal products containing substances without MRLs and the need to provide a
control mechanism to protect consumers from possible harmful residues.

1. Welcomes the objectives of the Commission to facilitate the veterinary use of medicinal products not
available in the Member State concerned but authorised elsewhere in the Community and to enhance
pharmaceutical firms(cid:146) interest in certain market segments;

Considers however that the Commission(cid:146)s hopes that applications for the extrapolation of MRLs will

2.
be submitted by interested organisations are unlikely to be met;

3.

Considers that there should be systematic extrapolation of MRLs between species;

4.
Urges therefore the Commission to make proposals for its immediate application and in particular
for modifying Annexes I, II and III of Council Regulation No 2377/90 in accordance with the CVMP
conclusions in its Note for Guidance;

5.
Considers that requiring species-specific analytical methods for the purpose of the MRL extrapolation
between species would negate the flexibility offered in the first place and therefore urges the CVMP, the
Commission and the Member States only to require the provision of such additional analytical methods at
the time of granting specific marketing authorisations;

6.
Considers that the extrapolation of MRLs will help to maintain many products intended for minor
species without compromising consumer protection, but will not solve the problem of equine medicines,
as many of the medicinal products used in equine medicine contain substances with no MRL in any
species at all;

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7.
Urges therefore the Commission to submit without delay proposals to amend Council Directive 81/
851/EEC and Council Regulation (EEC) No 2377/90 to allow in horses the veterinary use of medicinal
products containing substances without MRLs, without prejudice to the need to protect human health;

Calls on Member States to cooperate on the establishment of a pan-European licensing system that
8.
will allow, in the near future, on the basis of mutual trust, any national market authorisation to be valid
throughout the European Union;

9.

Instructs its President to forward this resolution to the Council and Commission.

13. Stability and convergence programmes

A5-0127/2001

European Parliament resolution on the annual assessment of the implementation of stability and
convergence programmes (2001/2009(INI))

The European Parliament,

(cid:129) having regard to the annual updates of the stability and convergence programmes drawn up by 14
Member States between September 2000 and January 2001 as well as the opinions of the ECOFIN
Councils of 26 November 2000, 19 January 2001, 12 February 2001, and 12 March 2001 on these
programmes,

(cid:129) having regard to the first stability programme of Greece, as well as the opinion of the ECOFIN Council

of 12 February 2001 on this programme,

(cid:129) having regard to the recommendation adopted by the ECOFIN Council of 12 February 2001 in
accordance with Article 99 (4) of the EC Treaty and addressed to Ireland with respect to the incon-
sistency of its stability programme with the Broad Economic Policy Guidelines of 19 June 2000,

(cid:129) having regard to the European Council resolution on the Stability and Growth Pact of 17 June
1997 (1), Council Regulation (EC) No 1466/97 of 7 July 1997 on the strengthening of the surveillance
of budgetary positions and the surveillance and coordination of economic policies (2), and the code of
conduct on the content and format of the stability and convergence programmes adopted by the
ECOFIN Council of 12 October 1998,

(cid:129) having regard to its resolution of 18 May 2000 on the Commission(cid:146)s recommendation for the broad

guidelines of the economic policies of the Member States and the Community (3),

(cid:129) having regard to the Presidency Conclusions of the European Council adopted in Lisbon on 24 March

2000,

(cid:129) having regard to Rule 163 of its Rules of Procedure,

(cid:129) having regard to the Report of the Committee on Economic and Monetary Affairs (A5-0127/2001),

A. whereas the stability and convergence programmes form a key part of the Community surveillance
procedure within the context of European economic coordination, which aims to ensure that Member
State fiscal policies observe the principle of budgetary prudence on a lasting basis, with a view to
laying firm foundations for price stability, sustainable growth and full employment,

B. whereas the Stability and Growth Pact defines a medium-term objective of achieving a fiscal position
that is balanced or in surplus and whereas only ten Member States meet this requirement; whereas
government debt is still unacceptably high in some Member States and whereas its rapid reduction is
dependent upon relatively optimistic scenarios in the stability and convergence programmes,

(1) OJ C 236, 2.8.1997, p. 1.
(2) OJ L 209, 2.8.1997, p. 1.
(3) OJ C 59, 23.02.2001, p. 228.