HKSAR v. Chow Heung Wing,Stephen and Others
Read the full judgment text of HCCC 437/2015 on BabelCite. This High Court CFI judgment was delivered on 8 June 2017.
1. Different aspects of the evidence intended to be called by the prosecution were being challenged. I decided to first deal with the broad principles in relation to three areas, ie expertise of experts on Cytokine‑induced killer (CIK) cell infusion therapy, relevance of the Good Manufacturing Practice (GMP) Guidelines and whether this is a case of joint criminal enterprise. I gave my ruling on 8 June 2017 and I indicated at the time that I would give my reasons later. This I now do.
Cites 3 cases
|
HCCC 437/2015 IN THE HIGH COURT OF THE HONG KONG SPECIAL ADMINISTRATIVE REGION COURT OF FIRST INSTANCE CRIMINAL CASE NO 437 OF 2015 ________________________
________________________ Before: Hon Barnes J in Court Date of Hearing: 2, 7 June 2017 Date of Decision: 8 June 2017 Date of Handing Down of the Reasons for Decision: 13 June 2017 ________________________ REASONS FOR DECISION ________________________ 1.Different aspects of the evidence intended to be called by the prosecution were being challenged. I decided to first deal with the broad principles in relation to three areas, ie expertise of experts on Cytokine‑induced killer (CIK) cell infusion therapy, relevance of the Good Manufacturing Practice (GMP) Guidelines and whether this is a case of joint criminal enterprise. I gave my ruling on 8 June 2017 and I indicated at the time that I would give my reasons later. This I now do. Expertise of experts re CIK 2.Of the experts to be called by the prosecution concerning the subject of CIK, D1 challenged the expertise of the following:
3.D2 does not challenge their expertise. 4.D3 challenged all of them save for Dr Raymond Liang (PW72) and Prof Ng Tak‑keung (PW74). 5.The main ground of objection by D1 and D3 in this respect is that whilst these witnesses are experts in their own disciple, they do not have any “hands‑on” experience in carrying out CIK on human beings and their experience are 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 Prof Yuen 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 do not qualify these witnesses to give expert evidence on CIK in this case. 6.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 are therefore not qualified to comment on CIK in this particular usage. 7.Reference was made to the evidence of Prof Yuen during the voir dire and I will not reiterate them here. Suffice it to say that when I came to my decision, I had fully considered the submissions together with the evidence cited. 8.The stance of the prosecution can be shortly stated. No matter what label is given to the CIK – be it for health care or an option for health care, it does not affect the analysis that it is a medical procedure. As such, the law requires and expects certain standards on those people who prepared and administered the cellular substance for infusion. There is also no magic in the label “CIK therapy”, it is a form of cellular therapy that doctors such as Immunologists and Haematologists would be able to understand and comment upon. There is no monopoly for someone who has practised CIK to be considered experts to the exclusion of others who had not actually practised such a procedure. What the science involved is an understanding of the anatomy of the body, how the blood cells work, an understanding of the claimed theoretical basis of CIK therapy, the effect of the extraction of T‑lymphocyte (T‑cell) and to multiply it by way of cytokine inducement, the claimed effect on the human immunity system, and the preparation and steps taken to ensure safety. In order to be an expert to give evidence, the expert does not need to have “hands‑on” experience. 9.All the experts the prosecution intends to call have the relevant expertise to comment on CIK therapy. The law 10.I will state in the outset that parties are ad idem as to the relevant law on this subject, as stated in The Queen v Bonython (1984) 38 SASR 45 (per King CJ at 46):
11.It is clear that in the present case, I only have to consider the 2nd question as there cannot be any serious issue in relation to the 1st question when one is considering CIK therapy in this case. My consideration 12.Having considered the legal principle enunciated in Bonython, and having considered the submissions (with reference to the particular field various witnesses were specialists of, and their Curriculum Vitae (adduced during the Voir Dire of D2)), I agree with the submission of the prosecution that it is not necessary to have any “hands‑on” experience before these witnesses can comment on CIK therapy. I do not accept that simply because CIK was not practised in Hong Kong, no one from Hong Kong is qualified to comment on CIK therapy. I have to decide whether any particular witness has acquired by study or experience sufficient knowledge of the subject to render his opinion of value in resolving the issues before the court. 13.Notwithstanding what the CIK therapy is labelled, I agree with the view of the prosecution that it is essentially a medical procedure, one involving cellular therapy: the drawing of blood from a person, the isolation of lymphocytes for ex vivo culture and manipulation, the harvesting of cultured cells, the purification by washing with Phosphate Buffered Saline (PBS) and the suspension in PBS and Albumin to make it steady for infusion back to the same person. Such a procedure falls within the remit of Immunology and Haematology. I am satisfied that those specialists who specialised in Haematology, Immunology, stem cell biology/transplantation, and bone marrow transplantation are qualified to give expert opinion on CIK. These witnesses are:
14.I would add here that although Dr Albert Lie (PW78) used expression such as “as far as I know” and “to the best of my knowledge”, such expressions does not mean he cannot give expert opinion on CIK therapy. 15.Whilst Prof Yuen Kwok Yung (PW69) is neither a Haematologist or Immunologist, he is an eminent Microbiologist whose work also involves the fields of Immunology and Haematology. Bearing in mind his expertise in Microbiology, the overlapping of this field with Haematology and Immunology, and his experience in ex vivo T‑cell expansion in animals (though not humans), I am satisfied that he is qualified to give expert evidence on CIK therapy, even though his involvement initially was to assist the authorities in locating the source of contamination. 16.I am also satisfied that Prof Ng Tak‑keung (PW74), a Consultant Microbiologist is qualified to give expert opinion on CIK. It should be noted that although Prof Ng said in his opinion “the indication of applying this potentially high risk procedure for purely cosmetic reasons is not justified from [his] point of view”, bearing in mind that the procedure took place under the umbrella of a beauty centre, I do not find that Prof Ng’s opinion was formed on a wrong basis, as submitted by counsel for D1. It is clear from the context that Prof Ng is referring to the application of this high risk procedure for non‑medical purpose. 17.That leaves me with the objection in relation to Mr William Chui (PW75). I will deal with his evidence in greater detail under the heading of GMP Guidelines. Bearing in mind his background and expertise (as a pharmacist and pharmacologist), I am of the view that he also possesses the relevant expertise to give opinion evidence on the set‑up of the Asia Pacific Stem Cell Science Limited (APSC) laboratory in relation to CIK procedure. GMP Guidelines 18.Prof Ng Tak‑keung (PW74), Mr William Chui (PW75), Prof Godfrey Chan (PW79) and Dr Raymond Liang (PW72) have all made reference to the GMP Guidelines, with Mr William Chui having given the most detailed opinion thereon (in a statement dated 20 April 2017.) 19.All three defendants challenged the admissibility of evidence relating to the GMP Guidelines. 20.All counsel questioned the relevance of the GMP Guidelines in this case. I combine all the objections here as some of them overlapped:
21.The stance of the prosecution was that it matters not whether the CIK procedure falls under the definition of “manufacture” or “pharmaceutical product and medicine” of PPO, adding that under the definition of the latter, the reference to “symptoms thereof” could be interpreted to cover CIK. 22.Mr Leung submitted that the case against all defendants was one of Gross Negligence Manslaughter (GNM). The prosecution needs to prove breach of duty. CIK involved cellular product or stem cells, anyone engaged in the preparation or production has to reach a particular standard. The GMP (1995) issued by Department of Health (DH) was in place in 2012. Whilst it was not a piece of subsidiary legislation, it was introduced to coincide with the licensing condition (as stipulated in the prescribed form for manufacturer’s licence under PPO (pointing to the now repealed Form 3 and Form 4). GMP (1995) was a reference against which one can measure whether the defendants’ conducts were up to the required standard. 23.Counsel for the prosecution also submitted that defence was not taken by surprise as references to GMP Guidelines were already made by various witnesses in their statements (in the committal bundle). Mr William Chui did no more than making explanations with reference to GMP documents itself to assist the jury. 24.Further, D1 in his application dated 28 April 2009 to have APSC admitted into the Science Park had made reference to the GMP Guidelines. In another document (PP268) prepared by Michael Wah (PW14) and D2 on 12 November 2012, the two reported to D1 why the laboratory at APSC had not obtained a GMP certificate. These two documents show that both D1 and D2 were aware of the GMP requirement. The lateness in serving Mr William Chui’s statement posed no prejudice. 25.Upon query raised by this Court, Mr Leung confirmed that the prosecution will 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 PPO. The prosecution intends to rely on the GMP Guidelines as a reference against which one can measure the reasonable standard, or 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. My consideration 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. 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:
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. (I note here that although the EU GMP was mentioned, I have not seen any evidence of such GMP Guidelines and I am not called up to rule on that.) 29.For these reasons, provided the evidence of the GMP Guidelines to be given by the experts falls under this limited fashion, and not based on their interpretation of the PPO, their evidence is relevant and admissible. 30.Although I have ruled Mr William Chui cannot refer to his latest statement in relation to GMP Guidelines, I bore in mind that Mr William Chui had given his opinion on the set‑up of the laboratory at APSC in his second statement (dated 29 July 2014). Should Mr William Chui refer to the GMP Guidelines, I would allow his evidence so long as he does not refer to the PPO. 31.As I have indicated, I am dealing with the broad principles in relation to the admissibility of evidence at this stage. Whether GMP Guidelines is relevant and admissible against D3, particularly in relation to the particulars of the allegation of alleged breach of duty against her; whether the US Pharmacology is relevant and admissible; whether the evidence of ASPC not being GMP compliant or not being accredited by the Hong Kong Accreditation Service (HKAS) are relevant and admissible, I will consider all these at a later stage. Joint Criminal Enterprise 32.The prosecution submitted that this case is one of joint criminal enterprise so that acts and declarations done by any defendant in furtherance of the joint enterprise is admissible against the other defendants, accepting that the verbal statement, demonstration and witness statements given by D2 do not amount to acts or declarations in furtherance of a joint enterprise. 33.The prosecution referred to the indictment (in particular the wording “together with [other defendants]” and the particulars in para “(ii)” and submitted that the three defendants are jointly charged with the offence of GNM. The three defendants are joint tortfeasors under civil law which co‑exists with joint enterprise under criminal law. The ordinary principles of the law of negligence apply here to ascertain the duty, breach and causation, and upon all these being proved, the jury must then go on to consider whether the breach should be characterised as gross and therefore a crime (citing R v Adomako [1995] 1 AC 171). 34.In this case, the prosecution says D1 launched a scheme whereby CIK was marketed and sold to customers of the “DR group”. D1 engaged D2 to make the cellular preparation at APSC and D3 to infuse the same into the relevant customer. From the perspective of civil law, where negligence is proved, each of D1 to D3 is jointly and severally liable as joint tortfeasors. D1 to D3 were part of a joint enterprise in that they all participated in a scheme entailing the marketing, preparation, and administration of CIK to patients (including the deceased). 35.The prosecution relied on the CFA case of HKSAR v Chan Kam Shing (2016) 19 HKCFAR 640 and submitted that “liability is independently based on each defendant’s participation in a joint criminal enterprise with the requisite mental state to constitute the offence relevance to the defendant in question”, which is applicable to the defendants in this case. 36.The prosecution relied on various cases, including the case of Sze Kwan Lung v HKSAR (2004) 7 HKCFAR 475 and submitted that defendants can be jointly charged with an offence of GNM. 37.The prosecution also relied on the “building‑block” concept in the case of R v Hayter (Paul Ali) [2005] 1 WLR 605, to support their submission that while D2’s verbal statement, demonstration and witness statements are not admissible against the other two defendants, the jury can be directed to use the fact of D2’s breach, if they so find at the end of the day, as evidence against the other two defendants. 38.Needless to say, counsel for D1 and D3 strongly objected to this approach of the prosecution. Without being disrespectful to counsel, I do not think it necessary to reiterate all the arguments here. I do not think it useful to consider the mens rea in GNM in a joint enterprise scenario as submitted by counsel for D1 (noting that I will have to deal with the mens rea in GNM generally at a later stage). Nor do I think it useful to consider the concept of “aggregation” here. Suffice it to say that I am not impressed with the submission of the prosecution that this is a case of joint criminal enterprise. 39.Whilst accepting that in deciding whether there was any negligence, the ordinary principles of the law of negligence applies, that does not mean that joint tortfeasors under civil law co‑exists with joint enterprise under criminal law. This is a rather bold statement and I find no support from any of the cases cited by the prosecution. 40.I am of the view that the observation of Bokhary PJ in Sze Kwan Lung (at para 39) relied on by the prosecution: “just because the prosecution did not seek to put forward a case of manslaughter by gross negligence at the original trial, it does not mean that they are precluded from doing so at the retrial” does not assist me in my task. 41.The main problem faced by the prosecution in their contention or submission that this case involves a joint criminal enterprise is the word “criminal” in joint criminal enterprise. 42.When one looks at the indictment, each defendant faces one count of GNM. They are not jointly charged under one count. Whilst it is true that in each count, the allegation is that a particular defendant, together with the other two defendants, unlawfully killed the deceased by gross negligence, these three counts do not allege or demonstrate any joint criminal enterprise. The words “together with” in the three counts serve to allege that the three defendants are joint tortfeasors (jointly and severally liable), but such an expression does not mean or demonstrate that they are members of a joint criminal enterprise. 43.The prosecution referred to the indictment and read out the alleged duty of each defendant, which are quite different. Then they referred to the wordings under particular “(ii)” against all defendants, which reads:
and submitted that the indictment demonstrates that there was a joint criminal enterprise. 44.With respect, I do not agree. It is a fact that the knowledge alleged is not a criminal offence. The prosecution is not alleging that having such a common knowledge is a criminal offence. The allegation against each defendant is that, with the knowledge alleged, they are in breach of their respective duty of care, with both the duty of care and the particulars of the breach being quite different against each defendant. 45.Contrary to the submission of the prosecution, the indictment does not demonstrate a case of joint criminal enterprise. 46.Further, I cannot see how, in the particular circumstances of this case, these three defendants can be said to have embarked on a joint criminal enterprise to be grossly negligent. 47.That being the case, the principle that acts and declarations made by a defendant in furtherance of a joint criminal enterprise being admissible against all other defendants have no application here. 48.As to the prosecution’s submission that the “building‑block” concept propounded in the unusual case of Hayter is applicable here, I have the following observations to make at this stage. 49.Firstly, the facts of that case was very unusual. Three defendants (R, H and B) were jointly charged with the murder of C. There was independent evidence against B, the wife, who had expressed her wishes to have her husband C killed. There was evidence of association between B and H (the middleman) and between H and R (the killer). The Crown conceded that the circumstantial evidence against H did not provide a case to answer unless it could be proved that R was the killer. The case against R was dependent on his alleged confession to his girlfriend. In response to a no case to answer submission, the trial judge ruled that if the jury were satisfied on evidence admissible against R that he was the killer, that conclusion was relevant in considering the case against H. In his summing up the judge directed the jury, in effect, that if they found R guilty they could use the fact of R’s guilt in their consideration of the cases of B and H, but they could not allow any of the evidence of the confession itself to play a part. H was found guilty and he failed in his appeal in the CA and the House of Lords. 50.It can readily be seen that the factual matrix of Hayter is very different from the case before me. 51.Secondly, the three defendants (B, H and R) in Hayter were jointly charged with murder, they had clearly embarked on a joint criminal enterprise. The case against the three defendants before me is not one of joint criminal enterprise. 52.Should the prosecution wish to rely on the “building‑block” concept in the absence of any joint criminal enterprise, I will deal with the submission if and when it arises.
Mr Raymond Leung SC, leading Mr John Marray, and Mr Eric Tsoi, counsel on fiat and Ms Margaret Lau SPP of Department of Justice, for HKSAR Mr Wong Man Kit SC, leading Mr Charles J. Chan, instructed by Messrs Day & Chan, for the 1st defendant Mr Albert Cheung, instructed by Messrs Lam, Lee & Lai, for the 2nd defendant Mr Peter Duncan SC, leading Ms Deanna Law, instructed by Howse Williams Bowers, for the 3rd defendant | ||||||||||||||||||||||
Cases cited in this judgment
Further hearings and rulings under HCCC 437/2015