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Decriminalisation sent back to basics

By News team

Decriminalisation of one-off dispensing errors has been put on the back burner after an amendment to the Health and Social Care Bill, intended to change the legal consequences of making unintentional dispensing errors, was withdrawn this week during a debate in the House of Lords.

A lack of consensus between pharmacy bodies, the General Pharmaceutical Council and the Department of Health on how to mount a legal defence means that this narrow legislative window of opportunity has closed (see Panel).

Instead, pharmacy minister Earl Howe revealed that the Medicines and Healthcare products Regulatory Agency will complete the first stage of its review of sanctions and penalties in medicines legislation — first announced early this year (PJ 2012;288:27) — by September 2012. By then, the agency will have scoped the coverage, conduct and timetable of the review and finalised the review team.

Last November, a proposed amendment to the health Bill suggested the introduction of a “due diligence defence” to deal with the threat of prosecution for those who make a one-off dispensing error (PJ 2011;287:667). Currently, Section 64 of the Medicines Act 1968 makes it an offence to sell or supply a medicine that is not of the quality or nature demanded. Head of public affairs at the Royal Pharmaceutical Society Charles Willis explained that while the MHRA review will not bring about decriminalisation, it is hoped it will remove the threat of imprisonment or fines for dispensing errors.

Earl Howe has also suggested that the Crown Prosecution Service take into account recent debate around decriminalisation, and encouraged further dialogue on the issue between the CPS and the DoH. Mr Willis said he hopes the CPS will review its guidance to prosecutors (PJ 2010;284:621), and produce “clear and unequivocal guidance that recognises the impact a prosecution for a dispensing error can have on reporting and learning culture”.

Profession responds

A joint statement from six pharmacy bodies — the Royal Pharmaceutical Society, the Independent Pharmacy Federation, the Guild of Healthcare Pharmacists, the Pharmacists’ Defence Association, the Pharmaceutical Services Negotiating Committee and Pharmacy Voice — said: “After taking detailed legal opinion, it became apparent that we could not support the idea of introducing into law a due diligence defence against prosecution for dispensing errors.

“It is good that this has been removed from the current legislative approach, and for there to be a focus on addressing the fundamentals at the heart of this matter.”

Citation: The Pharmaceutical Journal URI: 11097336

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