Cablegate: Fda Internet Pharmacy Meetings in Quebec City

This record is a partial extract of the original cable. The full text of the original cable is not available.

201807Z Jan 04





E.O. 12958: N/A

1. Summary: FDA representatives met with Quebec officials
January 12 to discuss the internet pharmacy trade and other
issues related to an upcoming meeting between FDA Commissioner
McClellan and Premier Charest in Davos. In his meeting with
Commissioner McClellan, Premier Charest is likely to ask when
the U.S. will implement the rest of legislation on U.S.
pharmaceutical imports. Despite differences in federal and
provincial systems, the Health Canada representative present
offered Ottawa's full support to Quebec on cross-border
enforcement investigations relating to provincial regulations.
Health Canada is moving forward with unannounced compliance
inspections on internet sites starting in February to examine
how regulations were being applied to these sites. End Summary

2. FDA Assistant Commissioner for International Programs
Melinda Plaisier and Director of Pharmacy Affairs Thomas
McGinnis had two meetings on January 19 to discuss the internet
pharmacy trade in Quebec. The first was with provincial
officials; the second with provincial pharmacy regulators, and a
Health Canada representative. The genesis of the meetings was a
request by Premier Charest to meet with Commissioner McClellan
in Davos January 23 to discuss the pharmacy issue, and concerns
about the impact of new U.S. bioterrorism regulations relating
to cross-border trade. FDA indicated that Commissioner
McClellan might also raise potential GMO labeling legislation in

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3. The President of the Quebec Order of Pharmacists (OQP)
Jean-Yves Julien and the Director of Investigations Jocelyn
Binet, representing the regulatory side of Quebec's
pharmaceutical industry, stressed the strict enforcement and
control regime on internet pharmacies in Quebec. Only about 4
% of the orders placed with Canadian internet pharmacies are
received in Quebec. Quebec is the only jurisdiction in North
America where one must be a registered pharmacist to own a
pharmacy, thereby affording strong legal remedies for violators.
He reported that no pharmacists in Quebec own internet sites
inside the province. In any case, OQP would oppose internet
pharmacies because they would not meet their professional
standards. Currently three internet sites in the Montreal area
are being sued, by the OQP, for selling medication abroad.

4. Prescriptions signed by U.S. physicians are not valid in
Quebec. Internet pharmacy businesses look for Canadian-licensed
doctors to co-sign or rewrite them without a consultation -- an
unethical practice, said Julien. Based on the Quebec code of
ethics, physicians and pharmacists must have face-to-face
contact with the patient or can be sued by the disciplinary
committee. Julien said, moreover, that his pharmacists are no
longer accepting a co-signature by a Canadian doctor at face

5. As the head of Quebec's pharmaceutical licensing body, Julien
underscored that pharmacists were not mere vendors or
distributors of drugs, but provided a professional service, a
dimension that he felt was too often neglected in the internet
pharmacy debate. The OQP is taking a very comprehensive look at
the safety and quality of the cross-border drug trade, with a
particular emphasis on services such as the appropriateness of
medications. Quebec passed new legislation last year, Bill 90,
that allows pharmacists to adjust prescriptions made by
physicians and request follow up procedures such as blood tests.
Pharmacists maintain the security of drugs and services and can
be sued for practices against the public interest. At this
time, at least one person is being sued personally for "illegal
exercise of a profession." The case is pending a decision by a
Superior Court judge. Julien also noted, in passing, that
direct advertising by drug firms to consumers is prohibited in
Quebec, making it easier for physicians to prescribe less
expensive drugs.

6. Chief investigator Binet told the FDA officials that the
OQP, the federal RCMP, and DEA officials based in the state of
Vermont have been working closely together on a number of cases.
He said that cross-border enforcement is extremely difficult
because of the complexity of getting Canadian law enforcement
officials across the U.S./Canada border. Cross-border travel in
the OQP investigations were facilitated only by virtue of
personal contacts within U.S. law enforcement, which insured
that a briefed-inspector was on the border when needed. The FDA
visitors offered to assist in facilitating entry into the U.S.
of an investigator, should the case arise again.

--------------------------------------------- ------------
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7. Representatives of two Quebec ministries, Laval Poulin,
Director of Intergovernmental Affairs at the Ministry of
Agriculture, and Richard St Cyr of the Ministry of Economic
Development, expressed concern about the potential impact on the
local health care situation because heightened demand for
prescription drugs from the U.S. In his meeting with
Commissioner McClellan, Premier Charest is likely to ask when
the U.S. will implement the rest of legislation on U.S.
pharmaceutical imports. Quebec is concerned that one impact
could be pressure to increase prices of drugs for the province's
universal medical plan.

8. FDA's Plaisier pointed to the exponential growth of the
international cyber drug trade over the last decade. While it
is an issue in several countries, recently the spotlight has
fallen on Canada. Pressure in the U.S. to provide access to
less expensive prescription drugs may give rise to new
legislation in Congress. FDA has been mandated to report back
to Congress by December on how to bridge the gap between the
U.S. and Canadian systems, said McGinnis. There are real
concerns about transshipments, drug subpotency and quality.
Counterfeiting is a huge concern. Drugs subject to a recall can
be swapped out and redistributed with a date change. Since last
summer, a number of controlled substances have begun to flow
into the country, i.e. codeine, valium, and ephedrine (diet
pills). Some of this is originating for the first time from
Canada. The Quebec side said they saw no trend toward
controlled drug exports from the province: pharmacists report
cross border visitors were buying largely medications for blood
pressure control, cholesterol, and erectile problems).

9. The meetings elicited lively and useful exchanges between
the FDA, Quebec provincial officials, OQP, and Health Canada.
Health Canada Associate Director General Daniele Dionne offered
full federal support to Quebec. She said Ottawa was ready to
work more closely with provincial regulatory bodies. FDA
officials were struck her notification that Health Canada was
moving forward with unannounced compliance inspections on
internet sites starting in February to examine how regulations
were being applied on these sites. Dionne said her Ministry and
FDA had recently signed an MOU on information sharing and
pledged to remain in close contact in this regard. She also
stressed the need for close federal/provincial cooperation.
With safety as the principal concern, she underscored that none
of the 6000 pharmacists in Quebec are involved in illegal
internet practices; cyber companies are going elsewhere because
of Quebec's effective regulatory system.

10. As the U.S. is Quebec's number one client in terms of food
exports, BTA legislation has a direct impact; the Charest
government has provided comments through the federal government.
Quebec's main concern is prior notification for importation
into the States: the province's concerns were reflected in the
initial regulations. Poulin said the province appreciated the
8-month soft enforcement period. The industry and farmers need
time to adjust; they are hopeful they will be adequately
prepared when the Act comes into full effect next summer. So
far, there has been no appreciable impact on the border, but the
program is new and it is still winter. The 8-month soft
enforcement period would end in the middle of the fresh produce
period. For the time being, transportation companies only
receive warnings at the border. Quebec representatives asked
whether it would be possible to harmonize the BTA regulations
with existing the FAST and CPAT programs at the border. FDA
replied that the initial BTA regulations were drawn up under a
tight deadline, but that there would be another 30-day comment
period in March.

11. Asked about potential food labeling legislation, the Quebec
officials said a parliamentary commission had been formed to
look at food safety. Under this umbrella the commission may
examine and suggest legislation on GMO labeling. The committee
is expected to report to the National Assembly in the spring.
Public hearings will follow. Both the federal and provincial
governments share jurisdiction on food labeling and must
harmonize their approach. Inter-provincial and international
trade is under federal jurisdiction while internal provincial
trade is under Quebec control.

12. Comment: The FDA representatives underlined that America
was primarily focused on safety issues, and the point was made
more effectively than has often been the case because they
emphasized that high American demand for drugs, combined with
the curtailing of deliveries by drug producers, would create
market pressures that would inevitably open the path to
counterfeiters and undermine even the efforts of even the best
regulatory authorities. This message was well received by the
Quebec side, for whom legal and professional (safety) issues are
as much at stake as political and economic concerns. The
participants all focused on the longer-term potential for
problems caused by the cross-border internet pharmacy trade.
Health Canada's participation was appreciated in that it allowed
the Quebec side to differentiate between provincial and federal
systems in a way that elicited cooperation.


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