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From the office of Senator Allison - 1602 Question on Notice answer
(1) What prompted the Government to set up an expert committee to review complementary healthcare.
(A) The Government established the Expert Committee on Complementary Medicines in the Health System in response to concerns and questions raised by health professionals, researchers, alternative medicine practitioners and consumer groups after the recent action related to Pan Pharmaceuticals Limited. These included concerns about the reliance consumers can place on complementary medicines when they are not assessed for efficacy by the Therapeutic Goods Administration (TGA), the lack of qualification and registration requirements for alternative medicine practitioners and the variability across jurisdictions of regulation of these groups.
(2) Why has the Government refused to allow a representative of the Complementary Healthcare Council to be on that committee.
(A)The Expert Committee on Complementary Medicines in the Health System is an expert committee, established to advise the Government on the regulatory, health system and industry structures necessary to ensure that the central objectives of the National Health Policy are met in relation to complementary medicines. Members of the committee have been selected on the basis of their expertise in relevant areas of the complementary medicines industry, not as representatives of various stakeholder groups. However, Mr Philip Daffy, who is a consultant to the Complementary Healthcare Council
(CHC) of Australia, is a committee member. Membership of the Committee also includes Mr Darin Walters, Chief Executive Officer of Blackmores Ltd, whose Chairman, Mr Marcus Blackmore, AO, is a member of the CHC.
(3) With reference to a report that a member of the committee, Professor Alistair MacLennan, has said that the Government should not support the complementary healthcare industry: Can the Minister confirm this statement; if so, should this predisposition not rule Professor MacLennan out as a suitable, unbiased member of the committee.
(A) Professor Alistair McLennan is an expert in complementary medicine epidemiology and the safety and use of complementary medicines within the Australian community, and as such, is an important member of the Expert Committee. I am not able to comment on whether comments purported to have been made by Professor McLennan have been reported accurately.
(4) (a) Who on the committee has expertise in regulatory controls to meet appropriate standards of quality, safety and efficacy; and (b) can details of this expertise be provided.
(A) (4), (5), (6) & (7) A list of committee members and their areas of expertise is attached.
(5) (a) Who on the expert committee has expertise on education, training and regulation of complementary healthcare practitioners; and (b) can details of this expertise be provided.
See previous answer
(6) (a) Who on the expert committee has expertise on the interaction between complementary and prescribed medicines and the communication of this information to healthcare practitioners; and (b) can details of this expertise be provided. See previous answer
(7) Will consumer representation be included on the expert committee; if so, how will consumer representatives be appointed. See previous answer
(8) Will the committee call for public submissions; if not, why not.
(8) & (9) The Committee has decided that public submissions will not be invited. It will draw on its expertise to develop its response. However, members may choose to consult with various stakeholder groups and individuals as they feel necessary to ensure fully informed discussion and debate.
(9) By what method will the committee collect evidence. See previous answer
(10) Why was the Pan Pharmaceuticals recall a Level 1 recall.
(10), (11) (a) & (b) & (12) All manufacturers of therapeutic products are required to comply with the Code of Good Manufacturing Practice. The Therapeutic Goods Administration (TGA) conducted a number of audits of the Pan Pharmaceuticals Ltd manufacturing premises, in February and April 2003. These audits revealed serious, widespread deficiencies in the company's manufacturing and quality control procedures, including falsification of documents, systematic and deliberate manipulation of test results, substitution or omission of active ingredients, and inadequate cleaning of equipment between manufacture of different products. Consequently, neither the safety or the quality of products manufactured by Pan Pharmaceuticals could be assured. The nature of some of the manufacturing breaches meant that some products could contain incorrect amounts of active ingredient and/or potentially harmful contaminants. The TGA was advised by an Expert Advisory Group that products manufactured under these conditions posed an imminent risk of death, serious illness or serious injury. The Group advised that the multiple failures of GMP identified with the company posed serious risks that would increase over time and could be realised at any time. It was for this reason that the recall was a Class 1 recall.
(11) (a) What other options were available; and (b) why were they not taken. See previous answer
(12) Why was it that Pan Pharmaceuticals' products other than Travacalm were recalled. See previous answer
(13) For each of those products recalled, what adverse reactions were reported. Still waiting for a response.
(14) Why did the Therapeutic Goods Administration (TGA) not examine all these products before doing a total recall.
(14) & (15) No amount of testing of the finished product would be adequate to ensure its quality and safety, given the widespread and serious nature of the breaches of manufacturing standards. Although a product could be tested to ensure the presence of stated amounts of ingredients, this would not guarantee that potentially harmful contaminants had not been introduced during its manufacture. It was not possible to identify which contaminants to test for, as every product manufactured by Pan Pharmaceuticals was a possible contaminant for every other product. Nor would testing give any surety that other tablets in the same bottle or other bottles from the same batch would give the same test results. The Expert Advisory Group advised the TGA that the public health risks were serious and immediate and would grow with time. The Group advised there was an imminent risk of death, serious injury or serious illness. This advice meant the TGA had to take immediate action to cancel Pan Pharmaceuticals Limited manufacturing licence and order the immediate recall of products manufactured by Pan Pharmaceuticals.
(15) Why did the TGA not inform the Complementary Healthcare Council so the industry could work with the TGA to test all products in question. See previous answer
(16) Can the Minister confirm that Pan Pharmaceuticals' largest overseas customer, Wallmart in America, is still selling Pan Pharmaceuticals' recalled products that they have tested and found to be good quality.
(16) & (17) The Government cannot comment on the veracity of these claims. The TGA notified all overseas health authorities whose countries had received Pan-manufactured products that the Australian recall had been undertaken. However, any action taken by those countries is a matter for them.
(17) Can the Minister confirm that Pan Pharmaceuticals' products are still being sold in Europe, and that in New Zealand they are being sold with approval from the New Zealand Ministry of Health. See previous answer
(18) Given that the number of adverse reactions from complementary medicines was reported by the Australian Adverse Drug Reactions Advisory Committee as averaging only 23 per year compared with 400 000 in 1999-2000 for prescribed drugs, why were prescribed pharmaceuticals not included in the review. The committee was established to examine the role of complementary medicines in the health system as a consequence of concerns raised by health professionals, researchers, alternative health practitioners and consumer groups following the recent product recall.
(19) Given that, according to the Complementary Healthcare Council, sales of complementary medicines are down 20 to 40 per cent and export sales are down by $200 million, does the Government intend to compensate small retail businesses for this economic loss and the general decline in consumer confidence. These questions are more appropriately addressed to the Minister for Small Business and Tourism.
(20) What response has the Government made to the request from the Complementary Healthcare Council for funds to invest in marketing for the industry and positive statements from the Government about complementary medicines. These questions are more appropriately addressed to the Minister for Small Business and Tourism.
(21) What is the progress on the Government's request to major distributors that claims by small businesses for refunds to consumers on recalled products should be expedited. These questions are more appropriately addressed to the Minister for Small Business and Tourism.
(22) Is the Government monitoring the financial impact of this recall on small business; if so, what is the impact; if not, why not. These questions are more appropriately addressed to the Minister for Small Business and Tourism. EXPERT COMMITTEE ON COMPLEMENTARY MEDICINES IN THE HEALTH SYSTEM
NAME - AFFILIATION - EXPERTISE
Dr Michael Bollen (Chair) - Former member of the National Health and Medical Research Council - Principal, BMP Healthcare Consulting Pty Ltd - Quality use of medicines, healthcare delivery, consumer medicines information and general medical practice
Dr John Aloizos - Chair, Australian Pharmaceutical Advisory Council - Implementation of all aspects of National Medicines Policy and general medical practice
Associate Professor Alan Bensoussan - Centre for Complementary Medicine Research, University of Western Sydney, Member, Expert Advisory Panel on Complementary Medicines - Use and evaluation of complementary medicines and therapies in clinical practice; practitioner education and training
Dr Kerry Breen - Chair, NHMRC Australian Health Ethics Committee - Ethical issues associated with the promotion and use of medicines
Professor Terry Campbell - Head of Department Department of Medicine St Vincent's Clinical School Member, Pharmaceutical Benefits Advisory Committee - Clinical pharmacology
Mr Philip Daffy - Consultant to the complementary medicines industry including the Complementary Healthcare Council of Australia - Product development complementary medicines
Dr Paul Dugdale - Chief Health Officer, ACT Department of Health - State and Territory issues associated with practitioner regulation, regulation of dispensed and extemporaneously compounded complementary medicines
Associate Professor John Eden - University of New South Wales, School of Women's and Children's Health - Use of complementary medicines and therapies in medical practice, particularly in women's health
Mr Ross Johnston - Vice President Manufacturing Operations Asia Pacific Wyeth - Quality assurance in the manufacture of complementary, OTC and prescription medicines
Professor Alastair MacLennan - Department of Obstetrics and Gynaecology, University of Adelaide - Complementary medicine epidemiology and safety of complementary medicines
Mr David McLeod - Naturopath, Fellow with the Australian acupuncture and Chinese Medicine Association - Use of complementary medicines in complementary medicine practice; practitioner education and training
Professor Stephen Myers - Director, Australian Centre for Complementary Medicine Education and Research, Southern Cross University/ University of Queensland Member, Complementary Medicines Evaluation Committee - Use and evaluation of complementary medicines in medical practice; practitioner education and training
Mr Anthony Nunan - Principal - Parade Pharmacy; Nunan's Watsonia Pharmacy; Heath's Road Medical Clinic Pharmacy, Chairman - Australian Medicines Handbook - Small business issues; quality use of medicines; postgraduate pharmacist education and training; pharmacy
Ms Juliet Seifert - Executive Director, Australian Self-Medication Industry - Quality use of medicines and industry issues, including complementary medicines
Associate Professor Anne Tonkin - Department of Clinical and Experimental Pharmacology University of Adelaide Former Chair, Complementary Medicines Evaluation Committee - Evaluation of efficacy and clinical pharmacology, medical education
Associate Professor Heather Yeatman - Graduate School of Public Health, University of Wollongong MEMBER COMPLEMENTARY MEDICINES EVALUATION COMMITTEE Member, Food Standards Australia New Zealand Board - Consumer issues associated with the use of complementary medicines, food and nutrition
Mr Darin Walters - Chief Executive Officer; Blackmores Ltd - Complementary medicines industry
Professor Bill Webster - Department of Anatomy and Histology, University of Sydney Member, Complementary Medicines Evaluation Committee - Toxicology and the safety of complementary medicines |
