Once a medicine is approved by Medsafe, it’s still up to Pharmac to decide whether to fund it. Photo / 123rf
Once a medicine is approved by Medsafe, it’s still up to Pharmac to decide whether to fund it. Photo / 123rf
OPINION
Economist Eric Crampton has proposed streamlining the approval of medicines by having us “piggyback” on the processes and expertise of other countries.
The proposal found its way into Act’s election policy, and has now made its way straight into the coalition agreement.
I think it’san excellent idea for the health benefits alone. As a way to cut unnecessary red tape, it’s a no-brainer.
At present, medicine approval is the job of Medsafe, a unit within the Ministry of Health with about 60 staff. Medsafe grants approval when a medicine is “expected to have greater benefits than risks if used appropriately”.
Once a medicine is approved by Medsafe, it’s still up to Pharmac to decide whether to fund it.
Under this system, there can be years of delay between a new medicine being approved for use overseas and being approved here.
The policy in the coalition agreement would slash that delay. If at least two trusted overseas regulators have approved a medicine, it would automatically be approved as safe for use here. Medsafe would be able to make an exception in extraordinary circumstances.
In my view, Crampton and Act leader David Seymour are to be congratulated for getting this “Rule of Two” into the coalition agreement. However, it’s not in the new government’s 100-day plan and so far there’s no timeframe for implementing it.
So, what could go wrong?
Medsafe says it is committed to facilitating our access to safe and effective pharmaceuticals. If so, why does Medsafe take an average of 630 days to approve medicines that have often already been approved for use in the US, the UK, the EU and Australia?
I don’t think Medsafe will loosen its control of medicines without a fight. Government agencies are not well known for agreeing to reduce their own scopes of activity, or powers. It’s a bit like turkeys voting for Christmas.
However, with Medsafe, it goes beyond simple patch protection. I’m sure the staff are genuinely committed to keeping us safe from the potential dangers of medicines: the trouble is, they are prepared to impose some very high barriers and costs to do so.
If Seymour manages to get the Rule of Two implemented, and I certainly hope he does, he could then move on to tackle another barrier — excessive restrictions on the prescribing and dispensing of medicines.
Complex regime for prescriptions
We have a complex set of rules that dictates how much medicine a doctor can include in one prescription, and how much medicine a pharmacist can hand over to a customer at one time.
Using pain medications as an example, low-risk medicines like aspirin and ibuprofen can be prescribed for three months at a time, and the full prescription can be picked up from a pharmacy in one go. Even this “low-risk” regime can be expensive for people taking medicines long term because patients have to pay their GP for a repeat prescription every three months.
The next group of medicines can be prescribed for three months, but can be dispensed only one month at a time. An example in this category is nortriptyline for nerve pain. On top of the inconvenience of monthly pharmacy visits, running out of medicines for pain can be a constant worry, especially when you are away from home.
The rules are more restrictive again for a third category, including opioids. Due to concerns these medicines were being over-prescribed in some cases, the Ministry of Health recently recommended a reduction from three-month to one-month prescribing. An example in this category is tramadol, used for moderate-to-severe pain.
Cancer and palliative care patients are among those who may need to take a pain medicine like tramadol for a longer period. They now have to obtain a repeat prescription from their doctor each month. For someone I know, it costs $30 for a one-month script.
Incredibly, when discussing the proposed changes, the Ministry of Health told Cabinet “… it is acknowledged that regulatory change will not have a significant impact on improving safe prescribing practices for opioids, or other controlled drugs”.
The analysis went on to say that the best response is to educate prescribers about safe use, as well as monitoring and taking action in cases of over-prescribing.
Kathy Spencer. Photo / Supplied
Medsafe could more usefully turn its attention to doing exactly that.
The vast majority of doctors could then be allowed to make decisions tailored to the patient in front of them, without unnecessary restrictions, and without wasting their time and our money issuing repeat scripts.
If Seymour, the new Minister of Regulation, can get medicines approved much faster, and loosen restrictions on prescribing and dispensing, he will have made a good start in his fight against red tape.
Kathy Spencer was a deputy director-general in the Ministry of Health, a general manager in ACC, and a tax manager in the Treasury.
