On May 9th, 2014, in preparation for the World Health Assembly (WHA), UAEM North America Delivered statements to the Department of Health and Human Services’ Delegation to the 67th World Health Assembly, followed by submission of the following written statement on main concerns addressed in the WHA agenda.
The main points that UAEM is focusing on for the WHA from May 19th to 24th are:
- Access to medicines as related to Hepatitis C, with a focus on the new Direct-Action Antivirals.
- Antimicrobial resistance (AMR), and possible solutions through alternative Research and development practices, which do not use traditional intellectual property incentives.
- A response to the Consultative Expert Working Group, which is charged with the task of finding new models of research and development for neglected tropical diseases.
- The need for access to medicines for non-communicable diseases in lower- and middle- income countries.
UAEM will be working with the International Federation of Medical Student Associations as well as Health Access International during the World Health Assembly. See below for the full statement to US Delegates:
Universities Allied for Essential Medicines Written Comments on 67th World Health Assembly
The need for innovative, non-IP-driven models of medical R&D is especially pressing now for addressing two major health crises facing the world:
The first is the challenge of neglected diseases or neglected tropical diseases — ailments that affect over one billion people worldwide according to the WHO. Unfortunately, those who suffer from these diseases are too poor to offer a lucrative return on private-sector R&D investment through patent-protected sales. We will only effectively develop new medicines and treatments for these diseases through other innovation mechanisms, including public-sector and university research and research driven by grants, prize incentives, open-source innovation, collaborative research platforms and other new R&D models. However, additional funding support is pivotal for long-term sustainability and success. Investing in NTD research and treatment is a cost-effect method to ensure health and economic prosperity.
Lest we think that high-income countries can ignore the threat of NTDs, we should note that climate change, globalized travel and migration, and other factors are causing tropical diseases to spread. Once largely-forgotten diseases of poverty like Dengue Fever, Chagas and West Nile Virus are now appearing in the United States and other high-income countries. For example, the CDC reported that 1/4655 blood donations in the United States was positive for T. cruzi, and the lack of effective diagnostics to screen for such diseases in blood banks can result in unhindered transmission and may constitute a potential future public health emergency.
The second health crisis for which we need new innovation models is the growth of antibiotic resistance. As WHO’s first global report on antibiotic resistance highlights, antibiotic resistance is now a serious worldwide threat to public health. No new forms of antibiotics have been developed in the past 30 years, while resistance to existing antibiotics is skyrocketing globally due to over-marketing, over-prescription and significant overuse in industrial agriculture.
We desperately need to spur research on new antibiotic treatments – but as with NTDs, traditional patent and Intellectual Property (IP) incentives are ineffective. Because sales of antibiotics must be limited to prevent resistance, recouping R&D investments through sales will never be a lucrative proposition compared to other pharmaceutical areas. Furthermore, the amount to which the price per unit for new antibiotics would have to be increased to match the return on long-term treatments for chronic illnesses like cancer and heart disease would be so exorbitant that it would be unaffordable to most health systems and insurers, let alone patients.
Thus far, policy responses such as the U.S. GAIN Act have failed to acknowledge these specific concerns, and have instead simply doubled down on existing R&D incentives by extending IP terms, exclusivity rights and other subsidies to the pharmaceutical industry while in some cases reducing safety and quality-assurance protections for new antibiotics, as well. At best, this approach amounts to “pushing on a string,” and is at worst simply a blank check to the pharmaceutical industry with no steps taken to ensure that any new treatments meet public health priorities or are affordable to patients in need.
As a rising generation of doctors, lawyers and medical researchers, we believe the antibiotic resistance crisis could be a unique moment for global leadership to pioneer new research models that simultaneously spur greater innovation than traditional models, and yield globally affordable public goods. But this will require more than just expressions of urgency coupled with cautious tweaks to failed approaches — we need daring leadership from governments and the international community.
Even in cases where IP-driven R&D may work to incentivize production of new drugs, it creates major barriers to access by giving price monopolies to major developers. The WHO has recognized this problem through the essential medicines list for years, but the list has largely failed to account for newer treatments that show dramatic advances in efficacy and safety.
A prime example of this failure is in the area of Hepatitis C treatment. Recently, as the WHO recognizes, advances in treatment have been made by the development of sofosbuvir, marketed by Gilead under the brand name Sovaldi – a new drug that can turn Hepatitis C into a manageable chronic illness, or even cure the disease (with estimated 90% efficacy) with very limited side effects. The problem is this drug is held on patent, blocking access by generic producers, and is being sold at a price of $50,000 and $100,000 USD per patient, per year – up to $1000 per pill. Estimates to the per-pill manufacturing cost of Sovaldi are between $68 and $136, making the brand-name pricetag quite a margin above production. This incredibly high amount could potentially be reduced in Lower- and Middle-income countries if the drug were added to the WHO essential medicines list. Leaving it up to industry to find solutions is not working, as proposed voluntary price reductions are cautious and still over-burdening to patients in developing countries, which are where the highest burden of Hepatitis C is found.
Instead, the WHO recently added pegylated interferon combined with Ribaviron to the essential medicines list. Although this treatment is decently effective (up to 80%), it does not meet the standard of care set by the release of sofosbuvir. In addition, this combination therapy has been found in clinical trials to cause increased risk of anemia in patients than single interferon treatment alone. The question remains as to how the WHO can ethically promote a treatment known to cause anemia, an already huge risk in LMICs, over a treatment that causes very little side effects and is significantly more effective.
The high price of Gilead’s new drug is just one illustration of the access challenge of the IP-driven R&D system. The same price barriers exist for many new medicines for treating non-communicable diseases, which the WHO has acknowledged as a pressing global crisis. In 2012, 11 of the 12 new cancer medicines approved by the US Food and Drug Administration cost over $100,000 per patient per year. Many developing countries are now issuing compulsory licenses to enable generic production of needed new medicines for cancers and other NCDs. We believe these countries have the right to do so in the interest of public health, under the legal flexibilities granted by the TRIPS agreement and the Doha Declaration. While those with interests in preserving pharmaceutical profits now try to insist that TRIPS/Doha Flexibilities are limited only to infectious diseases, this is a misrepresentation of the legal rights actually granted by these agreements.
Unless to global community gives developing countries better avenues to give their people affordable access to NCD medicines, they can and will continue to use the flexibilities granted by TRIPS. The Essential Medicines List alone has thus far not been an adequate mechanism for tackling the dramatic price inflation of new and potentially life-saving pharmaceutical products. In order to protect the public health interests of people in LMICs as well as those in our own nations, we desperately need an “access-first” approach to essential medicine policy and pricing, which in turn requires entirely new approaches to research and development.
The WHO Executive Board recently heard from the Consultative Expert Working Group on Research and Development (CEWG). After the release of a groundbreaking report that established a framework and key principles for new R&D models, “demonstration projects” were selected that would ostensibly test these innovative and alternative approaches. University Allied for Essential Medicines does not believe that the demonstration projects adequately reflect the recommendations of the CEWG report. Instead, the WHO generally endorsed more traditional grant proposals. Although suggested by CEWG and project applications, no innovation inducement prizes to delink R&D incentives from product prices were included. No truly new incentive mechanisms were included. Four of the 7+1 demonstration projects do not include clearly defined strategies for access licensing or open knowledge sharing. We feel that with these weaknesses, these demonstration projects are lacking in their potential effect, and will not do much to effectively test or pioneer new R&D processes in their current form.
In summary, in all of the above areas we hope to see much bolder action from the global community to advance truly innovative approaches to research and development, and to ensure that new and groundbreaking medicines are affordable and accessible to all patients in need, regardless of geography or income. We hope our voices as students and as emerging global health leaders can provide some inspiration for new approaches and brave steps forward during the 67th World Health Assembly.