How Patent Law and Medical Regulations Could Affect New Zealand’s Access to a COVID-19 Vaccine

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New Zealand has allocated an undisclosed sum, in the hundreds of millions of dollars, to access COVID-19 vaccines when they become available.The funding comes on top of a NZ $ 37 million vaccination strategy, but the government has not released details due to trade sensitivities that “could prevent the best possible deal for New Zealanders.”

In addition to the intricacies of global efforts to develop, test, and distribute a vaccine, there are also domestic legal issues the government may need to consider, particularly in patent law and regulatory review of drugs.

Legislative changes aimed at ensuring the sustainability of the law could avoid delays and reduce access costs.

Patent law and access

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

But to get a patent, the invention must be new and not obvious. There may be enough public information about vaccines currently under investigation or in testing that it is difficult for a company to prove novelty or non-obvious.


Also read: Whoever invented a coronavirus vaccine will control the patent – and, most importantly, who will use it


Even if a vaccine was somehow protected by a patent in New Zealand, the government is already negotiating to access it.

If negotiations fail or the prices charged are too high, New Zealand law permits compulsory licensing and Crown use of patented inventions. Both are also permitted under international trade law.

At the moment, an application for a compulsory license is only possible after the failure of negotiations with a patent holder and if three years have passed since the grant of the patent (or four years since the filing of the patent application ). But international trade law states that any obligation to negotiate with the patent owner can be waived in the event of a national emergency or other circumstances of extreme urgency.

Parliament should consider amending New Zealand’s patent law to make it clear that, in a national emergency, anyone can apply for a compulsory license at any time, without having to negotiate with them first. the patent owner.

International and New Zealand law allows the export of pharmaceutical products manufactured under compulsory license to solve a serious public health problem in another country. This could prove to be important for the countries of the Pacific.


Read also: Why “vaccine nationalism” could condemn a plan for global access to a COVID-19 vaccine


Government emergency access

Departments can use patented inventions for Crown services. This can be delegated, for example, to a local pharmaceutical manufacturing company.

In an emergency, the Crown is not required to first negotiate a license with the patent owner. The Crown also does not have to wait a certain amount of time.

This currently covers protecting the security or defense of New Zealand, 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 make the law permanent, Parliament should consider changing the definition of “emergency” to specifically include health emergencies. .

The state use provisions would allow the government to make and use any vaccine or patented drug and sell any product in excess of its requirements. This would allow the sale to a Pacific country for a nominal amount.

All new drugs must have regulatory approval from Medsafe.
Hagen Hopkins / Getty Images

A vaccine must be safe

Unlike patent protection, there are no exceptions to regulatory review of drugs. Anyone wishing to distribute, sell or advertise a drug in New Zealand must have regulatory approval from Medsafe.

Applicants must submit information and data on the drug product and the proposed label uses. This includes reports on all tests and clinical trials, as well as safety and efficacy data. Medsafe decides whether or not to approve a drug based on this information.

The process can be long and delay access to a vaccine. But Parliament could legislate on a “highway” of restricted regulatory review – if regulatory approval for a vaccine is granted elsewhere, such as the European Union, Australia or Canada, it could automatically gain approval in New Zealand.

Other aspects of the regulatory process will determine the cost of a vaccine.

Generic drugs – mostly knockoffs – make pharmaceuticals cost competitive. Generic pharmaceutical companies generally do not generate data or perform clinical trials. Instead, they show their product to be equivalent to the original drug and ask Medsafe to use the original data to determine safety.


Read also: Creating a COVID-19 vaccine is only the first step. It will take years to manufacture and distribute


But Medsafe is not allowed to use the data it receives for one application for the evaluation of another for five years. Any vaccine could become obsolete within five years.

There is an exception allowing Medsafe to use data if it is “necessary to protect the health or safety of members of the public”. It can be argued that competition, lower prices and wide distribution of a COVID-19 vaccine meets this requirement. Parliament should change the law to make this clear.

If we allow generic companies to rely on data from original innovative companies, there would be at least two entities in the market competing with the same vaccine.

We don’t know what’s coming, but that shouldn’t stop us from perpetuating our laws and regulatory processes for the various possibilities. New Zealand must take advantage of the flexibilities of international trade law to get a COVID-19 vaccine, maybe even two or three, to New Zealanders as quickly and inexpensively as possible.

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