"Fast-track" for emergency medicines
"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