Replies to LegCo questions
LCQ1: Use of registered pharmaceutical products
Following is a question by the Hon Andrew Cheng and an oral reply by the Secretary for Health, Welfare and Food, Dr York Chow, in the Legislative Council today (February 8):
Question:
In early December last year, some private clinics and medical centres operating
as a conglomerate were found to have administered vaccines not registered in
Hong Kong on people. In this connection, will the Government inform this
Council:
(a) whether the Department of Health (DH) has tracked down all the clinics and
medical centres which acquired such vaccines and contacted all those who have
been injected with such vaccines, and whether the DH has seized all such unused
vaccines;
(b) of the respective legislation or codes of practice breached by doctors of
private clinics, persons-in-charge of medical centres and doctors employed by
such centres for possessing or using pharmaceuticals which are not registered in
Hong Kong, and the legal and professional consequences that they have to bear;
whether the persons involved in the above vaccination incidents will be held
liable; if so, of the details; and
(c) whether it will take measures to prevent the recurrence of similar
incidents; if so, of the details?
Reply:
Madam President,
(a) As soon as coming to notice that some members of the public were
administered flu vaccines which had not been registered in Hong Kong, the
Department of Health (DH) immediately contacted the relevant medical centres to
find out the source of such vaccines, and inspected the clinics and medical
centres implicated in the incident, including three private practice clinics and
three medical groups. DH seized all 1,347 doses of vaccines relevant to the
incident. The DH also instructed the medical groups and private practice clinics
concerned to contact all those who had been administered the above vaccines to
see if they had experienced any adverse effects. Most of the clients have been
contacted and no adverse effects were found to have developed after injection of
these vaccines. There are still 13 persons who have not been contacted as these
persons have not provided the medical centres/clinics concerned with valid
contact details. Since the incident coming into light, DH has been urging people
who have been administered the concerned vaccines to get in touch with the
medical centres/clinics. Up to the present moment, DH has not received any
reports of adverse effects relating to the injection of these flu vaccines.
(b) Under the current Pharmacy and Poisons Ordinance, all pharmaceutical
products for sale in Hong Kong including vaccines must first be registered with
the Pharmacy and Poisons Board. Anyone who is in possession of any unregistered
pharmaceutical product for the purpose of sale commits an offence and is liable
on conviction to a maximum fine of HK$100,000 and to imprisonment for 2 years.
As a statutory body tasked to regulate the professional standards and conduct of
registered medical practitioners in Hong Kong, the Medical Council of Hong Kong
(the Medical Council) issued a Professional Code and Conduct for the Guidance of
Registered Medical Practitioners to ensure that members of the general public
are provided with medical services which meet the required professional
standards. The Professional Code requires medical practitioners to ensure that
the drugs they prescribe and dispense are suitable for use by their patients.
The Medical Council is vested with statutory powers to conduct disciplinary
inquiries into any case of suspected violation of the Professional Code by
medical practitioners and to impose punishments of different degrees to those
medical practitioners who are found guilty of dereliction of professional
responsibilities.
The DH has just completed the investigation into the incident of unregistered
vaccines. Advice is being sought from the Department of Justice on whether
prosecution is to be instituted against those involved. If those prosecuted and
convicted because of the above incident are medical practitioners, the DH will
follow the established procedures to refer the case to the Medical Council for
follow-up action to determine whether the medical practitioners involved have
been in violation of the Professional Code.
(c) As said earlier, under the current Pharmacy and Poisons Ordinance, all
pharmaceutical products for sale in Hong Kong must first be registered with the
Pharmacy and Poisons Board and possession for the purpose of sale of any
unregistered pharmaceutical products is an offence. The Ordinance also requires
that importers, exporters and wholesalers of pharmaceutical products must obtain
a licence from the Pharmacy and Poisons Board. In addition, the current Import
and Export Ordinance also stipulates that importers/exporters of pharmaceutical
products are required to apply for an import/export licence as appropriate from
the DH for every batch of pharmaceutical products to be imported/exported.
Importers, exporters and wholesalers of pharmaceutical products are required to
keep a record of transactions of the pharmaceutical products. The record is
subject to inspection by pharmacist inspectors from the DH, and DH will step up
inspection in this regard.
The Customs and Excise Department adopts risk management strategies to inspect
inbound and outbound goods and luggage by sea, land and air. If any
pharmaceutical products are found to be imported or exported illegally, the
relevant persons will be prosecuted and the relevant products will be seized.
To enable the sectors concerned to have a better understanding of the Pharmacy
and Poisons Ordinance, the DH has issued a letter to all medical practitioners
in Hong Kong after the incident to remind them that they should use only
registered pharmaceutical products. The DH has also organised two seminars in
December 2005 to explain to the medical groups about the requirements relating
to the procurement, dispensing and recording of pharmaceutical products as
stipulated in the local legislation on pharmaceutical products. The medical
groups have also been reminded that no unregistered pharmaceutical products
should be used. In order to better monitor the operation of the private medical
services, the DH is considering to make proactive inspection visits to private
clinics including those operated by medical groups to ensure that their
operation is in compliance with the relevant legislation.
Ends/Wednesday, February 8, 2006
Issued at HKT 12:22
NNNN