Industry Trends

Topics and Trends Report, Q3 2009

SANDOZ CANADA RECEIVES APPROVAL FOR FIRST SUBSEQUENT ENTRY BIOLOGIC

April 22, 2009- Sandoz Canada announced that it has received market authorization for Omnitrope™ in Canada. Omnitrope(TM) is the first version of a previously approved recombinant biotechnology drug to be approved by Health Canada under the regulatory term Subsequent Entry Biologic (SEB). Approval of Omnitrope as first Subsequent Entry Biologic increases access to high-quality medicines and offers patients safety and efficacy combined with greater cost effectiveness

WIDER PRESCRIBING RESPONSIBILITIES IN ONTARIO

The Health Professions Regulatory Advisory Council (HPRAC) recently published a document that advocates non physician prescribing of drugs. The report calls for a new Council, (yet another council) on regulatory excellence that would reduce the time it takes for professions to begin prescribing and increase accountability.

They are recommending some prescribing rights to Pharmacists, Dental hygienists, and Naturopaths. They also recommend a range of medications that can be prescribed by Optometrists, Nurse, Midwives, Chiropodists and podiatrists.

Needless to say, once again the Medical profession objects. Dr. Ken Arnold, President of the Ontario Medical Association, responded that having pharmacists being able to prescribe independently was “counterproductive and dangerous.”

NATIONAL PHAMACEUTICAL CONGRESS III

annual National Pharmaceutical Congress was held March 25, 2009 in Toronto and featured senior level executives on the podium and in the audience, resulting in a pertinent and relevant event. It is refreshing that the brand pharmaceutical industry came together to discuss communication challenges and strategies not only with the physician, but also the pharmacist, nurse practitioner and the patient. As an industry that prides itself on research and development, we learned that there has been a 12% decrease in Canadian clinical trial investment and, that much of that investment is being lost to emerging markets - BRIC (Brazil, Russia, India, and China) countries.

SPEED OVER SAFETY

The Canadian Center for Policy Alternatives released their report that states that Health Canada’s approach to drug regulations put too much emphasis on speeding up drug approvals and too little on following the safety profile of drugs once they hit the market. They actually state that Health Canada cannot alter safety labels on a product. Oh wait, the author is Dr. Joel Lexchin and is called “Drug Safety and Health Canada: Going…Going…Gone?”

BIOTECH CASH REPORT?

Although Canada is considered one of the world’s top 5 biotechnology markets, Peter Brenders, President and CEO of BIOTECanada, commented, at the National Congress, that 50% of the 300+ biopharmaceutical companies in Canada will be out of cash by the end of this fiscal year. Typically this segment has been funded by private equity in the past but, big Pharma licensing and consolidation through M & A may dominate themes for the foreseeable future. The alternative to M & A is less attractive as it means layoffs, potential bankruptcy, the cancellation of drug trials, and ultimately less molecules launched in Canada.

PMPRB CONTINUES TO FLUX

It appears that Rx&D is cautiously optimistic that PMPRB’s new Guidelines will be acceptable to the Industry. It is amazing the level of PMPRB staff headcount as well revenue budget that was recently approved by the Treasury Department. The PMPRB is continuing to blur the lines and attempting to expand their remit, and now has more
resources to do so!

OBAMA LEGISLATION FUELS PRESSURE ON CANADIAN EXECUTIVES ON CROSS BORDER

Most Canadian CEO’s have received calls from their US or European parent company asking what plans are in place to address the potential of increased cross border pharmaceutical sales. 2004 saw the height of the problem at about $1.0 billion, which we estimate dwindled to 100 million in 2008, due to industry allocation programs and other key environmental developments. A Washington Drug Letter published March 9, stated new legislation at the US Senate, would allow wholesalers and pharmacists to import prescription drugs from Australia, New Zealand, Japan, Switzerland and countries in the EU. Peter Lurie, deputy director of health research at Public Citizen – stated "the real solution is price controls” and "the ability to track [an imported] drug, beginning with the raw materials used to make it through all of the wholesalers, should be a part of any bill." Lurie also noted that Canada, " already had that requirement, and in that respect, imports from Canada might actually be better” than pharmaceutical products from US suppliers.

Make sure your company has done due diligence on this front and a plan is in place to monitor and assess north south trade.

REMOTE DISPENSING AND E-PRESCRIBING - THUMBS UP OR DOWN?

The Ontario Pharmacist Association (OPA) announced March 19th, they do not propose changes be imposed on the profession or any business model. The college does however want to ensure that public safety is top of mind, specifically with emerging technologies with prescription services such as e-prescribing and remote dispensing. The OPA council will approve preliminary proposals this June 2009 with the intent of final ratification by September 2009. These regulatory proposals would still need to be submitted to, and subsequently approved by, the Ontario government before remote dispensing to the public by pharmacists in accredited pharmacies can occur. According to Deanna Williams, the registrar of OCP, Ontario College of Pharmacists, (i) current legislation, Drug and Pharmacies Regulation Act(DPR Act) does NOT permit remote dispensing of medication to the general public by accredited pharmacies: (ii) legislative amendments (to the DPR Act) and NEW regulations (made under the DPR Act) are required before remote dispensing can occur as noted above: and (iii) the OPA will follow the college’s usual consultative process as it develops the appropriate regulations needed to ensure public safety and member accountability.

GUIDANCE NOW FINAL FOR DATA PROTECTION FOR INNOVATIVE DRUGS

On March 24, 2009, Health Canada released the final version of the guidance document titled “Data Protection under C.08.004.1 of the Food and Drug Regulations” (the Guidance). The Guidance was first published in draft form on June 25, 2007, followed by a comment period during which stakeholders were encouraged to provide feedback. The Guidance is effective March 30, 2009.

The Guidance relates to the administration of section C.08.004.1 of the Food and Drug Regulations (the Regulations) and is applicable only to those drugs that have received a Notice of Compliance (NOC) on or after June 17, 2006.

Under section C.08.004.1 of the Regulations, “innovative drugs” that contain a medicinal ingredient, not previously approved in a drug by Health Canada, are entitled to an eight- year term of data protection. This term can be extended for an additional six months for pediatric population submissions.

BC LEGISLATION NOW ALLOWS NATUROPATHS TO PRESCRIBE DRUGS

In this crazy world, we have just noticed that the recent legislation in BC allows Naturopaths to prescribe drugs once they pass a new certificate course….go figure the logic in this?

For more information, please call Joe Knott at 416-516-3524
Email: jknott@pangaea-consultants.com
www.pangaea-consultants.com