The only appropriate course of action, in the view of the PDA, was that if gross negligence manslaughter offences had been ruled out following investigation then the entire matter should then have been referred to the RPSGB and handled as a professional disciplinary and not as a criminal matter.
Although the PDA had dealt with several potential gross negligence manslaughter cases against pharmacists before, the case of Elizabeth Lee was the first one involving the PDA that was actually going the distance, in this case to a High Court. Previous court cases, such as the peppermint water and the Prestatyn cases, which involved Medicine’s Act offences had all been managed by legal teams established through employers. Consequently, this case provided an opportunity to create important legal precedents which would potentially protect pharmacists in the future.
When Elizabeth Lee went to the Old Bailey in 2009 to face two charges under the 1968 Medicines Act, the PDA’s defence team argued that she should not have faced either of the charges as they simply did not technically apply in the case of a dispensing error.
The offence under Section 85.5 – for attaching the wrong label to the medicine, was not an offence that could have been committed by Elizabeth Lee as technically this was an offence that could only have been committed by a pharmacy business.
The offence under Section 64.1 – for providing the wrong product, was a section of the Act that the PDA argued was specifically designed to be used in situations where an adulterated product or a product of a poor quality was supplied and not at all designed to be used in dispensing error situations.
Had these arguments been accepted, then she would not have been convicted, furthermore, in the future, other pharmacists would have been spared the experience too, as the Police would not have been able to use the Medicines Act in the way that they had previously.
At the original 2009 Old Bailey trial, following an initial not guilty plea from Elizabeth Lee, the PDA’s defence team approached the bench prior to the start of the hearing to put their legal arguments. However, the judge made it clear that it was unlikely that these arguments would succeed. It was obvious that any jury made up of members of the public would be influenced by the judge’s directions on points of law which would have significantly reduced the chances of success. This created a further risk: had Elizabeth Lee been found guilty after initially pleading not guilty, then she would have received a more severe sentence. Consequently, in a tactical move, the plea of guilty was entered for the Section 85.5 offence (wrong labeling), so as to enable these arguments to be heard in a higher court, the court of appeal.
Elizabeth Lee was therefore convicted for an offence under Section 85.5 (labeling offence) but the judge left the 64.1 offence in abeyance.
No one imagined that despite a guilty plea, which guarantees a ‘discounted’ sentence from the court, the judge would then give Elizabeth Lee a custodial sentence. This development was to result in substantial shock waves reverberating throughout the entire profession of pharmacy and beyond.
The Appeal
The original strategy and legal arguments were maintained and on May 26th 2010, the Appeal of Elizabeth Lee was heard by three senior judges at the Royal Courts of Justice.
Added now to the list of objectives, was the task of overturning the custodial sentence handed down in the original hearing and also to ensure that this was to be the last court appearance for Elizabeth Lee.
The Success
After a considerable legal argument between the defence and the prosecution, the Appeal judges stated that (and we quote) “this was a case that has succeeded in raising novel questions about the construction of the Medicines Act” and they agreed with the PDA’s ‘novel’ construction. Consequently, they quashed Elizabeth Lee’s conviction and as a result, her custodial sentence was automatically erased.
The effect of the way that we asked ‘novel questions’ about the construction of the Medicines Act and the fact that the Appeal Court judges agreed with us is that it has been clarified that offences under Section 85.5 can only be committed by owners of businesses and not by the pharmacists that they employ (whether employed or self-employed). That same legal construction does not just apply to Section 85.5 of the Act, but also to other sections as well, such as Sections 52, 65.1, 65.2, 85.3 and 85.4 and these describe various other offences that employees and locums would have previously been exposed to that they will no longer be.
As a result, in future, if a pharmacist attaches the wrong label to a dispensed medicine (or other offences described in the additional sections above), then they will no longer be vulnerable to criminal proceedings, and they should potentially only face professional disciplinary proceedings.
The full transcript of the judgement can be found here
The Disappointment
The Section 64.1 offence (for providing the wrong product) that had been considered at the original 2009 Old Bailey hearing had been left in abeyance. At the Court of Appeal, it was put to the judges that they should consider leaving the Section 64.1 offence in abeyance. This was because Elizabeth Lee had never pleaded guilty to that offence at the first trial. But also and more importantly, because we had been led to believe that new protocols were to be released imminently by the Crown Prosecution Service. These protocols would ensure that pharmacists who commit oneoff dispensing errors which are related to a death and where investigations rule out gross negligence manslaughter should be referred to the RPSGB so as to face professional discipline and not criminal proceedings under the Medicines Act.
Had the judges agreed to this proposal, then Elizabeth Lee would have been able to leave the court with no criminal conviction to her name and this was the whole aim of the PDA’s defence strategy.
However, the Crown Prosecution Service lawyers in a surprising revelation argued that no such protocol was imminent as discussions between the various parties that were working on it had reached an impasse. The impression created was that it could even take a year to resolve. Furthermore, they indicated that if the judges did leave the offence in abeyance as requested by the defence team, then they would in any event instigate a fresh prosecution and trial for offences under Section 64.1 of the Medicines Act.
Even though the PDA’s team had legal arguments to defend such action, if it came, this was not a viable option as it was no longer appropriate to expect Elizabeth Lee to wait another long period to face the prospect of more court appearances, nor (quite understandably) did she have the desire to do so.
Consequently, under an established legal procedure the prosecution asked the judges to substitute the Section 85.5 offence with the Section 64.1 offence and with the agreement of Elizabeth Lee the judges did this. As far as sentencing was concerned, the judges stated that they agreed with our arguments that the original sentence that had been initially imposed was manifestly excessive and they ruled that the penalty should be a fine of £300 payable within 28 days.
The Result
- The original conviction of Elizabeth Lee for offences under section 85.5 of the Medicines Act have been overturned.
- Pharmacists (unless they are owners) should not be charged with such an offence again (nor for offences under Sections 52, 65.1, 65.2, 85.3, 85.4).
- With the appeal against the Section 85.5 conviction successfully upheld, the custodial sentence originally received by Elizabeth Lee is automatically overturned.
- The substitution of the Section 64.1 offence resulted in a conviction, but with a fine of £300.
- The judges agreed that Elizabeth Lee’s original custodial sentence was manifestly excessive.
Unfinished Business
As a result of the PDA’s strategy substantial progress was made, not just for Elizabeth Lee but for the wider profession.
Nevertheless there is a sense of frustration and a feeling of unfinished business at the conclusion of this episode. Elizabeth Lee still has a criminal conviction and the PDA’s aim was to have all criminal sanction removed. Although some personal difficulties have been removed for Elizabeth as a result of her successful appeal against Section 85.5 and the custodial sentence being quashed (like visa applications to certain countries or job applications for example) there is still the question of whether an offence under section 64.1 of the Medicines Act (wrong product supplied) is appropriate in the event of a dispensing error. However, in the event that another PDA member should be unfortunate enough to face such a prosecution, then the PDA will not shirk from the task of taking up the legal challenge.
The mission to decriminalise dispensing errors continues
Following this case and directly because of the surprise revelations about the alleged impasse over the Crown Prosecution Service protocols, the PDA applied significant pressure to both the Chief Executive of the Crown Prosecution Service and also to the new Pharmacy Minister, Earl Howe. Through previous dealings with Earl Howe on both the Elizabeth Lee case and also on Remote Supervision, the PDA knows that the new Pharmacy Minister shares our concerns. This pressure has been amplified by further letters from parliamentary supporters such as Baroness Cumberledge who is the acting chair of the All Party Pharmacy Group.
A twist in the tale
In a further surprising twist to this tale, the long awaited protocols (described in the next article) were finally and suddenly released not one year after the Appeal of Elizabeth Lee, but just three weeks after.
The reality about the delays turned out not to match the report given by the Crown Prosecution Service to the judges in the court of Appeal and we cannot but wonder what the judges would have decided about leaving the Section 64.1 offence in abeyance had they known that they were indeed just about to be released.
This last development has created many concerns within the profession and what it undoubtedly shows, is that the world of healthcare practice can truly be a hostile place. Members can be reassured that the PDA has already written to the Appeal Court judges and brought these ‘developments’ to their attention. At the time of going to press, we await a response.