Council conclusions

of 5 June 2001

on the epidemiological situation of variant Creutzfeldt-Jakob (vCJD) and a proactive strategy on zoonoses, in particular transmissible spongiform encephalopathy (TSE)

(2001/C 175/02)

THE COUNCIL OF THE EUROPEAN UNION

1. CONSIDERING that a significant increase of reported food-borne diseases of zoonotic origin, including both emerging and re-emerging diseases, has been recorded in most Member States during the last decades;

2. CONSIDERING that vCJD is a disease that is always fatal and also affects younger people;

3. STRESSING that a high level of human health protection is to be ensured in the definition and implementation of all Community policies and activities;

4. RECALLING the communication from the Commission on the health strategy of the European Community, in which the need to properly link actions in the framework of public health with health-related initiatives in other policy areas is emphasised, and in which the Commission declares its intention to establish mechanisms to ensure that policies and activities contribute to health protection, as well as the Commission proposal for a public health programme;

5. RECALLING the conclusions of the European Council in Nice on 7 to 9 December 2000, which take note of the measures already taken in order to combat BSE and emphasise that more intense efforts in the field of human medicine and veterinary research are essential if the prevention, diagnosis and treatment of this disease are to be guaranteed;

6. REAFFIRMING its wish, expressed in the Council conclusions of 14 December 2000 on BSE and the epidemiological situation of variant Creutzfeldt-Jakob, to develop efforts to identify the consequences for human health of the BSE epidemic;

7. RECALLING Decision No 2119/98/EC of the European Parliament and the Council setting up a network for the epidemiological surveillance and the control of communicable diseases in the Community, including food-borne diseases, such as vCJD, and other diseases transmissible by non-conventional agents;

8. WELCOMING the comprehensive inventory of European research on TSEs presented by a group of leading experts established by the Commission, which addresses strengths and weaknesses of European research in this field as a basis for identifying major issues for further research efforts;

9. RECALLING that the Commission's proposal for the sixth framework programme 2000 to 2006 for research, technological development and demonstration activities sets out food safety and health risks as a priority area, including research on methods of analysis and detection of chemical contaminants and pathogenic micro-organisms, impact of animal feed, and the use of subproducts of different origins for that feed, on human health, and the epidemiology of food-related diseases and genetic susceptibilities;

10. RECALLING Commission Directives 1999/82/EC and 1999/104/EC changing the Annexes to Directives 75/318/EEC and 81/852/EEC with the aim to minimise the risks for transmission of TSE through medicinal products (including natural remedies and homeopathics) for human and veterinary use, Directive 76/768/EEC on cosmetic products, Directive 93/42/EEC on medical devices and Council Recommendation 98/463/EC establishing the acceptance criteria for blood and plasma donors;

11. RECALLING the Commission's proposal for a directive setting standards of quality and safety for the collection, testing, processing, storage, and distribution of human blood and blood components and amending Council Directive 89/381/EEC;

12. CONSIDERS that monitoring and prevention of zoonoses, including TSE, require a proactive and coordinated strategy in the field of human health, including epidemiological surveillance of human cases and timely assessment of risks to human health;

13. EMPHASISES the need for scientific research on emerging and re-emerging diseases of zoonotic origin, including the origin and possible transmission of TSE agents, the development of methods to render TSE agents inactive, clinical and laboratory diagnostic procedures concerning TSE and measures to identify risks of iatrogenic transmission and develop protective measures against the possible risks;

14. UNDERLINES the importance of the public's awareness of the magnitude of different health risks, thus allowing them to make informed choices with regard to such health risks;

15. UNDERLINES the need for adequate risk communication to the public and to the medical and social professions in order to avoid patients with vCJD, as well as those with sporadic and familiar CJD and related diseases, being stigmatised as well as deprived of appropriate medical and social care;

16. CONSIDERS that the Member States and the Commission should continue and further develop their efforts in the field of prevention of zoonoses, in particular TSE. It encourages the Member States to:

(a) ensure efficient and reliable epidemiological surveillance for human cases of zoonoses, including TSE;

(b) promote good practice for risk communication to the public on emerging and re-emerging diseases such as vCJD;

(c) exchange information and knowledge on good practice for medical and social care of patients with CJD, including vCJD, and the relatives of the patients;

(d) promote and coordinate research in this area;

(e) cooperate closely with the Commission and other international forums, such as the WHO, in particular in the aforementioned areas;

It invites the Commission to:

(a) develop integrated mechanisms to ensure that relevant Community policies and activities contribute to health protection against risk from zoonoses, including TSE;

(b) strengthen and further develop, in particular within the network for epidemiological surveillance and control of communicable diseases, efficient and reliable strategies and methods for the prevention and control of zoonoses, including TSE, at Community level, as well as to develop methods to assess the risks to human health accompanying various zoonoses, including TSE, and to consider such assessment in the development of Community policies;

(c) strengthen and further develop the existing surveillance mechanisms on vCJD at the Community level, in order to make full use of the data on human cases within the network for epidemiological surveillance and control of communicable diseases in the Community, in order to improve assessment of risks to human health;

(d) support, in particular within the framework of the network for epidemiological surveillance and control of communicable diseases, exchange of information and knowledge on good practice for risk communication to the public on emerging and re-emerging communicable diseases such as vCJD;

(e) consider measures on the safety of organs and substances of human origin;

(f) promote research in the health context, within the appropriate legal framework, building upon the Inventory on National Research on TSE in Europe, and with particular regard to:

- the origin and possible transmission of TSE agents,

- methods and products to render TSE agents inactive,

- clinical and laboratory diagnostic procedures concerning TSE, particularly early diagnostic procedures relating to accessible peripheral tissues,

- identifying risks of iatrogenic transmission and developing protective measures against the possible risks,

- investigation of possible therapies;

(g) continually review, in the light of existing knowledge, the protective measures undertaken against possible risks of iatrogenic transmission, such as through pharmaceuticals, cosmetic products and medical devices, applying, as appropriate, the precautionary principle;

(h) support the exchange between the Member States of information and knowledge on good practice concerning measures to eradicate risk and to better guard against the possible risks of iatrogenic transmission;

(i) cooperate closely with other international forums, in particular, the WHO;

(j) report to the Council on these matters as soon as possible.