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Covid Vaccines for Canada- A Sad Story.

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IntroductionCovid Vaccines for Canada- A Sad Story.

I have been closely following the Covid vaccine issue in Canada and felt compelled to write about it. As President and CEO of GlaxoSmithKline Canada for 16 years, I was intimately involved in the production and distribution of the Canadian vaccine for the H1N1 pandemic in 2009. All of the vaccine for that pandemic was produced in the GSK vaccine factory in Quebec City. The campaign, although there were a few glitches, was a tremendous success. The vaccine was developed, rolled out and injected into millions of Canadians in just several months. I give great credit to the Chief Public Health Officer at that time, David Butler-Jones and the Deputy Minister of Health, Morris Rosenberg, for their leadership and collaboration during that pandemic.

Millions of doses of Canada’s annual flu vaccine are also produced in the GSK facility in Quebec City. This despite comments by Mr. Trudeau and some of his Ministers that this facility was closed down during the Harper years.

So why is Canada lagging the rest of the world in developing and rolling out a Covid vaccine? Why is Canada down the priority list of countries to receive supplies of vaccine? Why does Canada not have the capability to produce vaccine for Covid? The story is a long one. Many mistakes have been made and there has been a real lack of vision particularly by successive Liberal governments, including the current one. The mistakes of the past are now catching up with us. “The chickens have come home to roost.” Let me explain.

Recognition of the Innovative Pharmaceutical Industry

First I want to say how proud all of us who have worked in the Global Pharmaceutical industry should be. From the outset of this pandemic I believed that it would be our industry that would solve the Covid challenge. It looks like that is coming true with a number of innovative vaccines being developed, tested and approved in less than one year. It is truly a modern miracle of science and a real tribute to the innovative pharmaceutical industry and its people. We are changing the course of history, solving the pandemic and saving million of lives around the world. In many countries we have done that in collaboration and partnership with federal governments.

The Canadian Pharmaceutical Industry

The issues we are facing today in Canada with respect to having early access to a Covid vaccine have their roots in history which go back 50 years.

In 1968 Pierre Trudeau and his government effectively eliminated pharmaceutical patents by implementing a regime of compulsory licensing. The objective was to lower pharmaceutical prices and encourage the establishment of a Canadian domestic industry. It was a massive failure. What it did do was lead to a number of multinational innovative companies immediately closing down their research centres in Canada. It also lead to the creation of a very powerful generic industry that does no innovative research and has now evolved into a commodity business competing globally on price.

The generic industry oligopoly emerged with Apotex and Novopharm dominating the landscape. For over 3 decades, under very favourable market conditions for those companies, Canadians ended up paying the highest prices in the world for generic drugs. The owners, Barry Sherman and Leslie Dan went on to become two of the 10 richest individuals in the country.

They also became two of the most powerful people in the country by hitching their wagons to the Liberal party of Canada. They were some of the biggest funders of Liberal candidates, MP’S and cabinet Ministers, particularly those in the Toronto area. That allowed them to dramatically influence pharmaceutical policy in Canada in their favour, particularly with respect to patent policy. Where is the domestic generic industry now when we desperately need innovative new medicines and vaccines to deal with Covid?

Although the Mulroney and Harper Conservative governments supported the innovative industry by improving the patent (and data protection)

landscape, Canada only partially recovered, and to this day does not have globally competitive patent protection for innovative medicines. This regime has led to many brand name pharmaceutical products losing their patent cover and market position early. So why would a company be motivated to invest in a country that does not adequately protect its innovation? Well they aren’t.

The pharmaceutical policy environment in Canada for the innovative industry has been quite unfriendly on other fronts as well. Successive Liberal governments of Pierre Trudeau, Jean Chretien and Justin Trudeau have created an environment which has discouraged innovative pharmaceutical investment in research, development and manufacturing in Canada. They have consistently put the Canadian CEO’s of global companies in a weak position to attract investment to Canada from their global corporations.

In addition to weaker patent protection compared with other Western countries, Health Canada continues to be one of the slowest regulatory agencies in approving new medications and vaccines. The pricing regime has deteriorated over the years with successive Liberal governments focused on ratcheting down the prices of innovative medicines. In fact, on January 1, 2021 the Trudeau government will enact new PMPRB

( Patented Medicines Pricing Review Board) regulations to drive prices down further. Not a good move during a pandemic when it is that industry that is ultimately going to save your bacon.

It is already apparent that these pricing regulation changes will impact when and if new innovative treatments for cancer and other critical diseases will come to Canada. How many more lives will be lost due to a lack of early access to new medicines because Canada is only looking for the best price and doesn’t want to pay for new innovations. Are we going to continue to make the mistakes of the past?

Unfortunately Health Ministers, Health bureaucrats and left leaning politicians only see medicines and vaccines as a cost to the health care system. They do not recognize the value those medicines bring to the system in reducing costs in other healthcare silos. Governments have also never recognized the value the industry brings to the innovative economy, despite the fact that Canada continues to lag the world in innovation, and is in real need of upping its game. The last global survey saw Canada slip

down the innovation list even further. Pharmaceutical jobs are some of the most high value jobs in the economy. The few politicians who do recognize that value are always shouted down by the Health Ministry and those who just want a lower price.

The bottom line is that despite numerous outreach efforts by the industry over the years, successive Liberal governments, including this one, have done little to nothing to create a favourable pharmaceutical policy environment. They have made no effort to work with the innovative industry to encourage a partnership which would deliver tremendous value to the healthcare system and the economy and give Canadians early access to new medicines and vaccines.

So, not surprisingly, the industry has gone elsewhere to invest where that positive environment exists. Good examples are the U.S., the U.K. and Europe. It should also come as no surprise that the U.S., with its Operation Warp Speed, lead by the former head of Vaccines for GSK, and its contribution of billions of dollars, is at the head of the line for a Covid vaccine and will begin to vaccinate its population by December.

The Pandemic Management Failures of the Trudeau Government.

Many want to praise the federal government for all the money they have shovelled out to Canadians during the pandemic. Many of the programs have been very beneficial and truly needed. It’s hard not to be a bit cynical though. It is well known that Liberal governments love to spend money and they love to say “their government” is making all this money available to Canadians. What they fail to say is that it is Canadian taxpayers, our children and grandchildren who are and will be paying for all this spending. And clearly they know that doing so will buy many votes for a long time. For example, why give money to well off seniors? Is it because they care or because it buys seniors’ votes? Governments of all stripes would have and could have done the same in terms of spending billions of dollars rolling out these programs under these circumstances. That is the easy part. That spending should not blind Canadians though to the fact that almost everything else regarding the pandemic has been poorly handled by our federal government.

They defunded our pandemic early warning system (GPHIN) which was state of the art globally. It would have warned us early on about Covid. By killing it they were flying blind and couldn’t react soon enough to stop the arrival of the virus. We could have and should have closed the border sooner.

Despite all the talk about documenting learnings from the SARS epidemic and the H1N1 pandemic, virtually none of the key learnings seem to have been documented and we have had to re-invent the wheel to a great degree.

One of the learnings was to have a stockpile of PPEs and antivirals. I don’t know about antivirals but the current government threw the outdated stockpile of PPE’S in the dumpster in 2019 and did not restock. We then had to scramble to find sufficient new sources and quantities but quickly recognized we had outsourced most of that production to other countries, particularly China.

Unfortunately Canada is also experiencing a record number of drug shortages, especially during Covid. Most of our medicines now come from other countries, such as China and India. Will we eventually have to wait in line for many of them as well as we have very little domestic manufacturing left? Do we have any secure sources of supply?

During the H1N1 pandemic it was agreed by everyone that Canada should never have just one local supplier of pandemic vaccine. Great idea, but there was no follow up planning to ensure we had vaccine manufacturing capability or secure sources of supply for the next pandemic. And here we are, scrambling for early access to vaccine.

Why is it that we can’t have more rapid tests available? The PCR testing is effective and accurate but it is slow and resource intensive. We just don’t have the capacity to do widespread PCR testing. So rapid tests would be very useful in some instances. They are not as accurate but if they were good enough for the NBA and NHL in allowing them to successfully run their seasons, they should be good enough for us.

The federal government, in its desire to show Canadians they were doing something about vaccines threw millions of dollars at 3 or 4 Canadian organizations which had never produced a vaccine and had little hope of

producing one in time for Covid. None of these will pay off in the near term, if at all. Medicago might be the best hope.

One of the first vaccines that the government bet on was the CanSino Chinese vaccine in partnership with the National Research Council, who were supposed to manufacture it. With all of our issues with China why would anyone bet on a partnership for a life saving vaccine with them? It was a dramatic failure as China never delivered the materials for the clinical trial. It went nowhere.

It would have been nice to have at least a couple of the new vaccines tested in Canadian clinical trials. Not one of them has been used in a major Canadian clinical trial. We need to ask ourselves why? Is it because of the poor relationship our government has with the key pharmaceutical companies?

We now know that Canada should receive about 6 million doses of the Pfizer and Moderna vaccines by the end of March. That means we can begin to vaccinate 3 million people. By that time the U.S. will have vaccinated 110 million people. The Canadian public should, and probably will be, outraged.

It appears that many countries are well ahead of us with respect to vaccine access. Countries such as Spain, Mexico, Indonesia, India, Germany, the U.K., etc. As Terrence Corcoran suggests in his opinion piece on Saturday November 28 this is due to Canada’s slow-off-the-mark contact and negotiation with Global Pharmaceutical companies. Government dithered and naively tried to find a way to develop a vaccine in Canada.

As a result of our poor positioning on the priority list, the government knows it has a real political problem which could lead to them losing the next election. So the political rhetoric is spinning out of control and Trudeau and his cabinet are out spinning and bending the truth. They are in panic mode and are blaming other countries, pharmaceutical companies, and the Conservatives for our poor position.

Dominic Leblanc stated on Power Play on CTV this week that GSK had closed its manufacturing for vaccines during the Harper years which is blatantly false. They have also stated numerous times that Canada has no

vaccine manufacturing capability because it left over the last few decades. That is also false. GSK and Sanofi manufacture multiple vaccines in Canadian plants. The NRC also has the ability to manufacture vaccines.

Trudeau is now telling Canadians that the hope is that the majority of us should be be vaccinated by the end of September. A few minutes later the deputy public health officer stated that it will probably be the end of 2021 but that “September and the end of the year are in the same ballpark.” And what does “the majority” mean? 50 percent?

We are fortunate that the National Vaccine Task Force, made up of prominent experienced research and industry experts made the recommendation to secure contracts with 7 different global pharmaceutical companies. This is one of the few bright spots of the pandemic planning.

Why is it that most other Western countries have a detailed plan that they have communicated publicly describing how many doses they expect, how they will distribute them, and who will get them? Meanwhile, we have none of that? In fact, they just appointed someone to plan the rollout. The lack of transparency of the Liberal government is shocking. We clearly do not have a plan yet and we are supposed to obtain approval of the Pfizer vaccine by December.

All this to say that much of the pandemic effort at the federal level, except spending money, deserves a failing grade.

So one has to ask the question, “How many more people will die in this pandemic who shouldn’t have if the federal government had done a better job over the last year? How much better off would Canada now be if in 1968 the Pierre Trudeau government had had a vision to develop and nurture the innovative pharmaceutical and vaccine industry?” Every month we don’t have a vaccine more people will get sick and more will die. At the current rate that means approximately 2500-3000 deaths every month. Months matter. Days matter. Unfortunately ‘The chickens have come home to roost” and Canadians will pay the price.

We reap what we sow.

Recommendations for the federal government

1. Develop and communicate the Covid vaccine plan specifics to the provinces and the public as soon as possible. Be honest and factual.

2. Build a secure domestic source of supply and appropriate stockpiles

   for vaccines, pharmaceuticals and PPEs so we will be ready for other

   emergencies.

3. Delay or cancel the implementation of the new PMPRB pricing

   regulations as a signal to industry that things have changed.

4. Establish a constructive working relationship with the innovative

   pharmaceutical industry. Build a policy platform that will make Canada globally competitive to attract innovation and investment. The Mulroney government took an initial step by improving patent protection and in return Canada saw a dramatic increase in investments from the industry.

Paul Lucas
(retired) President and CEO GlaxoSmithKline

November 2020