UK REGULATOR HIGHLIGHTS PRESCRIPTION TO OTC SWITCHING

Representatives of OTC groups in the UK have issued an update on the European Union's (EU) progress on prescription-to-OTC switches. Officials at Britain's drug regulator, the MHRA, note that the process could have important benefits in extending data exclusivity for drugmakers, as well as improving patient care.

Since 2002, approximately 39 active ingredients have been moved to OTC status in the EU. Although this has only added six genuinely new compounds to the OTC sector, the rate of switching has doubled since 2002 to about ten each year.

Much of this trend is attributable to the cost incentive for large healthcare providers in awarding drugs non-reimbursable status. Nevertheless, the MHRA insists that switching will expand treatment, and hopes to issue streamlined rules for the practice in the short term.

Greater switching carries powerful incentives for drugmakers. The EU is shortly due to lift a ban on OTC status for certain indications, including chronic asthma, diabetes, tuberculosis and some other serious infectious diseases. Further, European officials are also reviewing legislation on patient information leaflets in order to enhance awareness of the risks of powerful former prescription drugs. This may well involve relaxing advertising standards, permitting marketers to mention that a product has regulatory approval. Switched drugs may also be eligible for a further year's data protection after expiry, provided significant new impact studies and clinical trials are carried out.

Nevertheless, some reports have already pointed to problems with the UK's current system for switching. Earlier this month, the MHRA apologised for "administrative errors" that led to the misreporting of a public consultation on a switch for US drugmaker Merck & Co's Zocor (simvastatin).