WRITTEN QUESTION E-1398/02

by Ria Oomen-Ruijten (PPE-DE) to the Commission

(15 May 2002)

Subject: The public health implications of prions

An article in the Journal of Biological Chemistry in August 2001 states that prions may be found in the urine of hamsters, cattle and humans suffering from TSE. The French authorities have decided to add a warning to products derived from urine in order to prevent transmission. That warning reads: The risk of transmitting infectious agents cannot be definitively ruled out where medicines prepared from human urine are administered. The same applies to hitherto unknown pathogens. (unofficial translation).

In this connection:

1. Can the Commission say what the implications of this are for public health in Europe?

2. How does the Commission intend to monitor this situation?

3. What specific steps have been taken to safeguard public health at both national and Community level?

4. What further studies have been carried out by the Commission to corroborate the results of the research as set out in the article referred to?

5. Can the Commission say what the implications are for the food chain or medicinal products derived from urine?

6. Can the Commission say whether there is a link between the results of the research referred to and the warning added by the French authorities to products derived from urine?

7. If the Commission reports such a link, can it explain why the warning has not been added in other Member States for the same products?

Answer given by Mr Byrne on behalf of the Commission

(3 July 2002)

The Commission is constantly monitoring all new scientific evidence related to transmissible spongiform encephalopathy (TSE's).

The new findings presented in the article in the Journal of Biological Chemistry referred to by the Honourable Member(1) have already been reviewed by the TSE/bovine spongiform encephalopathy (BSE) ad hoc group of the Scientific Committees and discussed by the Scientific Steering Committee (SSC) at its meeting on 6 and 7 September 2001. The minutes of this meeting are published at http://europa.eu.int/comm/food/fs/sc/ssc/out233_en.pdf.

The SSC considered that the authors of the scientific paper in question may have identified an important phenomenon, but that their work needs to be further pursued, independently verified in other qualified laboratories, replicated and extended before the results can be considered proven and final conclusions can be drawn.

Research on Shaked et al suggestion that the detection of UPrPSc can be used to diagnose humans and animals incubating prion diseases is carried out under the 5th Community Framework programme for Research and Technological Development (RTD). Following the call for proposals for RTD actions on TSEs in the Quality of Life Programme (QoL-2001-TSE, closed: 18 October 2001), two projects are under negotiation, both with components addressing this finding, aiming to develop the diagnosis of human prion diseases.

The first aims to standardise the detection of abnormal PrP in urine using the capillary electrophoresis technique and Western blotting. It will also collect samples for others to use for further research. The second project aims to compare the sensitivity and specificity of new prion detection tests including PrPSc detection in urine. The latter project includes members of the team who published the above paper.

It is expected that both of these projects will start to provide corroborative data on the findings referred to by the Honourable Member within the next three years.

For the time being, the SSC considered it premature to revise its opinions with respect to the safety of animal and human tissues or products. However, the Commission will, with the help of the Scientific Committees, closely monitor the results of urine infectivity studies related to the Shaked et al research and take the necessary steps as soon as more consolidated scientific evidence is available.

(1) Shaked et al; A protease-resistant prion protein isoform is present in urine of animals and humans affected with prion diseases; JBC, Vol. 276, No 34, 24 August 2001, p. 31479-31482.