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Fitness Coalition, LI Law Firm Spearhead Lawsuit Against Cuomo

SYOSSET, NY —Two weeks after Michigan’s Supreme Court overturned the continued emergency executive orders of Gov. Whitmer, a coalition of business owners on Long Island are hoping their own lawsuit will achieve the same result in New York.

The New York Fitness Coalition, an advocacy group of gym owners who came together during the coronavirus pandemic, is leading the class-action lawsuit. A news conference to announce the lawsuit is being held Wednesday at the Sysosset office of The Mermigas Law Group, P.C.

Charlie Cassara founded the New York Fitness Coalition, which sued Gov. Cuomo in July, seeking an injunction of Cuomo’s orders in order for gyms to reopen. This lawsuit, Cassara, says is a broader effort to declare the extended emergency executive orders that Cuomo uses to mandate the COVID-19 business and school regulations as unconstitutional and illegal.

“This wasn’t his job,” Cassara told Patch. Once the original aims of the state of emergency were fulfilled in the early months of the pandemic, the unilateral executive authority of the governor’s emergency powers were no longer needed, or legal, he says.

Cassara owns a health club, SC Fitness, with two Long Island locations. He tells Patch that the regulations his industry has to operate under are “unsurvivable.”

“33 percent capacity is a joke, and then you add six feet, contact tracing—We can’t live under these orders.”

Representatives from other industries including restaurant owners, as well as teachers and parents concerned about the impact of the mandates on education, are also involved in the suit, Cassara says.

“Now regular citizens of New York can jump on board. Cuomo keeps saying he is going to give the authority back to the state [legislatures] and local executives, but every week there is a new excuse.”

A similar legal challenge was raised against Pennsylvania Gov. Wolf, which initially was won before being overturned in federal appeals court.

This article originally appeared on the Syosset Patch

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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

What Is Proposition 23, The Dialysis Clinics Law?

LOS ANGELES, CA — California voters can be forgiven a sense of deja vu, having voted down a law governing dialysis clinics just two years ago. But the 2018 measure and this year’s Proposition 23 are fundamentally different.

Voters in 2018 rejected Prop 8, which sought to cap dialysis clinic profits. Proposition 23, focuses on patient safety and clinic oversight.

So what exactly would Prop 23 do?

It would require dialysis clinics to have a doctor or nurse practitioner onhand when patients are being treated, and it would require clinics to report patient infections to the state and federal government. It would also prohibit clinics from closing without state approval and prohibit them turning away patients because of their source of payment.

Opponents of the measure argue that these requirements are unnecessary and costly. Clinics would be forced to close down, and patients will lose access to the care they depend upon for survival. Supporters, which include the California Democratic Party and the Service Employees International Union-United Healthcare Workers West, argue that the measure is needed to ensure basic standards of care for 80,000 Californians who depend upon dialysis for survival. It is needed to ensure that patients in rural and low-income communities have the same access to quality dialysis care as any patient in the state, they argue.

“This initiative will make common-sense improvements to dialysis treatment that will protect some of the most medically vulnerable people in our society,” reads the official ballot argument in support of the measure. “Don’t listen when the dialysis industry claims the initiative will create huge new costs or say patients will be harmed or claim that it will create a shortage of doctors—those fake arguments are just designed to use patients and the coronavirus pandemic as scare tactics in their dishonest public relations campaign. The fact is, these corporations can easily make these changes and still make hundreds of millions of dollars a year without disrupting our healthcare system. Proposition 23 will make the changes we need to truly protect dialysis patients.”

Opponents of the measure, which include the state Republican Party, the California Medical Association, the California NAACP State Conference and the American Legion, Department of California, argue that this measure will hurt dialysis patients across the state.

“This useless bureaucratic mandate would increase clinic costs by hundreds of millions annually, putting half of all clinics at risk of closure,” reads the official ballot argument against the measure. “Prop. 23 dangerously reduces access to care, putting vulnerable dialysis patients at serious risk…Proposition 23 would take thousands of doctors away from hospitals and clinics—where they’re needed—and place them into bureaucratic jobs at dialysis clinics where they aren’t. This is not the time to make our physician shortage worse.”

Dialysis clinics have spent more than $85 million to defeat the measure, and the Yes on 23 campaign funded by the labor union has spent a little more than $6 million to pass the measure.

This article originally appeared on the Los

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

Trump’s doctor leans on health privacy law to duck questions

WASHINGTON (AP) — President Donald Trump’s doctor leaned on a federal health privacy law Monday to duck certain questions about the president’s treatment for COVID-19, while readily sharing other details of his patient’s condition.

But a leading expert on the Health Insurance Portability and Accountability Act said a more likely reason for Dr. Sean Conley’s selective disclosures appears to be Trump’s comfort level in fully revealing his medical information.

“That’s a little head-scratcher,” said Deven McGraw, a former career government lawyer who oversaw enforcement of the 1996 medical privacy statute. “It’s quite possible the doctor sat down with the president and asked which information is OK to disclose.”


At a press briefing at Walter Reed National Military Medical Center, Conley, the White House physician, reported the president’s blood pressure — a little high at 134/78 — and respiration and heart rates, which were both in the normal ranges.

But when reporters pressed for details on the results of lung scans and when Trump had last tested negative for COVID-19, the doctor demurred, citing HIPAA, as the law is commonly known.

“There is no special protection for lung scans,” McGraw pointed out.

“It really is what the president authorizes to be disclosed,” she explained. “So I am going to have to assume there was a judgment call on what information the president was comfortable releasing to the public.”

The selective disclosure raised more questions about what the president’s doctors aren’t telling the public. Trump returned to the White House later Monday.

House Speaker Nancy Pelosi said it’s “disconcerting” that information coming from Trump’s physicians “must be approved by the president.”

Pronounced “hippah,” the law essentially prohibits disclosure of a person’s medical information without their consent. Many people hear about HIPAA when they call the hospital seeking information about the condition of a relative and they’re told they can’t have it because of the law.

“HIPAA kinda precludes me from going into too much depth in things that, you know, I’m not (at) liberty or he doesn’t wish to be discussed,” said Conley, who holds the rank of Navy commander.

McGraw said there’s a question about whether the White House physician may even be covered by HIPAA. The law is written to apply to doctors and entities that bill for insurance coverage.

That said, a president, like any other individual, has the right to control personal medical information, said Iliana Peters, who also served as a career lawyer overseeing HIPAA enforcement at the Department of Health and Human Services.

“As the person who is the subject of the records, (Trump) owns the right to privacy over his medical record and he gets to decide how that information is shared certainly with the public, and certainly with the media,” said Peters. “That is the case with any one of us as a patient.”

Peters said “there may be multiple things going on here in that certain disclosures have been authorized and others haven’t.”

Speaking on MSNBC, Pelosi argued that a president has an

Fatal cases of COVID-19 at nursing facilities prompt new California law

Patients were moved from Riverside's Magnolia Rehabilitation and Nursing Center in April after staff failed to show up. Gov. Gavin Newsom has signed a law requiring the reporting of deaths during health emergencies. <span class="copyright">(Gina Ferazzi / Los Angeles Times)</span>
Patients were moved from Riverside’s Magnolia Rehabilitation and Nursing Center in April after staff failed to show up. Gov. Gavin Newsom has signed a law requiring the reporting of deaths during health emergencies. (Gina Ferazzi / Los Angeles Times)

With skilled nursing homes hit particularly hard by the COVID-19 pandemic, Gov. Gavin Newsom on Tuesday signed a law requiring those facilities in California to report disease-related deaths to health authorities within 24 hours during declared emergencies.

The law was written in response to concerns that health agencies were slow to respond to outbreaks in skilled nursing facilities because they did not receive timely information about them.

So far, more than 5,630 residents and staff at skilled nursing facilities in the state have died from COVID-19 — 36% of California’s fatalities from the coronavirus. The percentage “reveals the significant weaknesses in the reporting system currently required by these facilities,” said Assemblyman Jim Wood (D-Healdsburg), who introduced the legislation.

COVID-19 outbreaks have occurred at some 1,164 skilled nursing homes and 379 assisted-living facilities in California, according to the state Department of Public Health. The spread at such facilities is alarming to health officials, who note that the virus is especially deadly for the elderly and for those with underlying medical problems.

Wood’s bill requires that records of deaths be compiled into a weekly report on the department’s website, and that residents of the facilities and their families be notified of COVID-19 cases.

“This data, which will be reported in a manner that protects an individual’s privacy, will help the state receive more timely data, helping us respond much more quickly to the spread of communicable diseases, such as COVID-19, and save lives,” said Wood, who is a dentist.

The measure, AB 2644, also puts into law current Department of Public Health guidance that facilities have a full-time staff member who is trained in infection prevention and control.

In the early weeks after the pandemic was declared in March, much of what the public knew about COVID-19 in nursing homes did not come from public health agencies but from relatives, staff members and facility administrators.

The state was slow to report to the public which skilled nursing facilities were dealing with outbreaks.

The reporting requirements in the new law will also help the state meet its mandate to send data on virus infections to the federal Centers for Disease Control and Prevention.

The measure was supported by groups advocating for the elderly, including the California Commission on Aging.

“This pandemic has highlighted the ongoing problems of poor infection control, understaffing and poor regulation of nursing homes here and across the nation,” Betsy Butler, the commission’s chairwoman, said in a letter to lawmakers, adding that the bill “takes meaningful steps to address these issues.”

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