Harmonisation- Waltzing with Matilda?
The proposal for a trans-Tasman agency to regulate therapeutic products
September 2002 Women's Health Watch
The proposal to establish a trans Tasman Agency to regulate therapeutic products raises interesting and sometimes vexed questions for consumers. Jo Fitzpatrick reports on some of these.
What is the harmonisation project? The goal of harmonisation is to establish an agency responsible for the regulation of therapeutic products in both Australia and New Zealand. Therapeutic products include prescription and over-the-counter medicines, medical devices and comple-mentary health care products - including dietary supplements, herbal and homeo-pathic preparations. New Zealand and Australia would both come under the umbrella of this agency with harmonised regulations for therapeutic products.
The areas to be covered by the regulations include pre-market testing and safety, approval to market, monitoring, setting quality standards for manufacturers and distributors and most aspects of marketing, labelling, advertising and post-market monitoring.
The level of regulation for each product is to be determined by the perceived degree of risk the product poses for the population. Individual products and manufacturers will all require licenses. A low-risk product may only need to be registered to receive a licence but higher risk products would require more rigorous standards. The agency will be funded by industry bodies to perform these tasks on a fee-for-service basis.
The Governance structure for the agency is a treaty signed and endorsed by health ministers in both countries (the Ministerial Council) and a board of five people including the chief executive. The agency would be answerable to both Parliaments and attorney generals and have offices located in both countries.
How is it supposed to work?
There is an underlying philosophy and a strong push for industry self-regulation models with government oversight by the proposed agency. These involve the industry setting up codes of practice and then monitoring code compliance. The role of the agency would be to oversee these processes and provide mechanisms to deal with breaches and complaints. The arguments for models of self-regulation are that industry pays much of the cost and they create a learning environment where the industry is responsible for setting standards and ensuring appropriate models of behaviour amongst its members. They are based on current NZ models, and in the advertising area are being vigorously promoted by the NZ Advertising Standards Authority, which operates in this way.
Womens Health Action has had some experience of laying complaints using these processes with the advertising Code for Therapeutic Products and the Code on Breast Milk Substitutes. Our experience is that agencies in this role get caught up in the process of helping industry get it right. Complaints are seen as irritating, and subtle attempts are made to discourage the laying of them. It is not uncommon to receive patronising explanations around your perceived misunderstanding of the code. There is a culture which views findings of code breaches as a failure of the government body to teach effectively. Complaints procedures are often difficult, tedious and protracted. There is little incentive to complain as penalties are generally limited to a series of wet bus tickets a formal apology, a promise to do better in future, a request to remove an advertisement (often gone for months anyway by the time the deliberation is made.)
Food for thought
A related agency following a similar model is the Australia New Zealand Food Authority (ANZFA) which was relaunched in Sydney in July this year as FSANZ (Food Standards Australia New Zealand). According to the press release from Trish Worth, the Australian Parliamentary Secretary, New Zealand was represented at the relaunching by Te Kumete Maori (a Maori food bowl) and it is unclear whether there were any New Zealand people present. One of the recurring concerns New Zealanders voice about the proposed new drug agency is the potential for a loss of sovereignty and control.
FSANZ is not a reassuring model in this regard as Australians dominate. The governance structure includes Australian states so that NZ is one voice in 22 or 23 on bodies such as the Ministerial Council and the Food Regulations Standing Committee; the Board of 12 has 3 New Zealanders. The organisational structure is heavily Australian with an Australian managing director who has four general managers reporting to him. Three of these have functional responsibilities related to the agencys work and the fourth is called simply general manager New Zealand.
The Ministerial Council for the therapeutic product agency is more balanced but includes only two health ministers one each for Australia and New Zealand. The proposed board is also very small with only five members and a built-in bias towards Australia. In cases of disagreement, the Australian health minister makes decisions on board members and three of the board members must be Australian residents. The agency is set up under Australian law and becomes an Australian agency in the event of dissolution.
In our submission, we suggest:
* a larger Ministerial Council while retaining the principle of equal country representation;
* inclusion of consumer representatives from both countries on the board;
* the removal of Australian residential requirements;
* a statutory obligation to consult with the community;
* including consumer participation in decision making bodies and processes.
We also suggest basing the agency in New Zealand, making it a New Zealand responsibility and ensuring that while functions are shared evenly between the two countries, some are carried out in both.
The current status
The agenda for a trans-Tasman Agency is well advanced and it unlikely that we will be able to change the fact of it, although it may be possible to have some impact on the form. (See box: Time line for the Joint Therapeutic Goods Agency) The agenda has been pushed by Government officials working alongside selected stakeholders. For the most part stakeholders have been industry representatives and officials. The participation of New Zealand consumers in the process has been sparse and mixed. We have been represented variously by Grey Power, the Consumers' Institute and Womens Health Action. Australian consumers have been represented by Consumer Health Forum (http://www.chf.org.au/).
More concerns about the proposal
All aspects of drug approval and monitoring are covered. Currently these aspects are handled in New Zealand by Medsafe, a business unit of the Ministry of Health, and by a number of committees made up of New Zealand doctors, usually of a high calibre. Drug monitoring in New Zealand is undertaken by the Centre for Adverse Reactions Monitoring (CARM) based at the University of Otago. Over the years, CARM has had difficulties in its relationship with the Ministry which has attempted to take it over, but the system is valued by doctors and it enjoys a world-wide reputation for having one of the highest reporting rates of adverse events in the world. Part of the reason for the relative success of the CARM system is its perceived independence from the Ministry.
The local Medicines Adverse Reactions Committee plays a role in advising Medsafe if it needs to take action over harms caused by drugs. Issues often have a New Zealand-specific dimension. For example, Medsafe took steps to warn women and doctors about the dangers of 3rd generation oral contraceptives, which were used in large numbers here (150,000 women). In Australia no such action was taken as it was not seen as a major issue because only 5,000 Australian women were using these OCs.
There are considerable concerns that if these functions are not locally run, the reporting rates of adverse events will fall, and that a trans-Tasman agency will be less accessible and less responsive to specifically NZ issues.
Complementary health care
The proposal includes complementary health care products and this is causing concern. Some members of the complementary health care industry argue that choice will be restricted and costs will escalate. (See www.choices.org.nz) Fears of excessive restrictive regulation are exacerbated by an existing Australian regime which is seen as draconian. The industry worked with government to produce a bill suited to New Zealand covering complementaries but this has been shelved. New Zealand comple-mentaries are worried that they are seen as minor players/junior partners who will be subsumed and bullied by Australia and multinational companies who have already met the Australian requirements; and that real consumer and local industry representation is not involved in ongoing planning and implementation. Certainly representatives from the complementary sector at the advertising meetings are multinationals who are seen to have a trans-Tasman focus. The complementary sector also needs to be treated as a legitimate player within the field and allowed to make self determining decisions within the context of the agency. There is a feeling that they are essentially snake oil merchants and past experience has seen them targeted disproportionately. A recent revealing example has been the response to kavakava compared to the responses to HRT drugs. The alternative is to lobby to pull complementary medicines out of this framework altogether.
The proposed scheme covers a huge range of products and activities so there are efforts to exclude certain categories of product from the system. The tension arises around what should be included in pre-vetting processes and what can be left to be picked up in complaints processes. The exclusions relate to low-risk products (devices and complementaries) with the suggestion that they can be registered without any pre-vetting. Exclusions can also relate to categories of people. There is a proposal that advertisements to health professionals would be exempt from pre-vetting procedures The assumption is that problems will manifest themselves in the complaints system.
Womens Health Action has difficulty with some of the proposed exclusions. We were delighted to see that medical devices, such as unmedicated IUDs, breast implants, hip joints, pacemakers, heart valves, and so on, would be regulated. At present there is no regulation of these, even though this has been promised since a Ministry IUD Advisory Committee recommended action in 1986. Devices implanted or placed in the body can do serious damage before people complain or the problem is identified. There is no justification for treating devices differently than medicines.
We disagree in principle with excluding advertising for health professionals. We believe advertising is advertising no matter the audience. This is compounded by the broad definition of health professional being proposed by the Health Professional Competence Assurance Bill and the experience with direct-to-consumer advertising in New Zealand. We don't believe that advertising is an effective medium for communicating quality information. Our recent HRT education campaign has revealed HRT prescribing practices which suggest that doctors need serious education and some oversight.
Womens Health Action has been involved in the Expert Committee on advertising partly because we have an active interest in direct-to-consumer advertising. We dis-covered the existence of the Experts Committee during our research for a paper on direct-to-consumer advertising. We were invited to attend the Expert Committee meeting in Auckland. At that meeting a number of participants commented they were pleased to see a New Zealand consumer representative. This meeting was being chaired by an Australian consumer representative who had been told there were no interested New Zealand consumers. We were then invited to attend a follow-up meeting in Sydney as New Zealand consumer representative.
WHA had a lively discussion about whether we would accept the offer of an airfare to Sydney on the basis that we were consumer representatives. We have some firmly held views and principles on consumer representation and felt uncomfortable about the issues of accountability around this process.(cf, www.womens-health.org.nz/consrep.htm) We had effectively inserted ourselves into the process at a late stage and, while consumers, did not feel we had done so as consumer representatives. There seemed to have been no clear strategy for the inclusion of New Zealand consumers built into the process. In New Zealand, there is no mechanism for engaging consumer groups at a national level and no consumer reference group available to nominate suitable people who will report back to the community. We have identified the need for this and have put forward funding proposals to establish a consumer network. These have not been funded. Our decision to accept was made because
* We had an interest in the area and were well acquainted with the issues
* The Experts Committee had few New Zealand voices and fewer consumer voices
* The meeting would provide us with an opportunity to identify key issues for NGOs and consumers and report back to the community.
When we rang to accept the invitation, Medsafe made endorsement from the community a condition of funding. This was a difficult request given the problems outlined above, and was complicated by a one week timeframe in which to achieve this. We felt this request revealed a poor understanding of the community and the accepted processes for securing representational endorsement. We would like to thank National Council of Women, Platform, Grey Power, the Federation of Womens Health Councils and Auckland Womens Health Council for their written endorsement. We are currently preparing a report for these groups on the Sydney meeting. It will be available for general distribution and a copy will also be sent to Medsafe for distribution.
Consumers need to have their interests appropriately addressed in the governance and management of an agency dealing with drugs and therapeutic products. Decisions and processes have implications for the elderly, mental health consumers and groups such as AIDs survivors who have contact with heavy duty pharmaceuticals as part of their everyday lives. It is important that consumers have the opportunity to do this themselves and that consumer representatives have the ability to solicit input and report back to these communities. There is provision throughout the harmonisation proposal for consumer representation in the governance structure and on committees in the work of the agency. Australia has two accredited consumer advocacy groups but there is no such body in New Zealand. This means that when NZ consumer participation is proposed, there are a range of solutions to meeting the need. They range from ill-defined lay participants to a nominee from the New Zealand Consumers Institute. Womens Health Action finds none of the suggested consumer representatives satisfactory. We would like a truly representative platform and a system of accountability and are working towards this. The first step is a consumer email list.