WRITTEN QUESTION E-2360/01 by Cristiana Muscardini (UEN) to the Commission. Continuing anomaly regarding supplementary patent protection certificates for Italian medicinal products.
Date: 2001-08-06
Institutions: European Parliament, Provisional data
Subjects: Italy, patent, patent law, pharmaceutical legislation, pharmaceutical product, restriction on competition

14.2.2002

EN

Official Journal of the European Communities

C 40 E/239

Will it be managing sensitive data? What procedures will it be using?

In view of the clear implications as regards privacy, does the Commission not think that adequate
monitoring of these procedures is necessary and that it would therefore be useful to introduce regulated
supervision of them by the European Parliament as a matter of urgency?

Answer given by Ms Schreyer on behalf of the Commission

(13 September 2001)

The new Directorate C of
infrastructure and of gathering and analysing all information that is relevant to its functions.

the European Anti-Fraud Office (OLAF)

is in charge of

the Office(cid:146)s IT

In this context Directorate C is interested only in data that is directly or indirectly linked with the forms of
conduct described in Article 2 of Decision No 1999/352/EC, ECSC, Euratom (1) and Article 1 of Regulations
Nos 1073/1999 and 1074/1999 (2),
including personal data. Data is either transmitted by public
authorities or gathered in the course of the Office(cid:146)s investigations. It is also gathered from open sources
(commercial databases, Internet etc.).

Data protection is organised in accordance with Regulation No 45/2001 (3). The designation of a data
protection officer is in motion. A European data protection controller is established by that Regulation as
an independent control authority.

Article 8 of Regulations Nos 1073/1999 and 1074/1999 requires the Director of the Office to ensure that
his staff comply with Community and national provisions relating to data protection, particularly as
regards the data to which Directive 95/46/EC (4) applies, and the Supervisory Committee monitors
compliance with that Article.

(1) Commission Decision of 28 April 1999 establishing the European Anti-Fraud Office (OLAF) (OJ L 136, 31.5.1999).
(2) Parliament and Council Regulations (EC) No 1073/1999 and (Euratom) No 1074/1999 of 25 May 1999 concerning

investigations conducted by the European Anti-Fraud Office (OLAF) (OJ L 136, 31.5.1999).

(3) Parliament and Council Regulation (EC) No 45/2001 of 18 December 2000 on the protection of individuals with
regard to the processing of personal data by the Community institutions and bodies and on the free movement of
such data (OJ L 8, 12.1.2001).

(4) Parliament and Council Directive No 95/46/EC of 24 October 1995 on the protection of individuals with regard to

the processing of personal data and on the free movement of such data (OJ L 281, 23.11.1995).

(2002/C 40 E/260)

WRITTEN QUESTION E-2360/01

by Cristiana Muscardini (UEN) to the Commission

(6 August 2001)

Subject: Continuing anomaly regarding supplementary patent protection certificates for Italian medicinal

products

Under Article 1 of the Italian Law No 349 of 19 October 1991, holders of a patent for an industrial
invention applying in Italy to a medicinal product or a process for the manufacture of such a product may
obtain a supplementary protection certificate valid for not more than 18 years from the date on which the
patent reaches the end of its legal life. Regulation (EEC) No 1768/92 (1) has laid down standard rules
governing the issue of such certificates by all Member States with effect from 2 January 1993. Article 20,
however, stipulates that the Regulation does not apply to rights acquired before the date of its publication
in the Official
Journal. Given that the force of the certificates issued under the pre-existing Italian
legislation will not expire until 2011, it is clear that products protected by the Italian legislation are being

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14.2.2002

treated differently from products protected by the other Member States, resulting in a distortion of
competition, especially in relation to products protected by certificates issued under the above-mentioned
Community Regulation. Among other things, this infringement of competition is severely impeding the
movement of what are termed (cid:145)generic(cid:146) drugs.

In the light of the foregoing:

1. Does not the Commission believe that the issue of supplementary protection certificates valid for the
extremely long period provided for in the Italian legislation is contrary to the Treaty rules on free
competition?

2. Does it not consider the anomaly in the Italian situation to pose an obstacle to the development of

generic drugs?

3. What steps will it take to make Italy remedy the harm that is plainly being done to free competition?

4. To remove the difficulties referred to above, does it not believe that it should propose amendments to

Regulation (EEC) No 1768/92?

(1) OJ L 182, 2.7.1992, p. 1.

Answer given by Mr Bolkestein on behalf of the Commission

(17 October 2001)

Council Regulation (EEC) No 1768/92 of 18 June 1992 concerning the creation of a supplementary
protection certificate for medicinal products (the SPC Regulation) entered into force on 18 December
1992. The SPC Regulation provides an extended period of patent protection for medicinal products which
have been subject to mandatory marketing approval at Member State or Community level prior to being
commercialised. The SPC Regulation stipulates the conditions which have to be fulfilled for granting a
supplementary protection certificate (SPC), as well as the effects and term of such certificates.

SPCs have to be applied for separately in each Member State in which protection is required and their
effects are limited to the territories of the Member States in which they are granted.

The Italian law on SPCs pre-dates the SPC Regulation by a little over a year and provides for terms of
protection between five and thirteen years longer than an SPC issued according to the Regulation under
analogous conditions. However, according to Article 20 of the SPC Regulation, the Regulation does not
apply to SPCs granted under national legislation before the Regulation came into effect. This provision is
therefore relevant and has the effect of permitting pre-existing Italian SPCs to continue to exist until they
expire with the passing of time. The Commission understands that SPCs are no longer issued under the
national law and nor have they been since the SPC Regulation came into effect.

While the Commission acknowledges that the difference between the terms of protection granted under
the Italian legislation and the SPC Regulation is significant, this difference was known at the time of
adoption of the Regulation by the Parliament and the Council and was nevertheless permitted to remain
intact for those certificates issued before the Regulation came into effect. This reflects a general reluctance
to disturb previously existing rights when harmonising intellectual property within the Community, and
implies an acceptance that some degree of disharmony will persist for a transitional period pending expiry
of all protection under the previous legislation.

the Commission is sensitive to the issues raised, and has in this connection received
Nevertheless,
representations from industry on the matter. Further detailed information has been sought in connection
with the products covered and the terms of protection granted, and when this is forthcoming the
Commission will be in a position to consider whether the effects of the differences in term of protection
under the respective instruments during the transitional period are sufficiently serious to warrant action.