SELECT MEDIA ARTICLES
Church, E. (22 Dec 2015). Halifax professor campaigns for increased access to drug-safety data. Globe & Mail.
Belluz, J. (30 Oct 2012). Dear Leona Aglukkaq: Researchers write the health minister on clinical trials. Maclean's.
Belluz, J. (23 Oct 2012). Dear Federal Minister of Health. Macleans.
Dolgin, E. (19 Oct 2012). Online trial registry proposed in Canada lacks teeth. Nature Medicine/ Spoonful of Medicine.
Zilio, M. (6 Nov 2012) Clinical Trial System to Blame for Canada’s Lagging Drug Innovation: Report. iPolitics.
Waldie, P. (13 Jul 2012). Drug Trials on Trial: Is It Really Greed Versus Good? The Globe and Mail.
McIlroy, A. (8 Jun 2012). Senator Probes Declining Drug Trials in Canada. The Globe and Mail.
Hoag, H. (5 Dec 2011). International Group Calls for End to Selective Reporting of Clinical Trials. University Affairs.
Anonymous. (5 Oct 2011). The Cochrane Collaboration Supports Free Access to all Data from all Clinical Trials.The Cochrane Collaboration.
Globe Editor. (7 Sept 2011). Drug trials should not be information inhibitors. The Globe and Mail.
The Gazette. (29 Aug 2011). Health Canada should publish clinical trial results, professor argues. Postmedia News.
Weeks, C. (29 Aug 2011). Clinical trial results should be public: CMAJ. The Globe and Mail.
Herder, M. (21 Dec 2015). Enacting pharmaceutical transparency—Who, what, how, when & why. All Trials..
Herder, M. (21 Dec 2015). Enacting pharmaceutical transparency—Who, what, how, when & why. Impact Ethics .
Herder, M. (23 Jun 2014). The opacity of Bill C-17's transparency amendments. ImpactEthics.ca.
Herder, M., & Krahn, T.M. Some numbers behind Canada's decision to adopt an orphan drug policy: US orphan drug approvals in Canada, 1997-2012.Healthcare Policy, 11(4), 70-81.
Herder, M. (22 Dec 2015). Reinstitutionalizing transparency at Health Canada.Canadian Medical Association Journal [PDF 192 KB - Open Access]. Early release, published at www.cmaj.ca.
Herder, M. Gibson, E., Graham, J., Lexchin, J. & Mintzes, B. (13 May 2014). Regulating prescription drugs for patient safety: Does Bill C17 go far enough? CMAJ, 186(8), E287-E292.
Schuchman, M. (6 Aug 2013). Health Canada's new clinical trials database should be mandatory
Miriam Schuchman, CMAJ.
Herder, M. (2011). Unlocking Health Canada's cache of trade secrets: Mandatory disclosure of clinical trial results. CMAJ.
Hébert P. & Fergusson D.A. (13 Jul 2010). Are we keeping research participants safe enough? CMAJ Editorial.
SELECT POLICY CONTRIBUTIONS
In November 2012, Françoise Baylis presented to the Senate Committee, this time highlighting the need to ensure that post-marketing surveillance is effective in capturing a drug's safety and efficacy for population sub-groups [PDF - 133 KB].
The committee tabled its second report in March 2013, Prescription Pharmaceuticals in Canada: Post-Approval Monitoring of Safety and Effectiveness [PDF - 4.4 MB].
Françoise Baylis' contribution on the need for post-appproval strategies for population sub-groups is referenced in the Comittee's second report (page 23).
Herder, M. (2 May 2016). House of Commons' Standing Committee on Health: Development of a National Pharmacare program.
Lack of transparency around pharmaceutical drugs continues to undermine patient safety and public health. The problem stems from the fact that lots of evidence about a drug’s safety and effectiveness is never published and remains inaccessible. While Canada seemed to be on a path to breaking norms of relevant secrecy with the passage of Vaessa's Law, in March 2016 Health Canada published its Draft Guidance about how it intends to interpret sections 21.1(3)(c), cementing an approach that has already stymied access to information regarding the safety and effectiveness of pharmaceuticals. The following letters from legal scholars, clinicians and researchers, and representatives of civil society are in response to Health Canada’s call for public commentary on its Draft Guidance. The letters call upon Health Canada to remove limitations on access to relevant information so as to exclude clinical data (relevant to drug safety and effectiveness) from the category of confidential business information.
- Herder, M. et al. (24 May 2016). Letter to Resource Management & Operations Directorate, Health Canada re: Draft guidance – Document: "Disclosure of Confidential business information under paragraph 21.1(3)(c) of theFood and Drugs Act".
- Spelsberg, A. et al. (24 May 2016). Letter to Health Canada re: Comments on March 10, 2016 Health Canada draft guidance document, "Disclosure of confidential business information under paragraph 21.1(3)(c) of theFood and Drugs Act".
- Lexchin, J. et al. (22 May 2016). Letter to Resource Management & Operations Directorate, Health Canada re: comments on Health Canada draft guidance document, "Disclosure of confidential business information under paragraph 21.1(3)(c) of the Food and Drugs Act" dated 10 March 2016.
Since 2012 Matthew Herder has published several papers, appeared before Parliamentary Committees on several occasions, and written a number of blogs and op-eds relating to pharmaceutical policy. These works focus on a range of topics, from improving the transparency of evidence behind pharmaceutical interventions as well as regulatory decision-making to orphan drug policy and investigations of national pharmacare.
In December 2013, the Government of Canada introduced Protecting Canadians from Unsafe Drugs Act (Vanessa's Law) Amendments to the Food and Drugs Act (Bill C-17). It was designed to improve Health Canada's ablity to collect post-market safety information and take action when a serious risk is identified. In June 2014, Herder presented to the Standing Committee on Health [PDF - 311 KB] calling for further amendments to make evidence and regulatory work transparent, and to make it absolutely clear that transparency trumps commercial claims. Vanessa's Law was subsequently amended to include a number of transparency related provisions, and then passed by Parliament in November 2014.
Herder has worked since the passage of Vanessa's Law to ensure that the legal changes are appropriately implemented by Health Canada. In December 2015, he published an article on reinstitutionalizing transparency at Health Canada and generated a template letter, calling on clinicians, researchers and others, to file requests with Health Canada for access to unpublished information about pharmaceutical drugs. This letter writing campaign was supported by a number of NGOs, including AllTrials, SenseAboutScienceUSA, Evidence4Democracy, and Canadian Doctors For Medicare.
In addition to these transparency related projects, Herder has written several papers relating to orphan drugs – therapies aimed at treating rare diseases. As a result of his work in this area, in May 2016 he was invited to appear before the House of Commons' Standing Committee on Health in connection with its study about national pharmacare.
Page last updated Spring 2016.