In June 2009, after the original prosecution of Elizabeth Lee for offences under Section 85.5 of the Medicines Act (wrong labelling), the PDA secured the support of the Government for the idea of a Crown Prosecution Service Protocol. The intention being that once Gross Negligence Manslaughter charges were ruled out then the Police would no longer pursue any offences under the Medicines Act, but would simply, as is its common practice when dealing with other health professionals where they have no other offences to refer to, hand the whole case over to the professional regulator; in the case of pharmacy it currently being the Royal Pharmaceutical Society of Great Britain.
Talks to pursue this initiative between the Department of Health, the Crown Prosecution Service and the Director of Public Prosecutions commenced almost a year ago and since the winter of 2009, the authorities have constantly indicated that the publication of these protocols was imminent.
As a consequence, during the Appeal hearing which was considering the conviction of Elizabeth Lee on May 26th at the Royal Court of Justice, her defence team sought, on two occasions to use the imminent release of the CPS protocols to secure a more favourable outcome?
On the first of these occasions, the defence teams approach was going to be that the appeal may well benefit from being heard, once the CPS protocols had been released as this would have had a beneficial effect on the appeal. However, the prosecution counsel, having just conferred with the CPS legal representative told the three appeal judges that the talks on the protocols had reached an impasse and that therefore their release was not at all imminent. When probed by the judges, the prosecution team indicated that they had no idea how long it would take for release of the protocols and that it could even be as long as a year.
As a consequence, the appeal had to proceed without their benefit. On the second occasion, the point in the appeal had been reached where it had become obvious that the original conviction for an offence under Section 85.5 (wrong labelling) was likely to be successfully overturned. The question then arose as to what was to be done with the original Section 64.1 (wrong product supplied) offence which had been left in abeyance from the original 2009 trial. The defence team argued that the judges should continue to leave this offence in abeyance, Elizabeth Lee had not previously pleaded guilty to it and that if it was left fully alone, then the effect of the CPS protocols (when they came) would mean that the CPS would not be proceeding with a prosecution.
Had the judges agreed with this then Elizabeth Lee would have left the court with no remaining criminal conviction.
However, the prosecution counsel acting for the CPS indicated that if the judges concurred with this suggestion, then the CPS would not be prepared to leave the Section 64.1 offence in abeyance and that they would instead initiate further criminal proceedings against Elizabeth Lee for breaches against this section of the Medicines Act.
The judges therefore were minded to seek a retrial to determine the Section 64.1 outcome, however, they considered the fact that Elizabeth Lee had no appetite for yet more court appearances and consequently, they decided to simply substitute the overturned Section 85.5 conviction with the Section 64.1 offence subject to a guilt plea.
According to Mark Koziol, PDA Chairman;
“This throws a huge question mark over the whole matter of whether these CPS protocols are about to be released or not, for if, as the CPS counsel indicated in court, they are mired in some sort of an impasse between government departments, then we need to get this resolved straight away. The profession was promised these protocols, not because of some special favour from the government, but because they would help to prevent defensive pharmacy practice such as refusal to participate in error log reporting and also in more professionally risky leading edge work. It would also have produced a level playing field in terms of how other healthcare practitioners are treated once gross negligence has been excluded. It is therefore not only unreasonable to expect the profession to wait any longer, but further delays are not in the public interest as they will have the effect of seriously destabilising the profession.”
He continued;
“if indeed there is likely to be protracted delay, then pharmacists have a right to know that their exposure to the risk of prosecution as a result of a one – off dispensing error is no less today than it was before the whole decriminalisation initiative commenced and that judging by the ‘hardball’ conduct of the CPS in the court of appeal, they can expect the CPS to take vigorous action against them.”
John Murphy, General Secretary of the PDA Union added;
“The words of the CPS that they genuinely understand the need for a protocol for pharmacists and that they are actively seeking to deliver one as soon as possible does not match their actions. During the appeal hearing, they had an opportunity to embody their words into actions, they could have allowed the defence efforts to use the imminent release of the protocols to produce a more favourable outcome for Elizabeth Lee, but they chose not to. Worse still, they even told the judges that they would ensure that Elizabeth Lee would face further CPS attention in the event that the judges left her original Section 64.1 offence in abeyance – as was the request of the defence.”
He continued;
“We have written to the Crown Prosecution Service and the Pharmacy Minister expressing our concerns in the strongest of terms. We have asked that they provide us with an accurate assessment of the current position so that we can decide upon what specific advice we can give to pharmacists in terms of how they should operate so as to lessen the risks. To instil some confidence in the process, we have also urged them to agree a fixed time frame in which to conclude this matter and to provide the profession with details. In light of what happened in the Court of Appeal, it is no longer acceptable to continue with the old message that ‘the protocols are imminent’.”