Case Document

100%Judiciary

HCCC 437/2015

[2020] HKCFI 2679

IN THE HIGH COURT OF THE

HONG KONG SPECIAL ADMINISTRATIVE REGION

COURT OF FIRST INSTANCE

CRIMINAL CASE NO 437 OF 2015

________________________

BETWEEN
	HKSAR
and
	MAK Wan-ling	Defendant

________________________

Before:

Hon Barnes J in Court

Date of Hearing and Decision:

15 October 2020

_______________

D E C I S I O N

_______________

The application

1.The prosecution intends to adduce evidence relating to the Good Manufacturing Practices Guidelines for Pharmaceutical Products (GMP Guidelines) against the defendant. The defence objects to its admission.

Prosecution’s stance

2.The prosecution submitted that the central issue in this case is whether the conduct of the defendant can be characterised as grossly negligent. At the core of an objective analysis by the jury will be the reasonableness of the conduct of the defendant in placing the blood product in the bodies of healthy women, in particular, the deceased. One aspect of the issues that the jury has to decide is whether the defendant should have placed products in the bodies of her patients coming from an unaccredited laboratory. The prosecution confirms that it is not their case that the defendant was responsible for the inner works of the laboratory. The prosecution submitted that the jury is entitled to know what standards are expected of laboratories, and in that context, what she should have considered in whether it was reasonable to accept products from that laboratory, particularly when there were no reports of testing on the products.

3.The prosecution accepts that a GMP standard is not an accreditation. However, the prosecution referred to paragraph 1 of the GMP Guidelines and submitted it is inconceivable that a laboratory would become accredited without at least adhering to those standards:

“Licensed pharmaceutical products should be manufactured only by licensed manufactures whose activities are regularly inspected by the Pharmacy and Poison Board. These Good Manufacturing Practices (GMP) guidelines should be used as a standard to justify GMP status which constitutes one of the elements of the WHO Certification Scheme on the Quality of Pharmaceutical Products Moving in International Commerce and as a basis for the inspection and licensing of manufacturing facilities.”

4.As experts will testify as to GMP and its importance, the prosecution is anxious to back that up with documentary material, giving the jury a clear understanding of how these practices are fundamental to their safety and should have been fundamental to the safety of the deceased.

Defence stance

5.The defence submitted that the GMP guidelines have no relevance to the case against the defendant. With reference to the history of what took place during the first trial, including a Ruling I made on 13 June 2017, subsequent statement and evidence of a particular expert witness: Professor William Chui, the defence submitted it was evident from the transcript references that this Court took the view that it was unfortunate that the GMP Guidelines had been introduced, that the value of the GMP guidelines was no more than a written reflection of what is common sense.

6.Further, the defence submitted that the cases against Chow Heung-wing, Stephen (D1) and Chan Kwun-chung (D2) were materially different from the case against the defendant (D3). The case against D3 in this retrial is a failure to ensure that “a properly accredited laboratory was responsible for preparing and producing the said blood product”. GMP is not an accreditation, they are guidelines issued by the Pharmacy and Poisons Board of Hong Kong in respect of pharmaceutical products. They have no application to cell therapy.

My consideration

7.For this re-trial, the particulars of breach alleged against the defendant (D3), after amendment, include the following under (2)(a):

“failing to ensure… a properly accredited laboratory was responsible for preparing and producing the said blood product”.

8.It is common ground that a GMP standard is not an accreditation. At present, there is nothing concrete before this Court to show that by attaining a GMP standard, it is one step closer towards getting an accreditation for the laboratory in question. It is also of importance that the GMP was for “Pharmaceutical Products” and it is questionable whether this GMP applies to cell products.

9.Whilst I appreciate the stance of the prosecution, I am not convinced that the rather voluminous 67-page GMP Guidelines is relevant to the issue of whether a laboratory is an accredited one or not.

10.With reference to the ruling I made in June 2017, it can be seen that I was very much influenced by the fact that both D1 and D2 were well aware of the GMP requirement and I allowed evidence relating to GMP to be given by experts provided their evidence was not based on their interpretation of the Pharmacy and Poisons Ordinance, Cap 138 (PPO). I intentionally left the question of whether GMP Guidelines was relevant and admissible against D3 to be considered at a later stage, which in the end did not materialised.

11.Even with the amendment adding the issue of an “unaccredited laboratory” against the defendant, I cannot see how details of a GMP Guidelines for pharmaceutical products can be relevant to the case against the defendant, particularly when there is no allegation or suggestion that the defendant was responsible for or had knowledge of, the inner running of the laboratory in question.

12.I had indicated during the first trial that much of what was written in the GMP Guidelines amount to common sense. The prosecution submitted that if they are common sense, why can’t the jury be provided with a written version of the common sense. In my view, just because much of what was written amount to common sense does not mean that the GMP Guidelines can automatically be placed in front of the jury. It is not admissible if it is not relevant, no matter how much it makes sense.

13.For these reasons, I rule that the prosecution cannot adduce the 67-page GMP Guidelines into evidence against the defendant.

14.Having regard to the need to avoid a substantial risk of prejudice to the administration of justice in the present on-going trial, it is ordered that the publication (in any form) of any report of the proceeding concerning this application be prohibited until the conclusion of this trial or until further order.