WRITTEN QUESTION E-2840/01 by Ursula Schleicher (PPE-DE) to the Commission. The use of bibliographical data in pharmacological research.
Date: 2001-10-17
Institutions: European Parliament, Provisional data
Subjects: competitiveness, data protection, document, drafting of EU law, globalisation, pharmaceutical industry, pharmaceutical legislation, scientific research

C 115 E/170

Official Journal of the European Communities

EN

16.5.2002

‘Construction site’ is defined in Article 2(a) as any construction site at which building or civil engineering
works are carried out, a non-exhaustive list of such works being given in Annex I (2).

This means that the construction of private housing is also covered by the provisions of the Directive.
Consequently, a Member State cannot grant exemptions from the obligation to appoint a safety
coordinator for the construction or renovation of private dwellings if several contractors are present on
the site.

However, it should be pointed out that this obligation would not automatically involve substantial extra
costs at this type of site. The coordinator may well be the client or the project supervisor. Moreover, it is
unusual for there to be a large number of contractors present on such sites.

As for the requirement to draw up a safety and health plan, Article 3(2) of the Directive requires the client
or project supervisor to ensure that a safety and health plan is prepared before a construction site is set up.
This requirement applies to any construction site covered by the definition given in Article 2 of the
Directive. However, the second paragraph of Article 3(2) of the Directive allows for derogations. Under this
Article, the Member States may, after consulting both management and the workforce, allow derogations
from the provisions of the first paragraph, except where the work concerned involves particular risks as
listed in Annex II or where the work requires prior notice under Article 3(3).

With regard to the implementation of Directive 92/57/EEC, all the Member States have to inform the
Commission of their national measures transposing the directive. To the Commission’s knowledge, there
have been no infringements or any other special problems concerning the directive’s implementation.

(1) OJ L 245, 26.8.1992.
(2) Annex I:

‘Non-exhaustive list of building and civil engineering works referred to in Article 2(a) of the Directive
1. Excavation. 2. Earthworks. 3. Construction. 4. Assembly and disassembly of prefabricated elements. 5. Conversion
or
fitting-out. 6. Alterations. 7. Renovation. 8. Repairs. 9. Dismantling. 10. Demolition. 11. Upkeep.
12. Maintenance = painting and cleaning work. 13. Drainage’.

(2002/C 115 E/177)

WRITTEN QUESTION E-2840/01

by Ursula Schleicher (PPE-DE) to the Commission

(17 October 2001)

Subject: The use of bibliographical data in pharmacological research

Progress in medical science means that expensive research projects must also be carried out on active
pharmacological substances which are already on the market, in order to:

= record the latest findings on their effectiveness and safety for the existing indication

= develop fields of application in addition to the existing indication or

= demonstrate their effectiveness in certain groups of patients (for example children or high-risk groups).

In particular, this involves clinical trials which can often incur costs of several million euros each.

As the European Court of Justice established some time ago, however, data on out-of-patent active
substances can also be used at any time by third-party firms for the approval of their own products,
without these firms having to contribute to the sometimes high financial cost of producing the data.

1. Which existing rules does the Commission believe promote the objective laid down in Directive
1999/83/EC (1), fourth recital?

2. What measures does the Commission consider necessary to protect firms engaged in research with
regard to the use of bibliographical data by third parties in approval procedures?

16.5.2002

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Official Journal of the European Communities

C 115 E/171

Is the Commission considering an amendment to the existing approval directive, e.g. introducing

3.
terms of copyright for the use of existing data or ensuring that third parties bear a share of the cost?

4. What further steps will the Commission take, for example in the context of the 2001 review, to
prevent any disadvantage to pharmaceutical companies which are willing to carry out innovative scientific
investigations = which are thus covered by the rules = as part of research into products they already have
on the market, as a result of the current competitive situation in the European Union?

(1) OJ L 243, 15.9.1999, p. 9.

Answer given by Mr Liikanen on behalf of the Commission

(7 January 2002)

the competitiveness of

One of the basic policy objectives in the field of pharmaceuticals is to foster innovation in order to
1.
favour
the challenges of
globalisation. This forms part of the overall goal set by the European Council in Lisbon in March 2000
in the fields of enterprise and innovation to create the ‘most competitive and dynamic knowledge based
economy in the world’.

the European pharmaceutical

industry and meet

The existing Community legislation contains the following elements to ensure sufficient protection of
2.
innovative research in the pharmaceutical sector: to protect such innovation against generic competition,
the pharmaceutical legislation contains provisions on data protection with the explicit objective to ensure
that innovative firms are not placed at a disadvantage. As a consequence, an application for a generic
medicinal product may rely on the results of pre-clinical and clinical trials presented for another medicinal
product only after expiry of the data protection period. This period is 10 years for centrally authorised
products. For nationally authorised products the period shall be at least six years, but it may be shorter if
the national legislation links the data protection to the expiry of the patent protection.

The detailed reference to published scientific literature on components of a medicinal product may replace
the results of pre-clinical and clinical trials only where these components have a certain well-established
medicinal use. It has been clarified that the period of time required for establishing such well-established
medicinal use must not be less than 10 years from the first systematic and documented use of that
substance as a medicinal product in the Community. This contributes to the protection of innovative
research, since the well-established use refers to the use for a specific therapeutic use. Hence, scientific
literature on a certain indication could replace new trials only where the product has been in medicinal use
for 10 years for this precise indication.

3. and 4.
Due to a number of developments, including the judgement of the European Court of Justice
in Case C-368/96, ECR 1998 I-7967, the Commission considers it appropriate to modify this legislative
protection of innovative research.

On 18 July 2001, it adopted the following proposals to amend the legislative framework:

= the data protection period should be extended to 10 years for all medicinal products, including those
legislation should not be allowed to shorten this
authorised on the national
protection period by linking it to a patent protecting the original medicinal product. This would
ensure homogeneous incentives to develop new medicinal products,
irrespective of the applicable
authorisation procedure;

level. The national

= additional data protection may be obtained for certain innovations regarding existing medicinal
products. In the area of medicinal products for human use, the protection period can be extended to
11 years if at least one new therapeutic indication is developed which brings a significant clinical
benefit in comparison with existing therapies.