CPhA: About CPhA: What's Happening: Government Relations: Submissions: The Canadian Pharmacists Association Submission to the Senate Committee on Social Affairs on Bill C-6 - The Personal Information Protection and Electronic Documents Act

Submissions: The Canadian Pharmacists Association Submission to the Senate Committee on Social Affairs on Bill C-6 - The Personal Information Protection and Electronic Documents Act (previously Bill C-54)

Presented by: Dr. Jeffrey Poston, Executive Director and Noëlle-Dominique Willems, Director of Government and Public Affairs

The Canadian Pharmacists Association, which provides leadership for pharmacists in all areas of practice, strongly believes that Canadians' right to health privacy protection is fundamental.

CPhA also believes that Bill C-6 is not appropriate for the protection of health information for the following reasons:

It is therefore important to propose specific health privacy protection legislation that will focus on harmonizing the various provincial legislations currently in place. We believe the federal government, and more particularly the Minister of Health, has a crucial leadership role in coordinating the harmonization process. Such a process requires time, well beyond that allowed for the current process, true public debate and consultation with the provinces and territories. In order to ensure that appropriate mechanisms are set up to protect all Canadians' privacy rights on health information, the Canadian Pharmacists Association proposes the following amendment to the Bill:

CPhA recommends that the Minister of Health and his provincial colleagues put privacy high on the agenda of their next meeting with the goal to harmonize provisions of the various provincial legislation on health information privacy protection. We would encourage the Senate Members to strongly recommend this approach to members of their parties in the House and particularly to the Minister of Health.

The Canadian Pharmacists Association would be pleased to assist in the public debate by providing information to patients. We all must strive to find a balance between the fundamental right to privacy and the public good derived from the sharing of health information, without undue barriers, that benefits all Canadian in our health care system.

Presentation to the Senate Committee on Social Affairs, Science and Technology

The Canadian Pharmacists Association (CPhA) wishes to thank the Committee Chair and members for allowing us to appear and comment on Bill C-6 which, if applied as currently written, could have an enormous impact on the way we deliver and manage our health care system.

Along with the Canadian Health Care Association, the Ontario Association of Medical Laboratories and the Canadian Nurses Association, we have sought a legal opinion from Heenan Blaikie and have submitted it to the Committee for its deliberations. We fully endorse the recommendations in the paper and would encourage Committee members to ponder its analysis. A team of lawyers around Mr. Eric Maldoff developed the document. As you may be aware, Mr. Maldoff was one of the members of the National Forum on Health named by the Prime Minister. His opinion is therefore based on a profound knowledge and understanding of our health care system.

As the professional body representing pharmacists in all areas of practice in Canada we would like to submit some additional comments and concerns stemming from the implementation of the proposed legislation and its impact on patients, pharmacists and the delivery of health care.

We would like to begin by reiterating our strong professional commitment to the protection of patient confidentiality and privacy based on our professional code of ethics and legal provincial standards of practice. We have also demonstrated our capacity to do this using technologies such as the electronic transfer of prescriptions for payment, on-line, to public and private third party payers for over 10 years without breach of privacy and confidentiality of the health information entrusted to us by patients.

1. Difference between health information and private information used within the framework of electronic commercial transactions

Health information is the most personal and sensitive of all information. All health professionals as attested by their codes of ethics and their practice for centuries have long recognized this fact. They have therefore set up processes and measures to ensure this protection with every new technology used to document, collect, store and exchange health information within the framework of the therapeutic relationship.

How far does the therapeutic relationship and intervention extend? From a pharmacist's perspective, this relationship covers all that is needed to ensure that the patient receives the benefits from the therapy recommended through a prescription by the physician. It therefore includes:

There are indirect therapeutic uses of that information that also need to be taken into account when looking at the difference between this type of information and personal information used in a purely commercial transaction:

The Canadian Standards Association explicitly recognizes the sensitivity of health information in its code and recommends that express consent provisions apply to it.

In contrast with personal health information, personal information collected for commercial purposes is mainly used for transaction verification. For example, a business will verify that when a check or payment is issued an individual has sufficient funds to cover it in their account. Collection for secondary purposes such as individual buying trends will also have as its main focus encouraging the person to buy another service or targeting promotions to this type of consumer. Health related data is not used for those purposes. It is used primarily to benefit an individual's health and secondarily to improve care and the delivery and management of health care. The payment method whether public or private, is incidental.

We therefore consider, as does the Heenan Blaikie legal opinion, that Bill C-6 was not conceived to cover health. It is inadequate to cover health and creates more administrative hurdles for the Canadian health system at a time when harmonization should be the focus of the federal government.

2. Bill C-6 will result in two levels of privacy protection one for the public sector and one for the private

While physician and hospital services are subject to the Canada Health Act and paid out of the public purse, many health services: the provision of medication, physiotherapy, psychological counselling and occupational therapy are provided through a mix of public and private funding and public and private delivery.

The public component itself is not uniform since the provinces decide what they will cover in addition to the hospital and physician services allowed for under the Canada Health Act. Most provinces have extended coverage to medications for some or all of their residents. They also cover various services such as physiotherapy, occupational therapy, psychological consultations and a variety of home care services. Because of these variations in provincial coverage, Bill C-6 will apply to services that are covered through private supplemental health insurance plans but not to those covered under provincial health care plans.

In some instances, prescriptions will fall under both public and private provisions in provinces where deductibles are so high that individuals have secured a private plan to complement the provincial coverage (e.g., Saskatchewan where the deductible is $1,700 per year). These cases constitute one of the many grey areas in the application of this bill since the transmission of the information to the provincial government for the purpose of tallying up deductibles is done under specific provincial health legislation and therefore falls under provincial jurisdiction (with implied consent for the transfer of that information as a basic principle). Another part of that same prescription for adjudication by a private insurer will fall under federal jurisdiction because of the provisions in Bill C-6. This will also apply in provinces such as British Columbia where the Pharmacare provisions make it a provincial health service but where some of the prescriptions are still in the private domain and their adjudication is done across provinces, therefore putting them under the provisions of Bill C-6.

This grey area appears to come close to encroaching on the provincial jurisdiction in health and could potentially form the basis for a reference to the Supreme Court or a constitutional challenge.

If implemented as currently written, the provisions of the Bill could apply to as much as sixty per cent of prescription medications in Canada. Express consent, as recommended for health information in Schedule 1, would have to be sought from patients for every foreseen use for that data at the time of the filling of the prescription - which this bill considers constitute a "commercial transaction". The bill does not specify who would be charged with explaining all the uses and obtaining consent from each patient. As front-line health professionals involved in the therapeutic intervention which this bill labels "commercial transaction" on prescription medications, pharmacists will be expected to obtain consent for uses ranging from claim adjudication of the prescription with the insurer to drug use review, discussion with physicians about the medication itself, its appropriateness, its coverage as well as the use of the data for research purposes. Consent would only be requested from patients covered under private drug benefit plans, patients covered under public sector plans waiting in line to be served at the pharmacy would probably wonder why they are not asked for their consent.

This would result in a perception of two levels of privacy protection, one for the public sector where consent is implied in most provinces, and one for the private sector where express consent would have to be obtained.

We would like to begin by outlining the current use made with the data collected from pharmacies.

Until now, Canadians have benefited from the use of data to improve health outcomes and the overall cost-efficient management of the system. There is an expectation by the public that health care providers will protect their personal health information. There is also an expectation that the system is designed to use data in order to improve health outcomes and the cost-effectiveness of the system as a whole.

In pharmacy in particular, this has been achieved through the seamless use of prescription data for the following purposes:

Although many of these uses have been done with either aggregated or non-identifiable data, the basis of the data resides in the collection of an individual's health information at the pharmacy level and one could argue that even the act of anonymizing the data for aggregation purposes would require patient consent. Failure to collect this primary data would result in a gap that could jeopardize health outcomes as well as the management of our health care system.

As front line health providers, pharmacists have long played a pivotal role in explaining changes in drug therapy, drug plans and coverage to patients as they come to the pharmacy to get their prescriptions filled. Each time a change occurs, time and effort are needed to ensure that patients understand how it will affect them or their family. In most provinces, the pharmacist has traditionally absorbed the ensuing costs with little or no recognition of the additional efforts required. The increasing number and variety of those changes prompted some CPhA members to request that a study be conducted to assess their financial impact. A study on the Evaluation of Pharmacy Resources Required when Submitting Prescription Claims to Drug Plans was conducted in 1997. It focused very narrowly on the routine changes occurring in claims adjudication in drug benefit plans. Total costs to pharmacy in staff time only were estimated at $142 million annually. This study was not done at a time when major changes were taking place but simply looked at everyday changes brought about in existing programs.

An assessment conducted in Quebec during its change over to a universal drug plan lead to estimates of $23 million over a period of three months in that province alone. In this case, the changes were more substantial than the everyday changes assessed in the CPhA study and the time involvement more important. These changes would more closely relate to those resulting from the implementation of the consent provisions contained in Bill C-6.

The costs resulting from its application could not be absorbed by pharmacists as other costs were, nor should they be. Since no impact assessment has been conducted by Industry Canada prior to introducing the Bill, CPhA feels it is its duty to the public and to its members to clearly outline the repercussions the Bill will have on the time required for patients as well as on costs to the overall health system.

For our analysis, we have classified the types of consent into three categories - administrative, health-related and research-related - to assess how they would impact patients, pharmacists, other health providers and the health care system. Please refer to the detailed analysis provided in Appendix I.

In order to obtain consent from the patient on all potential uses for the data, discussions will average 21 minutes unless clarifications are needed from the physician, in which case the patient and pharmacist will need to spend 26 minutes together. The cost to pharmacists only is estimated at $2,430,000,000 - this does not include administrative costs.

This amount only represents the estimated impact on pharmacists. In order to get a complete picture of the impact of C-6, other providers such as dentists, nurses, laboratory and home care professionals would also need to assess additional time requirements and costs as they provide services covered by private plans or paid out-of-pocket by patients.

Expediency may lead to administrative solutions such as those recommended by Industry Canada representatives that a notice be put on a wall or a blanket agreement be signed initially by patients. CPhA feels that this would de facto negate the importance of the consent and not correspond to the level of express consent recommended by the CSA code. Trading rights for convenience's sake is not in our view the proper way of protecting patients' privacy rights on health information.

The Canadian Pharmacists Association feels that the cost increases C-6 could impose on already stretched finances needed to be taken into account before proposing such sweeping changes to the way privacy has been protected in the health care field to date. As we have already outlined, the use of electronic transactions in pharmacy has been a fact of life for 10 years. CPhA is dedicated to ensuring through its Pharmacy Electronic Communications Standard that privacy protection meets the highest requirements possible.

4. Amendment to recognize the different nature of health information compared to commercial information and the need to protect the privacy of personal health information

The Canadian Pharmacists Association appreciates the efforts of the Senate in its attempt to recognize the shortcomings of Bill C-6 and to address them. Amongst ourselves as well as with other health associations we have debated various ways of improving the Bill's application to health. We are certain you appreciate that it is not an easy task.

Short of proposing sweeping amendments that risk changing the scope of application and the intent of the original legislation, we feel that a suspension of the bill's application to health for a set period of time in order to allow for public debate, consultation with the provinces and consensus building among health providers is the appropiate course of action. This will allow the federal government, the provinces and territories to consult and agree on harmonization principles for health privacy protection legislation that will support the principles of portability and access enshrined in the Canada Health Act which all provinces have reaffirmed during the Social Union negociations. It will also enable Canada to meet its European Union trade commitments by allowing full application of C-6 to true commercial transactions.

We are left with mixed feelings about this bill. As a profession we strongly believe in privacy protection as attested by our code of ethics and the fact that we remain one of the most trusted professions. Pharmacists have managed confidentiality issues with a high degree of professionalism over the years and are committed to ensuring that the privacy of their patients is safeguarded throughout all the electronic transmissions of data for primary and secondary uses. As excited as we all are about the advances in electronic commerce, and the need to set up appropriate controls to ensure that consumer privacy is respected, we believe that C-6 is not the appropriate tool to achieve this goal in health-related fields.

We fear that a bill which was initially intended to cover an area in rapid expansion, that of electronic commerce, has now been broadened to such an extent that not all areas of its implementation have been thought through. A legislation that is not clear enough to answer questions and concerns raised by a growing number of stakeholders is legislation that needs much more work than the current process allows for.

In order to meet our commitments on privacy protection to the European Union for trade purposes, we would recommend that Industry Canada clearly state that health does not fall under trade provisions anymore than it did under NAFTA. This would be consistent with the fact that the components of health that are in the public sector are already carved out since C-6 does not apply to them. We would also like to underline the fact that in some EU countries, health has specifically been carved out of the application of the EU directive. This is the case in Great Britain where an exemption for "medical purposes" has been adopted and interpreted broadly.

We believe that C-6 is ill suited for health purposes and would fully endorse the Heenan Blaikie recommendation that health be carved out of the application of the bill to allow for specific proposals on personal privacy protection to be developped for the broad continuum of health. We therefore encourage the Committee to support the amendment contained herein.

We would recommend that the Minister of Health and his provincial colleagues put privacy high on the agenda of their next meeting with the goal to harmonize provisions of the various provincial legislation on health information privacy protection. We would encourage the Senate Members to strongly recommend this approach to members of their parties in the House and particularly to the Minister of Health.

The Canadian Pharmacists Association would be pleased to assist in the public debate that should take place on privacy protection. CPhA is committed to patient empowerment as demonstrated through the production of patient information and our increasing role in educating and counselling patients on an ever-growing array of health related issues. We would also want to participate in the provision of information to patients and in discussions on finding a balance between the right to privacy and the public good derived from the sharing of information, without undue barriers, that benefits all Canadian in our health care system.

The Impact of Initiating Express Consent Provisions on the Patients and Pharmacists and on Costs to the Health System (Administrative)

Commercial Transaction: Collection of prescription information for transmission of claim to insurer/third party payer for reimbursement purposes and management of the private drug benefit plan.

Express Consent Requirements: Explaining in detail to patients why the pharmacist now needs to obtain consent to forward the information to the insurer for reimbursement and for the management of the drug benefit plan.

Impact of Consent Refusal: Claim cannot be forwarded, the data is not collected for any other use, except keeping a patient profile in the pharmacy computer. The patient must pay out of pocket. The employer cannot manage the drug benefit plan in a cost-effective manner and may refuse to cover the individual in the future.

Time Involved: The time involved in explaining to the patient the reason for this new process (2 min.), the need for consent to transmit data for reimbursement (2 min.) and the use of the data for the plan analysis (3 min) will take an average of seven minutes. This additional delay will also impact other patients whether covered by public or private plans. All changes usually lead patients to ask questions about the reasons for the change as well as about any use he/she was not aware of previously. Seven minutes is therefore a conservative estimate of time needed for the discussion that will take place. In Quebec, the initial explanation was averaged at 10 minutes per intervention.

Estimated Cost: To explain to the patient and obtain consent - $7.00 (based on a $60.00 suggested hourly rate for cognitive services above the professional fee - this is a conservative figure that does not take into account the overhead costs of running a pharmacy). We will assume that only 50% of the prescriptions will be in a third party sponsored plan that would necessitate an electronic transaction to take place.

The Impact of Express Consent on the Patient-Pharmacist-Physician Relationship and on Costs to the Health System (Health-related)

Commercial Transaction: Collection of prescription information for transmission of claim to insurer/third party payer for reimbursement purposes

Subsequent Action: Contacting physician or his/her agent to clarify prescription information

Express Consent Requirements: Explaining in detail to patients why the pharmacist needs to call his/her physicians to obtain express consent from patients (and respond to inquiries as to how this change has come about - Industry Canada initiated)

Detailed potential reasons: Listing of the main Therapeutic Problems requiring an intervention according to the Community Pharmacy Interventions Study, CPhIS, published by CPhA in 1996

Dose Different From Previous Rx	Drug Duplication	Drug Abuse
Wrong Strength	Side Effects	Quantity too high
Dose Too High	Contraindicated	Ineffective Treatment
Interaction	Directions unclear	Quantity too low
Wrong Drug	Directions Wrong	Treatment Duration
Allergy	Form Missing	Clarify Quantity
Dose Too Low	Wrong Form

Impact of Consent Refusal: Lower level of care. Risk to the health of the patient depending on the problem detected by the pharmacist.

Time Involved: The time involved in explaining to patients the reason for calling the physician and obtaining their consent will take an average of five minutes. This additional delay will also impact other patients whether covered by public or private plans. Pharmacists can seldom speak immediately to a physician or his/her agent. The time between the initial call and the response can vary between 2 minutes and 24 hours. The patient therefore has to wait to receive the appropriate treatment. The time calculated is the time taken by the direct intervention with the patient.

Estimated Cost: To explain to the patient and obtain consent - $5.00 (based on a $60.00 suggested hourly rate for cognitive services above the professional fee - this is a conservative figure that does not take into account the overhead costs of running a pharmacy). The discussion with the physician has traditionally not been charged by either physician or pharmacist.

The Impact of Express Consent on Drug Use Review, Patient Health Outcomes and on Costs to the Health System (Health-related)

Commercial Transaction: Collection of prescription information for transmission of claim to insurer/third party payer for reimbursement purposes

Subsequent Action: Online real time Drug Use Review - program integrated as an enhancement of services provided through the claims adjudication process

Express Consent Requirements: Explaining the purpose and the process of the drug use review. Though it is primarily to benefit the health of the patient, since it is a use of the data with a third party, the purpose needs to be clarified and consent obtained

Impact of Consent Refusal: Lower level of care, varying degree of impact on the health of the individual

Time Involved: Variable depending on the state of mind and the literacy level of the patient - average 5 minutes

Estimated Cost: Average of $5 per intervention (based on a $60.00 suggested hourly rate for cognitive services above the professional fee - this is a conservative figure that does not take into account the overhead costs of running a pharmacy). We will assume that out of about the one hundred and fifty million prescriptions paid for privately, 50% are paid through electronic transactions.

Impact: The patient will spend an average of 5 minutes more in the pharmacy. This additional delay will also impact other patients whether covered by public or private plans. The pharmacist would charge the additional cost to the insurer. The insurer would pass it on through higher premium or co-pays.

The Impact on Research, on Population Health and on Costs to the Health System (Research-related)

Commercial Transaction: Collection of prescription information for reimbursement by third party payer.

Subsequent Action: Transmission of this data to a central repository - either through the insurer or through a research organization (CIHI, IMS, Brogan) for 1) post-marketing surveillance of drugs, 2) pharmaceutical market research, 3) aggregation for epidemiology, outcomes studies, 4) population health and 5) management of the overall health system.

Express Consent Requirements: Explaining the purpose of various researches uses for the data. Though it is primarily to benefit the health of the patient and the population, since it is a collection of the data by a third party following a commercial transaction, the purpose needs to be clarified and consent obtained.

Impact of Consent Refusal: Data cannot be collected and is not available for any of the above purposes. Could lead to incomplete data on drugs - post-marketing surveillance would be almost impossible especially for diseases where breach of privacy could have a detrimental impact on the person (AIDS - sexually transmitted diseases). Would have an impact on the quality of the research done and slow down progress on finding cures for certain conditions. Would prevent governments from managing the system due to lack of complete information.

Time Involved: Average of 10 minutes (conservative estimate in view of the nature of the uses that need explanation). The various types of research and their benefits will require lengthier explanation time than obtaining consent for purposes more directly related to the health of the patient. Some of the above uses are absolutely required such as the collection for general data on the health system (use 5), population health (use 4) and the requirement of post-marketing surveillance (use 1). At the very minimum therefore 7 minutes should be allowed for explanation on research purposes. Since it may prove unwieldy to go back to patients individually to obtain consent for epidemiology studies, we would assume that this purpose should also be covered for all the transactions.

Estimated Cost: Average of $10 per intervention (based on a $60.00 suggested hourly rate for cognitive services above the professional fee - this is a conservative figure that does not take into account the overhead costs of running a pharmacy).

If the consent provisions of Bill C-6 applied evenly across Canada, it would have an impact on 150,000,000 prescriptions. Even the prescriptions for which patients pay out-of-pocket would require consent to be transmitted to private companies or governments for basic assessment of costs in this area - we therefore need to take into account the total number of prescriptions in the private sector.