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European court upholds UK ban on Halcion

Clare Dyer, legal correspondent , BMJ

The manufacturer of the sleeping pill triazolam (Halcion), banned from sale in the United Kingdom since 1993, has failed in its attempt to invoke European Community law to get the ban reconsidered.

The European Court of Justice in Luxembourg has held that the UK system for challenging drug bans by judicial review proceedings in the High Court complies with European Community law.

In judicial review cases, the court will not re-examine the evidence which led to the decision and substitute its own findings, but will look only at whether the decision was one which the administrative body could reasonably have reached based on the material before it.

The manufacturer of triazolam, Upjohn, lost its original challenge against the ban, which was imposed by the Medicines Control Agency, in the High Court in 1993. The court refused to refer the case to the European Court but the company appealed and the Court of Appeal agreed to refer three questions to the Luxembourg court.

After the drug's marketing licence was suspended in the United Kingdom in 1991, France and the Netherlands referred triazolam to the Committee for Proprietary Medicinal Products, made up of the European Community member states and the European Commission. The UK suspension continued until June 1993, when the Medicines Control Agency revoked the drug's licence. Three months later, the Committee for Proprietary Medicinal Products decided not to recommend a ban.

The European Court held that courts in member states were not under a duty to look at the scientific evidence and determine whether the decisions of drug licensing authorities were correct. It was enough for the court to verify that the authority's decision was not vitiated by error or misuse of power. The national courts do not have to take account of scientific evidence emerging after the original decision to ban the drug, the court ruled. If new material came to light, the company would be able to make a fresh application for marketing authorisation.