New Rule For Faster Medicines Approvals Welcomed By Patients

Brain Tumour Support NZ welcomes the announcement today from Associate Health Minister David Seymour that promises to speed up Medsafe’s approval process for new medicines.

The new rule, known as the “Rule of Two”, allows Medsafe to approve new medicines within 30 days if that medicine has already been approved by two recognised jurisdictions. Such jurisdictions will initially include Australia, the United States, Canada, the United Kingdom, the European Union, Singapore and Switzerland.

Chief Executive of Brain Tumour Support NZ, Sarah Verran, said that the Rule of Two will provide meaningful benefits to brain tumour patients, especially those with highly malignant tumours for which there is currently no cure, by bringing them to market sooner.

“Sadly, brain cancers often don’t respond to traditional treatments like surgery, radiation or chemotherapy, which means the only hope for these patients are new targeted treatments, such as immunotherapies or cell based therapies”, Sarah said.

“New Zealand is typically at the end of the queue when it comes to new medicine approvals, with the US, UK and Australia approving medicines months or years faster than New Zealand. Brain tumour patients can’t wait months or years for these medicines, they need them today,” Sarah said.

She emphasised that Medsafe approval is only the first step in obtaining widespread access to new medicines, which often come with a hefty price tag. Following Medsafe registration, the medicines must still be funded by Pharmac before being affordable for most patients.

Sarah cites the example of bevacizumab, which was approved by Medsafe to treat brain cancer in 2009, and for which patients are still fighting for access to 16 years on.

While praising the Rule of Two as a step in the right direction, Brain Tumour Support NZ is seeking further reforms to speed up the registration process for new medicines, especially those being developed for rare cancers and disorders such as brain tumours.

“Many pharmaceutical companies are slow to register their products in New Zealand. They regard us as a small market and a tough market in which to gain reimbursement (from Pharmac),” according to Sarah.

“We believe Medsafe should instigate schemes such as an Orphan Drug Designation, as many other countries have, which offer incentives for companies to register their products here. Such incentives could include an exemption of registration fees or extended patent protection,” she said.

“A simpler, faster registration process such as that promised by the Rule of Two is a fantastic start and we’re encouraged by the current government’s ongoing commitment to streamline access to new medicines for the benefit of all New Zealanders.”

ABOUT BRAIN TUMOURS 

• Around 350 New Zealanders are diagnosed with primary brain cancer each year representing 1.4% of all  cancers diagnosed. Many more are diagnosed with secondary, or metastatic, brain tumours (cancers  which have spread to the brain from elsewhere in the body). 

• The 5 year survival rate for glioblastoma, the most common type of brain cancer in adults, is just 5%.  Survival rates for brain cancer have not improved significantly in the last 30 years. 

• Around 260 New Zealanders die each year from brain cancer, making it the 10th most fatal cancer. • Brain cancer is the biggest cancer killer of children in New Zealand, being responsible for 42% of all  childhood cancer deaths (almost double that of leukaemia). 

• Brain tumours can affect anyone, of any ethnicity, and at any age. The causes of most brain tumours are  unknown so prevention and screening are not possible. 

Website: www.braintumoursupport.org.nz

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