Canada is protecting the drugmaker of swine flu vaccine from lawsuits over potential side effects, Canada's top doctor has confirmed.
Dr. David Butler-Jones told a media teleconference Wednesday that Canada will shield GlaxoSmithKline in the unlikely event there are problems with the vaccine, but it will not shield health practitioners who make mistakes in administering the shot.
"We're not obviously anticipating problems with it, but indemnification for a vaccine is important if someone does malpractice, basically injects someone the wrong way or causes harm because of their practice," he said.
"That's not a vaccine issue, it's a practice issue," he added.
The Public Health Agency of Canada had initially refused to say if Canada would shield drugmakers the way other G-8 governments have done.
They have signed a confidentiality agreement with the vaccine manufacturers...
Feds mum over legal protection for swine flu vaccine makers
By Steve Rennie (CP) – Sep 20, 2009
OTTAWA — The federal government won't say if Canadians who suffer harmful side effects from the new swine flu shot can take the vaccine maker to court.
The Public Health Agency of Canada will not reveal whether drug companies are shielded from H1N1 flu vaccine lawsuits in this country like they are in the United States.
"This is a complex issue which is currently being examined by the federal government," spokeswoman Nadia Mostafa said in an email.
"It raises legal questions involving federal/provincial and public/private sector jurisdictions. The federal government will provide additional details around this issue in due course, following appropriate discussions/deliberations."
That effectively throws a shroud over Ottawa's arrangement with pharmaceutical giant GlaxoSmithKline, which has a contract to produce 50.4 million doses of pandemic vaccine at its facility in Ste-Foy, Que.
Conversely, the United States has been open about its decision to protect vaccine makers, government officials and others from lawsuits over the vaccine.
Health and Human Services Secretary Kathleen Sebelius has granted legal immunity to "individuals and entities involved in all stages of 2009 H1N1 influenza vaccine development, testing, manufacture, distribution, prescribing, administration, and use," says a U.S. Health Department website.
That protection doesn't extend to harm caused by wilful misconduct.
GlaxoSmithKline was as tight-lipped as the Public Health Agency when asked if it was protected from Canadian lawsuits over its vaccine.
"GSK is discussing issues relating to potential liability exposure associated with pandemic preparedness products, including vaccines, in the context of its pandemic planning negotiations with all governments, including the Canadian government," company spokeswoman Michelle Smolenaars Hunter said in an email.
"The details of the contract negotiations with the Canadian government are confidential and cannot be discussed further."
Vaccine makers in the U.S. have been protected from lawsuits over the use of childhood vaccines since the 1980s. Instead, a federal court handles claims and decides who will be paid from a special fund.
The decision to protect vaccine makers came after the 1976 swine flu outbreak, when 40 million Americans were vaccinated in a national campaign.
But that scare never morphed into the deadly pandemic officials feared.
Instead it touched off a flurry of injury claims from Americans who suffered side effects from the vaccine - including about 500 people who developed a paralysing condition called Guillain-Barre Syndrome.
However, that syndrome was never conclusively linked to the 1976 swine flu shot, and experts don't think a repeat is likely.
B.C. doctors treat swine flu by telephone
Last Updated: Monday, October 5, 2009 | 11:54 AM PT
The Canadian Press
As health officials in British Columbia brace for a resurgence of the H1N1 swine flu virus, the province and B.C. Medical Association have agreed the province's doctors will be paid to diagnose and treat swine flu over the phone.
Under the agreement, doctors will receive a $14.74 payment for telephone advice regarding the highly contagious virus and a $31.15 fee for office visits.
The new office-visit fee is the same as the regular fee for office visits, but it won't be subject to current provincial rules limiting doctors to seeing about 50 patients daily.
Provincial health officer Dr. Perry Kendall says both new codes are temporary and will offer increased access to care and the option of telephone advice is a sensible alternative to having swine flu patients visit a doctor's office.
Family physicians and specialists have been able to claim for H1N1 telephone advice since Oct. 1, but the office-visit fee code won't be enacted until Kendall advises that swine flu cases have outstripped seasonal flu cases.
Cases in AlbertaNumber of hospitalized confirmed cases of pandemic H1N1 influenza as of October 2, 2009.
|Area||Year to Date|
|Edmonton and area||49|
|Calgary and area||49|
Total number of deaths to date: Eight (8)*
* One death out of country resident
Flu shot plans vary across Canada
Last Updated: Friday, September 25, 2009 | 10:28 PM ET
Provinces and territories appear to have no standard approach to flu vaccinations as they examine preliminary research suggesting people who have had seasonal flu shots might be at greater risk of catching swine flu.
Ontario's chief medical officer of health announced a three-pronged approach to flu vaccination in the province Thursday:
- Seasonal flu vaccinations for people older than 65 and residents of long-term care homes will take place in October, since those groups are considered to be at greater risk from that flu than from swine flu.
- A wider swine flu vaccination campaign for the rest of the population starting in November, when a vaccine becomes available against the H1N1 influenza A virus, the swine flu strain that has been spreading worldwide since April.
- Seasonal flu vaccinations for people younger than 65 — but only after the H1N1 shots have been given.
A similar approach in delaying seasonal flu vaccinations has been adopted by Quebec, which will hold off seasonal shots until January, as well as by Saskatchewan and Nova Scotia. Other provinces, including British Columbia, are also considering it.
But New Brunswick hopes to complete its seasonal vaccination program by mid-October, instead of offering the shots in November as in previous years.
Newfoundland and Labrador has recommended the seasonal flu shot be given out starting in October to anyone over the age of 65, residents of long-term care homes and adults and children with chronic heart or lung disease. The province plans to offer swine flu shots starting in November, or earlier if deemed necessary.
Other provinces and territories haven't formally announced their flu shot plans yet.
Call for national approach
Most provinces and territories have been reviewing their vaccination plans since Canadian researchers found people who had received the seasonal flu vaccine in the past were twice as likely to get the H1N1 virus. The research has not yet been peer-reviewed or published.
Theoretically, antibodies created by the immune system after exposure to bacteria or a virus can facilitate the entry of another strain of the virus or disease. The effect has been seen for other viral vaccinations but never for influenza, said Dr. Donald Low, chief microbiologist at Mount Sinai Hospital in Toronto.
"I think it's a reason that it would be great to have a national policy on this because we're now hearing messages from different provinces about different approaches to this issue with these new results that have come out," Low said Friday.
"That is also going to confuse individuals," especially since the research finds are confusing to doctors and medical researchers as well, he said.
Dr. David Butler-Jones, Canada's chief public health officer, said people should follow vaccination advice from their provincial and territorial medical officers of health.
"I'm not worried about the seasonal vaccine," he told reporters.
The head of the U.S. Centers for Disease Control said Friday his agency would love to see Canadian data that appear to link getting a seasonal flu shot with catching swine flu.
U.S. data don't suggest that the seasonal flu vaccine "has any impact on the likelihood of getting H1N1," Dr. Thomas Frieden said. He has ordered his own scientists to review the findings.
Meanwhile, the CDC is recommending that vaccinations for both seasonal and H1N1 flu go ahead as quickly as possible.
Butler-Jones noted that the Canadian government has purchased 600,000 more doses of H1N1 vaccine that does not include an adjuvant, a substance used to boost immune response.
About 1.8 million doses will be offered to pregnant women and children under the age of three, since there is little clinical data on the safety and effectiveness of the adjuvant in those two groups.
As of Thursday, there were 78 deaths in Canada among people with confirmed H1N1, up by two since Sept. 12. There were also 15 people in hospital and three admissions to intensive-care units in that time, Health Minister Leona Aglukkaq told reporters.With files from The Canadian Press