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18 Oct 18 18 Oct 18

MSF addresses Canada's Standing Committee on Health to call for better access to essential medicines

Last year, Canada's Parliament passed Motion M-132 on federally funded health research. The motion calls on Canada’s Standing Committee on Health to study how to improve access to Canadian-funded health research, with the aim of lowering the price of medicines in Canada and globally, and making access to medicines more affordable.

Doctors Without Borders/Médecins Sans Frontières (MSF) welcomes this motion. Our organization delivers emergency lifesaving medical care to vulnerable people around the world who have been cut off from essential health services, and we believe that improved access to affordable medicines is essential to prevent needless death and suffering. Today, MSF Canada's humanitarian affairs advisor, Jason Nickerson, is addressing Parliament's Standing Committee on Health, in order to highlight the urgent priorities that must be considered in this urgent study on federally funded health research.

What follows is a transcript of his statement to the Committee:

Good morning, and thank you for the opportunity to address the Committee on this important topic.

By way of introduction, I am the Humanitarian Affairs Advisor for Doctors Without Borders or Médecins Sans Frontières – MSF – in Canada, and I am based here in Ottawa. I am also a respiratory therapist with clinical and public health experience across Canada and internationally, and have a PhD in population health and have worked as a clinical scientist in hospitals and universities.

MSF is an international medical humanitarian organization that provides impartial medical assistance to people affected by armed conflicts, natural disasters, disease epidemics, malnutrition crises and other emergencies. Last year, our teams carried out over 10.6 million outpatient consultations, treated more than 2.5 million cases of malaria, and cared for more than 200,000 people on first-line antiretroviral therapy for HIV. We’re also the largest non-governmental provider of tuberculosis treatment in the world, and last year started more than 18,000 people on first line treatments for TB and 3,600 people on treatment for drug resistant TB. We have operations in over 70 countries.

To deliver high-quality medical care, MSF needs both affordable access to and innovation for drugs and other health products like diagnostics, vaccines, and medical devices and have worked for decades to push for more affordable access to them and for health research systems that prioritize public health needs.

I want to first note that the M-132 study has the potential to get to the heart of some of the other issues that the Committee is studying or has studied, including access to treatments for rare diseases, antimicrobial resistance, and even pharmacare – while each of these issues is complex, the fundamental question is often similar: how can we best develop and deliver new, needed drugs and other health products and ensure that patients in Canada and around the world have timely, affordable access to them?

The fundamental issue here is not just high prices. High prices are a symptom of a broken health research and innovation system. The fundamental issue is how this system is working and the outputs it’s producing. The problem is clear: the business model that underpins the health research and innovation system that we have is not delivering drugs and other health products that are affordable and that address global public health priorities. If we want different outputs, we need a different model.

The Four Ps:

I’m going to give the Committee four Ps to consider to better align Canada’s health research system with patient needs and access:

  • Prioritize health needs and use partnerships to develop and deliver products to meet them
  • Have policies to ensure access to new health products developed with public funds
  • Pay for it

Prioritize health needs and use partnerships to develop and deliver

Canada has the ability to prioritize health research that responds to public health needs, and does so through a number of different ways. However, while these priorities may open up avenues of funding for discovery of new health products, the main mechanism by which drug discoveries move out of labs and into the development pipeline is through commercialization – generally exclusive licensing or sale to the private sector, in exchange for royalties, but with few to no safeguards that ensure that Canadian and other patients around the world will be able to access the final product, even when the public has paid for the discovery. During the rare diseases study, the Committee heard from a witness who noted that because Canada lacks the infrastructure to support research and development, we’ve become “net buyers” instead of net contributors to drug development.

Drug development is a costly endeavour. However, while the pharmaceutical industry says it costs billions to develop a new drug, that is not MSF’s experience.

In 2003, MSF, along with five public research institutions, founded the Drugs for Neglected Diseases initiative – an international, not-for-profit research and development organization that was created to respond to the frustration of being faced with having to use medicines that were ineffective, highly toxic, unavailable, or that had simply never been developed despite a public health need. DNDi has been an experiment in innovation both in what it did – develop new treatments for neglected populations – and how it did it – by testing a model of drug development driven by patient needs, not profit maximization.

To date, with total expenditures of $375-million (Canadian), DNDi has delivered seven new treatments for four diseases (malaria, sleeping sickness, viral leischmaniasis, Chagas disease, and pediatric HIV) that are affordable, adapted to the places where our patients live, and not patented. In addition, DNDi has created a robust pipeline with 30 R&D projects covering six disease areas, including 15 potential new chemical entities – new drugs. Factoring in the usual attrition rates in the field of infectious diseases, DNDi estimates it can develop an improved treatment (for example by repurposing a drug, which the Committee discussed earlier) for $14-58 million and can develop a new chemical entity for $144-216 million. That’s much cheaper than the billions of dollars the pharmaceutical industry says it costs them.

How?

Through partnerships and collaboration and guided by principles. The DNDi model is what’s known as a Product Development Partnership (or a PDP). DNDi does not have its own laboratories or manufacturing facilities, it relies on partnerships to integrate capabilities from academia, public research institutions, non-governmental organizations, health charities, governments, and the more than 20 pharmaceutical companies that DNDi has partnered with on early stage research, clinical development, and implementation.

This model creates a framework for collaboration among the actors involved to better leverage research investments to more efficiently address public health priorities. The work is guided by access and affordability principles to ensure the final products are available to patients who need them.

The product development partnership approach guided by principles of access and affordability could be adapted to the Canadian context and could be used to develop and deliver new products that are needed by Canadian patients and which serve a global public good. This could be applied to solve pressing public health problems, for example developing new short-course oral cures for tuberculosis, which the Committee heard during its study on antimicrobial resistance are desperately needed in Canada and in low- and middle-income countries.

Our policy recommendation No. 1: Identify priorities for health research and development that address global public health needs. Once priorities are identified, funders should think through the steps that needed to develop and deliver tools to address them from start to finish. Act as the coordinator of needed innovation and experiment with Canadian models of product development partnerships that leverage the expertise and investments of government, universities, industry, and civil society to develop new drugs and health products to address the priorities.

Have policies to ensure access to new health products developed with public funds

This of course needs to have policies in place that ensure access to the innovations developed with public funds.

Canada needs policies that articulate not only the desire, but the ways in which funders of health research are maximizing the use of public funds to deliver public goods. The Canadian Institutes of Health Research (CIHR), the main funder of biomedical research in Canada, has a mandate to support the creation and translation of new knowledge into improved health for Canadians, and into more effective health services and products.  While this mandate includes reference to developing new needed health products like medicines, vaccines, diagnostics, and medical devices, what this mandate lacks is a clear commitment to ensuring that Canadian and other patients will have access to the products that are developed with the federal funds that are provided to researchers and research institutions.

Ensuring a public return on public investment should be a guiding principle of publicly-funded health research. In the context of the development of drugs, devices, vaccines, and other health products, this should translate into timely, affordable access to products developed in whole or in part with Canadian public funds. Profitability – for research institutes, for investigators, or for the Government of Canada – should not be a guiding principle behind decisions on how or whether to develop or commercialize health products.

Our policy recommendation No. 2: Federal funding agencies, like CIHR and others, should require recipients of public funds to have access and affordability policies in place for discoveries that are made with public funds. This could be one of the Institutional Eligibility Requirements for receiving federal funding, and could include the broadly applicable institutional plans and principles to guide the way universities manage their discoveries, to better ensure publicly-funded discoveries are affordable, globally accessible, registered in countries that need them, and that the science used to develop them is made available for others to build on.

Pay for it

Financing and incentive mechanisms must be sustainable, and include appropriately designed incentives that delink (or as it was referred to on Tuesday – decouple) the cost of R&D from the price of medicines. Setting priorities and creating a framework to coordinate product development through a principle-driven partnership model is one step toward this, but it is important to also create the appropriate incentives to participate in it. One example is the use of prize funds to reward researchers who reach certain milestones in product development (for example, the registration of clinical trials or new chemical entities) and who agree to license the products to developers, who will ensure affordable and accessible pricing and registration. Instead of relying on royalties as a means of revenue generation, which are maximized through the use of high prices, undermining access to publicly-funded discoveries, Canada could replace the royalty incentive and reward researchers who reach certain milestones with cash prizes such as bursaries or additional grant funding.  

Our policy recommendation No. 3: Experiment with the use of different funding mechanisms and incentives that delink the cost of R&D from the final price of new health products. Consider how funding agencies could reward health researchers who meet milestones for developing new health tools and who agree to access and affordability conditions. Any rewards that are provided should require recipients to have an access strategy in place for the product to ensure it will be available and affordable for patients.

Thank you very much for having me today. I want to emphasize that if members of the Committee have any additional questions or want clarification, that they are welcome to contact me. I would also encourage the Committee to consider additional hearings on this issue in order to hear from other organizations with experience and expertise in this area, who I know would be interested in speaking with you. Thank you.

Jason Nickerson is a humanitarian affairs advisor with Doctors Without Borders/Médecins Sans Frontières (MSF) Canada. He addressed the Canadian Parliament's Standing Committee on Health regarding the Study on Federally Funded Research (M-132) on October 18, 2018.

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