Secure equitable access to treatment for patients

93

d. Open innovation models reduce duplication and costs of RD

As demonstrated by the Open Source Drug Discovery consortium in India, ChEMBL-NTD, WIPO Re: “ea h, the Medi i es fo Mala ia Ve tu e s ope a ess Pathoge Bo o G“K s Ope La , initiatives for open innovation are flourishing, and while it may be too early to evaluate their impact, they are a clear illustration of a trend toward a more open approach to boosting innovation. Health RD to address unmet needs requires new innovative licensing models as well as open models for sharing knowledge and research data. RD strategies based on open innovation models are critical to boost innovation globally, reduce duplication and costs of RD, and speed up delivery of new medicines to patients. DNDi estimates its costs of development to range from EUR 10-40 million for an improved treatment, and EUR 100-150 million for an NCE including attrition rate but not in kind. Although it is difficult to compare costs of development between different business models , the fi st ea s of DNDi s e pe ie e i di ate that i o ati e ‘D odels a both deliver rapidly for patients and potentially be more efficient than the traditional pharmaceutical business model. This may be explained by the more open, collaborative modus operandi, the emphasis on leveraging expertise from a wide range of partners in a non-competitive way, and the fact that DNDi first products capitalized on low-hanging fruits.

e. Innovative regulatory pathways are needed to ensure timely patient access to treatments,

reduce total costs of delivering treatments, and ultimately support greater capacity strengthening in disease-endemic countries Innovative regulatory pathways are needed to expedite access to essential medicines in developing countries, while ensuring that new treatments are safe, effective and of quality, and reduce costs linked to regulatory approvals, while strengthening local regulatory capacity. I add essi g de elopi g ou t ies health eeds, the a gu e t that Western regulatory authorities are the only certified sources to evaluate the quality, safety, and efficacy of medicines should be challenged, in particular for assessing the risks and benefits of health products for diseases predominant in developing countries, for which therapeutic options are often severely limited. It is urgent to strengthen capacities of poorly resourced regulatory bodies in developing countries notably through enhanced formal collaboration with regulatory bodies of well-resourced and experienced drug regulatory authorities particularly in endemic countries or of so- alled st i ge t regulatory authorities, in partnership with WHO Prequalification Programme. It is fundamental to stimulate, support, and promote ongoing regional initiatives that aim at accelerating scientific riskbenefit adjusted reviews and rationalise mutual recognition of regulatory policies within regional zones where disease prevalence is similar 17 . 17 For instance with support from WHO , the African Medicines Regulatory Harmonization AMRH initiative set up with Regional Economic Communities RECs to increase access to good quality, safe and effective medicines through harmonizing medicines regulations, and expediting registration of essential medicines. 94

f. Leadership of disease-endemic countries in the coordination of RD, especially in defining

priorities based on patient needs and in allocating resources to identified priorities. The sustainability of essential health innovation and access critically depends on public leadership in defining needs and setting RD priorities under WHO coordination. It also depends on Go e e ts ole i p io itizi g esea h a d desig i g ade uate atio al poli ies to e su e treatment access for patients. The CEWG report identified inadequate coordination and priority-setting as an important weakness in the existing global RD system and recommended pooling at least 20 of national funds through an international mechanism. The set-up of a Global Health RD Observatory under the auspices of WHO represents an important first step for prioritizing global health RD needs and gaps. A well-managed and transparent Observatory will be essential, especially if funding pools become established. So far there has been no inter-governmental, politically legitimate system for RD priority-setting at the global level, so an Observatory would be a key starting point. While by itself an Observatory will not address all of the challenges posed in the CEWG report, WHO member states should allocate resources to ensure that a Global Health RD Observatory can function. At a minimum, the observatory should perform two critical functions: one that is primarily technical monitoring and o e that is o e politi al, a el , p io it -setting and coordination. In regard to priority setting, the structure, governance, and accountability mechanisms are critical and need to be carefully designed. 18 In addition, the set-up of a pooled fund for health RD hosted by WHOTDR, as agreed to consider by WHO Member States 19 ,could facilitate additional commitments from public funding from a wide range of traditional donors as well as emerging economics and other low- and middle-income countries. Financial participation of pooling would not only facilitate coordination, but could also help ensure that global public priority-setting processes would be matched with at least some financial resources 20 . New sustainable financing mechanisms and increased resources are necessary to provide adequate, predictable funding, and ensure public responsibility in addressing global health RD needs. 18 IOM Peter Hotez, Rachel Cohen, Carol Mimura, Tadataka Yamada. Stephen L.Hoffman, and Deepali M. Patel. Strenghtening Mechanisms to Prioritize, Coordinate, Finance, and Execute RD to Meet Health Needs in Developing Countries, January 2013. http:www.iom.eduGlobalPerspectives2013StrengtheningMechanismsRD.aspx 19 WHA6715 point 4 noted, without prejudice to future discussions in the context of recommendations of the Consultative Expert Working Group on Research and Development Financing and Coordination and actions on other sustainable mechanisms for financing health research and development, the assessment made by the Secretariat and the possibility of using an existing mechanism to host a pooled fund for voluntary contributions towards research and development for type III and II diseases and the specific research and development needs of developing countries in re latio to t pe I diseases . http:apps. ho.i tg e hapdf_filesWHA A _DIV - en.pdf 20 Moon Suerie, MPA, PhD, Demonstrating financing: considerations for a pilot pooled international fund for RD. May 2014. http:www.dndi.orgimagesstoriesadvocacypilot-pooled-international-fund_web.pdf