Boosted Fines May Be Short-lived

Thursday, June 23rd 2005

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Long-promised new Therapeutic Goods Administration (TGA) sanctions and penalties, finally revealed in draft legislation sent to industry representatives in recent weeks, could be cut short by trans-Tasman harmonisation.

According to Dr Tony Lewis, executive director of the Complementary Healthcare Council which represents complementary healthcare businesses in Australia, the TGA has been unable to say how the new penalties will operate once joint regulation comes into effect.

"We can''t quite figure out the implications for trans-Tasman. We''ve asked will the legislation be continued on post trans-Tasman and non-one seems to know what will happen," Dr Lewis said.

"I don''t know how it will work in a joint regulatory environment. If it were intended that there be mirror legislation in New Zealand, it could be a barrier to trans-Tasman."

The bill containing the new penalties - which include criminal sanctions and fines of up to $500,000 for an individual and $5 million for a company for breaches of TGA regulations - is due to be presented to the Australian Parliament this week according to the schedule of legislation for the winter sessions, but there is no equivalent bill scheduled in NZ.

Lesley Clarke, chief executive of the Researched Medicines Industry in NZ said, "My understanding is that the TG Amendment Bill is a domestic matter for Australia and separate from what is being progressed between Medsafe and the TGA for the JTA. What the rules will be for sanctions under the JTA legislation has yet to be agreed and the industry on both sides of the Tasman will be consulted in due course. In the interim, if Australia sees the need to change its current rules now (rather than wait for the JTA) they are of course free to do so - just as we would be if there was a matter we needed to address here. Whatever is passed in Australia in this interim period will not necessarily have application under the JTA as NZ and Australia will have equal say on all matters from Ministerial Council down."

However, the Australian government has claimed that it already has Medsafe''s agreement to the legislation.

Medsafe team leader for trans-Tasman, Susan Martindale, said, "The bill you refer to, and the associated penalties, are a domestic bill for Australia only. Australian and New Zealand officials are working on sanctions and penalties that would apply under the joint regulatory scheme. They have not been finalised."

Although Medicines Australia and the Australian Self-Medication Industry have both said they find the amendments to TGA sanctions acceptable and feel they will not have a marked effect on the bigger end of the industry, Dr Lewis said smaller companies represented by his peak body were worried over a lack of clarity in, and consultation about, them.

"For smaller players the big penalties are a real issue because they could drive some out of business," he said. The lack of a scale of penalties in the bill and a right of appeal only to the TGA or the Federal Court were problematic as well.

Dr Lewis criticised a lack of consultation, saying it appeared the TGA was determined the bill should be pushed through quickly despite sending a draft out to industry bodies. Much of the practical detail would have to await the publication of guidelines which were not subject to parliamentary scrutiny, he said.

"We are being asked to trust the regulator that the legislation is OK and the guidelines will be OK," Dr Lewis said.

Footnote from Ideal Health

Related articles can be found here:

Bitter pill: Govt surrenders $200m industry to Australian control

Complementary Health Response Disappoints Sue Kedgley

Govt Suffers Setback on Trans-Tasman Plans

NZ Health Trust Newsletter

Pharmac Warns Huge Fees Will Price Medicines Off the Shelf

Speech by Green Health spokesperson Sue Kedgley to the Natural Healthcare Policy Debate

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