Solomon Nwaka, African Network for Drugs and Diagnostics Innovation

Name of Lead Author: Solomon Nwaka
Organization: African Network for Drugs and Diagnostics Innovation
Country: Ethiopia

ABSTRACT

Achieving Sustainable Development Goal 3, and related 2030 development goals will require coordination and support for enhanced discovery, development and delivery of essential health technologies within Africa and other developing countries. We present African Network for Drugs and Diagnostics Innovation (ANDI), as a sustainable and bottom-up model to promote research, innovation and access to health technologies to improve health and wellbeing of people developing countries, especially. The model leverages available local capacity to support technology development and market entry to improve health care delivery in Africa. It aims to create a sustainable platform for health innovation in Africa. This means that capacity is built around projects and outcomes and impact are measurable. The core activities of ANDI include: a) Needs and gap analyses as well as identification of viable project opportunities; b) Brokerage and establishment of partnerships among local and external partners (global partnerships) to support project validation, coordination and capacity building as well as transition to scale and market access. Training for management of intellectual property, technology transfer and licensing are integral part of this approach; and c) Advocacy and networking to enhance R&D output through knowledge exchange and open knowledge platforms. We believe that our contribution meets the criteria established by the High Level Panel. The approach creates sustained local innovation, human resource development, public-private partnerships as well as development of private sector and social enterprises in Africa, all in support of increased access to essential health technologies to poor populations. Local regulatory and policy frameworks that support such efforts should be fast-tracked, including through capacity building.

Submission

Promoting Locally Driven and Integrated Model for R&D and Access to Essential Medicines

1. Introduction
In the developing world, over six million people die from neglected diseases such as malaria, sleeping sickness as well as the lesser known parasitic diseases (1). In addition, over 360 million disability-adjusted life years (DALYs) are lost globally due to these diseases (1). The African continent bears the greatest burden of these diseases, and is currently experiencing a surge in deaths due to non-communicable diseases such as cardiovascular disease, cancer, diabetes and respiratory diseases. Unfortunately sustained indigenous research and development (R&D), manufacturing and access mechanisms for health technologies (drugs, vaccines, devices/diagnostics and other health tools) needed by its citizens have not received much attention.

A recent article by heads of the WHO, UNAIDS and UNIDO titled “Commodities for better health in Africa – time to invest locally” (2), states: “Now is the time to forge new partnerships that can support all African countries. The goal is to address health inequities and build capacity to meet supply shortages for essential health commodities that cannot be sourced reliably and sustainably from outside the continent. Africa remains dependent on imported medicines and other health technologies – a risky situation in a continent with the world’s highest prevalence of HIV. The 7.6 million Africans living with HIV now on antiretroviral treatment and millions more waiting depend on 80% of antiretroviral medicines being imported from outside the continent. The local production of medicines and other essential health commodities is important for all health challenges faced by the continent. Demand for health commodities is growing rapidly. The ageing population in Africa requires access to a growing range of medicines and assistive technology that cannot be met with Africa’s existing manufacturing capacity and sources of supply. The world is calling for a new, more inclusive global development framework for the post-2015 era.” While the article focused on local manufacturing, the argument is also true for R&D for health technologies.

1.1 Health R&D and innovation landscape in Africa
A landscape analysis that informed the establishment of the African Network for Drugs and Diagnostics Innovation (ANDI) (3, 4), showed that significant health R&D capacity exists in different parts of Africa, but this capacity is fragmented, uncoordinated, and not properly utilized to address the continent’s health challenges. It further showed that lack of intracontinental collaboration and low levels of investment, contributes to gaps in the continental R&D, a lack of local ownership, and suboptimal utilization of available research capability.
Consistent with these results, a new analysis by ANDI and partners, based on publication outputs by African scientists with their global peers between 2010 and 2015 show the following trends for 20 prevalent African diseases and technologies:

a) Of some 7.5 billion articles produced from 2010 to 2015, only about 0.4% include African authors, suggesting that Africa still lags behind in health research and innovation;
b) A number of African institutions are leaders in their areas of focus, suggesting that scale and technical know-how can be improved if more partnerships are created with established institutions (Figure I);
c) Intra-African networks are not well articulated (Figure I), but national clusters are improving and most of the time a foreign institution serves as a bridge between African countries.
Regarding patents, only about 0.22% of patents filed globally in 2014 for the same indications originated from African innovators, suggesting that Africa represents a small subset in terms of innovation as measured by patent filing, and highlights the need to support local innovation (Figure II).

These data support: a) The need to invest in the translation of African innovations from bench to market by leveraging existing capacity; and, b) The concerted focus of ANDI in building capacity and partnerships to address the health needs of the African population through both intra-African collaboration as well as North-South and South-South collaborations.

Figure I:  Pattern of collaboration in traditional medicines R&D. Intra African Collaboration is timid. Cities where most connected institutions are located are shown as top 20 institutions.

Figure II: Patenting trends for key diseases and technologies of interest to Africa. Average of 0.2% of patents emerge from Africa.

We present ANDI as a sustainable and bottom-up model to promote research, development and access to health technologies to improve health and wellbeing, as envisaged by Sustainable Development Goal (SDG) 3, and related 2030 Agenda for Sustainable Development. We discuss the ANDI’s operational model and how it can contribute to the sustainable implementation of SDGs and related global and regional strategies, if properly resourced. Indeed, the work of ANDI touches on others SDGs that deal with innovation, partnerships, poverty alleviation, water and sanitation (5).

2. ANDI Mission, Vision and Operational Model
ANDI’s mission is to promote and sustain African-led health innovation to address the continent’s health needs through the assembly of collaborative networks, and building of capacity to support public health and development.
ANDI’s vision is to create a sustainable platform for health innovation in Africa to address the health challenges of the continent and populations in need.

2.1 Value Proposition
Since 2008, ANDI has been promoting the need to harness the untapped power of local collaboration as well as equitable North-South and South-South partnership, towards health R&D and technology development aimed at solving the basic health challenges of the African continent and other developing countries. It supports translation of local technologies from laboratories to markets. ANDI offers a clear understanding of the medical needs, ongoing health R&D and innovation activities and capabilities, as well as pan-African due diligence on ongoing innovations. Through its initiative on mapping the R&D landscape in Africa, pan-African COEs, Innovation Awards and regional hubs, as well as project identification, fellowships and training, ANDI could determine those R&D programs most likely to lead to potential products that meet the needs of the African population. ANDI’s pan-African granting experience has allowed ANDI access and better understanding of the state of science across more than 50 countries.

2.2 ANDI’s Open Innovation and Business Model
The basic principle for ANDI’s open innovation and business model (Figure III) lies in the realization that a more integrated and holistic partnership approach that shares lessons across diseases and technology platforms promises to be more successful in the African context, where resources are very limited (6).

Figure III: ANDI Innovation and Business Model – aligns available R&D and technology development expertise with specific diseases or health conditions in an integrated and holistic way.

The model leverages available local capacity to support technology development and market entry to improve health care delivery in Africa. This means that capacity is built around projects and outcomes and impact are measurable. The core function and activities of ANDI are: a) Needs and gap analyses as well as identification of viable project opportunities; b) Brokerage and establishment of partnerships among local and external partners (global partnerships) to support project validation, coordination and capacity building as well as transition to scale and market access. Training for management of intellectual property, technology transfer and licensing are integral part of this approach; and c) Advocacy and networking to enhance R&D output through knowledge exchange and open knowledge platforms.

2.3 ANDI as a Facilitator and Catalyst
ANDI’s Strategic Plan defines the role of ANDI as a “broker”, “facilitator” and “catalyst” in advancing local technologies with potential for impact in Africa and other developing countries (6). To this end, ANDI is focusing on filling a critical gap by driving local innovations out of the so-called 'valley of death' that will lead to eventual commercialization and impact. This will not only have positive impact on public health, but also human resource development and job creation - all of which contribute to sustainable development. In the developed world and advanced economies, clear processes for addressing resource needs that bring concepts into development exist, but in developing countries especially within Africa, such mechanisms are not readily available, and where they do, they are in their infancy.
Consistent with the above, recent reports have shown that numerous technologies that come out of African laboratories with the potential to support healthcare are not further developed due to lack of suitable mechanisms to support rigorous proof of concept, scale up, commercialization and marketing (7, 8, 9, 10). Also, local mechanisms for addressing transition of technologies from laboratory to industry, including IP and financing mechanism are not well established.

These are significant gaps and a niche that ANDI is focusing on through partnership with others. The ANDI-supported bCPAP (Pumani) for newborn with respiratory distress and phototherapy device for children with jaundice, progression of diagnostic kits to support the control and elimination of schistosomiasis, cell phone based coding system for diagnosis and monitoring of disease, and the reformulation of NIPRISAN for sickle cell disease in Africa, are such projects which require a truly innovative financing model to further support validation, industry scale up and market access. Figure IV shows a summary of ANDI’s growing portfolio of project and initiatives

Figure IV: ANDI Portfolio – specific projects are circled. 43 ANDI pan African Centres of Excellence are shown in blue. These centres support project and capacity building. ANDI’s innovation awards and needs assessment initiatives are not shown.

The implementation of these activities is supported by a growing number of pan-African Centres of Excellence (CoEs), which ANDI identifies, based on a transparent and criteria based process. These CoEs are the engine for project implementation, capacity building, tech-transfer and concerted North-South and South-South collaborations.

3. Lessons Learned, Challenges and Opportunities
ANDI has passed through several challenges and successes, and as a growing organization has drawn lessons to improve its work.
Lessons Learned: Some of the lessons include: a) Many African institutions focus on R&D that can address local health needs but lack sustained support to translate research into policy and health products. Given adequate incentives, African institutions are very keen on working together or partnering on projects that can transform health care delivery in Africa; b) Intra-African collaborations or networks as well as local leadership are very important for success; c) The perception by many from within and outside of Africa is that ANDI’s vision, mission and modus operandi are unique and more relevant today than ever before; and, d) The ANDI model can make significant impact with modest but steady funding stream (which is presently lacking).

Challenges: Human and financial sustainability remains a major challenge for ANDI and its work. Experiences over the past few years have shown that ANDI can make significant contribution to enhancing health innovation in Africa with a modest but steady funding stream. ANDI is working on two potential financing or resource mobilization pathways to support its work and attain sustainability: a) Grant and subscription-based funding for the generation of core and non-core funding to be held as Pooled Fund; and, b) An Impact or Social Venture Fund, to be professionally managed for growth and impact.
ANDI’s human resource challenges are linked to financing. Presently, ANDI has nine full time equivalents in addition to successful use of volunteers secured through the United Nations Volunteers program. Additionally, ANDI has established as secondment program whereby partners and stakeholders can second staff to the ANDI Secretariat. While these approaches are promising and should be promoted more broadly, ANDI needs a critical mass of full time Secretariat staff to support its technical, advocacy and fundraising work – this will contribute to sustainability.

Opportunities: Notwithstanding the challenges described above, some of the opportunities that ANDI is working to maximize include: a) Post-2015 development agenda and SDGs as well as relevant regional declarations in Africa such as the AU Agenda 2063; b) Increasing interest to support and advance local innovations, through regional R&D, manufacturing and regulatory initiatives; c) Limited pan-African initiatives engaged in the implementation of global and regional strategies or resolutions on health R&D and technology development; d) Expressed commitments by stakeholders including African government and development partners in support of initiatives like ANDI, such as the Global Strategy and Plan of Action (GSPoA) on Public Health, Innovation and Intellectual Property (10), various G7 and regional commitments; e) Over 40 CoEs spread across the continent with potential for collaboration on projects and capacity building; g) Enthusiasm by African researchers, institutions and CoEs to become more engaged in addressing the needs of the continent; and f) Need to validate the regional regulatory harmonization efforts in Africa with projects that emerge from Africa (11), for example through the work of ANDI and its partners.

4. Organizational Structure
ANDI’s organizational structure consists of the governing bodies and Secretariat (Figure V). This structure acknowledges the substantial geographical, cultural, and epidemiological differences within the Continent as well as the need for robust governance and oversight support structures.

Figure V. ANDI Organization Structure

4.1.1. ANDI Governance
The Board is the highest governing body that ensures a wider stakeholder representation. It drives strategic design and policy making, which in turn are implemented and operationalized by the Secretariat. The responsibilities of the Board are three-fold: a) Determines ANDI’s strategy and priorities; b) Approves work-plans and budget; and c) Defines the advocacy strategy and supports its implementation by engaging with governments, businesses and individuals.
The three committees of the Board include: a) The Executive Committee of the Board (ECB) with the responsibility of regularly monitoring the work of the Secretariat and making recommendations to the Board. The ECB also provides policy and operational support to the ANDI Secretariat. The ECB is made up of the Chairperson, Vice Chair and Executive Director of ANDI; b) Fundraising Committee of the Board (FCB) that supports the Board and Secretariat on fundraising in accordance with its terms of reference. Its membership includes the Chair of the Board, Executive Director, and other representatives approved by the Board; and, c) The Scientific and Technical Advisory Committee (STAC) that provides independent scientific and technical advice to the Board and the ANDI Executive Director in accordance with its terms of reference. Although STAC is highlighted as a committee of the Board, it should be noted that STAC is an independent body that is composed of independent experts acting on their individual capacity.

4.1.2. ANDI Secretariat
ANDI is a partnership presently hosted by and derives its legal status from the United Nations Office of Project Services (UNOPS). That said, the long-term goal of ANDI is to become a fully independent intergovernmental entity. A fully functional ANDI Secretariat will continue to be lean (about 22 full time Secretariat staff plus volunteers), with a headquarters or central office and regional hubs in the five regions of Africa (Figure VI). Presently, ANDI is working with about nine full time staff members and 4 volunteers.

Figure VI: ANDI Secretariat Organogram. Note the lean and relatively flat structure of the ANDI Secretariat.

5. Monitoring, Evaluation and Reporting
A results based monitoring and evaluation framework with inputs, outputs, outcomes and impact are employed by the ANDI. Clear indicators that guide the Secretariat in its daily work as well as support the ANDI Board, STAC and Stakeholders in their oversight and evaluation of the work of ANDI. Risk assessment and management practices are employed in the management and oversight of ANDI.

6. Conclusion
We believe that our contribution meets the criteria established by the High Level Panel: a) it addresses policy incoherence as they relate to inequity in innovation and access to medicines, and promotes use of existing international frameworks such as TRIPS flexibilities. Our approach delinks the cost of R&D from the price of final product, b) the outcomes and impact of our approach include sustained access to easy to use, affordable and quality health technologies. The approach create sustained innovation, human resource development, public-private partnerships as well as development of private sector and social enterprises in Africa in support of local innovation, c) Our contribution requires enhanced political and financial support for the goals to be achieved and sustained. The institutional and governance structures are in place and there is room to further strengthen them. Our contribution advances sustainable health outcomes by ensuring that that the people most affected by diseases take the lead in addressing the health challenges that affect them the most, and d) Our contribution and approach is evidence based.

Imagine a world where African countries, initiatives and laboratories are contributing significantly in the discovery, development and delivery of the health products that they need the most. Local regulatory and policy frameworks that support such efforts should be fast-tracked, including through capacity building. A successful implementation of the SDGs would require such a bottom up approach.

References and Bibliography

1. Institute for Health Metrics and Evaluation (IHME). Global Burden of Disease Study 2010 (GBD 2010) Results by Cause and by Region 1990-2010, 2013. [Accessed online Feb 9th 2016]: http://ghdx.healthmetricsandevaluation.org/global-burden-disease-study-2010-gbd-2010-data-downloads
2. Sidibé M, Yong L, Chan M. Commodities for better health in Africa – time to invest locally, 2014. Bulletin of the World Health Organization; 92:387-387A. DOI: http://dx.doi.org/10.2471/BLT.14.140566
3. The Strategic and Business Plan for ANDI 2010-2015. [Accessed online Feb 9th 2016]: http://www.who.int/tdr/publications/documents/sbp_andi.pdf
4. Nwaka S. et al. Developing ANDI: A Novel Approach to Health Product R&D in Africa, 2010. PLoS Med 7(6): e1000293. DOI: 10.1371/journal.pmed.1000293. http://journals.plos.org/plosmedicine/article?id=10.1371/journal.pmed.1000293
5. Sustainable Development Goals. [Accessed online Feb 9th 2016]: http://www.un.org/sustainabledevelopment/
6. The Strategic Plan for ANDI 2016 – 2020 (to be publicized shortly).
7. Nwaka S. et al. Analysis of pan-African Centres of excellence in health innovation highlights opportunities and challenges for local innovation and financing in the continent, 2012. BMC Int Health Hum Rights 12(11): DOI: 10.1186/1472-698X-12-11.
8. Nordling L. Changing council, 2014. Nature Medicine 20:113–116 DOI:10.1038/nm0214-113.
9. Mackintosh (Ed) et al. Making Medicines in Africa; The Political Economy of Industrializing for Local Health 2015. [Accessed online Feb 9th 2016]: http://www.palgraveconnect.com/pc/doifinder/view/10.1057/9781137546470
10. The Global Strategy on Public Health Innovation and Intellectual Property. [Accessed online Feb 9th 2016]: http://www.who.int/phi/publications/gspa-phi/en/
11. Ndomondo-Sigonda M, Ambali A. The African Medicines Regulatory Harmonization Initiative: Rationale and Benefits, 2011. Clin Pharmacol Ther. DOI: 10.1038/clpt.2010.299

David Webb, British Pharmacological Society

Name of Lead Author: Professor David Webb
Organization: British Pharmacological Society
Country: United Kingdom

Abstract

The British Pharmacological Society (BPS) is a UK learned society with the mission of promoting and advancing the whole spectrum of pharmacology, and a leading organisation in the practical application of pharmacology around the world. BPS acknowledges the importance of the various criteria outlined in the Call for Contributions around widening access to medicines and seeks to contribute in the areas of ‘Impact on Public Health’ and ‘Implementation’.

The importance of adequate healthcare infrastructure and systems, to allow newer medicines to be used appropriately, monitored as necessary and for adverse effects to be managed effectively is emphasised. The specialist skills of pharmacologists are felt to be particularly useful for the task of managing medicines utilisation.

The processes and activities required to maximise the benefits, in terms of population health, of widened access to medicines, and the roles in which pharmacologists could/should take leadership roles to optimise the use of medicines, maximising benefits and minimising (or managing) risks, are described. These processes/activities are categorised by the locus of intervention, namely national or regional/local levels.

Wider access to medicines will only achieve the greatest impact on population health if the outlined processes/activities form a central part of implementation procedures, and are carefully integrated such that prescribers get clear and consistent advice and information. The training and experience of pharmacologists in all of these areas place them, almost uniquely, in the ideal situation to ensure the essential harmonisation and consistency of advice.

Although there are individual physicians with informal interests in therapeutics and clinical pharmacology in most countries, those with the best training and experience to provide leadership in the context of wider access to medicines (namely clinically-trained pharmacologists) are in particularly short supply in developing countries, where widened access to medicines will pose real medicines management challenges.

Submission

The British Pharmacological Society (BPS) is the primary UK learned society concerned with research into drugs and the way they work. Our nearly 4,000 members work in academia, industry, regulatory agencies and the health services, and many are medically qualified. The Society covers the whole spectrum of pharmacology, including laboratory, clinical, and toxicological aspects.

BPS is pleased to have the opportunity to offer its input to the deliberations of the UN Secretary-General’s High-Level Panel on Access to Medicines. We note the main focus of the Panel on policy incoherence, particularly lack of coherence amongst the needs of medicines developers, the precepts of human rights legislation and the requirements of trade legislation. These are very important issues that we readily acknowledge impact on access to medicines worldwide, but they are not primary areas of expertise for the BPS.

We also note, however, that the panel seeks contributions in the areas of ‘Impact on Public Health’ and ‘Implementation’, and it is in these areas that we believe we have experience and expertise which may be of value.

While access to medicines is a public health issue in all countries, we believe that simply improving access, both to old and new medicines, will not, of itself, improve public health outcomes optimally. Healthcare infrastructure must be in place to allow newer medicines to be used appropriately, monitored as necessary and for adverse effects to be managed effectively. Thus, for example, wider access to medicines for reducing cardiovascular risk will still require the availability of methods to measure underlying cardiovascular risk (blood pressure and lipids levels), while newer medicines for treatment of diabetes requite access to blood glucose measuring technologies. Some drugs require monitoring of plasma levels of the drug in order that they are used effectively and safely (e.g. gentamicin, some anticonvulsants). New biologic agents such as anti-TNF medicines are highly effective in many inflammatory diseases but can produce serious adverse effects (e.g. re-activation of tuberculosis, invasive fungal infections) – the balance of risk and benefit with these medicines only favours benefit if methods to identify and monitor these serious adverse effects are in place.

Beyond ensuring that the appropriate healthcare infrastructure is in place, improved access to medicines will produce the best population health outcomes only if they are used most appropriately, which requires that they are managed within the prevailing healthcare system. The task of managing medicines utilisation is one where the skills of pharmacologists, including those with additional clinical training (referred to as ‘clinical pharmacologists’), are particularly useful (Aronson, 2010; Birkett et al., 2010).

The last decade in particular has seen the role of clinical pharmacologists in high-income countries develop significantly, moving them from a largely research role into leaders in areas of medicines policy development, prescribing monitoring and management of medicines use. Such developments have not always been mirrored in other countries, where many (even the majority) of clinically trained pharmacologists working in medicines research and development, often in the pharmaceutical industry, leaving the healthcare system without their important expertise (Zagorodnikova et al., 2015)

We hope it will be useful to outline in more detail the processes we feel are required to maximise the benefits of wider access to medicines and the roles in which pharmacologists can and do take leadership roles to maximise the benefits (and minimise the risks) of drug therapy (Aronson, 2012a and 2012b)

Processes and Activities at National Level

Drug licensing/registration – with widened access to medicines, it will be important that national drug licensing/registration processes are in place in each country to ensure that the ‘risk:benefit’ profile of each medicine favours benefit over risk in the population of each country. Racial, genetic and co-morbidity factors may make the risk:benefit assessment different in different populations, or at least identify sub-groups of patients in whom the risk:benefit profile may be adverse. Pharmacologists are ideally trained to lead on these assessments and ensure that new medicines are really likely to benefit overall health.

Health Technology Assessment – health technology assessment (HTA) is defined as “the systematic evaluation of the properties and effects of a health technology, addressing the direct and intended effects of this technology, as well as its indirect and unintended consequences, and aimed mainly at informing decision-making regarding health technologies”. It is highly appropriate that medicines are subject to HTA if the most efficient use of limited financial resource is to be achieved. Those countries which have adopted a robust HTA approach to medicines (e.g. United Kingdom, Sweden, Australia, Canada) have shown repeatedly that newer and more expensive medicines do not necessarily lead to improved patient outcomes, and that for many patients very similar outcomes can be achieved with the use of older (and usually considerably cheaper) drugs. This frees resources in the healthcare system for the use of more expensive products of proven clinical advantage where appropriate, achieving greater population health-gain with the same use of resources.

Clinical pharmacologists are very well placed to lead on HTA of medicines, providing useful clinical and scientific inputs to sit alongside inputs from (for example) health economists. Experience in the UK suggests that it is the clinical uncertainties (rather than economic uncertainties) that pose the biggest challenges in HTA of medicines and so those with pharmacological expertise are of particular value.

It is noteworthy that the founding Chairs of the 3 national medicines HTA bodies in the UK (the National Institute for Health and Care Excellence (NICE), the Scottish Medicines Consortium (SMC) and the All-Wales Medicines Strategy Group (AWMSG)) were all clinical pharmacologists, as have been many of their successors.

Guideline development – rational and efficient use of medicines can be helped by the development of locally-relevant evidence-based clinical guidelines. These aim to ensure that the right medicine(s) get to each patient to maximise the health benefits while avoiding over-treatment, which wastes resource and may lead to undesirable side-effects for patients. Clinical pharmacologists are well placed to be involved, alongside relevant clinical specialists, in developing such guidelines; though there are many internationally-developed guidelines available, evidence suggests that developing guidelines locally (or adapting international guidelines to local circumstances) improves adherence to the guideline, optimising its impact.

While clinical specialists have a key role in guideline development, the clinical pharmacologist adds value from a more detailed knowledge of the individual medicines and also an understanding of potential problems (such as drug:drug interactions) in patients with multiple co-morbidities, an increasingly common situation in all countries.

Formulary development – the development of a formulary or ‘limited list’ of medicines that are therapies of first or second choice can improve both the effectiveness and safety of prescribing. Prescribers become familiar with a small number of frequently used medicines, aware of indications, dosage and adverse effects; this can avoid prescribing errors, which otherwise can have adverse outcomes. Use of the same ‘formulary’ in primary and secondary care facilitates patient care as they move between these sectors and avoids undesirable changes in therapy.

Hospital and community pharmacies can also hold stocks of fewer individual medicines; that simplifies and reduces their workload and may allow financial savings if less total drug stock has to be held. Adherence to formulary recommendations can also be a useful index of prescribing quality and can be fed back to individual prescribers with a view to quality improvement.

The formulary content should be carefully harmonised with the content of clinical guidelines and outcome of medicines HTA reviews to avoid any ‘mixed messages’ to prescribers. Clinical pharmacologists are ideally placed to develop and maintain formularies. Note that in larger countries, or where there is significant heterogeneity in healthcare provision within a country, it may be appropriate to develop formularies at more local or regional levels (see other activities below) (Reynolds, Fajemisin and Wilds, 2012).

Processes and Activities at Regional/Local Level

Education of prescribers – wider availability of medicines will require substantial educational input to prescribers to ensure that medicines are used effectively and safely. While some of this work can be done through guidelines (see above), there is also a need for more personalised education delivered directly to prescribers. This is particularly true in the context of multiple co-morbidities, which may find prescribers faced with significant poly-pharmacy (many medicines) and, for some patients, conflicting or mutually exclusive treatment options. In these circumstances, real knowledge and understanding of medicines, rather than simple following of guidelines or protocols, are essential. Indeed, there may be circumstances in which knowledge of medicines and good prescribing practice may require to be formally assessed before allowing an individual clinician to prescribe.

Individual prescribers or clinical specialists may take a lead in these initiatives, but there is a significant risk that educational and assessment activities will be overlooked in the general enthusiasm to introduce new therapeutic options. Clinical pharmacologists are ideally placed to act as leaders, developing and delivering education and assessment packages and co-ordinating the activities and inputs of others (Williams, 2012).

Good prescribing practice and medication errors – widened access to medicines will only be safe and effective if the right medicine (at the right dose, the right time and the right route of administration) gets to each patient. Prescription errors are a significant patient safety concern in all healthcare systems. While education can help reduce errors, it is important that good prescribing processes (and recording of prescribing) are in place as getting these processes correct can significantly reduce the risk of errors. In addition, monitoring of actual errors, analysis of causes, feedback to prescribers and improvements to prescribing practice are all needed to create a safety culture and minimize the risks to patients. Clinical pharmacologists are trained in this area and can take a system-wide approach to minimizing errors and improving safety in all clinical areas (e.g. primary and secondary care) (Agrawal et al., 2009).

Local protocol development – while nationally-developed evidence-based guidelines are very important, there will frequently also be the need to develop local prescribing protocols, showing how guideline recommendations are to be implemented in clinical settings at local or regional level. Clinical specialists need to be closely involved, but again clinical pharmacologists can take a lead role in protocol development. Indeed, by overseeing protocol developments across a wide range of therapies, they can ensure consistency of approach and harmonisation across protocols, both important to promote the safest use of old and new medicines (Reynolds and Barker, 2012).

Anti-microbial stewardship – the worldwide developing problem of anti-microbial resistance is a challenge to all healthcare systems and to public health policy. Programmes aimed at controlling the use of anti-microbials, both in terms of number of patients treated and type of anti-microbial used, can make significant positive differences to patterns of antimicrobial resistance. Such programmes often involve use of locally-developed protocols or guidelines, coupled with monitoring of actual anti-microbial prescribing (and anti-microbial resistance patterns) and feedback to prescribers on adherence to protocols (or even incentivising prescribers to follow guidelines). These programmes are often described as ‘anti-microbial stewardship’.

Clinical pharmacologists are trained in good anti-microbial use, can readily act as a link between microbiologists and prescribers (around local patterns of anti-microbial resistance), and understand (and can develop) methods of monitoring prescribing to allow the feedback which has been shown to be a big driver of prescribing change.

Additional Notes on Processes and Activities

Wider access to medicines will, we believe, only achieve the greatest positive impact on population health if these processes and activities form a central part of the implementation procedure. In the ideal scenario, these processes and activities would be in place, tried and tested before additional therapy options were introduced, but if this is not possible then the new processes should be introduced alongside new medicines as part of wider access implementation.

Most importantly, the processes and activities described above must all be carefully integrated such that prescribers get clear and consistent advice and information. For example, only licensed medicines should be subject to HTA, and only medicines approved by HTA should be recommended in clinical guidelines, local protocols and be found in formularies, while educational activities should focus on medicines in formularies and protocols. This aim should maximise the appropriate use of medicines and minimise inappropriate use (or use of inappropriate medicines), bringing the greatest patient (and public health) benefits at the least cost, thus allowing even more patients to be treated.

While individual clinical specialists, both physicians and pharmacists, have much to contribute to many of these processes and activities, the training and experience of clinical pharmacologists in ALL of these areas places them, almost uniquely, in the ideal situation to ensure the essential harmonisation and consistency of advice.

Clinical Pharmacology in Developing Countries

We have noted that clinical pharmacologists are well placed to take leading roles in the implementation activities described above. The specialty is small but well developed in higher-income developed countries but the situation is rather different elsewhere. The status of clinical pharmacology in developing countries was reviewed in 2013 by Walubo (2013) – it would not be sensible to attempt to summarise his excellent paper here, but some interesting points include:

• Of 52 African countries, only 5 have a pharmacology society and only 1 (South Africa) recognises the specialty of clinical pharmacology
• Of 18 Latin American countries, only 7 have a pharmacology society and none recognises the specialty of clinical pharmacology
• Of 26 Asian countries, only 8 have a pharmacology society and only 3 (Philippines, India and Thailand) recognise the specialty of clinical pharmacology

While there are probably individual physicians with informal interests in therapeutics and clinical pharmacology in most countries, we believe that the above data suggest that those with the best training and experience to provide leadership in the context of wider access to medicines are in short supply. Even in India, where training programmes and specialty recognition exist, the great majority of clinical pharmacologists work within the pharmaceutical industry, possibly making their skills unavailable to the health-care system (Kshirsagar et al., 2013).

While, as noted above, we regard the implementation processes and activities as more important than the identity of those providing leadership, we think that development of ‘medicines management leaders’ in countries with limited clinical pharmacology resources is a priority alongside wider access to medicines (Lehmann, Stork and Guharoy, 2006).

Summary of main points:

• Adequate healthcare infrastructure and systems must be in place to allow both newer and current medicines to be used appropriately, monitored as necessary and for adverse effects to be managed effectively.
• Clinically trained pharmacologists have many skills to offer in the task of managing medicines within the healthcare system.
• Processes and activities should be built or improved at national level in anticipation of widened access to medicines by establishing drug licensing/registration systems, conducting the systematic evaluation of the properties and effects of health technologies, and developing locally-relevant evidence-based clinical guidelines and formularies or “limited lists” of medicines that are therapies of first or second choice.
• Processes and activities should be built or improved at regional/local level by providing education for prescribers, developing local prescribing protocols and mechanisms for anti-microbial stewardship.
• These processes and activities should form a central part of the implementation procedure of widening access to medicines and should be carefully integrated.

Bibliography and References

Agrawal A et al. (2009) Medication errors: problems and recommendations from a consensus meeting. British Journal of Clinical Pharmacology, 67(6): 592–598. doi: 10.1111/j.1365-2125.2009.03414.x

Aronson, Jeffrey K. (2010) A manifesto for clinical pharmacology from principles to practice. British Journal of Clinical Pharmacology, 70(1): 3–13. doi: 10.1111/j.1365-2125.2010.03699.x

Aronson, Jeffrey K. (2012a) Balanced prescribing – principles and challenges. British Journal of Clinical Pharmacology, 74(4): 566–572. Published online 2012 September 5. doi: 10.1111/j.1365-2125.2012.04413.x

Aronson, Jeffrey K. (2012b) What do clinical pharmacologists do? A questionnaire survey of senior UK clinical pharmacologists. British Journal of Clinical Pharmacology, 73(2): 161–169. doi: 10.1111/j.1365-2125.2011.04079.x

Birkett D et al. (2010) Clinical pharmacology in research, teaching and health care: Considerations by IUPHAR, the International Union of Basic and Clinical Pharmacology. Basic & Clinical Pharmacology & Toxicology, 107(1): 531–559. doi: 10.1111/j.1742-7843.2010.00602.x

Kshirsagar NA et al. (2013) Clinical pharmacology training in India: Status and need. Indian Journal of Pharmacology, 45(5): 429–433. doi: 10.4103/0253-7613.117718

Lehmann, DF, CM Stork, and R Guharoy (2006) Hospital pharmacology: An alternative model for practice and training in clinical pharmacology. Journal of Clinical Pharmacology, 46(8): 850-4.

Reynolds, DJ and CI Barker (2012) The roles of clinical pharmacologists in formulating medicines policy locally. British Journal of Clinical Pharmacology, 73(6): 931–933. Published online 2012 February 23. doi: 10.1111/j.1365-2125.2012.04240.x

Reynolds DJ, O Fajemisin, and S Wilds (2012) Local formularies. British Journal of Clinical Pharmacology, 74(4):640-3. doi: 10.1111/j.1365-2125.2012.04269.x

Walubo, Andrew (2013) The current status and trend of clinical pharmacology in developing countries. BMC Pharmacology & Toxicology. Published online 2013 Sep 28. doi: 10.1186/2050-6511-14-49

Williams, David (2012) Monitoring medicines use: the role of the clinical pharmacologist. British Journal of Clinical Pharmacology, 74(4): 685–690. Published online 2012 May 3. doi: 10.1111/j.1365-2125.2012.04316.x

Zagorodnikova, GK et al. (2015) Clinical pharmacology in Russia - historical development and current state. European Journal of Clinical Pharmacology. 71(2):159-63. doi: 10.1007/s00228-014-1787-6

Dennis Liotta, Emory Univeristy

Name of Lead Author: Dennis Liotta
Organization: Emory University
Country: United States

Submission

Extending the DRIVE Model to Africa by Dennis Liotta
Presented at a TEDx held at the United Nations Office in Geneva on 11th February, 2016 by Dennis Liotta

Zika Virus. Dengue Fever. Chikungunya. These diseases, which are all transmitted by the Aedes mosquito, afflict millions of people around the world. Very recently, the WHO, for only the fourth time in its history, declared the current Zika virus outbreak to be a global health emergency. Although Zika Virus, Dengue Fever and Chikungunya have all been known for decades, no drugs have ever been developed to treat them. Why? Because their markets are too small to gain the attention of pharmaceutical companies.

The cold, hard truth is that it can cost billions of dollars and take over a decade to develop a new drug. So, pharmaceutical companies almost always pursue drugs for diseases likely to result in the largest profits. Unfortunately, this model is ill suited for diseases that primarily afflict the poor of the world – the so called neglected diseases.

The Centers for Disease Control in Atlanta estimates that annually 3 billion people worldwide are at risk of contracting a neglected disease and, of those, more than half a million people each year will die. So, just imagine the worldwide impact if we could develop a viable approach for creating drugs for neglected diseases!In 1990, when this picture of a young man dying of AIDS appeared on the cover of LIFE magazine, the virus was taking the lives of many of our most promising and creative people. At the time AIDS was a neglected disease, since infected patients didn’t live long enough to create a sustainable market. During this period, I was an organic chemistry professor at Emory University and saw an opportunity to use my skills and experience to help get this heartless killer under control. So, I made it my personal goal to create drugs that were so effective that AIDS could be transformed from a death sentence to a manageable chronic disease.

After some time my lab was able to prepare some promising new compounds and file our first US patent application on them on Feb. 1, 1990, which, fortuitously, was seven days ahead of our competition. This proved to be the crucial step in securing our rights to the drugs, lamivudine and emtricitabine, both of which have profoundly transformed how we treat HIV infected patients.

When combination therapies first became available in the mid 1990s, patients were required to take 15 to 20 pills each day, some before they ate and some after they ate. Due to the complexity of the regimens, non-compliant patients were at risk of developing resistance. By 2006, however, patients could take Atripla, which combines three drugs, one of which is emtricitabine, into a single daily dose. This regimen is so effective that patients who take it can now live virtually normal lives for decades. In the United States we estimate that over 90% of all HIV infected persons on therapy take or have taken one of our drugs.

Our success here, which shows that drugs can come from sources other than pharmaceutical companies, also had a downside. It took thirteen years to develop emtricitabine and I’ve often wondered how many lives were lost during that time.

Clearly, we needed a better way to develop drugs, particularly drugs for neglected diseases.

To do this, we must find ways of catalyzing more research in this area. One novel approach to this comes from networking organizations, like WIPO Re:Search, that match innovators with potential partners to create a kind of “speed dating” mechanism for early stage therapeutics development.

Secondly, we need to address the funding gap in the development process, known as “the valley of death”, where promising technologies can wither and die due to a lack of sufficient infrastructure and resources. At present, most of the funding for neglected disease research comes from philanthropy, but, with only philanthropic funding, it’s hard to sustain a development process that might take a decade or more to complete. As one possible solution to this problem, we invested some of our emtricitabine patent royalties into a small, non-profit drug development company called DRIVE, an acronym for Drug Innovation Ventures at Emory. DRIVE is led by a team of highly experienced scientists, many of whom have been successful at developing antiviral drugs. Without shareholders or investors, DRIVE can address the most critical unmet needs rather than those that might produce the highest profits.

DRIVE’s focus is on single stranded RNA viral infections. These infections, most of which only have modest commercial potential, account for approximately 80% of our worldwide viral disease burden. By targeting a mixed portfolio of major market and neglected diseases, DRIVE was able to use revenues obtained from licensing the patent of a large market drug to subsidize research on neglected viral diseases. Thanks to lessons learned, this process took only 15 months, which is notable since the comparable process for emtricitabine took 4 years.

So, how can we expand DRIVE’s proof of concept into a worldwide framework that could more rapidly address neglected viral diseases? How can we, as a global community, assemble the pieces needed to develop drugs for diseases of the poor, like Dengue Fever, Chikungunya and Zika virus?

Over the past 15 years, I have worked extensively in Africa with drug development scientists and entrepreneurs. I have seen first hand the quality of the science and the passion people bring to diseases that affect their own communities. So, selecting Africa as the first target region for our worldwide initiative seemed obvious. In November, 2015 we entered into a formal partnership with ANDI, the African Network for Drug and Diagnostics Innovation, which is a UN-based organization, headquartered in Addis Ababa.

This partnership involves two components, the first of which is the training of African scientists in the business and legal aspects of the biopharmaceutical sector, helped, in part, by our colleagues here in Geneva at the World Intellectual Property Organization. The participants will be selected from the over 40 ANDI Centers of Excellence and will be taught the intricacies of creating pharmaceutical development plans along with the intellectual property management needed to support those plans. The second component of our partnership involves the creation of regional hubs distributed around Africa that are modeled after DRIVE and leverage ANDI’s expertise in promoting African-led health innovations.

Just like with DRIVE, each hub will focus part of their attention on a disease with large market potential and use revenues from those activities to subsidize development of therapies for neglected diseases. Importantly, since this model involves partnerships with government and non-government agencies, we can assure that drugs derived from this initiative will be affordably priced and accessible to all.

Imagine a world where important healthcare solutions emerge from focused networks of scientists and entrepreneurs operating through creative, non-profit structures. Imagine a world where today’s neglected diseases become tomorrow’s treatable conditions, just as we saw with AIDS. Imagine a world where companies that focus on neglected disease can do good and do well at the same time. Even better, imagine a world where neglected diseases are things of the past. Thank you.

Bibliography and References

The Centers for Disease Control and Prevention. June 2011. http://www.cdc.gov/globalhealth/ntd/

Sandeep Kishore, Rachel Kiddell-Monroe, and Ruth Lopert, Yale University

Name of Lead Author: Sandeep Kishore, Rachel Kiddell-Monroe, and Ruth Lopert
Organization: Yale University
Country: United States

Abstract

In 2015, the 20th World Health Organization (WHO) Expert Committee on the Selection and Use of Essential Medicines (the EML Committee) added highly expensive cancer, hepatitis C, and tuberculosis medicines to the WHO Essential Medicines List (WHO EML) for the first time. The EML Committee went on to acknowledge that several of these essential drugs, such as trastuzumab for HER2+ breast cancer, were clearly unaffordable in many countries. Although there were a handful of patented and expensive medications for rare diseases (for example, factor VIII for hemophilia) already on the WHO EML, the Committee has been criticized in the past ---predominantly before 2002---for its recommendations of only affordable medicines. The 2015 additions remedied this. Further steps are, however, critical to turn this important initiative into practical benefits for patients and payers. Given that no official entity is entrusted with making essential medicines on the WHO EML affordable, we suggest that the WHO take a leadership role in addressing this policy gap. Here, we propose a mechanism that could help. By adopting an Essential and Affordable Medicines Board to complement the EML Committee, and by actively engaging civil society organizations in its work, the WHO can bridge the gap and fulfill its mandate to ensure the highest attainable health standard for all.

Submission

Introduction
In 2015, the 20th World Health Organization (WHO) Expert Committee on the Selection and Use of Essential Medicines (the EML Committee) added highly expensive cancer, hepatitis C, and tuberculosis medicines to the WHO Essential Medicines List (WHO EML) for the first time. The EML Committee then went on to acknowledge that several of these essential drugs, such as trastuzumab for HER2+ breast cancer, were clearly unaffordable in many countries. For the EML Committee, these recommendations were “…the starting block and not the finishing line…[t]he hard work begins with efforts to ensure that those medicines are actually available to patients.”1

The decision to include medicines like trastuzumab on the WHO EML has been the clearest indication to date of a revitalization of the concept of essentiality. Although there are a handful of patented and expensive medications for rare diseases (for example, factor VIII for hemophilia) on the WHO EML, the Committee has been criticized in the past for its recommendations of only affordable medicines. Indeed, for several years, compelling arguments have been made to add certain patented and relatively expensive drugs to the WHO EML, because essentiality cannot, and should not, be contingent on price or affordability.

The 2015 additions to the WHO EML are a bold and welcome development. The WHO expects that this will support efforts to reduce prices. However, in its report, the EML Committee recognized that the additions alone would not be enough to bring prices down.4 Indeed, placing a drug on an EML “does not guarantee patient access.” The EML Committee “therefore recommended that WHO collaborate with countries in taking measures to ensure that this objective is achieved.”4

It could be argued that including a medicine with a high unit cost from the WHO EML on a national EML would prompt efforts to moderate price and promote affordability. But whose responsibility should it be to stimulate lower costs? Although we commend the EML Committee for taking this important step, we must go further to realize its ambition and make essential medicines affordable.

In this article, we raise three issues:
(1) the need for renewed clarity in the definition of essential;
(2) the need to address the ongoing policy gap between essential and affordable medicines; and
(3) a potential strategy to bridge this gap using a multi-centric approach.

Defining essential medicines: context and recent developments
The WHO EML is a formulary of 406 medications for adults that should be accessible to populations globally. When it was first published in 1977, the WHO EML was intended to underscore the idea that some medicines are essential and to recognize that access to these medicines is unequal across countries and across populations.

Today, the WHO EML serves as a global standard to guide countries in identifying medicines that should be not only widely available in national health care systems, but also affordable to individuals and the community. By updating the WHO EML every two years, the WHO has demonstrated that it is a dynamic document that can be readily updated as new treatments emerge and as public health priorities change with changing patterns of disease. It is used by all UN organizations and by more than 150 countries, where it forms the basis for coverage-program formularies and national EMLs. Since the first WHO EML, there have been at least 134 national EMLs established, and 94% of countries with EMLs claim to use them as the basis for public drug procurement.

In 2013, two coalitions of civil society organizations (CSOs) independently submitted requests for additions to the EML. One was for imatinib mesylate (Glivec®, Novartis) to treat chronic myeloid leukemia, and the other was for trastuzumab for HER2+ breast cancer. Both medications were still patented at the time, and both carried high price tags. The EML Committee acknowledged their effectiveness but rejected the applications, noting that a new, systematic approach would have to be developed to consider the pricing and addition of such expensive therapies.

In conjunction with the Union for International Cancer Control, the EML Committee subsequently undertook a major review of the oncology section of the WHO EML. On 8 May 2015, they announced that 16 oncology drugs (including imatinib and two biologics, trastuzumab and rituximab) and four major medications for hepatitis C would be added to the WHO EML,1 knowing that these drugs are unaffordable for many governments. In the United States, the hepatitis C drug sofosbuvir (Sovaldi) costs more than $80,000 for a 12-week treatment course, and imatinib typically sells for over $10,000 for a 30-day supply of the 400-mg dose.

We agree with the recent Lancet commentary, which noted that the inclusion of the newly listed drugs---without regard to price---“is consistent with the definition of essential medicines.”5 However, the outstanding question is whether the additions reflect a new interpretation of essential.

Prior to 2001, the way essential medicines were selected suggested that a medicine needed to be available at a low unit price to be included on the WHO EML. A WHO technical report from 1977 stated that “[c]ost represents a major selection criterion. In cost comparisons between drugs, the cost of the total treatment, and not only the unit cost must be considered.” This prevented many HIV/AIDS medicines from inclusion, implying that the treatments were not essential. Countries were not adding these antiretroviral therapies to national EMLs, nor were they receiving or allocating funds to treat HIV/AIDS patients.
The enormity of the HIV/AIDS crisis, and specifically the lack of access to lifesaving medication for people living with HIV/AIDS, challenged this approach once and for all. A special session of the EML Committee convened in 2001 to revise the criteria. These criteria, which still appear on the WHO website, state that although “the absolute cost of the treatment would not constitute a reason to exclude a medicine from the Model List… cost-effectiveness comparisons may be made among alternative medicines within the same therapeutic group.” This established a framework for comparing value for money among similar medicines. However, it provided no guidance for assessing drugs with a high unit cost that were the only available treatments for a particular condition or population (e.g., trastuzumab for HER2+ breast cancers) or represented a major advance in therapy (e.g., sofosbuvir for hepatitis C).

The recent additions to the WHO EML spotlight the term essential. We urge the WHO to take this opportunity to make a clear public policy statement that (1) clarifies that the designation of a medicine as essential depends on its clinical utility and (2) states explicitly that neither the unit price nor the overall cost of a medicine are relevant considerations. Such a move would both confirm and reinforce the important step the EML Committee has made to ensure that “those [medicines] that satisfy the priority health care needs of the population” are included in the WHO EML.

The policy gap in governance
Reinforcing clinical essentiality as the sole criterion for adding a medicine to the WHO EML also highlights a policy gap in the governance of essential medicines that has been known for decades but has yet to be formally addressed by the WHO. The gap lies between the addition of an essential medicine to the WHO EML and the transformation of that medicine into one that is both essential and affordable.

We propose the creation of both a policy space and a mechanism to transition medicines from essential to essential and affordable. There is currently no WHO department or group focused solely on ensuring that medicines on the WHO EML become sufficiently affordable for inclusion on all national lists. This gap needs to be filled to reinforce the concept of the EML. Since the adoption of the Trade Related Aspects of Intellectual Property Agreement (TRIPS) in 1994, CSOs have taken on the responsibility for filling the policy space. Recognizing that affordability is one of the most important barriers to medicine access in a majority of countries, CSOs have promoted the use of TRIPS flexibilities to address the barriers created by patent monopolies and have developed alternative incentive mechanisms for access and innovation in biomedical research and development (R&D).

Using the 2001 Doha Declaration on TRIPS and Public Health that attempted to redress the ethical gaps created by TRIPS, CSOs (together with some national governments) have been trying, with widespread and notable success, to bridge the gap between “essential” and “essential and affordable”. Through its innovative and remarkably resilient efforts, civil society has made a profound difference, and in doing so, has highlighted the incongruity of a biomedical R&D paradigm that continues to fail patients worldwide. It is time for the WHO to leverage its role as a global health steward to capitalize on the strength and experience of civil society to facilitate access to and affordability of medicines globally. Nowhere is this more relevant than for new products for cancer, hepatitis C, and tuberculosis.

Minding the gap: a multi-centric governance proposal
In its report, the EML Committee cited a number of policy levers at the disposal of individual countries to make essential medicines affordable.4 Particular mention is made of individual country/WHO collaboration. However, rather than concentrating on parallel bilateral relationships, the objective should be the establishment of a global multi-centric mechanism that brings together the WHO, national governments, and civil society to develop a comprehensive, systematic, and collective approach to promoting affordability and access.

Although it is beyond the scope of this paper to fully elaborate a mechanism, not least because any such mechanism should be developed in consultation with relevant stakeholders, we offer a broad suggestion: the establishment of a WHO Essential and Affordable Medicines Board (EAMB). The EAMB would operate under the auspices of the WHO, with full and open formalized collaboration with CSOs and national governments. Inspired by and benefitting from the lessons of the UNITAID governance model, which utilizes innovative financing to drive down drug prices, the EAMB would strive to make affordable WHO EML medicines currently out of reach for most countries because of their high unit price or overall cost. With a mandate to receive proposals on country-specific and general barriers to access and affordability from countries and CSOs, the EAMB could prioritize, propose, and monitor the resulting bilateral-, multilateral-, and mixed-stakeholder solutions. The EAMB would be positioned to deal with system financing issues such as downstream barriers to affordability (e.g., over-pricing by distributors, prescriptions, tariffs, and the paucity of financial support pledged by countries) as well as oversee inter-governmental organizations for medicines, particularly for non-communicable diseases (NCDs).

The EAMB would utilize the WHO EML as its principal reference tool. Initially, the EML Committee could flag essential medicines considered unaffordable in one or more member states. The EAMB would then use their knowledge of the biomedical R&D environment to bring about the necessary changes. To ensure transparency and accountability, the EAMB would publish regular reports of its progress, highlighting successes and challenges, and presenting proposals for systemic solutions.

An EAMB would play a critical role in publicly recognizing and accounting for medicines that need special measures to ensure affordability and would reinforce the concept of an essential medicine. Because another body would work to make an otherwise unaffordable essential medicine affordable, the mandate of the EML Committee would no longer be clouded by concerns that medicines on the WHO EML are, in reality, unavailable to national governments. The implementation of an EAMB would move the issue of medicine affordability from the informal realm, where individual patients or lobby groups have to fight for the right to access a medicine, to a formal space, where government policy makers and NGOs work together to promote access for all.

Conclusion

We welcome the important step taken by the EML Committee and commend the recent addition of several important medicines with high unit costs to the WHO EML. Not only did this clarify the role of the EML Committee, but it also officially recognized the policy gap in access to medicines that CSOs have attempted to fill for years.

Further steps are, however, critical to turn this important initiative into practical benefits. The WHO’s adoption of an Essential and Affordable Medicines Board and active engagement of CSOs can bridge the gap and fulfill the WHO’s mandate to ensure the highest attainable health standard for all.

Bibliography and References

1 World Health Organization. WHO moves to improve access to lifesaving medicines for hepatitis C, drug-resistant TB and cancers. News release. 8 May 2015. Available from: http://www.who.int/mediacentre/news/releases/2015/new-essential-medicines-list/en/
2 Stolk P, Willemen MJ, Leufkens HG. Rare essentials: drugs for rare diseases as essential medicines. Bull World Health Organ 2006;84(9):745-51. doi.org/10.1590/S0042-96862006000900018
3 Saez C. WHO reviews its essential medicines list; some new candidates under patent. Intellectual Property Watch [Internet]. 2015 [cited 13 November 2015]. Available from: www.ip-watch.org/2015/04/21/who-reviews-its-essential-medicines-list-some-new-candidates-under-patent/
4 World Health Organization. The selection and use of essential medicines: report of the WHO expert committee. World Health Organ Tech Rep Ser 994. Geneva: World Health Organization; 2015.
5 Gray AL, Wirtz VJ, ’t Hoen EF, Reich MR, Hogerzeil HV. Essential medicines are still essential. Lancet 2015;386(10004):1601-3.
6 Representatives of various civil society organizations (CSOs) met at the Open Society Institute on July 29, 2015, and affirmed that the need to reconfigure civil society’s engagement with the WHO is a priority. This includes decisions regarding the inclusion of medicines on the WHO EML and efforts to ensure their affordability. This paper was prompted by those discussions.
7 World Health Organization. WHO model list of essential medicines-19th list (August 2015) [Internet]. Geneva: World Health Organization; 2015 [cited 10 December 2015]. Available from: http://www.who.int/selection_medicines/committees/expert/20/EML_2015_FINAL_amended_AUG2015.pdf?ua=1
8 Abegunde D, Auton M, Cameron A, Ewen M. The world medicines situation: prices, availability and affordability [Internet]. Geneva: World Health Organization; 2011 [cited 2016 Jan 21] Available from: http://apps.who.int/medicinedocs/documents/s18065en/s18065en.pdf
9 Van den Ham R, Bero L, Laing R; WHO. The world medicines situation 2011: selection of essential medicines [Internet]. Geneva: World Health Organization; 2011 [cited 2016 Jan 21] Available from: http://apps.who.int/medicinedocs/documents/s18770en/s18770en.pdf
10 World Health Organization. The selection and use of essential medicines: report of the WHO expert committee. World Health Organ Tech Rep Ser no. 985. Geneva: World Health Organization; 2013.
11 Hill A, Cooke G. Hepatitis C can be cured globally, but at what cost. Science 2014;345(6193):141-2. Available from: http://www.sciencemag.org/content/345/6193/141.summary
12 GoodRx [Internet]. [cited 6 November 2015]. Available from: www.GoodRx.com
13 World Health Organization. The selection of essential drugs: report of a WHO expert committee. World Health Organ Tech Rep Ser no 615. Geneva: World Health Organization; 1977.
14 World Health Organization. model list of essential medicines-12th list (April 2002) [internet]. Geneva: World Health Organization; 2002 [cited 10 May 2015]. Available from: http://apps.who.int/medicinedocs/en/d/Jh3003e/1.html
15 World Health Organization. The selection and use of essential medicines: report of a WHO expert committee. World Health Organ Tech Rep Ser no 914. Geneva: World Health Organization; 2003.
16 Sell SK. TRIPS and the access to medicines campaign. Wis Int Law J 2001;20(3):481-522.
17 Musungu SF, Villanueva S, Blasetti R. Utilizing TRIPS flexibilities for public health protection through South-South regional frameworks. Geneva: South Centre; 2004. Available at: http://apps.who.int/medicinedocs/pdf/s4968e/s4968e.pdf
18 Kiddell‐Monroe R. Access to medicines and distributive justice: breaching Doha's ethical threshold. Dev World Bioeth 2014 Aug;14(2):59-66.
19 Kiddell-Monroe R. A non-state centric governance framework for global health. Barcelona: IS Global; 2013 [cited 2015 Dec 10]. Available from: http://www.isglobal.org/publication/-/asset_publisher/ljGAMKTwu9m4/content/a-non-state-centric-governance-framework-for-global-health
20 UNITAID, founded in 2006, is a global health initiative governed by a board of WHO, national government, and civil society representatives that uses a broad menu of policy tools to reduce prices of high priority medicines. http://unitaid.org/en/who/about-unitaid
21 Cameron A, Roubos I, Ewen M, Mantel-Teeuwisse AK, Leufkens HG, Laing RO.
Differences in the availability of medicines for chronic and acute conditions in the
public and private sectors of developing countries. Bull World Health Organ 2011;89(6):412-421.
22 A proposal has been made by Knowledge Ecology International to create a category in the EML for drugs (and diagnostics) that are essential, if available at affordable prices. This is an interesting approach but the authors of this paper believe that it could wrongly imply that medicines should be essential only if they are offered at affordable prices. In this paper, we argue the contrary---medicines are essential based on clinical need (irrespective of cost), and we must make them affordable. In other words, affordability should be the consequence of, not the precondition for, essentiality. http://www.who.int/selection_medicines/committees/expert/ 20/reviews/open-session_KEI-statement_18-apr-15.pdf

Jean-Francois de Lavison, Ahimsa Partners

Name of Lead Author: Jean-Francois de Lavison
Organization: Ahimsa Partners - Ahimsa Fund
Country: France

Abstract

This initiative is of great interest to me, as I am convinced that it is through establishing new models and new approaches, without dismissing the value of previous models, that we will succeed in improving the situation regarding universal access to healthcare, if everyone makes a contribution. We need a global partnership, headed by a veritable leadership structure to oversee its operations. My varied and international experience has led me to conclude that we have all the assets necessary to improve the situation, but that it is only through a determination to work together in a different manner that we will achieve this goal. I have more than 35 years of experience in public health and 29 years in the vaccines and diagnostics industry (http://www.institut-merieux.com/), where I was responsible for international development and relations with major international bodies. I also have five years of experience in the world of foundations, as Treasurer of Fondation Mérieux (http://www.fondation-merieux.org), and six years in the humanitarian sector, as President of Institut Bioforce Développement (http://www.institutbioforce.fr/).

Having spent many years working with businesses, foundations and humanitarian organizations, I created Ahimsa Partners with a view to providing support to major players in global public health (e.g. WHO, Global Fund, Bill & Melinda Gates Foundation, FIND, WHO/TDR) by implementing innovative models to help to reduce the disparity between the world's richest and most impoverished populations. I thus created Ahimsa Fund, in late 2012, in order to establish holistic healthcare projects (prevention, diagnostics, treatment, monitoring) in the field (e.g. prevention of infectious diseases in Brazil, HPV prevention in Burundi, prevention for women and children in India, immunization in the Philippines, mobile medical camps in Nepal). Ahimsa Fund also organizes numerous forums for discussion on the subject of universal access to healthcare for the entire global population (http://www.ahimsa-fund.com/infos/report/ - http://www.ahimsa-fund.com/infos/report-2/).

Submission

My professional involvement in the private sector, as well as with foundations and humanitarian organizations, means that I am familiar with the global public health community and have significant networking opportunities therein.

I have developed this expertise through various projects and my experience with:

The Bill & Melinda Gates Foundation:
- Foster a business environment that promotes the sale, distribution, support and training in point-of-care (POC) solutions.
- Develop business standards and best practices focused on the delivery of POC diagnostics in the developing world.

WHO:
- An external working group (EWG) was convened on October 4-6, 2011, by the World Health Organization (WHO), to review the scope and effectiveness of WHO prequalification programs for medicines, vaccines, diagnostics and devices for immunization and reproductive health. A SWOT (strengths, weaknesses, opportunities and threats) analysis was put forward to identify successes and issues, as well as key challenges and opportunities for resolution.

UNITAID:
- Consultation to provide guidance on the design of market entry solutions to support UNITAID point-of-care market entry activities.

WHO/TDR: On social innovation.
- In the past few decades, great progress has been achieved through innovation in medicines, devices and vaccines, but we have neglected to innovate in the delivery process. The Sustainable Development Goals call for a new healthcare paradigm that includes social, environmental and economic factors. The objective is to integrate healthcare delivery solutions and the social innovation approach in health system policies and practices, through three areas: research, practice and influence.

We need to develop a strong public private partnership (PPP), engaging the main stakeholders, in order to obtain strong commitments from governments and scale-up and implement successful initiatives. We will need to have impact on policy coherence, by developing and leading an efficient PPP. Leadership will be key if we are to have a real and effective impact on public health. We will need to evaluate and monitor this impact and work with existing organizations on this issue.

If successful, this initiative would have a direct impact on human rights and on the SDGs, with very real results. We propose to engage young people. We are committed to transmitting and to using the international network of committed young people so as to engage them on the project, and in the implementation and follow-up of the various phases. We will need to assess the feasibility of new models to be delivered to global health constituents in order to deliver real results. These models may foster competition and innovation among diagnostic providers. We will have to assess what financial incentives can be put in place or redirected to facilitate these new models, with the objective of reaching more constituents. We will need to devise new models that are appropriate for low- and middle-income countries. A project of this kind will have to consider new business models and new financial incentives. We will need to create a new approach to leverage financial resources and expertise, and develop new partnerships among the main healthcare stakeholders. The intention will be to establish new and innovative models providing cost-effective solutions for the developing world, while simultaneously offering increased opportunities for participants to achieve an acceptable return on investment.

Ahimsa’s experience of the private sector, with the international network of foundations and in the humanitarian field, provides a strong network and useful expertise in this area. Likewise, its experience with the main global health partnerships (Stop TB, UNAIDS, Roll Back Malaria, and the Global Fund private sector constituency) will be an advantage, as will Ahimsa’s current position in the field of global health. Coordination and leadership in a multi-cultural environment, two important skills that are currently lacking, will be key in the success of such an initiative. Due to its expertise and engagement in the field of global health, Ahimsa can make an important contribution to such an initiative.

Bibliography and References

Over 35 years of international experience in the field of global health Jean-François worked in the pharmaceutical industry for 29 years, holding various several international positions and participating in the Merieux Group’s international expansion in Europe, Asia, the Middle-East, Africa and Latin America. He was appointed Corporate Vice President of the holding company, Institut Mérieux, in charge of Global Health and International Affairs. During the same period, he was Treasurer of Fondation Mérieux. He has been elected President of the European Diagnostic Manufacturers Association (EDMA), the organization that represents the European in vitro diagnostics industry on a worldwide level.

Through his extensive international experience in both developed and developing countries, Jean-François has acquired unique skills in the field of global health. His strong commitment to providing a response to the urgent needs of emerging countries prompted to the launch of Ahimsa Partners in January 2010. Through innovative business and financial models, and collaboration with new generations of leaders, Ahimsa Partners proposes innovative partnerships in the field of global health. Ahimsa Partners’ objective is to engage the various stakeholders in the global health landscape (private and public sectors, international organizations, foundations, NGOs, etc.) in order to establish innovative initiatives throughout the world. (www.ahimsa-partners.com)
Jean-François is the founder and President of Ahimsa Fund (www.ahimsa-fund.com), a non-profit organization (endowment fund) whose objective is to make good health contagious. Ahimsa Fund focuses on the world’s most underprivileged populations and develops realistic, innovative, cost-effective and replicable public health initiatives with the objective of empowering the local population.

For eight years, Jean-François has been the acting President of Bioforce Institute, a human resources management organization for international aid that works with NGOs and trains over 350 students on humanitarian actions every year. In addition, Jean-François is involved in many projects with top-tier international business schools (Hong Kong University, Georgetown University, INSEAD, HEC, EM Lyon, BRAC University), relating to the bottom of the worldwide population pyramid and social business. He teaches Business Ethics at HEC in collaboration with a Benedictine monk. Recently, Jean-François de Lavison has contributed to various reports:

- The Business of Health in Africa: Partnering with the Private Sector to Improve People’s Lives (International Finance Corporation, in collaboration with the Bill and Melinda Gates Foundation),
- Tackling Tuberculosis: The Business Response (World Economic Forum / Harvard School of Public Health),
- Diagnostics as essential tools for containing antibacterial resistance (Uppsala, Sweden),
- The Race Against Drug Resistance (Center for Global Development),
- A proposal for pay-for-success prizes for milestone-based incentives (BIO Ventures for Global Health (BVGH),
- Prizes for Global Health Technologies (Center for Global Health).

Contributions to various conferences:

- Ahimsa RoundTable Forum: June 2013:Global Health and Faith based communities: http://www.ahimsa-fund.com/infos/report/
- Ahimsa RoundTable Forum June 2015:Global Health and Faith inspired communities: http://www.ahimsa-fund.com/infos/report-2/
- Fondation Pierre Fabre: “Santé Publique dans les pays du Sud : le rôle de la France ». http://www.fondationpierrefabre.org/sites/default/files/publications/fichiers/actes_21_novembre_2014_3.pdf
- WHO :Global Consultation on Interoperability Diagnostics Standards : http://apps.who.int/iris/bitstream/10665/181059/1/9789241509305_eng.pdf
- Dubai International Humanitarian Aid & Development Conference: https://www.eiseverywhere.com/ehome/index.php?eventid=128440&tabid=292928

Daniele Dionisio, Policies for Equitable Access to Health

Name of Lead Author: Daniele Dionisio
Organization: PEAH – Policies for Equitable Access to Health
Country: Italy

Abstract

The 2030 Agenda for Sustainable Development, to be adopted this week at UN Headquarters, could fall short of its health targets unless the governments embark on “U-turn” changes to rectify the dysfunctions in global governance that undermine health.

Submission

In today’s world landscape, which is torn by dis-alignment, litigations and frictions among the involved parties, the root causes of health inequities are to be found in weaknesses in political domains at the supranational level. As reported [1], these include: democratic deficit, weak accountability, institutional stickiness, missing institutions and restricted policy space for health. This context entails that unbiased solutions [2] for global health only hinge on political will to improve equity, coherence, coordination, collaboration, transparency and accountability both at domestic and international level.

Unfortunately, the current governments’ directions and trade agreements, largely by the European Union (EU) and the United States (US), run contrary to these principles while turning intellectual property (IP) agendas into policies which protect monopolistic interests at the expense of equitable access to care and lifesaving treatments in resource-limited settings. In this connection, since the incentives of the current patent system are driven by profits, where short-term maximization of returns to shareholders is prioritized, the lower-income countries lacking profitable pharmaceutical markets are all the more discriminated. Overall, this represents the failure [3] of the current policies for global health as featured, just for example, by the mismanaged [4] containment of current Ebola epidemic.

Meanwhile a 2030 Agenda for Sustainable Development [5] is to be adopted this week at UN Headquarters. The Agenda consists of 17 Sustainable Development Goals (SDGs) and 169 targets that aim [6] … to be a charter for people and the planet in the twenty-first century. They will stimulate action over the next 15 years in areas of critical importance towards building a more equitable and sustainable world for all. As highlighted [7], …..In that scheme, the health goal ranks high as an overarching aim amidst the other 16 SDGs. It includes [8] nine targets: three relating to MDGs, three to non-communicable diseases and injuries, and three cross-cutting or focusing on systems encompassing UHC, universal access to sexual and reproductive health care services, and also to reduced hazards from air, water and soil pollution. Furthermore, the health goal strictly entwines with a number of the other 16 proposed goals. For example, health is a contributor to (and a beneficiary from) poverty reduction, hunger relief and improved nutrition, safer cities, lower inequality, sustainable consumption, affordable and clean energy, toxic chemicals management, clean water and sanitation, and to the efforts to combat climate change and safeguard aquatic and terrestrial ecosystems as well.

Relevantly, what expectations on the world landscape mentioned above? Hopes that comprehensive, non-discriminatory health goals could easily be reached are hardly credible with the load of unresolved issues still on the table. As argued [1] “…Achieving health equity is not just a matter of coming up with technical solutions and providing the means to finance them. We have to consider the political landscape and rectify the dysfunctions in global governance that undermine health… Admittedly, governments in the most affluent countries look like they wouldn’t be ready to embark on these gaps as an opportunity to advance public health over political and commercial interests.

Call for Common Governance Agenda

As such, prospects for global health goals only depend on non-stop, multi-sector engagement worldwide to pressure governments into making “U-turn” changes by common measures on a shared agenda that include:

• Rejecting pressures towards adopting heightened IPRs and strengthened enforcement mechanisms as the keys to foreign investments and innovation. Reportedly [9],…inclusive evidence typically shows that most low- and middle-income countries do not benefit economically from IP maximization since they are net importers of IP goods and since the path to technological development is ordinarily through copying and incremental innovation-development tools that are severely undermined by IP monopoly rights and their related restrictive licensing agreements…

• Rejecting World Bank income classification to measure a country’s capacity to afford high-priced medicines. As argued [10], ...the World Bank classification dates back to the 1980s and only measures a country’s per-capita average of total income. However, the map of poverty has changed since the 1980s. Today, the majority of the world’s poor no longer live in poor countries, but rather in places where there is greater wealth along with higher inequality. Relevantly, MSF recently contended [10] that ….the US Medicaid-defined poverty line ($21.50/person per day) would be a far more reliable tool to estimate how many millions will live below it once countries cross the high-income threshold. As regards TPP countries, MSF also highlighted [10] that …In eight of the 12 TPP countries for which there is data, more than a quarter of a billion people will live below the US Medicaid line when their country is classified as high income. By the time Malaysia and Mexico reach high income designation, more than 80 percent of their populations will still fall below this poverty line. Among current high-income TPP countries, the percentage of the population under this poverty line ranges widely, going as high as 69 percent in Chile.

• Rejecting privatization policies, including by publicly funded insurance packages using networks of private providers. As reported [11], ….while reinforcing the notion that healthcare is a commodity and not a basic human right, this approach, proposed by the World Bank and their allies, has several problems and side effects: fragmentation of care, higher cost, precedence of procedures over preventive medicine and further dismantling of the public healthcare system. At the same time, insurance packages divert attention and funds from a more comprehensive approach directed at modifying the root causes of disease, through socioeconomic interventions aimed at increasing equity. Inherently, as per a report [12]from the Philippines, …the current privatization policies of the Philippine government do not provide an answer to the enormous health needs. Despite the name of the Philippine “Universal Health Care” program that claims to “bring equity and access to critical health services to poor Philippinos”, commercialization of health services will do exactly the opposite. Unfortunately, the European Commission is supportive of these policies and formerly approved a contribution of euros 33 million in support of the Health Sector Reform Agenda of the Philippine government….

• Rejecting closed doors negotiations since they blur transparency.

• Banning the non-violation nullification of benefits (NV [13]) clause under TRIPS.

• Banning TRIPS-plus clauses, including investor state dispute settlement (ISDS) provisions, that could negatively affect health and worsen inequalities in access to care and treatments.

• Withdrawing pressures on LMICs to jeopardize the use of TRIPS safeguards and flexibilities relevant to the price of medicines.

• Pushing for open knowledge and new approaches to pharmaceutical innovation that do not rely on the patent system and de-link the costs of R&D from the price of medicines.

• Promoting technology transfer with least-developed countries without exporting excessive IP standards through assistance programs.

• Backing generic competition as the most effective way to lower medicine prices in a sustainable way.

• Backing governments that make use of TRIPS safeguards and flexibilities to protect and promote public health.

• Linking together patent offices and legislators worldwide to develop evidence-based reforms of the patent regime of medicines. As contended [14], …[I]f countries set higher standards for incremental innovation patenting, and permit citizen or third-party review of patents before and after examination, then we will likely see increased generic competition in the …..market, new combination therapies, and lower … prices. In the longer term, higher inventiveness standards will help clear the patent thicket to allow new products to develop, and push industry towards genuine innovations….

• Calling on [3]companies to join the Medicines Patent Pool [15].

• Actively supporting partnership agendas (as per DNDI [16] and GAVI examples [17] among others) that are devoted to the development of new medicines and vaccines for neglected diseases that disproportionately affect poor population settings.

• Ensuring that the Global Fund to Fight AIDS, Tuberculosis and Malaria continues [3] to use generic medicines and support UNITAID work to make quality medicines and diagnostics available and affordable.

• Ensuring that revenues from a Financial Transaction Tax (FTT), whose approval is [18] in slow progress in Europe, will be substantially committed to development and for the fight against health scourges, diseases of the poor and pandemics. FTT revenues would be a resource for the EU to channel towards the WHO and Global Fund needs. An FTT would be instrumental to the spirit and resolutions of latest WHO Assemblies. Hence, it should be up to the EU to push that non-discriminatory access to health and lifesaving medicines becomes a substantial objective for FTT revenues.

• Ensuring that leading institutions and organizations enhance working with health ministries to strengthen national systems, invest in infrastructures, improve transparency and accountability, and boost needs-driven rather than market-driven rules. This would mean giving up “closed doors”€negotiations and adopting multi-sector participatory models for decisions affecting national health, growth, employment and budgets.

• Ensuring that international agreements include clauses whereby donors must strengthen WHO-aligned quality clauses in tender transactions with non-governmental organizations, while purchasers must insist that manufacturers and distributors supply medicines that meet WHO requirements, and governments must authorize export only of products meeting WHO quality, efficacy and safety standards.

• Ensuring that research and innovation for health is linked [19] to improving economic prosperity and is critical to eradicating poverty, since poor health and disability contribute substantially to poverty.

• Ensuring that indicators [19] for R&D for health tools that primarily affect LMICs address a comprehensive set of outcomes including financing, infrastructure and human resources needs, enabling policies, necessary partnerships, capacity strengthening, and access requirements.

• Ensuring that any research and innovation indicators measuring progress against the goals and targets outlined in the post-2015 agenda also increase accountability of researchers, governments, and funders, and inform research processes. Ultimately, the success or failure of the post-2015 agenda relies [19] just as much on how the goals and targets are implemented as it does on how progress will be measured. In support of the inclusion of research and innovation for health in the post-2015 agenda, over 150 organizations and individuals last year signed a petition [20] to Secretary General Ban Ki-Moon and Member States urging the UN to keep the research, development, and delivery of new and improved health tools for diseases and conditions impacting LMICs at the heart of the post-2015 development agenda.

• Seeking synergies among global level institutions to address global health challenges, support stronger leadership by the WHO to improve global health, enhance dialogue and joint action with key players, including UN agencies involved in global health, international financing institutions, regional organizations, regional health networks, and countries, in order to coordinate actions, advance in the achievement of commitments, and avoid overlapping and fragmentation.

• Seeking synergies for equitable health access with fast growing, including BRICS and N-11 [21], middle-income country economies.

• Pushing for more complementaryrelations [22] among World Bank, IMF, ADB, AFDB, AIIB and the BRICS Development Bank as regards the development and health needs of marginalized population settings in LMICs.

• Pushing for full exemption [23] of out-of-pocket expenses for the poor; poor-friendly pathways towards universal health coverage; heavy taxation on tobacco and other harmful substances; and reduction or elimination of agricultural export subsidies [24] and energy subsidies on air-polluting fuels.

• Opposing land grabbing, deforestation and state-managed food reserve dismantling policies.

• Reversing “brain drain”, health worker shortage by a transformation [25] of the present training approach, as to adapt curricula to local needs, promote strategies to retain expert faculty staff, expose trainees to community needs during training, promote multi-sector approach to education reforms, and strengthen links between the educational and health care delivery system. Western academic institutions’ role is to facilitate the process.

• Asking for the European Medicines Agency (EMA) to be financed only through [26]EU budget as per application fees channeled to the European Commission. This would improve transparency and accountability.

• Asking for anti-counterfeit laws and law enforcement policies not to substitute for effective national regulatory frameworks.

• Asking for organizations with potential conflicts of interests and IP perspectives to issue statements eschewing the use of IP law to counter generic medicines.

• Asking for investment in technologies to detect “bad medicines”to be followed up [27]with provisions to increase public awareness and incident reporting, along with regulations on medicine quality that include definitions as per shared WHO terms.

Bibliography and References

[1] As reported: http://www.peah.it/2014/07/the-political-determinants-of-health/
[2] unbiased solutions: http://www.ip-watch.org/2014/01/23/global-health-2035-report-flawed-projections/
[3] the failure: http://haieurope.org/wp-content/uploads/2014/09/Trading-Away-Access-to-Medicines-Revisited.pdf
[4] mismanaged: http://www.futuremedicine.com/doi/pdf/10.2217/fvl.15.16
[5] 2030 Agenda for Sustainable Development: https://sustainabledevelopment.un.org/content/documents/7891Transforming%20Our%20World.pdf
[6] aim: http://www.un.org/apps/news/story.asp?NewsID=51872#.Vf6f5t_tmko
[7] As highlighted: http://www.ip-watch.org/2015/09/02/universal-health-coverage-millennium-development-goals-and-post-2015-the-improvable-way-forward/
[8] includes: http://apps.who.int/gb/ebwha/pdf_files/WHA68/A68_14-en.pdf
[9] Reportedly: http://www.peah.it/2014/10/the-dangers-of-the-indian-governments-flirtation-with-u-s-pharma-and-the-risks-for-indias-coherent-pro-public-health-ip-policy/
[10] As argued: http://www.huffingtonpost.com/dr-manica-balasegaram/tpp-still-a-terrible-deal_b_5584810.html
[11] As reported: http://www.peah.it/2014/04/what-is-behind-the-sudden-global-marketplace-call-for-universal-health-care-co-opting-in-the-making/
[12] as per a report : http://www.peah.it/2014/07/philippines-european-development-cooperation-should-not-support-commercialisation-of-health-care-exacerbating-inequality/
[13] NV: http://www.ip-watch.org/2011/12/13/out-of-a-dilemma-banning-the-non-violation-clause-under-trips/
[14] As contended: http://www.peah.it/2013/10/whats-in-the-hiv-drug-pipeline-advocating-for-a-healthier-innovation-system/
[15] Medicines Patent Pool: http://www.medicinespatentpool.org/
[16] per DNDI: http://www.dndi.org/
[17] GAVI examples: http://www.gavi.org/
[18] approval is : http://www.slideshare.net/ManfredNolte1/financial-transactions-tax-update-october-2014
[19] is linked: http://blog.ghtcoalition.org/2014/09/24/making-the-case-for-research-and-innovation-for-health-in-the-post-2015-development-agenda/
[20] last year signed a petition: http://blog.ghtcoalition.org/2014/09/18/over-150-organizations-and-individuals-urge-un-to-keep-health-rd-at-the-heart-of-the-post-2015-agenda/
[21] N-11: https://en.wikipedia.org/wiki/Next_Eleven
[22] more complementaryrelations: http://thediplomat.com/2014/07/3-reasons-the-brics-new-development-bank-matters/
[23] for full exemption: http://www.afdb.org/fileadmin/uploads/afdb/Documents/Publications/Global%20health%202035%20-%20a%20world%20converging%20within%20a%20generation.pdf
[24] of agricultural export subsidies: http://www.odi.org/comment/6953-european-union-eu-budget-common-agricultural-policy-cap-trade
[25] by a transformation: http://www.peah.it/2013/10/training-health-personnel-in-resource-limited-settings/
[26] be financed only through: http://www.ema.europa.eu/ema/index.jsp?curl=pages/about_us/general/general_content_000130.jsp&mid=WC0b01ac0580029336
[27] to be followed up: http://www.ip-watch.org/2012/04/02/who-eu-%E2%80%9Cbad-medicine%E2%80%9D-plans-flaws-coordination-gaps/?utm_source=post&utm_medium=email&utm_campaign=alerts
[28] research project PEAH – Policies for Equitable Access to Health: http://www.peah.it/
[29] d.dionisio@tiscali.it: mailto:d.dionisio@tiscali.it
[30] https://twitter.com/DanieleDionisio: https://twitter.com/DanieleDionisio
[31] Health Advocates Demand U-Turn In EU Trade Policy To Align With Its Health Objectives : http://www.ip-watch.org/2014/09/29/health-advocates-demand-u-turn-in-eu-trade-policy-to-align-with-its-health-objectives/
[32] IP, Trade And Public Health Leaders Turn A Page In History Together : http://www.ip-watch.org/2011/11/24/ip-trade-and-public-health-leaders-turn-a-page-in-history-together/
[33] ECOSOC Calls For Intensified Efforts On Public Health And Use Of TRIPS Flexibilities : http://www.ip-watch.org/2009/07/16/ecosoc-calls-for-intensified-efforts-on-public-health-and-use-of-trips-flexibilities/

Tabitha Rono, Christina Health Association of Kenya

Name of Lead Author: Tabitha Rono
Organization: Christian Health Association of Kenya
Country: Kenya

Absract

The 1978 Alma-Ata conference had developing countries make great strides in primary health care, however when there was a shift to selective primary healthcare the social dimension of health was overlooked. Infectious diseases pose great challenges to global communities especially developing countries and this is linked to social determinants of health inequalities. Governments in developing countries will have to consider identifying these social determinants of health inequalities, strengthen public private partnerships and invest in evidence based research. These actions will help increase ownership and line health to economic development. Developing countries will then be able to make evidence based decisions. Though viable there are a number of challenges from: disproportionate influence to global health of politically and economically powerful countries, lack of baseline data to inadequate government political capacity to address social determinants of health inequalities. In conclusion there will be need of increased collaboration, accountability and transparency by both developed and developing countries and commitment to global health. All these is aimed at getting local solutions to health and improving health care for all.

Submission

Globally health systems are struggling with a myriad of complex challenges with growing demand for health and need to contain costs to manage the health systems. This is pushing for more evidence based decision making to ensure equity. However, there is a need for rebalancing of policy away from downstream secondary care (Hunter, 2007) to upstream public health.

Since the recession experienced in 2008, there has been dwindling funds with increased demand of value for money. After the 1978 Alma-Ata Conference, developing countries made important steps in improving population statistics by involving action on main social determinants (WHO, 2005). When this approach was changed to selective primary health care based on a small proportion of cost –effective interventions the social dimension was overlooked. A point in case is the Ebola hemorrhagic fever that escalated due to neglect of understanding the cultural influences and this lead to a global problem. Infectious diseases like Ebola and HIV are social diseases and addressing their social determinants helps reduce the risk and it is time that health was looked at from a social perspective.

Achieving the highest attainable quality of life is faced with glaring health inequalities across nations. Addressing these health inequalities will require an in-depth look at the social determinants of health and how they relate to health outcomes. European countries reviewed their policies to address several health inequalities. These policies centered around: taxation and tax credits, sickness and rehabilitation benefits, old age pensions, maternity or child benefits, unemployment benefits, housing policies, labor markets, communities and care facilities (Marmot, 2005) .Developed countries have worked on incorporating these aspects in their policies but developing countries have lagged behind.

What actions can developing countries take in order to address health inequalities? Health inequalities in developing countries have been associated largely with poverty. The United Nations report on the world social situation points out a broader and more comprehensive approach to poverty reduction incorporating socio-political dimensions (United Nations, 2005). This includes improvement in education, health and increased political representation in making of laws. There are three actions that developing countries can adapt to reduce health inequalities:

1. Identify social determinants of Health and address systematically This aspect has not been critically looked at and appreciated. In health policy social determinants of health focus on societal conditions affecting health status of individuals and their ability to remain healthy and cope with illness and ill health (Lee, et al., 2007)). As much as this comprises of medical technologies, use and scope of public health intervention it does not strictly deal with public and health policies. This thus explains the reason most heath policies in developing countries have not incorporated this to address health inequalities.

Governments and communities need to participate actively in identifying the social disparities and prioritize activities to address them. An example is a training conducted by PEPFAR in Kenya through collaboration with one local and one international university on community asset mapping and faith health collaborative leadership programme. One high burden county was identified and selection of communities supported by government and other stakeholders in HIV care were involved in identifying the social determinants as relates to HIV. This training was an eye opener with participants appreciating themselves as important community assets and there were many local resources that had not been explored with conflict seen as a good thing in addressing problems. Funding was not given to the participants to carry out the activities but they used what was available to address the social determinants identified. Out of this training the participants formed collaborations in the community.

2. Strengthen Public Private Partnership Private public partnership has been defined as a long term contract between a private party and government agency aimed at providing public service where the risk and management is it’s responsibility (World Bank, 2012). A number of developing countries in Africa are implementing free or low cost health care service but there are challenges as relates to quality. The private sector in Sub-Saharan Africa has increasingly become an important source of healthcare and private providers are preferred because of the long opening hours, larger supply of pharmaceuticals and health care personnel, trust and courtesy of personnel (Konde-Lule, et al., 2010). In Kenya the government acknowledges the role that the private sector plays. One such partnership is the collaboration of government agencies with organizations like Medicines for essential drug supply (MEDS) a faith based supply chain system supplying county governments with drugs and supplies at subsidized costs. Another example is the support from the Clinton foundation and CDC to support government supply chain system where health facilities can get results of viral loads and PCR online. Health facilities can follow up online their submission of reports on consumption and receipt of lab commodities like test kits, viral load and PCR kits. The government has been able to engage the private health sector to provide health to government employed staff. The need to improve equity pushed for the formation of the Kenya Private sector alliance that actively engages the government on policy formulation and implementation.

3. Investment in evidence based research The healthcare market is one that is complex and this has made it a far reaching problem to attain universal access to health care. There are complex challenges facing health systems from increased demand for healthcare, constant flow of new interventions and treatment, rising public expectations to introduction of cost containment measures (Hunter, 2007). However there is a changing trend in disease pattern caused by various factors like global warming, terrorism and changed health lifestyle. It will be noted that there has been less research of new drugs with the already existing drugs becoming less potent against microorganisms and its irrational use leading to resistance and evolving of microorganism. Globally there is reduced funding and an increased move to value for the dollar meaning achieving more with less.

Developing countries however have not been able to link health and its role in the economy and this could be due to varied factors. Taking Kenya that is a developing country, its health policy document acknowledges not using disease burden and cost effectiveness in determining priority interventions (Ministry of Health, 2012). Increased use of economic analysis in the UK and other developed countries has assisted in informing on adoption of health technologies and reimbursement decisions in health care. The UK government for instance has the National Institute for Health and Clinical Excellence (NICE) that helps in decision making. The ability of this institution to conduct economic evaluations especially where there are uncertainties leverages policy makers (Andronis, Barton, & Bryan, 2009). However, developing countries lack such partnerships and investments are made based on donor interest. This leads to less commitment by the governments and introduction of several health technologies that are not harmonized and evaluated objectively. Developing countries stand to benefit greatly knowing that they have limited resources and work on minimizing wastage of those resources. Limitations in implementation of the actions The three actions require investment and support from the global health bodies and developed countries in partnerships with developing countries. However this is impeded by global health inequalities between developed and developing countries. International communities formed a world trade system that has been successful in enforcing norms that facilitate global economies, however human health has been given least attention. International health regulations are limited in scope and rooted by power structures (Gostin, 2005). The rapid spread of infectious diseases like Ebola hemorrhagic fever and now Zika will require nations to re think and incorporate international health laws for the best interest of its population. Economically and politically powerful countries have had disproportionate influence on global health agenda furthering their economic interest through creation and protection of intellectual property rights for pharmaceutical companies making it unaffordable in developing countries. This imbalance thus means developing countries will continue experiencing health inequalities and will not be able to effectively address these challenges if their capacity for disease surveillance and response to emerging infections are not addressed. Data is very important as it informs on progress in health care. Developing countries face the challenge of having accurate data and utilization of the same for decision making. The World Health organization points out that public health decision making depends critically on timely availability of sound data (WHO, 2005). However there is the problem of duplication, distortion or manipulation of data, lack of reliable data on health inequalities and misuse of constrained resources associated with inability to link budget allocations and health needs. To implement these actions we will need baseline data on health inequalities but this data may not be available. Lastly there have been powerful ties between business and political elites (UNRISD, 2010) with international attention in developing countries being on corruption and crony capitalism. There are great strides that developing countries are making with support of civil society organizations and the private sector. Governments in developing countries need political capacity building to be able to link health and economic growth. Developing countries have different political systems and this will pose a challenge in implementing universal health. The political shift should be on building political capacity whether it is a democratic or authoritarian state and increasing public awareness and transparency. Conclusion Addressing health inequalities requires consultative efforts with shift on evidence based information and localization of strategies that will leverage on the sustainable goal three. Focus should shift from instant impact to gradual and sustainable results..

Bibliography and References

Bibliography
Andronis, L., Barton, P., & Bryan, S. (2009). Sensitivity analysis in economic evaluation: an audit of NICE current practice and a review of its use and value in decision making. Health Technol Assess, 1-81.
Gostin, L. O. (2005). World Health Law: Toward a new conception of global health governance for the 21st Century. Yale Journal of Health Policy,Law and Ethics, 413-425.
Hunter, D. J. (2007). Managing for Health. New York: Routledge Taylor and Francis Group.
Konde-Lule, J., Gitta, S. N., Lindfors, A., Okuonzi, S., Onama, V. O., & Forsberg, B. C. (2010). Private and Public healthcare in rural areas of Uganda. BMC International Health and Human Righsts, 1-8.
Lee, K., Koivusalo, M., Ollila, E., Labonté, R., Schrecker, T., Schuftan, C., & Woodward, D. (2007). Globalization, Global Governance and the social determinants of health: A review of the linkages and agenda for action. Ottawa: Globalization Knowledge Network.
Marmot, M. (2005). Social Determinants of Health Inequalities. The Lancet, 1099-1104.
Ministry of Health. (2012). Kenya Health Policy 2012-2030. Nairobi: Ministry of Health.
United Nations. (2005). The inequality predicament: report on the world situation 2005. New York: United Nations.
UNRISD. (2010). Combating poverty and inequality: structural change, social policy and politics. Geneva: United Nations Research Insitute for Social Development.
WHO. (2005, April 4-6). Improving health information systems at country level. The "Montreux Challenge": Making Health Systems Work. Geneva, Switzerland: world Health Organization.
World Bank. (2012). Public-Private Partnerships Reference guide version 1.0. Washington DC: International Bnak for reconstruction and development.

Abstract

Submission

Jean-Paul Ngueya

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Name of Lead Author: Jean-Paul Ngueya
Organization: Afrique Avenir
Country: France

Abstract

Today in the imagination of many people, they no longer die of HIV/AIDS. The objective of the communication with users during this period is to promote the changes conducive to health behavior by raising questions, having reflections, and exchanges on the theme of HIV/aids. This is to make them aware of the risks involved in these times of strong emotions. It is also to change the representation of negative behavior related to HIV transmission and the failure to use condoms during casual sexual intercourse.(Examples “whatever happens, effective treatment exists”; “the condom decreases pleasure”; “once without a condom will not hurt”; “condoms are used by people who do not trust other people”: “it is used by sexual vagabonds”; “you do not die of Aids it is just a chronic disease”; “you only live once, life is short”; “condoms are not effective”; “I am allergic to latex”). 

Submission

The fight against Sexually Transmitted Infections and HIV/AIDS is everyone’s and requires permanent solidarity on a global scale. This solidarity is not limited to researchers and donors but also mass media, policies, educators, parents, children, patrons, institutions, and other organizations not named here. “The treatment is important, but we urgently need innovations to prevent the spread of HIV” Bill Gates highlighted in his annual letter on HIV/AIDS.Sub Saharan Africa is the hardest hit region with 67% of the people in the world living with HIV. The project I am sharing is a concrete example of this innovation and what can be done in the world on the occasion of popular events like “FESMIK” ( Kribi International Music Festival ) it will take place 08 to 14 February 2016 in Kribi , the principle city in Cameroon, on the coast of the Atlantic Ocean. As an activist very engaged in the fight against HIV/AIDS for more than two decades,I play a role in the extension of this fight in France, which I first conducted in Africa in my home country. I am available to share my journey with you, in this struggle that humanity is still paying a heavy price for. Effective treatments that improve the quality of life for those infected are not available for all yet. This should not be a reason to lower our guard in terms of prevention. We need to find new strategies to enhance detection, prevention, and to fight against forms of discrimination against people living with HIV/AIDS.

Today in the imagination of many people, they no longer die of HIV/AIDS. The objective of the communication with users during this period is to promote the changes conducive to health behavior by raising questions, having reflections, and exchanges on the theme of HIV/aids. This is to make them aware of the risks involved in these times of strong emotions. It is also to change the representation of negative behavior related to HIV transmission and the failure to use condoms during casual sexual intercourse.(Examples “whatever happens, effective treatment exists”; “the condom decreases pleasure”; “once without a condom will not hurt”; “condoms are used by people who do not trust other people”: “it is used by sexual vagabonds”; “you do not die of Aids it is just a chronic disease”; “you only live once, life is short”; “condoms are not effective”; “I am allergic to latex”)

From 08 to 13 February, 2016, the young volunteers of Cameroon and the world will meet on the festival site and other party locations (bar dancing, clubs) visited as part of an awareness campaign for the prevention of Aids. The participation in this exciting and human adventure is voluntary and open to all young people of Cameroon and the world. Registration and motivation of the candidates is mandatory and must be sent to the email address ngueya@yahoo.fr before 30 December 2015. The selected volunteers will be informed by email or phone and need to take part in a mandatory training scheduled for 05 and 06 February 2016, from 8:30-17:30. This training will be both theoretical and practical to help the young people have information specific to the prevention of STI/AIDS/HIV tests, and the fight against forms of stigma and discrimination of people living with HIV/aids, to acquire notions about the different attitudes to adopt during the exchanges which should in principle have a maximum limit of 10 minutes. Stimulation exercises will be scheduled at the end of it.

The strategy is for these young people to be involved throughout the festival site and other recreational settings, invite themselves to tables or groups of people and try to steer the conversation to get the messages across. Volunteers will be distinguished by T-shirts badges and bags containing materials for prevention (condoms, pamphlets... ). Posters on incentives for HIV testing, hepatitis, prevention, and fight against the discrimination of people living with HIV/Aids will be placed strategically throughout the country. If the opportunity is available, a recreational evening followed by a raffle dedicated to volunteers involved in the project will take place at a nightclub in the city February 14, 2016 from 22 until dawn. TO BE IN SOLIDARITY in all the options is to save lives supporting this project. The contribution of all is essential and indispensable.

Bibliography and References

Mr. Jean Paul Ngueya was born in Cameroon and now lives in France. He is bi-lingual in French and English. Mr. Ngueya is a life-long advocate, educator, and counselor in the area of HIV/AIDS, especially for young people under 25 years old. He also specialized in issues surrounding displaced persons, orphaned and immigrant communities.

In various capacities he has promoted access to affordable and relevant services that reduce HIV/AIDS. He has promoted safer sexual activities and has provided psychosocial care for individuals with Sexually Transmitted Infections (STI), including HIV/AIDS.

Mr. Ngueya since 2007 has worked at Afrique Avenir, that advocates for populations of Africa, Antilles and Caribbean. In this capacity he goes to nightclubs were the young people are to educate and advocate for the prevention of STI, including HIV. At the nightclubs he offers to both patrons and staff preventative advice, distributing material (condoms, brochures, flyers, leaflets. While in the nightclub he responds to questions, constructs contact networks (connections, figures of authority)

Mr. Ngueya has also worked with Medecins D’Afrique /Europe (Doctors of Africa/ Europe). During that time he organized nutrition workshops for people living with HIV/AIDS (PLWHA) ; provided Psychosocial support and introduced a warm ambiance at meal times with music, stories and entertainment. Mr. Ngueya was responsible for the pre-test and post-test activities for the Nonoxynol-9 Research Study Project with Family Health International. Mr. Ngueya was also in charge of
counseling (psychological care for people infected and affected by HIV/AIDS) at the day hospital in Douala, Cameroon. Mr. Ngueya has many year of experience volunteering for various causes and organizations that includes Enfance Espoir, Secours populaire Français, and. Ensemble contre le sida.

Mr. Ngueyas professional presentation for international Conferences have included
2009 San Francisco (USA) : Promoting sexual and reproductive health by regulating behavioral attitudes and spreading information; 2008 Dakar (Senegal) : The impact of nutrition workshops on hospitalized migrant patients infected with HIV; 2003 (Punta del Este): The impact of social perceptions in the prevention of HIV and STI’s ; 2002 Antwerp (Belgium) : Advisory role in a study of preventative research on HIV/AIDS; 2000 Durban ( South Africa ): The social representation of AIDS; and 2001 Ouagadougou (Burkina Faso) The positive regulation.

Mr. Ngueya formal education includes a university Diploma in the “Sexual Health and Human Rights, training in Counseling, Guidelines for HIV/AIDS
messages, and training in writing film scripts. His hobbies and interests include football, documentary films, and travelling.

References
Mark Brennan-Ing, PhD
Senior Research Scientist
Center on HIV and Aging Alain Giami
AIDS Community Research Initiative Directeur de Recherche/ Professeur
Of America INSERM-CESP –U1018
230 West 38th Street 17th Floor 82, rue du Général Leclerc
New York, N.Y. 10018 F-94276 Le Kremlin-Bicêtre Cedex
Tel: +1 (212) 924-3934 ext 131 Tel: +(33) 1 45 21 22 89
mbrennan@acria.org alain.giami@inserm.