Safety norms deal on the cards

Date: 12/06/1997

By Mark Turner

EU AND US negotiators appear to have finally agreed to recognise each other's safety standards in medical equipment and pharmaceuticals.

But it remains unclear how quickly Union governments will sign up to the deal.

Washington and Brussels were due to initial a wide-ranging 'mutual recognition agreement' today (12 June) which would, in broad terms, allow authorities on both sides of the Atlantic to accept each other's national mechanisms for safety inspections of goods from telecoms to boats.

If the deal goes ahead, it will cut costs in sectors estimated to be worth around 35 billion ecu a year.

But with eyes fixed firmly on the bilateral negotiations, divisions within the EU have until now been ignored - and officials are warning that this may have been a dangerous oversight.

At a recent meeting of trade experts, a number of countries, including Italy, Germany, Spain and Belgium, cautioned against rushing into anything and said they intended to examine the emerging text closely before committing themselves.

Bonn, for example, was worried that American safety provisions on medical devices did not reach international standards, while Paris expressed concerned about granting the US Food and Drug Administration (FDA) powers to investigate equipment in France without prior approval. Other countries remained wary about the confidentiality of data elicited during safety inspections by US agencies.

Although it is solely up to the European Commission to decide when to initial a text, the deal cannot enter into force until it has been signed by Union governments.

However, EU negotiators remain upbeat, saying that a recent meeting of the Union's 113 committee revealed clear support for the text. “While theoretically possible, it is very unlikely that the member states will go back on a deal once initialled,” said one.

This week's agreement followed some last-minute brinkmanship from both the FDA and Trade Commissioner Sir Leon Brittan, whose office claimed publicly last week that there were “some signs of backsliding on the US side”.

But negotiators now believe that they have found compromises on all the major sticking points, particularly over medical devices and pharmaceuticals.

The two sides will need to exchange full certificates of inspection for goods, rather than mere certificates of compliance, and Union and US authorities will retain certain rights to inspect items on each other's territory.

Should either side suddenly refuse to recognise standards in any one of the sectors covered by the agreement, the whole deal would be forfeit unless the other party consented. Confidential commercial and financial information will be kept secret.

Finally, the US will commit itself to applying the deal throughout its territory, which could be difficult as it has been negotiated only by the federal executive. If it fails, the accord could be terminated.