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LCQ11: Hospital Authority Drug Formulary
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     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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