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February 12, 2003
"Fast-track" for emergency
medicines
The government has announced changes it wants to make to the law
to speed up the assessment and approval of animal and human
medicines, vaccines and pesticides that contain new organisms -
including genetically-modified organisms - or hazardous
substances and that may be required in an emergency.
Generally, these must go through full assessment by the main
decision making body, the Environmental Risk Management
Authority (ERMA), including public notification and consultation
before they can be used here. This means potential delays in
bringing in medicines in a health or biosecurity emergency.
To overcome this, the government is proposing a new fast-track
system to be used to deal with emergencies. Under this proposal
decisions could be made to allow the products to be imported
without the level of detailed information or full formal
processes required under normal circumstances.
"This does not mean these products will not be scrutinised
before the decision is made to use them," the Environment
Minister Marian Hobbs said. "Rather experts will be charged with
weighing up the relative risks and benefits in view of the
situation at the time."
The fact that they have been given the go-ahead for release in a
health emergency would also not affect their status as a new
organism or hazardous substance. Once the emergency was over, a
normal application would need to be made for the medicine,
vaccine or pesticide to be used again.
"This is a vital area for New Zealand, especially in a world
where bioterrorism has become a real threat and where the
disease-free status of our livestock is vital for our valuable
export markets," the minister said.
"The Royal Commission on Genetic Modification, in its July 2001
report, recommended identifying the medicines that might be
needed in an animal or human health emergency and seeking prior
approvals for them.
"Government officials have thoroughly investigated that approach
and found it is not possible. Among the problems they found were
that there would be nothing to guarantee that a particular
product would be available when needed, while giving
pre-approvals to a vaccine for a disease like foot-and-mouth
could raise questions in our overseas markets about New
Zealand's disease-free status."
The government has also put forward changes to the HSNO Act to
streamline approvals for new medicines made from, or containing
new organisms, including genetically-modified organisms.
At present, these medicines have to be approved by Medsafe (for
human medicines) or the Agricultural Compounds and Veterinary
Medicines (ACVM) Unit of the Food Safety Authority (in the case
of animal products) for safety, quality and effectiveness. They
also have to be assessed by the Environmental Risk Management
Authority (ERMA) in terms of risks to the health and safety of
people and the environment.
Under the proposed changes, ERMA could delegate the approval of
medicines that met a set of criteria for 'low risk' to Medsafe
or the ACVM unit alone. To maintain the integrity of the system,
ERMA would set guidelines for approvals and regularly audit
them.
Medicines containing new organisms that did not fit the
'low-risk' criteria would still require full ERMA approval,
including public consultation.
"The Royal Commission on Genetic Modification found the dual
approval system required of all medicines caused confusion and
added to compliance costs for companies wanting to market these
products," Marian Hobbs said.
"The changes we are proposing
will ensure that the cost of obtaining approval to market animal
and human medicines is not so high that it deprives New
Zealanders of potential health and other benefits, but at the
same time ensures measures to protect the health and safety of
the public and the environment are maintained where
appropriate."
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