HKSAR v. CHOW HEUNG WING, STEPHEN AND ANOTHER

HCCC 437/2015

[2018] HKCFI 526

IN THE HIGH COURT OF THE

HONG KONG SPECIAL ADMINISTRATIVE REGION

COURT OF FIRST INSTANCE

CRIMINAL CASE NO 437 OF 2015

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DECISION
(On Prosecution’s Application for Costs)

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Application

1.  This is the Prosecution’s application for costs against both the 1st defendant (D1) and the 2nd defendant (D2) pursuant to s 12 of the Costs in Criminal Cases Ordinance, Cap 492 (CCCO).

2.  The Prosecution’s application against D1 is based on the following two grounds:

(1) D1 had unjustifiably put the Prosecution to prove the expertise of various eminent experts in Hong Kong; and

(3) D1 unjustifiably took issue with the undeniable fact that the designation of “DR” represented him in respect of matters evidencing his control over the DR group as well as APSC and Mesotherapy Centre, which was at the core of the trial.

3.  The Prosecution also asks for costs against both D1 and D2 on the following ground:

(2) D1 and D2 had unjustifiably challenged the relevance of the Good Manufacturing Practice (GMP) when they well knew that GMP would be a core theme throughout the trial.

The Law

4.  Section 12 of CCCO provides the power of the Court to award Prosecution costs for indictable offences:

“Where a defendant is convicted of an offence by or before the District Court or the Court of First Instance, the District Court and the Court of First Instance may, in addition to such sentence as may otherwise be passed by law, order that costs be awarded to the prosecutor.”

5.  The general principles for awarding costs can be found in Section 15 of CCCO:

“In any criminal proceedings—

(a) the costs that may be awarded by virtue of an order shall not be punitive but shall be such sums as appear to a court or a judge reasonably sufficient to compensate any party to the proceedings for any expenses properly incurred by him in the course of those proceedings, including any proceedings preliminary or incidental thereto;

(b) a court or a judge may have regard to any assessment laid before it or him for their assistance by any party to the proceedings of the amount of costs properly so incurred by any such party;

(c) an order as to costs shall be such as a court or a judge considers just and reasonable;

(d) the amount to be paid in pursuance of an order as to costs shall, unless an order for taxation is made under section 20, be specified in that order;

(e) the question of whether or not an order as to costs ought to be made in respect of any expenses properly incurred by any party to the proceedings in the course of the proceedings, including any proceedings preliminary or incidental thereto, may be adjourned until the end of those proceedings;

(f)     a court or a judge may take into account any other order as to costs which has been made in respect of those proceedings.”

6.  As to the relevant principles, both counsel for the Prosecution and for D1 referred me to the following two cases: HKSAR v Chan Kwok Wah [1995‑2000] HKCLRT 202 and HKSAR v Chan Kwok Hung [2000] 3 HKLRD 389.  Counsel for the Prosecution also referred me to HKSAR v Cheng Tak Wai [2002] 4 HKC 458 and HKSAR v Hon Ming Kong [2014] 2 HKLRD 710.  Counsel for D2 did not make any specific reference to any authorities.

7.  In Chan Kwok Wah (a case involving the issue of awarding costs to the prosecution in summary proceedings), Patrick Chan CJHC (as he then was) has this to say:

“14. .... A defendant is presumed innocent until he is proved guilty, and the prosecution bears the burden of proving the defendant’s guilt beyond reasonable doubt. This is a fundamental constitutional right enjoyed by a defendant. Accordingly, it is an indirect deprivation of a defendant’s fundamental constitutional right to penalise him in costs merely because his plea of not guilty has rendered it necessary for the prosecution to adduce evidence against him or because his defence has not been accepted by the court. .... In my view, in applying the Costs in Criminal Cases Ordinance, the magistrate must consider whether there have been special circumstances as a result of which the prosecution incurred additional costs. These circumstances may include the defendant’s conduct throughout the trial, for example, by deliberately making difficulties about the prosecution witnesses, intentionally lengthening the trial, or putting the prosecution to proof of insignificant matters or undeniable facts. The Magistrate also has to consider the defendant’s financial condition before deciding whether to order the defendant to pay costs of the prosecution.”

8.  In Chan Kwok Hung, Yeung J (as he then was) called for a common sense approach depending on the facts of each case (at p 393J to 394B):

“Indeed, in my view, an order for costs against the defendant when he pleaded guilty to the charge should not normally be made. An order for costs should not, and could not, be made as a means to impose additional penalty on a defendant or on any other person. An award for costs should normally only be made when in the opinion of the court, the way in which the defendant approaches the investigation and/or the prosecution of the case constitutes an abuse resulting in the prosecution having to incur extra costs which, in the normal course of events, would not or need not be incurred.

Of course, this observation is not meant to be a strait‑jacket approach and an element of discretion or perhaps common sense is called for depending on the facts of each individual case.”

9.  In Cheng Tak Wai, Mayo VP referred to Chan Kwok Wah and stated:

“11. What emerges from this is the necessity for it to be established that there is some feature of the trial indicating that as a consequence of the way in which the defendant conducted his defence unnecessary or additional expenditure has had to be incurred by the prosecution or that the defendant has wilfully wasted the court’s time.”

10.  Counsel for the Prosecution referred to Hon Ming Kong and submitted that a wider consideration for the award of prosecution costs can be seen there, citing the concerns expressed by Stock VP (as he then was) for the taxpayers as a result of the prosecution policy not to seek costs in view of the facts of that particular case:

“12. I started by saying that the waste of public funds in this case was extraordinary; and indeed it was. Many, though not all, of the long and numerous delays were symptomatic of a culture in which the convenience of counsel rules the day. Satellite proceedings were launched which should never have seen the light of day. Teams of counsel were changed time and again. The first applicant has to date enjoyed the benefit of no fewer than eight different leading counsel and, despite the ability which seems apparent therefrom to afford that kind of representation (which is of course his right), no application was made upon conviction of the applicants for the costs of the prosecution, costs which must have been enormous; a lack of action which we were told accords with standard policy – if that be so, it is a policy about which taxpayers should be concerned....”

11.  I am in agreement with the reasons and sentiments expressed in all these decisions and I will consider this costs application accordingly.

Ground 1: unjustifiably challenged the expertise of eminent experts

12.  In my Decision dated 8 June 2017 (Reasons for Decision handed down on 13 June 2017), I set out the experts to whom D1 (and also D3) challenged (see para 2 and 4 of the Decision).

13.  The main ground of objection by D1 and D3 was that whilst those experts were experts in their own discipline, they did not have any “hands‑on” experience in carrying out Cytokine‑induced killer cell therapy (CIK) on human beings and their experience were limited to reading journals or doing study on non‑human subjects.  They had not conducted any study into the administration of CIK.  They had not undertaken research into CIK.  They had not written any articles on the topic of CIK (save for Professor Yuen Kwok Yung but his article was in relation to the women who had received the very CIK involved in this case).  Being experts on Haematology, Oncology, Microbiology, or Immunology did not qualify these witnesses to give expert evidence on CIK (see para 5 of the Decision).

14.  Counsel for D1 also stressed that in this case, the CIK procedure involved was not for any medical purpose, but for health promotion, these witnesses were therefore not qualified to comment on CIK in this particular usage (see para 6 of the Decision).

15.  I agreed with the Prosecution and held that the CIK therapy was essentially a medical procedure notwithstanding the label of healthcare.  Such a procedure falls within the remit of Immunology and Haematology.  I was satisfied that those specialists proposed to be called by the Prosecution, who were trained in and knowledgeable about Haematology, Immunology, stem cell biology/transplantation, and bone marrow transplantation were qualified to give expert opinion on CIK (see para 13 of the Decision).

Prosecution’s Submission

16.  The Prosecution submitted that D1 had unjustifiably put the Prosecution to prove the expertise of the abovementioned experts such that D1 had wilfully wasted the Court’s time:

(1) throughout the hearing for preliminary issues and/or trial, D1 never called any expert to give oral evidence to show that the usage of CIK “forms part of a body of knowledge or experience which is sufficiently organised or recognised to be accepted as a reliable bodyodd knowledge or experience” (The Queen v Bonython (1984) 38 SASR 45);

(2) in the course of the trial, D1 admitted that he understood the administration of CIK was a “medical procedure”.  Contrary to the “healthcare” submission, it was an undeniable fact that D1 knew that the administration of CIK was akin to a form of medical treatment, albeit a “wrong” one as explained by Professor Yuen;

(3) further, the knowledge of D1 as to the nature of CIK is borne out by the deliberate decision not to advertise to avoid detection by the authorities. Internal emails and the admission application form to Hong Kong Science Park show D1’s knowledge as to the international trend of regarding cellular therapy as medicine so that GMP would be required and expected;

(4) it now transpires that D1 had consulted his own immunologist Professor Halpern and haematologist Professor Gregory Cheng on the efficacy of Natural killer (NK) cells.  Regardless of the fact that those 2 experts were not supportive of the efficacy and/or safety of CIK, it lies ill in D1’s mouth to submit that the usage of CIK did not fall within the discipline or expertise of Immunology and Haematology;

(5) D1 well knew that the contrived differentiation between “healthcare” and “medical treatment” would never afford a valid defence.  D1 himself was unable to produce any peer‑reviewed journal to demonstrate that the usage of CIK was for promotion of healthcare.  On the contrary, all the articles (whether produced by D1 or the Prosecution) clearly show that the usage of CIK was still under clinical studies; and

(6) it can hardly be said that D1 was a “CIK expert” when he had only received a day and a half “training” on the usage of CIK in Guangzhou Military Hospital on 7 February 2012.  In the absence of any “CIK experts”, D1 had simply put the Prosecution to proof of insignificant matters.

17.  Accordingly, it was submitted that the unnecessary attendance of the various experts inevitably escalated the Prosecution’s costs and in turn wastage of taxpayers’ expenditure.  The challenge of the various experts was wholly unjustified but calculated to “throw a spanner in the work[s]” resulting in a waste of the Court’s time and that of the experts despite their busy schedules.

18.  At the trial proper, the expertise of the various experts was still challenged in cross‑examination, albeit to a lesser extent.  Further, for reasons best known to D1, he produced 2 experts reports from Professor He and Professor Wu, which were not accompanied by their curriculum vitae (CV).  It is a matter for D1 whether to call his proposed experts. However, the fact of the matter is that the Prosecution was put in an unenviable position of having to grapple with a large volume of medical literature without any focus and was required to anticipate the infinite number of ways in which such medical literature might be deployed.

D1’s response

19.  Counsel for D1 submitted that D1’s challenge to the expertise was fully justified.  Further, the defence had taken a very reasonable approach in this matter, having only cross‑examined Prof Yuen Kwok Yung on matters which were necessary and made no request for further experts to be called, thus not wasting the court’s time.

20.  Counsel reiterated the main grounds of objections raised at the time and submitted that the challenge was within proper limit.  Counsel further submitted that such objective limitation of the expertise required judicial ruling in order to ascertain whether the experts intended to be called were qualified to do so.  It is the duty of the Prosecution to prove expertise, and the defence should not be held liable when there was, and presumably still is, no expert with practical experience in that field in Hong Kong.

21.  Counsel submitted that the expertise of the prosecution witnesses (PWs) in this case was not a subject of “insignificant matters or undeniable facts” and no “unnecessary or additional expenditure” had been incurred.  The challenge was proper and genuine and could not be said to be a “wilful waste of court’s time”.

22.  Further, counsel for D1 submitted that the defence was entitled to challenge the expertise without calling his own expert. Whether those PWs were qualified as experts was a matter for the Prosecution to prove, and not for the defence to disprove.

23.  As to the submission by the Prosecution that D1 had wilfully wasted the court’s time, counsel for D1 submitted that those matters are irrelevant as to whether the PWs were experts: –

(1) Since the Prosecution claimed that the PWs were experts on CIK matters, it is incumbent upon the Prosecution, and not the defence, to establish that CIK forms part of a body of knowledge or experience which is sufficiently organized or recognized to be accepted as a reliable body of knowledge or experience.

(2) Whether or not the CIK therapy was a “medical procedure” or “medical treatment” does not prove one way or the other whether the PWs were CIK experts.

(3) D1’s decision not to advertise CIK and whether D1 knew CIK would be treated as medicine had no bearing as to whether the PWs were CIK experts.

(4) The consultation of Prof Halpern and Prof Gregory Cheng on CIK matters by D1 did not mean that they were CIK experts, still less does it prove that the PWs were CIK experts.

(5) Whether the differentiation between “healthcare and medical treatment” was a genuine one or whether it afforded a valid defence have no bearing on whether the PWs were experts on CIK.

(6) Whether D1 was an CIK expert and whether the defence had called any CIK experts did not detract from D1’s right to challenge the expertise of the PWs on CIK matters.

24.  Counsel for D1 also submitted that it is unfair for the Prosecution to criticize the so-called “challenge” done before the jury, the jury ought to know that these experts did not have hands‑on experience in CIK to enable the jury to decide what weight to give to the experts’ evidence.

25.  Counsel for D1 also submitted there is no substance in referring to matters pertaining to the defence experts.  The reports contained the working and “hands‑on” experience of them in CIK.  There is no standardized form of CV in expert reports.  In any event, the challenge to the expertise of the PWs were raised and decided before the jury was empanelled and the preparation of the Prosecution to deal with potential defence experts had nothing to do with the challenge made before.

My consideration

26.  Having considered the submissions of the Prosecution and D1, I am in agreement with D1 on this matter.  It is a fact that none of the PWs to be called by the Prosecution has “hands‑on” experience in CIK.  There was never any challenge that all these PWs are indeed experts in their own field.  Whether these PWs, by virtue of the expertise in their own field but without any hands‑on experience in CIK, could give expert evidence on CIK was not an insignificant matter.  The defence did no more than necessary to bring out their concern so that this Court could properly consider and decide whether those PWs could give expert evidence on CIK.

27.  Counsel for D1 did act reasonably and in my view, sensibly, by restricting the cross‑examination on Prof Yuen and did not require the Prosecution to call all the other PWs to given evidence.  The time spent on this issue was limited.

28.  It was proper for the defence to bring to the attention of the jury the limitation of the expert evidence (ie without actual “hands‑on” experience on CIK) so that the jury could consider the weight, if any, to be given to such expert evidence.  Again, counsel for D1 acted very sensibly and did not cross‑examine the experts in the presence of the jury more than necessary.

29.  As it cannot be said that it was an undeniable fact that eminent experts in their own fields, but without actual or hands‑on experience in CIK, must be regarded or recognized as experts in CIK, the challenge was properly mounted by D1.

30.  Whether the defence called any defence experts, and whether the defence had provided reports purported to be expert reports to the Prosecution but in the end did not call those witnesses, has no bearing on D1’s challenge on the admissibility of the experts’ evidence.

31.  For these reasons, I find that D1 should not be ordered to pay the Prosecution’s costs on this ground.

Ground 3: D1 unjustifiably took issue with the undeniable fact that “DR” represented him in respect of matters evidencing his control over the DR group as well as APSC and Mesotherapy Centre, which was the core of the trial

32.  As this ground only relates to D1, I will deal with this ground before Ground 2, which concerns both D1 and D2.

Prosecution’s Submission

33.  The Prosecution submitted that while a defendant should be given proper opportunity to defend his case without fear of adverse legal costs, a line should be drawn when the matter contested is clearly unjustifiable or unarguable.

34.  Throughout the trial, D1 contested that he was not the author of some of the documents with the designation “DR”.  In particular, during the course of the Prosecution’s case, it was put to various witnesses that “DR” represented “Dermal Rejuvenator”, the name of a trademark.

35.  Counsel for Prosecution submitted that this is yet another unjustified challenge of putting the Prosecution to proof of undeniable facts resulting in unnecessary time and costs being wasted:

(1) it is noteworthy that D1 had stopped referring to “Dermal Rejuvenator” during the course of the Prosecution’s case after the evidence of Madam Woo Wing‑Yan (Clerk at Prince Edward) (PW38), who clearly stated that DR represented D1;

(2) therefore D1 should never have suggested that “DR” was not him across the board.  This was what he was trying to do initially until his realisation that most of the DR staff clearly identified “DR” as being him in personam;

(3) even on D1’s own case, he never denied that he was the author of some of the documents with the designation “DR”.  He was simply trying to “cherry‑pick” those “DR” documents which were favourable to his defence case.  For example, D1 claimed credits for reminding the staff in the DR notices not to “hurt” customers, when it suited his case;

(4) in the DR notices, all D1 could argue was that not everything in the notices could be attributable to him personally.  However, he well knew that when the notices were properly read in context, his involvement in the matters alluded therein could be discerned and verified against other evidence.  For example, D1 well knew that he was the one who “drilled” the staff to trick disgruntled customers; and

(5)     at the end of the day, the bottom‑line is that D1 approved of and/or had knowledge of the notices and never objected to any of such notices or any part thereof.

36.  The issue of identifying “DR” is clearly unnecessary and irrelevant in the context of D1’s defence (ie defence of honest belief and cut‑throat vis‑à‑vis D2).

37.  It is a complete waste of Court’s time to defend the charge of manslaughter on the false assumption that D1 would be acquitted on the basis that the Prosecution could not identify who “DR” was.  This is at a par with D1’s disingenuous attempt to hide behind the corporate veils of his companies.

D1’s response

38.  Counsel for D1 submitted that the stance of D1 on this matter was to stress that DR does not necessarily refer to him and he might not have personal knowledge of the content of each document.  This is a simple and reasonable approach.  Given that D1’s knowledge was a very important aspect of his defence across so many issues introduced by the Prosecution, it was only fair for him to be allowed to make it clear that DR does not equal to a personal designation for him.  Whether or not it is to be accepted is a matter for the jury.

39.  Counsel for D1 submitted that to grant costs under this heading would essentially mean to punish D1 for running his defence on the aspect of his personal knowledge on relevant matters.  To illustrate the point by way of contrast, D1 had readily accepted that “TEMP” was an email of him.  In any event, the way the defendant dealt with this issue was simply to put D1’s case to the PWs in a short question, and for D1 and his defence witness to tell the jury in a short way what DR in the Notices stand for.  It did not occupy a lengthy part of the trial at all.

40.  Counsel for D1 also referred to the willingness of D1 to agree to the lengthy draft “Admitted Facts” and was the earliest amongst the parties to express such willingness.  It would be unfair for the Prosecution to pick “DR” and leave the “Admitted Facts” and embark upon an unusual course of asking for costs against a co‑operative defendant.

41.  Counsel for D1 also submitted that there were unsuccessful applications made by the Prosecution which occupied a lot of this Court’s time, such as the application to amend the Indictment at the eleventh hour, and the application to revisit this Court’s earlier ruling on the elements of mens rea in gross negligence manslaughter.  D1 had to spend a lot of legal costs to resist these applications which were ruled by this Court to be without merits.

42.  Counsel for D1 also submitted that the Prosecution had laboured on a number of issues which were not really in dispute with great details of evidence.  Again D1 had to bear his own costs on these matters.

43.  Further, counsel for D1 submitted that it has been held that an award of costs against the defendant is part of his sentence (referring to HK Archbold 2018 p 644 para 6‑50).  D1 has been sentenced to 12 years’ imprisonment, which is more than adequate to punish him.  D1 should not be subjected to an additional costs order.

My consideration

44.  Having considered the submissions of both the Prosecution and D1, I agree with the submission of counsel for D1.  Although it was put to a few witnesses that “DR” stands for the trademark and not a reference to D1 personally, D1 never said that he had nothing to do with the daily notices issued to the staff of the beauty centres.  Whether he was in control of the DR group of companies (all limited companies), and if so, to what extent he controlled those companies, was an essential issue to be decided by the jury.  In any event, questions relating to “DR” did not occupy much of the trial time at all.

45.  It is indeed a fact that a lot of the evidence was readily agreed by D1 to be in the admitted facts, which saves a lot of time (even though the trial still took twice as long to try).  Without those extensive admitted facts, the trial would have taken even much longer.

46.  For these reasons D1 should not be ordered to pay the Prosecution costs on this ground.

Ground 2: relevance of GMP

Prosecution’s submission

47.  Counsel for the Prosecution referred to the grounds raised in objection, as summarized in my Decision (para 20).

“20. All counsel questioned the relevance of the GMP Guidelines in this case. I combine all the objections here as some of them overlapped:

(a) whether CIK procedure falls under the definitions of ‘manufacture’ and ‘pharmaceutical product and medicine’ in the Pharmacy and Poisons Ordinance Cap 138 (PPO) is a matter of law, not for Mr Chui to express his opinion on;

(b) there is a real issue whether PPO applies as it is questionable whether CIK falls under the definition of ‘manufacture’ (due to the application to individuals which was expressly excluded in the definition); and whether the preparation in the CIK process amounts to ‘pharmaceutical product and medicine’ (as the CIK was not intended for the use in relation to disease, abnormality or organic function in human or animals, but for the purpose of health care);

(c) if CIK does not fall into either definition, then GMP Guidelines have no application;

(d) if there has to be a decision on whether CIK falls into either definition, there will be a complication as to whether this question should be dealt with by the judge or the jury;

(e) in 2012, there was no legal requirement relating to GMP Guidelines in PPO, the law changed in 2015, with GMP Guidelines being introduced for the first time;

(f) the statement of Mr Chui was only served very late on the defendant (in May 2017), it is unfair to the defence to have to deal with this; and

(g) GMP Guidelines have no relevance to the particulars alleged in the indictment.”

48.  Counsel for Prosecution then referred to my ruling that the relevant GMP Guidelines (1995) issued by the Department of Health was of relevance in this case (para 28 of my Decision):

“28. Bearing in mind that the prosecution intends to rely on the GMP Guidelines as a reference against which one can measure the reasonable standard; that the GMP Guidelines represents the reasonable standard at the material time for the preparation and manipulation of cells in terms of safety, and bearing in mind that the prosecution will adduce evidence of the following two documents:

(a) D1’s application dated 28 April 2009 for APSC to be admitted into the Science Park, in particular the following contents ‘.... [t]he new company will be offering peripheral blood stem cell banking to people from around the world. Furthermore, after obtaining GMP licensure (sic) from Hong Kong Health Department and the EU GMP accreditation it will be offering to patients and their doctors autologous culture of peripheral blood stem cells at a cost‑effective price, which is not currently available in Asia’; and

(b) The internal document prepared by Michael Wah (PW14) and D2, reporting to D1 why the laboratory at APSC had not obtained a GMP licence.

I am of the view that the relevant GMP Guidelines issued by the DH is of relevance in this case as both D1 and D2 had demonstrated knowledge of the GMP requirement....”

49.  Counsel for Prosecution submitted that D1 and D2 had unjustifiably challenge the relevance of GMP when they well knew that the spirit and principles under GMP would be one of the maters at the core of the trial.

50.  The Prosecution also submitted the following:

(1) seeing the challenge on the relevance of GMP had failed, D1 served on the Prosecution 7 volumes of defence bundles (including one translation bundle) on 22 June 2017, which contained a large number of documents concerning GMP;

(2) immediately before D1 commenced to give evidence on 6 September 2017, he produced another volume of defence bundle (VII) again containing large number of documents concerning GMP;

(3) throughout the trial, D2 also produced two defence bundles containing various documents concerning GMP.  Therefore it is an undeniable fact that GMP was relevant in the respective defence case, namely the defence of cut‑throat and/or “honest belief” that the APSC was operating up to GMP standard;

(4) despite their unwarranted submission on the application of PPO (Cap 139), the ordinance never had a part to play in the trial in that D1 and D2 claimed that APSC had achieved GMP standard, albeit not yet accredited, without any consideration of the PPO at the time of the incident.

51.  The Prosecution submitted that it is beyond dispute that D1 and D2 had put the Prosecution to proof of undeniable facts in an attempt to mislead the Court and the jury as to the relevance of the GMP Guidelines.  Despite the inevitable recurring theme pertinent to GMP at the trial, D1 and D2 had chosen to contest the application of GMP when the relevance must be known to them.

D1’s response

52.  Counsel for D1 submitted that the issue of GMP was introduced by the Prosecution together with the application of the PPO which was seemingly relied upon by the Prosecution as the basis to introduce the GMP.

53.  The challenge was hence mainly in relation to the 3rd statement of PW75 Mr William Chui which was dated 20 April 2017 and served to the defence shortly before the trial began.

54.  It was clear that in his statement Mr Chui had gone beyond his expertise and commented that CIK procedure falls under the ambit of the PPO.  This Court’s ruling made it clear that Mr Chui was not permitted to define the law or explain what the section was about.

55.  It is important to recall that there was no law or rules governing CIK therapy and therefore any introduction of a certain standard or guidelines as if it was a legal requirement would be misleading to the jury. It was only when this Court enquired with the Prosecution the purpose of adducing GMP evidence then the Prosecution said that its use was limited to it being a reasonable standard at the material times, based on a common sense approach.

56.  The Ruling of this Court had also imposed a limitation to the relevancy of this area of the evidence.

57.  Counsel for D1 submitted that the challenge was necessary and reasonable, and was partly successful, that if the defence had remained silent and had not made the challenge, the PPO would have been introduced before the jury by the Prosecution in an impermissible way, which would have derailed the whole trial.

58.  Counsel for D1 submitted there was never any claim by D1 that he did not know anything about GMP.  D1’s defence was that there was no statutory requirement for GMP in relation to CIK matters, and yet D1 still aimed at achieving it in order to attain a high standard.  The PWs were cross‑examined and the defence evidence were led along this line.

59.  Counsel for D1 submitted that there was no demand for the Prosecution to do more than following the Ruling and it was up to the Prosecution to elaborate the contents of the GMP by way of live evidence or submissions.  The challenge to the GMP and the relevant evidence were all done within proper limits in accordance with the factual defence ran by D1.

D2’s response

60.  Counsel for D2 referred to the fact that counsel for Prosecution stated for the “very first time” during the hearing that the Prosecution would not rely on the provisions of the PPO to introduce the evidence of GMP guidelines, and the fact that this Court ruled that GMP was relevant and admissible on a limited basis, and submitted that the challenge mounted by D2 was not wholly without merit.

61.  Counsel for D2 submitted that it was the failure on the Prosecution’s part to identify the basis on which GMP was relied upon that led to the lengthy written and oral submissions advanced by the defence.

62.  Counsel for D2 also submitted that D2 only produced the volumes of documents in light of this Court’s ruling, and that most of the documents relating to GMP were produced for the purpose of contradicting allegations made by D1 against D2.

My consideration

63.  The challenge by the defence in relation to GMP mainly aimed at the statement of Mr William Chui and the reference to the provisions of the PPO.  It should be noted that before I made my consideration, upon query by this Court, the Prosecution made its stance clear for the very first time. The Prosecution confirmed that it would not rely on the provisions of the PPO to introduce the evidence of the GMP Guidelines; nor was there any allegation of negligence arising out of any alleged breach of the PPO. The Prosecution intended to rely on the GMP Guidelines as a reference against which one can measure the reasonable standard.  Put another way, the GMP Guidelines represents the reasonable standard at the material time for the preparation and manipulation of cells in terms of safety.

64.  I then made the following observation in my consideration before I made my ruling (para 26 and 27 of my Decision):

“26. Whilst I understand that in his work, Mr William Chui would need to have an understanding of the law in relation to pharmaceutical matters, such as the PPO, I do not think there is any dispute that Mr William Chui is not permitted to give his opinion on the legal definitions of ‘manufacture’ and/or ‘pharmaceutical product and medicine’ under PPO.

27. Mr William Chui’s opinion on the GMP Guidelines (dated 20 April 2017) was based, in my view, wholly on his interpretation of the law in relation to the definitions in PPO.  As the prosecution have clearly confirmed that they are not relying on the provisions under PPO, but that they are relying on the available GMP Guidelines at the time in 2012 (ie GMP Guidelines (1995)) as a guide to demonstrate what a reasonable standard should have been, any opinion expressed by Mr William Chui in relation to the definitions and application of PPO is not relevant and inadmissible.”

65.  The Prosecution had not made clear at the beginning on what basis the GMP guidelines were relied upon.  Instead, the statement of Mr William Chui (provided shortly before the trial) was intended to be used by the Prosecution.  That being the case, it cannot be said that the challenge was improperly mounted.  The defence was in fact successful in obtaining a ruling that Mr William Chui was not permitted to give opinion on the law.  With the concession made by the Prosecution during the hearing of the submissions, it then became clear on what basis the Prosecution intended to rely on the GMP guidelines.  As a result of this Court’s ruling on the limited use of these guidelines, D1 and D2 produced documents relating to GMP guidelines in their defence.

66.  In these circumstances, I do not agree that D1 and D2 had unjustifiably challenged the relevance of the GMP.  D1 and D2 will not be ordered to pay the Prosecution’s costs on this ground.