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Proposed new drug regulations will hurt all Canadians — and Ottawa has been warned

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In December 2017, the federal government proposed amendments to the regulations governing the Patented Medicine Prices Review Board (PMPRB), the federal organization that has set ceiling prices for new medicines for the past 30 years. The revisions are intended to make prescription medicines more affordable. The final regulations, shared last week in the dead of summer, are virtually the same as those originally proposed, despite strong concerns about their negative effects having been expressed by patients, the pharmaceutical industry and others.

The amendments, due to come into effect in July 2020, include three significant changes. The first is on the roster of countries whose drug prices are compared with the proposed Canadian price in the PMPRB’s international comparison. Six lower-price countries are replacing two with higher prices. The effect of the switch will be to reduce the maximum prices for new medicines in Canada to around the median of prices charged in over 30 OECD countries.

Ottawa is either burying its collective head in the sand or deliberately misleading Canadians

The second change is that the PMPRB will be required to assess the “value” of each new drug using cost-effectiveness analyses already reviewed by the Canadian Agency for Drugs and Technologies in Health (CADTH) when it makes its reimbursement recommendations to Canada’s public drug insurance plans (except those in Quebec). CADTH doesn’t set prices but frequently recommends big reductions — 50 to 80 per cent, sometimes over 95 per cent — to achieve cost-effectiveness.

The third major change is a requirement for pharmaceutical manufacturers to divulge information to the PMPRB on confidential rebates and other commercial terms negotiated with Canadian insurance plans.

The federal government says its amendments will not impact the way pharmaceutical companies view Canada as a place to do business. It is either burying its collective head in the sand or deliberately misleading Canadians.

A well-defined relationship exists between the market prices of medicines and manufacturers’ investments in a country. Pharmaceutical R&D investment in Canada is about $30 per capita. In the U.S., where drug prices are considerably higher, it is more than C$360 per capita. In New Zealand, where prices are tightly controlled, pharmaceutical investment was under C$10 per capita in 2011 and may be less today after several leading pharmaceutical companies ceased or severely restricted R&D in response to new, more rigid price controls.

The governments of Ontario and Quebec, where 84 per cent of the pharmaceutical investment is spent in Canada and 87 per cent of the industry’s employees are based, understand the risks to investment and jobs posed by the regulation amendments and have warned Ottawa.

Market price restrictions also negatively impact new drug launches. An analysis of the relationship between the number of new drug launches in each of 31 OECD countries and the associated price level for patented drugs, per capita gross domestic product and total population in each country demonstrated that price was the only variable that was a statistically significant predictor of the number of new drug launches.

Greater access to newer medicines has been shown in numerous studies to improve patient health by preventing premature death and/or significantly improving patients’ quality of life. But patients cannot benefit if pharmaceutical companies do not seek regulatory approval for their medicines because they view Canada’s market conditions unfavourably. This already occurs in Canada — about 20 per cent of new therapeutic drugs approved in the U.S. do not come here — and it undoubtedly impacts New Zealand: only 54 per cent of new drugs approved in the U.S. receive regulatory approval there.

Pharmaceutical companies might be able to adjust to a change in the PMPRB’s international price comparison leading to around a 20 per cent reduction in new drug prices, but any requirement for much greater reductions, say 40 to 80 per cent, would render most business models unsustainable. And if business-sensitive information regarding confidential rebates and other commercial terms negotiated with payers does not remain confidential, companies’ prices and sales in other countries will be jeopardized, thus further reducing Canada’s market appeal.

A company’s sustainability depends on its ability to keep its profitability attractive to investors, who want long-term predictability in the company’s capacity to generate and commercialize its innovative products. The federal government’s amendments to the PMPRB may make medicines more affordable for some patients, but they will certainly reduce Canada’s attractiveness as a jurisdiction in which manufacturers seek regulatory and reimbursement approval for new beneficial drugs, and that will hurt all Canadians.

Nigel Rawson is president of Eastlake Research Group, based in Oakville, Ont, and an affiliate scholar at Toronto’s Canadian Health Policy Institute.

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Ottawa sets monthly record for total COVID-19 cases with 99 new cases on Friday

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Sixteen days into October, Ottawa has already set the record for most cases of COVID-19 in a single month.

Ottawa Public Health reported 99 new cases of COVID-19 in Ottawa today, and three more deaths linked to novel coronavirus.

Ontario’s Ministry of Health had reported 108 new cases of COVID-19, but there is sometimes a lag in COVID-19 case reporting between Ontario and Ottawa Public Health. On Wednesday, Ontario reported 39 new cases in Ottawa, while Ottawa Public Health reported 45 new cases.

There have been 1,511 laboratory-confirmed cases of COVID-19 in Ottawa in October, surpassing the September record of 1,413 new cases.

Since the first case of COVID-19 on March 11, there have been 5,908 laboratory-confirmed cases of COVID-19 in Ottawa, including 301 deaths.

Across Ontario, there are 712 new cases of COVID-19 on Friday. Health Minister Christine Elliott reported 213 new cases in Toronto, 135 in Peel Region and 62 in York Region.

HOSPITALIZATIONS IN OTTAWA

One more person was admitted to an Ottawa hospital with COVID-19 related illnesses on Friday.

Ottawa Public Health reports 47 people are currently in hospital with COVID-19, including eight in the intensive care unit.

ACTIVE CASES OF COVID-19 IN OTTAWA

The number of active cases of COVID-19 increased on Friday.

There are 792 active cases of COVID-19 in Ottawa, up from 777 active cases on Thursday.

A total of 4,806 people have recovered after testing positive for COVID-19.

The number of active cases is the number of total laboratory-confirmed cases minus the numbers of resolved cases and deaths. A case is considered resolved 14 days after known symptom onset or positive test result.

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Ottawa mayor rejects possible return of Ottawa-Gatineau border checkpoints, ‘I really don’t think they work’

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Mayor Jim Watson does not want to see police checkpoints return to the five interprovincial crossings between Ottawa and Gatineau, saying “I really don’t think they work.”

Earlier this week, Gatineau Mayor Maxime Pedneaud-Jobin told the Ottawa Citizen that police checkpoints could return to the Ottawa-Gatineau border at “any time,” with the final decision in the hands of the Quebec Government. Earlier this month, Dr. Brigitte Pinard of the Centre Integre de sante et de services sociaux de l’Outaouais said border checkpoints were “possible,” adding “right now, our message is to limit large gatherings.”

When asked by CTV Morning Live host Leslie Roberts about the possibility of police checkpoints returning to the Ontario-Quebec border, Watson said he did not think they worked back in the spring.

“There were so many gaps when the police were not there, and people just figured out I’ll go at an earlier time or a later time. We saw police officers sticking their heads in the car with no masks, so that was not healthy for those individuals,” said Watson Friday morning.

“It’s a costly expense when our police are stretched already to the limit trying to do the work, to have them set up at five different bridge points potentially 24 hours a day would cost hundreds of thousands of dollars every month and I think the money is better spent.”

On April 1, Gatineau Police and the Surete du Quebec set up checkpoints along the Ottawa-Gatineau border to limit non-essential trips into Gatineau. Gatineau Police estimated the random police checkpoints between April 1 and May 17 cost the service more than $400,000.

Mayor Watson tells CTV Morning Live that the Quebec Government’s decision to move Gatineau into the “red zone” two days after Ontario moved Ottawa to a modified Stage 2 should help.

“We are a close relationship and when things happen in Gatineau there’s often a trickle effect over here and I think the fact that we’re both in the red zone, and Quebec of course is the worst hit province, at least levels the playing field for our restaurants and bars,” said Watson.

“I think in the past what had happened was our restaurants and bars would close and then the ones in Gatineau would stay open, and then people from Ottawa would go over there irresponsibly, in my opinion, and then come back potentially with the virus and spread it here.”

While border checkpoints would limit the non-essential travel across the Ottawa-Gatineau border, Watson says that’s not the way to beat COVID-19.

“The message is very clear, stick to your household. This is not the time to have an AirBNB party or a keg party in your backyard, or have 20 people or 30 people in for an engagement party. I know a lot of these get-togethers are important socially for people and emotionally, but we have to ask people to be reasonable and responsible, and this is not the year to do those kinds of things.”

Roberts asked the mayor if he would have a conversation about border checkpoints with Gatineau’s mayor.

“I had it the first go-around, but at the end of the day I also respect their jurisdiction and their autonomy. It is the province that would have to impose that, not the municipality,” said Watson.

“From our perspective, we don’t think it’s an effective use of resources. We want to continue to get the message across that we can win this battle against COVID-19 if we socially distance, we wear a mask, we actually follow the simple rules that are put forward.”

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Ottawa woman breaks 14-day quarantine rule to work at long-term care home: police

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OTTAWA — A 53-year-old Ottawa woman is facing charges under the federal Quarantine Act after Ottawa police say she failed to self-isolate for 14 days after travelling abroad and returned to work at a long-term care home.

Ottawa Police say information was received indicating that an Ottawa woman had travelled abroad. She returned to Canada on Sept. 26, so she was required under federal law to quarantine for 14 days, until Oct. 9

“The woman decided not to respect this order and went to work on Sept. 30 at a long-term health facility in Ottawa,” police said in a news release. “When management was apprised of the situation, she was immediately sent home. The facility immediately activated mitigating self-isolation and cleaning protocols and informed all persons that had been in contact with the subject.”

Police say none of the residents of the long-term care facility have tested positive for COVID-19 as a result of the woman attending work.

Ottawa police say this is the first person they have charged under the Quarantine Act during the pandemic.

The woman is charged with failing to comply with entry condition under section 58 of the Quarantine Act and cause risk of imminent death or serious bodily harm under section 67 of the Quarantine Act.

The maximum penalty for causing risk of imminent death or serious bodily harm is a $1 million fine and three years in prison. For failing to self-isolate for 14 days, she faces a $750,000 fine and up to six months in jail.

Police did not release the name of the woman, nor where she worked. The woman is due in court on Nov. 24.

Ottawa Mayor Jim Watson’s office issued a statement following the announcement of the charges.

“Mayor Watson was disturbed to learn about the alleged carelessness of the individual in question. This type of reckless behaviour could have harmed their colleagues, and more importantly, the residents of the long term care home. We must all do our part to limit the spread of COVID-19 in our community.”

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