WRITTEN QUESTION E-2306/02 by Phillip Whitehead (PSE) to the Commission. Pharmaceutical review and generic medicines.
Date: 2002-07-25
Institutions: European Parliament, Provisional data
Subjects: European industrial area, European patent, competitiveness, data protection, generic drug, medicinal product, patent law, pharmaceutical industry, pharmaceutical legislation, public health

14.8.2003

EN

Official Journal of the European Union

C 192 E/57

(2003/C 192 E/055)

WRITTEN QUESTION E-2306/02

by Phillip Whitehead (PSE) to the Commission

Subject: Pharmaceutical review and generic medicines

(25 July 2002)

In its proposal (1) for the amendment of the Community Code relating to pharmaceutical products for
human use (amending Directive 2001/83/EC (2)), the European Commission has proposed in Article 10 to
extend the period during which original pharmaceutical products are protected from generic competition.

In order to help the European Parliament understand the current status of protection for pharmaceutical
products in the EU, could the European Commission indicate:

1. Regarding patents:

(cid:1) how many patents cover pharmaceutical products and what these patents cover,

(cid:1) whether or not the Commission has assessed how many patents are already available or are going

through the application procedure for new indications and formulations;

2. Regarding supplementary protection certificates:

(cid:1) how many SPCs have been granted since the introduction of the Regulation,

(cid:1) total sales value earned by the pharmaceutical industry from these SPCs;

3.

regarding data exclusivity/protection period:

(cid:1) once the data exclusivity period has elapsed, does the ‘protected’ data become publicly available,

(cid:1) if so, how is this data accessed?

(1) COM(2001) 404 final (cid:1) OJ C 75 E, 26.3.2002, p. 216.
(2) OJ L 311, 28.11.2001, p. 67.

Answer given by Mr Liikanen on behalf of the Commission

(3 September 2002)

For a number of reasons, the situation for innovative pharmaceutical industry in Europe is much less
favourable than in other areas and in particular in the United States. As a consequence, European industry
loses ground in terms of competitiveness and key research continues to shift outside Europe (see e.g. the
report prepared by Alfonso Gambardella, Luigi Orsenigo and Fabio Pammolli on ‘Global Competitiveness
in Pharmaceuticals. A European Perspective’, available on http://pharmacos.eudra.org/F3/g10/docs/com-
prep_nov2000.pdf).

One deficiency persisting in the Union is the fragmentation of
intellectual and
commercial property. In response, the Commission’s proposal to amend Directive 2001/83/EC foresees to
harmonise the so-called data protection period on the level of 10 years. This level of data protection
currently applies to centrally authorised products, in particular highly innovative biotech products, whereas
the period for nationally authorised products is at least six years.

the protection of

In drafting this proposal, the Commission has taken account of ongoing legislative activities in the sector
of intellectual and commercial property. However, the Commission does not possess exact figures either
on the number of patents and supplementary protection certificates relating to medicinal products or on
the total sales volumes earned by the pharmaceutical industry in result of such patents and certificates.

Patents are obtainable through two distinct routes, namely the European Patent Office and the national
patent offices, but in all cases, once granted, they are maintained solely at Member State level. There are no
co-ordinated statistics available showing how many patents are in force at a given time for a specific kind
of product. Supplementary protection certificates similarly are granted and administered exclusively by the
Member States. The Commission does not systematically gather or collate any central statistics.

C 192 E/58

Official Journal of the European Union

EN

14.8.2003

The provisions on the data protection do not lead to a publication or public accessibility of the data
submitted by the first company. The documentation on safety and efficacy of the reference product is
submitted by the first company to the competent authority. It remains within the authority and is not
disclosed. As a principle, neither generic companies nor the public have access to this data.

For a generic application, it is not necessary that the company actually holds this data.

The generic applicant
the necessary
bioequivalence studies with his generic product. He then submits the required documentation on the
bioequivalence as well as on the quality of the generic product to the competent authority.

the reference product and uses them for

takes samples of

(2003/C 192 E/056)

WRITTEN QUESTION E-2326/02

by Daniel Varela Suanzes-Carpegna (PPE-DE) to the Commission

Subject: Community responsibility for conservation measures

(26 July 2002)

In its proposals for a reform of the Common Fisheries Policy (CFP) which were adopted by the College of
Commissioners on 28 May 2002, the Commission confers new powers on the coastal states to enable
them to devise technical measures applicable in the waters under their jurisdiction which would require
only the Commission’s authorisation. Specifically, the coastal Member States would be allowed to adopt
rules applicable within the knot 0 to 12-mile zone to all vessels and emergency measures applicable in
other zones to all Community vessels.

In view of the fact that there is already a Community procedure enabling the Commission to adopt short-
term emergency measures which are subsequently submitted for ratification by the Council, what reasons
justify the creation of this new procedure?

Does the Commission believe the transfer of such powers to the coastal states to be in accordance with
current Community law? If so, on the basis of what legal precepts?

Lastly, does the Commission not think that it should be the one to adopt such measures, in order to
uphold the principle of neutrality?

Answer given by Mr Fischler on behalf of the Commission

(16 September 2002)

In the Honourable Member’s written question,
it is referred to Articles 8 and 9 of the Commission
proposal. Article 8 provides for Member States emergency measures and Article 9 for Member States
measures within the 12 nautical mile zone.

As Article 8 provides for short-term emergency measures, Article 9 provides for measures in the 12-mile
zone which do not have this urgent feature. It is not a new procedure since this is at the present time
stated in Article 46 of Council Regulation (EC) No 850/98 of 30 March 1998 for the conservation of
fishery resources through technical measures for the protection of juveniles of marine organisms (1), indeed
with a different formulation (it applies to ‘local stocks’) but similar in its effect.

Of course, there is a difference between this Article 46 and Article 9 as proposed, since Article 46 does not
apply to vessels from other Member States. But the Commission is of the opinion that restrictive measures
for conservation and management within this zone must not apply only to vessels from the coastal
Member State concerned but also, in order to have a full effect, to the other vessels entitled to fish in this
area.