Policy and Politics

Canada (see below for USA)

Patent Medicines Prices Review Board. Canada. Drug shortage in Canada and their impact on Public Drug Plans, September 2022. [FINALLY!!]

Press release, Record increase in patented medicine sales in Canada, while pharmaceutical R&D investment remains at historic lows, Annual Report of the Patented Medicine Prices Review Board for 2015, Government of Canada, 17 August 2016.

Health Canada launches Public Register for all companies committed to providing public notifications of drug shortages and discontinuation, 20 June 2016.

Proposed new regulations for making drug shortage notification mandatory, Canada Gazette, 20 June 2015. See also Health Canada press release, 20 June 2016.

Health Canada, Multi-Stakeholder Committee on Drug Shortages, Guidance Document to Mitigate Drug Shortages through Contracting and Procurement, June 2015

Rona Ambrose, Drug shortages complex global problem [Ambrose RE-announces plan first announced last February], Hill Times, 20 April 2015. By 20 June no evidence of any effect.

Canadian Federation of Medical Students urges the federal government to make drug shortages a priority, Position Paper, first approved 2010, revised September 2014.

Health Canada, Products affected by action to stop imports from Apotex and IPCA laboratories in India, 30 September 2014.

Public Health Agency of Canada, Recommended management of gonococcal infections during the cefixime shortage  [until September 2015], 26 September 2014.

Despite the lack of action taken 12 February (see below), Health Canada seeks input on Notification of Drug Shortages, 22 May 2014.

On 12 February 2014, Conservative majority in House of Commons voted against Bill of Mont Saint-Bruno Saint-Hubert MP Djaouida Sellah, MD (see below) that would have made advance notification mandatory as it is in USA (Hansard). Dr. Sellah argues that the solution is prevention and claims that the government is failing to act.

Health Canada, Drug Shortages Protocol and Toolkit, Health Canada Fact Sheet, September 2013.

Caroline Cambourieu, Paul Grootendorst, Aidan Hollis, Anne Pascale Pomey, Generic Drug Pricing Policy in Quebec, June 2013.

Multistakeholder Steering Committee on Drug Shortages in Canada, Multistakeholder tookit for improved understanding and transparency of drug shortage response in Canada, 2013. As of 9 April 2014 no more meetings were held or have been planned (Source: office of Dr Hedy Fry, MP).

The Council of the Federation at its meeting in July 2013 plans to extend its bulk purchasing of drugs (by nine of the ten provinces) from 6 to 12 drugs and it may include brand name products as well as generics. It claims that the previous year’s decision saved $100M (see below). In early 2016, the federal government announced its interest in participating with provinces in bulk purchasing.

Nadeem Esamil, Laura Dawson, Kristina Lybecker, The Trade and Economic Benefits of Enhanced Intellectual Property Protection for Pharmaceuticals in Canada, Fraser Institute, 9 July 2013.

On 5 February 2013, NDP Member of Parliament and physician Dr. Djaouida Sellah gave notice of the following motion (read it; see it on video)

That the Committee undertake, following its study on technological innovation in health care, a study of at least five meetings on the progress of the implementation of the motion adopted on March 14, 2012, by the House of Commons aiming to establish a nationwide strategy to anticipate, identify, and manage shortages of essential medications, and that the Chair report the Committee’s findings to the House. Hansard

NDP health critic Libby Davies asks a question in the House of Commons about the persistent drug shortage still affecting 94% of pharmacists in Canada, 31 January 2013, youtube video and link to Hansard transcript of Question Period, with her question and Minister Aglukkaq’s reply.

The Council of the Federation finally announced which drugs it will bulk purchase, as planned six months earlier, 18 January 2013. Read more here.

  • Atorvastatin – for high cholesterol.
  • Ramipril – for blood pressure and other cardiovascular conditions.
  • Venlafaxine – for depression and other mental health conditions.
  • Amlodipine – for blood pressure and angina.
  • Omeprazole – for gastrointestinal conditions.
  • Rabeprazole – for gastrointestinal conditions.

Bill C- 398 An Act to Amend the Patent Act [to enable supply of drugs to nations with HIV, malaria, and tuberculosis]. Private Member’s Bill. First Reading 12 Feb, 2012. Narrowly defeated November 2012. Read more here.

The Council of the Federation. From Innovation to Action. The First Report of the Health Care Innovation Working Group. July 2012. Response to drug-shortage webmaster’s questions sent on 27 July, answered on 14 September 2012 (item will download to your computer). Reaction from Canadian Pharmacists Association, 26 July 2012. Invited feedback from the Best Medicines Coalition, 6 November 2012.

Drug Supply in Canada: A Multi-Stakeholder Responsibility, Report of the Standing Committee on Health, June 2012. Government response expected in early October 2012. For Government’s response October 2012 click here.

Health Committee of the House of Commons heard three days of witnesses on the topic between 27 March and 3 April 2012 (Meetings 36, 37, 28). Testimony for 27 March, for 29 March and for 3 April. For Report see item above October 2012. For Government’s response October 2012 click here.

U Toronto Bioethicists and Ontario Government, Ethical framework for resource allocation during the drug supply shortage, 20 March 2012.

Libby Davies (NDP) motion on drug shortages, requiring drug companies to report, adopted unanimously, 14 March 2012 (Hansard search on “Business of Supply”). NDP Statement,  on the adoption of the motion New Democratic Leader Nycole Turmel.

Emergency debate on drug shortages, House of Commons (transcript at Hansard), 12 March 2012.

NDP health critic Libby Davies calls for Emergency Debate in the House of Commons. (Hansard search “Request for Emergency Debate”) 9 March 2012.

Liberal Health critic Dr. Hedy Fry and Liberal Industry critic Geoff Reagan, Conservative Incompetence on Drug Shortages Risks Patients’ Lives, Liberal Party of Canada Press Release, 8 March 2012

Bashir Jiwani, Criteria for Allocating Injectable Alkaloids during a period of undersupply, 8 March 2012.

Ontario Minister Deb Matthews’ Statement on Sandoz Drug Supply, Ontario Ministry of Health and Long Term Care, press release, 7 March 2012

Kingston and the Islands MP Ted Hsu (Liberal), letter, Kingston Whig Standard, 13 January 2012

NDP on failure of health accountability, Press Release, 20 December 2011

Liberals demand Federal Gov’t action, Press Release, 24 November 2011

Hon. Hedy Fry (Lib) asks questions of Health Minister about drug shortages in Health Committee meeting, 21 November 2011, twice  Hansard (15:55 and16:55).

Health Canada’s web page on shortages, 23 November 2011

Liberal Party Health Critic, Dr Hedy Fry, challenges Minister of Health, 21 November 2011

FDA Warning letter to Novartis re Sandoz, Boucherville, Quebec, 18 November 2011

Liberal Party of Canada Press Release, 24 August 2011

Liberal Party of Canada, Dr. Carolyn Bennett, MP, 11 Feb. 2011

Ontario Ministry of Health and Long-Term Care, Fair Drug prices for all Ontarians: McGuinty Government Finalizes Plan to Lower Generic Drug Prices, press release, 7 June 2010

Dr. Chaim Bell (St. Michael’s Hospital, and University of Toronto), Dr. David Griller, Joshua Lawson, Dusan Lovren (latter 3 of Secor Group), Generic Drug Pricing and Access in Canada. A commissioned discussion paper by Secor Consulting, June 2010.

Some useful documents

Goverment of Canada, Competition Bureau, Benefitting from Generic Drug Competition in Canada. The Way Forward, November 2008

Government of Ontario, Transparent Drug System for Patients Act, 2006

How drugs are reviewed in Canada, Federal Gov’t report, August 2001

Margaret Smith, Chronology of Patent Protection in Canada, Government of Canada, 30 March 2000.

Paul Grootendorst, Aidan Hollis et al. New approaches to rewarding pharmaceutical innovation CMAJ 183(6), 5 April 2011, 681–685.

Angela J. Anderson (University of Tulsa College of Law), Global Pharmaceutical Patent Law in Developing Countries- Amending TRIPS to Promote Access for All, bePress Legal Series, paper 1109, Berkeley Electronic Press, 2006. For more on TRIPS amendments, click here. For Canada’s failure to amend TRIPS in order to help needy countries obtain essential medicines for HIV, malaria and tuberculosis, click here.

United States

FDA. FDA Evaluation of Infant Formula Response, September 2022.

Erin H, Fox et al., ASHP guidelines on managing drug product shortages, Am J Health-Syst Pharm 2018; 75:e593- 601. Press release

U. S. Government Accountability Office, Drug shortages: Certain factors are strongly associated with this persistent public health problem, July 2016.

U. S. Government Accountability Office, Drug shortages: better management of the Quota process for controlled substances needed; coordination between DEA and FDA should be improved. February 2015.

U.S. Government Accountability Office, Group Purchasing Organizations: Funding structure has potential implications for Medicare costs. 24 November 2014.

Food and Drug Administration, Department of Health and Human Services, REPORT TO CONGRESS. First Annual Report on Drug Shortages for Calendar Year 2013 (Required by Section 1002 of the Food and Drug Administration Safety and Innovation Act Public Law 112-144), February 2014

Government Accountability Office (GAO), Drug Shortages. Public health threat continues, despite efforts to ensure product availability, 10 February 2014

FDA, FDA acts to prevent more drug shortages, 31 October 2013.

US Court of Appeals. Prisoners on death row win ruling that FDA must not import thiopental for lethal injections from other countries, 23 July 2013. read the ruling here.

Thomas Bollyky, ‘Preventing Pharmageddon: Treatment Access for Noncommunicable Diseases,’ Policy Memorandum No. 32, Council on Foreign Relations [a US think tank], May 2013.

Press release, Congressman Edward J. Markey, Top Democrats call for GAO [GOvernment Accountability Office] investigation into link between drug shortages and increased reliance on compoundingpharmacies, 15 November 2012. Markey et al. Letter here.

Philip M. Rosoff et al., Coping with Critical Drug Shortages: An Ethical Approach for Allocating Scarce Resources in Hospitals. Archives of Internal Medicine, September 2012.

FDA responds to Congressional accusations that it caused the drug shortage, 23 July 2012, reported by Daniel Weiss, 7 August 2012.

US House of Representatives, Committee on Oversight and Reform, The FDA’s Contribution to the Drug Shortage, 15 June 2012

Food and Drug Administration Safety and Innovation Bill S.3187.ES with Title X on Drug Shortages passed Senate in late May 2012.

It then passed the House of Representatives as the S.3187:Food and Drug Administration Safety and Innovation Act on 20 June 2012.

It has several passages referring to the drug shortage; however the Bill had been amended and the following language was removed.

    • “an evaluation of … the impact of contracting practices by market participants (including manufacturers, distributors, group purchasing organizations, and providers) on competition, access to drugs, and pricing of drugs”

US House of Representatives, Committee on Energy and Resources, Subcommittee on Health, “Examining the increase in drug shortages,” 23 September 2011.