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PAN Pharmaceutical scare

PAN Pharmaceutical scare

By Sue Kedgley MP

In my last newsletter, I mentioned that Ministry of Health officials had been issuing ' scare ' stories about dietary supplements to justify their argument that New Zealand should hand over regulation of our dietary supplements to the Australian Therapeutic Goods Agency (TGA).

On the face of it, the latest scandal surrounding Pan Pharmaceuticals, and the recall of 1600 dietary supplements, appears to be just the sort of ' scare ' that could justify Australian-style regulation. It has certainly rocked the dietary supplements industry and has been used, in the media and elsewhere, to try to discredit the entire industry.

But on reflection, the scandal points to such systemic failure on the part of the TGA it begs the question: why would we hand over control of our dietary supplements industry to one of the most bureaucratic, highly regulated and expensive systems in the world when it couldn ' t even pick up serious safety and quality breaches right under its nose.

The Australian TGA has a supposedly rigorous auditing and post-marketing surveillance system that costs industry millions of dollar in fees. Why then did it take so long to uncover such major deficiencies in the manufacturing and quality control of Pan Pharmaceuticals? And when it did pick up problems with pharmaceutical medicines (not dietary supplements), why did it wait three months and then dump on the entire dietary supplement industry with no warning or consultation?

Every one of the dietary supplements that the TGA has recalled was licensed by the authority (at great expense to industry) and made under pharmaceutical Good Manufacturing Practice standards. The TGA tick of approval is supposed to provide a guarantee to consumers that every product is safe, true to label etc. But the recall of 1600 licensed products begs the question: what is the point of such an expensive licensing regime if it cannot provide assurances to consumers?

Other questions being asked include: why is it that the scandal, and subsequent recall (and media reporting of it) has focussed entirely on dietary supplements, when the original products that sparked the recall (two travel sickness tablets called Travacalm Original and Travacalm HO) were not dietary supplements at all, but over-the-counter medicines? Travacalm Natural (a ginger product) was found to be of good quality.

Why have pharmaceuticals produced by Pan Pharmaceuticals never been recalled, but remain on sale?

And if the systemic failure that led to the recall was the failure of manufacturing standards and quality control within Pan Pharmaceuticals, then why not recall all products made by Pan?

Our Minister of Health Annette King was quick to suggest that the scandal showed up the urgent need for better regulation of dietary supplements in New Zealand. She even accused the industry of trying to stall regulations to set up a register of dietary supplements.

What she didn ' t mention was that there had been agreement between the industry and the Ministry of Health way back in 1998, to set up such a register, and license manufacturers and suppliers of dietary supplements. The industry was expecting tougher regulations to be introduced in 2000. They were devastated to discover that the Minister of Health had pulled the plug on the agreement, and decided to merge with the TGA instead.

The Green Party has also asked what exactly were the grounds for the massive recall of PAN products marketed in New Zealand? The recall took place under Section 40 of the Food Act, which says that the Minister of Health can recall any food (or dietary supplement) that is ' unsound or unfit for human consumption, or is damaged or deteriorated or perished, or that is contaminated with any poisonous, deleterious or injurious substance ' .

While there can be no question that the two Travacalm pharmaceutical products were unfit for human consumption, some are wondering what evidence there is that all of the more than 700 dietary supplements that have been recalled here were unfit for human consumption? If there isn ' t clear evidence that all of these products were unsafe for human consumption, what was the basis of the recall? Could the recall have been something of an over-reaction?

I have asked these questions of the Minister of Health. I shall publish the Minister ' s responses in my next newsletter.

Health Select Committee Inquiry into the proposed joint trans-Tasman Therapeutic Goods Agency

The Health Select Committee has held the first meeting of its inquiry into the most appropriate regulatory framework to govern dietary supplements and traditional remedies in New Zealand. The inquiry is considering whether this should be by the proposed Trans-Tasman Therapeutic Goods Agency (TTTGA), or another regime (which is highly relevant questions in view of the Pan Pharmaceuticals scare).

The hearings are going well and will continue on 14 May in Wellington. All the background papers and submissions made to the inquiry have been tabled and are now available to the public. They can be obtained from the Secretary of the Health Select Committee Catherine Parkin. Her address is: c/- Parliament, Wellington. Telephone: 4709558. Email: catherine.parkin@parliament.govt.nz Perhaps the most interesting documents are Medsafe ' s submissions to the inquiry: (Submission 131, 131 B and 131 C). These include an economic impact report carried out by the NZ Institute of Economic Research assessing the impacts of establishing a single regulatory regime for all therapeutic products across Australia and New Zealand; There is also a paper summarising submissions made in response to its discussion paper last year proposing regulation of dietary supplements through the Australian TGA (submission 131 B).

Health Professionals Competency Bill Update

The Health Select Committee has just completed its consideration of the Health Professionals Competency Bill. The Bill will be reported back to Parliament within the next week. As soon as it is tabled in the House (probably next week), it will be available to the public. I have been working closely with the acupuncture profession seeking to include them and osteopaths, in the Bill.

Discussion Document: Complementary and Alternative Medicine

The Ministerial Advisory Committee on Complementary and Alternative Health (CAM) - set up as a Green Party budget initiative - has released a discussion document on Complementary and Alternative Medicine: Current Policies and Policy Issues in New Zealand and Selected Countries.

The document identifies key policy questions surrounding CAM and seeks feedback on questions it says will help it to advise the Minister of Health on CAM policy in New Zealand.

Submissions close on Friday May 30 2003.

It is vital that as many people as possible respond to the questionnaire. Otherwise the Government may conclude there is little interest in complementary health, and may not bother to extend the life of the committee. It only takes a few minutes to fill out the questionnaire which is available on the following website www.newhealth.govt.nz/maccah.htm There will also be two public meetings held in Christchurch and Wellington at the following times:

Christchurch: Sudima Hotel Grand Chancellor, cnr Memorial Ave and Orchard Rd, Friday June 6, 7.30-9pm

Wellington: Copthorne Hotel, Plimmer Towers, cnr Boulcott St and Gilmer Tce, Friday June 27, &.30-9pm.

It is important that as many people attend these meetings as possible to ensure that a good discussion.

The key points in the discussion document are as follows:

The discussion document notes there is at present no ability to provide policy advice to the Government on CAM in New Zealand and suggests it might be appropriate for the Ministry of Health to establish a unit for this purpose. It notes that the UK Government has set up a team to advise policy makers on CAM-related matters, implement statutory regulation of CAM practitioners and promote best practice in integrating CAM into mainstream healthcare.

The most radical suggestion in the document is that consideration should be given to integrating CAM treatments into our publicly funded health system. It asks whether people think there should be greater integration of CAM into mainstream health - especially general practice, hospitals, pain management clinics and hospices.

At present, CAM is not formally integrated into our public health system, although ACC subsidises the cost of some treatment for acupuncture, chiropractic and osteopathic services. Work and Income New Zealand (WINZ) may also pay a disability allowance for fees for alternative treatment needed by a person because of their disability. Some vitamins and supplements can be included in this allowance. CAM services are also incorporated into some hospitals and health services.

The discussion document notes there is a lack of comprehensive, reliable and objective information about CAM, although a Ministry of Health database of CAM research (another successful Green budget bid) will be set up at the end of 2003. It will provide information about CAM safety, effectiveness, regulation, complaints procedures and practitioners, so that consumers can make informed choices about their health care. It will also provide consumers with summaries of existing international CAM research.

It asks who should be responsible for providing consumer information - and suggests the Ministry of Health collaborate with the CAM sector to provide quality, independent information, including a variety of viewpoints. It questions whether that information should be released to the public via booklets, Internet or other media sources.

The discussion document says there is a lack of high-quality evidence on the safety and cost-effectiveness of many CAM treatments, although research is improving. Very little research has been carried out in New Zealand, and there is no current specific policy on CAM research.

It suggests New Zealand should look overseas for the bulk of such research, and devote resources to evaluating existing international research. It recommends an established research institute such as the Christchurch-based New Zealand Health Technology Assessment be responsible for this role.

The document suggests integration of CAM could occur in practitioner training, with CAM practitioners receiving some basic medical training. The depth of medical training varies considerably at present among different CAM practices.

It asks whether mainstream medical practitioners should undergo some formal education about CAM, noting medical schools currently offer no formal study options - although most nursing courses do at least touch on CAM.

The document says integrated services would encourage mutual respect and tolerance between mainstream and CAM practitioners, and would enable patients to be open with their doctor about any CAM medicines they were taking. Other noted benefits include high-quality training and research, networking to disseminate good practice, mutual recognition of the limitations of practitioners and services, and enabling patients to actively participate in their own healing processes.

It says there is a need for effective regulation of the complementary and alternative health sector to protect consumers from unsafe practitioners and products; and compares current CAM policies in New Zealand, the United Kingdom, Australia, the United States, Canada, Singapore and China. At present, chiropractors are the only statutorily regulated CAM profession. Practitioners of other CAMs may register with a voluntary, self-regulating body.

The Health Practitioners Competence Assurance Bill (which will shortly be debated in Parliament) will regulate osteopathy and, hopefully, acupuncture. Other CAM professions can be extended statutory recognition in future without the need for separate Acts of Parliament.

Before doing so, however, each profession will need to reach general agreement within the profession on qualifications, standards and competencies. It suggests the development of a common process to guide different CAM groups to a common level from which to apply for statutory regulation. It suggests the process could also guide other CAM practices that opt for voluntary self-regulation and alternative best-practice options.

The document examines the advantages of regulation on the CAM sector, identifying enhanced professional status, the opportunity to enforce minimum standards for training and professional practice, and the possibility of entitling practitioners to insurance-based or mainstream funding. Disadvantages include the cost of becoming registered, the possibility that some practitioners could lose the right to practise, restriction of consumer choice and increased costs to consumers. The cost of statutory regulation tends to be substantially higher than voluntary regulation.

The document asks how mainstream health professionals such as doctors, nurses and dentists who also practice CAM should be regulated, and suggests that voluntary CAM regulatory bodies could make specific rules for members who are also regulated health professionals.

It questions how CAM practitioners practising more than one form of CAM should be regulated. Should they be regulated separately under each modality or should there be special regulatory arrangements for multi-modality practitioners? In the UK, the House of Lords Select Committee cautioned against multi-therapy practitioners with inadequate training in one or more therapies.

The document whether CAM practitioners should be required to have sufficient medical science education to be able to make safe diagnoses and know when to refer patients on.

Finally, the document identifies the goals of the New Zealand Health Strategy - designed to improve the health of the public - and asks whether greater integration of CAM into mainstream medicine would help to achieve these objectives.

Some of these objectives are to reduce smoking; improve nutrition; reduce obesity; increase physical activity; reduce suicides and suicide attempts; minimise harm caused by alcohol and other drugs to individuals and the community; reduce the rate and impact of cancer, diabetes and cardiovascular disease; improve oral health; improve the health status of people with severe mental illness; and ensure access to appropriate child health care services.

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