e-drug
[Top] [All Lists]

[e-drug] Fixing Canada's Access to Medicines Regime - Update Jan 2011

E-Drug: Fixing Canada's Access to Medicines Regime - Update Jan 2011
--------------------------------------------------------------------

Dear colleagues,

>From the Canadian HIV/AIDS Legal Network
--
Fixing Canada's Access to Medicines Regime:
Campaign for life-saving treatment at critical stage

UPDATE
January 2011

The campaign in Parliament to fix Canada's Access to Medicines Regime (CAMR) - 
so that more affordable live-saving medicines can get to developing countries - 
continues and is now at a critical juncture.  

On November 1, 2010, the Parliamentary committee studying Bill C-393 voted, by 
the slimmest of majorities, to strip the bill of its "one-licence solution", 
the key provision to streamline the current cumbersome regime.  Now the bill is 
back in the House of Commons, where this damage can be reversed if Members of 
Parliament take action.  If Bill C-393 is to make meaningful reforms to 
Canada's Access to Medicines Regime, the "one-licence solution" (described 
further below) must be restored.  Fixing CAMR in this way would help supply 
access to affordable life-saving medicines to people in the developing world.
 
Debate on Bill C-393 is currently scheduled to start on Monday, January 31, 
2011, the first day that Parliament reconvenes after the holiday break.  But 
the bill faces three challenges, all of which can be overcome if the political 
will is mobilized in Parliament:

1. A new sponsor for Bill C-393 in Parliament  

The MP who originally introduced Bill C-393 is no longer in the House of 
Commons.  Therefore, while debate on the bill can proceed in Parliament, the 
bill eventually needs a new sponsor in order to be brought to a final vote.  
There are MPs who want to take the bill forward to a vote, but making this 
minor procedural change requires unanimous support in the House of Commons.  
Three of four parties in the House of Commons - the New Democratic Party, the 
Liberal Party and the Bloc Québécois - have committed that they will respect 
the spirit of Canadian democratic debate and allow Bill C-393 to go to a vote 
with a new sponsor.  But the Conservative government has not yet given this 
commitment - even though they have been asked repeatedly and this procedure has 
been done on numerous occasions before.  In fact, Prime Minister Stephen Harper 
has himself had this same courtesy extended to him in Parliament: before his 
party was elected and he became Prime Minister, he previously had his own 
private member's bill in the House of Commons and when he stepped down as an 
MP, the House agreed unanimously to transfer the bill to a new MP.  Given 
statements by some MPs, including Conservative MPs, there are real concerns 
that the government will block a motion to accept a new MP as sponsor of Bill 
C-393. 

2. Restoring the "one-licence solution"  

Bill C-393 needs to have the "one-licence solution" restored and the bill, 
including this clause, must then be supported by a majority of MPs in the House 
of Commons when it comes to a vote.  A motion to reinstate the "one-licence" 
clause of the bill has been introduced and will be part of the upcoming debate 
when Parliament resumes.  There is solid support for the "one-licence solution" 
but Big Pharma is lobbying hard against it.  MPs need to hear from their 
constituents that they want and expect them to vote in favour of restoring this 
essential clause to Bill C-393, and to then vote in favour of the bill itself.

3. Efforts to limit the duration of any reforms to CAMR: the proposed "sunset 
clause"  

The Bloc Québécois has recently put forward a motion to limit the changes to 
CAMR by Bill C-393, including the "one-licence solution", so that they will 
last for only 4 years.  After that time, the reforms would automatically 
expire, and the law would revert to the existing cumbersome rules of the 
current CAMR.  This is certainly not in the best interest of those in desperate 
need of life-saving medications: if we already know that the current CAMR has 
failed, why would we return to it after fixing its key flaws?  The Bloc 
Québécois motion does allow that the changes to CAMR could be further extended, 
but only if the federal government adopts a resolution to do this, which must 
then be supported by a majority in both the House of Commons and the Senate.  
These would be difficult hurdles to overcome, particularly in the face of 
guaranteed opposition from Big Pharma to any extension of the changes to CAMR.  
There is no sound rationale for such a "sunset clause" that would limit the 
changes improving CAMR to such an arbitrary and short timeframe.  But such a 
time limit would likely have the effect of creating, yet again, a disincentive 
to using even a streamlined CAMR.  It limits the economies of scale and 
commercial viability needed for generic manufacturers to participate in any 
significant way, and it does not give developing countries the certainty they 
need about longer-term, sustainable sources of supply from those manufacturers. 
 


Background

Canada's Access to Medicines Regime (CAMR) was a unanimous pledge by Parliament 
to help people dying in developing countries because they lack access to 
affordable medicines; it is Canada's implementation of a 2003 agreement 
negotiated by all countries of the World Trade Organization (WTO).  This 
agreement was to create more flexibility in rules on pharmaceutical patents so 
that lower-cost, generic versions of expensive, brand-name patented drugs could 
be exported to countries with insufficient capacity to manufacture their own.

To date, CAMR has delivered only one medicine to one country (Rwanda) since 
Parliament created it in May 2004, almost 7 years ago.  CAMR is clearly not 
working.  

Bill C-393 was introduced in the House of Commons in May 2009 to address the 
unnecessary deficiencies and limitations in CAMR that render it so weak.  Bill 
C-393 aims to put in place a "one-licence solution" as a way to remove the 
current practical barriers to making use of CAMR.  

The current CAMR includes a cumbersome case-by-case approach with lots of red 
tape and disincentives for both developing countries and generic drug-makers.  
Instead of the current country-by-country, order-by-order process of compulsory 
licensing currently found in CAMR, a reformed law would require only one 
licence on a patented pharmaceutical product.  The one-licence solution 
originally proposed by Bill C-393 would let a generic drug-maker get a single 
license allowing a medicine to be exported to any of the countries already in 
the current law, and to supply the quantities of medicines required by 
countries as their needs evolve over time (rather than a pre-determined and 
fixed "maximum quantity"), without having to go through drawn-out and uncertain 
processes every single time.

As a condition of the licence, the generic manufacturer would still pay 
royalties to the patent-holder(s) based on the sales of the generic product.  
(The existing formula in CAMR for calculating royalties that must be paid on 
any given contract is perfectly adequate and provides clarity and certainty to 
all involved, including the generic manufacturer getting the licence.)

By streamlining CAMR, Bill C-393 makes the entire system more user-friendly and 
allows Canada to follow through on Parliament's promise to help developing 
countries gain access affordable medicines for AIDS and other urgent public 
health needs.

Without this change, CAMR will continue to languish unused.  But if this change 
is adopted, there is already a public commitment from Canada's largest generic 
drug manufacturer that, as a first next step, it will make a child-friendly 
version of the three-in-one AIDS drug that is urgently needed for export.  This 
product is one of the "fixed-dose combinations" (i.e., products combining 
multiple medicines in a single dose) that is needed for treating children and 
infants with HIV.  Apotex Inc. has committed to producing a paediatric 
formulation of this product which it will seek to export under compulsory 
licence to eligible importing countries: 
http://www.apotex.com/global/about/press/20090918.asp.

But Bill C-393 is facing stiff opposition from the patented pharmaceutical 
industry, and especially the lobby group "Canada's Research-based 
Pharmaceutical Companies (Rx&D)".  Companies such as GlaxoSmithKline and 
Boeringer Ingelheim have testified in Parliament against the proposed reforms, 
and have been advancing numerous objections to them, including the inaccurate 
claim that the reforms are not in compliance with Canada's obligations as a WTO 
Member.  The International Federation of Pharmaceutical Manufacturers 
Associations (IFPMA), the global lobby group for "Big Pharma", has also lobbied 
against Bill C-393, testifying against it before a Parliamentary committee.

Results of a nation-wide poll show very strong public support for fixing CAMR 
(www.aidslaw.ca/publications/publicationsdocEN.php?ref=994).  Numerous 
prominent Canadians, including the former Prime Minister whose government 
enacted the original CAMR law, have called on Parliament to move forward with 
Bill C-393 (www.aidslaw.ca/publications/publicationsdocEN.php?ref=996 .  

The Canadian HIV/AIDS Legal Network has been spearheading the campaign for CAMR 
reform, and a broad range of civil society organizations and concerned 
individuals have been mobilized to press the case.  These include the 
Grandmothers to Grandmothers Campaign, Dignitas International, the Interagency 
Coalition on AIDS and Development, UNICEF Canada, Oxfam Canada and Oxfam 
Quebec, Canadian Crossroads International, RESULTS Canada, Universities Allied 
for Essential Medicines, l'Association québécoise des organismes de cooperation 
internationale (AQOCI), student groups, local and national AIDS organizations 
and others.  Treatment activists will continue campaigning in support of the 
proposed reforms - and in support of saving lives.


For more information and to take action...

1. Visit www.LetParliamentVote.ca to take urgent action to demand that the 
respect our democratic process and allow Bill C-393 proceed to a final vote, 
rather than derail an important humanitarian initiative on a procedural 
technicality.

2. More information can be found at www.aidslaw.ca/camr, including this 
important overview, "Fixing Canada's Access to Medicines Regime (CAMR): What 
You Need to Know About Bill C-393" 
(http://www.aidslaw.ca/publications/publicationsdocEN.php?ref=1149).  You can 
also find other key documents, including the full text of the Legal Network's 
brief to the Parliamentary committee 
(http://www.aidslaw.ca/EN/camr/documents/CHLN_BillC-393_INDUbrief_21Oct2010_EN.pdf)
 that studied Bill C-393 and the submissions from numerous other experts 
(http://www.aidslaw.ca/EN/camr/index.htm#Documents).

3. Watch a short video on why CAMR needs to be fixed, with interviews with the 
Legal Network, UNICEF Canada and African grandmothers and AIDS activists, at 
www.aidslaw.ca/camr. 

4. Join the Facebook group on reforming CAMR for more important updates 
(http://www.facebook.com/group.php?gid=59539586156).

If you have any questions or require additional information, please contact our 
Outreach Coordinator, Lindsey Amèrica-Simms, at lsimms@aidslaw.ca.

###
________________________________________________
Richard Elliott
 
Executive Director | Directeur général
Canadian HIV/AIDS Legal Network | Réseau juridique canadien VIH/sida 
+1 416 595-1666 (ext./poste 229) | relliott_aidslaw
www.aidslaw.ca | www.twitter.com/aidslaw 
Access to Medicines Campaign: www.aidslaw.ca/camr | www.aidslaw.ca/facebook
Campagne pour accès aux médicaments : www.aidslaw.ca/rcam | 
www.aidslaw.ca/facebook



<Prev in Thread] Current Thread [Next in Thread>
  • [e-drug] Fixing Canada's Access to Medicines Regime - Update Jan 2011, Richard Elliott <=