DTB Views Consumers And EU Licensing

The introduction of uniform arrangments for drug licensing throughout the European Union is welcome and could bring greater openness, says the UK Drug and Therapeutics Bulletin, but consumers should be represented on the Committee on Safety of Medicinal Products, and assessment reports for new drugs must be produced promptly, made widely available, and contain as full details of the basis of the product's approval as possible.

The DTB welcomes the obligation on the European Medicines Evaluation Agency to produce assessment reports for drugs approved by the centralized procedure or after arbitration. But the detail contained in the reports and even their availability is uncertain, as they will be provided only to "interested persons," and then only after information deemed commercially confidential (the definition of which is not yet clear) is removed, it says. Openness would permit doctors and patients greater understanding of the drugs available and offer a way to check against abuse and incompetence by regulatory authorities.

The new system should help cut wasteful bureaucratic duplication, shorten the time taken for drugs to reach the market and allow greater sharing of information on medicines after licensing, says the DTB. To assist in monitoring it, license numbers should indicate whether the application was granted by the centralized, decentralized or national procedure, it suggests.