Update on the Issues Facing the Industry

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Update on the Issues Facing the Industry

• Presentation by
• Russell Williams, President
• Canadas Research-Based Pharmaceutical Companies
  (RxD)
• The Ontario Pharmaceutical Marketing Club
• Toronto, Ontario
• April 2, 2007

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The RxD Community Our Mission

Improve the quality of life of all Canadians
and enhance our health-care system by fostering
the discovery, development and availability of
new medicines and vaccines.
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The Value of New Medicines

• Our medicines and vaccines help people live
  longer, healthier and more productive lives.

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The Value of New Medicines
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The Value of New Medicines
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Lifecycle of a New Medicine
Lifecycle of a new medicine from discovery to
patients access
First Synthesis of Drug Candidate
Pre Clinical Research
Phase I Clinical Trials
Phase II
Phase III
Registration Submission
Regulatory Approval
Basic Research Drug Discovery
PMPRB CDR Provincial Listings
Pharmacovigilance / Phase IV Studies
0
5 years
10 years 15
years Patent expiry
(20 years after filing)
6 months
8 years
Data Protection
Pediatric Protection
RD process for a new compound
Pharmaceutical product on the market
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Barrier to Access Comparative CDR Study
82
80
76
72
72
58
52
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N.B. Seventy (70) or more public plans in Ohio
and Oregon make a majority non-recommended drugs
in Canada available for coverage on their plans.
Ohio public plans list 15 out of 24
non-recommended CDR-reviewed drugs, and Oregon,
12 out of 24.
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Access to Medicines and Vaccines
Through Government drug plans, Canadians on
average have access to less than 20 of new
medicines approved by Health Canada
Provincial Listings of Innovative Medicines
Launched December 1, 2004 to November 30, 2006
103 Products Launched
Note These statistics are based on the
introduction of 103 products. Source IMS
Health, Provincial Reimbursement Advisor
(February 2007).
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The Truth on Pricing

• Patented prescription medicines are on average 8
  below the international median.
• Generic drugs in Canada are on average 30 more
  than the international median.
• 22 Consumer Price Index increase in 10 years.

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Milestones Data Protection

• Data Protection
• PM(NOC) Regulations

A Step Forward for INNOVATION in Canada
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IPP Data Protection/PM(NOC) Regulations

• Final Regulations passed on October 5, 2006 with
  final Canada Gazette Part II published on October
  18, 2006.
• Prior to Data Protection improvements Canada was
  the only G7 country without effective data
  protection.
• Eight years data protection can also include
  additional six months of data protection for
  paediatric clinical trials.
• Regulations include broader definition to include
  biologics.
• Hopeful that the Regulations will foster
  innovation in biopharma sector and provide
  incentive to commercialize products in Canada.
• Encouraged that a positive environment will
  attract RD into new medicines and vaccines.

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IPP Data Protection/PM(NOC) RegulationsNot
Over Yet Next Steps

• Will pursue submission regarding forms and
  guidance documents to ensure implementation.
• Will review and monitor the PM(NOC) Regulations
  to fully understand the impact of the changes.
• Concerned incremental innovation will no longer
  be respected and recognized.

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Milestones Politique du médicament

• The four pillars of Quebecs Drug Policy
• A better access
• The optimal use
• Maintaining a dynamic industry
• Fair and equitable pricing

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Challenges

• Ontario - Bill 102
• Supplier rather than Partner
• Cost Containment
• Price Roll Back
• Building new relationship

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Challenges

• NPS
• CDR
• PMPRB

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Other Initiatives Hearts Minds

• Phase I - Launched January 2006
• Television and print ads
• Phase II Later in 2007
• Member companies contributions in communities
  across Canada

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Other Initiatives Code Improvements

• Effective January 1, 2007
• Education for Health-Care Professionals Section
  4Establishes reasonable limits on the common
  practices of training health-care professionals
  (HCPs) who will, in turn, train other HCPs on new
  medicines/indications
• Continuing Health Education Section
  4AClarifies that a member company is
  responsible for activities organized by a third
  party on a members behalf
• Market Research Section 12Clarifies the
  differences in the roles between sales and market
  research activities participation in market
  research by sales representatives is prohibited
  also prohibited - any follow up by sales
  representatives with those contacts derived
  specifically from market research studies.

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Whats at Stake Moving Forward

• Breaking down barriers
• Research must be rewarded
• Integral partner of the health-care system

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Question Period