Best Medicines Coalition
Submission to the Standing Committee on Health
March 6, 2008

Introduction: Post-market surveillance support

The Best Medicines Coalition (BMC) is a national alliance of organizations and individuals, representing those living with or affected by chronic disease or illness. With a core mandate of ensuring access to the best evidence-based medicines for Canadians, BMC’s patient representatives are actively involved in discussions about drug review reform, patient safety, and general health policy development. Improvement of post-market pharmaceutical surveillance in Canada is a key BMC goal.

This coalition encourages implementation of a robust system of comprehensive reporting, monitoring, analyzing, disclosing, and communicating of a prescription drug’s adverse effects throughout its use over time.

Even though drugs are studied extensively before being approved for sale in Canada, a drug’s adverse effects might not emerge until it has been widely used in a real world setting. Identifying adverse events is critical, but we caution against a ‘knee-jerk response’ that would cut off a medication from the entire population when only a particular sub-set could be negatively affected.

We seek a national system whereby patients have full and timely access to medicines with full disclosure of each medicine’s known risk/benefit profile.

Advancement: Progressive Licensing Framework

The BMC fully supports the work of Health Canada’s Progressive Licensing Framework (PLF) initiative and the proposed life cycle concept. Ongoing work in modernizing the regulatory framework while working toward harmonizing Canada with international regulatory standards is imperative. We recognize that the current, outdated regulations are insufficient to address the current and future needs for the complex and sophisticated treatment approaches necessary for Canadian patients.

We support the life cycle approach because we believe it will improve health outcomes while enhancing the collective ongoing knowledge base of how each medication works – good and bad – in real world situations. We believe that adherence to the PLF will enhance ongoing drug safety in Canada by better reflecting the “safety, quality, and efficacy” mandate of Health Canada. This approach will allow for a more comprehensive range of responses to drug safety issues, rather than necessitating a full retraction from the market, as prompted by current legislation.

Further, the BMC applauds the Health Canada team, under the direction of David Lee, of the Therapeutic Products Directorate, for its inclusive and consultative approach to PLF policy development, particularly inviting patient input to PLF development and to real world drug safety and efficacy data collection.

Issues: Multi-stakeholder involvement in solutions

To move toward effective post-market surveillance, the system requires major advances in comprehensive adverse events reporting. Current statistics put this reporting rate at just 1-10%. Even with the complexities inherent in a valid reporting system, it is incumbent on Health Canada to increase this reporting rate quickly and drastically.

We recommend broadening the base of sources for adverse event reporting. All players in the healthcare system – patients, caregivers, professionals, institutions, industry, and governments – have a role in ensuring comprehensive reporting of adverse events. Reforms must move forward that will balance responsibilities in reporting of adverse events, which currently lies primarily within the pharmaceutical industry.

Although controversial, we recommend exploration of mandatory reporting. Here are some ways BMC suggests for improving reporting within various sectors:

Patients:

Currently, most patients are not aware that they are able to report an adverse event directly, and this warrants a major public education campaign. Through such a campaign, those taking prescription medications and some over-the-counter products could learn to provide necessary feedback regarding any negative experience.

A newly developed, consumer-friendly form is in the final phase of development. Ideally, pharmacists could issue this form to patients when filling a prescription.

Professionals:

In addition to being the conduit for ‘information transfer’ to the patient, exampled above, pharmacies could display reporting information notices and MedEffect banners, to direct patients on how to report an adverse event.

Currently, health professionals only report the most serious adverse events and there is little evidence that reporting goes much beyond this. Attitudes and practices regarding reporting must be addressed within the community, with a goal to increasing reporting rates. Medical education curricula, as well as that of other healthcare professionals, should include a module on adverse reporting and its importance. Continuing education on this topic for practicing professionals as well as awareness campaigns aimed at these audiences could also prove beneficial.

Hospitals:

Despite the many obstacles and resourcing considerations, mandatory hospital reporting is integral to a comprehensive system. The current infrastructure for monitoring of hospital incidents could be enhanced and broadened, with processes put in place to ensure system-wide reporting and tracking. The goal of mandatory hospital reporting of adverse events should not be punitive; rather it should be to raise the importance of reporting adverse events and to increase the knowledge base, for improving health outcomes.

Resourcing and Infrastructure: Putting concepts to work

In any meaningful discussion about the future of post-market surveillance, resources must be addressed. This includes human and financial resources in addition to infrastructure development. We encourage the Government of Canada to provide Health Canada with the authority and adequate funding for all components necessary to ensure a viable program. In addition, the Government of Canada must allocate resources so that other players in the system, including patients, professionals, and hospitals can serve a meaningful role.

Post-marketing surveillance of pharmaceuticals is uniquely complex and involves a range of stakeholders. To date, many have made significant contributions nationally to explore various implementation frameworks, particularly the shared responsibility model and interdependent strategies model with a national body linking independent research networks as outlined in the Real World Safety and Effectiveness discussion paper. We urge policy makers to take action to move these concepts forward so that an effective system of post-marketing surveillance can become a reality. Inclusion of all relevant stakeholders, including patients/consumers, must be a central principle to all ongoing work.

About the Best Medicines Coalition

The Best Medicines Coalition is a patient-driven and volunteer-based organization committed to safe and timely access to the best evidence-based medicines. The Coalition is comprised of representatives of patient groups (see list below) as well as some individual patients. Together these representatives form a Steering Committee from which an Operations Committee, including a Chair and Vice Chair, are elected. This submission to the Standing Committee on Health has been developed and approved by the Operations Committee.

Since its inception in 2002, the BMC has emerged as a recognized voice for patients across Canada and it is frequently called upon by policy decision makers at both federal and provincial levels of government to convey patient positions and concerns. Furthermore, the organization has been instrumental in the emergence of a strong patient network across Canada and the legitimization of patient involvement in public policy development.

To sustain the organization and its work, the BMC solicits funding from a variety of organizations, including private and public sector sources, and funding is accepted in the form of unrestricted grants. The pharmaceutical industry is a major supporter, including both trade associations and individual companies. BMC has also received government grants for special projects and government funding is regularly provided to cover expenses where BMC members are invited to participate in policy consultations. Various BMC members also provide financial contributions and support the organization by working on its behalf on a volunteer basis. Members do not receive any personal financial compensation for their work on behalf of the BMC. To ensure that the mission and goals of the BMC are not influenced or jeopardized, all members adhere to clear Principles and Codes for Ethical Conduct and Partnerships as part of BMC’s Terms of Reference.

BMC Operations Committee
Louise Binder, Canadian Treatment Action Council (Chair)
Linda Wilhelm, Canadian Arthritis Patient Alliance (Vice Chair)
Lynn MacDonald, Independent member
Denis Morrice, Epilepsy Ontario

Participating Organizations
Arthritis Consumer Experts - www.arthritisconsumerexperts.org
The Asthma Society - www.asthma.ca
Canada’s Association for the Fifty-Plus - www.carp.ca
Canadian Arthritis Patient Alliance - www.arthritis.ca/capa
Canadian Breast Cancer Network - www.cbcn.ca
Canadian Cancer Action Network - www.ccanceraction.ca
Canadian Hemophilia Society - www.hemophilia.ca
Canadian Pain Society - www.canadianpainsociety.ca
Canadian Skin Patient Alliance - www.skinpatientalliance.ca
Canadian Society of Intestinal Research - www.badgut.com
Canadian Treatment Action Council - www.ctac.ca
Cancer Advocacy Coalition of Canada - www.canceradvocacy.ca
Centre for ADD/ADHD Advocacy Canada - www.caddac.ca
Epilepsy Ontario - www.epilepsyontario.org
Hepatitis C Council of British Columbia - www.bchepcouncil.ca
HepCURE - www.hepcure.ca
Lung Cancer Canada – www.lungcancercanada.ca
Lymphoma Foundation Canada - www.lymphoma.ca
Osteoporosis Canada - www.osteoporosis.ca
Ovarian Cancer Canada - www.ovariancanada.org
Tourette Syndrome Foundation of Canada - www.tourette.ca

Presenting for the BMC to the Standing Committee on Health:

Linda Wilhelm, Vice Chair, Operations Committee
Since 2004, Linda has served on BMC’s Operations Committee, representing the Canadian Arthritis Patient Alliance, and she was elected Vice Chair in 2007. She has also been board chair for the Arthritis Society of New Brunswick, is board of the Region 2 Health Authority in New Brunswick and has participated in various Health Canada expert advisory panels on access and safety issues. Linda is based in Midland, Kings County, New Brunswick and regularly travels nationally discussing treatment and patient care issues.

Gail Attara, Member, Steering Committee
Gail is an active member of BMC’s Steering Committee and previously served on the organization’s Operations Committee. Gail represents the Canadian Society of Intestinal Research, where she has served as executive director since 1996, leading the Society's development from a small provincial charity into a national presence. Her motto, "the patient comes first," directs her resolve for patient-focused healthcare. Gail has a solid background in public relations and fundraising and is an active community volunteer in Canada, serving on numerous Boards. Gail serves on a B.C. PharmaCare Review Committee and is a member of the Better PharmaCare Coalition. Gail is also the Chief Executive Officer of the newly-formed GI (Gastrointestinal) Society / Société Gastro-intestinal.