Bill C-398 - The Debates

Diogenes's picture

Bill C-398, a sham piece of legislation that will change Canada's Patent Act, has now had two hours of debate in the House of Commons. It now proceeds to a vote scheduled for Wednesday, November 28th. 

If this law passes, cheap copycat drugs (for humanitarian purposes) made by Canadian manufacturers can be sold to ANY developing country that might need it instead of the developing countries that take the time to apply for this exemption.

The current regulations, known the Canadian Access To Medicines Regime (CAMR) have worked before in an open tender supply of an AIDS retroviral drug to Rwanda in 2007-08. Since then Rwanda has continued this program with great success under a similar arrangement with drugs supplied by manufacturers in India.

Apotex, the supplier in the Rwanda shipments, complained bitterly of the government red tape involved, though there is no evidence of undue or unreasonable delay on the part of the government in processing their application.

Bill C-398 not needed.

What appears to be a grassroots campaign is actually a carefully scripted industry driven lobby effort to distort international law to favor Canada's Big Pharma players - the leading members of the CGPA.

The biggest myth here is that Bill C-398 is free humanitarian aid -- that a small change to Canadian intellectual property law will somehow save hundreds of thousands of lives in Africa and around the world.

If this all seems to be good to be true it's because it is. Why Canada would be alone in the world in using this approach to humanitarian aid?

The actual text of the bill is confusing. It repeals this and adds that. There is no side by side comparison of the old and the new.

So we have to rely on what our politicians say in the debate and how they vote.

Below are excerpts from these debates that I thought best demonstrated the forces at work here. Twelve MP's  participated in the two hours of debate. As you can imagine, coming from a group whose job requires that they say something important, most of what was said in debate has been ignored.

On the left is the Left - NDP and Liberal MP's who will be voting YEA in the Nov. 28th vote. On the right is the Right - Conservative MP's who intend to oppose Bill C-398.

The emphasis is mine. The bolding on the left side is intended to sometimes set off either bullshit or irony alarms, sometimes to just to highlight the simple truth.

This excerpts below are undeniable cherry picking, but links are provided for the reader so they can see exactly what cherries were picked.  Just click on the MP pictures and decide for yourself.

It's quite remarkable to see the left pimping for Canada's Big Pharma and Canada's 0.01%.

I'm no fan of Harper's Government™, but I'm siding with the Conservatives critics on this one. May the NAY's take the day.

Excerpts from Oct 16 C-398 debate

Hélène Laverdière - NDP

Mr. Speaker, it is a somewhat emotional moment for me to see debate begin this evening on Bill C-398, the purpose of which is to reform Canada’s access to medicines regime. Essentially, this bill could save hundreds of thousands of lives.


The essential point is that reforming Canada’s access to medicines regime is a win-win situation. The pharmaceutical companies win, of course. They gain access to new markets—markets, it is important to note, that are of little or negligible importance to the biggest pharmaceutical companies.


Canadian taxpayers also win. They win, first, because the bill will not cost them a single penny.


As has been said, it is very simple: the generic drug companies will allow medicines to be supplied that will be cheaper, much cheaper, because the competition the generic companies engage in, in the markets, is the biggest factor in reducing the cost of medicines; in fact, this factor can reduce costs by up to 95%.


I cannot underscore enough the importance and quality of Canada's pharmaceutical industry and its capacity to positively contribute to resolving a global problem. Of course there are other suppliers of generic products in other countries, but I have tremendous faith in the capacity of Canada's industry and the quality of its products. We must not forget the importance of competition for reducing prices either.

Ted Hsu

The core of Bill C-398 is to provide the so-called one licence solution, which would remove the need for each individual country to make a request for a compulsory licence to produce generic drugs that are needed for serious health problems in these countries. It would remove the need for individual countries to apply and, instead, a Canadian generic pharmaceutical manufacturer would apply for the licence for all countries.

In fact, the advantage of importing drugs from Canada is that products are manufactured with higher standards and with better quality control.

Paul Dewar - NDP (on a visit to the Congo)

I was then taken to a warehouse, which Canada in the past had been helping out, where medicines were stored. That warehouse was half empty. This was the place where the medicines were stored for the people who had been tested and identified as having the HIV virus, in some cases full blown AIDS and other diseases were reliant upon. I was stunned.

Was that glass half empty or half full, Paul?

When I go back to Congo with any member of Parliament and we go to that warehouse after people have been tested, we will not see an empty warehouse. We will see it full. We will see people being taken care of. When we are asked, we can say that we stood up, we were there for people and we made a difference.

Chris Warkentin - CPC

There are clear reasons to believe that the proposed amendments would be inconsistent with Canada's trade obligations and harm our relationship of trust with our international trading and research partners.

These rules require that countries have to notify the World Trade Organization of their intention to use the system. Bill C-398 would remove this requirement and, along with other proposed changes, would alter the intended purpose of the regime. It would also remove the mandatory safety reviews by Health Canada that are currently required.

Bev Shipley - CPC

Of all the countries that have put in place an access to medicines regime, Canada is the only country to successfully use its regime to export drugs to a developing country. It took the government just two weeks to grant Apotex Inc., a Canadian generic pharmaceutical company, a license to export an HIV-AIDS drug to Rwanda. Canada's access to medicines regime, with the appropriate safeguards in place, ensured that high quality Canadian generic drugs reached those who needed them most. Rwanda now has one of the highest rates of antiretroviral coverage at almost 90% and HIV prevalence is now below 3% of the general population of Rwanda.


In fact, Bill C-398 would remove essential safeguards. The bill would allow a generic manufacturer to export an unlimited amount of its drug. It would remove mandatory safety reviews by Health Canada, and it would reduce the transparency of the system. Bill C-398 would risk exported drugs being diverted back to richer, developed country markets.

Excerpts from November 21 C-398 debate

Hélène Laverdière - NDP

Mr. Speaker, tonight we will have the second hour of debate on Bill C-398 before it is referred to a committee.

This bill would help save lives by fighting such illnesses as HIV-AIDS, tuberculosis and malaria in developing countries. It is actively supported by tens of thousands of Canadians.

However, there is misinformation about this bill circulating on the other side of the House.

Bill C-398 would not weaken existing safeguards ensuring medicines are not diverted. The bill would not remove measures to ensure the quality of medicines sent abroad. The bill would not violate Canada's obligation under the WTO.

This bill would save lives. It should not be voted upon on the basis of hearsay and misinformation.

Frank Valeroti - Lib

Throughout the entire life of the current legislation only one country benefited, Rwanda, leaving the manufacturing company, Apotex, so frustrated that it stated it would not use CAMR again until it was reformed.


Bill C-398 includes the amendment pertaining to the definition of pharmaceutical products, including wording specific to the World Trade Organization General Council's decision of August 2003, reflecting international agreement on eligible drugs. Importantly, it also includes a one licence solution, enabling generic manufacturers to simultaneously sell multiple times to any country listed in schedule 2, cutting down on repetitious and burdensome red tape.

I would like to briefly address four myths about the bill.

Jasbir Sandhu -  NDP

The bill proposes a reasonable, one licence solution that would allow generic manufacturers to supply approved medication to any eligible country on the WTO list of countries that are in need of affordable medicines.

This need is dire. CAMR is broken and it is failing to meet its goal. In five years, CAMR has been used only once to supply a single order of three in one AIDS medicines to Rwanda, but this one instance required years of effort and was so complicated that CAMR has not been used since then.


The bill would not cost any money to taxpayers either, not a penny. We can provide access to affordable, quality medicines to enable people in African countries and other developing nations to survive and thrive, without costing Canadian taxpayers a cent. Also, the market for medicines in poorer countries represents a very tiny portion of global sales for brand name pharmaceuticals.

Hélène Laverdière - NDP

In the last week, alone, I have received over 2,800 emails of support in my office. The grandmothers have collected over 23,000 signatures in support of this bill through their cross-Canada petitions.


We know that generic manufacturers support this bill, and they are ready to provide a one-dose AIDS medication for children should this bill become law.

Mike Lake - CPC

The case for Bill C-398 rests on a few basic myths.

The first myth is that the Canadian access to medicines regime does not work. In fact, Canada is the only country in the world to have used this kind of regime to export medicines. In 2007, it took the Canadian government only 15 days to issue a licence, resulting in the shipment of nearly 16 million tablets to Rwanda for the treatment of HIV-AIDS.

A second myth is that Bill C-398 will save lives. This bill would in fact do nothing to save lives or deliver a larger quantity of essential medicines to developing countries in need. Rather, Canada's approach in funding medicines for those who need them most is saving lives and will continue to do so.

These amendments will not change the economics of drug supply. Less costly alternatives will always be available from emerging markets. Canada is not and will never be a low-cost producer, such as India or other emerging economies. India supplies over 80% of donor-funded antiretrovirals to developing countries.

This is not only about one country. Brazil, Thailand and South Africa also produce a significant amount of affordable medicines. We should not be surprised that even after CAMR was requested and used successfully to send medicines to Rwanda, that country soon found a more affordable alternative source in India.

The bill also ignores what the World Health Organization's panel of independent medical experts from the developed and developing world have said. Over 98% of the medicines on the World Health Organization's list of essential medicines are either generic or not patent protected in the developing world.


According to the joint United Nations program on HIV-AIDS and the World Health Organization, an estimated 8 million people living with HIV in low and middle-income countries were receiving antiretroviral therapy at the end of 2011. That is a 25-fold increase over the last decade, and I do not want that number to be skipped over.

Kevin Sorenson - CPC

The Canadian access to medicines regime is still available to countries that need it. Canada is the only country to have used this tool to export medicines successfully.

Prior to Canada using the regime to import drugs in 2007, there is the example of Rwanda that my colleague pointed out, which was already procuring generic HIV drugs, primarily from India, at a steadily declining price. Today Rwanda does not need Canada's access to medicines regime for those drugs. Canada can be involved in many other ways. India is now supplying Rwanda with the same product produced by Apotex under Canada's access to medicines regime at a much lower price than we would provide.


The approach proposed in Bill C-398, the so-called “one-licence” solution, would hinder innovation and research in Canada. In addition, many of the bill's proposed changes would violate our international trade obligations. The approach suggested by the bill would allow the Commissioner of Patents to grant an export licence without first verifying whether the importing country has made the necessary notification. In fact, a licence would not only be issued without knowing where the product will be shipped and the identity of the buyers, but also with no indication of the amount being purchased. This would cause serious transparency problems and would increase the potential for the diversion of drugs away from the people who need them the most.



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