WRITTEN QUESTION E-1508/02 by Mihail Papayannakis (GUE/NGL) to the Commission. Veterinary medicinal products in the EU.
Date: 2002-05-29
Institutions: European Parliament, Provisional data
Subjects: EU law - national law, European Medicines Agency, animal health, approximation of laws, marketing, pharmaceutical legislation, public health, veterinary drug, veterinary legislation

14.11.2002

EN

Official Journal of the European Communities

C 277 E/221

It should be noted that there are already opinions issued by distinguished jurists as well as decisions by the
Greek courts (275/1993 by Areios Pagos (Supreme Court) and 5239/2001 and 5240/2001 by the Athens
Appeal Court) vindicating IKA’s scientific and health care staff and recognising that these doctors have
work contracts of an indefinite duration, exactly as stipulated by Directive 1999/70/EC.

Is the Commission aware that the Greek government intends to apply this directive in a selective manner?
What action does it intend to take to ensure that the Greek government complies with the directive’s
provisions, to protect the 5 500 IKA doctors and to ensure, as far as possible, that this large security
organisation, which is responsible for providing medical care to millions of Greeks, functions more
harmoniously?

(1) OJ L 175, 10.7.1999, p. 43.

Answer given by Mrs Diamantopoulou on behalf of the Commission

(27 June 2002)

Directive 1999/70/EC concerning the framework agreement on fixed-term work concluded by ETUC (1),
UNICE (2) and CEEP (3)
is applicable to fixed-term workers who have an employment contract or
relationship as defined in law, collective agreements or practice in each Member State. The Directive does
not exclude the public sector from its scope.

One of the purposes of the Directive is to prevent abuse arising from the use of successive fixed-term
contracts. It is, however, up to the Member States themselves to decide, after consultation of the social
partners, under what conditions fixed-term contracts shall be regarded as ‘successive’ or deemed to be of
indefinite duration.

As for the deadline for implementation, Greece has made use of the additional year granted by the
Directive, and shall, therefore, implement the Directive before 10 July 2002. The Greek Government has
not yet communicated to the Commission how it intends to legislate.

The Commission intends to evaluate the implementation in all Member States by the end of 2002 and will
take the necessary measures if it considers that the implementation is not correctly done.

(1) European Trade Union Confederation.
(2) Union of Industrial and Employers’ Confederations of Europe.
(3) European Centre of Enterprises with Public Participation.

(2002/C 277 E/243)

WRITTEN QUESTION E-1508/02

by Mihail Papayannakis (GUE/NGL) to the Commission

Subject: Veterinary medicinal products in the EU

(29 May 2002)

Licences for the distribution and supply of proprietary veterinary medicinal products are increasingly being
issued by the European Agency for the Evaluation of Medicines, while the separate national bodies for
issuing such licences are gradually being restricted to a supervisory role.

While this facilitates the functioning of the single internal market, other problems are arising:

= because of the cost, small firms operating in this area producing traditional medicinal products cannot

support their case to the European Agency for the Evaluation of Medicines;

= small traditional ruminants in many countries, chiefly in southern Europe, together with equidae, do
not have any proper kind of scientific treatment available to them (nor, of course, are checks carried
out on residues) since producers are either unwilling or unable to carry out the relevant studies (on
waiting times etc.). Thus veterinarians give these animals treatment based on traditional methods and
there is no guarantee of food safety for products derived from them.

C 277 E/222

Official Journal of the European Communities

EN

14.11.2002

In view of the above, could the Commission say:

1. whether it is true that there has been a dramatic decrease in the range of proprietary veterinary

medicinal products in the EU?

2. whether there is in fact a problem concerning medicinal products for small ruminants and equidae?

Answer given by Mr Liikanen on behalf of the Commission

(4 July 2002)

The Commission is fully aware of the issue of availability of veterinary medicinal products (VMPs)
especially to treat horses and other species like small ruminants as well as for certain indications (‘minor
uses’). The Commission however does not agree that there is a dramatic decrease in the range of VMPs in
the Union.

The current evaluation system for approval and surveillance of VMPs is based on quality, efficacy and
safety criteria under an umbrella of the protection of human and animal health and the environment, laid
down in Community law (1).

The European Agency for the Evaluation of Medicines (EMEA) is the body, which gives opinions on
applications concerning specific types of VMPs, such as products produced using certain biotechnological
procedures (2). However, numerous VMPs are authorised nationally by two or more Member States
following the Mutual Recognition Procedure. The majority of products are thus still authorised by the
competent authorities in Member States.

A precondition for granting a marketing authorisation for VMPs for food producing animals is the
establishment of maximum residue limits (MRLs) according to Council Regulation (EEC) No2377/90 (3).
Some substances for which MRLs could not be established (because these products or their metabolites are
toxic in any concentration) have already lost their marketing authorisations for food producing animal
species. Substances with no MRLs are not allowed to be used in VMPs since 1 January 2000.

However, the loss of these substances does not mean that there are no therapeutic alternatives. Some of
the substances without MRL have been replaced by other substances for which MRLs are established, and
which are effective for the same clinical condition.

To improve the availability of medicines for certain species, the Committee for Veterinary Medicinal
Products (CVMP) recently recommended the extension of the existing MRLs for substances used in major
species to be used to set MRLs for other food-producing species (through extrapolation).

Additionally, Council Directive 2001/82/EC (4) provides provisions to avoid shortfalls in supply of
medicines. In Article 10 of this Directive exceptional conditions are laid down for the use of VMPs in pet
and food producing animals. According to the so-called ‘cascade’, veterinarians are enabled to use VMPs
authorised for another food producing species or for another indication in the same species.

As already mentioned in the Communication from the Commission to the Council and the Parliament on
the ‘Availability of veterinary medicinal products’ (5), the Commission decided to propose amendments to
Directive 2001/82/EC in the framework of the current revision of the pharmaceutical legislation (6) also
aiming in improving availability of VMPs. These proposals consist mainly in facilitating the cascade
provisions and making their use compulsory for Member States. The extension of the administrative
protection of scientific data provided for by the applicant for a marketing authorisation should bring
further incentives to the veterinary pharmaceutical industry especially for minor species. Regarding horses
in particular it is proposed to allow the use of a substance without MRL, under the only condition that the
concerned animal is excluded from the nutritional chain.

14.11.2002

EN

Official Journal of the European Communities

C 277 E/223

A surveillance system establishing measures to monitor certain substances and residues thereof in live
animals and animal products in accordance with Council Directive 96/23/EC (7) also ensures the safety of
products originating from small ruminants (sheep, goats) and horses.

(1) Parliament and Council Directive 2001/82/EC of 6 November 2001 on the Community code relating to veterinary

medicinal products, OJ L 311, 28.11.2001.

(2) Council Regulation (EEC) No 2309/93 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, OJ L 214, 24.8.1993.

(3) Council Regulation (EEC) No 2377/90 of 26 June 1990 laying down a Community procedure for the establishment
of maximum residue limits (MRLs) of veterinary medicinal products in foodstuffs of animal origin, OJ L 224,
18.8.1990.

(4) Directive 2001/82/EC of the Parliament and of the Council of 6 November 2001 on the Community code relating

to veterinary medicinal products, OJ L 311, 28.11.2001.

(5) COM(2000) 806 final.
(6) OJ C 75 E, 26.3.2002.
(7) Council Directive 96/23/EC of 29 April 1996 on measures to monitor certain substances and residues thereof in
live animals and animal products and repealing Directives 85/358/EEC and 86/469/EEC and Decisions 89/187/EEC
and 91/664/EEC, OJ L 125, 23.5.1996.

(2002/C 277 E/244)

WRITTEN QUESTION P-1519/02

by Anne Ferreira (PSE) to the Commission

(22 May 2002)

Subject: Defining the status of the European estate agent

Estate agents in the EU countries are increasingly involved in cross-border transactions. However, the rules
governing the profession vary from country to country, resulting in differing charges and varying levels of
consumer protection.

In order to protect consumers, to harmonise the European Union internal market and to improve the
profession’s image, harmonisation is needed at European level of the requirements to which estate agents
are subject.

In order to do this, it would be necessary to make compulsory and to harmonise:

= a professional third-party insurance,

= a financial guarantee.

What is the Commission’s position on this question?

Answer given by Mr Bolkestein on behalf of the Commission

(19 June 2002)

Although Real Estate Agents can in principle benefit from the right to establishment and the freedom to
provide services, as foreseen in Articles 43 and 49 of the EC Treaty,
legal and administrative barriers
remain for cross-border activities, including different requirements relating to professional insurance and
guarantees. This reflects a more general problem of the Internal Market for services characterised by a
variety of remaining barriers which effect both providers and receivers of services.

Against this background the Lisbon European Council (19 and 20 June 2000) invited the Commission to
propose a comprehensive Internal Market strategy to remove barriers to services.