BIOTECanada

BIOTECanada

December 12, 2007 11:00 ET

BIOTECanada: Canadians Disadvantaged by Closed Decision Making About Their Health Care Options

OTTAWA, ONTARIO--(Marketwire - Dec. 12, 2007) - The Canadian national biotechnology association today called for an open and transparent system of decision making within the Common Drug Review (CDR) to help ensure Canadian patients have the best options for their health care.

"It is vital our public system be accountable to patients, doctors and healthcare providers in order for us to realize new options for health care delivery in Canada," commented Peter Brenders, President and CEO of BIOTECanada. "We have been making representations to CDR for almost three years, encouraging them to adopt basic principles of fairness in their decision making. During this time, thousands of Canadians have been denied access to treatments and therapies that could improve their health and offer them a better quality of life."

The Parliamentary Standing Committee on Health later today will release their report resulting from hearings held earlier this year on the Common Drug Review and its process for review and consideration of recommendations for new and innovative drug therapies. In their appearance earlier this year, BIOTECanada offered three suggestions to help improve the availability of health innovations to Canadians. They are designed to bring Canada up to international standards of patient access, and include:

- Having CDR recognize the value of innovation,

- Developing a separate review mechanism that can evaluate treatments for rare diseases, and

- Ensuring this process becomes fully accountable to the Canadian public by holding open meetings of its review committee.

To encourage further investment and development of innovative health interventions, Canada, through the CDR review, must recognize the value of innovation. In the United Kingdom, for example, the National Institute for Clinical Excellence (NICE), a common comparator to CDR, explicitly takes into account the innovative nature of technology and wider societal interests. NICE also works with a citizens' council in making reimbursement decisions on new medicines. Incorporating these elements of the NICE system into the CDR would begin to demonstrate the Canadian system can accommodate the needs of vulnerable patient populations and values the innovation of breakthrough therapies.

"The ability for all Canadians to realize these true improvements approved by Health Canada as safe and effective for their health care is severely hampered by this current process. This is particularly unacceptable if you are a patient living with a rare disease. New biotech therapies for rare illnesses are being routinely rejected by the CDR, leaving entire patient populations suffering outside of our medical health care system," commented Sean Thomspon, Vice-chair, of BIOTECanada's Health Advisory Board.

There are at least 27 Canadian companies that have received U.S. Food and Drug Administration orphan product status for the products they are developing, the very types of products that CDR has consistently rejected. One in every ten Canadians suffers from a rare disorder.

The CDR process has let down those in need from getting access to innovative treatments. The challenging patient access environment in Canada presented by CDR is becoming well-known around the world and places Canada out-of-step with other global evaluation bodies. The same data submitted to the CDR have been used by other jurisdictions throughout the world to approve public access for these products, and many countries have developed unique programs and mechanisms for the review of treatments for rare diseases.

The members of BIOTECanada recognize the complexity of some of these issues and are willing to work with the provinces and CDR toward solutions that can bring innovative therapies to the Canadian patients who need them.

About BIOTECanada - www.biotech.ca

BIOTECanada is dedicated to the sustainable commercial development of biotechnology innovation in Canada. It is the national industry-funded association with over 215 member companies representing the broad spectrum of biotech constituents including emerging and established companies in the health, agricultural, and industrial sectors, as well as academic and research institutions and other related organizations.

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