Proceedings of the Standing Senate Committee on
Social Affairs, Science and Technology
Issue 12 - Evidence - April 30, 2014
OTTAWA, Wednesday, April 30, 2014
The Standing Senate Committee on Social Affairs, Science and Technology met this day, at 4:22 p.m., to continue its study on prescription pharmaceuticals in Canada.
Senator Kelvin Kenneth Ogilvie (Chair) in the chair.
[Translation]
The Chair: Welcome to the Standing Senate Committee on Social Affairs, Science and Technology.
[English]
I'm Kelvin Ogilvie, a senator from Nova Scotia and chair of the committee. I'll invite my colleagues to introduce themselves, starting on my left.
Senator Eggleton: Art Eggleton, senator from Toronto and deputy chair of the committee.
[Translation]
Senator Chaput: Maria Chaput from the province of Manitoba.
[English]
Senator Enverga: Tobias Enverga from Ontario.
Senator Seidman: I'm Judith Seidman from Montreal, Quebec.
Senator Stewart Olsen: Carolyn Stewart Olsen, New Brunswick.
The Chair: Thank you, colleagues. I want to remind everyone for the record that this is our final meeting with regard to Phase 4 of a study on prescription pharmaceuticals, and we are dealing with the issue of unintended consequences. We have back Dr. Sharma and her colleagues from Health Canada, and the Healthy Environments and Consumer Safety Branch is also at the table. I understand there is perhaps some more advice in the room if we should need it.
Given the nature of the day, I haven't had a chance to speak with you yet, but I understand, Dr. Sharma, you're going to address us and largely cover answers to the questions that were posed at the end of the last meeting. Then we will go directly into questions. Is that satisfactory to our witnesses? Excellent.
Perhaps I'll just introduce all of you. From the Health Products and Food Branch, we have Dr. Supriya Sharma, Acting Associate Assistant Deputy Minister; and Robin Chiponski, Director General. From Healthy Environments and Consumer Safety Branch, we have Barbara Moran, Director, Prescription Drug Abuse Bureau, Controlled Substances and Tobacco Directorate; and John Worgan, Director, New Substances Assessment and Control Bureau. Welcome to the committee, Mr. Worgan.
Back again, we have from the Public Health Agency of Canada Dr. Theresa Tam, Branch Head, Health Security Infrastructure Branch.
Dr. Sharma, the floor is yours.
Dr. Supriya Sharma, Acting Associate Assistant Deputy Minister, Health Products and Food Branch, Health Canada: I need to apologize for the length of my opening remarks. There were a number of questions that we got at the last session, so we wanted to make sure those were covered off.
[Translation]
It is a pleasure to be here today and to have an opportunity to further explain Health Canada's role in regulating prescription pharmaceuticals.
[English]
As indicated during the meeting of April 10, I am currently the Acting Associate Assistant Deputy Minister and Senior Medical Adviser of the Health Products and Food Branch Inspectorate. I'm joined by my colleagues, who have been introduced already. We are accompanied by our colleagues from the Healthy Environments and Consumer Safety Branch and the Public Health Agency of Canada.
At the conclusion of the last meeting, they asked us to follow up on specific questions, so we've prepared the remarks accordingly.
On April 10, the committee raised questions on prescription drug abuse. Members were particularly interested in Health Canada's approval of generic OxyContin. I would like to begin by addressing these questions.
As I have mentioned in previous presentations, for a prescription pharmaceutical to be marketed in Canada, a manufacturer must submit scientific evidence demonstrating that the pharmaceutical meets the regulatory requirements under the Food and Drugs Act and its regulations for safety, efficacy and quality for its intended uses.
After a pharmaceutical is authorized for sale in Canada, Health Canada monitors its safety by evaluating reported adverse drug reactions, reviewing periodic safety update reports and analyzing information gathered from various sources, such as medical and scientific literature, other regulatory agencies internationally and manufacturers.
Prescription pharmaceuticals containing controlled substances, such as the opioids, receive further oversight through the Controlled Drugs and Substances Act, which balances access to controlled substances for legitimate medical, scientific or industrial purposes while minimizing the risk of diversion to illicit markets or uses.
In the case of OxyContin, the brand-name pharmaceutical had already been on the market for many years and was being used for the relief of moderate to severe pain in cases such as the treatment of cancer pain and in palliative care settings. Information on the potential for addiction and abuse was communicated to health care providers and consumers through the approval of the final product monograph for OxyContin. Physicians were advised to prescribe and handle such drugs with caution, assess patients for their clinical risks for abuse and addiction prior to prescribing the drug, and routinely monitor patients for signs of addiction and abuse.
Following the expiration of the patent for the brand name OxyContin in 2012, generic companies were able to demonstrate drug equivalency and bio-equivalency for generic versions of the pharmaceutical. These generic versions of OxyContin obtained market authorization from Health Canada after having been deemed to meet the regulatory requirements for safety, efficacy and quality for the approved indications and conditions of use as per the Food and Drugs Act and regulations, with the same information provided to health care professionals in the product monographs.
With respect to the committee's question regarding whether Health Canada would consider delisting generic OxyContin from the Non-Insured Health Benefits Program for First Nations and Inuit Health, I can confirm that long-acting oxycodone was delisted from this formulary in February 2012.
Moreover, generic long-acting oxycodone was never added to the formulary when it became available in 2012 and remains excluded from coverage under the Non-Insured Health Benefits Program.
In addition, while OxyNeo was introduced to the Canadian market in February 2012, it is also not listed on the Non-Insured Health Benefits Program Drug Benefit List. Requests for coverage are considered on a case-by-case basis, and coverage may be granted in exceptional circumstances, such as for palliative care.
As the committee is aware, with the introduction of generic oxycodone, tough new measures were introduced specifically to address concerns related to the generic versions of OxyContin. In addition to requirements to report loss and theft, companies are required to report suspicious and unusual activities to Health Canada. The department has also asked manufacturers to submit risk management plans that outline their proposed strategies to monitor, respond to, and educate health care professionals and the public on known and potential risks.
Health Canada inspectors will investigate suspicious activities, and appropriate action will be taken, up to stripping companies of their licence to distribute or sell narcotics. If an illegal activity is suspected, Health Canada inspectors also refer the case to law enforcement authorities such as the Royal Canadian Mounted Police.
Mr. Chair, we take all reports of potential diversion of controlled substances very seriously. Health Canada will continue to work with the United States on their analysis of border and other data that may indicate suspicion of illegal products entering their states.
The committee also asked to obtain more data and statistics on generic OxyContin. It is estimated that sales of generic OxyContin represent approximately 1 per cent of all opioid sales in Canada. Health Canada is closely monitoring sales and loss and theft reports for these and other opioids.
As this 1 per cent figure indicates, hospital and pharmacy purchases of generic OxyContin have remained small compared to OxyNeo and other opioids. Moreover, the reported losses and/or thefts of generic oxycodone have been small relative to the number of units purchased and are not disproportionate to those of other opioids.
Health Canada is following up on the reporting requirements that were put in place, and I can report that licensed dealers are supportive of these new requirements and compliance is nearing 100 per cent. All reports are reviewed with particular attention to regional distribution of sales, unusual volume of transactions from regulated parties and unusual volume per transaction.
In conclusion, the evidence at this moment does not demonstrate unusual patterns of diversion of generic OxyContin.
Mr. Chair, given that the prescribing of medication falls within health care professional practice, addressing gaps in health care professional education on prescribing practices is a critical step in addressing prescription drug abuse.
In response to your question regarding Health Canada's role in informing provinces and territories of serious medication issues with certain drugs and alternatives, as a regulator, the department regularly provides safety information to health care professionals, Canadians and provinces and territories. This is done through product monographs, pharmaceutical labels and risk communications such as recall notices, drug safety alerts, information updates, foreign product alerts and notices to hospitals.
In addition, Health Canada monitors the safety of marketed prescription pharmaceuticals and conducts drug safety reviews should safety concerns arise. If the safety review identifies new risks associated with the health product, Health Canada may take a number of actions, including notifying Canadians and health care professionals; requesting changes to the product labelling; requesting additional information, studies or further monitoring; and, if necessary, withdrawal from the Canadian market.
Furthermore, as part of the Regulatory Transparency and Openness Framework, announced by the Minister of Health earlier this month, Health Canada will post summaries of drug safety reviews to provide Canadians with plain- language descriptions of Health Canada's findings and decisions.
As the committee knows, in the 2013 Speech from the Throne, the government committed to expanding the scope of the National Anti-Drug Strategy to include prescription drug abuse. The Economic Action Plan 2014 built on that commitment with a $44.9 million investment in this area. Further to the question from the committee, I can confirm this is new money.
The committee asked how many Canadians are addicted to the opioids prescribed to them. The short answer is that we don't know this number.
Jurisdictions are at different stages in their ability to collect and monitor data on prescription drug use, including utilization patterns and potential harms of certain medications. This makes it difficult to provide definitive statistics of the number of Canadians suffering from addiction issues resulting from a legitimate prescription.
Expanding Canada's capacity to monitor the impacts of substances that are at high risk for abuse is a priority for all levels of governments. In September, the federal, provincial and territorial health ministers agreed to work together to strengthen and expand prescription monitoring programs by establishing a pan-Canadian prescription monitoring network. The establishment of a prescription monitoring network will facilitate the sharing of information across jurisdictions as well as help to inform development of monitoring programs in other jurisdictions that currently do not have them.
The committee also asked to obtain more information about drug take-back programs. The improper storage and disposal of prescription pharmaceuticals is certainly an area of concern for the federal government. Sadly, the home represents one of the most common sources of supply for misuse and abuse by family members and friends.
The government continues to work in partnership with the Association of Chiefs of Police and Partnership for a Drug-Free Canada to support National Prescription Drop-Off Days. These are an opportunity to remind Canadians how they can safely dispose of unused prescription pharmaceuticals to protect themselves and their loved ones from the health risks associated with misusing, inappropriately using or improperly disposing of these medications. Last year's event resulted in over two tonnes of prescription pharmaceuticals being returned safely. Another National Prescription Drop-Off Day is scheduled on May 10, 2014.
In addition, most provinces have established or are developing province-wide programs where Canadians can return unused and expired pharmaceuticals to pharmacies. These programs are generally initiated by provincial governments, the pharmaceutical industry and/or pharmaceutical associations with the objective to increase the safe disposal of pharmaceuticals and to reduce pharmaceutical waste.
On drug shortages, the committee raised a number of questions pertaining to the extent of shortages over the past year, how shortages are communicated, federal regulatory authorities and provincial drug formularies.
During my previous appearance, I spoke about the collaborative multi-stakeholder approach being spearheaded by Health Canada and Alberta Health through the Multi-Stakeholder Steering Committee on Drug Shortages. As I mentioned, Health Canada is working closely with key stakeholders from across the Canadian drug supply chain to advance concrete actions to prevent, mitigate and communicate information on drug shortages. This approach has resulted in real, concrete tools and advancements in the collaborative management of actual shortages, such as the Multi-Stakeholder Toolkit, which sets out the distinct roles and responsibilities of stakeholders; the Protocol for the Notification and Communication of Drug Shortages, which establishes clear expectations for the sharing of drug shortage information; and the industry-run website, drugshortages.ca, which provides Canadians with important information on shortages and discontinuances.
On this last point, drugshortages.ca was launched in March 2012 at the demands of the federal Minister of Health for greater industry transparency. Drug suppliers are expected to provide public notification of all potential and actual shortages on this site, which is updated regularly by drug suppliers with information about actual or potential shortages and discontinuances.
Health Canada has worked with industry associations and sent letters directly to drug suppliers making clear our expectations that all drug shortages and discontinuances be posted. The result has been steadily growing compliance on the part of industry, and since March 2012 more than 600 drug shortages and discontinuances have been posted on drugshortages.ca, with approximately 450 of these postings made over the past year.
To put these numbers into context, it is worth noting that Canadian drug suppliers are publicly posting a much greater range of shortages than seen in other jurisdictions. For instance, the United States Food and Drug Administration system limits public notification to only a small percentage of shortages, with the greatest impact on public health. In contrast, Health Canada expects that all shortages, both actual and anticipatory, are posted.
But clearly, notification alone is not enough. This is why Health Canada is taking concrete action to prevent shortages from occurring in the first place. Through the Multi-Stakeholder Steering Committee, we are working with stakeholders across the drug supply chain to address the root causes of shortages to develop better prevention and mitigation strategies, to identify contracting and procurement best practices, and ultimately to prevent and reduce the likelihood of future shortages.
Of course, no amount of federal effort alone is going to prevent all shortages, and that is why Health Canada is in regular contact with stakeholders across the Canadian drug supply chain, including health care professional associations, patient advocacy groups, industry associations, wholesalers and distributors, and provinces and territories.
This communication is essential to understand the extent and impact of shortages, and most importantly to facilitate coordinated actions that help to lessen the impact on Canadian patients and those who care for them.
But there's always more that can be done. This spring Health Canada announced the implementation of a public notification register for drug shortages. The register will publicly list on Health Canada's website all companies that have committed to advance notification of shortages, as well as publicly post letters to those manufacturers that are responsible for a shortage but fail to provide Canadians with timely, comprehensive and reliable notification.
Moving forward, Health Canada will continue to work with key stakeholders, including health care practitioners and patients, to make sure they have the information they need.
As emphasized throughout the discussion on drug shortages, and central to Health Canada's overall approach, there are a number of key players in the drug supply chain that have distinct but complementary roles in sustaining a robust drug supply chain and in addressing drug shortages.
Health Canada is responsible for regulating the safety, efficacy and quality of drugs; manufacturers are responsible for ensuring their drugs are compliant with the Food and Drugs Act and Regulations, and for supplying them; and provinces and territories for maintaining drug formularies and the delivery of health care services.
However, as the federal regulator, it is not the role of Health Canada to second-guess provincial and territorial formulary decisions, which necessarily vary from jurisdiction to jurisdiction based on many factors, including population health needs, cost-effectiveness and the input of patient groups, industry and other stakeholders.
What Health Canada can do is continue to work with key stakeholders, including provinces and territories, so that patient access to necessary drugs is taken into account and collaborative action is taken when shortages occur. On that, federal-provincial collaboration on drug shortages has been exemplary.
Finally, you have asked whether Health Canada has the legislative or regulatory authority it requires to tackle drug shortages. As the federal regulator, Health Canada already has a number of tools and strategies available to reduce the occurrence and impact of drug shortages.
In certain circumstances, Health Canada may work with international counterparts to identify additional sources of supply and to share needed safety and quality information. Health Canada can also expedite the review of drug submissions, or provide the health system with priority access to alternatives through the Special Access Programme.
These are all useful tools, but, as noted by the House of Commons Standing Committee on Health in 2012, the single most avoidable cause of drug shortages is the tendency to award single-source contracts for bulk purchases or for manufacturers to rely on single suppliers for their raw materials and active pharmaceutical ingredients. That is why Health Canada worked with the Multi-Stakeholder Steering Committee to launch a dedicated Contracting and Procurement Best Practices Working Group.
With patient safety as our number one priority, Health Canada will continue to expect even greater efforts from industry to ensure Canadians have access to a safe, sustainable supply of necessary drugs; to prevent shortages from occurring; and to provide timely public notification when they do.
Tackling not only notification but prevention, mitigation and crisis management, we have found that our multi- stakeholder approach has resulted in concrete tools and real action. Going forward, if it becomes evident that these efforts are not working, are insufficient, or that key stakeholders are not fulfilling their responsibilities, all further options, including regulatory actions, can be examined.
Moving on to a different topic, the committee raised questions on pharmaceuticals imported from other countries.
Health Canada has provided the committee with two lists in response to some of these questions, the first being a list of countries with which Canada has mutual recognition agreements; and the second being a list of Ranbaxy Canada's foreign sites.
It is important to note that for every pharmaceutical imported into Canada, there is a Canadian importer who must hold an establishment licence which lists the foreign sites from where the pharmaceutical comes. All manufacturing sites are subject to the same regulatory requirements under the Food and Drugs Act and Regulations, regardless of whether they are in Canada or abroad.
The safety and quality of imported pharmaceuticals is verified by Health Canada through detailed information on the manufacturing processes, which the department obtains from the Canadian importers and inspections.
As indicated previously, when an importer is authorized to import and sell pharmaceuticals in Canada, it must ensure their products meet the requirements of the Food and Drugs Act and Regulations, including that they must be manufactured at a facility compliant with Canadian Good Manufacturing Practices requirements.
If a problem arises with an approved pharmaceutical on the market, Health Canada works closely with the implicated areas of industry to ensure that these product-specific issues are resolved, regardless of where the pharmaceutical is manufactured. Measures such as suspension or cancellation of a market authorization or regulatory stop-sale can be taken to protect the health and safety of Canadians.
As indicated during previous presentations, 50 per cent of foreign sites from which pharmaceuticals are imported into Canada are located in countries with which we have a mutual recognition agreement. These agreements recognize the equivalency of the Good Manufacturing Practices compliance programs of these other regulators. Of the other 50 per cent, half are from the United States and the other half are from countries such as China and India.
From a trade value perspective, Canada's market for pharmaceuticals totalled $22.2 billion in 2013. Part of this market is supplied through imports of pharmaceuticals totalling $13.7 billion, or 62 per cent of Canada's market. Canada's key trading partners are the United States and major European Union countries, who deliver 85 per cent of our imported pharmaceuticals.
Even though Health Canada can access information about country of origin for every drug product on the Canadian market through the drug submissions it received over the years, in 2004, Health Canada started collecting such information when sponsors apply in a format that is more easily accessible. Companies are asked to provide the name of the countries where the final dosage form of the pharmaceutical is manufactured. It is important to note that this may not necessarily be the countries where the product is labelled and packaged or where the active pharmaceutical ingredients come from.
Currently, there are 15,868 pharmaceuticals authorized for sale in Canada. Since Health Canada introduced its new information-gathering process, we have been able to compile for the committee information on the country of manufacture for 54 per cent of those products, or 8,554. Of those, trade values set aside, 51.6 per cent are manufactured in Canada; 22 per cent in the United States; 4.6 per cent in India, followed closely by Germany, with 4.1 per cent, the United Kingdom at 3.3 per cent and France at 3.1 per cent. Between 1 and 3 per cent comes from Puerto Rico, Italy, Switzerland, Ireland and Belgium. Less than 1 per cent comes from various other countries such as Australia, Israel, Netherlands, Denmark and Spain.
With regard to the committee's statement that the European Union tests every single batch of imported medicine, it should be noted that many trusted regulators have different regulatory requirements for testing of imported prescription pharmaceuticals. Specifically, the European Union does not test each batch of imported prescription pharmaceuticals. Instead, a qualified, responsible person is designated who is part of the pharmaceutical company to certify that, one, each batch of the finished product is in compliance with Good Manufacturing Practices; two, the requirements of the marketing authorization are met; and three, the batch is suitable for release before being released for sale or supply or for export.
The committee also asked for specific data on random testing conducted for the border control of prescription pharmaceuticals.
Requirements to test finished products for identity and for meeting specifications, both imported and domestic, are established under the Food and Drug Regulations. Testing must be conducted by the importer or the Canadian pharmaceutical manufacturer prior to being made available for sale in Canada.
Health Canada, however, does conduct testing of a limited number of products to screen for undesirable contaminants or active ingredients as part of good manufacturing product inspections, in support of compliance investigations or where an imported product is suspected to contain an undisclosed regulated substance. In 2013, Health Canada conducted a total of 466 tests of samples for human pharmaceutical drugs.
As the committee noted during the previous session, recently the United States Food and Drugs Administration imposed an import ban on certain pharmaceutical products from an Apotex site in Bangalore, India. Health Canada recently issued a non-compliant rating for the same Apotex site in India, based on a review of Good Manufacturing Practices evidence.
Health Canada has chosen not to implement a full importation ban because of the medically necessary nature of the pharmaceutical products from this site. However, requirements for additional testing have been implemented. Health Canada will continue to monitor this situation, and should a risk to health be identified at any time, immediate action will be taken to protect the health and safety of Canadians, while maintaining necessary access to the pharmaceutical product.
In the case of Wockhardt Limited, Health Canada is aware of the United States Food and Drug Administration warning letter related to the Chikalthana facility. There are no importers in Canada importing from this facility, and therefore no actions were required to be taken by the department. Before a product could be imported, an importer would need to apply for an establishment licence with Health Canada and the facility would have to be approved by the department for Good Manufacturing Practices.
Lastly, on patient safety and adverse drug reactions, the committee asked Health Canada to indicate what legislative changes the department would like to see and would need in order to further protect Canadians with regard to prescription pharmaceuticals on the Canadian market.
It should be reiterated that Canada has one of the safest and most rigorous drug regulatory systems in the world. As indicated previously, for prescription pharmaceuticals to be marketed in Canada, a manufacturer must meet the requirements of the Food and Drugs Act and its regulations by submitting evidence demonstrating that a drug is safe, effective and of high quality for its intended use. The benefits of a drug must always outweigh its risks.
That being said, prescription pharmaceuticals are never completely risk-free, and some safety concerns may only emerge once a pharmaceutical is on the global market.
Health Canada mitigates these risks by understanding a number of post-market surveillance and monitoring activities that I mentioned previously, such as the collection and review of adverse drug reaction reports, the review of periodic safety updates submitted by manufacturers and analysis of information gathered from various sources such as medical and scientific literature, other regulatory agencies internationally, and manufacturers.
Nevertheless, while actions are taken on an ongoing basis to strengthen post-market safety, Health Canada still does not have all of the legislative authorities that are currently available to such international counterparts as the United States and Europe.
That is why, on December 6, 2013, the Minister of Health tabled the Protecting Canadians from Unsafe Drugs Bill, or Vanessa's Law, proposing legislative changes to better protect patient health and safety and to provide greater consumer confidence in therapeutic products on the Canadian market.
The provisions of Vanessa's Law are tailored to provide major improvements in patient safety and to help protect Canadian families from unsafe prescriptions and non-prescription pharmaceuticals and unsafe medical devices. The new authorities would help Health Canada to gather more safety information and take swift action when problems arise.
For example, if a new safety signal were detected, Health Canada would have the ability to compel the pharmaceutical company to compile information such as a new clinical study, order a label change or recall a therapeutic product. Non-compliance with these requirements could result in prosecution with higher fines and penalties that reflect the seriousness of the violations.
Furthermore, the committee asked whether and how Health Canada responds to adverse drug reaction reports submitted by health care professionals. The department does respond to these reports. Once a report is submitted, Health Canada acknowledges its receipt by sending a letter by mail or email to health care professionals and consumers who reported by fax, mail or telephone.
Online adverse drug reaction reports receive an acknowledgement following their submission. The acknowledgements provide a tracking number which may be used as a reference in case additional information on a specific adverse reaction report is necessary.
As well, depersonalized excerpts of adverse reaction reports are made available to health care professionals on a quarterly basis through the Health Canada website.
Health Canada also shares information with health care professionals from sources such as scientific literature studies conducted by manufacturers and information from other regulators through the posting of drug safety reviews and risk communications.
Moreover, as I mentioned previous previously, Health Canada is now posting summaries of post-market drug safety reviews that provide Canadians and health care professionals with plain-language descriptions of Health Canada's findings and decisions, including what was assessed, what was found and what action was taken.
These and other initiatives are part of Health Canada's ongoing regulatory modernization efforts. These efforts will increase the safety of Canadians with regard to prescription pharmaceuticals on the Canadian market. The department will monitor and evaluate the results of these initiatives once they have been implemented to ensure that they fully meet their objectives. As a result, it would be premature at this point to speculate on any further legislative or regulatory changes which could be needed.
[Translation]
Mr. Chair, this concludes my opening remarks. I appreciate the opportunity to be back before the committee. I am ready to answer any questions you may have.
[English]
The Chair: Thank you, Dr. Sharma. Before we go to questions, I will ask two or three questions for pure clarification of your document.
First, on page 30, you said in the top paragraph ``measures such as suspension or cancellation of a market authorization,'' et cetera. Do you have the authority to cancel the authorization for a prescription pharmaceutical?
Dr. Sharma: We do. There are two authorities in the current act and regulations. One is section C.01.013, followed by C.01.014. That allows the department to request information on the safety, effectiveness and efficacy of the product to determine the risk-benefit assessment. At that point in time, if that risk assessment showed that the benefits do not continue to outweigh the risks, we can issue a stop sale on that product. In effect, that is the stop sale.
There is one other provision in the act and regulations. That is in C.08.006, subsection (2), which allows us to do that even more rapidly. There is a provision there where if there is an immediate risk to health, we will suspend the notice of compliance. Then there is a process to be followed whereby a drug committee is put together with a representative identified by the department, one identified by a drug company and then a third. Then they bring together a committee to assess the safety of the product. Until that decision and that debate have taken place, we can order the temporary stop sale of the product.
The Chair: Okay. That was a critical issue as to whether you actually have the authority to issue a stop sale. Thank you. You have answered that in the affirmative.
On page 33, to clarify, in the question that the committee asked with regard to European testing, I believe the inference was of drugs directly from India and not implying that they tested every drug entering the European Union. I believe that is where the focus was with regard to the question.
I appreciate your comment that they don't require testing of every batch imported into the European Union, but the question was specifically with regard to those emanating from India. I am just clarifying that. We will be coming back to India later.
Senator Eggleton: May I ask a question?
The Chair: The issue of India will be dealt with separately. I am just dealing with clarifications now. We will come back to that. I am clarifying text at the moment, that is all.
With regard to page 37, in the case of Wockhardt Limited, the specific drug referred to was insulin that had been banned. You are saying no insulin from Wockhardt is entering Canada, is that correct?
Dr. Sharma: It was banned specifically from that Chikalthana facility. That facility does produce insulin. From that facility where the import ban was placed, we are not getting any product into Canada from that facility.
The Chair: No insulin from that facility.
Dr. Sharma: That is right.
The Chair: Thank you. I covered the ones for clarification.
Now to the serious part of the questioning from my colleagues, beginning with Senator Eggleton, to be followed by Senator Seidman and then Senator Stewart Olsen.
Senator Eggleton: I will also pick up from the document. On page 32, you say that you have been able to compile for the committee information from the country of manufacture for 54 per cent of these products. What happened to the other 46 per cent? You don't know?
Dr. Sharma: The other percentage of the products was from the time before 2004, when we were not systematically collecting it in the same way. It is there if you go back to the databases. You have to manually search through each drug submission. These were since 2005 and it was more accessible through the database. That is why we provided those numbers.
Senator Eggleton: These are numbers related to the current situation in and are 100 per cent current?
Dr. Sharma: That is right; yes.
Senator Eggleton: Above that, you said, ``Companies are asked to provide the name of countries where the final dosage form of the pharmaceutical is manufactured. It is important to know that this may not necessarily be the countries where the product is labelled and packaged or where the active pharmaceutical ingredients come from.''
That is an issue, too, because the spokesman for the parent company of Ranbaxy indicated that some of the drugs coming into Canada were part of an old drug inventory from the Toansa and Duas plants but were sent off to another facility for packaging. How do you know which one? Given that we are talking about a criminal operation here because they were convicted, how can you be satisfied that they aren't taking these drugs from the place of manufacture into another place and labelling them and you let them through because they are not from the notorious factories?
Dr. Sharma: On the establishment licence, I will defer first to Ms. Chiponski and then we can answer the rest of the question as well.
Robin Chiponski, Director General, Health Products and Food Branch Inspectorate, Health Canada: When an establishment licence application comes in, what they identify on their application is the type of manufacturing that they do in each facility. So it could be a finished dose manufacturing and they start to specify things like whether it is a sterile product versus a tablet form. They distinguish by the characteristic of the product and not necessarily by the products themselves. That type of information is identified on the establishment licence when they make their application.
However, the supply chain issue that the senator has raised isn't necessarily reflected in the establishment licence application per se, but if they are using other facilities for other parts of that manufacturing process those sites also have to be listed on the establishment licence. Good Manufacturing Practice evidence would also have to have been submitted for those associated sites.
Senator Eggleton: What if they don't? How can you trust a company that has been convicted and fined for substandard drugs?
Ms. Chiponski: The conviction that you are talking about, senator, refers to issues that were identified in 2008. So the period 2008 to 2014, that length of period, reflects the rather lengthy legal process that those findings in 2008 were identified by the U.S. FDA.
However, since then, other jurisdictions such as the U.K. and Germany have gone into those sites since 2008 and have provided us with information on their assessment of the Good Manufacturing Practices for those associated sites. Based on that evidence, Canada found those sites to be compliant, as well.
Senator Eggleton: That's kind of curious. You or someone did say something similar last time, which is in the minutes. You spoke about the Ranbaxy sites:
. . . we noted that we had [mutual recognition agreement] partners as well as the [World Health Organization] that concluded that the sites in question were in compliance.
So you went on to reiterate to this committee that Health Canada did decide that the sites were in compliance. Yet here I have a document from the World Health Organization. It's not 2008; it's January 24, 2014. It talks about suspension of a manufacturer and a suspension of these drugs from these various sites of Ranbaxy, plus a statement from the EMA, which is the European Medicines Agency. Anyway, it's the medicines authority for the European Union. It talked about the fact they've now been suspended. This is something that came out just three weeks ago; this is not 2008 stuff.
Why do you still have these Ranbaxy medications listed? You even have one of them in the list you gave today — at least one of them — that comes directly from one of the sites that is subject of the prohibition by these other entities.
What you told me last time doesn't appear to be right. Have you been misleading this committee?
Ms. Chiponski: No, senator, I haven't been misleading the committee. There are many sites that Ranbaxy has in India. The site you're speaking about — is it the Toansa site with regard to January 2014?
I have information that's been provided to me since then that concerns were identified and that we had worked with Ranbaxy Canada to place a hold on importing and distributing on those specific sites until we could review the information to determine the extent of the issues. Ranbaxy did that and complied with that request willingly.
The WHO did follow suit to our decision, and then we reviewed the inspection information and granted them a compliance rating with some terms and conditions. The Irish Medicine Board recently conducted an unannounced inspection of that same site in March 2014 and deemed the site to be compliant. That report is expected to be available to us shortly.
The site I was referring to in our previous appearance was a different site.
Senator Eggleton: I don't find that very satisfactory. I'm calling them a criminal operation, because they were convicted. Even the Indian government doesn't have much faith in Ranbaxy. The World Health Organization said that one in five drugs made in India is fake. I'm concerned about the protection of the Canadian public in this.
I think the words you come with here today in this statement are all very nice, but it's processed rhetoric. I don't know that Canadians should have any confidence in the stuff you're saying.
I want to go onto another issue, and that is the issue of counterfeit drugs. We have legislation that is against counterfeit drugs, whether sold here in Canada or sold anywhere else — by a Canadian outfit or whatever. I can read you the exact — but you probably know what it is. We had witnesses who came before us who said they could not find any evidence of a single prosecution in Canada against persons selling unapproved medicines on the Internet, the Internet being the focal point for most of this.
But what they said they found that was interesting was that the Americans are prosecuting several Canadians for this crime. In fact, one of our witnesses supplied to me — and I'll table it with the committee — some documentation pulled off the Internet with respect to such counterfeit drugs. It was very interesting, because the doctor involved pulled off something here in Canada from a company called www.northdrugstore.com and also pulled it off in another country and got a different store name in another country.
The one that was pulled off in this country indicated that some of these products, which have not been approved by Health Canada, were in fact not available in Canada. Okay, that's logical. But then the same product, a product called eriotinib — I don't know whether that's the designated number or the name of the product. They say the product can't be found in terms of Canada. Then when you go to the other country, it is available, and there's a fair bit of information about this whole operation that clearly ties it to Canada to the point where they even have the address — it's an address in Toronto — and a phone number.
If all this evidence exists about the Internet and can be found by somebody just going online both in this country and in another country, why aren't you doing more to prosecute against this illegal — and some of this stuff is really dangerous. Some of this stuff may not have any validity in terms of approved ingredients at all. In fact it may be extremely harmful to people in this country or some other country.
We have an address, and we have a phone number. Why aren't we prosecuting these people? The Americans are.
Ms. Chiponski: I can address that question.
It is a challenging area for Canadians to identify legitimate Internet sales or providers and those that are not. Those who are intentionally trying to deceive Canadians obviously take extra measures to bypass the normal procedures for maintaining legitimate supply chain and controls. So that does become more challenging.
You also add on the layer of how the Internet allows people to be able to manipulate their presence or the information that they present to the world. That problem was recognized by an American-based organization called the National Association of Boards of Pharmacy that looked at — and Canada participated in that discussion — how to evaluate the operationalizing of the ``dot-pharmacy'' Internet suffix as a measure to begin to help Canadians discern between legitimate and illegitimate providers.
There was the specific question about why we do not prosecute. Because some of these organizations are intentionally operating out of the normal supply chain, the normal measures are not necessarily effective. For that reason, the entire Canadian legislative and regulatory frameworks that touch Health Canada, the Royal Canadian Mounted Police and the Canada Border Services Agency must be considered. Some of those examples include the Criminal Code, the Patent Act, the Trade-marks Act and the Customs Act.
Health Canada's role in that process is this: When we become aware, we provide information to our partners that I mentioned in this legislative and regulatory framework; we provide testing support; and we also support the Public Prosecution Service of Canada. Health Canada contributes to that discussion in that way.
Senator Eggleton: I'm sorry; that's just not credible. You say your main concern is the safety of Canadians, and yet the evidence could be gathered easily. I can give it to you: 2 Toronto Street, suite 462. There's a phone number here and everything. If you're concerned about the safety of Canadians, why aren't you going out to get this kind of information, working with the partners in the RCMP or the Canada Border Services Agency or wherever and trying to put a stop to this? The Americans seem to be doing it.
Let me ask one more question, if I might. You've mentioned working with partners — the RCMP and the Canada Border Services Agency. My understanding is that, since 2008, the RCMP, Canada Border Services Agency and you have participated in Operation Pangea, an annual international week of action tackling the Internet sale of counterfeit drugs.
In June 2013, the RCMP, CBSA and Health Canada intercepted prohibited and counterfeit pharmaceuticals entering Canada through the mainstream, seizing in excess of 238,000 units of illicit and counterfeit medication worth in excess of $1 million.
If you can get that kind of a take in one week, why aren't you doing this every week? Why aren't you doing it throughout the year? Also, why aren't better tools provided to the enforcement agencies? For example, in some countries they have a piece of equipment called a Raman spectrometer, which apparently can be used in testing medicine through its packaging. You simply point the device at a sample and it will give you an idea of whether that medicine is authentic. The FDA is apparently using it, U.S. customs authorities are using it and several other countries, including Nigeria, are using it. Why aren't we using this? Why aren't you recommending to the enforcement agencies that we use this kind of equipment to help in the detection, and why aren't we doing it more than one week a year?
Ms. Chiponski: I'll answer the specific question about the technology and I'll let my colleague Dr. Sharma answer some of the other questions. We in fact are using that technology at the borders and we are working in conjunction with our FDA colleagues on piloting that technology and looking at it in different contexts in three different regions in Canada.
Senator Eggleton: I think we better check the minutes, because I think they said this wasn't being used. Okay. But why aren't you doing it more often then?
Ms. Chiponski: With respect to the Operation Pangea question?
Senator Eggleton: Yes.
Ms. Chiponski: My understanding is that CBSA processes — I just want to make sure — 137,000 postal products as well as 100,000 courier products per day. I think that's what they provided through previous testimony or made available to me. So they are considering quite a bit of products as those products pass through our borders in the different mail centres, and they are using a risk-based approach based on information that Health Canada has provided.
With respect to Operation Pangea, the operation of that exercise is a different intent and a different magnitude than day-to-day operations. It's a concerted blitz, which Health Canada does take on from time to time outside of Operation Pangea exercises.
Dr. Sharma: In terms of the concerns around Internet pharmacy, they're definitely shared by the department as well. One of the biggest challenges with respect to companies that purport to be in Canada, when the RCMP and other law enforcement agencies track them down, is the vast majority of them are actually not physically in Canada. The way they've rerouted their Internet sites will reflect or seem to reflect that they're actually in Canada. But what they're doing is bringing in drugs or active pharmaceutical ingredients from other countries and shipping it directly. Many of those products don't even come through Canada.
We work with the RCMP to try to track down if we do have Internet pharmacies that are operating on Canadian soil and if there are counterfeit. To be perfectly frank, if we do push to the point where we're looking at action or legal action, when you look at the fines and penalties we have at this point in time, they're laughable. That's why when we're moving forward with Bill C-17, we've gone from maximum fines of around $5,000 to fines that could go up to $5 million and up to two years in prison. Part of the reticence is that if you move forward with legal action, what are you actually gaining in terms of the ultimate outcome?
With respect to the Raman spectrometers, I can confirm we did receive them in 2013. It was part of a work-sharing initiative along with the United States Food and Drugs enforcement group, so we are deploying those and seeing how effective they are. For people who aren't familiar with them, it's a blade emitting wavelength. They use that to scan the products and we get information in real-time to decide if things should be stopped at the border for suspicion of counterfeit goods.
Senator Seidman: I want to ask, if I might, one quick question of clarification regarding your presentation to us today, Dr. Sharma. It involves drug shortages. You said, if I understood correctly, that you do not require any legislative authority to reduce the impact of drug shortages at the present time, or you implied that in what you said. I just want to clarify.
Dr. Sharma: Yes, and the issue for us in terms of drug shortages is complicated and complex. From our perspective, we have the tools, if a drug shortage arises, if there needs to be federal action either to expedite a review or to try to source another product from another jurisdiction. We have the compliance and enforcement discretion to bring it across the border. We have authorities through our Special Access Programme to bring products in on an exceptional basis. But that is at the pointy end of the stick, the time when we're in the face of a drug shortage. What we're really looking at is the more upstream work with the provinces and territories and at the root cause of shortages, along with industry, to say can we actually roll that process back and prevent them from happening, rather than having to step in at the federal level when they're already occurring to provide emergency responses in terms of providing access to patients.
Senator Seidman: Thank you. That's helpful.
Now I would like to approach antibiotic use in farm animals, if I may. I'd like to approach it in the context of a report that came out today from the WHO, which I'm sure you're aware of, that urgently requests countries to act now because of a very serious threat that antimicrobial resistance poses to public health. I know that a national action plan was produced by the Canadian Committee on Antibiotic Resistance 10 years ago, and it was never implemented.
My first question is to ask you what happened.
Dr. Sharma: I would have to go back, senator, to specifically look at that report. I'm not familiar with the content of that. But I could speak to the actions that we're currently taking on antimicrobial resistance. Specific to those, I would have to get back to you on that.
Senator Seidman: I'd like to go to specific questions about antibiotic use in farm animals, and if you could get back to us about what happened to that plan. It was produced 10 years ago and the committee was disbanded in 2009.
Dr. Sharma: Would you know if that was the Public Health Agency-led initiative?
Senator Seidman: Yes, the Canadian Committee on Antibiotic Resistance.
Dr. Sharma: I'll refer that question to my colleagues in the Public Health Agency to follow up.
Dr. Theresa Tam, Branch Head, Health Security Infrastructure Branch, Public Health Agency of Canada: The key elements of the plan, we believe, are sound, and we are implementing a number of these. In line with the WHO report that was published today, the focus was on surveillance.
So the WHO report today shone an international spotlight on antimicrobial resistance as a key issue globally and indicated, amongst other things, that surveillance on a whole number of specific pathogens, like tuberculosis, HIV, influenza, is key. Canada does have a surveillance system to monitor those, and that's indicated in the report.
The senator also asked about antimicrobial resistance in food-producing animals and in the food chain. That's also reflected in the WHO report. That calls for integrated surveillance systems. In Chapter 5, Canada is one of 11 countries — in the European area, the United States, Japan and Canada are the only countries that have an integrated surveillance system. Previous witnesses have indicated that the Canadian integrated program for antimicrobial resistance surveillance is a flagship and extremely important in enabling us to look at data on both antimicrobial use — the amount — as well as antimicrobial resistance from food-producing animals, food and humans.
I think some of the concerns were the amount of priorities we put on those flagship surveillance systems. I just want to reiterate that it is the agency's priority, as well as the ministers' and the provincial and territorial governments', that we continue to support these surveillance systems, and we actually should be building on them.
I think whilst we have the data, we do know that there are some areas of strengthening on integration with academic, private sector, and different levels of government. It's a complex issue.
Senator Seidman: I don't mean to interrupt you, Dr. Tam, but if I could ask some specific questions about this. For example, in the fall of 2013, Dr. David Butler-Jones, former Chief Public Health Officer, published a report that said that in Canada more than three quarters of the antimicrobials are used in animals.
I do recognize that Health Canada did put out a notice to stakeholders on April 10 talking about plans to remove growth-promotion hormones used in animals and tried to bring Canada in line with actions taken by the FDA. But this committee, in fact, heard about two loopholes that allow uncontrolled importation of antibiotics for use in animal feed. One was own-use provision, and the other was actual importation of active pharmaceutical ingredients.
Are you aware of the loopholes that allow for uncontrolled importation of antibiotics for use in animal feed in Canada, and is Health Canada willing to close those loopholes?
Dr. Sharma: Yes, definitely we're aware of those. Just to clarify, the importation for personal use of antibiotics are actually for the over-the-counter antibiotics only. There is no importation for personal use for animals, otherwise for the prescription pharmaceuticals, for prescription antibiotics. But even within that group, we're working with the provinces and territories to look at what's being brought across the border on the over-the-counter part, and how much, and the judicious use of the products. The same with the active pharmaceutical ingredients; we actually didn't have a regulatory framework for the active pharmaceutical ingredients up until recently, so now we're looking at tighter controls over the active pharmaceutical ingredients.
With respect to the use, though, it still comes down to the judicious and appropriate use of the antibiotics, whether they're non-prescription or prescription. That's why we're referring to the collaborative efforts through the animal associations, as well as through the provinces and territories, to make sure that people are aware of that.
On the labelling, in terms of the growth promotion claims that are currently on the products, we haven't authorized any new claims for more than a decade. Now it's the process to go back and retrospectively look at the antibiotics that are there and systematically remove those claims. We're working with the United States in step to have all of those done in the same time frame as the United States plans to have those done. That should all be completed by December 2016. They certainly have more products in the United States than we have in Canada, but we're aligning to have that done at the same time.
Senator Seidman: There was a piece in the paper this past weekend about kicking the antibiotics addiction with strict regulations: ``As Canada dawdles, Denmark shows the world how to stop mass medicating animals.''
Is Health Canada aware of the strategy being used in Denmark, which is really impressive? For example, they banned growth promoters more than a decade ago. They passed legislation that stopped veterinarians from profiting from sales of antibiotics to farmers. Farmers obtain antibiotics only through prescription at a pharmacy. They created VetStat, a national system that tracks antibiotic use down to the individual farm and herd. In 2010, they developed a yellow card system that singles out farmers using high levels of antibiotics.
As a result, they've also reduced the use of human antibiotics in farm animals, which gets back to the resistance argument. If farmers reduce the use of antibiotics that are used in humans, this certainly prevents the emergence and spread of bacteria resistant to drugs used to treat infections in people.
I'd like to hear your response to what Denmark has done to deal with this very serious issue.
Dr. Sharma: Thank you. We are aware of the Danish situation and we've worked with our international counterparts closely. Specifically, the recommendations around the WHO call for talking about increased veterinarian oversight over the use of antibiotics, prescription and otherwise. Again, that's what we're working with our counterparts on. It starts coming down to what the federal oversight portion is. From the regulatory perspective at Health Canada for the Health Products and Food Branch Inspectorate, it is that market authorization part of it that we're looking at, so focusing on the labelling, on information in terms of the cautions on it, making sure that people have enough information to use the products appropriately, and then working with the practitioners as well.
Certainly we'll take that into consideration as we move towards the plan. We're very concerned about the statistics that the WHO has come forth on. We're now talking about a pre-antibiotic era and a post-antibiotic era, where we have diseases in humans that are not sensitive to the very basic antibiotics that we've been using for a long period of time. There definitely has been an international call for everyone to look at that, and we're working together with our colleagues in agriculture, as well as especially in the United States and through the European Union, to do that.
We've also led the way in certain areas in terms of standards for some of these products. There's a group called the Veterinary International Conference on Harmonization, and Health Canada specifically, as representatives, has contributed to that process. A lot of the guidance documents focused on antimicrobial resistance and the appropriate use of the antibiotics have come also from Canadian leadership. But obviously, from the call we've seen from the WHO today and the information that we have from surveillance, we still have a long way to go.
Senator Seidman: I think probably we do. Do you have some timeline on putting what is a growing crisis in some kind of order to protect Canadians?
Dr. Sharma: In terms of the timelines on the specific products, we have a three-year transition plan that will be happening for the specific information on the products, and then it depends on working with our counterparts as to how long the rest of the process will take. A lot of those levers are actually in the provincial and territorial domain, so it will depend on the individual provincial responses to some of the calls for action.
Senator Stewart Olsen: Thank you all for coming back.
I have a couple of questions, more to clarify exactly how the department works and puts things together, that I find a bit troublesome.
I'm noting that in almost everything that's being said today, it's always ``our partners,'' ``other countries.'' When we talk about our mutual recognition agreements, it's always ``We rely on our partners.''
I would like to know what Canada is doing proactively. I'm not seeing any plan here for our own audits, field visits or oversight. I've heard a lot of sentences about our partners, our partners, our partners. I always prefer a more proactive department. I'd like to hear more about how we're handling anything in a proactive way.
Dr. Sharma: Is that with respect to the specific inspection activities?
Senator Stewart Olsen: It could be with respect to anything. I'm not convinced, just from hearing the answers to all the questions, actually, that we take any kind of a lead in moving forward ourselves. I believe Ireland did its own site visit. Surely a country the size of Canada and with our use of drugs, we should be spearheading something like that and not relying on Ireland. I know we have trusted partners, and I know that's all good, but I'm hesitant to think that we're taking a back seat and taking everyone's word for all of these happenings. We are basing a lot on what people say, or I could be mistaken; I could have misread this totally.
The Chair: We will not go through the entire pharmaceutical bailiwick. Give us an example where you believe Canada has taken a proactive position with regard to protecting people with regard to potential issues surrounding prescription pharmaceuticals, whether it is in livestock or in humans.
Dr. Sharma: Maybe I will defer to my colleague just on the inspection side. The reason we are speaking as much as we are about relying on our partners is because a lot of the questions have focused on the foreign inspection sites. Internationally we have worked with partners because for an individual site we were having multiple countries coming in —
The Chair: Please, Dr. Sharma, just an answer to the question. Give us an example of a proactive position where Canada has taken a lead with regard to the issues in question surrounding prescription pharmaceuticals.
Dr. Sharma: There is a whole host of issues.
The Chair: We only want one.
Dr. Sharma: Yes.
Ms. Chiponski: I have one. I have in front of me a list of 14 foreign site inspections that Canada led over the course of 2013-14. Our information was shared with other mutual recognition partners who relied on the conclusions that we arrived at.
Dare I raise the subject, but we have five different sites in India where Canada led the GMP inspections.
Senator Stewart Olsen: I think it is important that we hear that.
Ms. Chiponski: There were a variety of different sites that we led, including ones in India. They were led by different regions in Canada, different representatives. Sometimes we did take along partners with us from other countries but those were ones that we participated in and physically went to the sites to evaluate.
I will take an American example. We looked at two sites over the summer last year and we determined that they had compliant ratings but there were some terms and conditions that we also applied on the licences because of observations that we saw during the inspections which we thought warranted it.
Senator Stewart Olsen: Can I get a clarification on why you initiated these site visits?
Ms. Chiponski: There are two scenarios where we initiative site visits. I cannot discern, but the two I just spoke about were because we received the GMP information provided to us by other regulators and did not feel the information was sufficient for us to arrive at a firm conclusion. The sites that I am talking about contained a lot of important, medically necessary products for Canada. We thought it was necessary for us to lead teams to go down and inspect ourselves to provide us with first-hand information.
When we receive risk signals such as that, or when we don't feel the information is sufficient for us to arrive at a conclusion, we initiate a visit. We can also initiate the inspection at the request of the company.
Senator Stewart Olsen: I do understand that and I think, Dr. Sharma, that is commendable, but you will understand that I look at that with a bit of trepidation because it always seems to be initiated from some other place. We don't seem to pick it up and find it. We may well have, but I am concerned that we rely on everybody else instead of moving forward with our own information. It was good to hear that we do site inspections; I am pleased about that.
The other question I want to come back to is OxyContin.
I understand what you are saying, namely that OxyContin does what it says it is going to do. That seems to be what you are looking at. However, is there any system in place where you say is this doing more harm than good? OxyContin is a highly addictive drug. That has been proven time and time again, and it is a short addiction period. You can be addicted in a couple of days.
What I am looking for here is why do we not just go in and ban the product? I understand that it may do exactly what it says it will do but, if the harm outweighs the benefit, is it not the responsibility of Health Canada to say, ``This drug is too dangerous to be approved in Canada?''
Dr. Sharma: That is the bar that we use for this whole class of products and all the opioids because of the way that they act. For a whole series of them, they could have addiction potential. The question is, is that enough to not have people who potentially could benefit from the products have access to them? That is what we always struggle with: Can we put measures and controls in place to be able to control the use of it and to monitor it to see if there are still concerns? If there are concerns that the risks outweigh the benefits, then we can step in.
We focus on the use —
Senator Stewart Olsen: No, I understand; you have made that clear. The only thing is, with a drug like OxyContin, there are other drugs used in pain management. This one has been shown to be very dangerous, too easily available, too easy to take. I don't see that the measures we have put in place are effective. That does concern me.
This is not precedent-setting in any way to withdraw this drug. Drugs have been withdrawn before. I think fentanyl is one that is still used in anesthesia. Physicians were prescribing it as a pain killer and that practice was discontinued. I could be mistaken with that drug, but I know this has happened before.
What has changed now that, when we get all these concerns raised, we just kind of leave it out there?
Dr. Sharma: I will address the fentanyl portion and then turn it over to my colleagues on the abuse and diversion side.
Fentanyl is currently still on the market.
Senator Stewart Olsen: It is on the market for anesthesia but not generally prescribed by physicians.
Dr. Sharma: It is still and there are other formulations. Fentanyl patches are used for pain management, so it is marketed.
Senator Stewart Olsen: But not —
The Chair: Let us not go there. I will interject. There is a conference down the street today. I assume you have people at that event —
Dr. Sharma: We do.
The Chair: — dealing with international best practices on this very issue. It is a complex kind of situation.
Let us get a quick answer from Ms. Moran with regard to that, and then, senator, can I move along?
Senator Stewart Olsen: Yes. I want to understand the process. I am not really looking at individual drugs, but I want to understand the process.
Barbara Moran, Director, Prescription Drug Abuse Bureau, Controlled Substances and Tobacco Directorate, Healthy Environments and Consumer Safety Branch, Health Canada: In the case of long-acting oxycodone, which is OxyContin, that is one of the big reasons why it was scheduled as a Schedule 1 under the Controlled Drugs and Substances Act. That means we have extra procedures in place. In fact, we put in extra procedures specifically related to long-acting oxycodone to deal with issues of diversion. It helps us to have a better understanding of where that drug might be diverted to. For example, we have loss and theft data going to law enforcement more quickly on that, as well as to Health Canada. We have reports of unusual orders that may be made of long-acting oxycodone as well as the sales reports. With all of that data, we are able to put a big emphasis on the tracking of that.
In addition, in terms of OxyContin, the drug formularies themselves have made decisions that have resulted in an overall decrease in the use of long-acting Oxycodone, both OxyNEO and the generic OxyContin that is out there, including our Non-Insured Health Benefits drug formulary.
Through this restricted coverage of that drug, I think there has been an overall decrease in the prescribing of it. That also deals with some of the issues on prescribing practices, the need to share best practices on that and the need to ensure appropriate education for prescribers on their treatment of pain.
Senator Stewart Olsen: Thank you.
Senator Eaton: It is lovely to see you all again; it is always interesting.
Regarding your public notification register for drug shortages, in the same area or on the same website, do you give suggestions for alternatives if Canadians are looking at it and see a drug that they are reliant on or that doctors might be able to go to?
Dr. Sharma: We don't do that on the drug shortages website. There are different mechanisms. Sometimes the companies will go through and provide, in the case of a shortage, all of the other manufacturers of exactly the same products or other organizations.
Senator Eaton: What do you mean? Take an easy drug. If drug X is in shortage, then other companies will come and say, ``But we have the same drug''?
Dr. Sharma: Actually, the company in shortage will often, through its distributors, provide the names of all the other companies that provide the same drug in the same dose marketed in Canada.
In terms of alternatives, so if it's not exactly the same drug — for example, if it is a generic — you might have five different generic companies making exactly the same product. That is easily interchangeable. If you have therapeutic alternatives, there are a number of other organizations that provide that, because it is more on the practice side of medicine and it may involve in some situations the off-label use. For example, the Canadian Pharmacists Association has their e-therapeutics initiative, and it talks about what the treatment might be and what potential alternatives are.
Senator Eaton: Are the shortages we are experiencing now on your public notification register mostly generic drugs?
Dr. Sharma: Over the years, we have seen a shift. The assumption we had initially when we started tracking them is that we would see similar shortages in Canada as we would see in the United States. Initially, we saw a lot of non- hospital-based products in the United States. The ones we are seeing in Canada tend to be a lot of hospital-based products, so we have a lot of sterile —
Senator Eaton: Hospitals I think order mostly generic drugs, don't they? Don't they mostly use generic drugs?
Dr. Sharma: It depends. All the pharmacies will dispense based on their prescriptions, and if there is a generic available, most will preferentially go to a generic because of the price. But we are seeing different distributions. For whatever reason, we are seeing more generic intravenous products that are used in hospitals. Again, that has been a bit different in Canada than south of the border.
We see them in clusters. So we have seen a group of cardiac drugs that were in shortages. We were seeing some basic intravenous fluids that were in shortages for a period of time. And then we were seeing a number of drugs around epilepsy and treatment of epilepsy. They come and go in different waves.
Senator Eaton: Have you found replacements for those drugs?
Dr. Sharma: Some of them. It depends on what product. For any given shortage, we would go in and say, ``Okay, there's a shortage of one product, and that is a small market share; it will not necessarily result in that much impact, because other products can come in.'' The ones we're concerned about are when you have multiple shortages from manufacturers of the same product. Obviously, that is a problem.
Senator Eaton: Does that happen often?
Dr. Sharma: It has happened recently on a number of generic products, and we are looking into why that is. Then we will look at whether there are either other dosage forms that are alternatives or other manufacturers we can go to.
Having managed these, especially recently, no two shortages are exactly alike. We have seen different circumstances around market share, how the products are provided, and what alternatives are either within Canada or outside of Canada. They are all slightly different in terms of their impacts.
Senator Eaton: Whenever I go and get a prescription, they often say, ``Would you like the generic or would you like the original?'' I always go for the original, because I think of the quality. Am I wrong?
Dr. Sharma: They are actually held to the exact same quality standards.
Senator Eaton: So they are tested the same?
Dr. Sharma: They are tested the same. Their Good Manufacturing Practices have to be the same, but the evidence to bring it to market would be different. The innovator companies would have to do all the background research, and the safety and effectiveness, and then the generic companies have to come in and demonstrate that their product is equivalent to that product.
Senator Eaton: So they are equivalent.
Dr. Sharma: They are equivalent. They have what we call the identical medicinal ingredient. The active ingredient causing the effect has to be identical, so it has to be exactly the same molecule. But then there are provisions depending on the product where you can have some of the non-medicinal ingredients. You can have some variability in some of the buffers, colourings or some of the other products. That is why generics do not necessarily look alike.
Senator Eaton: So it might have different side effects than the brand?
Dr. Sharma: It should have the same, because the testing has to show that when you take it, it has the same effect on the body.
For example, if someone has a sensitivity to a specific colouring or buffer, you might see a difference between a brand name and the generic. For example, for a blood pressure medication, if you are taking the brand or generic, if you have seen one effect on the blood pressure from the brand, you should see the same with the generic.
Senator Eaton: To follow up on Senator Seidman and go to a completely different area, I want to ask about antibiotics in animals. We're doing a lot of trade deals, or are in the midst of negotiations. Are animals and antibiotics, and animals and hormones brought up? Should they be brought up? Might that be a way of lowering the general use of antibiotics that are given to animals on a frequent basis?
Dr. Sharma: Certainly in the trade discussions that have happened, especially the importation of animal-based food products, the issues around how those products are manufactured and processed come in. When we are having any discussions around antimicrobial resistance from a health perspective, we are also working with our colleagues at Agriculture and Agri-Food Canada; they have their trade liaisons with their counterparts as well.
It is part of the discussion, but in terms of specific trade discussions and antimicrobial resistance, I would have to get that information.
Senator Eaton: For instance, in the trade discussions with the EU we have just concluded, they have no restrictions on importing animals that have been fed antibiotics. Am I correct, or do you not know?
Dr. Sharma: I don't know. I would have to check. I am sorry.
The Chair: I want to interject, because I want to get a couple of things on the record. We have to finish this meeting at 6:15.
The shortage issue is not your responsibility, but I will get it on the record. If you have a quick comment on it, that is fine. My understanding is that the shortage issue is substantially an issue within the provincial jurisdictions with regard to the purchase, et cetera, of pharmaceuticals, the distribution through the pharmacist and so on.
There it is further my understanding that there used to be a practice whereby pharmaceutical companies could offer the pharmacist and the distributors a certain bonus for maintaining a 90-day supply of prescription pharmaceuticals. The provinces have decided that the bonus received for creating that inventory should go to them, not to the pharmacist. As a result, inventories have dropped to roughly two to three days; there is no advantage to a pharmacist to maintain a long supply, et cetera.
Again, we can only deal with things that are on the record, so I am putting this on the record. This is not a Health Canada issue directly. If you have a quick comment on that, fine; if not, I will move on to the next issue.
Dr. Sharma: We have heard that the procurement practices and the professional allowances may have influences on the ordering practices, how many alternatives would be available and the amount of product that would be available in each pharmacy. We have heard that.
The Chair: It clearly does affect that, because it goes all the way back. If the pharmacist has a 90-day supply, the supplier has to have a longer-term supply in order to have the distribution chain go along on. So it is something that is impacting, but I just wanted that on the record.
With regard to a question asked of you last time regarding the clinical trials website, you indicated that you had just learned of it the day before. But I understand it was back up on the 24th. That was interesting; that was coincident with another announcement, I believe.
But the question I have for you today is this: In looking at that site, it really does not provide Canadians with any real information other than that a clinical trial is occurring, the product being tested and the sponsor of the clinical trial. They don't know where it is occurring; they don't have any ability to interact and possibly have their physician be in touch with the clinical trial and perhaps try to participate in the clinical trial.
Is there a plan to enhance this website in that direction?
Dr. Sharma: Yes. The website just started compiling and posting information in April 2013, so we are looking at what information is there and what people have found useful, and there are plans to expand it. We have not decided on exactly what fields would be most useful at this point in time, but it was a start and we are looking at expanding it.
The Chair: From the point of view of its being information for Canadians, their ability to know where the trial is occurring is valuable.
I want to spend a couple of minutes on India, our favourite source of products. Senator Eggleton pursued this along the line that we require be pursued. Given your responses at the last meeting, he has asked specific questions. I am still confused by your answers.
We have very recent evidence that the WHO and Europe have not found certain suppliers in India to be in compliance, specifically Ranbaxy and its facilities, but others as well; yet at the last meeting, as Senator Eggleton indicated, you said: ``. . . we noted that we had MRA partners as well as the WHO that concluded that the sites in question were in compliance.''
We took that to mean you were saying that the sites for Ranbaxy were in compliance. In actual fact, the Ranbaxy sites were not in compliance. Indeed, the company themselves had agreed to voluntarily suspend distribution of products from their plants. Europe has not given blanket compliance to the production facilities in India.
Right at the moment, are there any production facility sites in India that Health Canada has not accepted as being in compliance?
Dr. Sharma: For Ranbaxy specifically or for all of India?
The Chair: No, I will put it broader. Are there any production facilities in India that could ship directly into Canada, either from the plant itself or via a generic producer or supplier within Canada? Are there any sites producing those materials that Health Canada does not find to be in compliance at the moment?
Dr. Sharma: Yes.
The Chair: Which ones are they?
Dr. Sharma: The one that I referred to in my opening comments was Apotex's Bangalore facility, and we have issued a non-compliant rating to that facility; that is in India.
With respect to the Ranbaxy ones, which are what our comments were on previously, products are coming into Canada from five Ranbaxy sites in India. Those five sites for products that are coming into Canada have been deemed to be compliant, and we have got the dates of our regulatory partners, or in some of these situations, in December 2013 we sent inspectors to India to inspect a Ranbaxy facility as well.
For the Ranbaxy ones that we have, those are a compliant rating at this point in time. But we do have other facilities in India for other companies that currently have a non-compliant rating.
The Chair: I want to deal with this question of MRA partners. My understanding is that our agreements with countries that are deemed to be MRA partners say that products from those countries are recognized by Canada to be in compliance because we have signed Good Manufacturing Practices with them; and the reverse is true, that products manufactured within Canada could be shipped into those MRA partner countries. It does not automatically apply to products produced outside of those countries and which they import. In other words, our agreements are only within the MRA partner group.
Dr. Sharma: That is correct.
The Chair: So the fact that they are accepting products on a given day from a particular plant in one of the non- MRA countries does not automatically mean that Canada should see its products from that country as being in compliance?
Dr. Sharma: That is correct. But we do work with them if they have gone in and done an inspection because they have the same standards within their own country that we have done through a process where we have done confidence building with them. So we have that reliance on their abilities in terms of doing the inspections.
If they have gone into a facility and done an inspection, we don't directly accept that as a rating, but we will rely on inspection results from those companies to inform the process. Then we have to make the decision on whether or not we will send inspectors to do that inspection ourselves if we need more information from the company or if we need to do anything else; it is a starting point.
The Chair: You said there are five plants which are currently not in compliance. Could you give us a couple of names?
Dr. Sharma: There was one plant that I referred to that was not in compliance, and that was the Apotex facility in Bangalore; for Ranbaxy, there were five sites in India that are in compliance.
The Chair: Could you give me the names of those five? Is Toansa one of them?
Ms. Chiponski: Toansa is a new one on my list.
The Chair: You consider it in compliance?
Ms. Chiponski: We are in the process of issuing a compliant rating, yes.
The Chair: You consider it to be in compliance. Name the other four.
Ms. Chiponski: Actually, that will be six, then, because there was an additional one.
Dr. Sharma: We have Ranbaxy laboratories in SAS Nagar and Mohali in Punjab; we have got a Ranbaxy facility in Dewas in Madhya Pradesh; we have got one in Paonta Sahib, which is in the district of Sirmaur in Ganguwala, Himachal Pradesh.
The Chair: So they will be on the record; I am not sure we have understood any of those names. I will ask you to supply them to the clerk following the meeting.
Senator Cordy: Going back to Senator Stewart Olsen's comments about OxyContin and the addictive traits that it has, before the generic version was approved by Health Canada, 12 of 13 provincial and territorial health ministers did not want it approved. All of them asked that if it was going to be approved it at least be delayed until further studies were done on it.
When we talk about risk-benefit, we know the risk is the addictive traits that it has. It is highly addictive, as Senator Stewart Olsen said. In fact, it is a form of heroin. Canadians are allowed to get it by prescription.
Yet you said that Health Canada doesn't know how many people are addicted to the opioids that are prescribed to them. You spoke earlier about how, when you are determining the safety of a drug, you look at the risk benefits. How can we determine whether or not it is safe if we don't know how many people are addicted?
I am not talking about down to the exact person, but certainly we should have a reasonable idea of how many people are becoming addicted to opioids and OxyContin in Canada. Surely this number is available somewhere.
Ms. Moran: As Dr. Sharma said in her opening remarks, unfortunately the state of surveillance data in Canada on prescription drug abuse is not great. It is one of the areas highlighted in the Budget 2014 announcement that there is a need to improve the surveillance data. Certainly we are undertaking efforts with provinces and territories as well as with a number of stakeholders to make some strides in this area.
We are taking what I call a mosaic approach to figuring out what the picture of prescription drug abuse looks like in Canada. We look at survey data. That is some of the data that you have heard where we were able to have a sense of what our youth are using in terms of psychoactive pharmaceuticals and where they are getting these pharmaceuticals from.
We also look at the drug supply surveillance data that we have. We have purchase data. We have drug seizure, loss and theft reports that we put into the picture.
Through the Canadian Institute for Health Information, we look at their emergency department monitoring data. A number of ongoing provincial studies give us some important insight into pharmaceutical abuse in Canada. We are also consulting with a number of experts, media reports, international data and so on. I know that certainly your committee has benefited from some very good witnesses in this regard. Beth Sproule, for example, is someone we work with closely in terms of improving the surveillance data in Canada.
Senator Cordy: But surely if 13 of 13 territorial and provincial health ministers wanted a delay in the approval of generic OxyContin — and you've said we don't have that information — surely you could have delayed it until you could have obtained some of that information. I don't have the numbers, but we've all heard instances of pockets within our regions where a number of young people have been addicted to OxyContin. We've certainly heard demographics of particular groups within our society, large numbers of which have been addicted to it. So I have to question why you would go ahead when you've already said earlier that you look at the benefits outweighing the risks, and yet the risk of OxyContin is the addictive trait it has. Yet, you've said the short answer is that we don't know. I find that very unusual.
Going back to Senator Eggleton's line of questioning — when you're near the bottom of the list, you're picking up on what people spoke about earlier — he spoke about online sales of pharmaceuticals and why we haven't prosecuted anyone, and yet we know these sales are taking place; you can just go on the Internet and find it.
Ms. Chiponski, perhaps I didn't hear what you said correctly. Did you say it was hard to differentiate between legal and illegal drug sales online?
Ms. Chiponski: The data available about legal versus illegal isn't robust.
Senator Cordy: What would be legal online, though? I didn't know there were any drugs that would be legal to sell online.
Ms. Chiponski: Some bricks-and-mortar-based pharmacies also have a web presence. For example, a traditional pharmacy which people are accustomed to may also make some of their products available online. That situation is much easier to determine, because you can go and visit the physical address. The practice of pharmacy has oversight as well; and then the actual practices in terms of the supply chain integrity that relate to the Food and Drugs Act and its regulations would also be subject to our compliance, enforcement and inspection programs.
However, there are some entities that, as Dr. Sharma said, purport to be Canadian and go to great lengths to actually conceal their real address. The likelihood of illegal activity being found in that type of entity is obviously much higher than the example I gave of a traditional bricks-and-mortar pharmacy also having an online presence.
Senator Cordy: But surely if we looking at a Lawtons pharmacy or a Shoppers Drug Mart pharmacy online, one wouldn't be as concerned as one would be from the pharmaceutical set that were brought forward today.
The Chair: I'm going to get you to ask your question. I have four other senators' questions, so I'll get your questions on the record and ask you to respond, and we'll come back and answer what we can seriatim as soon as all the questions are asked.
Senator Cordy: Regarding random testing, you said on page 35 that in 2013, Health Canada conducted a total of 466 tests of samples. That's fine, but I wonder if you could put the parameters around that: Out of how many drugs? What percentage were 466 tests?
The Chair: Senator Seth, I will get you to ask your questions and then I'll follow along. We'll get as many answered before 6:15 as we can, but we're not going to get too many.
Senator Seth: Thank you for your presentation. It was interesting, complicated and difficult to answer. I'll come to the point.
I want to know about the program establishing a pan-Canadian monitoring network. I'd like to know more detail about that, how it will work. I think this will be a great solution for all questions being asked.
The second question is in regard to Aboriginal communities. What are some of the changes being implemented by Health Canada to prevent and respond to potential misuses of prescription drugs in Aboriginal communities?
Senator Enverga: Gary Holub of Health Canada mentioned sufficient safety, efficacy and quality in the intended patient population before they can be granted market authorization, that is, before approving the drugs. Will Health Canada consider addiction risk or danger of abuse as a factor in sufficient safety in the intended patient population?
Would Health Canada be able to insist that an abuse-resistant property has to be included if it finds that there may be an issue of addiction risk? This is more in reference to the generic long-acting OxyContin, which is still being sold right now.
Finally, are you working with the World Health Organization with regard to antibiotic resistance?
The Chair: As I mentioned last time, the clerk will follow up with you from the transcript to make sure you get all the questions clear.
Senator Chaput: I would like to know what Health Canada's plan is. I don't want something long in the answer. You said you have issues and concerns, you work with partners, but you also said that you have a plan.
In that plan, I would like to know the following: What are the strategies that you have identified where you can make a difference and where you have the authority to make it — so you can help this committee to make recommendations — not according to working with the others, but what you can do. What's your authority? What issues have you identified, and what changes will you make to those issues? We'll see if it works out.
Senator Seidman: I would like you to respond at some point to the whole ceftiofur situation, which is injected into hatchery eggs. CIPARS had a finding regarding this which prompted Health Canada to merely issue a package warning of the dangers of extra-label use; however, there was absolutely no regulatory power behind it.
The fact is that the study in 2010 was a very effective study showing the science behind what happens when you use this kind of substance in eggs, and its direct impact on a population.
Bottom line, what stops Health Canada from acting with force on the dangerous use of antimicrobials in food- producing animals?
The Chair: We have a chance to answer a couple of quick questions, so perhaps you can answer Senator Seth's question with regard to the pan-Canadian pharmaceutical strategy.
While you're doing that, if Senator Enverga would pick out one of his questions that he thinks can be answered in two minutes.
Ms. Moran: Thank you for the question on the prescription monitoring program. Prescription monitoring programs are recognized internationally as a best practice in addressing prescription drug abuse, and that's because they can provide timely and crucial information on a patient's medical history. Back in the fall, federal, provincial and territorial health ministers directed officials to work on a prescription monitoring program network. Essentially, we have prescription monitoring programs in some provinces and territories. There's an interest in trying to get prescription monitoring programs in all provinces and territories. What the network would be about is being able to share best practices, provide a forum for sharing of information amongst all of those prescription monitoring programs, and provide a bit of a role in mentoring potentially the other jurisdictions so that they can put a prescription monitoring program in place in their jurisdictions.
The Chair: We're pleased to hear that because we recommended along those lines, I believe, in an earlier phase. That's very encouraging.
Senator Enverga, the question you wanted answered in two minutes or less.
Dr. Sharma: I'm wondering if the two-minute response would be on how we're working with the WHO. The other ones are slightly longer. I've conveniently chosen one that my colleague, Dr. Tam, will answer.
Dr. Tam: My answer is that absolutely we're working with the WHO. The agencies actually look to us as a centre of expertise. We're working with the WHO on the global surveillance aspects and looking at addressing some of the gaps, particularly in the Americas region. Part of that includes looking at standardization of the antimicrobial resistance testing in the food-borne bacteria, but we're now also starting on the human side, looking at standardization. Otherwise you cannot compare antimicrobial resistance information across jurisdictions.
The Chair: For this whole area of pharmaceuticals, we're now completing a fourth phase of our investigations into it. It's an absolutely critical area for the health of peoples around the world, but we're concerned primarily with Canadians. We've been looking at issues all the way from how drugs get approved to begin with — that is the clinical trial phase that we looked at — through various aspects to, now, the unintended consequences.
Very clearly, what we have seen — and, in fact, what your colleagues who are at the conference today will see another example of — is that one of the critical issues for citizens to be protected, for organizations like Health Canada to be able to protect Canadians, is to have highly effective electronic data on the prescription practices and distributions within the country, or, to put it in a more important context, electronic health and electronic medical records.
The evidence shows that where those occur, even in adjacent states in the United States, the ability to deal effectively with prescription pharmaceuticals — and certainly in the areas of abuse, the OxyContin areas — the effectiveness is far greater than it is if you've got, in the case in the United States, an isolated state. We have understood, across the four studies, that in actual fact the great information that is potentially available from when drugs are actually approved and get out into the population, which is the ultimate clinical trial, the actual information on the reaction of drugs within the population, and, particularly, adverse drug reactions, is very limited. Bill C-17 will presumably increase the amount of data from hospitals, but that's only a small fraction of the total human perspective, which ranges all the way from persons not taking their full prescription to ones taking their prescription along with a batch of other medications that ultimately lead to contraindicated problems.
The ultimate issue comes back to data collection. One of the major failures of our country as a whole — and I'm not ascribing this to Health Canada — is with regard to the health information network of a collection of data, the ability of people like Health Canada to analyze that data on a much larger basis. Until we get there, we're not going to make the advances that we could.
However, we have heard of many areas, over the course of these four studies, where we should be making much more rapid advances. We're pleased to see that Bill C-17 reflects some of those areas. I think that if you were to ask the committee members, we would like to see Bill C-17 to go further, but, by golly, we'll take it because the last time there was an effort to do this, it stalled on the Order Paper and didn't get anywhere. Many of your answers have predicated your ability to operate on Bill C-17 getting passed. I don't even want to think about where we'll be if it doesn't make it through prior to the election in terms of its being something to protect Canadians.
I will admit we have been confused by some of your answers. I think we have found them difficult to interpret directly in terms of the information we were looking for. I'm not ascribing any motive or blame in that regard. I'm just saying it's a complex area. We understand that. We're looking at it from the point of view of asking specific questions. The answers have not always helped us with regard to those areas, but I think we've made a lot of progress and have gotten a lot of data. We certainly appreciate your participation, wherever we have asked, with regard to appearing before us.
I want to acknowledge all of the witnesses that have appeared before us in this session because this is our last formal meeting. The committee now goes into deliberations to give advice with regard to developing its report and to move forward and ultimately develop that report. We are very likely to have a summary analysis, following the fourth report, where we may have a round-table discussion on one or more occasions, and, presumably, we will identify people within Health Canada that we may want to appear there.
I know this has been a very serious examination with Health Canada in this meeting and the previous one, and we appreciate the fact that you have been very respectful in handling all of the issues that have come forward. We now have to make our own decisions on what you've told us, and we will do that. We very much appreciate your having appeared before us. We thank you. I thank you on behalf of the committee.
I thank my committee members. Your questions are all ones that are time-consuming in terms of response. I've attempted, as best as possible, to get through every committee member, but some of the questions have led to answers that took a lot longer time than is normal in these answers. I apologize to those committee members who didn't get their questions answered in the live committee meeting, but you will get the answers. They have agreed to submit the responses, and those will be available to us as we develop our report.
On that note, I declare the meeting adjourned.
(The committee adjourned.)