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SOCI - Standing Committee

Social Affairs, Science and Technology


Proceedings of the Standing Senate Committee on
Social Affairs, Science and Technology

Issue 20 - Evidence - October 1, 2014

OTTAWA, Wednesday, October 1, 2014

The Standing Senate Committee on Social Affairs, Science and Technology met this day at 4:13 p.m. to study Bill C-17, An Act to amend the Food and Drugs Act.

Senator Kelvin Kenneth Ogilvie (Chair) in the chair.


The Chair: Welcome to the Standing Senate Committee on Social Affairs, Science and Technology.


I am Kelvin Ogilvie from Nova Scotia. I would like to start by asking my colleagues to introduce themselves.

Senator Eggleton: Art Eggleton from Toronto, and I'm deputy chair of the committee.

Senator Cordy: Jane Cordy from Nova Scotia.

Senator Enverga: Tobias Enverga from Ontario.

Senator Nancy Ruth: Nancy Ruth from Ontario.

Senator Seth: Asha Seth from Ontario.

Senator Stewart Olsen: Carolyn Stewart Olsen from New Brunswick.

Senator Seidman: Judith Seidman from Montreal, Quebec.

The Chair: We are dealing with Bill C-17, An Act to amend the Food and Drugs Act. The short title is the ''Protecting Canadians from Unsafe Drugs Act,'' or Vanessa's law.

We have four categories of witnesses today. I will call them in the order they appear on the agenda. At the end of all presentations, I will open the floor to questions from senators.

First, we have Jim Keon, President of Canadian Generic Pharmaceutical Association. Please proceed.


Jim Keon, President, Canadian Generic Pharmaceutical Association: Thank you, Mr. Chair and honourable senators, for inviting Canada's generic pharmaceutical industry to contribute to your study.


We're hoping today to contribute to your study of Bill C-17, Vanessa's Law.

The Canadian Generic Pharmaceutical Association represents companies that specialize in the research, development, production and sales of high-quality generic medicines, fine chemicals and new chemical entities. We are Canada's primary pharmaceutical manufacturers and exporters and are among the top R&D spenders across all sectors. Our industry employs more than 12,000 Canadians in highly skilled scientific and manufacturing positions.

Generic pharmaceutical companies have an essential role in Canada's health care system. We provide safe, proven alternatives to more expensive brand-name prescription drugs. We are proud of the fact that two of every three prescriptions in Canada are now filled with generic medicines — two out of three prescriptions are now filled with generics. Today, four or five prescriptions for generic medicine can be filled for the cost of one equivalent brand-name prescription. That is the value our products bring to the system — the savings and head room for other aspects of the health care system. In 2013 alone, the use of generic prescription medicines saved governments, employers and consumers approximately $13 billion.

Generic drugs are approved for sale by Health Canada and are bioequivalent to the brand-name version. Each product must also meet the rigorous and internationally accepted standards established by the Food and Drugs Act and its regulations. Generic medicines are required to have the same quality, purity, efficacy and safety profile as the branded drugs.

By the time a generic version is licensed for sale in Canada, the drug has generally been on the market for between 12 and 15 years in Canada and other jurisdictions. Typically, the safety profile of the drug is well established. Even so, Canada's generic drug companies take their responsibilities with respect to patient safety very seriously. Patient safety is paramount.

As I said in my testimony before the House of Commons committee, the Canadian Generic Pharmaceutical Association supports Bill C-17. We continue to support the bill as amended by the Standing Committee on Health with the following comments.

Mandatory adverse drug reaction reporting: While drug companies have had a mandatory reporting requirement for many years, the health care professionals, who are the primary point of contact for patients, have had no such obligations. As such, the CGPA supports the mandatory requirement for prescribed health care institutions to report adverse drug reactions. This new requirement will help to narrow an important information gap and will improve both the quality and quantity of ADR information available.

Post-market surveillance: As pervious witnesses have testified, Health Canada has been moving towards a life-cycle approach to drug regulation for several years. The generic pharmaceutical industry is supportive of this approach. We look forward to consulting with Health Canada on the specific details of the regulations and guidance that will be associated with the changes in Bill C-17. In particular, we recommend that the regulations and guidance specifically clarify any shared duties or actions between generic and brand manufacturers of the same drug.

Bill C-17 expands the powers held by the Minister of Health. A dialogue between officials and companies is always important to ensure Health Canada has access to full information with respect to a drug. Once Bill C-17 is enacted, the Minister of Health will have expanded powers to obtain safety information, modify labelling, recall drugs, or take other corrective actions, and obtain a court injunction on 48-hours' notice or no notice at all in the event of a perceived health risk. The CGPA supports the new powers provided to the Minister of Health as a last resort when there's an actual risk to patient safety.

In closing, I want to say a word on the quality of generic medicines and to address recent media reports and comments made at this committee with respect to the quality of generic medicines sold in Canada. Pharmaceutical products are one of the most regulated products in Canada. Generic medicines sold in Canada are approved by Health Canada and must meet the ongoing good manufacturing requirements and other requirements of Health Canada to remain on the market. This includes products sold in Canada by CGPA member companies including Ranbaxy and Apotex, who have been cited recently, as well as products sold in Canada by Teva, Pharmascience, Sandoz, Actavis, Mylan, Taro and PPC.

As I mentioned earlier, two out of three prescriptions in Canada are filled with generics. Health Canada and other regulators sometimes quarantine or recall products. These are often done in response to a potential concern, and in most cases the potential concerns are removed when further testing and verification is conducted. In many cases, recall may also pertain only to a single lot. So we have to be careful when responding about specific situations.

I assure this committee that the generic medicines sold by CGPA members in Canada meet or exceed Health Canada's high, internationally recognized standards. They are available on the marketplace in Canada because they have met Health Canada's stringent requirements.

Thank you for this opportunity to share our industry's views on this important piece of legislation. I look forward to answering your questions.

The Chair: Thank you, Mr. Keon.

I will now turn to Consumer Health Products Canada and Gerry Harrington, Director of Public Affairs.


Gerry Harrington, Director of Public Affairs, Consumer Health Products Canada: I would like to thank the members of the committee for the opportunity to comment on Bill C-17.


I am Director of Public Affairs for Consumer Health Products Canada. CHP Canada is the association representing the manufacturers of over-the-counter medicines and natural health products, in roughly equal number, which together we refer to as consumer health products.

Our mission is to advance evidence-based self-care and the vital role that consumer health products play in the health of Canadians and the sustainability of our health care system. We look forward to this discussion on Bill C-17 as we see it as the most significant update to the Food and Drugs Act in more than half a century.

I would like to begin by reiterating CHP Canada's strong support for the provisions of this bill. Consumer health products play a critical role in the health of Canadians by enabling them to manage many minor and chronic ailments safely and effectively, and even to help prevent the onset of more serious diseases. Over 95 per cent of Canadians avail themselves of consumer health products in the practice of self-care. This type of self-care is not only an important part of their own personal health management, but also contributes significantly to the cost effectiveness of our health care system by helping them to avoid unnecessary doctor visits and other insured health services. But in order for those benefits to accrue to Canadians and their health care system, appropriate legislative and regulatory infrastructure has to be in place to ensure that these products are indeed effective and, most importantly, that they can be used safely by Canadians without medical supervision.

Before commenting further, I would like to point out one aspect of this bill that continues to puzzle CHP Canada somewhat. We believe that the patient safety benefits of Bill C-17 should accrue to all consumer health product users. Given that the safety criteria that separate both natural health products and over-the-counter medicines from prescription drugs are exactly the same, we continue to believe that both classes of consumer health products produced by our members should fall within the scope of this bill.

Having said that, the heart of the matter is all consumer health products should be regulated through a consistent risk-based framework. For that reason, we applaud the Minister of Health's announcement this past June that her department will soon begin a public consultation on just such a regulatory framework for consumer health products.

CHP Canada supports the modernization of the administrative elements of the Food and Drugs Act with respect to penalties and ministerial authority to order product recalls, which bring this legislation into line with the authorities in similar legislation such as the Canada Consumer Product Safety Act, and similar statutes among our key trading partners.

CHP Canada also supports the provisions of the act empowering the minister to require new information in respect of an authorized therapeutic product, to order new label information on authorized therapeutic products, and requiring the mandatory reporting of adverse reactions by specific health institutions. We note that all of these provisions align with the recommendations made by this committee in its report entitled Prescription Pharmaceuticals in Canada: Post-Approval Monitoring of Safety and Effectiveness.

While these post-approval decisions won't often find applications to consumer health products since the criteria for gaining non-prescription status in the first place include having an established safety record, we believe that adding these tools to the regulator's tool box will provide new flexibility when safety issues arise in a consumer setting.

CHP Canada's main concern with Bill C-17 relates to its treatment of confidential business information. In a piece of legislation that otherwise goes a long way toward aligning the Food and Drugs Act with other product safety legislation in Canada and with similar legislation in other jurisdictions, the treatment of confidential business information diverges from that path. The lowered threshold for the release of CBI by comparison, for example, to the Canada Consumer Product Safety Act, is puzzling since both are modern pieces of legislation intended to protect the same Canadian consumers. As a practical matter, this is a concern for many of our members who sell products regulated under both acts.

At the international level, the provisions related to confidential business information raise a number of concerns and seem at odds with worthwhile initiatives on regulatory cooperation with our most important trading partner. Both the lowered threshold for the release of CBI and the lack of provisions holding recipients of CBI to respect that confidentiality are at odds with the practices of our major trading partners. These provisions are also at odds with the principles underlying the Regulatory Cooperation Council, established by the Canadian and U.S. governments. The success of this initiative relies on the free flow of information between the regulatory agencies of each country, which could be undermined if their respective treatment of CBI does not align.

A similar ''chill'' in the sharing of information could occur between Health Canada and the EMA, the European Medicines Agency, which also provides stronger protections for confidential business information. CHP Canada believes that the free flow of information amongst regulators is an important part of ensuring patient safety, and thus we question whether these provisions in Bill C-17 could prove counterproductive in that regard.

Based on the above considerations, we respectfully recommend that the committee consider aligning the provisions around confidential business information with the provisions of the Canada Consumer Product Safety Act.

Thank you very much for your time and attention, and I look forward to your questions.

The Chair: Thank you, Mr. Harrington.

I will now turn to MEDEC and Klaus Stitz, who is Vice President of Regulatory Affairs.

Klaus Stitz, Vice President, Regulatory Affairs, MEDEC: I thank you for providing the opportunity to speak to you today. I represent MEDEC, the national association of the medical devices industry in Canada.

MEDEC and its 130 mostly small- and medium-sized members have publicly expressed full support of Bill C-17. Providing safe and innovative medical technologies that advance the quality of medicine and patient care is the number one priority of our member companies. Patient safety is a responsibility where regulators and industry meet.

MEDEC appreciates that the consultation of Bill C-17 helped clarify with Health Canada a specific long-standing patient safety issue related to the sale and reuse of reprocessed single-use medical devices in Canada. This practice is without any federal regulatory oversight and raised concerns regarding product safety and quality, legal liability and transparency for patients when, instead of original licensed single-use medical devices, their reprocessed variants could be used in medical procedures.

Health Canada has now acknowledged that the current Food and Drugs Act provides the authority to regulate this practice and that they can devise regulations that improve patient safety and bring Canada in alignment with other leading jurisdictions.

Many times in the past, MEDEC has expressed support for modernization of the Food and Drugs Act in conversations with Health Canada. Regulatory experience has shown where, since the inception of the act, further powers for Health Canada are needed to fulfill their mandate on behalf of Canadians and, at the same time, strengthen the alignment with regulators in the markets of Canada's most important trading partners.

Bill C-17 focuses on vigilance and action of Health Canada in the post-market, the pivotal phase in the product's life cycle after it has been approved based on controlled clinical studies and was released into ''real world use.'' The bill aims for greater transparency — a term that seems to mean different things to different people.

Transparency relates to the availability and communication of data or information. Regulators, including Health Canada, receive signals and data related to product safety and performance from many sources. The way they act on that information or share it appears to be different.

Bill C-17 will improve the reporting by health care institutions. Reporting by health care professionals is — and has been for a long time — mandatory in other jurisdictions. MEDEC hopes that proactive domestic reports, in addition to the international exchange of adverse event data and the current reporting by manufacturers, will lead to better data quality. Action or transparency depends a lot on the interpretation of data that enables science-based decision making and communication.

So far, the Sentinel pilot of active adverse event data gathering in Canada has not contributed much information but confirmed trends already shown in the reporting by industry.

The antonym to ''transparency'' is ''privacy.''

Despite the full support of MEDEC for Bill C-17, we have been asked by our membership to speak about their concerns related to the significant amendments regarding confidential business information that were added last minute without allowing for the customary level of scrutiny and external analysis, including legal and stakeholder review.

MEDEC's full submission to the committee and the included white paper addresses in detail these concerns regarding CBI disclosure, which our members in other sectors in the therapeutic products community share equally.

MEDEC members understand and support the need of patients and their caregivers for transparency in a timely, tangible and consistent fashion. But transparency regarding the patient safety aspects of a therapeutic product is not all about confidential business information.

Our members believe that minor changes to Bill C-17 in its current form can take care of these real and significant issues. The CBI disclosure clauses are perceived unbalanced and out of step with domestic and foreign approaches in this matter. For example, they allow for considerable interpretation when language like ''the product may present a serious risk'' or ''the purpose of the disclosure is related to the promotion of human health'' provides no clarity about the limitation of the disclosure for the mitigation of a serious and imminent risk of injury or public health.

The amendments also differ significantly from the standard contained in the existing Canadian legislation and practice, most notably in both the Canada Consumer Product Safety Act and Human Pathogens and Toxins Act. Even in the latter case, where the protection of human health would be of great concern when dealing with such human pathogens as the Ebola virus, the disclosure of CBI is more restricted. The standard set in CCPSA would be supported by MEDEC members.

The amendments are also inconsistent with the approach of Canada's most important trading partners to the disclosure of CBI in their own jurisdictions and to trade secrets, and with Canada's international obligations. Bill C-17 could make Canada the most permissive jurisdiction which disadvantages Canadian manufacturers and is a disincentive for foreign manufacturers to disclose sensitive information when seeking approval for a market authorization in Canada. This seems to make no sense as the government makes attempts to remove red tape and align regulations.

The amendments also do not distinguish confidential business information from ''trade secrets'' contained in submissions of manufacturers to the government. Trade secrets do not play a role in the protection of public health.

Finally, the amendments do not provide for the duty to notify the person to whose business or affairs the information relates, even not after the fact for the sake of transparency.

How minor changes to Bill C-17 can strike a balance and secure transparency and enhanced patient safety while maintaining protection of CBI where needed in this competitive global marketplace is detailed in our submission in Appendix 1.

Clear and modern legislation that includes the ability to disclose CBI to protect the health of Canadians but maintains appropriate legal safeguards aligned with comparable domestic and international legislation will provide a regulatory climate that is supportive of manufacturing, commercialization and appropriate use of therapeutic products, including innovative medical technologies in Canada.

In closing, I would like to mention that the support of MEDEC members for Bill C-17 will not change whether the bill reads the minister ''may'' or ''shall'' in relation to the mitigation of imminent and serious health risks provided that the bill strikes the balance between transparency for the purpose of improving patient safety in Canada and the legitimate request of the industry for the protection of confidential business information from competitive exploitation.

Thank you.

The Chair: Thank you, Mr. Stitz.

I will now turn to Rx&D and welcome Walter Robinson, Vice President, Governmental Affairs; and Jared Rhines, Vice President, Scientific and Strategic Affairs.

Jared Rhines, Vice President, Scientific and Strategic Affairs, Rx&D: Mr. Chair and honourable senators, thank you for inviting Rx&D to appear before you today on Bill C-17. My name is Jared Rhines, Vice President of Scientific and Strategic Affairs at Rx&D, and I am joined by my colleague, Walter Robinson, Vice President of Government Affairs.

Rx&D represents over 50 research-based pharmaceutical companies and members who discover, develop and deliver innovative medicines and vaccines to Canada.

To be perfectly clear, we support the principles, objectives and direction of Bill C-17. We stated this publicly when the bill was first introduced, and we reiterated our support during hearings before the House of Commons Health Committee this past spring. This should not be a surprise as Bill C-17 further codifies the manner in which our members already work with Health Canada to ensure and promote patient safety.


Walter Robinson, Vice President, Government Affairs, Rx&D: We also note that Bill C-17 is, in some instances, a mirror of this committee's four-part study on the use of prescription pharmaceuticals in Canada, a study that we welcomed and in which, as you know, we actively participated.

As we have noted before, our members' activities are guided by a clear code of ethical practices. Acceptance of, and adherence to, this code, in letter and in spirit, is a mandatory condition of membership in Rx&D.


Mr. Rhines: We do have a concern with one element of Bill C-17 that arose during an expedited clause-by-clause review and amendment process after the House of Commons Health Committee finished hearing from witnesses. However, we believe that this can be rectified to further strengthen the bill, and we will return to this matter shortly.

By way of background, we contribute $3 billion annually to the Canadian economy and our members invest over $1 billion each year in Canada. Approximately 75 per cent of this amount is directed to over 3,000 clinical trials across the country.

Clinical trials are required to bring safe, innovative and effective medicines, vaccines and devices to market. They enable our clinicians to have access to state-of-the-art technologies and push the frontiers of medical knowledge. Most importantly, these trials provide hope to patients and their families who have failed on or do not respond to conventional therapy.

Efforts in Bill C-17 to improve the transparency of Canada's clinical trial regime are welcomed by our members. Just as we have done in other countries, we look forward to working with federal officials and our partners in the hospital and academic sectors to bring about these changes.

Mr. Robinson: We are also proud of our long-standing partnerships with the Canadian Institutes of Health Research and its work to advance SPOR, the Strategy for Patient-Oriented Research. In addition, we are engaged in several groundbreaking partnerships with various provincial bodies and agencies. For example, in Ontario, we have partnered with the local LHINs and the Ontario Lung Association to develop new care pathways for COPD patients.

In New Brunswick, we are working with the government there to standardize clinical order data sets in hospitals for diabetes patients.

In British Columbia, we are part of an exciting personalized medicine initiative to explore how pharmacogenomic markers can improve prescribing decisions to eliminate unnecessary adverse events for seniors who are often on multiple medications.


These partnerships to drive real-world evidence generation are aligned with the principles of post-market surveillance espoused in Bill C-17.


Mr. Rhines: Legislative and regulatory modernization of the Food and Drugs Act is long overdue. Health Canada should have a modern, efficient and effective compliance and safety regime, a regime that is world leading in its scope and receives the confidence of Canadians.

In the interest of patient safety, we also believe Bill C-17 can be further improved by providing additional oversight power to combat counterfeiting and encouraging the dispensing of approved Canadian labels, including by appropriate electronic means.

With all that said, to be honest, we find ourselves in a very difficult position today. While we support the tenets of C-17 and want to support the bill in its entirety, we feel obligated to highlight a specific issue that pertains to changes introduced to the standard for disclosing confidential business information. In the rush to conclude Bill C-17 before the summer recess, this change to Bill C-17 did not receive the customary scrutiny or expert stakeholder input prior to being adopted by the house.

As currently written, confidential business information in Bill C-17 is understood broadly to include business information that is not publicly available. The definition in the bill includes trade secrets, such as proprietary manufacturing processes. It is any information that has economic value to a business or its competitors and may not be related to patient safety at all.

Rx&D is strongly supportive of providing the minister with specific powers to respond to threats to the health of Canadians that may include circumstances where it is essential to disclose confidential business information to address an imminent and serious risk to human health, without notice or consent.

For example, this is the approach in the Canada Consumer Product Safety Act adopted in 2010 and the Human Pathogens and Toxins Act adopted in 2009. The threshold, or bar, in both of these acts permits disclosure only when the risk is serious and imminent. Both acts also require a close link between the disclosure and addressing the risk in question.

Using these acts as benchmarks, the current language in proposed section 21 of the bill before you is problematic in that it is imprecise. It also is inconsistent with other global regulatory approaches and appears to be inconsistent with Canada's commitments to protect trade secrets.

There have been suggestions that our concerns could be addressed through regulations. In examining the bill, we are unable to identify a specific regulatory pathway to this end.

Therefore, our request is straightforward. The disclosure threshold language in Bill C-17 should be adjusted through minor amendments to section 21, which we have placed before you and tabled with the committee clerk.

As Health Canada's peers such as the FDA, EMA and others demonstrate, disclosure in support of increased patient and public safety can be managed in a way that also protects confidential business information. These changes do not detract in any way from the legitimate and welcome effort in Bill C-17 to ensure that the minister has the ability to respond as necessary to urgent situations that require action to protect Canadians — again, and in closing, an ability that we fully support.

Thank you for your attention, and we look forward to your questions.

The Chair: Thank you all very much. I will now open the floor up to questions from colleagues. I will start with Senator Seidman, who is the sponsor of the bill in the Senate.

Senator Seidman: Thank you very much for your presentations. You referred to our four-part study, and we did quite a thorough study of post-market surveillance. In this bill, there are proposed new sections that authorize the minister to order the holder of a therapeutic product authorization to conduct an assessment of the therapeutic product. In your view, should pharmaceutical companies be responsible for conducting that post-market surveillance activity, or should that be the responsibility of a third party?

Mr. Rhines: Post-market assessment needs to be a shared responsibility. There needs to be an elevated requirement for clinicians to report adverse events. There has to be improved education for consumers to know when to report an adverse event. There needs to be greater transparency. Right now, pharmaceutical companies receive adverse event information, and adverse event information can go right to Health Canada as well without going to the company. Currently, that information that Health Canada receives is not shared with the company, so Health Canada has a more fulsome set of data than we do.

It's a problem that needs to be fixed collectively. There has to be better knowledge transfer. We have to better understand who has the data, how we get that data into one place and then make the assessments together.

Mr. Stitz: Senator Seidman, when it comes to the question that you raised, that Health Canada would wish to impose additional studies to be done, this is I wouldn't say the end point but pretty much an advanced point of conversation between Health Canada and the company in question or, if it is for a group of products because it's a chemical entity, for a group of companies as well. There is a dialogue of what information Health Canada has and would wish to verify by a study.

It also plays into this question whether the study done by industry is of an independent nature. I know people question whether studies by industry are neutral, honest and truthful. I was opposed to any of these suggestions because our scientists are patients as well, and they do not want to have treatment with drugs or devices that get into the market on faulty studies and results.

This study can be done in the routine way as clinical trials are being done in the industry now, but they need to be based on a consent between the regulator and the industry understanding what the ask is, what the study should prove, and then bring in clinical experts to make this study happen.

Senator Seidman: This bill stresses the importance of a life-cycle approach to pharmaceutical drugs in this country as opposed to just the clinical trial process. We move into post-market surveillance and some mechanism to deal with that.

I understand what you're saying, but one of the issues that came up in our study had to do with population subgroups that are not part of clinical trials generally, so children, seniors, women, pregnant women. These are people who take products that have not been tested on them. I don't have to tell you that.

Now we're in a situation post-market, drugs on the market. Do pharmaceutical companies conduct any post-market studies themselves, on their own initiative, on following a drug that's used in a population subgroup?

Mr. Stitz: I have to refer this to the pharmaceutical industry.

On the medical device side, the use of medical devices not according to instructions for use and the claims or authorization included by patients is not considered under the responsibility of the manufacturer. It's considered off-label use. This is part of the science of medicine where the clinician can decide whether he can justify the use of a medical device on a not-included patient group. We have the advantage with medical devices in that they do not interfere that much with pregnancy or any like abnormalities in a patient cohort. That's how I would answer that.

Senator Seidman: You're saying it's an academic study, basically, so it's third party research.

Mr. Robinson: There are two questions there, one around population subgroups specifically and the other around the greater phenomenon of post-market surveillance.

We commend the Minister of Health in charging the Council of Canadian Academies to take out — you may have seen their study last week with respect to specifically pediatric trials and the importance of properly designed, regimented and approved clinical trials in that subpopulation. Many of us are parents. That is an extremely important thing. We hope the minister and this committee study their work, and we're actually looking at their recommendations with great interest.

To come back to the larger question of post-market surveillance, what we're seeing around the world is more and more the health technology assessment bodies are asking for post-market surveillance in terms of you get increasing coverage with evidence, which happens in a real-world environment, post-market surveillance in terms of the reimbursement of your product on a formula. That's becoming more the norm than the exception to the rule.

As we mentioned in our testimony, we are investing in value-demonstrating initiatives at Rx&D to drive real-world evidence for COPD patients. Those studies are independently assessed. We contribute, but we have ethics boards that look at them. We have an independent evaluator in Ontario for our VDI there. In B.C. with the personalized medicine initiative, that's an independent effort to eliminate unnecessary adverse events in seniors' populations.

For the industry in and of itself, whether Bill C-17 asks for that or not, that is a direction where the industry is going because we have to generate real-world evidence and also show and track the safety profile of a medicine as it changes over five, ten or fifteen years or through the life cycle of its use in a wide variety of populations.

I hope that answers your question.

Senator Seidman: It does. It is actually very helpful. Thank you.

Is this information made public as you accumulate it?

Mr. Robinson: The three studies I can speak to specifically are in MOUs with the respective provincial governments, and there is a commitment to make those findings public, whatever they may be.

Senator Eggleton: I have three questions. To get them in, I'm going to try to make this as short as I can, and I would appreciate if the answers could be as short and concise as possible.

On the confidential business information, Mr. Harrington, you started off by saying that the threshold is lower than what it is in the Canada Consumer Product Safety Act. I'm not quite clear about that wording. I have a copy of those provisions in the act in front of me, sections 15 to 18. I also have a copy of what is in Bill C-17, and I have now the suggestions from Rx&D. Where is the wording different? Where do you see that as problematic? I looked over Rx&D, and I'm not a lawyer, but the wording is very nuanced and subtle. It doesn't seem to be much different. Maybe some of these words have a different meaning in a legal context, so perhaps you could run through that for me. It's on this piece of paper that we all have. Mr. Harrington and anybody else who would like to comment would be fine.

Mr. Harrington: The primary difference we notice is that the language in the Canada Consumer Product Safety Act refers to the existence of a serious and imminent risk, whereas Bill C-17 talks about there may be a serious risk of human injury to health.

The issue, whether there is a bar at all, comes down to whether there may be a risk in the field of regulating pharmaceutical safety. That does not convey a very strong sense at all by comparison to the language in the CCPSA that speaks to a clear and identified risk.

The use of the term ''imminent,'' as my colleagues from Rx&D pointed out, is tied to the urgency of the release of information and hence taking away the requirement to notify the holder of that confidential business information in advance.

Mr. Rhines: That's a great question. Thank you for asking it. We've obviously had a lot of discussions around this. We're unclear as to the legislative intent around this. It seems like the bill is trying to do two things at once, and we're not quite sure it does either in the way that it was intended.

It seems to be trying to get at the imminent and urgent public health risk, which we agree with. It also seems to be trying to get a little bit at clinical trial transparency. The Consumer Health Products Act and the Human Pathogens and Toxins Act say that it's essential to address a serious and imminent danger, whereas that's not in Bill C-17. It says ''may present a serious risk of injury to human health,'' but it doesn't stop there. It goes on to say ''that the Minister believes it is necessary to determine whether the product presents such a risk.''

With the threshold to release information in context, there are no parameters as to what that information is. We understand that there is value in clinical trial data and the trends that presents. But if there is an interest in disclosing that trend data for non-imminent risk, why is there no notice? Why is there no consent?

It seems that we are combining attempts to get at clinical trial transparency, which we completely support and do elsewhere in the world and can share the list of things we do, and addressing an urgent and necessary risk. It's not doing either. Sort of the source of our confusion and our concern, senator, is that it doesn't have to be necessary or urgent, and it could be not only to protect but also to promote human health.

It's very vague, and we don't see a pathway to correct it in regulation. So it is our request that a minor amendment be made to address this issue, which causes significant concern and is far more broad than I believe was intended.

Senator Eggleton: Do the rest of you support the amendments they have suggested? You might respond in that way as well.

Mr. Stitz: Yes, I think I can withdraw my comment because I have the CPSA here in front of me. It's very clear where the deviations are, and some of them have been highlighted.

One other is the necessity in the Consumer Product Safety Act that disclosure happens to people who sign confidentiality agreements with regard to the information received and the information of the sponsor of the confidential business information that this person has transparency of the disclosure. It is very clear where the deviations in these two acts are.

Senator Eggleton: A witness last week suggested that the power of recall might be like a nuclear option: very sudden, swift and big. Somebody else called it a ''sledgehammer.'' What they thought might work better if there was a two-stage process was a suspension to start with and then a recall at a later stage, if necessary. I guess the argument they're making is you might not know all that fast that a recall is justified; and it's a big weapon.

I believe there are provisions in the Food and Drugs Act for suspension, but the question arose as to whether they worked in concert with this. It's not really seen as part of that system. I just want you to comment on this question of suspension being part of it.

Mr. Rhines: We actually agree with that comment. There is a process called ''Provision to Stop Sale,'' which is a more graduated approach to recall. It was in previous proposals and was in an initial draft to the legislation but was omitted from Bill C-17.

As you stated, it would allow for a more graduated approach to managing risks. It could also prevent someone from selling a product if they haven't complied with the recall. We do think there is an opportunity for a graduated approach, and a provision to stop sale would be one of those.

Mr. Keon: Even under the current act, the minister has the authority to request quarantines. That is happening now with certain products coming from an Indian plant. As you said, this allows for further testing to determine whether that product needs to be recalled. Going forward, in most cases, it would appear to be the proper way to proceed rather than an immediate recall, unless there is clear and overriding evidence.

Mr. Stitz: The term ''recall'' in the medical device industry is defined in the medical devices regulations. There are a number of different layers. For example, a recall can be a change to the labelling of a device so that it can be used properly and risk can be mitigated; the reduction of claims that can be made for this device so it not used for this but for that; the remainder of the claims is also a recall; the modification of the manufacturer of the equipment on site, like the addition of something to irradiation equipment like an MRI at the site of the hospital is also a recall, so that product would be temporarily not used until it is upgraded or modified or set back to its original function. That's also a recall.

When we read ''recall'' in Bill C-17, we understand ''withdraw from the market.'' That decision is the last and utmost weapon if there is harm that cannot be avoided or mitigated in other ways. That's definitely an issue, because here the question is: How you recall a product that is currently walking around with you as an implant? You cannot recall that product. We understand this is not a problem that can be handled by Bill C-17 and the regulations take care of this already.

Senator Eggleton: Another witness last week suggested the following: Change the definition of ''medical device,'' as defined under paragraph 2(1)(b), from anything used in modifying a body structure to anything used to promote health such as sterilizing equipment, autoclaves, ultraviolet lamps, ethylene oxide sterilizers, and non-physical aspects of medical devices. This includes software used to operate items such as insulin pumps and pacemakers. The deputant said unregulated, unsafe software can kill you the same as unsafe hardware. The point is this: Should we not be amending ''medical device'' to include those? What comment do you have on that?

Mr. Stitz: I think the person who said that might have overstated his or her knowledge a bit.

Medical devices that contain software are regulated for the hardware and the software. An insulin pump with software can only operate if the software is also safe and effective. That is part of the evaluation that the Medical Devices Bureau does. The software parameters and architecture have to be displayed and demonstrated in the application. That is in the regulation and is part of the medical device.

Also, software that comes from the cloud, as we have right now with a lot of wellness software — where you can have a wristband that calculates the steps you take and how many calories you burn — there is a question as to whether this is health-related software or only wellness software. There is a distinction between those. If the software provides a decision point with regard to an illness, this software is also regulated independently as a medical device.

We don't see a problem there, although as the technology evolves and as this software appears on all kind of platforms, such as iPhones, there is an evolution of the regulatory framework, but the framework can cover that.

Finally, to what you asked first on the sterilizers and equipment being used in hospitals to make sure those devices that are reprocessed are safe for reuse, there is a process in place that certifies this equipment and takes care of any modification and manipulation to this equipment. There are provinces that have regulations in place, for their hospitals, which says these types of maintenance or service operations can only be done by people that are authorized by the manufacturer. Otherwise, someone could construct a different piece of that. It is not that much of a risk.

The Chair: Thank you, Mr. Stitz. I think your opening comment was one of the most diplomatic wordings we have heard in some time. We were aware you would be appearing today, and that question was definitely going to come up, so thank you.


Senator Chaput: Let us assume that Bill C-17 is a step in the right direction — not perfect, mind you, but a step in the right direction — and it grants the minister more power. What would change in terms of your responsibilities once it comes into force? Would you have more obligations as far as certain activities are concerned? My question is for all four of you.

Mr. Harrington: Senator Chaput, nothing would change for the manufacturers. The provisions in the bill represent practices that are already in place within the industry, especially as regards over-the-counter products.

I am going to switch to English.


In the consumer health products industry in particular, most of the provisions of this bill, frankly, will not often apply to our products other than the enforcement provisions such as the fines, penalties and so on. Our industry has a long record of being highly compliant with the requirements of the law.


Mr. Robinson: I agree with Mr. Harrington. Generally speaking, we already work that way with Health Canada. The industry works with Health Canada in order to promote and protect the safety of Canadians.


Where I think things would improve is driving more of a degree of collaboration and partnership with Health Canada, our academic partners in post-secondary and acute health sciences centres, specifically in the areas of clinical trial registration and disclosure, and mirroring international efforts that are under way. It is a continually evolving area. The only other part, where Mr. Rhines and some of the other witnesses were before you, is the disclosure around confidential business information. Again, we are supportive of the bill and the direction of the bill; we just do not understand the legislative intent. We think we can fix that in the context of the minor amendments we have suggested around imminent and serious risk in setting a threshold for the disclosure of confidential business information.

Mr. Stitz: I apologize for not being able to talk to you in French, but I can offer German.

I think what is said can be underlined by MEDEC as well. The bill, in its majority, does not set the manufacturers' new standards. However, we will see what regulation — where a lot still needs to be a digested — will bring to the table. And there is dialogue necessary when it comes to regulations that give life to these statements that the bill has.

With regard to studies to be done in the post-market and when Health Canada believes that additional evidence is available or should be created, again, this is something where Health Canada and the industry need to work together on how to manage it, how to get the job done and get the answers to the table. The industry supports that completely. Otherwise, our mandate or our primary priority to look for patient safety would be an empty word.


Mr. Keon: Overall, I agree with my colleagues. The changes set out in the bill enhance the minister's ability to work with the industry. Practices changed a few years ago. For the time being, I am not sure that practices will change a whole lot. New rules will be in place, and companies will, of course, follow them. For the time being, however, I think the big difference is that the minister's powers will be more clearly defined.

Senator Chaput: Do you think it is important that the minister have more clearly defined powers?

Mr. Keon: Yes.


Senator Enverga: Thank you for your presentations today, gentlemen. It was great and I learned a lot of things.

My question is for Rx&D. First, how much of the current Canadian pharmaceutical market does your member organization represent? Is it the majority, would you say?

Mr. Robinson: In terms of our members in the market, of the active participants in the innovative brand name sector, I believe we would have about 75 to 80 per cent. We represent the overwhelming majority of innovative companies in the Canadian marketplace or market authorization holders, and we represent, in large measure, the majority of the global players.

I would also add, though, that sometimes there is a misconception. We have small and emerging Canadian pharmaceutical and biopharmaceutical companies in our membership as well and have built alliances with many of the life sciences and biotechnology organizations around the country. We have argued before this committee on intellectual property protection in phase 1 of your study, and other issues around modernizing the Canadian clinical trials regime. They are equally important to small Canadian biotechs as they are to our large transnational members.

Senator Enverga: One of the reasons I asked is that you have a code of ethical practices, and it seems that you have the power to penalize your members if they are prone to violating the codes. Will Bill C-17 help your cause, or will it even take away the values that you have been telling your members?

Mr. Rhines: I think the code is an example of the ethical way in which we engage. There is very tangible evidence that we behave in an ethical fashion. The code is far broader than C-17. Our code of ethical practices governs how we engage all stakeholders. It is how our companies behave. There is an element of promotion covered in the code, but as it relates to clinical trial generation or data that may be part of what is disclosed here, our code is far broader. We are happy to provide copies. It governs every interaction our members have with stakeholders, whether it is government, physicians or patient groups.

Senator Enverga: Everybody will have a code of ethics, but will Bill C-17 help your organization?

Mr. Stitz: It will not play into our codes because those two elements stand side by side but independent from each other.

Mr. Keon: Our code of marketing conduct generally goes to the commercial practices of our member companies.

Generic pharmaceutical companies typically market and promote their products with pharmacies, not with doctors, because by the time we come on the market, it is 12 or 15 years after a product has been introduced. Typically by then the physicians are quite familiar with the product. Our companies compete to have their products carried in the various pharmacies, whether it is Shoppers Drug Mart or Jean Coutu. Our code of marketing conduct really goes to the marketing and commercial aspects.

Mr. Harrington: I can echo what my colleagues have said. Our code uses the current laws as a starting point and extends into marketing practices in terms of communication with consumers, et cetera, that are not covered by the regulations and legislation. In that sense, it would not alter the scope of our code. It certainly points in the same direction.

Senator Enverga: But it will help?

Mr. Harrington: It certainly doesn't hurt.

Senator Seth: Thank you very much for your presentations. My question is a bit tricky.

If the minister were to recall a drug, believing that it is detrimental to the health of Canadians, and it was discovered later on that it was safe, does that make the minister vulnerable to lawsuits from the pharmaceutical industry and health care providers? If so, could the minister and the government be sued for the loss of product sales?

Mr. Keon: Was the question to me?

Senator Seth: Anybody can answer.

The Chair: Whether you wanted it or not, you are on.

Mr. Keon: Our recommendation to the minister is that while this bill will give the minister increased powers to recall unsafe drugs, in most cases that is best done in consultation with the companies. As we talked about earlier, there can be stages to this. There can be a determination that the product should be quarantined and not shipped until further studies can be done, et cetera. Under those circumstances, I don't see any particular liability issues for the minister.

In general, the Crown, if it is operating responsibly under various statutes, is protected. It is when the Crown is acting without proper concern and care that there would be issues of liability. I don't think that Bill C-17 particularly exposes the Crown that way.

The Chair: Just to let you know, we will have the lawyers from the ministry to answer this question directly.

Mr. Robinson: To pick up on Mr. Keon's point, and it speaks to the relationship our members have with officials at Health Canada, the minister is given the authority by Parliament to protect and promote the health of Canadians. It is broad, it is sweeping and no one questions it; it is his or her role.

In response to Senator Eggleton's question, the graduated approach you can take to ensure that it is in the interest of the member, the manufacturer, to ensure that the product is safe and doing what it says it does for patients. That graduated approach and working with the officials, those decisions made by the minister are made with the greatest of care, rigour and dialogue. So the areas of exposing the minister to litigation, I don't believe the risk is more than it was before this bill was introduced.

As Mr. Keon said, that's a hard case to prove, and that is not the record of our member companies in Canada.

Mr. Stitz: Senator Seth, the decision to interfere with the right to market which was granted after evaluation of the data available for the product, either through suspension or recall, is a serious decision.

In Canada, we are between 30 million and 35 million people. The U.S. is 10 times our size and Europe is 15 times our size; so if something happens in the post-market, this would be evident in other markets much faster or in much higher numbers than in Canada; and there will be no action taken or not taken in the Canadian environment that is imperative by evidence or signals that come from other markets with a higher population and a higher penetration of these products, absolutely.

Mr. Rhines: It is important to know that recalls aren't all of a sudden at the whim of the minister. Considerable dialogue goes on between the minister and the manufacturer at that point. When you have reached the point of recall, there has been a considerable discussion and dialogue and either the minister has the answers that he or she needs and decides there is no need for a recall, or they don't have the answers and errs on the side of patient protection. This is not something that happens out of the blue. It is not prolonged in terms of time, but there is an ongoing discussion between manufacturer and minister to make sure that the answers to the questions are provided.

Senator Seth: As you have said, Mr. Rhines and Mr. Robinson, you believe that Bill C-17 can be further improved by providing additional oversight power to combat counterfeiting and encouraging the dispensing of approved Canadian labels including by appropriate electronic means. Can you explain more about this?

Mr. Robinson: I will take the second question first as we argued and presented in our appearance before the House of Commons Health Committee.

The challenge for Canadians when they get their prescription dispensed, whether that be an innovative medicine or a generic medicine, there is still not a 100 per cent standardization of the record you would get as a patient to say that this is the medicine you have received, it is from this family of medicines; it is designed to treat such and such a condition for which your health care professional has prescribed, and here is how you should take it, with or without food, and here are the side effects you may have in terms of the risk and benefit. You may have upset stomach and be nauseous, whatever the case may be. Sometimes the dispensing of that information by electronic means may not coincide with the Health Canada approved product label and monograph. We believe it should.

In the context of counterfeiting, there were provisions in the former Bill C-51 two parliaments ago which spoke not only in terms of anti-deceptive measures, but anti-counterfeit measures to ensure that no person should manufacture a label, package, sell, import for sale or advertise a therapeutic product that resembles one that already has a market authorization or establishment licence and is likely to be mistaken for that product.

We know the government has some anti-counterfeiting legislation, but we think there could have been things within Bill C-17 to strengthen that in the interests of protecting and promoting patient safety, and we made those recommendations before the house in June.

Senator Cordy: Thank you to our witnesses for being here today. I'd like to follow up on the questions that Senator Seidman asked related to post-marketing surveillance. She asked you who should be responsible for it. I can't recall exactly what you said, but I think you said you certainly had some good scientists in your pharmaceutical industry that could do post-marketing surveillance.

The reality is that there is a lot of data out there that we don't even necessarily know about. One of the witness who appeared previously said at his hospital, half of the clinical trials done in any given year are sponsored by individuals or researchers themselves in their departments, so they have a huge source of valuable data that Health Canada in most cases would never be made aware of. So there are pockets of information out there on post-surveillance.

The thing that we found as a committee is that there might have been some of this information out there — this bill, you are right, is looking for more transparency — but it is not really getting to the citizen. If you look on the Health Canada website, you would have to be a genius with computers to try to find it. Even then, the site was actually down on several occasions when we looked. What is the best way? We can gather this information, but how do we make sure this data is in useable form for the consumer in Canada?

Mr. Rhines: That is an excellent question and I think it is incredibly important. We know that Health Canada has taken steps to improve the transparency or the availability of safety data to consumers. We have had conversations with them. We agree with you completely that the presentation of the data has to be in context. I think there are a couple of things to consider. One is: Is it understandable to the average consumer? Can they read something and make sense of it?

I consider myself an educated consumer. If I Google information on certain drugs that I take, it is scary to me sometimes, and I understand what I am looking for. It is very important that the consumer understands the context, the benefits versus the risks, and makes informed decisions with their health care providers based on the information they have.

Our industry would welcome taking an active role in working with our colleagues at this table, academics and Health Canada to figure out the best way to make sure that the information that Canadian patients need to make smart decisions about their health care, drug choices and safety profiles is made available to them.

Mr. Harrington: I would echo what my colleague Mr. Rhines has just said and emphasize that it goes well beyond information from clinical trials or adverse drug reactions, et cetera. We live in a world where there is a wealth of information, but there is a lot of competing sources of information that are sometimes contradictory. It is very difficult for patients and consumers to feel confident that they are following the right road and are getting reliable information.

This is an area that we as an organization have spent some time looking at and speaking to consumers and researching and trying to get an understanding of. We see some tremendous initiatives out there. Certainly a lot of the provincial governments have taken on exercises, such as the B.C. Health Guide and Telehealth Ontario, those types of patient information systems. I cannot overstate the importance of that to getting positive outcomes. The information we feed into that through clinical trials and post-marketing surveillance is important as well, but really just having well differentiated and reliable health information in general to patients is a hugely undervalued issue at this point.

Mr. Stitz: I have been, in the course of my career, at uncountable numbers of medical conferences and congresses where clinicians present their work and the research that they have done with a number of patients, mostly small numbers, and the conclusions that they may want to draw from the data they have gathered. Most of the time, they end up saying that it may be concluded from here but it does not actually change the medical science, but it could be an impulse for further research and study. What I want to say is that the data of the researcher is known to him as inconclusive, incomprehensive and only fragmented.

As well, two weeks ago, I was at an international medical devices regulators' forum in Washington where the FDA was spearheading a project for the medical devices industry called MDEpiNet, which is an attempt to make data in patient registries that researchers run in clinics available for the assessment of that data. You should have seen that discussion around the table because everyone is concerned about the quality of the data, the consistency of the data, how the data is being generated and how you get from metadata to conclusive data that is comparable. A study can be run in any part of the world. As an example, a registry for hips and knees is running in about 20 countries. The data being input in these registries, you can put them one over the other and come to the same conclusion.

There is an ongoing process driven by regulators to make this information available for more signals and more evidence that can lead to decision making, but we are only at the beginning of that pathway and there is a long journey to get there. I am not talking about the question of who owns this data, because it is a costly enterprise to generate.

Mr. Keon: Health Canada has taken some steps this year, and I would acknowledge that. The minister announced an openness and transparency framework. They have started, for example, posting drug safety review summaries. They are attempting to make them practical and not 100 pages that only an expert clinician could understand, but someone even like Jared might understand, so that patients could understand what are the therapeutic values and the side effects of a product. That is an initiative, and we have supported Health Canada on that and have worked with them on certain summaries that have been done. That is an area that we would promote.

Mr. Robinson: To put it in context, you have data, and you aggregate it and get information, but without context there is no utility for Canadian patients and health care professionals.

The issue of transparency and the openness framework would certainly push the minister and other regulatory bodies to be even more aspirational. The pharmaceutical industry and the device industry are often portrayed as, ''You need to put more data out there so people know.'' To what end? It has to inform that virtuous circle of medical education, proper diagnosis, and, if pharmacotherapy is required, proper prescribing and appropriate dispensing respecting provider and prescriber choice; generating post-market surveillance, the real world evidence, which was the first question we received from the government side today; to then come back to better patient outcomes and drive better prescribing and better diagnosis. That is the cycle. We need to actually put those four things forward for utility. To what end? As public policy-makers, that needs to be kept front and centre. That would get all the stakeholders in the room and the other interveners you saw before us to go to that end.

I think that is what is missing in the debate right now around patient safety and drug safety. We would support that.

Senator Cordy: This is great. There is a lot of information out there. I think what you have said is that it is one thing having the information; another thing is being able to use it appropriately, because what might be good for one person isn't good for another. You have to know that every drug has a side effect and, as someone said earlier, you have to weigh the pros and cons. Do you want to take it being aware that that?

I was reading the testimony of one of the witnesses who appeared before us and was instrumental in the development of this bill. One of the things was the timeliness of getting this data. It's one thing to collect the data and maybe a year and a half or two years later we're made aware of it. But if there's a significant risk, then how do we ensure that the data is gathered? You've explained the importance of that and the necessity for it to be readable by the average person. How do we ensure that the data are collected, collated and made usable and that it doesn't take two years to do it?

Mr. Rhines: That's a great point. We have to figure that out. I'm not sure that this bill is the place to figure that out, to be honest. I think that gets at longer term evaluation of safety data, and I'm not sure that's the spirit of this imminent risk bill. Rx&D and our members would welcome this dialogue. I find it personally unfortunate that you have Health Canada in front of you one day, academics in the room another day and us on a third day. We'd love to sit at a table with all of them and figure it out.

The Chair: That's for safety purposes.

Mr. Rhines: This bill should address that.

Mr. Stitz: We appreciate that.

Mr. Rhines: There is an opportunity to figure out the needs of each of the parties with the patient at the centre and work together to resolve that. The way to get at that is with a broader and more thorough and thoughtful solution.

Mr. Keon: I don't know about timing, per se, but the bill is an improvement over the current situation in that the mandatory requirements for reporting ADR have been there for manufacturers, but now they're being expanded to health care professionals and institutions, and I think that's a good thing. Through regulations, perhaps we can encourage that to be done in a timely way; and Health Canada has to respond in a timely way too. Going forward, this bill should have that information available much more broadly and from better sources.

Mr. Stitz: The timeliness of action taken has to do with a number of things, one of which is the strength of the signal. If the signal we receive in the post-market from adverse events is strong, then the decision making is relatively clear cut, black and white. If the signal is weak, the question relates to the quantity of signals that we receive, like something that doesn't do any good. Something that is a waste of money, time and effort should also not be dispensed to patients.

The bill of course moves in the right direction as we mandate institutions to report side effects or adverse events. We then get more signals that allow us to operate on signals that are weaker but give us a more complete picture. We are going in the right direction.

Senator Nancy Ruth: Gentlemen, you keep talking about transparency and ongoing discussions with the Minister of Health and you say how good it is. Yes, I believe it would be great if you were all in the room together with a patient-centred focus.

I'm interested in the changes that you've requested, which narrow the framework of the minister. The ''may'' and ''shall'' and so on give more choice to the minister than the kinds of things you have talked about, such as ''imminent risk'' and ''necessary'' and so on. I would like each of you to give me at least two examples of a CBI that will be more protected by these changes to the bill that you've requested. Do you get what I want?

The Chair: They understand and are just trying to figure out who's going first.

Mr. Harrington: We are not concerned about the minister's ability to intervene to protect the safety of Canadians but about at what point the release of business information becomes critical. For the type of commercial business information that might be involved, one thing that concerns us is that we don't have a definition. You could be talking about manufacturing information that is not necessarily related directly to the safety of the product, but the current bill doesn't make that distinction. That has tremendous commercial value to a manufacturer, particularly in the consumer health products sector where there is no intellectual property protection generally left as these are not patented medicines. Manufacturing information can be extremely important, commercially.

That very breadth of the definition as it stands right now combined with the lack of an adequate threshold for the release of the information make it disturbing.

Mr. Stitz: You will hear all of us backpedalling on this topic because the term ''confidential business information'' is a legal term and very broad, and we are not submitting information to the government. I do not know, for example on a medical device application, what the content of confidential business information may be so as to give it to you.

The question is: To what extent is confidential business information necessary to be disclosed to protect the health of Canadians? Our position is that if there is doubt about whether this information will be disclosed as confidential or shall be released under this act, then the threshold needs to be so high that the cause is imminent risk; and this is permissive.

If this can be done in a different way, information can be released. If we hear in Timbuktu that risks are appearing, and it is verified, then this can be disclosed at any time to alert the Canadian public or medical community to watch out for these types of situations.

It's a little bit about answering the question this way or the other way around. We ask for protection in proportion to the intellectual property that is at stake, not for having the ability to disclose, but disclose only when the threshold is really met.

Mr. Keon: In response to the question, I did not put forward suggestions for amendments to the CBI, so I have no comment.

Mr. Rhines: We're not going to backpedal on our position, actually. We feel fairly strong in our position.

The context of imminent and necessary has a couple of ramifications. It's not only narrowing what CBI is but also some of the downstream events. For example, if it's not necessary and urgent, we're not sure there's a ''why.'' If there are no disclosure measures, notification measures or requests, then it's not urgent and necessary. Health Canada collects a plethora of information around the products, which we're obligated to provide under confidentiality. It includes manufacturing practices, equipment, packaging techniques and a lot of things that for the innovative pharmaceutical industry is incredibly important to our business. These are examples of CBI that don't relate to patient safety and shouldn't be included in this bill.

But as the bill currently written, it is so broad that it cannot be fixed by regulation because regulations can't narrow the broadness. The only hope of getting it corrected is with this minor amendment; but it does include that information.

You've asked for two and I've given you three to make up for the other guys not having enough. That's where we're at. It's necessary and imminent; otherwise it's unclear to us why the following things don't apply.

Senator Nancy Ruth: This isn't going to come out of the blue, though. My understanding is there are ongoing discussions on various issues with Health Canada. You would be objecting if there was a demand, if a civil servant told you in the ministry that, ''Hey, we have to look at X, Y and Z.'' I understand the issue of the profit line and disclosure and how you will protect what you do and make your money.

Mr. Rhines: The problem is the way the language is written in the bill, which is what we have to go on. The conversation that you're referring to doesn't have to happen. The conversation doesn't have to be, ''We want to see this and we want to know this.'' There is no notification, no disclosure. There is not even an after-the-fact notification. There is no, ''Company X, we just disclosed this information on manufacturing practices, just so you know, to the following people.''

There are other concerns with the bill. There are concerns around who it can be disclosed to. It's to any government body in any jurisdiction, any individual for protecting or promoting human health.

In combination with that, with no urgency or imminence, we are very concerned. If it was necessary and urgent, you wouldn't get complaints about confidentiality. We wouldn't expect to be notified before it happens, but if it's not imminent and urgent, the downstream portions of the bill confuse us and expose — again, we have to go by the bill, because we don't believe regulations can fix it. So it's the bill. The conversations you refer to cannot happen according to the current language.

Mr. Harrington: To add to what my colleague said, one of the things that's puzzling — and it perhaps arises out of the way these amendments were made, the timing and compression of that process — is that the legislative intent is still unclear to us, how these departures from current practice in the CCPSA and the pathogens act add to the safety support that this bill provides to Canadian consumers. We are not seeing that connection.

Hence, looking at the proposed amendment — and Senator Eggleton asked the question and I failed to answer it — we would support it. One of the reasons we can support it is because we see in no way that this undermines what we understand the intent of the bill to be.

Senator Nancy Ruth: Mr. Stitz, when Senator Eggleton was asking you about the software that goes with the hardware, I wasn't quite sure that your answer included the autoclave, and I'm curious about that.

Mr. Stitz: I said that autoclaves are sold to hospitals by autoclave manufacturers, and those autoclaves are being serviced and maintained by the industry according to the requirements to keep them safe and effectively working.

There are regulations in the provinces that require maintaining their accreditation under the Canadian hospital accreditation act to make sure that the service and maintenance of these devices only happens without compromising their effectiveness. The manufacturers are operating or offering these devices according to standards that are available in the Canadian Standards Association, and also they fall under the equipment and are considered in our industry as medical devices, also falling under the regulations right now.

Senator Seidman: I have a question about the confidential business information issue that still feels to me a little unresolved.

If I might make a comment about the conversation you have just been having with Senator Nancy Ruth, some might ask why the minister should notify or seek consent from the industry if that minister believes that a product presents or may present a serious risk of injury to human health. That's the basic issue.

If you see a potential injury to Canadians, a serious risk — it says ''serious risk'' — why would the minister seek permission to make that notification? Some may ask that question, and I really don't want to debate it, but I want to tell you that if I read from our report on post-approval monitoring of safety and effectiveness, the committee heard overwhelming testimony in support of a life-cycle approach and the need for new legislative authorities in order to properly implement it. Witnesses suggested that Canada has not kept pace with its global partners in this regard. We then make reference to the European Union and the U.S. who have modernized their approaches. Officials from the FDA described updated approaches to regulation and a legislative approach to dealing with these issues.

I think we were left with the distinct impression that the European Union and the U.S. both now have much more refined, targeted and stricter transparency rules, post-approval monitoring and disclosure rules. I would like to know how it is, because you strongly say, that this is in contravention of or different from global regulatory approaches, be they the U.S. or the European Union.

Mr. Robinson: I remember reading the report with great interest, senator.

In the areas where we were behind the Europeans and the Americans in certain respects in a regulatory response, in clinical data transparency and reporting, the minister has taken steps to correct that. The areas in which we were behind the United States and our European Union counterparts are in some of the post-marketing surveillance and some of the regulatory authorities there.

We have testified that the areas where Canada is now perhaps going above and beyond where the FDA and the EMA are is in their legislation, and they address ''serious'' and ''imminent.'' In terms of the threshold, this legislation is out of step with Canadian legislation and out of step with where the FDA and EMA are on disclosure.

To come back to my earlier answer, where they are in front is some of that other clinical data disclosure and transparency where people say, ''We believe there may be a risk,'' and there are ways to disclose that and get at it as the safety profile of a medicine changes. It's not inconsistent.

There is also a component here that this is a global industry, and it's very essential for the safety and protection of not only Canadian citizens but global citizens that our regulators work together and speak the same language and have the same rules. That's not an abdication of sovereignty but an expression and manifestation of greater sovereignty. Our government and the United States are doing that through the Regulatory Cooperation Council, and we believe some of these issues are at a great place where they can be addressed and dealt further, once C-17 is passed, hopefully with some minor amendments.

To clarify where we as witnesses thought Canada could learn from Europe and adopt things from what the Americans and Europeans are doing, on this small issue of CBI, we are actually out of step with existing legislation.

When I think about the Human Pathogens and Toxins Act, in terms of a serious and imminent risk, something that can move across the world in 18 hours on a global flight and that is the threshold there, we think it should be the threshold for dealing with those safety issues in this piece of legislation.

Senator Seidman: There is a difference between Ebola and stroke or something like that. I can understand an imminent threat when it refers to Ebola as you suggest in your allusion here, but it is quite different if the risk is a stroke down the road somewhere because of the use of a particular agent. That's not necessarily imminent, but it is serious.

Mr. Rhines: I think there are a couple of things to consider. The bill allows the minister to disclose if he or she believes there may be a risk, or to assess if there is a risk. The other part of it is that disclosure can happen to any government or person responsible not only for protecting but for promoting health.

The threshold is very low with not a defined purpose of protecting health. Promoting health is very broad and there is no necessity there. There is a combination of things. To be very honest, we felt the easiest way to fix it was by correcting the threshold, because if the threshold is correct, then it saves some of the downstream concern around promoting health, around confidentiality, because nobody would argue that point. We wouldn't expect to be notified if you're out to protect an imminent risk.

If it's not imminent, then the other things seem to not make as much sense. Why wouldn't you notify before or after? Why wouldn't you seek consent? Why wouldn't you have the discussion that Senator Nancy Ruth implied before?

It's an important distinction, and it deviates from not only our own domestic legislation but from how the FDA handles confidential information, how our Australian colleagues handle it. It is very different. I'm not sure if it was intentional or an oversight in language, but that deviation is a significant and important one that should be addressed.

Mr. Stitz: I would like to refer to the word ''may'' in the context of checks and balances. ''May'' is a very broad opening without checks and balances, and in the context of the further subclauses of the CBI disclosure paragraph, it weakens that threshold, as my colleagues were saying, even more. That's where we think is the concern that the industry has.

I'm not going to appeal that. Decisions are being made on a science base because when we talk about an adverse event, we may sometimes have to err on the safety side. Still, ''may'' is too far on the weak side.

Senator Seidman: I wrote down the language you used: ''greatest of care,'' ''dialogue,'' et cetera. Do you not think that Health Canada and the minister would work with stakeholders, including industry, to develop operational protocols for these CBI provisions?

Mr. Stitz: The question is whether that bill, as we have it in front of us, provides a guarantee or carte blanche. To me, the way the rules are written right now, it does not require that. As an industry, we sometimes feel that we only get what is required. We would like to have the language to be as explicit and clear so that we know where everybody stands and what everybody can do.

Mr. Rhines: It's also important that we don't consider this about the current Minister of Health, who we have that relationship with and her organization. I think we heard earlier that this is the first major change in 50 years, so this is a bill that we have to be willing to accept for the next 50 years, and it's imperative that we get this right.

This is not about relationship. This is not about operational protocols from the current leadership. It's about getting the bill right so there is not the ability for interpretation or misinterpretations, and we think that these are a minor couple of words that really do address the issue.

Senator Seidman: Doesn't Health Canada work with stakeholders to develop operational protocols for all kinds of things in legislation? The legislation never deals with operational protocols.

Mr. Rhines: But the operational protocols and regulations can't restrict the bill. They can't narrow it; they can only expand it. If you have a bill, as currently drafted, which is very broad, with no definition of what CBI is, you can't easily narrow it with regulations or protocols, which is why we've raised the concern to you now, because this is, as we view it, the only available mechanism to address the issue.

The Chair: I want to come to this general issue. We will, as I indicated earlier, have the minister and officials, including lawyers, to ask questions on terminology. However, my review at the language suggested in the amendments suggests that ''serious'' and ''imminent'' are very serious terms, and they do impose a very significant requirement on anybody applying that language.

I think there really is an issue of substantial change in the amendments that are proposed, but we will get further clarification on that next week.

What we have to appreciate is that the minister is dealing with the health of Canadians. You have just recently indicated that a great deal, when you're looking at it from your perspective, depends on the minister of the day and the way that minister operates.

It's fair to say, from looking over the last 50 years, that the same applies to industry in reverse; therefore, if we look at the amendments in Bill C-17, what they appear to do is to give the minister a series of opportunities to take relatively quick response, where warranted, to protect the health of Canadians.

I've understood all the issues you have raised, and I appreciate it. We are dealing with human nature and human beings in a very complex situation. It's equally fair to say that there has been enormous pressure on the minister and the department to deal with perceptions in the real world, that there needs to be a very significantly enhanced response to issues that are well described over the last 10 or 15 years in terms of how products in this area have played out.

We have heard your input on this aspect of confidential business information, which, if I go back to the earlier response that Senator Seidman referred to, the idea of working with Health Canada to work things out over a period of time, the minister has a series of options to take that escalate the issue. One would assume that releasing confidential business information would occur at a point where that has become essential to resolve the issue. But I take your point; you can't be sure of that. I understand that part.

We are certainly going to pursue questions of the minister on this and try to get as much clarification as we can because there is no doubt, as you and every witness before us has indicated, upgrading Canada's legislation in this area is essential. It is long overdue.

We will attempt to reach the best conclusion we can with regard to interpreting the witness evidence in terms of protection of Canadians on the one hand, but ensuring that we don't, on the other hand, destroy the means by which they get access to further and new medicines which also would not be protecting Canadians.

These are the issues that we have to wrestle with as we look at the testimony before us. We are human beings as well. You know that we have looked at this area very thoroughly as a committee. I can assure you we will do our best in reaching a decision on all the evidence we have before us, but we appreciate that this is not a simple matter, no matter what dimension you look at.

With that, on behalf of the committee, I want to tell you how much we appreciate the degree that you have delved into responding to questions in areas for which there is not a simple answer, but there is an important issue and important answers.

On that note, I want to thank my colleagues again and declare the meeting adjourned.

(The committee adjourned.)

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