Leveraging of existing knowledge and expertise through solid alliances with public and

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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.