WRITTEN QUESTION E-1572/02 by Reimer Böge (PPE-DE) to the Commission. Registration of alternative remedies in veterinary medicine.
Date: 2002-06-04
Institutions: European Parliament, Provisional data
Subjects: alternative medicine, animal product, approximation of laws, foodstuff, health legislation, veterinary drug, veterinary legislation, veterinary medicine

14.11.2002

EN

Official Journal of the European Communities

C 277 E/227

The approach taken by the proposal is to harmonise the law in this area but not to enlarge the scope of
what can currently be patented under the European Patent Convention and national laws. The proposal is
not intended to favour any one particular grouping over any other. Everybody, whether they be patentees
or users of potentially patented technology, should benefit from the greater legal certainty brought about
by the harmonisation.

(1) COM(97) 314 final.

(2002/C 277 E/249)

WRITTEN QUESTION E-1572/02

by Reimer Böge (PPE-DE) to the Commission

(4 June 2002)

Subject: Registration of alternative remedies in veterinary medicine

There is a growing interest among both breeders and consumers in the use of homeopathy and other
farm animals, particularly those used for food. Given the
alternative therapies in the keeping of
increasingly criticised use of antibiotics, etc.,
this trend is to be welcomed. However, veterinary
practitioners have complained that, under Directive 92/74/EEC (1) of 22 September 1992, the simplified
registration of homeopathic remedies for farm animals is no longer admissible and that plant-based
remedies must even go through the entire registration procedure.

What is the Commission’s opinion of the experiences with the registration procedure under Directive 92/
74/EEC?

Does it believe that it is possible to simplify the registration procedure for alternative remedies in the field
of veterinary medicine?

(1) OJ L 297, 13.10.1992, p. 12.

Answer given by Mr Liikanen on behalf of the Commission

(27 June 2002)

The functioning of the two simplified registration procedures for human and veterinary homeopathic
medicinal products, which were established in 1992 by Council Directives 92/73/EEC and 92/74/EEC of
22 September 1992, has been analysed and evaluated in the Commission Report to the Parliament and
Council on the Application of Directive 92/73/EEC and 92/74/EEC of 14 July 1997 (1). This analysis was
based on an in-depth study on the application of both Directives in the human and the veterinary sector,
performed by independent consultants. The report concludes that the two Directives have contributed to
achieve a certain, but not yet satisfying degree of harmonisation. In order to prepare possible legislative
amendments, the report invited the Parliament and the Council to express their views on certain issues like
the scope of the simplified registration procedure or the obligation to mutually recognise registrations
granted by other Member States.

Taking into account such views, the Commission does see the possibility to improve the registration
procedure for homeopathic medicinal products. The Commission’s proposal to review the Community’s
pharmaceutical legislation (2) of 26 November 2001 contains a number of amendments, that relate to the
registration of human and veterinary homeopathic medicinal products.
It is proposed to oblige the
Member States to establish a simplified registration procedure, whereas at present it is an option only.
Furthermore, the scope of the simplified registration procedure is widened in so far as the strict limitation
to non-food producing animals is deleted, referring however to the provisions of Council Regulation (EEC)
No 2377/90 of 26 June 1990 laying down a Community procedure for the establishment of maximum

C 277 E/228

Official Journal of the European Communities

EN

14.11.2002

residue limits of veterinary medicinal products in foodstuffs of animal origin (3). Furthermore, the soft
obligation to ‘take due account of registrations and authorisations previously granted by another Member
State’ is turned to a clear obligation to initiate a particular mutual recognition procedure, obliging the
Member States to use their best endeavours to reach agreement within the newly established coordination
group.

(1) COM(97) 362 final.
(2) OJ C 75 E, 26.3.2002.
(3) OJ L 224, 18.8.1990.

(2002/C 277 E/250)

WRITTEN QUESTION E-1575/02

by Laura González Álvarez (GUE/NGL) to the Commission

(4 June 2002)

Subject: Nitrogen dioxide emissions from large-scale ‘existing’ power plants in Spain

In reply to my written question (P-3645/01 (1) on Spain exceeding the nitrogen dioxide emissions limits for
large-scale ‘existing’ power plants laid down in Directive 88/609/EEC (2), the Commissioner said on
6 February 2002 that she had no data later than 1966. The Commission undertook to provide me with
data on the emissions in question, and referred to Directive 2001/80/EC (3) which extends the scope of its
predecessor and lays down stricter conditions regarding emissions. The group which had protested,
‘Ecologistas en Acción’ (Ecologists in Action) has recently written me again providing fresh proofs of the
government’s failure to comply with the legislation.

What has the Commission done in connection with this complaint?

What measures does it intend to take, within what time scale, to prevent these Regulations from being
breached, and thus guarantee respect for Community law?

Has the Commission replied to ‘Ecologistas en Acción’?

(1) See page 13.
(2) OJ L 336, 7.12.1988, p. 1.
(3) OJ L 309, 27.11.2001, p. 1.

Answer given by Mrs Wallström on behalf of the Commission

(10 July 2002)

Spain has submitted new data concerning the emissions of nitrogen oxides from ‘existing’
large
combustion plants in accordance with Council Directive 88/609/EC of 24 November 1988 on the
limitation of emissions of certain pollutants into the air from large combustion plants.

The data submitted showed the following emissions:

@ 1997: 270 kilotonnes (kt);

@ 1998: 231 kt;

@ 1999: 268 kt;

@ 2000: 284 kt;

From the above it is clear that emissions of nitrogen oxides have increased above the emission ceiling
foreseen for 1998 (277 kt) further to Article 3 § 2 of Directive 88/609/EC and Annex II to that Directive.
It should be noted that the Directive does not foresee any emission ceilings for the other years.