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.

1. Is it correct that, 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)?

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?

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?

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