Skip to Content Facebook Feature Image

Hong Kong Secures Continued Access to Global Adverse Drug Event System VigiLyze for Enhanced Pharmacovigilance

HK

Hong Kong Secures Continued Access to Global Adverse Drug Event System VigiLyze for Enhanced Pharmacovigilance
HK

HK

Hong Kong Secures Continued Access to Global Adverse Drug Event System VigiLyze for Enhanced Pharmacovigilance

2024-09-13 14:30 Last Updated At:09-15 00:08

DH and Center for Drug Reevaluation of National Medical Products Administration sign Agreement on Authorizing the Department of Health of the Hong Kong Special Administrative Region to Use VigiLyze - the Uppsala Monitoring Centre Adverse Drug Event Information System

The Department of Health (DH) and the Center for Drug Reevaluation (CDR) of the National Medical Products Administration (NMPA) today (September 13) signed the Agreement on Authorizing the Department of Health of the Hong Kong Special Administrative Region to Use VigiLyze – the Uppsala Monitoring Centre Adverse Drug Event Information System (Agreement). The Agreement authorises the DH to continue making use of the Uppsala Monitoring Centre (UMC) adverse drug event information system, VigiLyze. The Hong Kong Special Administrative Region (HKSAR) Government expresses gratitude to the NMPA for their trust and support to the HKSAR Government in the area of pharmacovigilance activities, which have played a positive role in developing Hong Kong into an international health and medical innovation hub.

Developed and maintained by the UMC for the World Health Organization (WHO) Programme for International Drug Monitoring (PIDM), VigiLyze is a global signal detection and signal management tool for adverse events of medicinal products. It is a web-based platform accessible to national pharmacovigilance centresof member countries of the WHO PIDM. Through its close integration with the WHO global database of adverse event reports for medicines and vaccines, VigiLyze provides member countrieswith global data on adverse events on medicines and vaccines, and access to related investigations. Being a member country of the WHO PIDM enables China to utilise this platform and enhance the national pharmacovigilance system. As a part of China, Hong Kong needs to obtain authorisation from relevant national units in order to use the platform.

The DH signed the Agreement with the NMPA for the first time in 2020. This Agreement played a significant role in the safety monitoring of COVID-19 vaccines during the COVID-19 pandemic. In response to the COVID-19 outbreak, two COVID-19 vaccines were authorised for emergency use in Hong Kong in 2021. The DH has put in place a pharmacovigilance system for COVID-19 vaccination, to detect potential signals of possible side effects of the vaccines. The DH has also established the Expert Committee on Clinical Events Assessment Following COVID-19 Immunisation (Expert Committee) to provide independent assessment on potential causal link between adverse events following immunisation (AEFIs) and COVID-19 vaccines used in Hong Kong and to provide expert advice to the Government on safety-related matters. The signing of the Agreement has allowed the DH to use VigiLyze's global adverse drug event data of COVID-19 vaccines to provide the Expert Committee with a reference to assist their causality assessment of AEFIs for COVID-19 vaccines, and also assisted the Expert Committee in identifying potential signs of possible side effects of the vaccines.

The signing of a new Agreement between the NMPA and the DH allows the DH to continue using VigiLyze, which fully demonstrates the country’s recognition of the HKSAR. The DH expresses gratitude to the NMPA for the continuous trust and support to the HKSAR Government in the area of pharmacovigilance activities. The DH hopes to continue collaborating closely with the NMPA and the CDR to ensure all pharmaceutical products used in Hong Kong meet the criteria of safety, quality and efficacy, to effectively safeguard public health.

At the same time, since putting forward in the Chief Executive's 2023 Policy Address the vision of developing Hong Kong into an international health and medical innovation hub, the HKSAR Government has been pushing ahead with multiple initiatives on all fronts to strengthen the HKSAR's capacity of drug evaluation for progressing towards a primary evaluation approach, and has achieved results, including the establishment of the Preparatory Office for the Hong Kong Centre for Medical Products Regulation (CMPR) under the DH on June 5, 2024, to put forward proposals and steps for the formal establishment of the CMPR, and to study the potential restructuring and strengthening of the regulatory and approval regimes for drugs and medical devices. The HKSAR Government will continue to strengthen policies and measures for the regulation of drugs and medical devices, and to build the capacity, recognition and status at different stages to ensure that the eventual approval mechanism of medical products in Hong Kong would be widely recognised internationally and by the Mainland, and develop Hong Kong into an international health and medical innovation hub, striving towards high-quality development.

Source: AI-generated images

Source: AI-generated images

Two foreign domestic helpers jailed for performing illegal work

One foreign domestic helper and one overstaying former foreign domestic helper were jailed by the Shatin Magistrates' Courts today (November 8) for performing illegal work.

During an anti-illegal worker operation conducted on November 6, Immigration Department (ImmD) officers from the Foreign Domestic Helpers Special Investigation Section raided multiple target locations including restaurants and grocery shops in the Islands District. Two Filipino males and one Filipino female, aged between 45 to 63, of which two were found to be current foreign domestic helpers while one of them was found to be a former foreign domestic helper who has overstayed in Hong Kong, were arrested while working as movers of food ingredients and as a dish-washing worker. Three employers suspected of employing the three illegal workers were also arrested.

Two of the arrested illegal workers were charged at the Shatin Magistrates' Courts today with breaching their condition of stay, and taking employment while being a person who, having been given permission to land in Hong Kong, had remained in Hong Kong in breach of their limit of stay imposed in relation to the permission and overstaying in Hong Kong respectively. Both of them pleaded guilty to all charges and were sentenced to a total of 14 months' imprisonment and six weeks' imprisonment respectively. The investigation against the remaining arrestees is ongoing, and more persons involved in the case may be arrested.

"A helper should only perform domestic duties for the employer specified in the contract. The helper should not take up any other employment, including part-time domestic duties, with any other person. The employer should not require or allow the helper to carry out any work for any other person," an ImmD spokesman said.

The spokesman also said, "Any person who contravenes a condition of stay in force in respect of him/her shall be guilty of an offence. Also, visitors are not allowed to take employment in Hong Kong, whether paid or unpaid, without the permission of the Director of Immigration. Offenders are liable to prosecution and upon conviction face a maximum fine of $50,000 and up to two years' imprisonment. Aiders and abettors are also liable to prosecution and penalties."

The spokesman warned, "As stipulated in section 38AA of the Immigration Ordinance, an illegal immigrant, a person who is the subject of a removal order or a deportation order, an overstayer or a person who was refused permission to land is prohibited from taking any employment, whether paid or unpaid, or establishing or joining in any business. Offenders are liable upon conviction to a maximum fine of $50,000 and up to three years' imprisonment."

The spokesman reiterated that it is a serious offence to employ people who are not lawfully employable. Under the Immigration Ordinance, the maximum penalty for an employer employing a person who is not lawfully employable, i.e. an illegal immigrant, a person who is the subject of a removal order or a deportation order, an overstayer or a person who was refused permission to land, has been significantly increased from a fine of $350,000 and three years' imprisonment to a fine of $500,000 and 10 years' imprisonment to reflect the gravity of such offences. The director, manager, secretary, partner, etc, of the company concerned may also bear criminal liability. The High Court has laid down sentencing guidelines that the employer of an illegal worker should be given an immediate custodial sentence.

According to the court sentencing, employers must take all practicable steps to determine whether a person is lawfully employable prior to employment. Apart from inspecting a prospective employee's identity card, the employer has the explicit duty to make enquiries regarding the person and ensure that the answers would not cast any reasonable doubt concerning the lawful employability of the person. The court will not accept failure to do so as a defence in proceedings. It is also an offence if an employer fails to inspect the job seeker's valid travel document if the job seeker does not have a Hong Kong permanent identity card. Offenders are liable upon conviction to a maximum fine of $150,000 and to imprisonment for one year. In that connection, the spokesman would like to remind all employers not to defy the law by employing illegal workers. The ImmD will continue to take resolute enforcement action to combat such offences.

Under the existing mechanism, the ImmD will, as a standard procedure, conduct an initial screening of vulnerable persons, including illegal workers, illegal immigrants, sex workers and foreign domestic helpers who are arrested during any operation with a view to ascertaining whether they are trafficking in persons (TIP) victims. When any TIP indicator is revealed in the initial screening, the ImmD officers will conduct a full debriefing and identification by using a standardised checklist to ascertain the presence of TIP elements, such as threats and coercion in the recruitment phase and the nature of exploitation. Identified TIP victims will be provided with various forms of support and assistance, including urgent intervention, medical services, counselling, shelter or temporary accommodation and other supporting services. The ImmD calls on TIP victims to report crimes to the relevant departments immediately.

Recommended Articles