WRITTEN QUESTION E-2306/02

by Phillip Whitehead (PSE) to the Commission

(25 July 2002)

Subject: Pharmaceutical review and generic medicines

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:

- how many patents cover pharmaceutical products and what these patents cover,

- 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:

- how many SPCs have been granted since the introduction of the Regulation,

- total sales value earned by the pharmaceutical industry from these SPCs;

3. regarding data exclusivity/protection period:

- once the data exclusivity period has elapsed, does the protected data become publicly available,

- if so, how is this data accessed?

(1) COM(2001) 404 final 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/comprep_nov2000.pdf).

One deficiency persisting in the Union is the fragmentation of the protection 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.

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.

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 takes samples of the reference product and uses them for 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.