New drug submissions in the United States and Canada 2014-2019: trends and policy implications.

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Summary

Pete Ecclestone  

Canadian Health Policy, October 2019. ISSN 2562-9492

Abstract

It is generally agreed by patients, government and industry that “new innovative medicines are critical to the Canadian Healthcare system” (Health Canada, 2017) (Health Canada, 2018) (Ernst & Young LLP, 2019). However, Canada may have passed a tipping point where we are no longer considered a premier jurisdiction to launch new medicines. On average the US FDA has approved 12 more New Active Substances (NAS) per year than Health Canada (HC) over the past 5.5 years. This difference peaked in 2018 when they approved 20 more than Health Canada. The time from application to approval, and backlog based on the FDA and HC’s own published metrics is not significantly different between the two jurisdictions. The gap in number seems to stem from companies not applying for review equally. 54% of US approved NAS not yet approved in Canada are to sponsors with no Canadian presence despite the Canadian government’s efforts to attract the biopharmaceutical industry with programs from Global Affairs Canada, Canadian Institutes of Health Research, The National Research Council’s Industrial Research and Assistance Program (NRC-IRAP), Export Development Canada (EDC) and the Business Development Bank of Canada (BDC).  Canadians need to determine why these medicines are not being submitted and address the issues with government before we fall any further behind in having access to quality innovative medicines.

References

1. Christel, M. (2018). Pharma Exec's Top 50 Companies 2018. Pharmaceutical Executive, 38(6). Retrieved from http://www.pharmexec.com/pharm-execs-top-50-companies-2018.

2. Crowe, K. (n.d.). Two Brothers - A Life Threatening Disease - And the Harsh Reality of Drug Prices. Retrieved from CBC News - Second Opinion: https://links.lists.cbc.ca/share/443/6bfb647e3a526fec1d6e5b3885a4bdc1439d9f180b650014.

3. Danzon, P. &. (2012). Effects of Regulation on Drug Launch and Pricing in Interdependent Market. Advances in Health Economics and Health Services Research, 23, 35-71.

4. Ernst & Young LLP. (2019). An Assessment of Canada's Current and Potential Future Attractiveness as a Launch Destination for Innovative Medicines. Ottawa: Innovative Medicines Canada. Retrieved July 30, 2019, from https://innovativemedicines.ca/wpcontent/uploads/2019/02/2019_01_29_-_IMC_PhRMA_LaunchSequencing_vFinal3.pdf.

5. Halyk, C. (2018, February 14). Consultation Responses - Letter from Janssen to Honourable Ginette PetitpasTaylor, Minister of Health. Retrieved July 30, 2019, from PDCI Market Access: https://www.pdci.ca/wp_content/uploads/2018/02/18-02-14-Janssen-PMR-CG1.pdf.

6. Health Canada - BGTD. (2019). Biologics and Genetic Therapies Directorate - Drug Submission Performance Annual Report Fiscal Year 2018-2019. Biologic and Genetic Therapies Directorate. Ottawa: Government of Canada. Retrieved from http://publications.gc.ca/collections/collection_2019/schc/H166-4-2019-eng.pdf.

7. Health Canada - TPD. (2019). Therapeutic Products Directorate - Drug Submission Performance Annual Report FIscal Year 208-2019. Therapeutic Products Directorate. Ottawa: Government of Canada. Retrieved from http://publications.gc.ca/collections/collection_2019/schc/H166-2-2019-eng.pdf.

8. Health Canada. (2017). Protecting Canadians from Excessive Drug Prices Consulting on Proposed Amendments to the Patented Medicines Regulations. Health Canada. Ottawa: Health Canada. Retrieved July 30, 2019, from https://www.canada.ca/en/healthcanada/programs/consultation-regulations-patentedmedicine/document.html.

9. Health Canada. (2018). Towards Implementation of National Pharmacare Discussion Paper. Ottawa: Health Canada. Retrieved July 30, 2019, from https://www.canada.ca/en/health-canadacorporate/about-health-canada/publicengagement/external-advisory-bodies/implementationnational-pharmacare/discussion-paper.html.

10. Health Canada. (2019). Service Standards for Drug Submission Evaluations (Pharmaceutical and Biologic Products) udner the Food and Drug Regulations - Health Canada. Ottawa: Government of Canada. Retrieved from https://www.canada.ca/en/healthcanada/corporate/about-health-canada/legislationguidelines/acts-regulations/service-standards-highvolume-regulatory-authorizations/service-standardsdrug-submission-evaluations-pharmaceuticals-biologicproducts-under-food.

11. Innovative Medicines Canada. (2017, June 28). Policy Position and Submission Papers - Submission Consultation Document, Protecting Canadians from Excessvie Drug Prices Patented Medicines Prices Review Board (PMPRB) and the Patented Medicines Regulations. Retrieved from Innovative Medicines Canada: http://innovativemedicines.ca/wpcontent/uploads/2017/08/20170628_PMPRB_Submission_Final_EN_final.pdf.

12. Innovative Medicines Canada. (2018, February 12). Policy Position and Submission Papers - Canada Gazette Part 1 Submission. Retrieved July 30, 2019, from Innovative Medicines Canada: https://innovativemedicines.ca/wpcontent/2018/02/20180212_IMC_CG1_Submission_Regulations_Amending_the_Patented_Medicines_Regulations_FInal.pdf.

13. Merck. (2017, June 28). Submission-Health Canada Consultation Paper Protecting Canadians from Excessive Drug Prices Consulting on Proposed Amendments to the Patented Medicines Regulations. Retrieved July 30, 2019, from PDCI Market Access: https://pdci.ca/wp_content/uploads/2017/08/MerckCanada-Inc..pdf.

14. Muhimpundu, V. (2018, October 15). Perspectives - The double-edged sword of the proposed PMPRB framework. Retrieved July 30, 2019, from National: https://www.national.ca/en/perspectives/detail/doubleedged-sword-proposed-pmprb-framework/.

15. United States FDA. (2019). PDUFA Reautorization Performance Goals and Procedures Fiscal Year 2018-2022. US Government. Retrieved fromhttps://www.fda.gov/media/99140/download.

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