Replies to LegCo questions
LCQ11: Hospital Authority Drug Formulary
Following is a question by Professor Joseph Lee and a written reply by
the Secretary for Food and Health, Dr Ko Wing-man, in the Legislative
Council today (October 30):
Question:
Some members of the pharmaceutical industry have relayed to me that it
takes a long time (up to several years for the longest) for completing
the procedures for the registration of new drugs in Hong Kong. Moreover,
the criteria and procedures adopted by the Hospital Authority (HA), the
Samaritan Fund (SF) and the Community Care Fund (CCF) for assessing
whether a drug should be included in the HA Drug Formulary (Formulary)
or in the scope of subsidies of the funds are not transparent. In this
connection, will the Government inform this Council:
(a) of the number of drug items in respect of which applications for
registration in Hong Kong had been made in the past five years; the
average, the longest and the shortest time currently taken for vetting
and approving applications for drug registration, with a breakdown by
the various vetting and approval procedures; whether the authorities
will review the existing vetting and approval procedures, establish
clear application guidelines and set a reasonable vetting-and-approval
timeframe so that drug registration in Hong Kong can be expeditiously
completed, so as to benefit the patients in need; if they will, of the
details; if not, the reasons for that;
(b) given that at present, committees have been set up by various
hospital clusters/hospitals to decide if drugs included in the Formulary
are to be used in the clusters/hospitals concerned as well as to oversee
and manage the Formulary, which may also submit applications to the HA
Drug Advisory Committee for evaluation of new drugs for the latter to
decide whether a drug should be included in the Formulary, whether it
knows the respective procedures of such committees in conducting the
relevant assessments; the average, the longest and the shortest time
taken for completing the procedures; whether the authorities will review
the existing assessment procedures with a view to streamlining and
shortening the time required for drug assessment with a view to
expeditiously including suitable drugs in the Formulary, so as to
benefit the patients in need; if they will, of the details; if not, the
reasons for that;
(c) whether the authorities will, in the long run, consider setting up
an independent committee to assess the inclusion of drugs in the
Formulary in a more effective and fair manner; if they will, of the
details; if not, the reasons for that; and
(d) whether it knows the procedures and criteria adopted by SF and the
CCF Medical Assistance Programme (before its incorporation into SF on
September 1, 2012) for assessing whether a drug should be included in
their lists of subsidised drugs?
Reply:
President,
The Hospital Authority (HA) implemented the Drug Formulary (Formulary)
in July 2005 with a view to ensuring equitable access by patients to
cost-effective drugs of proven safety and efficacy by standardising the
drug policy and drug utilisation in HA. The Formulary is developed with
appraisal of new drugs and review of the prevailing list of drugs by
relevant experts on a regular basis. The review process is based on
scientific and clinical evidence, in which the safety, efficacy and
cost-effectiveness of drugs will be considered. The views of patient
groups will also be taken into account. Changes to the Formulary will be
made as appropriate.
In recent years, HA has kept expanding the coverage of the Formulary to
benefit more patients. In this financial year, the Financial Secretary
announced in the Budget passed earlier that an additional $44 million
would be allocated to include in the Formulary two chemotherapeutic
drugs for cancer treatment and to expand the application of two special
drugs. At present, there are more than 1 200 standard drugs in the
Formulary, all of which have been included after going through a
stringent, objective and scientific process.
As regards self-financed items in the Formulary which are subsidised by
the safety net, HA has put in place the Samaritan Fund (SF) to provide
financial assistance for patients who have met the clinical criteria and
passed the means test so that they can purchase the self-financed drugs.
Moreover, the Community Care Fund (CCF) Medical Assistance Programme
also provides assistance for needy patients.
My reply to the various parts of the question is as follows:
(a) Under the Pharmacy and Poisons Ordinance (Cap. 138), pharmaceutical
products must be registered with the Pharmacy and Poisons Board of Hong
Kong (Board) before they can be sold and distributed on the market.
Applicants are required to submit the relevant information (including
the product's formulation, specification, manufacturer's licence,
reports on clinical and laboratory tests, etc.) to prove the safety,
efficacy and quality of the pharmaceutical product before approval for
registration is granted by the Board. For pharmaceutical products
containing new chemical entities (i.e. active ingredients which have not
been registered in Hong Kong), applications should be submitted to the
Pharmacy and Poisons (Registration of Pharmaceutical Products and
Substances: Certification of Clinical Trial/Medicinal Test) Committee
(Registration Committee) for approval. In such cases, legislative
amendments, including the moving of motions and gazettals, are required
in order to incorporate the new chemical entities into the relevant
schedules to the ordinance. As for pharmaceutical products without new
chemical entity, which are generally known as "generic drugs", the
Registration Committee has empowered the Drug Office of the Department
of Health to approve their registration.
The Board approved an average of about 1 100 applications for
pharmaceutical product registration (including new chemical entities and
generic drugs) annually in the past five years. The number of
applications approved each year is listed in the table below:
Year Number of
registered pharmaceutical products
----
--------------------------------------------
2008 1 056
2009 1 735
2010 1 360
2011
731
2012
679
DH has always placed emphasis on service efficiency and has pledged that
no less than 90% of applications for pharmaceutical product registration
would be processed within five months upon the submission of all
required documents by the applicants. According to the Board's
information, DH fulfilled the above performance pledge in the past five
years, with about 96% of applications processed within five months on
average.
DH has adopted various measures to expedite the approval of registration
of pharmaceutical products with new chemical entities. Such measures
include increasing the frequency of meetings of the Registration
Committee where necessary to process the applications, and notifying the
pharmaceutical industry in advance the dates of meetings of the
Registration Committee in the coming year. The Food and Health Bureau
(FHB) and DH have also maintained close co-ordination in the relevant
legislative amendment exercises.
To help the pharmaceutical industry better understand the registration
requirements of pharmaceutical products, the Drug Office of DH has
published and uploaded to its website a detailed guide to the
registration of pharmaceutical products. In addition, DH organises talks
on a regular basis to explain the registration requirements to the
industry and answer enquiries. Practitioners are also encouraged to
direct their enquiries to and seek assistance from DH. DH will continue
to maintain close communication and liaison with the industry to review
and refine the pharmaceutical products registration mechanism in due
course.
(b) HA appraises new drugs and reviews the prevailing drug list in the
Formulary regularly through an established mechanism. The HA Drug
Utilisation Review Committee (DURC) conducts periodic reviews of
existing drugs in the Formulary and the Drug Advisory Committee (DAC)
systematically appraises new drugs for inclusion into the Formulary.
Both the DURC and DAC are supported by expert panels which provide
professional advice on the selection of drugs for individual
specialties. They also provide professional advice on safety, efficacy
and cost-effectiveness. Besides, the Drug and Therapeutics Committees of
individual clusters/hospitals are also responsible for monitoring and
administering the implementation of drug utilisation policy at
cluster/hospital level. They may also submit applications to the DAC for
appraisal of new drugs for incorporation into the Formulary.
The DAC conducts meeting once every three months. At every meeting, the
DAC was able to complete the appraisal of all applications received and
determine whether the new drugs would be incorporated into the
Formulary. As such, there is no longest and shortest assessment time.
(c) HA has established an effective and flexible mechanism under which
experts appraise new drugs and review the drugs covered by the Formulary
on a regular basis. The mechanism has developed continuously in line
with such core values as evidence-based medical practice, rational use
of public resources, targeted subsidy and opportunity cost, etc. The
review process is based on scientific and clinical evidence, in which
the efficacy, safety and cost effectiveness of the drugs are considered.
Reference is also made to international recommendations and practices,
development in technology, drug classification, disease states,
patients' compliance to medication, patients' quality of life, actual
experience in the use of drugs, comparison with available alternatives,
and views of professionals and patient groups. This mechanism has been
operating effectively. Apart from putting the drug policy of Hong Kong
in line with international developments, it also helps to ensure that we
will keep introducing new drugs into the public healthcare system.
HA keeps in close liaison with patient groups and listen to patients'
views about the Formulary. To further increase transparency and patient
participation, HA holds consultation with patients' organisations about
the Formulary and SF every year. During the consultation, HA will,
besides informing patients' organisations of the latest development of
the Formulary and SF, listen to their major concerns and opinions and
relay their views and suggestions to the relevant committees for
consideration. In addition, the Chief Executive of HA meets with patient
representatives regularly and listen to their views about patient
services. This platform gives HA an additional channel to communicate
with patient groups on issues related to the Formulary. In order to
enhance the transparency of inclusion of new drugs in the Formulary and
improve the communication with patients' organisations, HA has uploaded
the membership composition of the DAC, the drug lists discussed at
meetings, the review outcome of each application and the reference
literature used for making the assessments to its intranet and the
Internet for public reference.
The Government and HA will continue to optimise the use of limited
public resources in a fair and effective manner to provide healthcare
services for more patients. We will also review the Formulary in
accordance with the existing mechanism and actual circumstances.
(d) Since its establishment, CCF has rolled out 18 assistance programmes
including two medical assistance programmes (First Phase and Second
Phase). The Second Phase Programme of CCF Medical Assistance Programme
has been incorporated into the Government's regular assistance
programme, i.e. SF, with effect from September 1, 2012.
SF and the First Phase Programme of the CCF Medical Assistance Programme
currently provide financial assistance for patients in need of specified
self-financed drugs. Both Funds periodically review their lists of
self-financed drugs. The HA Drug Utilisation Review Committee (DURC)
will submit recommendations to revise the lists of subsidised drugs to
the two Funds on a regular basis.
For drugs to be covered by SF, recommendations of the DURC, if endorsed
by the Samaritan Fund Management Committee, will be submitted to the
Medical Services Development Committee of the HA Board for approval. For
drugs to be covered by CCF, recommendations of the DURC, if endorsed by
the HA CCF Administration Committee, will be submitted by HA to the CCF
Task Force under the Commission on Poverty (CoP) for consideration. Upon
endorsement by the Task Force, the recommendations will be submitted to
the CoP for approval.
In deciding whether the drugs should be covered by the Funds, the
committees under HA will take into account various factors such as
safety, efficacy, cost-effectiveness, international recommendations and
practices, estimated number of beneficiaries, financial implications on
the Funds, etc.
Ends/Wednesday, October 30, 2013
Issued at HKT 18:58
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