Pharmacapsules - November 2004

Edited by Adrienne Blanchard and Jennifer Wilkie

Contents

• Canada And U.S. Cooperate On Competition Law Enforcement

• Physician Survey Identifies Future Supply And Access Problems

• Generic Manufacturer May Fund Internet Pharmacy Association

• C.D. Howe Institute Says "Close Internet Pharmacies"

• Missouri Adopts Illinois' Internet Pharmacy Program

• Illinois Governor Seeks Flu Vaccine Outside United States

• Improved Patient Safety Priority For World Health Organization

• European Commission Proposes Regulations For Compulsory Licenses For Medicines

Canada and the U.S. have signed a "Comity" Agreement to enhance cooperation between their respective antitrust/competition enforcement agencies. The Agreement seeks to minimize duplicative and sometimes conflicting enforcement efforts. It establishes a formal mechanism whereby Canada can request that the U.S. investigate and take action against civil anti-competitive activities occurring principally in the U.S. that have an impact in Canada. Equally, the U.S. can seek similar assistance with respect to civil anti-competitive activities occurring principally in Canada that have a cross border effect.

While the Agreement is meant to promote cooperation in certain circumstances, it does not impose any positive obligations to investigate a complaint from their neighbour on either Canada or the U.S.

Under the terms of the Agreement, neither country is precluded from initiating its own investigation and enforcement action even if similar procedures are already underway in the other country. However, in certain circumstances, Canada and the U.S. can defer or suspend their own enforcement actions and let the other country, where the anti-competitive practices are principally occurring, investigate and remedy them.

The Agreement dovetails into the previous 1995 Canada-U.S. cooperation agreement that provided for mutual notification and coordination of enforcement activities in specific circumstances. The 1995 Agreement deals with how and when the two countries will help each other with their respective civil investigations. This new Agreement goes one step further in that it closely mirrors a comity agreement signed by the U.S. and the European Community in 1998.

The text of the Agreement can be viewed at:
http://competition.ic.gc.ca/epic/internet/incb-bc.nsf/en/ct02957e.html

For further information on this and other competition law issues, contact Bill Vanveen or Francois Baril.

A survey of more than 21,000 physicians, conducted by the College of Family Physicians of Canada, the Canadian Medical Association, and the Royal College of Physicians and Surgeons of Canada, shows that access to care and wait times for Canadians is due to a low physician supply. Sixty percent of family physicians are either limiting the number of new patients they see or are not taking new patients at all. A third of specialists said the wait time for non-urgent cases referred to them was greater than three months. Further, a large number of physicians are reaching retirement and women, who make up over half of all new physicians coming out of medical school, on average work about seven fewer hours a week than their male colleagues. The profound changes to the health-care system produced by these shifts will have to be addressed by governments, according to a Canadian Medical Association spokesperson.

Further information may be found at:
http://www.cfpc.ca/nps/English/pdf/Media%20Releases/Recent/National%20Physician%20Survey%20Press%20Release_Oct%2027%2004.pdf

An e-mail obtained by the media suggests that a generic drug manufacturer, Apotex, has discussed offering money to a group representing Internet pharmacies in exchange for increased sales of its products. An International Pharmacy Association spokesperson said that discussions with the generic company are ongoing that the Internet Pharmacy Association is "seeking any opportunity we can for funding."

A spokesman for the company denied that it was in negotiations with the Internet pharmacy group. A spokesman for Rx&D, the association that represents innovative companies in Canada, stated that legal questions about patent infringement are raised by the sale of some generics into the U.S. market and that "the generics appear to be associating themselves with a business that has questionable ethics in terms of the relationship between the health-care professional and the patients."

For more information, please see:
http://www.canada.com/health/story.html?id=c0d3ef21-85c0-4051-80df-f78747ce0633

A study released by the C.D. Howe Institute says that Canada's Internet pharmacies represent a threat to domestic drug supplies and prices, and that the federal government should act now to close these businesses.

The authors of the study say that Canada has not to date suffered a serious shortage of drugs or big price increases because the cross-border trade remains mostly illegal and the volume small. However, they warn that this situation could quickly change if legislation is passed in Washington to legalize imports. The study states that the Canadian government should act sooner rather than later to shut down the cross-border trade. Acting now would be consistent with the current U.S. FDA policy, which prohibits imports of drugs from Canada. If, however, the next President implements legislation to facilitate drug imports, "it would look hostile on Canada's part to immediately prohibit drug exports."

A news article written by an author of the study can be found at:
http://www.canada.com/national/nationalpost/news/newsletter/story.html?id=e5145324-f91c-4232-88f2-f1c4bf2e7863

The study is located at:
http://www.cdhowe.org/pdf/commentary_205.pdf

Missouri Governor Bob Holden announced that Missourians can immediately start participating in Illinois' new mail-order system for buying prescription drugs from a provider in Canada, namely CanaRx Services Inc. of Hamilton, Ontario. The Missouri governor made the announcement alongside Illinois Governor Rod Blagojevich, who promoted the idea and opened the system, known as I-SaveRx, for business on October 4, 2004. Governor Holden stated that the I-SaveRx system allows people without insurance to take advantage of cheaper drug prices in Canada, Ireland and the United Kingdom. In doing so, Missouri brushed aside the U.S. FDA's opposition to the I-SaveRx system, which it considers a violation of federal law that restricts importation of drugs.

For more information, please see:
http://www.stltoday.com/stltoday/news/stories.nsf/stlouiscitycounty/story/BDE23118046EC42B86256F3C001271ED?OpenDocument&Headline=Missourians+may+buy+drugs+from+Canada

http://missourinetdrugs.notlong.com/

Illinois Governor Rod R. Blagojevich, one of several leaders of state efforts to buy prescription drugs from outside the United States, including from Canada, recently detailed that he has secured at least 30,000 doses of flu vaccine in conversations with European drug wholesalers. The Governor wants permission from the U.S. FDA to buy the doses for residents of Illinois. He requested that the federal Center for Disease Control (CDC) allow Illinois to use federal funds to purchase the extra doses, but stated that if the CDC refuses, the state will cover all of the costs itself.

For more information, please see:
http://www.nytimes.com/2004/10/25/national/25flu.html?ex=1099720468&ei=1&en=52ed307775c79759

http://www.healthtalk.ca/flu_vaccine_import_10252004_3932.php

http://www.timesdaily.com/apps/pbcs.dll/article?AID=/20041025/ZNYT04/410250343/-1/APN

The World Health Organization (WHO), along with a global group of ministers of health and senior officials, academics and patients' groups, has announced the launch of the World Alliance for Patient Safety. The Alliance plans to reduce the adverse health and social consequences of health care, by taking steps to cut the number of illnesses, injuries and deaths suffered by patients using clinics and hospitals. Dramatic decreases in adverse effects in health care and declines in expenditure are expected as a result of the Alliance's strategies. Issues such as research developments, delivery issues and knowledge on a worldwide scale will be undertaken by political leaders in several countries.

Further information may be found at:
http://www.who.int/mediacentre/news/releases/2004/pr74/en/

European Commission Proposes Regulations For Compulsory Licenses For Medicines

The European Commission has proposed a Regulation to allow manufacturers of generic pharmaceuticals to produce patented medicines for export to "countries in need" who do not have sufficient capacity to produce them. The Regulation would implement the August 30, 2003, World Trade Organization (WTO) Decision. Under the Regulation national authorities in the European Union can grant compulsory licences for such production if certain conditions are fulfilled. National laws do not allow compulsory licences for export since the WTO TRIPS Agreement allows compulsory licences to be issued only if they are "predominantly for the supply of the domestic market." The WTO Decision addressed the difficulties raised by this restriction by waiving this obligation.

For more information, please see:
http://europa.eu.int/comm/trade/issues/global/medecine/pr291004_en.htm

The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.