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Leader's LetterMarch 2007
Therapeutic Products and Medicines Bill As many of you will be aware New Zealand First voted in favour of the Therapeutic Products and Medicines Bill going to select committee. The primary reason for our support was the mixed messages we have been receiving about support for the Bill in the community. By supporting the Bill to a select committee we have tried to ensure that the wider community can have their voices heard. Widely divergent views from different industry sectors needed to be balanced and a way forward established. The manufacturers involved make products ranging from pharmaceuticals to medical devices (including such things as heart stents, valves and plasters) and complementary products. Without having the Bill at a select committee it has been very challenging to work with the wide range of messages we have been receiving. The latest version of the Bill is different from that originally proposed by the Minister of State Services in 2002 when the Health Select Committee first reviewed the proposal. The Bill has had a long and complex history. The proposal for a joint agency to regulate pharmaceuticals, medical devices, and complementary medicines has been around for six years during which time the debate about the merits of the proposed Authority has been vigorous - and the facts have sometimes been ignored. We must be clear about several critical aspects of this matter. The first is that the pharmaceuticals and medical devices industries are generally supportive of this move, while the complementary medicines industry is divided. New Zealand First has been lobbied by both sides. We have heard from manufacturers of therapeutic goods, consumers, and lobby groups. We have had several well-publicised concerns about the establishment of a joint regulatory agency with Australia and we have lobbied hard to have these concerns resolved. The first was that of sovereignty. We wished to avoid any possibility of New Zealand being treated as another Australian state in any regulatory regime. This issue has now been resolved and under the proposed regime New Zealand will have equal status with Australia. A range of checks on the new agency will be held in New Zealand hands, including the ability to have the agency appear before a select committee. This is where much of the misinformation on the proposed agency has arisen. This is not an Australian takeover - we are assured of that. It is a genuine joint agency, with New Zealanders looking after New Zealand interests and Australians looking after their interests, despite the information that is being heard to the contrary. The most crucial aspect of this shift is that it has fundamentally altered the way that Australia will enter its negotiating position on joint future regulatory regimes - that is, no longer will New Zealand settle for anything less than equal status. This is a significant shift, and it is one that New Zealand First has helped secure. Other issues relate to the cost of the proposed agency and the impact of this on the local complementary medicines industry. Two background matters have to form part of these considerations. The first is that the situation of an unregulated complementary goods industry would have ended one way or another. If the joint agency did not proceed a local regulatory regime was to be implemented. Both would add costs to the industry and cause the removal of some products which did not meet the regulatory standards. From a health and safety point of view, this is vital. Consumers need to know that what is written on an ingredient label is what is actually contained in the product, and at the level specified. We often hear that complementary products must be safe because there have been no deaths attributable to them. The reality is that many patients who are using - or have recently used - complementary medicines do not tell their healthcare professional about this. Many healthcare professionals don’t ask their patients and even fewer record the use of complementary medicines on patients’ medical records. The end result is that many healthcare professionals would not consider the use of complementary medicines as a potential cause of any adverse reactions described by patients and consequently the use of such medicines would not be recorded in any medical notes or even considered routinely in the certification of any death. As in other countries there is substantial under-reporting of any adverse reactions. Secondly, the costs need to be put into perspective. The total cost of the proposed new agency for complementary medicines is around $18 million a year. New Zealand First has secured a 50 percent subsidy. This brings the cost to $9 million. Given that an estimated 60 percent of New Zealanders use these products this equates to a cost of around $3 per person per year. The registration will also be phased in over five years; there will be time for manufacturers to adjust. The complementary medicines industry is not unified and the claims and counterclaims on all sides are quite exaggerated. Regulation was inevitable and the new agency will provide a high standard of regulation at a lower cost. Companies who export to Australia, North America and Europe already have to meet equivalent standards and they are generally supportive of the joint agency. This legislation will actually give them a reduction in the costs that they currently incur and encourage some of the smaller companies to export. Ultimately, this is a matter of balancing widely different views on the way forward. For New Zealand First, the achievement of a 50 percent subsidy, the protection of New Zealand’s sovereignty, and the opportunity for informed debate, tipped the scales in favour of supporting this Bill going to a select committee. We now await the report back from that committee. Barbara Stewart MP
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