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?

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

1. One of the basic policy objectives in the field of pharmaceuticals is to foster innovation in order to favour the competitiveness of the European pharmaceutical industry and meet 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.

2. The existing Community legislation contains the following elements to ensure sufficient protection of 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 authorised on the national level. The national legislation should not be allowed to shorten this 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;

- 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.