monthly reporter newsletter

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FEATURES

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Powered by the Bio-economy: National Biotechnology Week Celebrates Biotech Convergence in our Economy

Excitement is in the air as the industry prepares for 2010 National Biotechnology Week. Our theme “powered by the bio-economy”, focuses on technology convergence and innovation.

A new launch partnership with the network of Genome Centres around Canada celebrates the 10th anniversary of the draft human genome sequence, and the important links between genomics, biotech and the broader economy.  Since it was decoded in 2000, the human genome has inspired new areas of research across the lifesciences; and in the health sciences, diagnostic capabilities have opened a new era of improving healthcare. To celebrate National Biotechnology Week 2010, the Genome Centres and BIOTECanada will be launching the week on September 16, with a series of exciting events taking place in communities across Canada: join Saskatchewan for a series of site visits to key facilities around the province; join LifeSciencesBC for an ‘amazing race’ around the BC Scienceworld; in Quebec visit Genome Quebec for a virtual game launch and much more.

BIOTECanada’s National Advocacy Day, a key feature of the week, is bigger than ever. A networking reception and exclusive thought leader dinner with innovation author Juan Enriquez, will kick-off the event on Monday September 20.  The following day, Tuesday September 21, will be a full day of meetings and roundtables between industry and key ministers, staff and civil servants.  To inquire about registering for these events please contact Cate McCready.

The association has identified a focus on the following priorities, as established by our policy committees and advisory boards, calling on our government to work with industry, and their provincial partners to:

Agricultural Biotech

•  Vote against Bill C-474, to show their support for the innovative biotechnologies that offer Canadian farmers value-added solutions in today’s competitive global markets. 

Industrial Biotech

•  Secure Canada’s place in the bio-economy by providing a minimum of $100 million per year to Sustainable Development Technology Canada to continue support for the next generation of industrial biotechnology and cleantech innovations.

Vaccines

• Build on the success of the National Immunization Strategy (NIS) program, established in 2003, by creating a permanent fund of a minimum $100 million per year to ensure newly recommended vaccines can reach all Canadians; and,
  

• Establish a sustainable funding mechanism to ensure adoption of new, recommended vaccines in public health programs within six months of their approval by Health Canada

Health

• Establish a dedicated Office of Orphan Products within Health Canada to stimulate the development and introduction of rare disease therapies through incentives for domestic research and a clearly defined regulatory pathway that recognizes the unique nature of rare disorders.

Financing

• Expand the applicability of the federal government’s flow-through shares program to Canada’s biotechnology sector.  

• Encourage investment in flow-through shares issued by biotechnology companies by broadening the definition of the Mineral Exploration Tax Credit (METC) to include qualifying bio-based research and development expenses.

Members are invited to join us for the reception and advocacy – and to take part in events across Canada.

Contact us today, or visit our website: www.ima GENEnation.ca for more information.

National Biotechnology Week is made possible thanks to the generous support of:

Council for Biotechnology Information, Amgen, Sanofi Pasteur Limited, Biovail, Genzyme, Janssen-Ortho and Pfizer

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Special Feature: Pressing matters in biotech
No magic bullets or one-size-fits-all strategies when it comes to attracting media

A former editor from a national newspaper, speaking to a group of communicators from the science and technology research community at a recent conference in Winnipeg, laughed aloud as he recounted some of the press releases that cluttered his inbox. Very few, he said, got a second glance past the headline, fewer were read in their entirety, and fewer still sparked a story in his publication.  Why? Primarily, because they didn't contain news, or if they did, the key facts were buried under a mountain of self-serving rhetoric. In short, they didn't tell a story that was worth telling... read the article by Narus Communications

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Policy Watch & Committee Watch - Building the Bio-economy

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TAKE PART IN OUR COMMITTEE WORK. UPCOMING MEETINGS:

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Take Part in Setting our Industrial Biotech Agenda: Bioproduct Thought-Leader Roundtables

During these roundtable meetings, BIOTECanada aims to discuss and analyze findings from recent focus group discussions and interviews held with bio-economy leaders from around the country to detail the top priority actions needed by Canada’s industrial biotech leaders to grow their industry.

The first phase of consultation, completed in July, involved individual interviews of nine primary industry associations and provincial governments.  The second phase will involve meetings with individual firms attending the Green Chemistry Network (Ottawa, August 16) and the Agricultural Biotechnology International Conference (Saskatoon, September 13). 

The results of the roundtables will be a strategic action plan the industry can use as a basis for engagement with federal and provincial governments, and with consumers and media.  The roundtables will also be seminal in setting and refining overall priorities for meetings to be held on the two days immediately following (Aug 17 and 18) with policy officials from Industry Canada, Natural Resources Canada and Agriculture and Agri-Food Canada.  The plan will also set the stage for meetings with Members of Parliament and Ministers at the upcoming National Biotechnology Week Lobby Day on September 21 in Ottawa.

To be a part of setting our industrial biotechnology agenda, please contact Mejda Lortie.

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Health Canada to Begin Technical Discussions on New Drug Regulations

BIOTECanada, along with several other associations, met with Health Canada on July 28 to learn more about plans for the new drug regulations.  Health Canada confirmed that the department is not planning to re-draft the legislative modernization Bill (formerly C-51) and advised associations to utilize the existing Bill as a guide moving forward.  BRAG Chair Lorenzo Biondi represented BIOTECanada at the meeting. The Department is planning to hold a series of four information sessions, for a month beginning in early October, to inform and assist officials drafting new drug regulations.

Officials proposed four information sessions will be held on the effort. These will be facilitated technical discussions on the following key topics: (1) pre-market filing requirements (clinical trial authorizations, benefit/risk management plans, protocol advice, pharamacovigilance plans); (2) market authorization conditions (on-market powers to require information, label changes, tests, studies, and recall); (3) power to request benefit/risk reassessments (market suspensions, revocations, registers); and (4) inspectorate issues (establishment licenses, import/export, sampling).

Health Canada is in the process of identifying meeting dates for the technical sessions and will liaise directly with associations and other stakeholders to determine final dates and identify technical experts. BIOTECanada is asking that member companies wishing to participate in one or more sessions indicate their interest to Graeme Fraser.

In addition to the sessions, there will be an opportunity for all interested parties to submit written feedback. BIOTECanada will be organizing working sessions to discuss member perspectives on these technical issues beginning in September.

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BIOTECanada Urges International Negotiators to Shape Negotiations on Access and Benefit Sharing, Reaffirm Unique Role 

Negotiations on an International Protocol for Access and Benefit Sharing (ABS) – the provisions governing how parties can access resources and division of benefits - under the Convention on Biological Diversity (CBD), will take centre stage at an upcoming meeting in Nagoya, Japan. This is an issue of considerable international importance as several countries are seeking to create new patent disclosure requirements or to change the international IP system to create additional enforcement mechanisms for the benefit-sharing sections of the Convention. The implications for biopharmaceutical, agricultural and industrial biotechnology development are profound.

As a home to the second largest global number of biotechnology companies and a member of the Convention on Biological Diversity, Canada has a unique role in shaping the outcome of these discussions.In coordination with Rx&D, CropLife Canada and the Canadian Chamber of Commerce, and our international counterparts at BIO and PhRMA, we have made the interests of Canada’s biotechnology industry clear:   in a letter to Environment Canada and International Trade, the industry reaffirmed the international protocol should not include patent disclosure requirements, nor should an additional international bureaucracy be established to administer the ABS provisions.

Canada is currently considering the developing of a domestic Access and Benefits Sharing Regime which could have a significant impact on how our genetic resources can be used in the development of new biotechnology applications.

It is with these considerations in mind, that BIOTECanada and our partners in this effort will engage with the Canadian government over the next several months to ensure that the resulting protocol reflects the intent of the CBD, and enables the use and development of genetic resources for the expansion of the bio-economy in Canada and globally. If you have questions or comments about Access and Benefit Sharing policy, please contact Phil Schwab or Mejda Lortie.

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BIOTECanada to Intervene In Supreme Court Case on Confidential Information. 

This is the first case regarding Access to Information that the Supreme Court has heard and implications for administration of the law may be far-reaching. 

Given the importance of confidential trade secret information to the developers of biotechnology applications across health, agricultural and industrial biotechnology sectors, BIOTECanada sought leave to intervene before the Supreme Court on behalf of our diverse membership and in support of a predictable, science-based regulatory system for biotechnology products.

The Court agreed to the motion, in part, due to the diversity of BIOTECanada membership and the unique perspective brought to the issue by early-stage, multinational and cross-sector member companies.

The BIOTECanada motion was prepared and represented by Gowling Lafleur Henderson LLP. The court is set to hear the case later in the fall.  BIOTECanada will have the opportunity to submit a 10 page factum to the court.  Members who would like to contribute substance to the factum or have additional questions about this issue, please contact  Philip Schwab.

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Subsequent-Entry Biologics Outreach Continues in British Columbia and Nova Scotia

The BIOTECanada SEB Task Force continued to meet with stakeholder communities over the summer. As many biologics are dispensed within a hospital setting, it will be critical to educate the hospital pharmacy community on patient safety and pharmacovigilance issues associated with SEBs.

On July 21, BIOTECanada Vice President, Philip Schwab, and member companies Janssen-Ortho, Roche, and Amgen met with representatives of BC Pharmacare in Victoria to discuss recent developments in the SEB regulations and reimbursement.  The group also met with the BC Pharmacy Association and the BC College of Pharmacists to inform their staff on the appropriate use of SEBs in practice in Canada.  A discussion with several oncologists from the BC Cancer Agency was a highlight of the visit, featuring a robust exchange of views about clinical efficacy and safety data that practising physicians will require as SEB products eventually enter the market. 

On August 10 in Halifax, Nova Scotia, BIOTECanada will host a special symposium on SEBs as part of the Canadian Society of Hospital Pharmacists summer education meeting.  The symposium will feature presentations by Dr. Karen Burke, Director of Regulatory Affairs at Amgen Canada and Dr. Agnes Klein of the Biologics and Genetic Therapies Directorate at Health Canada. Dr. Leigh Revers of the University of Toronto at Mississauga, who recently published an article in the Canadian Pharmacists Journal on SEBs will also present on the panel. 

The outreach effort aims to sensitize physicians and pharmacists to the need to ensure patient safety in the use of SEBs in clinical practice, and will continue into the fall. For more information on SEB outreach please contact Philip Schwab .

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NEW MEMBERS

BIOTECanada welcomes new members:



Arnold & Porter LLP is an international law firm with over 650 attorneys practicing worldwide in more than 25 practice areas spanning a broad spectrum of the law, with a primary focus on litigation, transactional matters, and regulatory issues. Our attorneys, many of whom have previous government agency experience, routinely counsel pharmaceutical, biotechnology, medical device, and diagnostic companies, as well as other healthcare entities, in responding to complex legal challenges in the US and Europe. Arnold & Porter professionals work together to provide our clients with seamless, comprehensive, and sophisticated analyses, and strong and zealous advocacy.

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