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最遙遠的距離 — 與藥劑師談新冠病毒疫苗

2020/12/20 — 13:11

Erga Omnes: Our Safest Distance with the Vaccine for COVID-19

【文:藍惠彥、王曼懿】

這一刻,我們是 2020 年的倖存者。

相信我的讀者也知道,我很珍惜的醫生朋友他和她 — 每天都冒著生命危險,在這場疫症中去努力救人。然而,藥劑師她的醫生朋友也是。那麼,在他們保護我們的時候,在我們的位置,我們可以如何好好保護他們。有天,實為法律博士的藥劑師和我為此進行學術討論;剛好今天,我們與大家談談新冠病毒疫苗與法律重視的公眾利益。目前為止,香港還沒有在醫學上的產品責任。鑒於我們在修讀法律時也會參考英國的案例,整理一下,我們可在此了解英國的法律 — The Human Medicines (Coronavirus and Influenza) (Amendment) Regulations 2020 (S.I 2020/1125) 及The Human Medicines Regulations 2012 (S.I 2012/1916),一同探討和提出建議,平衡必切性與社會的需要。

以我們對自身專業的熱誠作為前提下,除了要基於公眾利益考慮,當局需要將責任涵蓋和所牽涉的範圍適當地予以釐清闡明。同時,我們亦相信隨着新冠病毒疫苗的開發,大眾市民應了解其作用及原理。有見及此,我們也和大家分享世界衛生組織(中文[1]英文 [4])作的介紹。

介紹一下藥劑師:

藍惠彥Venus W.Y. LAM),現攻讀法學專業證書,香港中文大學法律博士,英國愛丁堡大學醫學法律碩士,香港及英國註冊藥劑師,倫敦大學學院藥劑學碩士。

廣告

詳盡的英文版本如下:

Erga Omnes: Our Safest Distance with the Vaccine for COVID-19 -- Discussion on Product Liability from the Perspectives of Public Interest

廣告

Venus W.Y. LAM and Vanessa M.Y. WONG
Venus W.Y. LAM. PCLL Candidate, Juris Doctor (CUHK), LLM Medical Law & Ethics (Edin), Registered Pharmacist (Hong Kong, United Kingdom), MPharm (UCL).
Vanessa M.Y. WONG. Juris Doctor Candidate (CUHK), MA Comparative Literature (HKU).

Introduction

We are told to keep our safe distance. In the outbreak of the Coronavirus, even a droplet is risky. As such, we are thankful for the availability of the vaccines. However, out of the political hot potato, our starting point here is of public interest.

What is the safest distance of our position with the vaccine for Coronavirus? In this article, we address the medicolegal issues as well as the balance of interests with potential solutions.

The Hong Kong Government has recently announced the supply of three vaccines. The vaccines must first be licensed in Hong Kong. Depending on the further evidence of safety and efficacy, the order will be placed.

It comes to the attention addressed on the vaccine hesitancy. Instead of the medical questions, this vaccine hesitancy implicitly attributes to the lack of trust. Taking Sinovac Biotech vaccine as an example, the lack of Phase 3 data caused the problem of trust. Although one might argue that the candidate vaccine is under the approval by the World Health Organisation (WHO), the problem presented here is the unclear clarification of safety and efficacy for the reliance of trust. Therefore, liability of the manufacturer, supplier and vaccinator is a key factor in building that trust.

No Specific Law in Medical Product liability in Hong Kong

At this moment, there is no specific regime of law with limited legislation governing medical product liability and consumer protection in Hong Kong. Basically, the legal basis for bringing a product liability claim arises from the law of contract, tort and breach of statutory duty.

Claims can only arise by tort of negligence with elements established in law. More specifically, Parties involved in the manufacturing and distribution of defective pharmaceutical products and medical devices are responsible for the safety, quality and efficacy of their products. This includes the product registration holder, manufacturer, importer and supplier of the product. As such, they may potentially be liable for the defects in these products.

Situations in the United Kingdom

The Human Medicines (Coronavirus and Influenza) (Amendment) Regulations 2020 (S.I 2020/1125) in the United Kingdom was amended in October 2020 for the preparation of vaccine to “cover temporary authorisations for vaccines, civil liability and immunity for participants in vaccination programmes, expansion of the healthcare workforce who can administer vaccines, promotion of vaccines and an exemption to wholesale licensing requirement.”[2]

Meanwhile, the UK Government has imposed further changes to the current Human Medicines Regulations 2012 (S.I 2012/1916) to support the rollout of the vaccine. In particular, the objective bystander test and an additional level of reassurance have been amended.

In balancing the accountability over negligence in safety and testing of pharmaceutical companies, and the liability for specific consequences from the emergency authorisation of the supply of the vaccine adhering the UK Government's conditions, the ‘objective bystanders’ test is now based on those with “relevant expertise in the subject matter of the breach”. It means that the extended immunity will be forfeited if there are any sufficiently serious breaches of the conditions set by the authority. It is to ensure only those who are “wholly or partly responsible” for a breach lose their immunity, rather than every personnel in the supply chain. [3]

Situations and Suggestions in Hong Kong

Based on our observation of the law and situations in the United Kingdom, it is possible to use policy to minimise the risk in the course of vaccination rather than the vaccine itself. Perhaps, this is a good time to raise a question: What is the liability of every person or entity involved in the vaccination scheme in Hong Kong? Will there be any waiver as it is an emergency rollout though it satisfies the efficacy and safety requirements of the Government? The general tort of negligence relying on case law and previous judicial decisions may not be sufficient to cover the specific technicality of a novel vaccine. Without an explicit legal and policy discussion, the amount of uncertainty clouds the trust among all parties.

Despite the confusion over the HK Government’s legal stance,  additional policy can be an interim measure to minimise the underlying risk in the course of vaccination. The UK has created an additional level of reassurance in relation to the expanded workforce by requiring the supervision of an additional experienced vaccinator, as they employ registered health care professionals who do not normally vaccinate to be trained for the administration of vaccination. 

The additional recruitment of registered healthcare professionals for vaccination is similar to the recruitment for the Universal Community Testing in September. With previous experience, the HK Government may be able to coordinate and provide adequate training even more swiftly to enable efficient, mass vaccination, once the vaccine, adequate storage and administering facilities are available.

Making our suggestions for the public interest and given the vaccination heavily relies on trust, the scope of liability of the personnel involved in the vaccination scheme, as aforementioned, shall be clarified. Also, if any unfortunate event happens, how the compensation will be made comes to be the crux of the concern for the COVID-19 vaccine.

Another key takeaway here is that the UK Government proactively seeks concerns and opinions from various stakeholders prior to the rollout of new law accommodating the introduction of COVID-19 vaccine. The consultation papers reflect how the general public, frontline healthcare professionals, suppliers and manufacturers weigh their interests in the promotion and liability of the vaccination programme. Government can then coordinate and offer the measures to best balance their interests and attempt to build trust among all. 

Due to the time constraint, setting up a committee or a department of various stakeholders and representatives may be the best reactive measure in the attempt of offering a balanced view.

As said, it might also be a good time to review the sufficiency of the product liability law in Hong Kong. It is also worthy to mention that the general public should be educated with the vaccine of COVID-19, in which we begin by sharing an educational video here [4] for everyone to understand the vaccine.

 

References:
[1] 世界衛生組織,疫苗如何发挥作用?
[2] Practical Law Life Science, COVID-19: Human Medicine Regulations amended to support vaccine rollout,Thomson Reuters. (online version) 
[3] Government response: consultation on changes to the Human Medicines Regulations to support the rollout of COVID-19 and flu vaccines,GOV.UK. (online version) 
[4] World Health Organisation, How do vaccines work?

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