Internal Market Council (Hansard, 20 January 1993)

§ Mr. Needham

I chaired the final Internal Market Council of the British presidency on 17 December. Overall this was a successful Council ensuring a satisfactory presidency for the United Kingdom on the single market. Twelve single market measures were agreed at this Council, and 90 overall during our presidency. This last figure is a record for any presidency. This confirmed the verdict of the European Council at Edinburgh that the White Paper programme is now complete in all essential respects. The single market is now open for business.

The Council agreed a common position on the future system for the authorisation of medicines in the Community. This package of measures comprises three directives and one regulation which establish new Community licensing procedures for human and veterinary medicines. The regulation creates a centralised licensing system for certain high technology medicines, and establishes a European Medicines Evaluation Agency to provide administrative and technical support for the new procedures.

The directives provide for a decentralised licensing system for other medicinal products, involving mutual recognition of member states' licensing decisions, with binding arbitration in the event of disputes.

The Council also agreed a common position on a directive harmonising laws relating to the civil use of explosives. The directive acknowledges the need to ensure that intra-Community transfers of explosives are properly controlled so that these potentially dangerous products are only shipped to those who have a legitimate reason to acquire them. The same provision will apply to domestic transfers of the explosives covered by the directive. The United Kingdom was able successfully to preserve our export controls on explosives; this helps ensure that they will not fall into the hands of terrorists in the United Kingdom, or third countries.

The Council reached agreement on a directive harmonising the safety and performance requirements for a wide range of medicinal devices. Products covered include tongue-depressors, bandages, artificial limbs, X-ray equipment, brain scanners and electro-cardiograms. The products are classed in four categories, to ensure that the level of control over assessment of conformity with the directive's requirements is proportional to the level of risk inherent in a device. This is an important directive, which will liberalise trade in a sector with trade worth £8 billion in the Community.

A number of significant single market measures were agreed, including common positions on the second 314W amendment to the machinery directive, the sixth amendment to the cosmetics directive, and directives on food hygiene, brakes of motorcycles and statistical units on industrial production. Final adoption was reached on extraction solvents, road and waterway controls on third country transport, and type approval of vehicle external projections. A regulation was agreed creating a fund for re-adaptation measures for Customs agents.

The Council also discussed a directive on copyright in cable and satellite broadcasting, the abolition of frontier controls, a directive on biotechnological inventions, an amendment to the food additives framework directive, the sweeteners directive, a directive on food labelling, and a regulation on dual-use goods.

I must regret the failure of the Council to reach agreement on the Community trade mark regulation. This important measure will establish a Community trade mark office. A trade mark registered with the Community trade mark office will be a unitary right having effect throughout the Community. It will be possible to enforce the rights conferred by it in a single legal action in court in one member state, with effect for all member states. We had put considerable effort into these measures during our presidency, and had cleared away a large number of reservations. However, continuing disagreement between member states over the language regime to be used at the office prevented agreement. I hope agreement can be finally reached under the incoming Danish presidency.