International Trade Committee on April 19th, 2021

[The Chair (Hon. Judy A. Sgro (Humber River—Black Creek, Lib.)), Liberal, Judy Sgro]

I'm calling meeting number 24 to order.

Today's meeting of the House of Commons Standing Committee on International Trade is webcast and is taking place in the hybrid format, pursuant to the House order of January 25, 2021.

I welcome all my colleagues back today on a beautiful Monday morning, and the start of, hopefully, a very successful week.

Pursuant to Standing Order 108 and the motion adopted by the committee on March 12, 2021, the committee will proceed with its study of Canada's international trade and investment policy with regard to selected considerations concerning the COVID-19 vaccines.

I'd like to welcome our witnesses this morning.

We have, as an individual, Brian Daley, lawyer and partner, Norton Rose Fulbright Canada. Hopefully, he's going to get hooked up to join the committee proceedings.

We have Marc-André Gagnon, associate professor, School of Public Policy and Administration, Carleton University.

From the Canadian Chamber of Commerce, we have Mark Agnew, vice-president, policy and international, and from Providence Therapeutics, we have Brad Sorenson, chief executive officer.

Professor Gagnon, you have the floor.

[Dr. Marc-André Gagnon, Associate Professor, School of Public Policy and Administration, Carleton University, As an Individual]

Thank you, Madam Chair.

I want to thank the committee members for the opportunity to speak with them. My presentation will focus on intellectual property related to COVID-19 vaccines, along with ways to increase vaccine manufacturing in Canada and abroad.

I'm an associate professor at the Carleton University School of Public Policy and Administration. I specialize in political economy in the pharmaceutical sector, and I have over 150 publications to my name. Aside from my role as an expert witness for Justice Canada in a 2020 Superior Court of Québec trial concerning the price regulation of patented drugs, I have no conflicts of interest to disclose.

In the early days of the COVID-19 pandemic, it was impressive to see how researchers from around the world worked together based on the principles of open science. They systematically shared data to sequence the virus genome, track the development and variations of the virus, or produce protective or screening equipment.

In Canada, the federal government passed the COVID-19 Emergency Response Act, Bill C-13, back in March 2020. This made it possible to use compulsory licences for six months for any technology related to COVID-19, in order to address potential shortages. This measure wasn't renewed in September 2020. However, the federal government can renew it at any time if necessary.

In May 2020, the World Health Organization, or WHO, established the COVID-19 technology access pool, or C-TAP, based on open science principles, in order to promote the sharing of expertise and knowledge regarding technology to combat COVID-19. The Unitaid-funded medecines patent pool, or MPP, also expanded its mandate to make it possible to share patents related to COVID-19.

Initially, things were very promising. There seemed to be a shift towards a scientific endeavour based on technological collaboration and data sharing to ensure that each country could maximize its efforts to fight COVID-19. Unfortunately, the old mindset of proprietary science for patents and technological monopolies quickly came back into play. No firm has yet agreed to share its technology with C-TAP or MPP.

Instead, each firm works in silos to maximize revenues. Vaccine firms have generally been very reluctant to negotiate licensing agreements to allow for increased production. AstraZeneca has been more flexible than other firms. However, this was part of the conditions that Oxford University established for supplying the vaccine. Since the potential revenues of firms depend on their ability to maintain control over technological expertise, this isn't surprising.

Each firm is seeking to control as much of its vaccine intellectual property as possible, rather than allowing for licensing agreements and maximizing overall production.

Even though governments have invested over $14 billion in vaccine development, it's still considered normal for vaccines to remain entirely monopolized by the private sector. The development of the COVID-19 vaccines by Moderna, AstraZeneca, Johnson & Johnson and Novavax was fully funded by public investments or non-profit organizations. Yet the vaccine is still monopolized by a firm-owned patent.

The prioritization of corporate property rights over global public health needs has led to the current situation. All countries are elbowing their way to the door of these firms so that the firms will agree to sell and deliver doses as quickly as possible to them, rather than to their neighbour. Regardless of public health priorities, it's everyone for themselves. It's vaccine nationalism.

However, Canada is doing quite well in this game of vaccine nationalism. It has managed to obtain a maximum number of doses amounting to 500% of its needs. Almost a quarter of the Canadian population has already been vaccinated.

Nevertheless, this game is highly troublesome in its own right. Production delays at Pfizer, Moderna and AstraZeneca have created major tensions in international trade. Instead of working together to produce as many vaccines as possible, countries are working against each other in order to distribute vaccines globally based on corporate priorities.

As of April 19, 2021, over 800 million doses of vaccine have been administered worldwide. Of these doses, 82% have been administered in wealthy countries, while only 0.2% have been administered in low-income countries, primarily through the COVAX initiative. It's estimated that the poorest countries will need to wait until 2024 to vaccinate their populations. In addition, Pfizer has just announced that its vaccine may require boosters, a third dose, and possibly annual boosters after that. This may further extend the delays for low-income countries.

Canada has vaccine production capacity. Why isn't that capacity being used right now to combat COVID-19?

In late January, Canada announced a $126 million investment in the National Research Council to expand vaccine production capacity.

The National Research Council is located on Royalmount Avenue, across the parking lot from PnuVax. For months, PnuVax officials have been touting their Health Canada-licenced assembly line and their readiness to begin producing a vaccine. However, they're unable to enter into licensing agreements with the various firms, and Canada isn't helping them negotiate with the firms. Canada has production capacity that isn't currently being used.

Recently, Biolyse Pharma, based in St. Catharines, Ontario, asked to list COVID-19 products under schedule 1 of the Patent Act. This would make it possible for the corporation to produce and export the Johnson & Johnson vaccine under a compulsory licence, for example through Canada's access to medicines regime, or CAMR. Yet Canada refuses to amend schedule 1 to allow a Canadian company to produce vaccines for low-income countries in the event of a pandemic. This is completely unacceptable.

Currently, about 100 countries, led by countries such as India and South Africa, are asking the World Trade Organization, or WTO, to suspend intellectual property rights related to COVID-19 in order to facilitate technology sharing and to allow for increased vaccine production by the end of the pandemic.

The suspension of the Trade-Related Aspects of Intellectual Property Rights Agreement, or TRIPS agreement, would be a much better tool than the current flexible measures in the agreement. I'm talking about article 31 of the agreement, which says that every country must obtain a licence. A country that applies for a compulsory licence can get one, but it must then figure out how to implement the compulsory licence within the country. A suspension of the agreement provisions related to COVID-19 products would give individual countries the chance to actually work together to use their production capacity. South Africa and India have vaccine production capacity that isn't currently being used because of the lack of flexibility in the TRIPS agreement.

However, Canada, the United States, Europe, the United Kingdom and Switzerland are adamantly opposed to this type of suspension of the TRIPS agreement. In many ways, Canada seems to have chosen to be part of the problem rather than the solution.

In its speech to the WTO on December 10, 2020, Canada blatantly lied—and I'm not saying this lightly. I very rarely use this type of language. Canada argued that the current flexible measures in the TRIPS agreement were sufficient. Canada said that this type of waiver was unnecessary because it was making its access to medicines regime, or CAMR, available to help low-income countries get the necessary treatments when they obtain compulsory licences without having local manufacturing capacity.

CAMR is currently such an ineffective bureaucratic atrocity that a country has used it only once, in 2007. Rwanda used it to get AIDS treatments, and subsequently criticized the ineptitude of the system. The system doesn't work. Instead, the system is designed to make it harder to access drugs during health emergencies.

The House of Commons even voted to reform Canada's access to medicines regime in 2013 because it was deemed completely ineffective. However, the delays in Senate ratification were so long that the reform died on the order paper.

On December 10, Canada even dared to claim that the fact that no one was using Canada's access to medicines regime meant that there was no need for flexibility and therefore no need to suspend the TRIPS agreement. Again, this is unacceptable. I have rarely felt so embarrassed to be Canadian as when I read Canada's downright ill-intentioned statement in the face of the critical global challenge posed by COVID-19.

Canada must stop being part of the problem. First, it must list COVID-19 health products under schedule 1 of the Patent Act now. There are rumours that, as early as this week, a country will ask CAMR to produce COVID-19 vaccines. However, at this time, Canada can't do so since it hasn't listed these products under schedule 1 of the Patent Act.

Second, it's necessary to support a TRIPS waiver for all COVID-19 products now, and to encourage all initiatives that make it possible to share open science technology for all COVID-19 products through patent pools such as C-TAP and MPP. I'm counting on Canada to be on the right side of history in this pandemic.

I'm ready to answer your questions.

[The Chair, Liberal, Judy Sgro]

Thank you very much, Professor. I'm sure there will be many questions.

We will go on to Mr. Agnew, please.

[Mark Agnew, Vice-President, Policy and International, Canadian Chamber of Commerce]

Madam Chair and members of the committee, it's a pleasure to be back at the Standing Committee on International Trade.

Given the ongoing vaccination program under way in Canada and around the world, this study comes at a critical moment. At the Canadian Chamber of Commerce, I have the privilege of working with many leaders in the life sciences industry. As you can imagine, we have been working even more closely with them over the last 12 months.

Like many Canadians, I look back 13 months and consider how rapidly the industry has moved. In preparation for this appearance, I reread some of the press coverage from spring 2020, which said it would take 12 to 18 months for a vaccine to be developed. Instead, industry has developed a vaccine in far less time. That tremendous effort should not be forgotten. I raise this not as a spurious piece of hindsight perspective but instead to underscore the importance of supporting innovation in the life sciences industry.

The committee will be hearing from others who are in the industry and better placed to speak to the science, whereas I'm going to come at this more from the trade perspective.

I want to speak first to the issue of the TRIPS waiver. Intellectual property is a critical element of supporting the innovation ecosystem that creates life-saving medicines. I mentioned a moment ago the breakneck pace at which innovation has occurred for the COVID-19 vaccines. R and D work is both capital intensive and labour intensive. Without strong intellectual property protections in place, this industry-led innovation that we've seen in the last year would have been tremendously hampered and certainly would not have been able to happen as quickly, because there would not have been adequate infrastructure in place to develop the vaccines.

There has been no evidence that IP rights are actually causing issues with the vaccine rollout globally. The challenges instead are related to the scaling up of production and the very complex supply chains that go into the COVID-19 vaccine process. Pfizer alone, for example, involves 280 components, 86 suppliers and 19 countries. There are also immensely complex storage requirements, sometimes called cold chains, as you may have seen in the media. I don't want to be glib, but this is far more complex than putting a couple of ice packs in a cooler box and shipping them off with some vaccines in vials. In this sense, the IP waiver proposal is a solution in search of a problem, since it would do nothing to address the underlying supply chain issues, such as the shortages of lipid that BioNTech needed Merck to backfill last year.

It's also important to take a longer-term perspective and recognize that if implemented, a TRIPS waiver would create lasting effects for companies and the decisions they make about their future investments in R and D and manufacturing. Certainly there's also the concern of a tit-for-tat war, as countries would go down this path.

It's also worth underscoring that there is already a process, as you heard a moment ago, under article 31 in the TRIPS, for governments to invoke compulsory licensing. Given that there's already a process available, which I would add has safeguards built into it, a broad and sweeping TRIPS waiver is actually an unnecessary mechanism.

Given all of that, we hope the government will not support a TRIPS waiver proposal that's being discussed in Geneva.

I'd like to now shift to talking for a moment about the EU's measures on the export of vaccines.

The Canadian chamber has strongly opposed measures that could restrict the export of vaccines. This is not only in Canada's self-interest, given our lack of domestic biomanufacturing capacity, but also because COVID-19 is a global pandemic that requires global distributions of the vaccines.

Our primary concern with the EU's export measures are twofold.

First, the directive leaves a significant amount of discretionary power to the European Commission and member states in its application. I know first-hand that Global Affairs Canada, including Minister Ng and Ambassador Ailish Campbell, have been working very hard behind the scenes. We have seen the benefits, given that no shipments to Canada have been blocked thus far. The same cannot be said for Australia, as the members of this committee I'm sure will have seen in recent media reporting.

Second, the EU's regulations set a very unhelpful precedent for other jurisdictions and risk making this type of behaviour much more acceptable, such that other countries may be more willing to execute these types of policies. The chamber has been working closely with our business association counterparts around the world to deliver the message to EU decision-makers that we should not be pursuing this message. We hope that the EU will focus instead on automatic approvals and shift efforts toward a transparency-based mechanism.

I'd like to spend a few moments discussing, from a trade perspective, some of the measures that could be pursued to ensure the movement of vaccine supply chains.

First, building on what I said a moment ago about export restrictions, we need to have greater specificity from countries on the export restrictions and their use as a policy tool. Much has been made over the last year about the phrase that export restrictions must be “targeted, proportionate, transparent and temporary”. Canada can play a lead role in global discussions to develop something in practical terms to operationalize this. There is the upcoming G7 trade ministerial meeting as well as the G7 leaders' summit, which are potential opportunities to move the dial forward. We also have upcoming bilateral discussions with the United Kingdom.

Second, Canada should also continue to take a leadership role in the Ottawa Group trade and health initiative and the Global Alliance for Trade Facilitation. Given the complexities of vaccine supply chains, we can support the developing countries by providing them with the know-how to get products across borders and into the arms of their citizens as quickly as possible.

Third, Canada should continue to engage in ongoing efforts at the WTO that are being led by Dr. Ngozi on the so-called “third way” for voluntary knowledge sharing. This would stay in line with the spirit of TRIPS article 31(b), which requires consultations with rights holders.

The international chamber has actually been putting some thinking into this, and they're considering the idea of some sort of vaccine clearing house that could act as a forum to help take the heat out of what has been a very fraught issue and allow for evidence-based discussions on supply chains. This is something we hope the committee and Global Affairs Canada will be able to explore further.

Thank you very much for the opportunity. I look forward to your questions.

[The Chair, Liberal, Judy Sgro]

Thank you very much, Mr. Agnew.

We'll go on to Mr. Sorenson.

[Brad Sorenson, Chief Executive Officer, Providence Therapeutics]

Thank you very much for the opportunity to join you today.

Messenger RNA is the most effective vaccine technology on the planet. The European Union has indicated that it intends to move exclusively to messenger RNA vaccines beginning in 2022. The U.S.A., while not publicly making this comment, has practically chosen messenger RNA vaccines for its citizens over other options by virtue of how it is procuring and distributing vaccines. This is not to mention the FDA's cautious stance on adenovirus-based COVID vaccines.

I see from the numerous press articles that Canada is now actively competing for 2022 booster vaccines. To date, only messenger RNA vaccine producers have publicly announced that they're working on a variant version of their vaccines for 2022 booster shots. Thus, I can only conclude that Minister Anand, on behalf of Canada, is negotiating with Pfizer and Moderna to secure booster mRNA vaccines for Canadians in 2022.

Providence Therapeutics is Canada's only messenger RNA vaccine company. Despite the fact that Providence has shared early clinical data with the Government of Canada that points towards a potentially best-in-class mRNA vaccine, and despite the fact that Providence, with its partners, has provided a clear path to manufacturing tens of millions of doses, Providence has not been contacted by Canada for its 2022 vaccine needs. We would welcome that engagement. Such an engagement would be consistent with every contract Canada struck with foreign vaccine companies in the summer of 2020 and would enable manufacturing to proceed as the vaccine moves through the regulatory process with Health Canada, just as was the case with foreign vaccine companies in 2020.

If commitments are made soon, Providence Therapeutics can provide enough booster vaccines for every Canadian by the first quarter of 2022. Canada has within its grasp the opportunity to be the first country in the world to fully vaccinate its citizens with an mRNA vaccine designed to protect against variants.

From day one, Providence has been prepared to prioritize Canada's needs. However, other than the purchase commitments by the Province of Manitoba, we have received no indication that Canada is interested in securing Providence vaccines for 2022. On the other hand, Providence has received serious inquiries for 2022 vaccine supply from multiple foreign buyers.

The COVID vaccines industry is worth hundreds of billions of dollars. As a measure of scale of the industry, Canada itself paid $8 billion for COVID vaccines in 2021 alone. Some portion of that economic activity could be boosting the Canadian economy and creating an export market, instead of simply adding to Canada's import costs.

Providence Therapeutics will be a major participant in the COVID vaccines industry. Here, before the Standing Committee on International Trade, we can all appreciate that Canada can and should lead other countries in demonstrating confidence in Canadian-made vaccines and in buying them. In this context, how sad would it be for the first major commitment for a Canadian-made vaccine to come from a foreign buyer? How unthinkable would it be that Providence would be forced to export world-class vaccines out of Canada when Canadian lives and livelihoods are under threat? None of us would want that. Early action by Canada can prevent what might be an unfortunate possibility.

I would like to formally ask this committee to consider passing a resolution to seek a commitment from the Government of Canada that if Canada continues to pass on its opportunity to buy Providence vaccines, it will not interfere with the exportation of Providence vaccines produced in Canada to countries outside of Canada. Even better, please consider passing a motion that encourages the Government of Canada to support Canadian vaccine manufacturing by buying from Canadian suppliers.

That is the end of my prepared comments, but given the comments from my fellow witnesses, I would like to add that the intellectual property situation related to messenger RNA is a lot more complicated than has been presented here. While my peers would like to suggest that they're willing to share intellectual property—Moderna has said that they wouldn't enforce patents—the reality is that their vaccines have been sequenced, and those sequences have been published. They are 90% alike.

Really, the only gatekeeping intellectual property in messenger RNA is related to lipid delivery. That gatekeeping is actually held by a Canadian company called Genevant, and Genevant is being infringed upon and not protected. We, Providence, are licensed and have secured a licence from Genevant, and we're playing by the rules. We are prepared—as I mentioned, we're negotiating with multiple other countries—to tech transfer. I am not interested in selling doses; I am interested in selling capacity. That's how this pandemic gets fixed.

We are going to be reaching out and contacting the WHO and discussing ways that we can work with them. We have been contacted by a consortium out of Africa and we're looking at doing that. We have been in discussions with the Government of Mexico. We're not focused strictly on first world countries; we're focused on the worldwide problem.

We need Canada's support. We need the ministries in Canada to share information across their ministries so that they can see what's being done.

Providence has shared data that demonstrates that we are safer and have fewer adverse events than our peers. We have a cold chain at -20° for long-term storage and transport, and we already have two months of data on refrigeration storage. Our immunological responses are superior. All of that will be confirmed publicly when we release our data to the public when the report is finalized from our phase I trial, but it is currently available to the Government of Canada for their review.

I don't know what else to do. We're trying to help the Canadian government understand that we have this technology, a world-class technology, at our fingertips.

I welcome questions.

Thank you.

[The Chair, Liberal, Judy Sgro]

Thank you very much, Mr. Sorenson.

We will move on to Mr. Daley, please.

[Brian Daley, Partner, Norton Rose Fulbright Canada, As an Individual]

Thank you very much, Madam Chairperson.

I am a partner at Norton Rose Fulbright in Montreal, where I am the pharmaceutical and life sciences international business group leader.

I specialize in patent litigation for pharmaceuticals and medical devices, so I have a perspective on how IP rights holders view and enforce their rights, both in Canada and internationally.

The views I express today are my own and do not necessarily represent the views of Norton Rose Fulbright.

I'm going to talk a little bit about supply chains and domestic manufacturing and what the implications are for Canada in light of the COVID-19 pandemic. I will talk briefly about some of the controls that already exist in Canada over patents, including compulsory licensing, and then talk a little bit more about the intellectual property context internationally with respect to certain of Canada's international trade agreements. I'll speak to some of the enforcement mechanisms that are available under those agreements, and then I will deal specifically with the issue of the TRIPS waiver.

As all of us know, manufacturing of many goods has shifted over the last decades to locations that offer economies of scale, lower costs, or more favourable tax and regulatory regimes. Medical goods are no exception. For example, China and India have become major manufacturers of active pharmaceutical ingredients and finished dosage forms in the last decades.

Medical devices and personal protective equipment are often manufactured abroad. As Mr. Agnew mentioned in his presentation, and as we have seen over the last year, we've learned a lot from COVID-19. We've seen procurement delays and competition for scarce supplies. We've seen hoarding or export restrictions by some countries, and we've seen political interference in supply agreements.

That leads to the question, which I think we've begun to answer over the last 13 months, of whether Canada should increase domestic production of certain medical necessities, particularly those that are related to COVID-19. In many cases the answer is clearly “yes”. Personal protective equipment, for example, will be essential in this and future pandemics, and we should maintain adequate stocks and have domestic sources of supply.

When we talk about medicines, vaccines and medical devices, the answer is less clear. It is impractical to have a completely domestic supply chain; there are simply too many drugs, too many components, and too many devices.

As we've seen, and as Mr. Sorenson explained, some of the vaccines that are available today use cutting-edge technology that is available in very few places. Nonetheless, domestic R and D and vaccine manufacturing capacity is crucial for our country.

In a paper that I published with some colleagues late last year, and which I believe led to my being invited to speak today, we proposed a hybrid solution that would allow regional supply chains for advanced complex supplies. This would allow us to retain efficiencies of scale. It would also allow us to take advantage of trade agreements that we already have in place, such as those with the European Union and with the United States and Mexico. In those circumstances, we would be dealing with trading partners that have comparable environmental, safety and labour standards, and standards that are often enforced by these international trade agreements. We generally share values and similar political systems with these trading partners.

In concert with this regional approach, we would continue to develop a reliable domestic supply for essentials, such as personal protective equipment and vaccines. We all know about the manufacture of N95 masks in Canada by 3M, as well as the recent agreement with Sanofi for vaccine manufacturing capacity in Canada. Those are good examples of encouraging domestic supply, and the government can, and should, continue to encourage innovative Canadian companies in this area as well.

With respect to intellectual property, it's not only medicines and vaccines that can be patented. Medical devices and personal protective equipment can also be patented, and this is the complication that would make the TRIPS waiver very difficult to bring into practice even if it were a good idea, and I'll suggest later that it is not. Encouraging domestic supply requires respecting the rights of intellectual property holders, and particularly patent holders. Patents are the most relevant type of IP protection in this area.

As you probably know, there are already compulsory measures in place under the Patent Act, and it's possible for compulsory licences to be granted in cases of a national emergency. One of the problems is that it's not clear what a national emergency is.

It's also not clear under the Patent Act how patent owners would be compensated in such cases. Section 19.4 of the Patent Act was implemented last March at the beginning of the pandemic. It authorized the commissioner of patents to permit the use of patented inventions, including by private parties, to the extent necessary to respond to the public health emergency. It provided that patentees were to be paid “adequate remuneration”. This expired in September of last year, and it was never used.

That is illustrative of the fact that allowing intellectual property rights to be overridden is not a good idea, and we've seen over the past year that it is not necessary, at least in the Canadian context.

Canada is signatory to several international agreements, such as CUSMA and CETA. Both of these, and TRIPS, allow governments to permit use of patented inventions in national emergencies without the patentee's authorization. Again, there's no clear definition over what constitutes a national emergency, and one country's unilateral declaration of a national emergency could invite complaints or retaliations by other treaty members.

That brings me to the specific TRIPS waiver request. As we know, some WTO members have requested a temporary waiver of TRIPS intellectual property obligations in response to COVID-19. In my view, there are multiple problems with this request.

First of all, and as Mr. Agnew mentioned, we're unaware of any concrete examples that would justify such as waiver. The original proposal, which you can find on the WTO website, cites one example, involving the Governor of Kentucky and N95 masks, from April of last year. That's the only example I saw on the WTO website.

The request also asks for a very broad exemption to sections 1, 4, 5 and 7 of TRIPS Part II. Again, there is no evidence that IP rights have impeded the international response to COVID-19.

One other point, one that has not been touched on, is that even if one were to try to implement this type of waiver, there is no practical way to identify individual patents that relate to fighting COVID-19. Many people have focused on vaccines, for example, but let's look at another important tool in fighting COVID-19, a medical device such as a ventilator. Ventilators per se are not patented. What is patented are certain functions that those devices perform, or components that are incorporated within them. These patents could be owned by the manufacturer of the ventilator, by related companies or even by independent suppliers. The ventilator manufacturer may purchase patented components from third parties or manufacture them under licence. There's no easy way to determine what patents are relevant, and, as I said, this is a wholesale renunciation or waiver of patent rights for an indeterminate period. There's no guarantee that this measure would increase manufacturing capacity, strengthen supply chains or improve distribution to less wealthy countries.

There is also the risk that widespread disregard of IP rights could lead to inferior quality products entering the market and even facilitate counterfeit products entering the international supply chain. Rights holders can and often do license their technology to trusted companies, and they're able to enforce strict quality control. In my view, that's a better solution than a wholesale waiver of intellectual property rights.

Those are my remarks, and I look forward to any questions you may have.

Thank you very much.

[The Chair, Liberal, Judy Sgro]

Thank you very much to all of the witnesses.

We'll begin questioning by committee members.

Mr. Aboultaif, go ahead. You have six minutes.

[Ziad Aboultaif, Conservative, Edmonton Manning, AB]

Thank you, Chair, and thanks to all the witnesses for their great testimony this morning.

We know that the Europeans did a temporary export transparency and authorization mechanism. It's a protectionist mechanism—we know that—even if it's temporary. I believe the pandemic is also temporary. On the other side, we see India and South Africa asking for a waiver, with push-back from the industries for sure, and also some intellectuals' opinions and some business opinions on the waiver and protectionism.

In Canada we have a history of not being able to protect intellectual property, and we have been losing big deals on businesses, on opportunities. We must remind ourselves that we are leaders on many fronts, whether on a pharmaceutical front or technological fronts or others, but we seem to be failing. We do have a shortage of supply in Canada now. There are delays on the purchase orders we have in place. It could be related to shortages in manufacturing or struggles on the manufacturing side, but at the end of the day, it's affecting us. It's standing in the way of opening our economy as early as other countries, such as the United States, Israel and others.

Mr. Sorenson, you have the technology. You have the capacity. You've been talking to the government. I was a businessman before I entered political life. How can the government work better with you? This is very critical. Having security over our supplies at all levels is very important, and especially now with the pandemic. How do you see that the government has been working with you? What would you like to see changed in order to be able to have the capacity we need?

[Brad Sorenson]

Thank you, Ziad.

So far the government has worked rather effectively when it comes to clinical trials. We've received support from the NRC. We're in phase II with the NRC. We've submitted our application to the strategic innovation fund for phase III.

I do have confidence that as our program progresses through the clinic, we will get appropriate support from the Government of Canada as it relates to the clinical trials.

[Ziad Aboultaif, Conservative, Edmonton Manning, AB]

When did you start talking to the government, if you don't mind?

[Brad Sorenson]

Well, phase I was announced last year. We were approached by the NRC for our phase II trial. We've had really good dialogue ever since phase I started. That process has gone on. That started probably about two months ago, as we geared up to conclude our phase I trial and release data. Although the NRC is capped at $10 million, which is certainly not sufficient to carry out phase II and phase III trials, the NRC has, through the bureaucracy, elevated us back up to the strategic innovation fund. That occurred about three weeks ago. We're now working with the strategic innovation fund.

Would I like it to go faster? Yes, but it's still progressing, and I believe that it will continue to progress and that we'll get the support we need for our clinical trials.

Part of the challenge we have, to communicate specific challenges, is the need of comparator vaccines. That was communicated last week to the finance committee. I've communicated it to multiple departments within Canada. I'm still awaiting a response—

[Ziad Aboultaif, Conservative, Edmonton Manning, AB]

Thank you—

[Brad Sorenson]

—so there are certain things there. What we're missing, really, is the manufacturing support. It seems as though all of the manufacturing support is targeted at a facility. They want to go and do a ribbon-cutting. What we need is the backing to go out and buy the raw supplies so that we can start making these important vaccines.

I personally—personally—guaranteed this week $5.5 million on a purchase contract for lipids so that we can keep our timelines. I don't know what else to do. We need the government to engage, and the government to engage quickly, if we want to have timelines that are relevant for the needs of Canadians and really for what's happening. The worldwide pandemic is still going on. It's still critical.

That's really what's lacking. That's what I need. I need that engagement on the raw materials supply front so that we can purchase those raw materials.

[Ziad Aboultaif, Conservative, Edmonton Manning, AB]

Thank you.

I heard yesterday—

[The Chair, Liberal, Judy Sgro]

Mr. Aboultaif, be very brief, please.

[Ziad Aboultaif, Conservative, Edmonton Manning, AB]

Thank you. I think I have 30 seconds.

[The Chair, Liberal, Judy Sgro]

It's 40 seconds.

[Ziad Aboultaif, Conservative, Edmonton Manning, AB]

I will sneak in a quick question here.

Some provinces are thinking of starting to make some purchasing agreements to buy vaccine. Have you heard of that? What do you think of that?

[Brad Sorenson]

My understanding is that they really can't do anything internationally. That's why Manitoba approached us, and we'll be signing a definitive agreement with them this week. We've also had some discussion with Ontario. That discussion is sort of on pause right now. They have their hands full.

As far as I can tell, Alberta has taken a different route. They've asked for proposals because they're looking to build industry. The proposal we have for them is currently being evaluated by PricewaterhouseCoopers.

[The Chair, Liberal, Judy Sgro]

Thank you, Mr. Sorenson.

We'll go on to Mr. Sarai for six minutes, please.

[Randeep Sarai, Liberal, Surrey Centre, BC]

Thank you, Madam Chair, and thank you to all our witnesses. You guys are very insightful in your respective fields.

Mr. Sorenson, you've completed phase I and are still doing phase II in trials. Am I correct?

[Brad Sorenson]

Our phase I trial is complete. The last follow-up visit for our subject is tomorrow. We will then lock all the data. Our CRO that's supporting us will complete the report. That report should be available within four or five weeks.

[Randeep Sarai, Liberal, Surrey Centre, BC]

I believe you've received funding from the federal government in the amount of $5 million. Is that correct?