LCQ7: Drugs for treating Coronavirus Disease 2019
It is learnt that, regarding the drugs for treating Coronavirus Disease 2019, the Hospital Authority (HA) at present uses only two oral drugs from pharmaceutical companies in the United States (US), namely Molnupiravir and Paxlovid. However, HA has not introduced the combination therapy drugs of Amubarvimab and Romlusevimab injection fluids as well as Azvudine oral drug which are from the Mainland and are new drugs approved for commercial launch by the National Medical Products Administration and approved by the National Health Commission for inclusion in the "Diagnosis and Treatment Protocols for Novel Coronavirus Pneumonia". In this connection, will the Government inform this Council:
(1) as it has been reported that Amubarvimab and Romlusevimab were approved for clinical trials in Hong Kong at the end of 2021, whether it knows such drugs' clinical trial results in Hong Kong and clinical data from Mainland hospitals, as well as the progress of application for their commercial launch in Hong Kong; if so, of the details; if not, the reasons for that, and whether it will obtain such data from the pharmaceutical company concerned and the Mainland authorities;
(2) as it has been reported that the price of Azvudine is much lower than the prices of the aforesaid two drugs from US pharmaceutical companies and that this drug has been extensively used on the Mainland, whether it knows the drug's clinical trial results and clinical data from Mainland hospitals; if so, of the details; if not, whether it will obtain such data from the pharmaceutical company concerned and the Mainland authorities, as well as introduce Azvudine;
(3) as it has been reported that Paxlovid outperforms Molnupiravir in terms of reducing risks of hospitalisation and death as well as viral load, whether it knows if HA has procured a larger quantity of the former than that of the latter; if HA has, of the difference in the quantities of these two drugs procured; if not, the reasons for that;
(4) whether it knows, in respect of the aforesaid two drugs from US pharmaceutical companies, their respective (i) quantities prescribed and numbers of patients prescribed with the drugs, (ii) expiry dates and quantities of the three batches due to expire, (iii) quantities of expired batches and means of disposal, and (iv) numbers of confirmed patients who experienced greater side effects after taking the drugs and the symptoms concerned; whether it has compiled statistics on the number of confirmed patients who were reluctant to take the two drugs and their reasons for that;
(5) as a study has found that the two drugs from US pharmaceutical companies are effective in preventing severe cases and reducing risks of death, whether it knows if HA will further relax its clinical guidelines on prescriptions of the two drugs, including lowering the relevant age restrictions and covering more high-risk patients; if HA will, of the details; if not, the reasons for that; and
(6) as it has been reported that some Mainland residents recently purchased Paxlovid through purchase agency channels in Hong Kong, and it is suspected that the process involved making profits by reselling this drug which is from the Government for free prescriptions, whether the Government has investigated if illegal acts were involved in the incident; if it has investigated and the outcome is in the affirmative, of the penalties which may be imposed on the offenders, and the measures in place to combat such acts; if it has not investigated, the reasons for that?
In consultation with the Hospital Authority (HA), the reply to the various parts of the question raised by the Hon Yang Wing-kit is as follows:
(1) and (2) According to the Pharmacy and Poisons Ordinance (Cap. 138) (the Ordinance), Certificate for Clinical Trial must be obtained from the Pharmacy and Poisons Board of Hong Kong (the Board) for conducting a clinical trial on pharmaceutical products on human beings in Hong Kong.
According to record, the Board issued one Certificate for Clinical Trial which involved BRII-196 (amubarvimab) and BRII-198 (romlusevimab) as trial drugs conducted in Queen Mary Hospital since 2020.
According to the Ordinance, pharmaceutical products must satisfy the criteria of safety, efficacy and quality for registration with the Board before they can be sold or supplied in Hong Kong. Applicants for registration of pharmaceutical products are required to submit the relevant documents to the Board in accordance with the Guidance Notes on Registration of Pharmaceutical Products/Substances as promulgated by the Board to support the safety, efficacy and quality of the pharmaceutical products. After the applicant has submitted the application with the required documents, the Board will vet and approve the registration application of pharmaceutical products according to the established procedures and requirements. However, the Ordinance allows the import of unregistered pharmaceutical product to be possessed or used for the purpose of treatment of a particular patient by a registered medical practitioner or conduct clinical trials.
As at January 8, 2023, the Board has not received application of registration of pharmaceutical product containing amubarvimab / romlusevimab nor application of registration of pharmaceutical product or Certificate for Clinical Trial of azvudine.
Regarding the treatment of COVID-19, the HA will continue to maintain close communication with the Mainland and overseas experts to understand the research and development of drugs treatment for COVID-19 worldwide. The HA will also continue to make reference to data and expert opinions in assessing and deciding whether to introduce other COVID-19 drugs, including amubarvimab / romlusevimab and azvudine. In addition, to cater for the patient's needs, the HA has been keeping in view the latest information from drug regulatory authorities and drug manufacturers, and has purchased and stockpiled appropriate medications, including COVID-19 oral drugs, according to the established mechanisms to ensure that patients are prescribed safe, efficacious and cost-effective drugs.
(3) Since the outbreak of the epidemic, the Government has been in close communication with the HA, keeping abreast of the changes in the epidemic situation, latest development of clinical treatment and evidence-based research, as well as making reference to the evolving data from drug regulatory authorities and drug manufacturers around the world (including the Mainland) so as to provide appropriate treatment for patients infected with COVID-19.
The HA aims to ensure that drugs of proven safety and efficacy can be prescribed for patients infected with COVID-19 based on prevailing scientific evidence. Experts from the HA closely monitor the efficacy and possible side effects of relevant drugs based on the evolving medical evidence. They will also make reference to the latest clinical development and research data in the Mainland and overseas to evaluate various drugs for treatment of COVID-19, so as to update treatment guidelines in a timely manner. The HA also procures appropriate quantities of the two drugs, namely Molnupiravir and Paxlovid.
The HA will continue to closely monitor the supply and utilisation of the relevant drugs, and stockpile suitable drugs in order to cater for the needs of patients. The HA will also maintain close communication with experts from the Mainland and overseas to understand the research and development of drugs treatment for COVID-19 worldwide.
(4) The HA is currently prescribing two COVID-19 oral drugs (Molnupiravir and Paxlovid) for suitable patients through various facilities including public hospitals, designated clinics, residential care homes for the elderly, holding centres, community isolation facilities and telemedicine service, etc. The HA also provides the relevant drugs to private hospitals and private doctors. As at January 2, 2023, more than 292 000 patients have been prescribed the two COVID-19 oral drugs, including more than 100 000 persons prescribed with Molnupiravir and more than 192 000 persons prescribed with Paxlovid. Overall, the HA has sufficient stock of drugs for prescription to COVID-19 patients, and the stock of the two oral drugs have yet to reach expiry date. The HA does not maintain the relevant statistics on the number of confirmed cases who refused to take COVID-19 oral drugs, or with adverse side effects after using the oral drugs.
(5) Regarding clinical guidelines, under the current practice, COVID-19 patients aged 60 or above, high-risk persons as well as persons with chronic illnesses under the age of 60 will be prescribed COVID-19 oral drugs according to their clinical conditions. The HA has been closely monitoring the latest development of epidemic situation, and will timely review the clinical guidelines for prescribing COVID-19 oral drugs so as to cover more suitable patients as well as reduce the risk of severe complications and death of patients.
(6) Currently, the COVID-19 oral drug (Paxlovid), which is supplied in Hong Kong by drug manufacturer, namely Pfizer Corporation Hong Kong Limited, has been registered as pharmaceutical product in Hong Kong by the Board in accordance with the Ordinance for COVID-19 treatment. According to the registration condition imposed by the Board, that COVID-19 oral drug belongs to Part 1 Third Schedule poisons under the Ordinance, i.e. prescription drug and could only be supplied to healthcare institutions and doctors in public and private sectors. Patients could only be prescribed the relevant drug by registered medical practitioners when needed, and drug retail outlets cannot procure the relevant oral drugs from suppliers nor sell them to the public.
According to the Ordinance, illegal sale or possession of unregistered pharmaceutical products or sale of Part 1 Third Schedule poisons, i.e., prescription drug, without a doctor's prescription, are criminal offences. The maximum penalty for each offence is a fine of $100,000 and two years' imprisonment.
The Department of Health (DH) has a mechanism in place to monitor the sale of pharmaceutical products in the market, and will collect intelligence through various channels. In light of the relevant media reports, the DH has proactively looked into the situation and stepped up relevant regulatory measures and inspections. The DH will conduct joint operations with other law enforcement agencies where necessary.
The HA also appeals to patients that if they are prescribed COVID-19 oral drugs after the consultation, they should take the relevant medications according to the doctor's instructions and complete the entire course of treatment. They should not give or sell the relevant medications to others.
Ends/Wednesday, January 11, 2023
Issued at HKT 16:00
Issued at HKT 16:00