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Canada enacts new regulations before US drug import rule | United States

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New Trump administration rule allowing US pharmacists and wholesalers to import prescription drugs in bulk from Canada comes into effect Monday.

The Canadian government has announced new measures it said are designed to prevent drug shortages, only days before a new Trump administration rule would allow pharmacists and wholesalers in the United States to import drugs from Canada.

In a statement on Saturday, Canada said that as of Friday certain drugs intended for the Canadian market were barred from being distributed outside the country “if that sale would cause or worsen a drug shortage”.

Companies also must provide the government with information about existing or potential shortages when requested. Those requests must be answered within 24 hours if there is a serious or imminent health risk, the statement said.

“Our healthcare system is a symbol of our national identity and we are committed to defending it. The actions we are taking today will help protect Canadians’ access to the medication they rely on,” Canada’s Health Minister Patty Hadju said.

US President Donald Trump announced plans late last year to allow US states and Indigenous governments to set up programmes to import prescription drugs from Canada as part of an effort to lower what are often exorbitantly high costs for American consumers.

That new regulation, known as the Importation of Prescription Drugs rule, comes into effect on Monday.

Under the new regulations, Indigenous governments, pharmacists and wholesalers will be allowed to propose drug importation proposals to the US Food and Drug Administrations (FDA).

Importers must demonstrate how those proposals respect US health and safety regulations and help reduce costs, the rule states.

“The purpose … is to achieve a significant reduction in the cost of covered products to the American consumer while posing no additional risk to the public’s health and safety,” according to the new rule.

Ottawa has said importing drugs from Canada would not help address high costs in the US since the Canadian market of prescription drugs represents only two percent of global sales.

The cost of prescription drugs in the United States is often exorbitantly high [File: George Frey/Reuters]

But several US states, including Florida and Vermont, have expressed an interest in importing drugs from Canada, the head of the US Department of Health and Human Services (HHS), Alex Azar, said last year, Reuters News Agency reported.

On November 23, Republican Florida Governor Ron DeSantis announced that he had submitted a proposal to the HHS to import medication from Canada.

The state will begin by importing drugs to help people with chronic health conditions including asthma, diabetes and HIV/AIDS, DeSantis said in a statement.

“For far too long, Floridians have been paying exorbitant prices for prescription drugs,” he said. “Today, we take another step towards lowering those prices.”

US pharmaceutical companies have raised opposition, however, and earlier this week, three industry groups filed a lawsuit against the new regulation, alleging it “disregards key protections … designed to ensure patient safety”.

“It is alarming that the administration chose to pursue a policy that threatens public health at the same time that we are fighting a global pandemic,” James Stansel, executive vice president of Pharmaceutical Research and Manufacturers of America, said in a statement.



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‘Chilling’ crackdown on dissent in Vietnam ahead of key congress | Vietnam News

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As Vietnam’s ruling Communist Party gears up for its most important meeting in years, its leadership has presided over an intensified crackdown on dissent, according to rights groups, activists and data collated by Reuters news agency.

A record number of political prisoners, longer jail terms, and increased harassment of activists in recent years have contributed to the crackdown ahead of this week’s Communist Party congress, a gathering to determine national leadership and policy that takes place once every five years.

The crackdown has left some international human rights groups and legislators questioning whether Vietnam has breached the spirit of trade agreements with Western countries – accords that have helped propel the country to a position of economic strength in Southeast Asia.

“I have been summoned by the police several times since December 9, 2020,” said Nguyen Quang A, a veteran activist in Hanoi, declining to detail the circumstances saying he was subject to an ongoing investigation. He told Reuters Vietnam’s security ministry had in recent weeks rounded up other government critics without saying why, citing his contacts with activists.

“They [the police] summon them and find reasons to convict them under those very fuzzy articles of criminal law. It completely violates the law but they use it very regularly,” said Quang A. “I’ve told them they can’t shut me up.”

Vietnam’s foreign ministry, which handles inquiries from foreign media, did not respond to Reuters’s request for comment on activist detentions.

‘Anti-state’

Despite reforms and increasing openness to social change, the Communist Party of Vietnam, led by 76-year-old Nguyen Phu Trong, tolerates little criticism and controls domestic media tightly.

Vietnam drew international condemnation this month when it sentenced three freelance journalists known for criticism of the government to between 11 and 15 years in prison, finding them guilty of spreading anti-state propaganda.

Journalists Pham Chi Dung, right, Le Huu Minh Tuan, centre, and Nguyen Tuong Thuy, left, stand between police during their trial at a court in Ho Chi Minh City, Vietnam January 5, 2021 [VNA/Handout via Reuters]

The country’s constitution says it protects “freedom of opinion and speech, freedom of the press, access to information, to assemble, form associations and hold demonstrations”.

In reality, public criticism of the party is not tolerated, and groups which promote democratisation are targeted by the authorities in a battle playing out online on platforms like Facebook, Vietnam’s premier platform for both e-commerce and dissent.

A Reuters tally based on state media reports found 280 people were arrested for “anti-state” activities over the five years since the last party congress: 260 were convicted, many being sentenced to more than 10 years in jail. In the five years leading up to the 2016 congress, there were 68 arrests and 58 convictions.

‘Force 47’

Last year, Amnesty International said it had recorded the most “prisoners of conscience” in Vietnam since it began publishing figures in 1996 – 170, close to double the 97 recorded in 2018. Of the 170, some 70 were arrested for online activism, Amnesty said.

In late 2017, Vietnam unveiled a 10,000-strong military cyber-unit, Force 47, to counter what it said were “wrong” views on the internet. According to rights groups, the unit also recruits volunteers online to target dissidents and activists.

Reuters reviewed dozens of posts across multiple Facebook groups and pages from December and January that claimed links with Force 47. Many attacked prominent activists, including Quang A, accused by one group of creating anti-state propaganda.

A woman wearing a traditional conical hat walks past a poster for the upcoming 13th national congress of Vietnam Communist Party on a street in Hanoi, Vietnam, January 18, 2021 [Kham/Reuters]

Some group moderators were dressed in military uniform in their profile photos while others ran pages for official local branches of Communist Party organisations.

Last November, Vietnam threatened to shut Facebook down if it did not toughen rules on local political content on the platform.

Facebook’s local servers were taken offline by the government earlier last year until it agreed to significantly increase policing of “anti-state” posts by local users, a request with which Facebook previously said it complied.

A Facebook spokesman said the company faced “additional pressure” from Vietnam to restrict content last year.

‘Driver’s seat’

For some, the crackdown has a connection with fluctuations in global trade ties with Vietnam.

“During the [former US President Barack] Obama administration, pressure on rights connected with TPP [trade] negotiations helped the cause of human rights activists and political dissidents,” said Phil Robertson, deputy Asia director at Human Rights Watch.

“The early visit of Prime Minister [Nguyen Xuan] Phuc in 2017 to the Trump White House saw human rights completely dropped from the agenda,” he said.

Robertson said trade tensions with China have also left Vietnam “in the driver’s seat” as US and European Union companies look for alternative supply chains, helping the Vietnamese economy thrive.

“The EU had an important opportunity to make real changes through the EU-Vietnam Free Trade Agreement,” said Robertson, referring to a pact that has been a boon for Vietnam. Instead, he said, the EU “fell short, settling for vague promises … instead of substantive changes”.

EU officials did not immediately respond to Reuters’s request for comment.

After the jailing of the three journalists earlier this month, the United Nations human rights office said: “Coming just weeks ahead [of the party congress], the convictions and long sentences are not only a blatant suppression of independent journalism but also a clear attempt to create a chilling effect among those willing to criticise the government.”

The United States described the sentences as the “latest in a troubling and accelerating trend of arrests and convictions of Vietnamese citizens exercising rights enshrined in Vietnam’s constitution”.



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