Canada: Pharmacapsules @ Gowlings - January 19, 2009

Last Updated: February 16 2009

Edited by Jennifer Wilkie and Chantal Saunders


  • Changes to U.K. Pharmaceutical Price Regulation Scheme Now in Effect
  • FDA Approves Guidelines to Inform Doctors of "Off-Label Uses" for Medicine and Medical Devices
  • 4.5 - 5.5% Growth Projected for the Global Pharmaceutical Market
  • Faster Review Offset by Longer Drug Development
  • Ontario to Introduce Province-Wide Academic Detailing
  • Recent Cases

Changes to U.K. Pharmaceutical Price Regulation Scheme Now in Effect
By Wayne Critchley

A new Pharmaceutical Price Regulation Scheme (PPRS) came into effect in the U.K. on January 1, 2009. The new PPRS represents the latest version of the profit control system which has been negotiated at regular intervals for over 50 years between the U.K. government and the Association of the British Pharmaceutical Industry (ABPI).

The U.K. Department of Health stated that the new agreement "means that more patients will benefit from a wider range of innovative drug treatments at a fair price." Among other things, it will continue to allow innovative manufacturers freedom to establish the launch price of new drugs and provide for modulated price cuts for existing drugs.

For a report on the new PPRS, please visit: Htmfiles/V3N01_20090106.en.html

FDA Approves Guidelines to Inform Doctors of "Off-Label Uses" for Medicine and Medical Devices
By Scott Robertson

The United States Food and Drug Administration (FDA) recently finalized guidelines which will allow pharmaceutical companies to inform doctors about unapproved uses of medicines and medical devices. This new policy will allow drug makers to market their medicines for uses not approved by the FDA.

In its guidelines the FDA stated "public health can be served when health-care professionals receive truthful and non-misleading scientific and medical information on unapproved uses."

By law, manufacturers are prohibited from marketing their medicines for uses not approved by the FDA. However, doctors can prescribe drugs for any use they see fit, a practice known as "off-label" use.

The "off-label" practice allows a doctor to prescribe a drug to a patient beyond what it is approved for. Alan Bennett, an attorney representing various drug makers in the US stated that the new guidelines, "will clarify how and when manufacturers can provide unbiased, unembellished articles from peer-reviewed journals to health care professionals."

According to a 2006 study published in the Archives of Internal Medicine, one of five prescriptions in the United States was written to treat a condition for which the drug was not approved.

Further support for the new guidelines was offered by Ken Johnson, a spokesman for the Pharmaceutical Research and Manufacturers of America when he stated that the guidance will help "assure that medical professionals receive timely and accurate medical information prior to the lengthy process" of securing FDA approval for wider use and can save lives, especially in practice areas where there are few effective treatments."

In its guidelines the FDA indicated that articles circulated by companies should come from peer-reviewed journals that require disclosure of conflicts of interest for researchers and encouraged companies to seek FDA approval for unapproved uses.

For more information, please see:

4.5 - 5.5% Growth Projected for the Global Pharmaceutical Market
By Melissa Binns

According to the National Association of Pharmaceutical Representatives (NAPRx), the global pharmaceutical market is expect to exceed $820 billion in 2009 growing by 4.5 - 5.5 percent. While the growth rate in established markets such as the U.S. is projected to slow due to the current economic climate and patent expirations, the pharmaceutical industry will remain an important component of the U.S. economy. Markets in Japan and the E.U. are forecast to see modest growth slightly higher than the U.S. rate. It is markets such as China, Brazil, India, South Korea, Mexico, Turkey and Russia (known as the "pharmerging markets") which are expected to increase rapidly at a combine rate of 11-15 percent, reaching $105-115 billion. These pharmerging makets are benefiting from increased government spending on healthcare and much broader public and private health care funding.

Specialty products are also expected to significantly contribute to the total market growth. These include: biologics which are expected to grow by 11-12 percent; HIV therapies projected for 13-14 percent growth; and most notably oncology products which are projected for a 15-16 percent growth.

For more information, please see:

Faster Review Offset by Longer Drug Development
By Roger Tam

According to the report Outlook 2009 released by the Tufts Center for the Study of Drug Development, gains made by the U.S. FDA in the speed of review of new drugs (average review time declined by 1.1 years in time 2005-2007 period) have been largely offset by longer clinical development times due to the complexity of the diseases being studied. Approval times continue to average around 8 years. According to Tufts director Kenneth I Kaitin, drug companies are employing various strategies to speed up clinical development. These include streamlining project management, strategic partnerships and licensing arrangements, use of surrogate endpoints and adaptive clinical trials.

For more information, please see:

Ontario to Introduce Province-Wide Academic Detailing
By Wayne Critchley

The Executive Officer of Ontario's Public Drug Programs has announced plans to introduce a province-wide academic detailing program. Academic detailing is the provision of independent, evidence-based information about best prescribing practices by a health educator to physicians on a one-on-one basis or in small groups.

The objectives of the new program in Ontario will be to:

  • encourage the use of the most therapeutically appropriate and cost-effective medications;
  • provide objective, evidence-based comparative drug information to physicians; and
  • reduce drug expenditures in Ontario to achieve value-for-money and ensure the best use of resources.

The Ministry of Health and Long Term Care issued a Request for Proposals ("RFP") on January 15, 2009 to invite bids to develop and deliver the program. Proposals are due by March 13, 2009 and a three-year contract could be awarded as early as May 1, 2009.

For more information, please see: drugs/opdp_eo/eo_communiq.html

Recent Cases
By: Beverley Moore

Apotex v. Sanofi Aventis; appeal of an interlocutory motion for recusal; 2008 FCA 394; Ramipril; December 10, 2008

The Court of Appeal upheld the decision of the trial judge, refusing to recuse herself from the trial of this proceeding.

Apotex had brought a motion for recusal based on the fact that the same judge was sitting in two other proceedings that involved overlapping issues to a degree. The Court stated that there is a strong presumption of judicial impartiality, particularly when the allegation of a reasonable apprehension of bias is based on the judge's previous encounter with the party in his or her judicial capacity.

The full text of the decision can be found at

Lundbeck v. Cobalt and ratiopharm; motion to strike a judicial review proceeding; 2008 FC 1379; Memantine; December 16, 2008

Lundbeck brought a judicial review of the Minister's decision to accept the generic companies' ANDSs for their brand of memantine. Lundbeck had received a Notice of Compliance with conditions ("NOC/c") in 2004, prior to the promulgation of the data protection amendments to the Food and Drug Regulations. However, the generic companies filed their submissions after the promulgation of these Regulations. Patents were listed on the Patent Register at the time of receipt of the NOC/c.

The Court found that, as Lundbeck was seeking relief relating to the Minister's application of the Food and Drugs Act in relation to ANDSs submitted by generic companies, there is no other purpose behind the judicial review but to block the Minister's review of those submissions. Thus, Lundbeck had no standing, including with respect to Lundbeck's challenges under the data protection provisions both old and new.

Furthermore, the decision of the Minister being reviewed was an interlocutory one. The final decision would be the Minister's determination as to whether to issue a NOC. There were no exceptional circumstances in this case to override that rule.

Full text of the decision can be found at:

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