pass around. Stop selling unlicensed natural health remedies: pharmacy regulator

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_Stop selling unlicensed natural health remedies: pharmacy regulators_

(http://www.nationalpost.com/story-printer.html?id=2534645)

Sunday, February 7, 2010

Stop selling unlicensed natural health remedies: pharmacy regulators

Tom Blackwell, National Post

National Post

Makers of natural-health products say they are bracing for widespread

layoffs and millions of dollars in losses after Canada's pharmacy regulators

issued a surprise directive recently urging druggists to stop selling

unlicensed natural remedies.

The order affects thousands of herbal treatments, multi-vitamins and other

products, most of them waiting for approval from Health Canada under a

backlogged, five-year-old program to regulate natural-health goods.

The National Association of Pharmacy Regulatory Authorities (NAPRA) says

pharmacists cannot be assured the products are safe until they are granted a

government licence, and should not sell them in those circumstances.

" Pharmacists are obliged to hold the health and safety of the public or patient

as their first and foremost consideration, " said the association's recently

issued position statement.

Representatives of the natural health industry, however, have reacted

angrily to the directive issued last month, predicting it will have little

impact on patient safety, while triggering an economic " crisis " for their

members.

" We are talking about job loss, we are talking about a lot of income loss,

we are talking about product stuck in warehouses that cannot be sold, "

Jean-Yves Dionne, a spokesman for the Canadian Health Food Association, said in

an interview.

A statement issued by the association calls the directive self-serving and

contrary to federal government policy.

" It has taken a sledge hammer to a finishing nail, " the group said. " It

will create confusion for consumers. It is the wrong thing to do. "

NAPRA is comprised of representatives of the provincial colleges of

pharmacy that regulate the profession. It is now up to the individual provinces

to

implement the statement. The Ontario and Quebec colleges have already done

so, with Ontario pressing pharmacists to not buy or order any more of the

affected products, and its neighbour pushing for druggists to also remove

unlicensed product already on their shelves, Mr. Dionne said.

Pharmacies, as surprised by the directive as anyone, are caught in the

middle, said Jeff Poston of the Canadian Pharmacits Association.

" One of the questions that everybody is asking in the pharmacy world is, ‘

Why now?' As far as people can determine, nothing has significantly

changed. "

A spokesman for NAPRA was not available for comment.

The controversy revolves around Health Canada's natural-health products

regime, launched in 2004 to vet treatments that had been virtually unregulated

before, in a new system some critics said was still too lax. As it

ploughed through tens of thousands of applications for licences, the department

said manufacturers could continue selling their products, so long as they had

at least applied for approval.

The department has issued about 18,000 natural-health licences, while at

least 10,000 products are still waiting for certification, industry

representatives said. The whole process was supposed to be done by this

January.

The natural-food association argues that it makes no sense for the pharmacy

regulators to try to block sales of products awaiting licences, when

Health Canada itself has said they can be sold pending an approval decision.

The industry is worth an estimated $1.5-billion to $2-billion a year, but

many producers are small operations with sales of $1-million to $2-million

annually and could be decimated by the directive, Mr. Dionne said. He cited

a call he got last week from a manufacturer in Nova Scotia who sells two

products -- a homeopathic remedy for diabetes-related pain and a

vitamin-based pill -- that are waiting for approval and could be forced off the

shelves.

" They are really panicking out there, " he said.

Some manufacturers could sell their products in health-food stores instead,

but others rely exclusively on pharmacies, said Mr. Dionne.

Gerry Harrington of Consumer Health Products Canada, another industry group

that represents natural-health producers, said his members strongly

support the regulations. NAPRA may be targeting others, though, who are trying

to

evade any government oversight, he said.

" There is a sub-set of companies out there who have no intention of

complying with the regulations, who have taken advantage of the interim

approach

to essentially ignore the regulations, " Mr. Harrington said. " Some companies

have chosen ... to lobby politically for an essentially unregulated or

minimally regulated industry. "

Meanwhile, Mr. Poston said pharmacists are pressing for the regulators to

lessen the disruption by phasing in the policy.

National Post

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