Replies to LegCo questions
LCQ11: Off-label use of Avastin
Following is a question by Dr Hon Pan Pey-chyou and a written reply by the
Secretary for Food and Health, Dr York Chow, in the Legislative Council today
(December 15):
Question:
Pursuant to section 36B of the Pharmacy and Poisons Regulations (Cap. 138 sub.
leg. A) (the Regulations), for the purpose of conducting a clinical trial on
human beings or a medicinal test on animals, application shall be made in
writing to the committee under the Pharmacy and Poisons Board (the Board). It
has been reported that the Hospital Authority (HA) is currently conducting a
clinical trial on the use of Avastin beyond its licensed indication (off-label
use), but it has not applied for or obtained a certificate from the Board in
accordance with the Regulations. In this connection, will the Government inform
this Council:
(a) whether it knows for how long the clinical trial on the off-label use of
Avastin has been conducted, and the total number of patients who have undergone
the trial;
(b) whether it knows the reasons why HA has conducted the aforesaid clinical
trial before obtaining the certificate issued by the Board;
(c) how the authorities will deal with the situation where a clinical trial is
found to have been conducted without applying for or before obtaining a
certificate as required by the Regulations; whether the authorities will
immediately prohibit such a trial from continuing; if they will not, of the
reasons for that;
(d) whether under the existing mechanism patients can clearly know if the
certificate for the clinical trial concerned has been obtained before giving
consent to undergoing the clinical trial; if they can, of the details of such
mechanism; if not, the reasons for the authorities not establishing such a
mechanism, and whether the authorities have conducted any assessment on how the
safety of patients can be safeguarded; and
(e) of the penalty for any organisation which has been found to have breached
section 36B of the Regulations; where the clinical trial of a pharmaceutical
product which is conducted without obtaining the required certificate has caused
serious side effects in the body of the participating patient, whether the
patient concerned will be entitled to compensation; if yes, who will be
responsible for paying the compensation?
Reply:
President,
(a) and (b) According to the Hospital Authority (HA), clinical trials on the
off-label use of Avastin are currently conducted by the Faculty of Medicine of
the universities. These clinical trials have gone through and passed independent
ethical reviews to ensure their safety and scientific validity. Enquiries can be
made with the universities concerned for the details of these trials.
On the other hand, HA is planning to conduct a local clinical study to compare
various drug treatment options (including Avastin) for treating wet age-related
macular degeneration so as to accumulate more local experience in the use of the
drugs. Details of the study are under planning and the study has yet to
commence.
(c) Generally speaking, a clinical trial is a medical procedure conducted with
patients' knowledge and consent. It also requires approval by the Ethics
Committee of the institution concerned and has to be conducted by registered
healthcare professionals. If any institution is found to conduct any clinical
trial without obtaining a clinical trial certificate, the Department of Health
will issue a letter to the institution concerned and require it to lodge an
application as soon as possible.
(d) Patient safety is the primary concern of public hospitals in the provision
of all their services, including clinical studies. HA has put in place stringent
guidelines and protocols for the conduct of clinical studies. All clinical
studies must go through and pass independent ethical reviews to ensure their
safety and scientific validity.
The scope of an ethical review mainly covers the theoretical basis of the
clinical study, patient safety and information pertinent to the "Participant's
Consent". The entire design of a clinical study must be target-oriented and it
is necessary to ensure that the potential risks borne by the participants are
kept to the minimum within the known extent of the risks. The design of the
clinical study must also comply with HA's patient safety guidelines and
requirements and participants need to be provided with appropriate medical
support throughout the study. Besides, a mechanism for notification of serious
incidents should be set up for the research project.
Institutions and researchers conducting a clinical study must explain the key
aspects of the study to participants in detail and obtain their informed and
voluntary consent in writing. The language used in the "Participant's Consent"
must be understandable and intelligible to the participants. All information
relevant to the participants (including the design, scope, objectives and
requirements of the research project as well as any possible discomfort or side
effects that may arise in the research process and assessment of potential
risks, etc.) must be included in the "Participant's Consent" so as to let the
participants know the content of the research project and the potential risks.
Participants have a full right to decide and make their own choice as to whether
or not to participate in the clinical study. They can also withdraw from the
clinical study during the research process.
In addition to the required independent ethical review as mentioned above,
institutions conducting a clinical study must also comply with other relevant
requirements.
(e) It is stipulated in section 36B of the Pharmacy and Poisons Regulations
(Cap. 138A) that for the purpose of conducting a clinical trial, application
must be made in writing to the Pharmacy and Poisons (Registration of
Pharmaceutical Products and Substances: Certification of Clinical
Trial/Medicinal Test) Committee. When amending the Pharmacy and Poisons
Ordinance and the Pharmacy and Poisons Regulations to implement the
recommendations of the Review Committee on Regulation of Pharmaceutical Products
in Hong Kong, we will impose a penalty in the legislation for the conduct of any
clinical trial without a certificate.
The "Participant's Consent" is an agreement between the institution conducting
the clinical study and the participant. Details about such Consent are provided
in the foregoing paragraphs. If a participant institutes any litigation or
lodges a claim for compensation in the course of clinical study, the institution
conducting the research project would need to bear the legal liability.
Ends/Wednesday, December 15, 2010
Issued at HKT 12:07
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