WRITTEN QUESTION E-1843/02 by Jan Mulder (ELDR) to the Commission. EU legislation on diagnostic tests for veterinary medicines.
Date: 2002-06-28
Institutions: European Parliament, Provisional data
Subjects: World Organisation for Animal Health, animal disease, marketing, medical diagnosis, pharmaceutical legislation, vaccine

C 28 E/146

Official Journal of the European Union

EN

6.2.2003

Answer given by Mr Barnier on behalf of the Commission

(25 July 2002)

Madeira (cid:1) along with the other outermost regions (cid:1) is covered by one of the six regional priorities
identified for areas with severe geographical or natural handicaps in the second Report on Economic and
Social Cohesion adopted on 30 January 2001 (1). Following the report’s adoption, the Commission began
wide-ranging discussions with regional and local bodies and associations on the future of cohesion policy
and structural policy (cid:1) culminating in the Cohesion Forum on 27 and 28 May 2002. The discussions will
continue and proposals will be made when the Commission adopts the third Cohesion Report at the end
of 2003.

Discussion is continuing on eligibility for Objective 1 and no decision has been taken at this stage. The
first Progress Report on Economic and Social Cohesion (2) reiterated the four possible options for regions
whose development is lagging behind, which include maintaining the current
threshold of 75 % of
Community gross domestic product (GDP).

It should be emphasised that the convergence of the outermost regions’ economies vis-à-vis the Union has
demonstrated the effectiveness of structural policy since 1989. Madeira has attained particularly convincing
results: in 1999 its per capita GDP reached 72 % of the Community average.

In order to provide more material for the discussions, the Commission has launched a study to examine in
greater detail the outermost regions’ characteristics, situation, needs and potential, and the nature and
impact of the Community and national policies implemented there. The study’s findings will be presented
to the regions concerned, together with specific development proposals. In this connection, the first
Progress Report points out that account will have to be taken of the specific needs of the outermost
regions identified in Article 299(2) of the EC Treaty. Moreover, the Commission acknowledged the regions’
contribution in February 2002.

Lastly, with regard to using new prosperity criteria for the distribution of funding, it should be noted that
no specific alternative proposal has so far been presented for determining the eligibility of regions whose
development is lagging behind.

(1) COM(2001) 24 final.
(2) COM(2002) 46 final.

(2003/C 28 E/168)

WRITTEN QUESTION E-1843/02

by Jan Mulder (ELDR) to the Commission

(28 June 2002)

Subject: EU legislation on diagnostic tests for veterinary medicines

Directive 1998/79/EC (1) concerns, inter alia, authorisation of in-vitro diagnostic tests for human use.

Is it correct

1.
in the European Union, no harmonised procedure for the authorisation of
diagnostic tests for animal diseases exists, or is authorisation of such tests covered under the rules for
veterinary products laid down in Article 1(2) of Directive 2001/82/EC (2)?

that,

With the new IOE rules on Foot-and-Mouth Disease adopted in May 2002, EU legislation on FMD may be
changed to include use of what are known as marker vaccines, with tests to distinguish between sick and
healthy (vaccinated) animals for combating the disease. Furthermore,
for other animal diseases with
mandatory declaration (e.g. Classical Swine Fever), similar combat strategies could be developed.

2. Will the Commission propose the use of marker vaccines in future strategies to combat FMD?

3. Will the Commission propose EU legislation for centralised authorisation of diagnostic tests for
animal diseases on the IOE A and B lists?

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Official Journal of the European Union

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In the legislation on authorisation of diagnostic tests for human use, a certain degree of flexibility is
allowed so that the requisite changes may be made to the authorisation following use and continued
testing of the diagnostic tests.

4.

Is the Commission prepared to take a pragmatic and flexible approach to authorisation?

Can the Commission, with the requisite cooperation of the Member States and within the IOE,

5.
ensure that the use of such diagnostic tests will be recognised and accepted by trading partners?

(1) OJ L 331, 7.12.1998, p. 1.
(2) OJ L 311, 28.11.2001, p. 1.

Answer given by Mr Byrne on behalf of the Commission

(3 October 2002)

With reference to the questions raised by the Honourable Member, the Commission wishes to reply as
follows:

1.

It can be confirmed that in-vitro diagnostic tests for veterinary use are not included in the scope of
Directive 98/79/EC (1) of the Parliament and of the Council of 27 October 1998 on Directive 2001/
82/EC (2) of the Parliament and of the Council of 6 November 2001 on the Community code relating
to veterinary medicinal products or of Council Regulation (EEC) 2309/93 (3) of 22 July 1993 laying
down Community procedures for the authorisation and supervision of medicinal products for human
and veterinary use and establishing a European Agency for the Evaluation of Medicinal Products.

2. The Commission draft proposal for a Council Directive concerning Community measures for the
control of foot and mouth disease (FMD) does include provisions on the use of tests for the detection
of antibodies against non-structural proteins in order to prove freedom from infection in a vaccinated
population of animals being susceptible to foot and mouth disease.

3. The Commission does not intend to propose a centralised procedure for the marketing authorisation
of diagnostic in-vitro tests for animal diseases included in list A or B of the Office International des
Epizooties (OIE).

However the Community has a system of reference laboratories which are responsible for carrying out
proficiency testing with the national reference laboratories in Member States and candidate countries
on the basis of agreed standard reagents.

In almost all cases where Community legislation requires the use of diagnostic in-vitro testing,
reference is made to the Manual of Standards for Diagnostic Tests and Vaccines of the OIE, which is
currently available in 4th Edition published in August 2001.

4. While always trying to take a pragmatic and flexible approach to the diagnostic in-vitro tests used in
laboratories, both in exporting third countries and Member States, the Commission, through its
aforementioned network of reference laboratories, makes every effort to ensure the highest possible
diagnostic accuracy of the tests applied in order to provide appropriate animal health guarantees
related to the results achieved in such testing.

In certain cases where such accuracy cannot be reasonably expected in third countries exporting to
the Union, provisions have been included in the appropriate animal health certificates which stipulate
that the test has to be performed in laboratories recognised by the Member State of final destination.

5. The Commission agrees with the Honourable Member, that in the case of a major infectious disease,
notably FMD, it is of vital importance that tests used for the demonstration of absence of infection are
properly validated. State of the art validation would be a convincing argument to persuade members
of the Sanitary and Phytosanitary Agreement of the World Trade Organisation to adhere to the rules
laid down in the Animal Health Code of the OIE.

(1) OJ L 331, 7.12.1998.
(2) OJ L 311, 28.11.2001.
(3) OJ L 214, 24.8.1993.