COUNCIL RESOLUTION of 20 December 1995 on medicinal plant preparations (95/C 350/05)

THE COUNCIL OF THE EUROPEAN UNION,

Having regard to the Treaty establishing the European Community,

Whereas, in its resolution of 30 November 1995 on the integration of health protection requirements in Community policies, the Council considers that the Community must pay particular attention to the impact on health of action proposed in a number of areas, including free movement of goods;

Whereas action to improve understanding of and address the effects on human health of the free movement of goods, in particular the free movement of medicinal products, should form part of the Community's overall strategy for action in the field of public health;

Considering the growing use of medicinal plants in the European Union;

Considering the impact of medicinal plant preparations on public health and the recommendations of the World Health Organization;

Considering the heterogeneity of the commercial presentation of those preparations on the market;

Whereas the safeguarding of public health must be a priority objective at Community level;

Whereas it is also necessary to pay appropriate attention to conditions which will ensure that the development of industry and the free movement of such products within the European Union are not hindered;

Considering the specific problems involved in checking raw materials and medicinal plant preparations from third countries in order to guarantee their quality;

Whereas it is appropriate to take into account the special characteristics of such preparations;

Whereas it is necessary to guarantee the protection of consumers' health throughout the whole process of manufacture, distribution and putting up for sale,

CALLS ON the Commission, in close cooperation with the Member States, to study the situation that exists and, in particular:

- whether there are public health concerns over medicinal plant preparations and raw materials that require action by the Community,

- whether Community rules relating to such preparations present any difficulties and what clarifications might be required regarding the legal status of medicinal plant preparations, having regard to the Community provisions on proprietary medicinal products,

- any checks required to ensure the quality of raw materials and medicinal plant preparations, including those imported from third countries,

- the specific conditions required to ensure the protection of public health.

COUNCIL RESOLUTION of 20 December 1995 on generic medicinal products (95/C 350/06)

THE COUNCIL OF THE EUROPEAN UNION,

Having regard to the Treaty establishing the European Community,

Whereas, in its resolution of 30 November 1995 on the integration of health protection requirements in Community policies, the Council considers that the Community must pay particular attention to the impact on health of action proposed in a number of areas, including free movement of goods;

Whereas action to improve understanding of and address the impact on human health of the free movement of goods, in particular the free movement of medicinal products, should form part of the Community's overall strategy for action in the field of public health;

Whereas matters concerning prices and public financing of medicinal products are the sole responsibility of Member States' authorities;

Whereas generic medicinal products can help bring greater transparency and competition to the market; whereas the use of such medicinal products can improve cost-effectiveness, as emphasized by the Commission in its communication to the Council and the European Parliament of 2 March 1994 on the outlines of an industrial policy for the pharmaceutical sector in the European Community;

Whereas, in its resolution of 19 November 1993 on public health policy after Maastricht, the European Parliament asks the Commission to look into whether it is possible to encourage greater use of generic medicinal products;

Whereas the non-proprietary names of generic medicinal products may make them more easily identifiable;

Whereas it would be very useful for Member States to know the situation regarding generic medicinal products, including branded generics,

CALLS on the Commission, in close cooperation with the Member States, to draw up, in the light of the guidelines in the Annex, a report concerning policy on generic medicinal products in the Member States of the European Union and in the other OECD countries, in particular the USA, Canada and Japan.

ANNEX

Aspects to be considered

1. Collation of existing provisions, including measures to promote the prescription and supply of generic medicinal products.

2. Collation of the technical requirements for the assessment of generic medicinal products, the conditions for registering them and the specific regulations making it easier to obtain marketing authorization for them.

3. Analysis of the impact on public health of price differentials for generic medicinal products as compared with patented products and of the market shares for generic medicinal products.

4. Collation of legislation applicable to the international trade.