Pharmacy owners will remain vulnerable to criminal prosecution for inadvertent labelling errors despite decriminalisation efforts, a leading healthcare lawyer has warned.

Government proposals to give pharmacy professionals a defence against criminal prosecution would fail to give adequate protection to contractors operating businesses under their own name, David Reissner, partner at law firm Charles Russell Speechlys, told C+D last week (May 28).

The Department of Health’s (DH) proposed defence would protect against prosecutions made under sections 63 and 64 of the Medicines Act 1968. Mr Reissner urged the government to update its plans to give pharmacists greater protection against section 85 – under which locum pharmacist Elizabeth Lee was prosecuted in 2009.

The section applies to labelling errors and can be used to prosecute all pharmacists. The MHRA told C+D yesterday (June 1) that it planned to change the wording "soon" to specify that pharmacists must have made the errors “in the course of their own business” to qualify for criminal prosecution, but Mr Reissner warned that this left open a loophole.

“This will be of no comfort to pharmacists who run businesses in their own names rather than through a company. They are still vulnerable to prosecution,” he stressed.

Numark raised similar concerns in its response to a government consultation on the planned legal defence. “Inadvertent mislabelling of dispensed medicines would, in most cases, fall into the category of inadvertent dispensing errors, yet would fail to be caught by the new defence,” Numark director of pharmacy services Mimi Lau pointed out.

Failing to address this issue would result in pharmacists continuing to feel the threat of criminal prosecution, Ms Lau argued, which would defeat the “principal objective” of changing the law.

The deadline for responses to the government’s consultation on decriminalisation was May 14. At the time of going to press, the DH was unable to confirm when it expected to finish analysing the consultation responses.
 

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