HESA Committee Report

Bloc Québécois – Supplementary Opinion
Report of the Standing Committee on Health
Post-Market Surveillance of Pharmaceuticals

The Bloc Québécois would like first of all to acknowledge the invaluable contribution made by the stakeholders and witnesses who took part in the study on the post-market surveillance of pharmaceuticals.

In response to the Standing Committee on Health’s report, which was the outcome of a study begun in January 2008 and concluded on June 17, 2008, the Bloc Québécois would like to voice reservations about some of the recommendations.  These reservations were discussed in committee but were not incorporated into the report, and the Bloc Québécois would like to emphasize them by taking advantage of the right to attach a supplementary opinion to the report.

v      THE importance OF REAFFIRMING QUEBEC AND PROVINCIAL JURISDICTION OVER HEALTH

1. Training of health professionals and professional regulatory bodies

The report refers repeatedly to the training of health professionals.  But such training, the education of health professionals, falls within the jurisdiction of Quebec and the provinces.  Recommendation 2 does mention this fact, but in our opinion it should be reiterated every time a reference is made to the training of health professionals (notably in recommendations 2 and 16).

It should also be pointed out that Health Canada has no authority to require health professionals or professional regulatory bodies to report adverse drug reactions:  professional regulatory bodies are governed by Quebec and provincial legislation.  It is our opinion that Recommendation 6, which calls for “funding for technological tools required to increase reporting by health professionals (physicians, pharmacists, nurses, etc.) in their daily practices”, should make this fact explicit.

With respect to these two aspects (training and duties of health professionals / management of professional regulatory bodies), a recommendation proposed by the Bloc Québécois should be noted:

BLOC QUÉBÉCOIS RECOMMENDATION

• That the optimal use of resources on the ground be encouraged with respect to post-market surveillance, while taking into account the fact that professional regulatory bodies fall under Quebec and provincial jurisdiction, that Health Canada cannot impose on any professional regulatory body a duty involving post-market follow-up, and that the training of health professionals is an educational matter, with education a jurisdiction exclusive to Quebec and the provinces.

2. Medical records management and e-prescribing

Bearing in mind that adequate post-market surveillance must be ensured while at the same time Quebec and provincial jurisdiction must be reaffirmed, the Bloc Québécois has certain concerns about Recommendation 15, which refers to additional investment in Health Canada’s Infoway and in e-prescribing.

Quebec is currently developing its own system for computerising medical records, an initiative that falls within its area of jurisdiction.  Quebec's Act respecting Health and Social Services and its Professional Code already regulate the management of medical records[1] and the terms and conditions for the prescribing of pharmaceutical products.[2]  The actions proposed by the Committee would be nothing but duplication.

We would have preferred Recommendation 15 to recognize that Quebec has the right to opt out with full and unconditional financial compensation for any investment having to do with Health Canada's Infoway and the e-prescription system, but our amendment was rejected in committee.

v      Respect FOR EXISTING structures IN Quebec

With regard to the reporting of adverse drug reactions, Quebec already has, in each of its health-care institutions, risk and quality management committees to which must be reported any care-related incident, including adverse drug reactions.

Though paragraphs 95 and 96 of the report refer to the existence of such structures, in Quebec in particular, at no time – as a witness from Quebec pointed out – is any mention made of the necessity of not duplicating existing structures should the reporting of adverse drug reactions become mandatory for hospitals.

It should also be made explicit that any mandatory reporting of adverse reactions by hospitals would be contingent upon the Government of Canada’s obtaining the consent of Quebec and the provinces, given that hospital management falls within their jurisdiction.  This being so, the report’s Recommendation 3 should have spelled out that Quebec and the provinces have jurisdiction.

The Bloc Québécois made two recommendations along these lines:

BLOC Québécois RecommEndation

• That the federal government recognize that Quebec has been proactive in this area, having adopted legislation on the safe provision of health services in 2002, that it take into account existing structures, and that it avoid all pointless and expensive duplication in its future initiatives involving post-market surveillance of pharmaceuticals.

Bloc québécois RecommEndation

·        That, if provisions were introduced to make the reporting of adverse reactions mandatory by health-care institutions and hospital employees, this would not apply to health-care institutions in Quebec because they come within provincial jurisdiction, and that the “Quebec clause” be taken into account.

v      RESEARCH INTO DRUG SAFETY AND EFFECTIVENESS:  THE IMPORTANCE OF PHARMACOEPIDEMIOLOGICAL STUDIES

Although Recommendation 10 speaks of the importance of multidisciplinary research into pharmaceutical safety and of incorporating pharmacoepidemiology into such research, it is our opinion that the Committee's recommendations could have been more far-reaching when it comes to pharmacoepidemiology.  They could have reflected the suggestions of some witnesses that conducting such studies should be mandatory once a pharmaceutical comes on the market.

The Bloc Québécois made the following recommendation in this regard:

BLOC QUÉBÉCOIS RECOMMENDATION

• That the government consider passing legislation making it mandatory to conduct pharmacoepidemiological studies when a drug comes on the market, to ensure that real-life safety data will be generated as rapidly as possible and communicated to regulatory bodies.

v      ReGULATORY REsources:  CONSIDERING THE possibilitY OF SETTING UP AN INDEPENDENT INVESTIGATIVE BODY

A number of witnesses stressed the importance of drawing a clear line between the authorities that approve pharmaceuticals and those that do post-market follow-up.  Health Canada has set up a separate unit within its Health Products and Food Branch to carry out post-market surveillance:  the Marketed Health Products Directorate.

But these are not two separate and independent bodies.  A number of witnesses argued, moreover, that there was a risk of an apparent conflict of interest, given that the same entity is responsible for both approval and surveillance of pharmaceuticals.

Although the Committee reiterates in one of its recommendations the importance of Health Canada's making a greater distinction and differentiation between the authorities responsible for approving pharmaceuticals and for monitoring them (as regards both mechanisms and funding), we think more is needed.  Consideration should be given to setting up an independent body that would be responsible for investigating incidents related to pharmaceuticals, as some witnesses suggested.  This independent body could, like the Transportation Agency, report direct to Parliament through the Queen's Privy Council.