WRITTEN QUESTION P-1834/00 by Hartmut Nassauer (PPE-DE) to the Commission. Dealing with the manufacture and distribution of pharmaceuticals in the central and eastern European applicant countries, and their impact on the EU after accession.
Date: 2000-05-31
Institutions: European Parliament, Provisional data
Subjects: Central and Eastern European countries, European patent, accession to the European Union, medicinal product

6.3.2001

EN

Official Journal of the European Communities

C 72 E/127

Answer given by Mrs Wallstr(cid:246)m on behalf of the Commission

(3 July 2000)

Lake Trasimeno has been designated by Italy as special protection area under Article 4.1 of Council
Directive 79/409/EEC of 2 April 1979 on the conservation of wild birds (1).

Therefore the provisions set in Article 4.4 of the same Directive apply,
i.e. Member States shall take
appropriate steps to avoid pollution or deterioration of habitats or any disturbance affecting the birds, in
so far as these would be significant having regard to the objectives of this article. Outside these protection
areas Member States shall also strive to avoid pollution or deterioration of habitats.

Detailed information is needed to correctly assess the case. For this reason a lettter has been addressed to
the national authorities.

(1) OJ L 103, 25.4.1979.

(2001/C 72 E/160)

WRITTEN QUESTION P-1834/00

by Hartmut Nassauer (PPE-DE) to the Commission

(31 May 2000)

Subject: Dealing with the manufacture and distribution of pharmaceuticals in the central and eastern

European applicant countries, and their impact on the EU after accession

The standards applying to the pharmaceutical industry in the central and eastern European applicant states
do not comply with those of the EU. Hence when these countries join, the EU will face serious problems:
among them, the fact that there is no protection of intellectual property comparable to the EU standard,
that existing commitments have not been met and that there is likely to be distortion of competition
against EU manufacturers.

1. What will the Commission do to introduce patent protection in the central and eastern European
countries and prevent patented products from being offered for sale there as generic medicines after
accession, as they are at present?

2. What action will it take to deal with the following:

(cid:129) To date, virtually none of the central and eastern European countries have fulfilled the commitments
they made in the Europe Agreements to introduce a level of intellectual property protection similar to
EU standards; such standards include the supplementary protection certificate for pharmaceuticals
(SPC), which is an integral component of Community law and intended to guarantee an appropriate
period of protection for pharmaceuticals in practice?

(cid:129) In many central and eastern European countries there is no effective patent protection on substances
for many pharmaceuticals introduced by western companies, as it was only introduced in the 1990s.
As a result, imitators are already copying drugs patented only in the present Member States, before the
patent expires in the EU, and are thus able to supply the markets with cheap copies?

(cid:129) Low social and economic standards and unfair competition arising from the absence of patent
protection are often forcing research pharmaceutical manufacturers to offer their original products
there for substantially lower prices than they would if there were proper cost calculation including the
total development cost?

(cid:129) There are still substantial deficiencies in the central and eastern European countries in the protection

of supporting documents submitted for the authorisation of pharmaceuticals?

(cid:129) Standards of law enforcement and the administration of justice do not comply with EU standards in

many central and eastern European countries?

C 72 E/128

Official Journal of the European Communities

EN

6.3.2001

(cid:129) There are likely to be competitive advantages for manufacturers in many central and eastern European
countries over EU manufacturers, as a result of failure to comply with international quality standards,
which push up costs, and government failure to enforce them?

Answer given by Mr Verheugen on behalf of the Commission

(30 June 2000)

The Commission considers that the large majority of the Central and Eastern European candidate countries
have made substantive progress in harmonising domestic legislation with the acquis in the pharmaceutical
sector. However, certain shortcomings still exist.

In the context of the accession negotiations, the Community has recalled the importance it attaches to the
existence of an equal level of protection of industrial property rights within the enlarged Union.

The Community has therefore suggested that a specific mechanism be provided in the accession treaty in
order to prevent distortions on the market for pharmaceutical products following enlargement. According
to this mechanism the holder of a patent or supplementary protection certificate (SPC) for a pharmaceu-
tical product filed in a Member State at a time when a product patent or SPC could not be obtained in a
candidate country for that product, would be able to rely on the rights granted by that patent or SPC in
order to prevent the import from that candidate country (following accession) and marketing of that
product in the Member State or States where the product in question enjoys patent protection or SPC
protection, even if this product was put on the market in the candidate country for the first time by the
SPC or patent holder himself or with his consent.

In addition, as regards the introduction of a supplementary protection certificate, the Community stressed
in the context of the accession negotiations that this Regulation is an essential part of the patent legislation
in the pharmaceutical sector and that it should be applied in the candidate countries as early as possible
and upon accession at the latest so that all patented pharmaceutical products with market authorisation
should be eligible for a SPC even if the date of the first market authorisation has already expired.

As regards the protection of supporting clinical trial data submitted for the authorisation of pharmaceu-
ticals, the candidate countries will have to take over the relevant (cid:145)acquis(cid:146) by the time of accession. Existing
obligations under the Trade-related intellectual property right agreement (TRIPs) are also relevant in this
context.

As part of the accession process, the candidate countries will also have to apply the manufacturing
practices and quality standards applied in the present Member States and comply with them fully at the
latest by the time of accession. In fact, many candidate countries have already made good progress in this
respect.

The Commission will continue to give special attention to legislative approximation as well as to the
reinforcement of candidate countries administrative capacity.

(2001/C 72 E/161)

WRITTEN QUESTION P-1835/00

by Gorka Kn(cid:246)rr Borr(cid:224)s (Verts/ALE) to the Commission

Subject: Trans-Pyrenean highway Navarre-Aquitaine

(31 May 2000)

The Government of Navarre is studying the possibility of building a highway across the Pyrenees linking
Pamplona/Iruæa and Bayonne.

Does the Commission support this project, as is claimed by representatives of said regional government?