The document presents an overview of the pharmaceutical industry in Canada, highlighting its sales as only 2% of the global market and the primary focus of industry employment in Quebec and Ontario. It covers key statistics including leading pharmaceutical companies, therapeutic classes, and the demographics of Canadian medical writers, including their education and sectors of employment. Additionally, it discusses training opportunities, medical writing income, and the regulatory environment for pharmaceutical advertising in Canada.

1. Medical Writing in Canada Presented at AMWA National Conference October 25, 2008, Louisvile, KY Amanda Strong [email_address] 514.239.2736 www.medicalcommunications.ca

2. Pharma in Canada Small market compared to USA: Sales represent only 2% of the world market 8th largest world market in sales employed about 40 000 people in 2005 plus another 35 000 indirectly Over 80% of industry located in Quebec and Ontario Source: Industry Canada. Canadian pharmaceutical Industry Profile. http://strategis.ic.gc.ca/epic/site/lsg-pdsv.nsf/en/h_hn00021e.html

3. Pharma in Canada Source: Industry Canada. Canadian pharmaceutical Industry Profile. http://strategis.ic.gc.ca/epic/site/lsg-pdsv.nsf/en/h_hn00021e.html

4. Pharma in Canada Source: 2005 drugstore and hospital purchases audit performed by IMS Health Top 10 leading pharmaceutical companies in Canada 3.2 552 Montreal Bristol-Myers Squibb 10 3.5 602 Montreal Merck Frosst 9 3.7 625 Quebec Sanofi-Aventis 8 3.8 647 Toronto Novartis 7 4.0 675 Montreal Wyeth 6 5.6 950 Toronto Apotex 5 5.8 996 Toronto GlaxoSmithKline 4 6.5 1,106 Toronto Johnson & Johnson 3 6.6 1,121 Montreal AstraZeneca 2 13.4 2,288 Montreal Pfizer 1 Market Share (%) Total Sales ($Millions) R&D Location Leading Companies Rank

5. Pharma in Canada Top 10 leading therapeutic classes (2005) Source: 2005 drugstore and hospital purchases audit performed by IMS Health 37.5 161.1 Proton Pump Inhibitor Pantoloc 10 17.3 178.7 Hematopoietic Agent Eprex 9 0.2 186.1 Systemic Anti-Arthritic Celebrex 8 17.5 198.6 Tranquilizer Zyprexa 7 8.3 227.5 Antidepressant Paxil 6 40.6 234.9 ACE Inhibitor Altace 5 17.1 250.2 Calcium Channel Blocker Norvasc 4 42.3 291.4 Cholesterol Reducer Zocor 3 1.4 424.3 Proton Pump Inhibitor Losec 2 32.5 625.7 Cholesterol Reducer Lipitor 1 2005 Growth (%) Total Sales ($ Millions) Therapeutic Subclass Leading Products Rank

6. Canadian Medical Writers 61% medical writers who responded to the survey reside in Ontario 3.1 Other 17.2 MD/PhD 20.3 MSc/MA 21.9 BSc/BA Highest Education (%) 76.6 Female 20.3 Male Sex (%)

7. Canadian Medical Writers Sectors of Employment of Medical Writers in Canada 10.2 ± 25.8 0.4 ± 2.1 Other 1.4 ± 4.6 4.3 ± 20.9 Non-governmental Organization 5.2 ± 11.5 0.2 ± 1.0 Governmental Organization 3.0 ± 9.7 4.3 ± 20.9 Research/Education Organization 6.2 ± 22.3 8.7 ± 28.8 Contract Research Organization 3.4 ± 7.9 4.3 ± 20.9 Healthcare Organization 22.9 ± 32.0 13.0 ± 34.4 Communication or Marketing 14.6 ± 26.4 12.4 ± 32.8 Journal or Publisher 1.7 ± 9.3 0 ± 0 Patient/Disease Association 1.3 ± 4.9 4.3 ± 20.9 Professional Association 24.5 ± 33.0 43.3 ± 50.4 Industry 5.2 ± 11.7 4.6 ± 18.9 Academia Freelance Employed

8. Canadian Medical Writers Yearly Income and Average Hours Worked per Week Source: 2008 AMWA Canada Salary Survey 26.2 – 33.8 37.1 – 40.2 95% CI 2, 45 30, 50 Min, Max 30.0 39.0 Median 30.0 ± 9.9 (22.5 ± 8.1 billable) 38.7 ± 3.7 Mean (± SD) Hours worked $48,223 – $76,740 $67,913 – $91,135 95% CI $1,000, $150,000 $40,000, $135,000 Min, Max $67,000 $75,000 Median $62,482 ± $36,044 $79,524 ± $25,508 Mean (± SD) Income Freelance Salary

9. Training in Canada Laurentian University, Sudbury Graduate diploma in science communication Full-time, 1-year Tuition $6000; most students eligible for entrance scholarships

10. Training in Canada Concordia University, Montreal 2 introductory stand-alone courses in medical writing (~$300) Manuscript preparation Pharmaceutical marketing Has been some discussions around creating a scientific or medical communications cont-ed certificate program available for completion online

11. Training in Canada University of Toronto 2 MSc programs in Biomedical Communications, however they focus on medical artwork Interactive media tools Illustration and animation Tuition about $7500

12. Training in Canada Canadian Institutes of Health Research (CIHR) Science Writer Scholarships / Health Research Communications Award $21-26 000 for 2 students enrolled in a post-graduate journalism or communications program Also fund health communications awards / programs Ie, Doctoral Research Award: CHE

13. Writing

14. Regulatory Environment Health Canada. Food and Drugs Act who can sell a drug and how; what standards need to be met for a drug to be sold in Canada; how drugs must be labelled and packaged

15. Codes of Conduct Rx&D Research Based Pharmaceutical Companies PAAB Pharmaceutical Advertising Advisory Board ASC Advertising Standards Canada CAMP Canadian Association of Magazine Publishers MAINPRO College of Family Physicians of Canada (CFPC)

16. PAAB & Health Canada Health Canada is an ex-officio observer and advisor “without relinquishing authority under the Food and Drugs Act” PAAB Commissioner works with Manager, Advertising and Risk Communications Section, Marketed Health Products Directorate at health Canada Bi-annual meetings (Source AMWA PAAB Workshop 2006)

17. PAAB Exemptions PAAB Review exemptions (6.6) personal solicited correspondence government agency requirements price lists ( no claims ) institutional messages with no product “ patient information ” direct to patients independent educational materials (no emphasis on sponsor’s drugs, see Health Canada guideline)

18. Data on File PAAB 3.1.2 Reviewed as part of NDS AND evidence of acceptance indicated by inclusion in the PM Citation in bibliography of PM does not indicate proof of acceptance

19. Published Article s Yes- Publication in a peer-reviewed journal (PAAB 3.1.1) No- Papers published in journal supplements unless the advertiser can demonstrate that the supplement has also been subject to a rigorous peer-review process similar to the attached journal (PAAB 3.1.2)

20. Published Clinical Trial Formulation / dose range must be as per PM and the same as used in Canada Open label trials are generally not acceptable Post hoc analyses an d pooled dat a are generally not acceptable Statistical analysis must be presented as part of any data presentation

21. Other Articles Review articles: Usually not acceptable Meta-analyses: Depends on design Guidelines and consensus statements Usually acceptable Claims must be consistent with PM Posters and abstracts Not acceptable

22. DTC Not allowed in Canada Consumer ads can identify drug or indication, but not both

23. Help Seeking Ads Okay when: No drug is identified No implication that there is one sole treatment available No drug manufacturer’s name is included

24. Third Party Content must be 100% independent of Pharma Pharma involvement limited to funding development and distribution Reps can not distribute (becomes advertising)

25. CHE in Canada Unaccredited must follow PAAB and Rx&D codes of conduct Accredited programs bypass the Rx&D and PAAB codes The two most common accreditation bodies in Canada are the two physician colleges: the CFPC and the RCPSC Accreditation is separate for each province

26. CHE in Canada Usually aim for national faculty Programs for Quebec are usually in French – but often initially written in English ‘ Firewall’ requirements between marketing and CHE

27. Service-orientated Items Service Orientated Items (Rx&D) Acceptable service-oriented items are defined as items whose primary goal is to enhance the health care professional’s or patient’s understanding of a condition or its treatment. Such items may bear the corporate name and logo of the donor, but must not bear the name of any medicine. Rx&D 8.2

28. Miscellaneous Ad boards Similar to US but limitations on distribution Conference Reports Must follow PAAB, Rx&D codes unless involvement strictly restricted to funding

29. Miscellaneous Probably similar to USA although market and budgets are generally smaller Hospital Patient advocacy (usually national) Publishers: textbooks, journals… Corporate communications Posters, abstracts, articles PR Conference coverage, journalism

30. Key differences Intensive pre-clearance process for marketing / CHE Strict regulations restricting communication to approved labeling Strict regulations on data presentation and acceptable references No DTC Fallout: website barriers Less use of technology and new media E-detailing or use of tablet PCs rare Less use of websites Restrictions on satellite symposia in Canadian conferences as well as distribution of post-conference materials Smaller budgets overall especially evident in CHE and less use of ad boards

31. Unique Opportunities Canadianising global or US materials especially relevant in advertising, sales rep training, interactive materials Backgrounders based on Canadian market Although writing is done in English, writers who can communicate in French are in demand

32. Finding Canadian Info For guidelines: CMA Infobase http://mdm.ca/cpgsnew/cpgs/index.asp Canada Health Portal http://chp-pcs.gc.ca/index.jsp Health and Wellness Resource Centre at La Bibliothèque Nationale (members) http://bibnum2.bnquebec.ca A searchable database for magazine articles on health and wellness Statistics Canada

33. Finding Work P.R.N Directory ( www.prnonline.ca ) Directory of pharma companies and suppliers Canadian Health network ( www.publichealth.gc.ca ) Provides a comprehensive list of health orgs in Canada: CharityVillage.ca occasionally has job postings for hospitals, foundations, academia and advocacy organizations Health Canada (jobs.gc.ca) Workpolis.com / Monster.ca AMWA / CSWA / STC-Canada List your services on AMWA-Canada or writers.ca ‘ Headhunters’