March 2013 – PEAH – Policies for Equitable Access to Health

GESPAM had the pleasure to interview Mr. Jorgen Stassijns as malaria advisor and specialist in tropical disease at the Belgian branch of Médecins SansFrontières (MSF). Mr. Stassijns is a medical doctor, working for MSF since 1998. He did missions in different countries, covering different medical fields: refugee projects in South Sudan and Guinea, TB project in Russia, access to health care project in Sierra Leone and migrant project in Belgium. Since 2007, Mr. Stassijns is working in the headquarters, first as medical-operational coordinator for projects in Eastern Africa, then as malaria expert

Interview

Jorgen Stassijns

Malaria Advisor and Specialist in Tropical Disease at the Belgian branch of Médecins Sans Frontières

Background information from WHO 2012 Malaria Report:

..... International disbursements for malaria control rose steeply from less than US$ 100 million in 2000 to US$ 1.71 billion in 2010 and were estimated to be US$ 1.66 billion in 2011 and US$ 1.84 billion in 2012.....

.....The enormous progress achieved appears to have slowed recently. International funding for malaria control has levelled off, and is projected to remain substantially below the US$ 5.1 billion required to achieve universal coverage of malaria interventions......

....There were an estimated 219 million cases of malaria (range 154-289 million) and 660 000 deaths (range 610 000-971 000) in 2010......Country level malaria estimates available for 2010 show that 80% of estimated malaria deaths occur in just 14 countries and approximately 80% of estimated cases occur in 17 countries. Together, the Democratic Republic of the Congo and Nigeria account for over 40% of the estimated total of malaria deaths globally. The Democratic Republic of the Congo, India and Nigeria account for 40% of estimated malaria cases.

.....millions of people continue to lack access to preventive therapies, diagnostic testing and quality-assured treatment.....

......resistance to artemisinins - the key compounds in artemisinin-based combination therapies - has been detected in 4 countries of the South-East Asia Region, while mosquito resistance to insecticides has been found in 64 countries around the world......

.....There is a critical need to strengthen malaria surveillance......

.....There is an urgent need to identify new funding sources to maintain and expand coverage levels of interventions so that outbreaks of disease can be avoided and international targets for reducing malaria cases and deaths can be attained.....

– GESPAM: Mr.Stassijns, as regards progress so far, how to maintain momentum and do the utmost to hold back malaria resurgence?

– Jorgen Stassijns: Over the past years, some successes have been achieved in malaria control, and in some countries, the numbers are going down. However, huge challenges remain in high burden countries such as DRC or Niger, contexts where MSF is active in the fight against malaria. In 2012 for example , the malaria burden in these countries has been higher than previous years. For some other contexts, reliable data are lacking. Clearly, all efforts to control malaria should continue and funding should be increased if we want to reduce the malaria burden.

– GESPAM: Do MSF functions include partnerships and collaboration with counterparts for malaria action?

– Jorgen Stassijns: In its projects, MSF always works in close collaboration with or in support to the National Malaria Programs in the countries. We don’t have formal agreements or partnerships with other actors.

– GESPAM: Pending or already made cuts in foreign aid expenditure are threatening the gains achieved in malaria control and prevention. Relevantly, adding to a December 2012 call by the Executive Director of Roll Back Malaria Partnership for “….new financing mechanisms..” including “.. financial transactions taxes..”, ALMA (African Leaders Malaria Alliance) recently asked for “…innovative financing mechanisms, including introducing levies on financial transactions…” to further scale up and sustain malaria control efforts.

Do you share that revenues from a Financial Transaction Tax (FTT) would be a suitable resource for the European Union to partly allocate to Global Fund needs for malaria fight?

– Jorgen Stassijns: I am a technical expert, not involved as such in financing mechanisms, so I can’t give a relevant opinion on that topic.

– GESPAM: What about MSF position regarding cheap for malaria medicines currently being rolled out by emerging countries’ industries?

– Jorgen Stassijns: MSF position has always been clear: patients suffering from malaria should have access to good quality antimalarial medicines. As MSF, we have put in place a system of quality control and work with validated manufacturers, some of them based in emerging countries.

– GESPAM: Do MSF functions include partnerships and collaboration with counterparts for malaria action?

– GESPAM: Parasite resistance to artemisinins (the key compounds in artemisinin-based combination therapies) has now been detected in 4 countries of the Greater Mekong subregion: Cambodia, Myanmar, Thailand and Viet Nam.

What extent are counterfeit and substandard medicines accountable for resistance?

– Jorgen Stassijns: This is probably one of the causes of the emerging resistance, together with other factors such as the availability of monotherapies. However, considerable efforts are being done to ban monotherapies and substandard drugs. In Cambodia for example, mechanisms have been put in place to provide the private sector – treating the majority of malaria cases – with quality antimalarial drugs. In Africa, resistance to artemisinin has not been documented (yet), but similar risk factors are present and everything should be done to avoid that resistance spreads to Africa.

– GESPAM: As per recent WHO release, “…Tracking progress is a major challenge in malaria control. At present, malaria surveillance systems detect only one-tenth of the estimated global number of cases. In as many as 41 countries around the world, it is not possible to make a reliable assessment of malaria trends due to incompleteness or inconsistency of reporting over time…”.

As such, how to strengthen malaria surveillance and ensure that interventions are delivered to areas where they are most needed?

– Jorgen Stassijns: Putting in place a performing surveillance is challenging and requires resources, but is a key intervention that allows to monitor the progress in malaria control.

– GESPAM: As recently stressed “…children with no immunity who have been protected over the past three years are beginning to get exposed, and the number of malaria cases among young children is expected to increase significantly this year if replacement nets do not come..”.

What about in your experience?

– Jorgen Stassijns: Long Lasting Insecticide Treated Nets (LN) are considered as one of the most effective tools for the prevention of malaria, but their lifetime is about 3 years. Therefore, regular replacement of the LN is needed. In some of the countries we’re working (Niger, DRC), funding for LN is insufficient and this could indeed have a negative impact on the malaria burden, and increase the number of cases.

– GESPAM: Thank you Mr. Stassijns for your insightful answers.

News Link n. 41

The news links are part of the research project GESPAM (Geopolitica, Salute Pubblica e Accesso alle Medicine/Geopolitics, Public Health and Access to Medicines), which aims to focus on the best options for the use of trade and government rules related to public health by resource-limited countries.

News Link 41

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–Research-based Pharmaceutical Industry and International Federation of Red Cross and Red Crescent Societies Join Forces to Prevent Non-Communicable Diseases

–Global health diplomacy: advancing foreign policy and global health interests

–U.S. CONGRESS PASSES BILL MAINTAINING FULL SUPPORT FOR GLOBAL FUND

–US Supreme Court To Hear Arguments On Pay-For-Delay Drug Deals

–Tackling poverty and disease with innovative health financing

–Role of Environment in Tackling Poverty in Focus at Discussion on Post-2015 Global Development Priorities

–At US-Led Workshop, African Stakeholders Call For âHome Grown IP Agendaâ

–How a new trade agreement will hurt the poorâs access to medicines

–KEI notes on the 16th Round of Trans-Pacific Partnership Agreement (TPPA) Negotiations in Singapore

–Japan Announces Goal of Joining Trans-Pacific Trade Talks

–BRICS Bank Provides Opportunities for Africa

–Strengthening the Expanded Programme on Immunization in Africa: Looking beyond 2015

–Accesso alle vaccinazioni nelle popolazioni migranti: convegno Roma 16 – 17 aprile 2013 ISTITUTO SUPERIORE DI SANITAâ

–Task shifting. Lâarte (e la necessitÃ ) della delega

–Cure primarie. Confronto shock tra UK e USA

–World Health Organization and Global Fund cite tuberculosis threat

–Director-Generalâs message on World TB Day

–Tuberculosis current concepts

–TB is a leading, but underdiagnosed, cause of child mortality

–African Health Ministers Commit to Ramped Up TB/HIV Treatment

–Tuberculosis: Europeâs Ticking Timebomb

–EU’s new research mechanism ‘complex and narrow’

–‘One step more for realizing the rights and dignity of women and girls’

–Analysis: Nepalâs maternal mortality decline paradox

–African Ministers Focus On IP Role In Innovation For Development; Less On Flexibilities

–Richard Smith: NestlÃ©âa force for good or ill?

WTBD press briefing at the UN Palais, 18 March 2013

Ladies and gentlemen, let me get into some specifics about the results of the joint work with the Global Fund on estimating the anticipated demand for international funding between 2014 and 2016 in 118 countries eligible to receive financing from the Global Fund.

WTBD press briefing* at the UN Palais, 18 March 2013

by Mario Raviglione, Director Stop TB Department

World Health Organization

â¢ Ladies and gentlemen, let me get into some specifics about the results of the joint work with the Global Fund on estimating the anticipated demand for international funding between 2014 and 2016 in 118 countries eligible to receive financing from the Global Fund.

â¢ Given the upcoming GF pre-replenishment conference in April aiming at raising the necessary resources for the global fight against HIV, TB and Malaria, we estimated the total funding needs, the amount of domestic resources that could be mobilized and the anticipated demand for international funding to close remaining gaps.

â¢ We estimate that about 4.8 Billion US$ is required every year for proper TB care and control efforts. If we assume that countries will continue to increase, to their ability, their domestic investments, we are left with an anticipated demand for international funding of 1.6 Billion US$ per year.

â¢ Of this gap for international funding, 900 Million US$ (almost 60%) is for African countries, that include most of the worldâs low-income countries.

â¢ The two areas with the greatest need of increased investment are (1) MDR-TB treatment, with 1.3 Billion US$ needed per year, and (2) the expansion of new rapid diagnostic and associated laboratory strengthening, with 600 Million US$ per year.

â¢ Of course, the largest investment remains that of the core essential elements of good TB care and control, that also prevent MDR-TB from emerging, that amount to 2.6 Billion US$ per year.

â¢ If we collectively succeed in mobilizing all the necessary resources, domestically and internationally, and fill all the gaps, then 17 Million people will be treated between 2014 and 2016, thus saving 6 Million lives.

* published with permission

News Link n. 40

News Link 40

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–The European health report 2012: charting the way to well-being

–INTERPOL and pharmaceutical industry launch global initiative to combat fake medicines

–A new direction for Italian development cooperation

–Italian aid office redefines collaboration with NGOs

–Unholy Alliance

–Global hunger and undernutrition could be worsened by climate change

–Now you too can vote on post-2015 goals

–Leaked IP Chapter Of India-EU FTA Shows TRIPS-Plus Pitfalls For India, Expert Says

–Strengthening Mechanisms to Prioritize, Coordinate, Finance, and Execute R&D to Meet Health Needs in Developing Countries

–Millennium Village Project

–Colera ad Haiti

–Issue 15 – 13 March 2013 Global Fund News Flash

–GLOBAL FUND APPOINTS MICHAEL BOROWITZ AS HEAD OF STRATEGIC INVESTMENT & PARTNERSHIPS

–The Global Fund Needs Japan Now More Than Ever, by Mark Dybul

–The Global Fund: Saving More Lives with Every Dollar

–IP, Health Concerns As TPP Talks Continue

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–Smartphones used to detect parasitic worms

News Link n. 39

News Link 39

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–Justine Greening speaks out for women and girls

–The truth about women and chocolate

–Guardian Reports On Discussion Of Commission On The Status of Women Outcome Document

–The private sector: the new black in womenâs economic empowerment

–Global Fund praises choice of Ray Chambers as special envoy

–Trade-offs in FY14: A Case for the Global Fund

–G-Finder Neglected Disease 2012 report

–Op-Ed: CIDA should work with the private sector

–The Real Story of Canada’s Attitude Toward Food Security

–Report On Antitrust Concerns: Seed Companies Working To Extend IPRs To Control Global Food

–Changing how food aid is allocated ‘may save more lives’

–Maize shortage renews debate over GM in Zimbabwe

–US Trade Policy to Focus on TPP, EU Talks in 2013

–Pending U.S. Court Cases on Intellectual Property and Their Relation to the Trans-Pacific Partnership Agreement (TPPA)

–Advance Market Commitments âpromising solutionsâ to global health challenges

–Governance Challenges in Global Health

–WTO: Wide Support For LDC TRIPS Transition Extension, With A Hitch

–European Patent Office Reports Record Patent Filings In 2012

–Indiaâs First Compulsory Licence Upheld, But Legal Fights Likely To Continue

–Bayer Will Appeal India Compulsory Licence On Its Cancer Drug

–Patent Pool-ViiV Collaboration On Paediatric HIV Sparks Reactions, Hope

Government of Canada misleads Parliament and public, kills bill on access to medicines for developing countries

This article outlines the basis of Canada's Access to Medicines Regime (CAMR), its principal deficiency (among several) and the key reforms proposed to fix it.  It also rebuts the most common misleading and misguided arguments that have been repeatedly advanced by both Canadian government officials and lobbyists for the brand-name pharmaceutical industry against those reforms.  (For more detailed analyses, see the materials online at www.aidslaw.ca/camr or www.medicinesforall.ca.)

Government of Canada misleads Parliament and public, kills bill on access to medicines for developing countries

by Richard Elliott*

Executive Director, Canadian HIV/AIDS Legal Network

March 4, 2013

Following intense advocacy by civil society organizations, Canada’s Parliament unanimously passed a bill in May 2004 that amended the Patent Act and the Food and Drugs Act to create what is now known as “Canada’s Access to Medicines Regime” (CAMR, www.camr.gc.ca ). The stated purpose of the regime was to help get lower-cost, generic medicines for public health needs to patients in developing countries, by enabling the compulsory licensing of pharmaceutical products during their patent term in Canada solely for the purpose of export to eligible recipient countries.

Sadly, despite the best efforts of civil society organizations, in its final form, the legislation created a regime whose processes and requirements are unnecessarily cumbersome and are ill suited to the practical realities facing developing countries and generic manufacturers. As feared, these have proven to be a disincentive to CAMR’s use. In almost 9 years, only one country (Rwanda) and one Canadian generic manufacturer (Apotex Inc.) have used the regime, and only one licence has been issued regarding one order of one medicine. At this writing, there appears to be little prospect of further use of CAMR unless it is reformed - and the Government of Canada has deliberately and repeatedly blocked amendments to the regime.

This article outlines the basis of CAMR, its principal deficiency (among several) and the key reforms proposed to fix it. It also rebuts the most common misleading and misguided arguments that have been repeatedly advanced by both Canadian government officials and lobbyists for the brand-name pharmaceutical industry against those reforms. (For more detailed analyses, see the materials online at www.aidslaw.ca/camr or www.medicinesforall.ca.)

Origins of CAMR: WTO consensus

In November 2001, following demands by developing countries and under pressure from health advocates concerned about the ways in which stringent intellectual property rules impede access to more affordable medicines, WTO Members unanimously adopted the Doha Declaration on TRIPS and Public Health. In the declaration, they agreed that the WTO’s Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) “does not and should not” prevent countries from protecting public health, and that the treaty “should be interpreted and implemented” in ways that let countries do this. They affirmed the right of every WTO Member to use the “flexibilities” in TRIPS “to promote access to medicines for all,” that this includes compulsory licensing, and that countries are free to determine for themselves the grounds on which compulsory licenses may issue.

However, they also recognized a barrier in TRIPS that makes it difficult for countries with insufficient pharmaceutical manufacturing capacity to “make effective use” of compulsory licensing to obtain lower-cost, generic pharmaceutical products. Article 31(f) of TRIPS limits the use of compulsory licences in potential exporting countries to “predominantly” supplying the domestic market, thereby restricting the quantity of generic medicines that could be exported to countries in need of imports. WTO Members committed to finding an “expeditious solution” to this problem; that solution ultimately took the form of the WTO General Council’s Decision of August 30, 2003. Subject to numerous conditions, that decision temporarily waives this restriction in TRIPS, allowing “eligible importing countries” with insufficient manufacturing capacity to tap generic producers beyond their borders to address domestic “public health problems.” In essence, it aims to put such countries in the same position of being able to use compulsory licensing as countries with their own capacity to produce generic pharmaceutical products.

Contrary to what some have repeatedly claimed, the wording of the 2003 Decision and the earlier 2001 Doha Declaration is explicit that these are not limited to addressing only emergencies or public health crises or epidemics, or only to supplying medicines for specific diseases such as HIV, TB and malaria, but rather to help countries address “public health problems.”

CAMR’s flaws and proposed reforms

With the passage of the Jean Chrétien Pledge to Africa in May 2004, Canada became the first country to enact a detailed legislative framework implementing the 2003 WTO Decision. The same month, Norway promulgated less detailed regulations to implement the decision, and a number of other jurisdictions have since followed suit. Sadly, with the exception of the single use of Canada’s regime, described below, the mechanism set out in the 2003 decision has gone unused in the near-decade since. It would be a mistake, however, to conclude - as the Canadian government has consistently reiterated - that Canada’s experience “proves” that its legislation embodies the expeditious solution that WTO Members promised in the 2003 decision. It should be noted that it took more than three years to achieve that single use of CAMR, in part because of the unnecessary hurdles built into it. It is shocking that Canadian government ministers and representatives characterize a single compulsory licence issued under CAMR, to supply a single order of one drug for one country, with little likelihood of further use, as a success in addressing the enormous global gap in access to affordable medicines. Rather, the experience of using CAMR provides important lessons about how important it is for countries to implement the 2003 WTO Decision in as simple and straightforward a manner as possible, which Canada has so far failed to do.

Instead of simply ensuring that the parameters set out in the 2003 WTO Decision are satisfied through conditions attaching to a compulsory licence once issued, CAMR unnecessarily “frontloads” a series of requirements - some of them defined more restrictively than the WTO Decision - into the process as preconditions to even seeking a licence. For example, before even being able to apply for a compulsory licence under CAMR, and thereby be in a position to supply a product legally to a would-be purchaser in an eligible importing country, a generic manufacturer must first convince the government of that country to file a notification with the WTO’s TRIPS Council setting out a specified quantity of the medicine. The generic manufacturer must then attempt to negotiate, for at least 30 days, with the company or companies holding the Canadian patent(s) on the product for a voluntary licence authorizing export to that country. That 30-day negotiation period does not begin running until the generic manufacturer discloses both a specific country and specifies a fixed, “maximum quantity” of the medicine for which it seeks a licence. In the absence of being able to provide such information, the process remains stuck in limbo - as was indeed the experience for some 18 months in the sole attempt to date to use CAMR.

It is only if and when this 30-day negotiation period has expired, with no agreement on the terms of a voluntary licence, that the generic manufacturer may then file an application to the Commissioner to Patents for a compulsory licence. Any licence issued by the Commissioner may only authorize the generic manufacturer to export up to the fixed maximum quantity previously specified, only to the country previously specified, and only for a maximum period of 2 years. (Regulations in CAMR set out the formula for calculating the royalty payable by the generic manufacturer to the patent-holder(s). This uses a sliding scale based on the importing country’s ranking on the UN’s Human Development Index, with a maximum royalty of 4% of the value of the contract between the generic manufacturer and the purchaser. In the case of the single licence issued to Apotex to supply 15.6 million tablets of an AIDS drug to Rwanda, the applicable royalty was 0.45%.)

In essence, Canada’s current law requires a separate negotiation and licensing process for every single drug order from every single country, with all the associated transaction costs. CAMR’s requirements, and their sequencing, create disincentives for both eligible importing countries that are potential purchasers of medicines and generic manufacturers that are the potential suppliers. It is one significant reason that the system has been used only a single time. For this reason, health and human rights advocates have, through a series of three different - and ultimately unsuccessful - private members’ bills in Parliament, between March 2009 and November 2012, proposed to streamline CAMR by creating a “one-licence solution,” among other reforms. These were first proposed by the Canadian HIV/AIDS Legal Network and other NGOs during a 2007 Parliamentary review of CAMR.

Under the proposed reforms, a generic medicines manufacturer could easily get a single compulsory licence to export lower-cost medicines to multiple countries already listed as eligible importing countries in the current law. This would clear the way for generic suppliers and developing countries to navigate the bidding and procurement process without multiple hurdles and uncertainty along the way, thereby making it the rapid solution that Canada and other WTO Members promised years ago. By enabling economies of scale, it would also make it even easier for Canadian generic manufacturers to offer even lower, more competitive prices to developing country purchasers. As required by the current CAMR and WTO law, the brand-name pharmaceutical company holding the patent on the product would still be paid a royalty on all sales of the product to eligible countries.

In the end, the third and final bill -(Bill C-398) introduced in Parliament in 2012 - proposed only two substantive reforms to CAMR (as outlined here):

– this streamlined “one-licence solution” for the compulsory licensing process; and

– an improved definition of “pharmaceutical product” for which a compulsory licence can be obtained and exported to eligible countries (so as to replace the limited list of products currently found in CAMR and directly incorporate the broader, more flexible language agreed upon in the 2003 WTO Decision).

The proposed reforms to CAMR were informed by the single experience to date of the hurdles encountered in attempting to use the current regime. Bill C-398 sought to simplify the process and make CAMR “fit for purpose.” As a result, CAMR could and would have been used as a means of supporting developing countries by creating another avenue for obtaining more affordable medicines needed to deal with public health problems, including HIV. Indeed, there was already a public, repeated commitment by Canada’s largest generic manufacturer to use CAMR, if reformed, to supply a much-needed medication to treat infants and children with HIV as a first, next step.

Misguided objections, misleading Parliament and the public: Canadian government and big pharma kill the bill

On November 28, 2012, Bill C-398 was put to a critical vote in the House of Commons, to determine whether it would proceed on to more detailed committee deliberations. Despite widespread support from the public, major national news outlets, prominent Canadians (including celebrities), faith leaders, and health professionals, the now-majority government of Prime Minister Stephen Harper maintained its staunch opposition to CAMR reform. Government spokespeople repeatedly mischaracterized the contents of the bill during Parliamentary debates. The government whipped its caucus in the House of Commons to require all Cabinet ministers and parliamentary secretaries to vote against the bill. It also exerted sustained pressure against those backbench MPs in its caucus who had previously supported these reforms in the previous bill brought before the previous Parliament. (In late 2011, the previous Bill C-393, proposing these same two reforms, had passed through the House of Commons with a solid 60-vote majority, including 26 backbenchers from the government’s own caucus. However, the government deliberately and repeatedly stalled it in the Senate, where it then died on the Order Paper when Parliament was dissolved for a general election.) This time, the pressure worked to kill the bill in the House even before further committee study: in the end, Bill C-398 was defeated at second reading by a mere 7 votes (148 against to 141 in favour).

In the days following, numerous MPs from the government caucus stated, in media reports and letters to constituents, that they “chose reason over emotion” in deciding to vote against Bill C-398, and attempted to justify their position by repeating the same inaccuracies about the bill and about the broader issue of access to medicines in developing countries that had by then become standard talking points from government spokespeople and big pharma lobbyists. A number of patently false claims were frequently reiterated by opponents of reform, and it is important to correct them.

First, Bill C-398 would not have removed measures to ensure the quality of medicines being supplied to developing countries. CAMR currently requires Health Canada review for all products exported under CAMR, which must mean the same regulatory standards as any product destined for sale in Canada. Even a cursory examination of Bill C-398 shows that it proposed no changes to CAMR’s existing requirements under the Food and Drugs Act.

Second, reflecting what was negotiated at the WTO in 2003, CAMR contains numerous safeguards aimed at preventing the diversion of medicines, including differentiating the generic product exported under CAMR from the brand-name product, as well as publicly disclosing detailed information, before each shipment, about the quantity being shipped and the chain of custody. Contrary to claims by the government, a reading of Bill C-398 illustrates that it would have preserved all these existing requirements. In fact, tracking the exact language of the 2003 WTO Decision, Bill C-398 would have added that any licence issued under CAMR only authorizes a generic manufacturer to produce and export the “expected quantities” of medicines that eligible recipient countries have notified in writing to the WTO (or, in the case of an importing country that is not a WTO Member, directly to the Government of Canada through diplomatic channels, as the current CAMR requires). Exceeding “expected quantities” notified by eligible countries would be a basis for terminating the compulsory licence. This would have allowed flexibility under a single compulsory licence to respond to eligible countries’ needs as they evolve, while still respecting WTO requirements.

Third, it can only be wilful blindness or intellectual laziness that leads to the claim that the “one-licence solution” or other reforms proposed in Bill C-398 would have put Canada in breach of its obligations under TRIPS. The “one-licence solution” proposed in the bill was drafted carefully, and reviewed by some of the world’s leading legal experts (some of whom testified before Parliament), so as to be compliant with WTO requirements. The changes to CAMR proposed in Bill C-398 reflected carefully the language of agreements negotiated by Canada and all WTO members - in particular the 2001 Doha Declaration and the 2003 WTO Decision which CAMR implements. This detailed information was provided to all MPs, time and again. In essence, the government chose to put its incorrectly narrow interpretation of TRIPS and of the 2003 WTO General Council Decision ahead of a workable mechanism to help save lives.

In addition to the evidently inaccurate claims about the contents of Bill C-398, some MPs who voted against it continued to circulate bizarre arguments in an attempt to justify their vote.

For example, some MPs continued to claim, illogically, that there is no need to fix CAMR to supply more affordable medicines because “the real barrier” is inadequate infrastructure in potential recipient countries. While it is true that there are multiple barriers to access to medicines, which vary from country to country, nobody credibly denies that the price of medicines is a key factor affecting access. Making medicines affordable, strengthening health systems and other initiatives to improve health in developing countries are not mutually exclusive; rather, they are complementary. All the clinics, doctors and nurses in the world won’t suffice if medicines are priced out of reach. Reforms to make CAMR work would have helped address one barrier; indeed, freeing up resources by securing medicines at lower prices would enable greater investments in strengthening health systems where needed.

Similarly strange is the unfounded assumption, regularly heard from numerous MPs, that Canadian generic manufacturers are unable to compete on price with generic manufacturers elsewhere. Yet the available evidence indicates the contrary, as they often do already. Furthermore, in the one instance of CAMR’s use, the Canadian generic company supplied the fixed-dose combination AIDS drug to Rwanda at the same price (19.5 cents US per tablet) then being offered by Indian generic manufacturers and won the contract through a competitive bidding process. Rwanda has since purchased more of this medicine from Indian generic manufacturers on numerous occasions at essentially the same price, according to figures from the WHO’s Global Price Reporting Mechanism. Furthermore, the simpler it is for generic manufacturers to use a regime such as CAMR to supply multiple developing countries, the greater the economies of scale and the lower the costs of production they can achieve, thus making them more competitive. The “one-licence solution” proposed in Bill C-398 would have actually made it easier for Canadian companies to compete globally to supply medicines at the lowest possible price. MPs who opposed the bill essentially voted to maintain barriers impeding Canadian companies from responding to global health needs.

That Bill C-398 was defeated by a combination of intellectual dishonesty and moral cowardice is bad enough. What’s worse is that Canada’s Parliament had a chance to do something to stop the tragedy of ongoing human suffering and death, and a bare majority failed to rise to the challenge. The experience to date also illustrates that the 2003 WTO Decision itself has failed to deliver what was promised, and that WTO Members must take alternative measures open to them - whether under TRIPS as it stands or by changing the treaty - so that sovereign states can indeed manage their intellectual property policy to promote “access to medicines for all.” Failing this, WTO Members’ earlier declaration, more than a decade ago, that TRIPS “does not and should not” prevent countries from protecting public health, including through the use of TRIPS flexibilities, is empty rhetoric.

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*Richard Elliott is the executive director of the Canadian HIV/AIDS Legal Network (www.aidslaw.ca), an organization working to advance human rights in the response to HIV, in Canada and internationally. For more information, see www.aidslaw.ca/camr and www.medicinesforall.ca.