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

An army of doctors. Access to an experimental drug. A special patient gets special care.

Trump’s caregivers are sparing nothing in their attempt to treat his coronavirus infection.

From his team of providers to his helicopter flight to the hospital to the experimental drug that fewer than 10 others have received outside a clinical trial, Trump has access to care available to few of the other 7.3 million people in the United States infected so far by the coronavirus. Even with symptoms that Conley appeared to describe as moderate at worst, the 74-year-old president is the VIP of VIPs in his battle against covid-19, the disease caused by the coronavirus.

“I think about it as a realist,” said Robert Wachter, professor and chair of the department of medicine at the University of California at San Francisco. “He is the president of the United States. For him to get the most vigorous therapies . . . even if we have not yet reached the point where there is enough evidence to make it available to everyone in the country, doesn’t seem off to me.”

“I think access to treatment and frequent monitoring is probably a good thing for evolving medical care of a new disease,” added John W. Mellors, chief of infectious diseases at the University of Pittsburgh Medical Center.

VIP treatment is a feature of American medicine. Major hospitals throughout the country have private spaces for celebrities, the super-rich and the influential, patients who want to be shielded from the public and just may make a large donation if they are happy with their care. They are U.S. citizens and foreign nationals from places including Saudi Arabia, China, Canada and Mexico.

The coronavirus pandemic, in contrast, has featured memorable scenes of community hospitals from New York to Texas nearly overwhelmed by desperately sick people, of doctors and nurses working around-the-clock with insufficient equipment. At least 208,000 people in the United States have died of covid-19, according to a Washington Post analysis.

Trump has been widely criticized for his handling of the pandemic, especially in the early months, when the federal government left states to scramble for face masks, ventilators and other equipment needed by caregivers and patients. That performance is his greatest weakness in next month’s election against his Democratic rival, former vice president Joe Biden, polls show.

In addition to his suite at the military hospital in Bethesda, Md., the most notable advantage Trump enjoys is access to an experimental antibody treatment that has been given to fewer than 10 people under the “compassionate use” program that the president’s doctors employed to obtain the drug from its manufacturer, Regeneron Pharmaceuticals. About 2,000 others have received the drug or a placebo because they are enrolled in the company’s clinical trial.

“The VIP treatment around antibodies is ethically troubling and yet there are many, many other things we do to support the president that are different from what you and I get, and we live with it every day,” Wachter said.

The drug has been touted as a potential game-changer by prominent scientists — a way

SilverSneakers: Gym Access, Online Fitness Classes and More

SilverSneakers is a program that gives Medicare-eligible adults access to gyms, community centers, online fitness classes, healthy living discounts and a fitness app and more. SilverSneakers is included in many Medicare Advantage plans and some Medical Supplement plans.

What is SilverSneakers?

Exercise is a crucial part of staying healthy for people of all ages, including older adults. Federal health guidelines recommend that adults participate in at least 150 minutes per week of moderate-intensity aerobic physical activity or 75 minutes of vigorous-intensity aerobic activity — or a combination of the two.

The SilverSneakers program is designed to help older Americans reach those goals by providing access to fitness facilities, online fitness classes and online workouts. Members get a basic membership to participating gyms and other locations, which typically includes access to cardio and strength equipment and amenities like pools and walking tracks.

Exercise classes may include cardio and strength classes, water aerobics and yoga. And if the gym isn’t your preference, SilverSneakers FLEX classes are taught at recreation centers and local parks, among other locations.

The program’s on-demand videos offer programs to help improve flexibility and mobility, balance, cardio or strength. There are videos on yoga, tai chi, fall prevention and nutrition information.

Although the membership is geared toward those 65 or older, there is no age requirement for participation if your Medicare plan offers this option. You simply must be eligible for Medicare.

Where is it available?

SilverSneakers gives older adults access to over 17,000 fitness locations nationwide, as well as live fitness classes designed for seniors and a library of online video workouts. To find a gym or class near you, you can use the online location tool or download the SilverSneakers GO app for iOS or Android.

Additionally, you can visit any SilverSneakers member location in the network. (You’re not limited to those in your area or only one location.)

How much does it cost?

There is no cost for SilverSneakers — it’s included with some Medicare Advantage plans and some Medicare Supplement (MediGap) plans. If you’re not sure if you’re covered, check with your plan provider.

Which Medicare Advantage plans cover SilverSneakers?

SilverSneakers is offered by some Medicare Advantage plans and a few MediGap plans. To find out what health plans in your area offer SilverSneakers as a benefit, use the plan’s online tool to locate participating health plans.

What’s happening now

COVID-19 is still a major concern for many older Americans since they’re at higher risk, and they’re more likely to have a preexisting condition that could lead to complications. The Centers for Disease Control and Prevention recommends avoiding crowds of all sizes, including the mall, the gym and community centers. There may be more specific limitations in your area if case numbers are high.

If your local SilverSneakers facility isn’t open for business or you aren’t comfortable going there, consider using SilverSneakers on-demand workout videos from home.

Additionally, even if you aren’t a SilverSneakers member, classes are currently available on its Facebook page for everyone.

Telehealth Patient Satisfaction Surges During Pandemic but Barriers to Access Persist, J.D. Power Finds

Amwell Ranks Highest among Direct-to-Consumer Brands; Cigna Ranks Highest among Health Plans

Telehealth has emerged as one of the bright spots in the “new normal,” giving patients the ability to meet virtually with healthcare providers from the safety and comfort of home. However, the technology is still experiencing growing pains. According to the J.D. Power 2020 U.S. Telehealth Satisfaction Study,SM released today, patient satisfaction with telehealth services has been increasing during the COVID-19 pandemic, but several barriers to access still exist for many patients, including those most at risk.

This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20201001005094/en/

J.D. Power 2020 U.S. Telehealth Satisfaction Study (Graphic: Business Wire)

“The COVID-19 pandemic has been a moment of truth for telehealth, and, by most accounts, the technology is rising to the challenge and delivering a high degree of satisfaction among those who use it,” said James Beem, managing director of global healthcare intelligence at J.D. Power. “However, even though the public awareness with Telehealth is higher due to the influence of COVID-19, the barriers for the consumer to engage with the technology has been a consistent theme in our research.”

Following are some key findings of the 2020 study:

  • Great patient experience: The overall customer satisfaction score for telehealth services is 860 (on a 1,000-point scale), which is among the highest of all healthcare, insurance and financial services industry studies conducted by J.D. Power.

  • Barriers to access persist: Though telehealth has been pitched as a solution to improve access to healthcare for everyone, more than half (52%) of telehealth users say they encountered at least one barrier that made it difficult to use telehealth. The most common hurdles are limited services (24%); confusing technology requirements (17%); and lack of awareness of cost (15%). Additionally, 35% of telehealth users indicate they experienced a problem during a visit. Tech audio issues (26%) are the most common problem.

  • At-risk patients have lower levels of satisfaction: Overall satisfaction is 117 points lower among patients with the lowest self-reported health status than among patients who consider themselves to be in excellent health. Similarly, healthier patients are significantly more likely to understand the information provided during the visit, receive clear explanations, feel their visits are highly personalized and obtain a high-quality diagnosis.

  • Safety becomes a top driver of utilization: Among patients who used a telehealth offering this year, 46% say their top reason for choosing telehealth was safety. That compares with just 13% in 2019.

Study Rankings

Amwell ranks highest in telehealth satisfaction among direct-to-consumer brands, with a score of 885. Doctor on Demand (879) ranks second.

Cigna ranks highest among payers of health plan-provided telehealth services with a score of 874. Kaiser Foundation Health Plan (867) ranks second and UnitedHealthcare (865) ranks third.

The J.D. Power U.S. Telehealth Satisfaction Study, now in its second year, measures consumer satisfaction with their telehealth service experience based on four factors (in order of importance): customer service (42%); consultation (28%); enrollment (19%); and billing and

WTO Should Play Role in COVID-19 Medicine Access: Candidate | World News

GENEVA (Reuters) – A key contender to head the World Trade Organization told Reuters on Tuesday she thinks the body should play a role in helping poorer countries access COVID-19 drugs and vaccines, and this topic should be part of negotiations if she wins.

Nigeria’s Ngozi Okonjo-Iweala, seen by delegates as a top candidate to lead the WTO, currently chairs the GAVI vaccine alliance board and stressed her credentials among five remaining candidates “at the intersection between public health and trade”.

“Trade can contribute to public health – seeing that connection, invoking those (WTO) rules, actively discussing COVID-19 issues and how WTO can help,” the former finance minister and World Bank managing-director said. “For me, that would be a priority.”

Okonjo-Iweala, one of two African candidates in the second of three rounds, says she is discussing with members the options for using WTO intellectual property rules to get special licences to deliver COVID-19 medicines to poorer countries.

“This is wonderful because it could also contribute to more accessibility and affordability eventually for vaccines and for therapeutics,” she said, adding she hoped such discussions would be part of a planned 2021 trade negotiations package.

She also said she would urge the at least 80 countries and territories which have raised barriers in response to the COVID-19 crisis, including on medical equipment, to lower them.

Interest in COVAX – the joint programme between GAVI and WHO to distribute COVID-19 vaccines equitably – is growing, she said. A GAVI spokesman confirmed there were 167 now committed to the plan – 75 wealthier economies and 92 poorer economies.

“Countries have been coming on their own … We are getting close to to the immediate goal (of $2 billion) which is very comforting because that means we can make advanced purchase commitments for vaccines,” she said, referring to the initial fund-raising goal to supply low- and middle-income countries.

China, Russia and the United States remain outside the plan.

Okonjo-Iweala urged African countries not to hedge their bets and sign separate procurement deals to COVAX, at least not in the initial phase which anticipates giving them enough doses to vaccinate up to 20% of their populations.

“If you make a mistake and procure the wrong thing people will run away,” she said, referring to vaccine scepticism.

She repeated pledges to reform the WTO and said she was having “constructive conversations” with Washington – a deep critic of the body and whose support is vital for any DG’s future tenure.

In a possible turning point in the race last week, two delegates said she received a standing ovation at a presentation before African ambassadors at which her rival, Kenya’s Amina Mohamed, also presented.

(Reporting by Emma Farge; editing by Stephanie Nebehay and Giles Elgood)

Copyright 2020 Thomson Reuters.

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