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The Conversation: How patent law and medicine regulations could affect New Zealand’s access to a Covid-19 vaccine

Prime Minister Jacinda Ardern speaks to a lab technician during a visit to the Malaghan Institute of Medical Research at Victoria University on August 27. Photo / Getty Images

By Jessica C Lai of The Conversation

New Zealand has allocated an undisclosed sum, in the order of hundreds of millions of dollars, to access Covid-19 vaccines when they become available.

The funding is on top of a $37 million vaccine strategy, but the government has not released specifics because of commercial sensitivities that “could prevent the best possible deal for New Zealanders”.

Apart from the intricacies of global efforts to develop, test and distribute a vaccine, there are also domestic legal issues the government might need to consider, particularly in patent law and the regulatory review of medicines.

Legislative changes to future-proof the law could avoid delays and lower access costs.

Patent law and access

Some fear pharmaceutical companies could patent a Covid-19 vaccine and hold the world hostage, demanding monopoly prices.

But to get a patent the invention has to be novel and non-obvious. There is possibly enough public information about vaccines currently under investigation or in trials to make it difficult for a company to prove novelty or non-obviousness.

Even if a vaccine were in some way patent-protected in New Zealand, the government is already negotiating for access.

If the negotiations fail or the prices demanded are too high, New Zealand law allows for compulsory licensing and Crown use of patented inventions. Both are also allowed under international trade law.

At the moment, an application for a compulsory licence is only possible after negotiations with a patent owner have failed and if three years have lapsed since the patent was granted (or four years since the patent application was filed). But international trade law states that any requirement to negotiate with the patent owner may be waived in the case of a national emergency or other circumstances of extreme urgency.

A model of a coronavirus is displayed next to boxes for Covid-19 vaccines at an exhibit by Chinese pharmaceutical firm Sinopharm in Beijing. Photo / AP
A model of a coronavirus is displayed next to boxes for Covid-19 vaccines at an exhibit by Chinese pharmaceutical firm Sinopharm in Beijing. Photo / AP

Parliament should consider amending New Zealand patent law to be clear that, in a national emergency, anyone can apply for a compulsory licence at any point, without the requirement to negotiate with the patent owner first.

Both international and New Zealand law allow pharmaceutical products manufactured under a compulsory licence to be exported to address a serious public health problem in another country. This might prove important for Pacific nations.

Government emergency access

Government departments can use patented inventions for the services of the Crown. This can be delegated, for example, to a local pharmaceutical manufacturing company.

In an emergency, there is no requirement for the Crown to negotiate a licence with the patent owner first. Nor does the Crown need to wait for a certain period of time to lapse.

This currently covers protecting New Zealand’s security or defence, or managing a state of emergency. A global pandemic can

How patent law and medicine regulations could affect New Zealand’s access to a COVID-19 vaccine

New Zealand has allocated an undisclosed sum, in the order of hundreds of millions of dollars, to access COVID-19 vaccines when they become available.

The funding is on top of a NZ$37 million vaccine strategy, but the government has not released specifics because of commercial sensitivities that “could prevent the best possible deal for New Zealanders”.

Apart from the intricacies of global efforts to develop, test and distribute a vaccine, there are also domestic legal issues the government might need to consider, particularly in patent law and the regulatory review of medicines.

Legislative changes to future-proof the law could avoid delays and lower access costs.

Patent law and access

Some fear pharmaceutical companies could patent a COVID-19 vaccine and hold the world hostage, demanding monopoly prices.

But to get a patent the invention has to be novel and non-obvious. There is possibly enough public information about vaccines currently under investigation or in trials to make it difficult for a company to prove novelty or non-obviousness.




Read more:
Whoever invents a coronavirus vaccine will control the patent – and, importantly, who gets to use it


Even if a vaccine were in some way patent-protected in New Zealand, the government is already negotiating for access.

If the negotiations fail or the prices demanded are too high, New Zealand law allows for compulsory licensing and Crown use of patented inventions. Both are also allowed under international trade law.

At the moment, an application for a compulsory licence is only possible after negotiations with a patent owner have failed and if three years have lapsed since the patent was granted (or four years since the patent application was filed). But international trade law states that any requirement to negotiate with the patent owner may be waived in the case of a national emergency or other circumstances of extreme urgency.

Parliament should consider amending New Zealand patent law to be clear that, in a national emergency, anyone can apply for a compulsory licence at any point, without the requirement to negotiate with the patent owner first.

Both international and New Zealand law allow pharmaceutical products manufactured under a compulsory licence to be exported to address a serious public health problem in another country. This might prove important for Pacific nations.




Read more:
Why ‘vaccine nationalism’ could doom plan for global access to a COVID-19 vaccine


Government emergency access

Government departments can use patented inventions for the services of the Crown. This can be delegated, for example, to a local pharmaceutical manufacturing company.

In an emergency, there is no requirement for the Crown to negotiate a licence with the patent owner first. Nor does the Crown need to wait for a certain period of time to lapse.

This currently covers protecting New Zealand’s security or defence, or managing a state of emergency. A global pandemic can trigger a state of emergency, as happened in New Zealand in March 2020. But to future-proof the law, parliament should consider amending the definition of “emergency” to specifically include health

Relaxed regulations have calming effect on Cy-Fair area nursing homes

After a heart-breaking five months of isolation, seniors in area nursing homes and assisted living centers have some new options for seeing their loved ones.

At a press conference on Sept. 17, Gov. Greg Abbott announced a new visitation guidance for eligible nursing homes, assisted living facilities, intermediate care facilities, home and community-based service providers, and inpatient hospice effective Thursday, Sept. 24.

“I certainly applaud Gov. Abbott and the HHSC (Health and Human Services Commission) on working to reduce and relieve some of the restrictions with visitation,” said Derek Prince, CEO HMG Healthcare who manages Park Manor of CyFair.


“We value the psycho and social well-being and family relationships,” he said. “It’s been extremely trying for our patient population and our families. We’re excited to be able to put this stuff together,” he said.

With the relief comes a bit of grief as well.

“They are also burdensome and duplicitous from the guidance we received from CMS (Centers for Medicaid and Medicare Services). It’s somewhat confusing at times,” he said.

“Slowly but surely we’re getting our arms around it and hopefully making a difference” the CEO said.

Prince described the visits under two categories: a regular visitor policy and an essential care worker designation.

Under the regular visitor policy, they are based on county positivity rates whether they are designated as indoor or outdoor visits. They can consist of outdoor no contact visits, open window visits, or indoor visitation with the use of plexiglass safety barriers, all attempts at preventing the spread of the coronavirus. There can be no physical contact between residents and visitors.

“Those can be scheduled by any loved one on our website with the Schedule A Visit button at an appropriate time,” he said.

The visits are allowed seven days a week and they allow for cleaning between each visit.

The potential is there for those visits to be taken away in the event of a breakout with patients or even staff.

The second category is an essential care worker designation. A resident or responsible party can designate two essential caregivers for each resident. They’re not required to adhere to social distancing. There can be contact and touch and can be in a patient’s room. Staff and other residents are still required to socially distance with the visitors.

“On the front end we have to provide training for all of the essential caregivers on facility policies and procedures regarding infection control, PPE, and hand hygiene. They still have to go through testing protocols to make sure they are safe,” Prince said.

Only one caregiver can visit a resident at a time. Some facilities place a time requirement on that from 30 minutes to an hour. Proper PPE must be used at all times during these scheduled visits, and the caregiver must test negative for COVID-19 within the previous 14 days