[Ip-health] Fwd: New CMAJ paper + call to action

Aidan Hollis ahollis at ucalgary.ca
Wed Dec 23 15:37:25 PST 2015


Many people on this list may be interested in this suggestion from Matt Herder:

"Who can use this letter?
Any “person who carries out functions relating to the protection or promotion of human health or the safety of the public” can use this letter. You don’t have to be a Canadian resident or citizen. As long as you fulfil that function, i.e. protect/promote human health or public safety, and the reason why you are asking for the information is “related to the protection or promotion of human health or the safety of the public”, you can use this letter and you are eligible to receive information from the Canadian regulator (Health Canada) about pharmaceutical interventions.

What can you ask for?

The legal provision that this letter takes advantage of gives the Canadian Minister of Health the power to disclose “confidential business information”. While many argue that drug safety and effectiveness information should not be categorized as confidential business information, the scope of that term in Canadian law is broad and the regulator has taken the position that unpublished safety and effectiveness data falls within it. So until that changes, it is critical to take advantage of Vanessa’s Law, which gives the Minister of Health the power to make confidential business information available to persons who protect/promote human health or public safety. Canada gets most of the drugs that go through the US Food and Drug Administration or the EMA. Health Canada thus has a valuable store of information in its possession."

More information below:
Begin forwarded message:

From: Matthew Herder <Matthew.Herder at Dal.Ca>
Subject: New CMAJ paper + call to action
Date: December 22, 2015 at 5:42:11 PM MST
To: Matthew Herder <Matthew.Herder at Dal.Ca>

Dear Colleagues,

I'm writing to ask for your help in disseminating a tool that I think can help improve transparency in pharmaceutical research and regulation.

By way of brief background, a short paper of mine -- out in CMAJ yesterday (and available open access) -- concludes with a call to action directed at MDs, biomedical researchers, health care professionals, civil society and investigative journalists to take advantage of a new mechanism in Canadian law that has the potential to open up a massive amount of data about the safety and effectiveness of drugs. To date, this new mechanism (in force since 2014) has only been used once; we need to change that.

So, to make the call to action, well, actionable, I've developed (with the help of a few colleagues) a tool -- a template letter -- that I'm hoping many will use to avail of this new mechanism. 

Links to the CMAJ paper (which unfortunately doesn't have the template letter linked to it) as well as one of the NGO websites that have posted an explanatory blog along with the template letter are below. It's the latter that is particularly essential to share.

Main CMAJ article:  <http://www.cmaj.ca/lookup/doi/10.1503/cmaj.150765>http://www.cmaj.ca/content/early/2015/12/22/cmaj.150765 <http://www.cmaj.ca/content/early/2015/12/22/cmaj.150765>

Website with blog + template letter:

 <http://www.alltrials.net/news/enacting-pharmaceutical-transparency-who-what-how-when-why>http://www.alltrials.net/news/enacting-pharmaceutical-transparency-who-what-how-when-why/ <http://www.alltrials.net/news/enacting-pharmaceutical-transparency-who-what-how-when-why/>

I hope you'll consider using and/or distributing this template letter via your respective email networks, social media, etc. I also welcome your feedback on this initiative. 

Sincerely,

//m. 

Matthew Herder, JSM LLM
Associate Professor, Faculties of Medicine and Law
Health Law Institute, Dalhousie University
Email: Matthew.Herder at Dal.ca <mailto:Matthew.Herder at dal.ca>
Twitter: @cmrherder
SSRN: http://papers.ssrn.com/sol3/cf_dev/AbsByAuth.cfm?per_id=952267 <http://papers.ssrn.com/sol3/cf_dev/AbsByAuth.cfm?per_id=952267>



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