Written Answers. - Proposed Statutory Instruments.

Ruairí Quinn


549 Mr. Quinn asked the Minister for Health and Children the proposed statutory instruments being prepared in, or under the auspices of, his Department; the proposed effect of each; and if he will make a statement on the matter. [19622/00]

Statutory instruments are being prepared as follows: To establish a health service accreditation agency. The purpose is to maintain and develop the accreditation scheme for hospitals which is currently in the final stages of preparation.

To allow for the application of a superannuation scheme to the staff of the National Council for the Professional Development of Nursing and Midwifery.

Order under section 32(1)(b)(ii) of the Animal Remedies Act, 1993 (No. 23 of 1993). The proposed effect of this order is to effect the repeal of the Therapeutic Substances Act, 1932 (No. 25 of 1932).

The Medicinal Products (Control of Paracetamol) Regulations, 2000. The proposed effect of these regulations is to further regulate the sale and supply of medicinal products containing paracetamol.

The Medicinal Products (Prescription and Control of Supply) (Amendment No. 2) Regulations, 2000. These regulations amend the Medicinal Products (Prescription and Control of Supply) Regulations, 1996 to 2000, concerning the application of the prescription and supply controls to certain medicinal products.
Revised Food Hygiene Regulations, 2000, are currently at an advanced stage of completion. The current Food Hygiene Regulations, 1950-1989, provide the framework for enforcing national food safety standards. Having considered developments at EU and national level, overlaps between the food hygiene regulations and other food safety legislation have been identified. Consequently, it is proposed to revoke the existing regulations and draft new Food Hygiene Regulations, 2000.
Two statutory instruments in relation to the infectious diseases maintenance allowance IDMA:
(1) To give effect to the IDMA annual budgetary increase.
(2) To give effect to the IDMA Christmas bonus payment.
It is proposed to make an order establishing the health insurance authority, pursuant to the Health Insurance Act, 1994. It is also proposed that, following establishment, functions, additional to those specified under the Act, will be conferred on the authority by further order.
The Health (Community Pharmacy Contractor Agreement) Regulations, 2000, are being prepared to amend the Health (Community Pharmacy Contractor Agreement) Regulations, 1996, which set out the criteria under which the chief executive officer of a health board determines applications for community pharmacy contractor agreements.
Three statutory instruments to provide a statutory basis for the role of the Eastern Regional Health Authority in relation to St. James's, St. Luke's and Beaumont hospitals.
In accordance with Government Decision S197 60B of 19 July 2000 approving a draft order entitled Misuse of Drugs Act, 1977 (Controlled Drugs) (Declaration) Order, 2000, legislation is being prepared to add a number of substances to the control schedules under the misuse of Drugs Acts, 1977 and 1984. These substance include substances with a potential for misuse in sports and 4MTA, a synthetic drug with similar effects to ecstasy.
Statutory instruments will also be employed to transpose into national law or give effect to EU directives and regulations harmonising the laws of member states as follows:
Directive 96/83/EC of the European Parliament and of the Council of 19 December 1999 amending Directive 94/35/EC on sweeteners for use in foodstuffs.
Commission Directive 98/66/EC of 4 September 1998 amending Directive 95/31/EC laying down specific criteria of purity concerning sweeteners for use in foodstuffs.
Commission Directive 98/86EC of 11 November 1998 amending Commission Directive 96/77/EC laying down specific purity criteria on food additives other than colours and sweeteners.
Commission Directive 1999/21/EC of 25 March 1999 on dietary foods for special medical purposes.
Commission Directive 1999/50/EC of 25 May 1999 amending Directive 91/321/EC on infant formulae and follow-on formulae.
Commission Directive 1999/75/EC of 22 July 1999 amending Commission Directive 95/45/EC laying down specific purity criteria concerning colours for use in foodstuffs.
Directive 1999/41/EC of the European Parliament and of the Council of 7 June 1999 amending Directive 89/398/EEC on the approximation of the laws of the member states relating to foodstuffs intended for particular nutritional uses.
Commission Directive 98/53/EC of 16 July 1998 laying down the sampling methods and the methods of analysis for the official control of the levels for certain contaminants in foodstuffs.
Commission Directive 2000/51/EC of 26 July 2000 amending Directive 95/31/EC laying down specific criteria of purity concerning sweeteners for use in foodstuffs.
Regulation (EC) No 258/97 concerning novel foods and novel food ingredients.
Regulation (EC) 1139/98 concerning the compulsory indication on the labelling of certain foodstuffs produced from genetically modified organisms of particulars other than those provided for in Directive 79/112/EEC.
Regulation (EC) 50/2000 on the labelling of foodstuffs and food ingredients containing additives and flavourings that have been genetically modified or have been produced from genetically modified organisms.
The Medicinal Products (Licensing of Manufacture) Regulations, 2000. These draft regulations propose to consolidate the statutory controls in relation to the manufacture of medicinal products for human use and to take into consideration the manufacturing requirements set out in EEC Council Directive 75/319/EEC, as amended, and including the principles and guidelines of good manufacturing practice for medicinal products for human use laid down in Commission Directive 91/356/EEC of 13 June 1991. The regulations also propose to establish controls over the manufacture and release of those medicinal products to be used in the conduct of clinical trials. These regulations have been circulated widely to the industry and other relevant groups for comments.