LabourMediaMilitaryOfficial LanguagesPharmaceuticals

LABOUR

Reversing Changes to the Federal Public Sector Labour Relations Act and other Acts (2018)
Canada Labour Code (harassment and violence), Parliamentary Employment and Staff Relations Act, Budget Implementation Act, 2017, No.1 (2017)
Canada Labour Code, the Parliamentary Employment and Staff Relations Act, the Public Service Labour Relations Act and the Income Tax Act (2017)
Public Service Labour Relations Act, the Public Service Labour Relations and Employment Board Act (2016)


Reversing Changes to the Federal Public Sector Labour Relations Act and other Acts 

Date: November 2018
Bill: C-62
Committee: National Finance
Chair: Hon. Percy Mockler (NB)
Deputy Chair: Hon. Mobina S.B. Jaffer (BC)
Deputy Chair: Hon. André Pratte (QC)
Bill sponsor: Hon. Diane Bellemare (QC)
Downloads: Read the Report

Summary:

Bill C-62 attempts to reverse changes to labour relations legislation between public sector employees and the federal government made under the previous Conservative government. Bill C-62 is a combined bill that included proposals from Bill C-5 and Bill C-34 in an attempt to move the changes through more efficiently.

Bill C-62 is actually in part a reversal of the controversial Conservative Bill C-59, which took away the negotiating power from unions and gave government unilateral powers to negotiate sick leave.

In addition, Bill C-62 restores the right of arbitration to public sector unions and reverses the right of government to unilaterally declare which public services are essential.  Arbitrators also no longer have to give undue consideration to two factors — recruitment and retention, and Canada’s fiscal circumstances — when making awards.  Finally, the notice to bargain will be reversed back to four months.

Bill C-62 will restore good faith bargaining to public sector unions. Before this legislation, the Liberal government negotiated 99 per cent of eligible contracts using an informal agreement and mutual trust. After the Conservatives changes, unions filed a number of lawsuits against the legislation, which were put on hold when the Liberals took power and promised to repeal the changes.

Impact:

The Senate report did not present any amendments or observations to the bill, although certain myths were dispelled during hearings, including that sick leave is a cashable benefit that employees can bank and then have paid out. There was concern that the legislation could be improved by amendment, but the decision was to simply reverse the legislation back to the place it was before the changes and then improve it later. Bill C-62 was passed in November 2018.


Canada Labour Code (harassment and violence), Parliamentary Employment and Staff Relations Act, Budget Implementation Act, 2017, No.1

Date: June 2018
Bill: C-65
Committee: Human Rights
Chair: Hon. Wanda Elaine Thomas Bernard (NS)|
Deputy Chair: Hon. Jane Cordy (NS)
Deputy Chair: Hon. Salma Ataullahjan (ON)
Bill sponsor: Hon. Nancy Hartling (NB)
Downloads: Read the Report

Summary:

Bill C-65 was introduced as a response to a number of high-profile incidents of harassment and abuse by politicians, as well as the wider #MeToo movement. It is legislation designed to protect federal employees from harassment and violence, including Crown corporations and parliamentary staff. It includes not only physical, but also psychological abuse.

It is a framework for all federally-regulated workplaces that has three goals: to prevent incidents of harassment and abuse, to respond to them in a timely and effective manner, and to support those who are impacted.

The Senate committee added a key amendment that clarified that even with this amended Labour Code, an individual could still make their concerns known through the Human Rights Act. Another amendment provided clarity for annual reporting requirements by the Minister responsible, while a final one ensured that those who received such complaints would be trained in how to respond appropriately.

Impact:

While C-65 provided the framework, regulations with more detail will be introduced as early as spring 2019. All federal workplaces will then need to comply with the changes. This will ensure all parliamentary employees, who previously had no such protection, will now have access to a safe workplace, in addition to other federal employees. Debates in the Senate made it clear that this legislation was only a starting point, and a culture change would also be necessary to see real progress.


Canada Labour Code, the Parliamentary Employment and Staff Relations Act, the Public Service Labour Relations Act and the Income Tax Act

Date: February 2017
Committee: Legal and Constitutional Affairs
Bill: C-4
Chair: Hon. Bob Runciman (ON)
Deputy Chair: Hon. George Baker (NL)
Bill sponsor: Hon. Diane Bellemare (QC – Alma)
Downloads: Read the Report

Summary:

Bill C-4 repeals the former Conservative government’s controversial anti-union Bills C-377 and C-525.

It seeks to restore balance between federally regulated employers and unions. It repeals two acts (formerly bills C-377 and C-525).

The Senate passed the bill without amendments.

Impact:

Bills C-377 and C-525 made significant changes to the legal framework for unions.

During the 2015 election campaign, both the Liberals and the NDP promised to repeal them.

Bill C-4 fulfills an election promise and recognizes the importance of the tripartite federal labour relations system.

The bill was covered in Huffington Post, Globe and Mail, Canadian Press and many union publications.


Public Service Labour Relations Act, the Public Service Labour Relations and Employment Board Act

Date: June 2016
Committee: National Security and Defence
Bill: C-7
Chair: Hon. Daniel Lang (YT)
Deputy Chair: Hon. Mobina S.B. Jaffer (BC)
Bill sponsor: Hon. Larry Campbell (BC)
Downloads: Read the Report

Summary:

Bill C-7 was legislation introduced to give the RCMP collective bargaining rights because of a Supreme Court ruling in 2015. This ruling stated that the internal system of negotiating employment contracts violated the members constitutional rights to freedom of association. The report made amendments to strengthen management rights and to ensure a secret ballot process was used during any union certification process. It also took out exclusions to collective bargaining, thereby expanding the types of issues that could be included in the bargaining process. Although the government claimed these exclusions were necessary because RCMP members would be joining the public service, it was noted that being a member of a police force was distinct from being a traditional public servant. The amendment also allowed more types of grievances to go before an arbitrator or a public service labour relations board.

Impact:

Bill C-7 was introduced into the Senate by Independent Senator Larry Campbell.  This was a departure from the norm, as government representatives usually introduce a bill. As Senator Campbell was a former RCMP officer, this made some sense. When the Senate sent the amended bill back to the House, the government eventually agreed to drop the exclusions, but did not allow the secret ballot. It also did not allow grievances to be heard by the Public Service Labour Relations Board.

The major impact of the Senate amendments was to ensure that RCMP members could collectively bargain on issues related to harassment and workplace wellness, appointments and appraisals, and measures to mitigate the impact of discharges and demotions of RCMP members. These were important issues to the RCMP membership given its recent history and the amendments were supported by the Mounted Police Professional Association.

MEDIA

Journalistic Sources Protection Act (2017)
Final Report on the Canadian News Media (2006)
The Uncertain Mirror: Special Senate Committee on the Mass Media (The Davey Report) (1970)


Journalistic Sources Protection Act

Date: 2017
Bill: S-231
Chair: Hon. Douglas Black (AB)
Deputy Chair: Hon. Carolyn Stewart Olsen (NB)
Bill sponsor: Hon. Claude Carignan (QC – Mille Isles)
Downloads: Text of the Bill

Summary:

After disclosure that Quebec police had spied on several Quebec journalists in 2016, Quebec Senator Carignan introduce legislation that would protect journalists’ sources. The committee provided five amendments to the bill, including expanding the definition of a journalist, ensuring all measures were considered to preserve the identity of a source, including general warrants in the warrant process, and balancing public interest and criminal prosecutions when considering legally revealing a source.

Impact:

The Senate amended the bill one further time before third reading, to stop a loophole that may have allowed journalists to use a separate process if any warrant was issued, even if they themselves had been guilty of a crime. The Senate passed the bill on April 11, 2017. As the bill had been introduced by a Conservative senator, many senators believed the bill would not pass the House of Commons under the new government. However, the House did pass the bill, with their own amendments. The bill sponsor, Senator Carignan, supported these amendments and felt they improved the bill. The Senate duly passed the bill with the House amendments on October 17, 2017. This is an excellent example of collaboration across political parties between the Senate and the House of Commons to pass needed legislation.

The legislation has already been used in Quebec on February 13, 2018, when a Quebec Court judge used S-231 to throw out subpoenas on two journalists forcing them to reveal their sources.


Final Report on the Canadian News Media

Date: June 2006
Committee: Transport and Communications
Chair: Hon. Lise Bacon (QC)
Deputy Chair: Hon. David Tkachuk (SK)
Downloads: Read the Report

Summary:

The Committee set out to to identify ways in which public policy could be rethought to foster healthy, independent news media for the 21st century. It was guided by the principle that freedom of the press is a central pillar of any democracy.  As its final report states,

To make informed decisions, citizens need a wide range of news and information. They also need access to a broad and diverse array of opinions and analyses about matters of public interest.

The report includes 40 recommendations and 10 suggestions covering a wide array of concerns expressed by witnesses:  media concentration; inadequate funding for the national public broadcaster and its unclear role and mandate; the legal and professional environment, as well as training for journalists; and federal support programs. As emphasized throughout the process, the Committee’s work and recommendations dealt exclusively with the architecture of Canada’s news media system and not news content.

Impact:

The Senate’s media report aroused significant public interest. As well, the government issued a formal written response to the report in November 2006.  On April 18, 2007, the Minister of Canadian Heritage, the Hon. Bev Oda, appeared before the Committee and explained that

… the government is acting on 30 of the 40 recommendations. It has already acted on two of the recommendations. We have given a directive to Canada Post regarding the Publications Assistance Program and we have enacted the whistle-blower legislation. The 28 other actions are currently under way, either directly as the committee suggested or in an alternative fashion. We believe seven recommendations require no action at this time because the conditions are already in place for the reviews that you have asked for.

In the fall of 2007, citing among other sources the Senate’s report, the CRTC held special hearings on media concentration of ownership and cross-ownership. On January 15, 2008, the CRTC announced a new approach to “to ensure that a diversity of voices is maintained in the Canadian broadcasting system.”  The new policies, aimed at the private sector, echo the Senate’s concerns with respect to concentration and cross-media ownership. Going forward, a person or entity will now be permitted to control only two of the following types of media that serve the same market:  a local radio station, a local television station or a local newspaper.

In addition, and also in line with the spirit of the Senate’s report, the CRTC has moved to ensure more independence on panels that deal with complaints. A minimum number of journalists will now be included on these Canadian Broadcast Standards Council panels.


The Uncertain Mirror: Special Senate Committee on the Mass Media (The Davey Report) 

Date: 1970
Chair: Hon. Keith Davey (ON)
Deputy Chair: Hon. L. P. Beaubien (QC)
Downloads: Read the Report

Summary:

Thirty years ago, the Senate declared “this country should no longer tolerate a situation where the public interest in so vital a field as information [is] dependent on the greed or goodwill of an extremely privileged group of businessmen” (page 66).  Ownership of about 50% of Canada’s mass media outlets (newspapers, radio and television) had become concentrated in group holdings by 1969.  Senator Keith Davey (ON) and his committee deplored the consequences of this shift, even though they predicted the trend would continue. Of dozens of recommendations, perhaps the most prescient was their call to action for everyday Canadians (at page 250):

Remember that freedom of the press is basic to all our freedoms, and that the greatest danger to press freedom is public apathy.  So if the media bore you or bother you, don’t just sit there. React …  Telephone the owner. Write to the editor. Call in on the hot line. Speak to the advertiser. Praise the performer. Some newspapers and magazines are beginning to open their pages to the people. They call it “participatory journalism.”  So participate.

Impact:

The Davey Report’s main recommendation (to establish a Federal Press Ownership Review Board) was never implemented.  Although the government did follow up with a 1981 Royal Commission on Newspapers chaired by Tom Kent, Senator Davey reported in 1990 that media concentration had by then escalated to 57%.  Today, of course, newspaper chains and television networks all across North America are fighting hard to stay afloat.  Concentrated ownership failed to guarantee their ultimate survival.

MILITARY

UN Deployment: Prioritizing Commitments at Home and Abroad (2016)
Training in Afghanistan: Include Women (2010)
How Are We Doing in Afghanistan? Canadians Need to Know (2008)
Canadian Troops in Afghanistan: Taking a Hard Look at a Hard Mission (2007)
Managing Turmoil: The Need to Upgrade Canadian Foreign Aid and Military Strength to Deal with Massive Change (2006)
The Government’s No. 1 Job: Securing the Military Options It Needs to Protect Canadians (2006)
Wounded: Canada’s Military and the Legacy of Neglect (2005)


UN Deployment: Prioritizing Commitments at Home and Abroad

Date: 2016
Chair: Hon. Daniel Lang (YT)
Deputy Chair: Hon. Mobina S.B. Jaffer (BC)
Downloads: Read the Report

Summary:

In the 2015 federal election, the Liberals made a promise to increase Canada’s role in UN peacekeeping operations. Upon election, it launched a Defence Policy Review to see how best to operationalize this. As a result of this, the Senate committee also took the opportunity to input into this process with this report.

The report found that there were many possible areas Canada could have a significant role in UN peacekeeping operations, and that some of these were non-military. These could focus on strengthening governance, providing training in policing and crime prevention and building the rule of law.

The committee also noted the fact that peacekeeping today is different than it was when Canada had a greater role in the 20th century. Twenty-first century peacekeeping more often than not  includes operating in near war zones instead of monitoring a pre-negotiated peace. There is a focus on keeping civilians safe and supporting peace, instead of simply monitoring it. There are also more training activities included in missions.

There were several recommendations coming from this report, with some highlighted. One was framed as a “Statement of National Interest,” noting that no UN peacekeeping efforts should be contemplated until Canada had met its pre-existing national and international obligations. Three other key recommendations included not agreeing to a UN mission deployment without first getting the consent of both the House and the Senate; focusing on the Americas and Africa for missions and cooperating with key regional partners to do so; and committing to formally establishing a Peace Operations Training Centre to share Canadian expertise with partners. Other recommendations included ensuring more women were part of peacekeeping missions (compliance with UN Resolution 1325); ensuring enough resources were available for returning veterans suffering from issues such as PTSD; and working with the UN to find ways to improve peacekeeping missions with regard to sexual exploitation and assault, prostitution, human trafficking and abuse of minors.

Impact:

Although the federal government had declined immediate peacekeeping support to Mali in 2017, in March 2018, the government agreed to send peacekeeping troops there.  This is considered a higher-risk mission, as 162 peacekeepers had been killed there since the mission began in 2013. Although there was no vote in either the House or the Senate prior to this announcement, the government did announce that the mission would include a strong female presence.

The report received media coverage on Radio Canada International, Esprit de Corps, CBC News, the Globe and Mail, and the Toronto Star.


Training in Afghanistan: Include Women

Date: December 2010
Committee: Human Rights
Chair: Hon. Nancy Ruth (ON)
Deputy Chair: Hon. Mobina S. B. Jaffer (BC)
Downloads: Read the Report

Summary:

The committee examined Canada’s role in supporting the promotion and protection of women’s rights as Canada extends its mission in Afghanistan to 2014. To advance women’s rights, the report recommends that the federal government work within two fundamental principles: women’s meaningful participation in the peace negotiations and the full preservation of women’s rights such as those currently guaranteed in Afghanistan’s constitution. These recommendations fall under five areas of focus: political reconciliation, security, justice, education and local development.

Impact:

PeaceBuild cited the Senate report in one of its backgrounder briefs called A woman‘s place is at the peace table: An analysis of women‘s participation in the Afghan peace process, re-emphasizing the call for the federal government to implement recommendations detailed in the Senate report.  Also, the PeaceWomen Project led by the Women’s International League for Peace and Freedom referenced the Senate report to bolster its support for women’s rights in Afghanistan.


How Are We Doing in Afghanistan? Canadians Need to Know

Date: 2008
Committee: National Security and Defence
Chair: Hon. Colin Kenny (ON)
Deputy Chair: Hon. David Tkachuk (SK)
Downloads: Read the Report

Summary:

“Canadians can be forgiven if they are confused about how well their Government’s mission to Afghanistan is going,”  according to the Senate’s National Security and Defence Committee.  This report, based on extensive testimony from hours of hearings, private interviews and three Committee visits to Afghanistan (2005, 2006, 2008), makes the case that Canadians need to know how success for the Afghan mission is measured, and if the human and economic costs are worth the gains.

In addition to making several recommendations for regular communications regarding progress, the report examines working relationships between various Canadian agencies involved in Afghanistan.  While obstacles remain, the Committee observed improved cooperation and coordination between Canadian military, diplomatic and aid personnel, as well as between Canadians and Afghan military, police and government representatives . Among other things, it recommended improved pay and bonuses to encourage more non-military government employees and contractors to deploy to Afghanistan and suggested there may be value in talking with the Taliban if it results in progress toward disarmament or ensuring the security of development projects.

Impact:

The most frequently debated recommendation in the Committee’s report was its suggestion to ‘talk to the Taliban.’  A year and a half later, however, the Globe and Mail reported that it “appears that peace talks with the Taliban have already begun.”  Despite Canada’s reluctance to participate, other NATO allies have committed hundreds of millions to a Peace and Reintegration Trust Fund.

As to progress reports and performance measurements, few official documents have been made available.  One cost estimate was published by the independent Parliamentary Budget Officer (PBO) four months after the Committee’s report was issued.  The PBO forecast that between $14 billion and $18 billion will have been spent on Canada’s Afghanistan mission for the ten year period extending from 2001 through to 2011 when our troops will be withdrawn.


Canadian Troops in Afghanistan: Taking a Hard Look at a Hard Mission

Date: February 2007
Committee: National Security and Defence
Chair: Hon. Colin Kenny (ON)
Deputy Chair: Hon. Michael Meighen (ON)
Downloads: Read the Report

Summary:

The Committee examined Canada’s involvement in Afghanistan. Canada’s role comes at a huge cost, both in lives and in billions of dollars. This report sets out to provide Canadians with answers to the following five questions:

  • What precisely is Canada’s role in Afghanistan?
  • What will define success for Canada in Afghanistan?
  • What are the realistic chances of achieving that kind of success in Afghanistan?
  • What costs are Canadians willing to pay to achieve success?
  • Is Canada’s mission to Afghanistan currently being deployed in a
    way that gives Canada the best chance of achieving success?

Impact:

Media coverage particularly focused on the recommendation to pull Canadian troops out of Afghanistan if NATO allies refused to allow their troops to fight on the front lines in Kandahar (see, for example, Montreal Gazette, February 12, 2007).  In January 2008, an Independent Panel on Canada’s Future Role in Afghanistan echoed much of what the Senate had recommended. The government adopted the Panel’s report (known as the Manley Report) in full.


Managing Turmoil: The Need to Upgrade Canadian Foreign Aid and Military Strength to Deal with Massive Change 

Date: October 2006
Committee: National Security and Defence
Chair: Hon. Colin Kenny (ON)
Deputy Chair: Hon. Michael A. Meighen (ON)
Downloads: Read the Report

Summary:

The third of a three-part series, this report describes scenarios for potential change at home and abroad – some of them probable, some of them improbable but all of them possible – and concludes that Canadians will be woefully unprepared if even a few of these scenarios play out. The report looks into the future and makes recommendations on changes necessary to guarantee the sovereignty of Canada and the national security of Canadians.

Part I scans the horizon for potential changes at home and abroad and advocates for change in three major areas:

  • an upgrade to our Canadian Forces to enable them to deal with more than one major crisis at a time;
  • rehabilitation of Canada’s foreign aid program so it can better deal with the root causes of international unrest, which would lessen the chance of Canada being forced into wars; and
  • an improvement in working relations with the United States – a relationship that must be taken advantage of in order to maximize our chances of succeeding in a world of flux.

Part II of the report focuses on the Canadian Forces, and a number of ways more government money and more intelligent government approaches could create a military capability consistent with that of a prudent and reasonable nation. For example, it highlights current per capita spending statistics, comparing Canada at $343 per person with the Dutch ($648), the Australians ($658) and the British ($903), and calls for an increase in personnel from 75,000 to 90,000.

Impact:

The three reports culminating in Managing Turmoil generated widespread commentary.  In October 2007, Policy Options published an article in which Senator Kenny is quoted discussing Canada’s recent defence spending.  The article predicts that Canada’s military budget will have grown by 37% over 2000-2001 when planned increases are fully implemented in 2010.


The Government’s No. 1 Job: Securing the Military Options It Needs to Protect Canadians

Date: June 2006
Committee: National Security and Defence
Chair: Hon. Colin Kenny (ON)
Deputy Chair: Hon. J. Michael Forrestall (NS)
Downloads: Read the Report

Summary:

The second of a three-part series, this report focuses on the Canadian Forces, and a number of ways more government money and more intelligent government approaches could create a military capability consistent with that of a prudent and reasonable nation. It recommends that Canada’s armed forces be rehabilitated by addressing issues of military infrastructure, levels of personnel, the complex military procurement process, military burn-out, and under-funding of the military.

The report also questions whether there is sufficient political will or public support to fix Canada’s military. An estimate of how much it will cost is offered, and identifies which holes are being mended, and which are being neglected.


Wounded: Canada’s Military and the Legacy of Neglect 

Date: September 2005
Committee: National Security and Defence
Chair: Hon. Colin Kenny (ON)
Deputy Chair: Hon. J. Michael Forrestall (NS)
Downloads: Read the Report

Summary:

The first of a three-part series, this report deals with the state of Canada’s military, itemizes the many problems facing Canadian Forces following decades of neglect, and scans the horizon for potential change at home and abroad. The report concludes that over the next two decades Canada’s armed forces will be more crucial to the well-being of Canadians than at any time since World War II. But, the Committee noted, the funding has not been there to end “Canada’s sad era of military darkness.”

OFFICIAL LANGUAGES

Modernizing the Official Languages Act – The Views of Official Language Minority Communities (2018)
The Vitality of Quebec’s English-Speaking Communities: From Myth to Reality (2011)
Environmental Scan: Access to Justice in Both Official Languages (2003)


Modernizing the Official Languages Act – The Views of Official Language Minority Communities

Date: October 2018
Committee: Official Languages
Chair: Hon. René Cormier (NB)
Deputy Chair: Hon. Rose-May Poirier (NB)
Downloads: Read the Report

Summary:

This interim report looks at the experiences of official language minority communities regarding the implementation of the Official Languages Act. This is the third phase of the committee’s study on the topic and focuses on its adoption in 1969 through to revisions in 1988 and 2005. The committee met with representatives from French-speaking minority communities outside of Quebec and English-speaking communities within Quebec.

Suggestions from witnesses included the need to review the Act on a more regular basis, modernize and coordinate implementation of the Act, strengthen the powers of the Commissioner of Official Languages, and find practical ways to enhance the vitality of minority language communities.

Witnesses also wanted the federal government to walk the talk and provide pragmatic leadership, including making bilingualism a requirement for Supreme Court of Canada appointments and having the Privy Council Office take a stronger role in the Act’s implementation.

Impact:

This committee’s final report will be due in 2019, and this second interim report provided valuable information and experiences of how minority language populations feel about the Act and how it can be improved.

The committee report was highlighted by CBC and Ottawa Life magazine.


The Vitality of Quebec’s English-Speaking Communities: From Myth to Reality

Date: March 2011
Committee: Official Languages
Chair: Hon. Maria Chaput (MB)
Deputy Chair: Hon. Andrée Champagne (QC)
Downloads: Read the Report

Summary:

The committee investigated English-speaking communities in Quebec in order to delve directly into the realities the communities are experiencing. Under federal law, the government has a responsibility to protect and promote both of Canada’s minority languages.  While French and English minority groups share similarities, they still experience separate and unique hardships which must be recognized.

The report outlined 16 recommendations primarily directed to federal government agencies and departments, urging them to increase the effectiveness of their services to Quebec’s Anglophone communities.

Impact:

The report was covered in a variety of news outlets such as the Quebec Chronicle Telegraph, the Epoch Times and CBC Montreal.  It was also mentioned on the webpage Quebec Community Groups Network.  While no official response has come from the federal government, the CRTC (Canadian Radio-television Telecommunications Commission) did send the document out to different coordinators in an attempt to further promote its message.


Environmental Scan: Access to Justice in Both Official Languages

Date: May 2003
Committee: Official Languages
Chair: Hon. Rose-Marie Losier-Cool (NB)
Deputy Chair: Hon. Wilbert Joseph Keon (ON)
Downloads: Read the Report

Summary:

The Environmental Scan was an outside report commissioned by the Minister of Justice. It focused on identifying specific needs in each province and territory to ensure access to justice in both official languages. The Committee reviewed the report and made 7 recommendations to the Minister, including incentives to attract bilingual judges, training, pilot projects and access to judicial documentation in both official languages.

Impact:

The government formally responded in November 2003.

PHARMACEUTICALS

Prescription Pharmaceuticals in Canada: Off-Label Use (2014)
Prescription Pharmaceuticals in Canada: Post-Approval Monitoring of Safety and Effectiveness (2013)
Canada’s Clinical Trial Infrastructure: A Prescription for Improved Access to New Medicines (2012)


Prescription Pharmaceuticals in Canada: Off-Label Use

Date: January 2014
Committee: Social Affairs, Science and Technology
Chair: Hon. Kelvin K. Ogilvie (NS)
Vice-Chair: Hon. Art Eggleton (ON)
Downloads: Read the Report

Summary:

The use of a drug is considered to be ‘off-label’ when a drug is used for dosage sizes, treatable conditions or populations beyond those approved by Health Canada. Off-label use is legal and has become increasingly common. A recent study suggests that up to 11% of all drugs prescribed are for conditions or circumstances that are not covered by Health Canada’s regulatory approval process.

Prescription drugs are frequently used off-label to treat vulnerable sub-groups such as children, women and the elderly because clinical trials do not usually include these populations.  Antipsychotics, for example, are among the most frequently prescribed medications used to treat young children with attention deficit disorder and autism spectrum disorder. In the absence of reliable information regarding the effects of drugs on vulnerable subgroups, doctors are forced to make decisions regarding off-label drugs by extrapolating from clinical trials involving young and middle aged adult men, despite the significant physiological differences between people of different genders and ages.

The Standing Senate Committee on Social Affairs, Science and Technology has suggested an approach that recognizes the necessity of off-label prescriptions while encouraging the implementation of measures that would enhance the safety of prescription drugs when they are used off-label. Highlights of its 15 recommendations include the following:

  • Implement an electronic prescribing system that would allow authorities to keep track of the conditions, age and gender for
    which drugs are being prescribed off-label;
  • Explore mechanisms by which health professionals can inform patients of off-label prescription drug use, including disclosure of information provided by prescribing physicians or dispensing pharmacists;
  • Make information sources such as the Australian Medicines  Handbookand the British National Formulary available to Canadian health professionals;
  • Heath Canada must facilitate access to its online adverse drug reaction reporting form; and
  • The Canadian Agency for Drugs and Technologies in Health should regularly conduct assessments of off-label drug uses to facilitate increased uniformity of formulary listings, prescribing
    guidelines and adverse reactions across jurisdictions.

Impact:

A number of advocacy groups have supported the Senate’s conclusions on off-label prescription drug use. The Canadian Life and Health Insurance Association commended the Senate for addressing off-label drug use. In its annual report, the Canadian Centre on Substance Abuse noted that the Committee’s recommendations are consistent with its First Do No Harm Strategy.

The Committee’s work on off-label drug use was covered by Vice.comPostmedia and iPolitics.  In June 2014, a Toronto Star  investigation  revealed  that Health Canada has secretly been collecting data on off-label prescriptions for several years. While Health Canada had documented nearly 400 cases of adverse reactions to off-label prescriptions, it failed to make the data public until pressed to do so.


Prescription Pharmaceuticals in Canada: Post-Approval Monitoring of Safety and Effectiveness 

Date: March 2013
Committee: Social Affairs, Science and Technology
Chair: Hon. Kelvin K. Ogilvie (NS)
Vice-Chair: Hon. Art Eggleton (ON)
Downloads: Read the Report

Summary:

The Senate Standing Committee on Social Affairs, Science and Technology issued a report looking at how prescription pharmaceuticals are monitored once they are sold in the marketplace. This is the second phase of a four part study.  Although the Committee noted an improvement in post-approval monitoring in recent years, it expressed concern that Canada is falling behind the international standard.

The report calls for sustained funding and regulatory reforms in order to improve the safety of Canada’s prescription pharmaceutical regime.  It made 19 recommendations, chief among which were the following:

  • that Health Canada adopt a life-cycle approach to monitoring drugs including long term studies of safety;
  • that funding for both pre- and post-approval drug regulatory activities be equal; and
  • that information and data from post-approval drug studies, especially with respect to risks and adverse reactions, be made publicly available.

Impact:

The Canadian Health Council was pleased to see their recommendations for mandatory post-market monitoring included in the report. The Toronto Star and iPolitics published articles focussing on the report’s criticism of Health Canada’s current monitoring regime. NationalHealthWatch.ca  summarizedthe Committee’s report.  The government agreed in principle with the recommendations and provided a list of its current activities.  In 2014, the Toronto Star reported that US Food and Drug Administration (FDA) inspectors had found defective drugs and procedures among Canadian companies.  The FDA reports are public, in contrast to Health Canada’s practice.


Canada’s Clinical Trial Infrastructure: A Prescription for Improved Access to New Medicines 

Date: November 2012
Committee: Social Affairs, Science and Technology
Chair: Hon. Kelvin K. Ogilvie (NS)
Vice-Chair:  Hon. Art Eggleton (ON)
Downloads: Read the Report

Summary:

The Senate Standing Committee on Social Affairs, Science and Technology undertook a study of prescription pharmaceuticals in Canada. The first phase looked at Canada’s approach to clinical trials as it pertains to drug approvals. Clinical trials are controlled tests of the efficacy, safety and adverse effects of drug treatment on human subjects and constitute an essential part of the drug approval process. Overall, the Committee concluded that Canada is lagging behind the global clinical trial market and action and reform is needed to attract industry to the high quality research environment that Canada can provide.

Highlights of the Committee’s 12 recommendations include the following:

  • transparency of clinical trials needs to be increased in a variety of ways such as mandatory registration of trials and data;
  • clinical trials need to include a diverse population in line with the targeted consumers for the product;
  • an accreditation program needs to be instituted for Research Ethics Boards;
  • the federal government needs to conduct a thorough study of intellectual property and tax incentive issues with a view to exploring options and recommending changes that will help to
    improve Canada’s global competitiveness in drug development; and
  • additional incentives need to be introduced to facilitate develop-ment of ‘orphan drugs’ for rare diseases.

Impact:

Rx&D, an association of research-based pharmaceutical companies, praised the report . The Canadian Paediatric Society, the Canadian Geriatric Society, Motherisk and Pregmedic wrote an open letter to the Health Minister announcing their strong support for including a diverse population of subjects in clinical trials.  PharmaWatch Canada, on the other hand, criticized the report for not looking into the greater commercial aspect of clinical trials.  The government agreed with mandatory registration but cited various reasons for not taking additional action on most of the Committee’s other recommendations.