PACP Committee Report

OBSERVATIONS AND RECOMMENDATIONS

Health Canada

Health Canada’s drug benefits program is managed by the Non-Insured Health Benefits (NIHB) Directorate located in the Department’s First Nations and Inuit Health Branch. The Non-Insured Health Benefits Program, which covers other health services apart from drug costs, has the largest number of clients (approximately 749,000) ^[3], and incurs the highest expenditures ($290 million in fiscal year 2002 03) of all the drug benefits programs. The program’s clients — registered Indians and recognized Inuit — receive coverage throughout their lifetimes.

The Non-insured Health Benefits Program has been the subject of audits by the Auditor General, in 1997 and 2000 ^[4], and the Committee has monitored the program and examined the findings of both audits ^[5]. The Committee maintains an ongoing interest in Health Canada’s delivery of this program, the health and safety of its clients, and the Department’s reporting to Parliament on the performance of the program.

Based on the recent audit, the Auditor General found that some elements of the program are functioning well. The electronic system used by Health Canada for processing claims now warns pharmacists when a client presents a prescription for a drug similar to one they are already prescribed (duplicate drug therapy) or when the prescribed drug is likely to produce a negative reaction when taken in combination with a drug patients are already using (drug to drug interactions). Pharmacists can ignore (override) these warnings, but the Department records these incidents, analyzes them, and responds when necessary. Pharmacists must explain why they have ignored warnings and failure to do so results in loss of compensation. The Department now makes use of data from this system to identify pharmacies for audit. Health Canada has also accepted most of the advice of the federal Pharmaceutical and Therapeutics (P&T) Committee regarding which new drugs to cover under the NIHB. When it comes to pursuing strategies to reduce costs, the Department’s policy states that it will only pay the best price for drug products in a group of interchangeable products. These steps are positive but lack of progress is still evident in several key areas.

The Committee has been deeply concerned about the Health Canada’s protracted efforts to obtain client consent to share data on drug usage to identify potential abuse and intervene to protect the health of beneficiaries. In April 2001, when the Committee expressed concerns that the Department’s consent initiative would take another four years to complete, departmental officials answered: “No, that is not correct. We will not be waiting four years.” ^[6] Almost four years have elapsed since that statement was made. While efforts to secure consent were underway, evidence suggests that First Nations’ clients have continued to suffer harm including loss of life due to the absence of rigorous monitoring, control, and intervention.

The consent gathering initiative has been costly and has produced disappointing results. In February 2003, Health Canada officials told the Committee that the Department had spent $3.2 million in fiscal year 2002 03 on an initiative to obtain client consent to share personal health information with health providers (doctors and pharmacists). These officials estimated that another $1.9 million would be spent on the initiative in fiscal year 2003-04 ^[7]. In its Departmental Performance Report for the period ending 31 March 2004, Health Canada announced that its consent gathering initiative had been “completed,” and offered the following explanation:

As a result of an evolving privacy environment and insights gained over the past three years, the NIHB Program was able to adopt a new approach to the consent initiative in February 2004. This has meant that the March 1, 2004 deadline for the submission of consent forms by First Nations and Inuit clients no longer applies; the NIHB Program will not require a signed consent form for day-to-day processing activities and program administration. NIHB clients will therefore continue to receive benefits for which they are eligible even if they have not signed a consent form ^[8].

The Committee believes that Health Canada must inform Parliament of the full cost of its consent gathering initiative along with greater specificity concerning the “evolving privacy environment and insights gained” by the Department surrounding the initiative. The Committee accordingly recommends:

TOP OF PAGE

RECOMMENDATION 4

That Health Canada provide information on the full cost of its consent gathering initiative under the Non-Insured Health Benefits Program, a full explanation of how the privacy environment has evolved in ways affecting the issue of consent and list the insights it has gained regarding the issue of consent in its performance report for the period ending 31 March 2005.

According to both the performance report and testimony given by officials before the Committee, when Health Canada has concerns about a client’s drug use, it will now “seek the express consent of clients to share their personal information with health care providers. This consent will be provided verbally or in writing.” In its performance report, Health Canada adds that “In a few cases, NIHB may refuse to pay for prescriptions until a patient safety plan is in place.” ^[9] Mr. Potter was unable to tell the Committee how many times verbal consent had been sought and obtained by the Department but stated that the Department did not expect it to happen very frequently. (15:1710) The Committee believes that Parliament should be kept informed of this activity and therefore recommends:

RECOMMENDATION 5

That beginning with its departmental performance report for the period ending 31 March 2005, Health Canada provide data on the number of times it has sought verbal and written consent from NIHB clients to share personal health information with health care providers, the number of consents given, the number of consents withdrawn, and the number of instances in which it has refused payments arising from lack of consent. Data on written and verbal consent must be presented separately.

Assistant Deputy Minister (First Nations and Inuit Health Branch) Ian Potter told the Committee that assurances had been given by the Privacy Commissioner and Justice Canada that verbal consent was sufficient to initiate the sharing of personal health information with health care providers. (15:1710) He also indicated that once consent, verbal or written, was provided, this consent would be valid indefinitely unless specifically withdrawn. (15:1715) In future contacts with pharmacists, no effort would be made to remind a client that she or he had previously consented to have their personal health information shared. While the Committee does not dispute Mr. Potter’s assertion that verbal consent is valid, it has concerns about this approach and about the ambiguity that surrounds the issue of consent generally.

In April 2001, Mr. Potter told the Committee that Health Canada had been obliged to stop sharing client information with health care providers and was advised that:

in the absence of either clear consent, allowing us to share that information, or legislation, which would provide us with the right to share that information, we should discontinue that due to privacy concerns. (Emphasis added.) ^[10]

Another Health Canada official, Dr. Peter Cooney, informed the Committee on the afternoon of 5 June 2001 that were the NIHB Program to have a basis in legislation, the Department would not need to enroll its clients in a consent initiative ^[11]. During a meeting held on the morning of the same day, Mr. Potter agreed that it would be preferable to have legislation, rather than policy (as is the case with the NIHB Program) as a basis for program delivery ^[12].

On the basis of the evidence presented to it, the Committee recommended that Health Canada review the option of giving the Non-Insured Health Benefits Program a legislative basis that would have enabled the Department to share client information with health care providers ^[13].

The government responded that this option had been “carefully” reviewed and rejected because “it was not clear that legislation would preclude the need for client consent.” It added that a legislative approach “would be perceived by First Nations and Inuit as circumventing the opportunity to inform NIHB clients about how their personal information would be used.” And, it added that “the time required to put such legislation in place would be considerable.” ^[14]

It was thus of great interest to the Committee when Madame Gosselin indicated, in her opening statement, that Health Canada “will be re-examining legislative options that could address the issue of the collection and disclosure of health information.” (15:1545) In this light, the Committee recommends:

TOP OF PAGE

RECOMMENDATION 6

That Health Canada complete its examination of legislative options, including the option of obtaining specific enabling legislation for the Non-Insured Health Benefits Program, that would permit the collection and sharing of client health information with health care professionals and report the conclusions to the Committee no later than 31 December 2005.

In its Tenth Report, 37th Parliament 1st Session (tabled 6th December 2001), the Committee recommended that Health Canada immediately upgrade its point of service system for pharmacies so that the system would provide the dates, quantities, and drugs prescribed of at least a client’s last three prescriptions and information on doctors visited. In its response, dated May 2002, the government indicated that once enhancement to the system had been implemented, access to patient medication history, including drug utilization review data, would be possible. To its dismay, the Committee has learned from the audit (4.34) that the Committee’s recommendation has not been implemented. Because the Committee believes that this information is of vital importance, it recommends:

RECOMMENDATION 7

That Health Canada fulfill its commitment made in response to the Tenth Report (37th Parliament, 1st Session) of the Standing Committee on Public Accounts by immediately upgrading its point of sale system in pharmacies to provide the dates, quantities, and drugs prescribed at minimum of a client’s last three prescriptions and last three doctors visited.