Committee Reports > List of Committees > Joint > 1975 > Committee on the Secondary Legislation of the European Communities > Report No. 08 - Statutory Instrument [16] made under the European Communities Act 1972

REPORT

1. The Joint Committee wishes to submit the following observations on two Statutory Instruments which were made under section 3 of the European Communities Act, 1972.

2. European Communities (Proprietary, Medicinal Products) Regulations, 1974 [S.I. No. 187of 1974]

This instrument purports to apply the terms of Council Directive 65/65 to proprietary medicinal products which were not on the market on 1st October, 1974.

The Directive deals with the approximation of laws relating to proprietary medicinal products for human use. Briefly it is designed to prevent the sale of these products except under an authorisation issued by a competent authority and (in Chapter IV) to prescribe rules for the labelling of such products.

By virtue of the Treaty of Accession Ireland is obliged “to apply progressively and by 1st January, 1978 at the latest the rules laid down in this Directive for specialities the marketing of which was authorised before accession”. Article 2 of the Accession Treaty would seem to make the Directive applicable to products coming on the market after accession.

It is understood from the Department of Health that it is intended to apply the Directive to products on the market before 1st October, 1974 progressively in further Regulations.

Article 5 of the Regulations provides for the payment of fees for the grant and renewal of authorisation. The Directive itself makes no reference to fees. Indeed it provides, in Article 21, that an authorisation “shall not be refused, suspended or revoked except on the grounds set out in this Directive”. The Joint Committee is advised, however, that the Commission does not regard the fees in this case as contravening the Directive.

In the Joint Committee’s view the provision regarding fees can be justified only if it is regarded as an “incidental, supplementary and consequential” provision within the meaning of Section 3 (2) of the European Communities Act, 1972. The Joint Committee does not regard the fees fixed in this case as unreasonable and accepts their imposition as being incidental to the implementation of the Council Directive. It should not be assumed, however, that the imposition of charges of this nature on the public can always be treated as an “incidental” matter coming within Section 3 (2) of the Act of 1972. The Joint Committee proposes to scrutinise any such cases that may arise in future.

The Joint Committee considers that Article 3 of the Regulations, which is the most important provision in the instrument, is very loosely drafted.

It provides that proprietary medicinal products not on the market on 1st October, 1974 “shall comply with the provisions of Chapters I, II, III and V” of the Directive and, from 1st October, 1975, with the provisions of Chapter IV. Chapter 1 deals with definition and scope; Chapter III with the power of competent authorities to revoke or suspend authorisation; and Chapter V is directed exclusively to Member States. If it is proper at all to speak of products as complying with statutory provisions it cannot be correct to require them to comply with obligations imposed on Member States and their competent authorities. Presumably the purpose of the instrument is to oblige persons seeking authorisation to comply with certain requirements and to give the Minister for Health authority to enforce the Directive. The Joint Committee believes that this object could have been achieved by more precise and apposite wording than that employed in Article 3.

3. European Communities (Wine) Regulations 1974, [S.I. No. 195 of 1974]

Commission Regulation No. 1769/72, as amended, (by seven other Regulations) deals with documents which are required to accompany consignments of wine and with the obligations of traders other than retailers in relation thereto. The domestic Regulations are intended to enable authorised officers to detect breaches of the Commission Regulation and they provide for penalties for such breaches.

On its first consideration of this instrument the Joint Committee was concerned because it appeared that a criminal offence was being created the nature of which was not apparent from the domestic instrument but seemed to depend on the construction of eight Community instruments. It has, however, been put to the Committee that the Community instruments being Regulations and directly applicable are already part of Irish law. The Joint Committee accepts this position but nevertheless considers that the domestic instrument could have been more precise in specifying the offence which it purports to create. Article 4 (2) provides that the penalty clause “shall not apply in relation to Article 2 and 13 of Commission Regulation 1769/72/EEC of 26th July, 1972”. It would have been preferable in the Joint Committee’s view to have stated precisely what the articles in the Commission Regulations are, the contravention of which makes one liable to the prescribed penalty.

The Joint Committee has been informed that the enforcement of these provisions has only involved the appointment of one junior civil servant as an authorised officer.

4. Other Instruments

The following Statutory Instruments were made under the European Communities Act, 1972 prior to 1st June, 1974 and were not confirmed by the European Communities (Confirmation of Regulations) Act, 1973:—

European Communities (Forest Reproductive Material) Regulations, 1973 [S.I. No. 165 of 1973].

European Communities (Vegetable Seeds) Regulations, 1973 [S.I. No. 173 of 1973].

European Communities (Seeds) (Amendment) Regulations, 1973 [S.I. No. 174 of 1973].

European Communities (Avena Fatua) Regulations, 1973 [S.I. No. 285 of 1973].

European Communities (Radio Interference from Vehicle Ignition Systems) Regulations, 1973 [S.I. No. 331 of 1973].

European Communities (Dairy Herds Conversion Premium) Regulations, 1973 [S.I. No. 345 of 1973].

European Communities (Road Transport) Regulations, 1974 [S.I. No. 57 of 1974].

European Communities (Italian Ryegrass Seeds) Regulations, 1974 [S.I. No. 113 of 1974].

European Communities (Retirement of Farmers) Regulations, 1974 [S.I. No. 116 of 1974].

European Communities (Classification of Wood in the Rough) Regulations, 1974 [S.I. No. 119 of 1974].

European Communities (Crystal Glass) (Amendment) Regulations, 1974 [S.I. No. 122 of 1974].

European Communities (Power of Central Bank in Relation to Certain Mutual Assistance by Member States) Regulations, 1974 [S.I. No. 125 of 1974].

European Communities (International Carriage of Passengers) Regulations, 1974 [S.I. No. 133 of 1974].

European Communities (Textiles) Regulations, 1974 [S.I. No. 139 of 1974].

The Joint Committee does not propose to offer any comments on any of these instruments at this stage.

(Signed) CHARLES J. HAUGHEY,

Chairman of the Joint Committee.

4th June, 1975.