Madam Speaker, it is a privilege to speak to Bill C-9 and specifically to some of the amendments in the first group.
I would like to tackle specifically one clause, a motion that we have submitted which I believe is important and will make the bill better. I am concerned it will not pass. I want to outline the reasons for moving that particular amendment.
First I want to thank my staff in Ottawa and in Windsor for the hard work they have done, in particular the Ottawa staff for the research that went into the bill. I thank the volunteers as well. I would also like to thank Stephen Lewis for his leadership on this initiative abroad. It simply makes another mark for Canada, that I hope will be successful.
The NDP is committed to ensuring that this very important humanitarian bill is passed as quickly as possible. A very important issue unfortunately has not been dealt with appropriately in the bill which could compromise its effectiveness.
As we all know, the bill was first introduced last November and after prorogation was reintroduced on resumption of Parliament in February of this year.
One of the chief points of contention with the bill was the issue of non-governmental organizations being able to contract directly with Canadian generics to purchase medicines for their programs in eligible developing countries.
During the weeks of testimony that the industry committee heard, a variety of NGOs, including Doctors Without Borders and Canadian HIV/AIDS Legal Network, testified about the importance of NGOs being able to produce lower cost pharmaceutical products directly, among other issues. I would like to thank them for all the work they have been doing abroad and also on this bill. I look forward to their achievements in the future. There are fine, capable people in those organizations.
NGOs testified that although the government intended to include NGOs, the language in the first version of Bill C-9 which identified governments and “agents” of governments as being eligible importers, the NGOs did not feel that this language adequately assured them of access to lower cost pharmaceuticals. It was inappropriate language terminology that hurt them.
Upon reflection of the various issues that were raised during committee testimony, the government proposed substantial changes to Bill C-9. It proposed removing the first right of refusal removal and opening the list of eligible importing countries to include many more developing countries. Of importance to consideration of this amendment, it changed the language about how NGOs could be involved. I commend those achievements, but unfortunately, they are changing it back again.
In its proposed amendments during clause by clause, the government put forward language in section 21.04 to remove the restriction of government or “agent of government” and replace it with “person or entity to which the product is to be sold”. The Canadian HIV/AIDS Legal Network issued a statement in support of that particular change saying it would allow NGOs to procure medicines from generic producers, assuming the NGO was legally entitled to import and distribute in the country where it was operating. This was a very progressive, important step by the government.
The difficulty with the issue is the following. No one was ever requesting that an NGO be allowed to contract directly with generic producers without the legal authority to do so in the eligible importing country. NGOs regularly receive their appropriate legal authority within whatever country they are operating to allow them to distribute medicines through their particular programs.
The more open language “a person or entity legally entitled to import and distribute”, however, was changed through a subamendment at the committee. I recognize that my colleague who presented the subamendment was attempting to clarify the language in the bill, but whether purposely or inadvertently, the language as it now stands would again prevent NGOs from participating. That is why I put forth the amendment at this stage to ensure that the language remained inclusive of NGOs.
The language in section 21.04(2)(f), lines 36 to 41 in particular, on page 6 of the bill reprinted as amended at committee, has been changed to “governmental person or entity or person or entity permitted by the government of the importing country”. This is problematic because it does not allow NGOs to contract directly. That is how they feel about the bill at this particular time. It is one of the challenges that we are going to see in the field.
The problem is that many countries, including Canada, do not necessarily provide the legal authority to procure and distribute pharmaceutical products through the government. In fact the best reference point is our own system. Here in Canada we have a commissioner of patents. Although created by an act of parliament and is part of the larger government structure, it is the commissioner of patents, not the government, who decides who is issued a compulsory licence to allow the sale and distribution of a particular pharmaceutical product. If a person obtains a compulsory licence under Canadian law from the commissioner of patents, there is nothing else the person needs in order to have the legal right to deal with that patented product in accordance with the terms and conditions of the actual licence.
It is the same in many countries around the world that also have positions of commissioners of patents. In other countries, such as South Africa, compulsory licences are issued through the courts and the legal system, not through the government.
Why is this language in its current form so problematic?
Let us assume for example that Doctors Without Borders in South Africa wants to import an anti-retroviral drug used in HIV-AIDS treatment for their programs in that country. A generic version could mean thousands of dollars in savings per year per patient. Under the current language of Bill C-9, Doctors Without Borders would have to first apply to get a compulsory licence and then, because of our law, would have to get some kind of authorization from the South African government to buy the anti-retroviral drug to use for their patients.
There is no process for that authorization in the South African government at the moment because it has a commissioner of patents that issues compulsory licences and a person or entity is not required under South African law to get anything other than a compulsory licence. That is the obstacle.
The bill is intended to be humanitarian in nature. As the minister stated in her opening comments to the committee, it is important that we have a bill that ensures that the regime not be abused, but that it also provides for the actual intervention of the drugs on the actual streets of the nations that need those types of support and supplies.
If we maintain the language around who a generic producer is able to contract with, in order to contract, NGOs would be required not only to obtain the compulsory licence, but also to get some kind of governmental authority; some kind of governmental authority that NGOs are not required to get by the laws of the country in which they are operating. It creates a circle. This circle is what is causing the NGOs to have problems and why we have this amendment.
Whatever process the eligible importing country has identified for issuing compulsory licences, whether it be through a commissioner of patents, through the courts or some other agency mandated by the government, should be enough of a legal requirement to allow NGOs to contract with generic producers. This is similar to our system here.
Again, I am not proposing that NGOs should be able to contract directly where they are not legally entitled to according to the laws of the country in which they are operating. I am simply proposing that we ensure that the language of our bill does not create further steps and barriers in the process of getting these much needed drugs to the people who need them, through the government or other person or entity legally entitled to do so.
Countries already have legislation regulating what drug products are approved for sale and use in their country. A compulsory licence would only be issued in cases where a drug is patented in that country and approved for sale and use.
There may be occasions where a country wishes to import a drug that is patented here in Canada but is not patented there. In that case no compulsory licence would be necessary by NGOs or other persons or entities wishing to distribute that pharmaceutical product, but it would still have to be approved for use and distribution, again by the importing countries under their own rules and regulations.
It is like it is here in Canada. There is Health Canada's process of determining safety of drugs and Industry Canada's process of placing products on the patent register and determining whether compulsory licences can be used.
Again, this amendment seeks not to change any of that, but seeks instead to respect the rules that are already in place in whichever importing country tries to participate under the regime that Bill C-9 would create. The change in language would ensure that there is no confusion between patent holder, generic producer, importing country, or NGO about whether a person or entity is eligible. Confusion can lead to legal battles and I know members on all sides of the House, as well as stakeholders, want to avoid that possibility.
We as parliamentarians should be respecting the sovereign process of legally issuing compulsory licences to NGOs or other organizations or persons for using patented pharmaceutical products within their own borders. We as Canadian parliamentarians do not need to tell other parliamentarians and representatives of other countries how they should do their job. We as Canadian parliamentarians cannot undermine the potential for success of this bill by including language that simply is not necessary and creates more burdens for the NGOs attempting to provide much needed health care services and governments that are dealing with health emergencies.
My amendment is simple. It proposes to return the language from what was passed at committee on a subamendment to the language proposed by the government in its own amendments to its own bill. The NGOs welcomed the government's language, as did the NDP, but we have not welcomed the new language that was passed at committee. This amendment does not propose to do anything but keep the process within established legal grounds and ensure that no additional barriers are placed in the way of NGOs attempting to deliver their humanitarian programs.
It simply boils down to this at the end. We felt that the government did a good job of listening to the NGOs and also to the witnesses at committee to deal with this problem and deal with an appropriate change from the first to the second draft. That is very important because they did change a number of different things. I commend the government for that.
Unfortunately, the subamendment, we believe, will create problems for the bill. That is why we would like to see this amendment pass. It would open up a better process for NGOs and those countries to be able to make sure that the humanitarian efforts of this bill are realized. At the end of the day, that is what all of us in Parliament want.
We want a bold initiative that is going to actually create opportunities for people who are sick and suffering, where health standards and impoverishment prevent people from achieving their fullest potential and cause death. We want to provide assistance with cheaper drugs to treat those illnesses.
That will not only make Canada a stronger nation, it will also provide for peace and security in the world.