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WHO Consultation – Essential medicines and basic health technologies for NCDs: towards a set of actions to improve equitable access in Member States

Organisation: Sanofi

We welcome the opportunity to respond to WHO Discussion Paper on “Essential medicines and basic health technologies for NCDs: towards a set of actions to improve equitable access in Member States” and look forward to contributing to the ongoing work in this area.

Sanofi welcomed the endorsement of the UN Political Declaration for the Prevention and Control of NCDs and the adoption of adequate tools (i.e. roadmap, policy options, targets, indicators), including the 80% availability target in WHO Global Action Plan on NCDs, to enable governments to operationalise their commitments and design their individual and coordinated agendas.

Given its wide portfolio of medicines, and long-standing global presence, Sanofi has developed a robust expertise in many communicable and non-communicable disease areas, in particular in understanding the impact of diabetes on the overall patient health, including its concomitant diseases. It has also built a successful track record in forging sustainable collaborations with partners on the field to strengthen local expertise in prevention, screening, care coordination, capacity building, education for healthcare professionals and patient empowerment. As countries seek to implement plans to reach the global target of “25 by 25”, Sanofi is committed to working with governments and international stakeholders, including civil society organisations, to strengthen national health systems and ensure populations’ access to healthcare and NCD essential medicines and basic technologies, by providing support to address the different obstacles throughout the Access Value Chain.

General comments:

1. Looking back at the achievements of the Millennium Development Goals (MDGs) and the epidemiological shift from infectious to non-communicable diseases, the discussion paper puts into perspective the urgency to transition to a systemic, patient-centred and integrated approach of healthcare, from prevention to detection, early diagnosis, treatment, care and disease management, with well-trained health workers and reliable healthcare services. Although mounting evidence demonstrates how millions of NCD-related premature deaths could be averted if added attention was put on prevention and early detection (e.g. WHO report “The Case for Investing in Public Health”, 2014), health systems are struggling to shift resources at earlier stages of the care pathway.

2. While the report provides a comprehensive understanding of the challenges and actions for more equitable access, there is scope to expand the commentary on the central role played by education of health workers, capacity building and patient empowerment. It also seems there is a disconnect between the box categories of the WHO framework for access to essential medicines, and the text description where different facts are mentioned, , in particular the role of intellectual property. Access to healthcare is not just a matter of patients having access to affordable medicines and vaccines; it involves a complex set of related issues of which affordability is only one dimension of the Access Value Chain.

3. If not coupled with practical solutions to improve healthcare delivery that also address the financial sustainability issue, enhanced care delivery systems will have only limited impact. Better

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knowledge of diseases and populations, adequate education of healthcare workers, enhanced patient empowerment, adapted solutions tailored to local environments, are key enablers for better access. But the challenge of how to manage more complex conditions with limited resources also requires the development of coherent health insurance schemes. The report should emphasise more the fundamental role of, Universal Health Coverage (UHC) as a powerful vehicle to accelerate progress in NCD outcomes, inequalities, and socio-economic impact.

4. The private sector, alongside governments and other stakeholders, has a key role to play to improve access, including through capacity building. Credible engagement and sustainable investments in healthcare from governments are essential to ensure the sustainability of a strong “multi-stakeholder” response that best harnesses the expertise of all stakeholders, including the private sector. The constraints and challenges of continued investment in R&D to bring new solutions and adapted innovation seem however to be somewhat underplayed and do not feature in the consultation document.

Question 1

• What lessons can be learned from access programmes for the Millennium Development Goals (MDGs) that are relevant for access to essential medicines and basic health technologies for NCDs, at the global, regional and country levels?

Much of the successes on health-related MDGs since 2000 can be ascribed to their clear focus on a limited number of health-related topics, addressed through a result-based management framework that stressed the usefulness of monitoring and evaluation in international work as well as a culture of transparency and evidence-based decisions. Key lessons learnt include a better acknowledgement on the fact that a) high-level political decisions are the key drivers for change and local action; b) vertical systems, however relevant to tackle perceived emergencies at the time (in particular the AIDS pandemic), will be inadequate to tackle NCDs given the multiple dimensions involved; c) the health industry has played a critical role in the development of breakthrough therapeutic innovations through its R&D in the field of HIV and malaria, somewhat less in tuberculosis, and has learnt to work in close collaboration with other stakeholders; d) a well-structured movement of civil society was instrumental in fostering concrete action and accountability.

However, this approach has shown its limitations and not all the goals will be met by 2015, partly because of the absence of a clear roadmap on how all sectors and stakeholders working together could contribute. The MDGs also suffered from their incomplete approach of human development, which resulted in a fragmented vision of health and healthcare systems that overlooked overarching issues, such as social determinants, health inequities and UHC The omission of NCDs in the MDG framework has prevented the devotion of much-needed attention and resources to NCDs.

• Are there specific examples of best practices and successful case studies on country-led initiatives to improve access to essential medicines and basic health technologies for NCDs?

The rise of NCDs stressed the need to rapidly shift to a new integrated model of care that values a holistic “health along the life course” approach across the healthcare pathway. The challenge of how to manage more complex conditions with few resources requires the development of integrated solutions, including medicines and services, to help patients achieve better outcomes and allow the overall management of NCDs.

Sanofi has greatly learnt about the importance to couple better care coordination between prevention, detection, early diagnosis, treatment, care and disease management across the therapeutic spectrum, with practical solutions to improve healthcare delivery that also address the financial sustainability issue. For instance, Sanofi has been one of the first healthcare companies to

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develop with governments, such as in Benin, Madagascar, Mauritania, Morocco, Guatemala, Comoros, Armenia, India and South Africa, comprehensive integrated programmes to improve access to mental health care. The guiding principles of these programmes are: 1) strong and sustainable partnerships enabling stakeholders from different sectors (public, private, NGOs, universities) to join forces for better outcomes; 2) adapted training for front-line healthcare professionals in diagnosis and treatment of mental disorders; 3) enhanced attention to combat stigmatization and discrimination by informing communities about the medical causes of mental disorders; 4) preferential pricing policies, including "no-profit no-loss" prices, to ensure sustainable access to medicines for the poorest.

• What were the critical success factors for these initiatives?

In addition to a strong political commitment, it seems critical to bear in mind the following factors (not exhaustive) to safeguard this progress and to continue to drive sustainable and equitable development.

- A coherent monitoring, assessment and accountability framework. The adoption of more coherent assessment frameworks to monitor programmes is critical to help governments track progress, in particular through clear health-sensitive specific targets and allocation of resources, as well as dedicated indicators that capture healthy life expectancy, mortality, morbidity and disability. It can also help ensure engagements are honoured on all sides.

- Acknowledging the need for a multi-stakeholder response. Success requires explicit alignment between all stakeholders on clearly-defined common goals as no one category can solve the issue of human development. All stakeholders should collaborate in a truly coordinated approach, acknowledging their shared responsibility in supporting both the individual and healthcare systems. Greater sustainability can come from coordination across the private sector, thereby ensuring its commitment to develop sustainable solutions that benefit societies as a whole.

- A multi-sectoral approach. The NCD issue at best resides on the agenda of Health Ministries but has yet to supersede the realm of health to make a more coordinated response an accomplished fact. All parties invested in NCDs who have a role to play must therefore endorse their roles and responsibilities. NCDs require the interaction of multiple policy dimensions and partnerships that convene UN, governments, civil society, and the private sector will be critical to accelerate progress.

- Supportive operating environment. While there is a need for greater support from more developed economies to assist least-advanced countries, it is also essential to yield stakeholders the ability to remain viable partners to allow change to occur. In order to deliver results on NCDs, effective policies supporting the development of an enabling environment fostering trust in partnerships will be essential to harness the contribution of all actors.

Question 2

• Are there other bottlenecks limiting access to essential medicines and basic health technologies for NCDs not mentioned above that need to be addressed? Which bottlenecks would you consider the three most important to be tackled?

The 4 key elements presented in the WHO framework for access to essential medicines – rational selection and use of essential medicines, affordable prices, sustainable financing, and reliable health and supply systems – reflect well the need for a systemic structural outline to address adequate access to medicines. As described by WHO experts, Sanofi believes that access to healthcare is not

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just a matter of patients having access to affordable medicines; it involves a complex set of related issues and overcoming them is not a trivial task. Obstacles to access to NCD essential medicines and basic technologies can arise at and need to be addressed at multiple levels, and understanding the continuum of obstacles is important to developing a coherent policy framework.

As a global healthcare company, Sanofi shares responsibility to improve access to quality healthcare with governments and other players, such as healthcare professionals, NGOs and the private sector. To address healthcare inequities, we support an integrated approach that spans the care continuum, from prevention to detection, early diagnosis, treatment, and care and disease management.

The framework developed by the RAND1 provides a comprehensive “Value-Chain” approach of the different obstacles preventing access to essential NCD medicines and basic technologies (summarized in Figure .3.1).

While a lot of similarities between the proposed WHO framework and the RAND approach can be identified, greater emphasis should also be put on capacity building to support access, both for healthcare professionals and patients. Access to effective, safe and quality treatment and care is hampered by overall limited healthcare system resources and capacity (e.g. disease awareness, prevention and screening campaigns, continuing education for healthcare professionals, adapted guidelines) as well as limited empowerment of patients in their own health. That is, access gaps stem from the lack of the following: R&D and adapted innovation, registration and availability of quality-proven medicines, patient awareness on NCDs, care seeking for the potential condition, diagnosis of the condition by an appropriate healthcare professional, instruction on treatment guidelines and adherence to treatment regimens, as described by the RAND report.

Additional comments can be made on the different sections, including the followings:

Poor implementation and use of standard treatment guidelines and Lack of adherence to good prescription practices. The support of various stakeholders in the healthcare ecosystem, in particular physicians, paramedic staff, pharmacists to name a few, is necessary to develop all-inclusive integrated support system for patients. Guidelines need to be adapted to local contexts and resources and also tailored to different categories of healthcare professionals, with a proper referral system.

Poor acceptability by patients leading to lack of adherence. Medical non- adherence is of growing concern to clinicians, payers and other stakeholders as it is increasingly associated with adverse outcomes and higher costs of care. One of the first steps to improve adherence is the recognition and understanding of the different dimensions of the non-adherence issue, its

1 S. Mattke and al., “Improving Access to Medicines for Non-Communicable Diseases in the Developing World”,

sponsored by the International Federation of Pharmaceutical Manufacturers and Associations (IFPMA), RAND Corporation, 2011.

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complex and multifactorial reasons, including by means of e.g. epidemiological/observational studies at various stage of medicines and technologies development. Collaborating with patients through customizable, scalable and sustainable services using technologies, gamification and analytics, are pathways to improve patient adherence to their treatments.

Reduced competition in production leading to market monopolies – a challenge for equitable access to insulin. The reference to “market monopolies” as a challenge for equitable access is inaccurate, given the number of actors present in this human insulin market for instance in India, Poland or China, since its listing on the WHO Essential Medicines Model List. However, biologics are substantially more difficult to manufacture than the so-called small molecule medicines. Production of biologics requires specific human skills, significant investments in dedicated manufacturing sites and particularly complex and stringent quality controls to ensure the production of safe, and quality medicines for patients. There may be a lack of incentive for new manufacturers.

High prices due to existing intellectual property rights for medicines still under patent: The Intellectual Property (IP) issue represents only a piece of a much larger picture, and it seems there is a discrepancy between the table and the text description in the document, where IP is not considered as the barrier to access given that most NCD essential medicines are off-patent (e.g. hypertension, palliative care). One out of three people in the world do not have access to essential medicines2. In most cases, the reason for inadequate access to essential medicines lie with important factors such as inadequate national health infrastructures and financing systems3, rather than patents. In fact, well over 90 per cent of all medicines on the WHO’s essential drugs list were off patent4, and in the poorest parts of the world a significant proportion of new medicines have to date been neither registered nor covered by actively enforced IP rights. A sustained collaboration is essential to balance the interests of both public health and the pharmaceutical industry expeditiously and without conflict. To provide quality affordable medicines, Sanofi has established a generic Division. A first internal assessment showed that Sanofi portfolio covers about 34% drugs of the WHO Essential Medicines list.

Weak civil structures for advocacy and accountability measures for NCD programmes. A strong civil society is essential to increase awareness globally on NCDs and foster local action. Sanofi supports NCD Alliance’s activities to provide support and expertise to local NCD Alliances, as well as the Union for International Cancer Control work (UICC) and the International Diabetes Federation (IDF)’s efforts on NCD advocacy and support for children through specific partnerships (e.g. My Child Matters – a comprehensive programme based on the concept that simultaneous improvements to healthcare infrastructure, training of qualified personnel, better public information and involvement of local governments are the key drivers of improving childhood cancer survival in developing countries; and KiDs and Diabetes In Schools [KiDs] – an educational initiative that aims to foster a safe and supportive school environment to create a better understanding of diabetes). Sanofi also supports the World Heart Federation (WHF)’s 25 by 25 target and CVD roadmaps programmes.

Inefficient public spending for NCDs. Government needs to take their share of responsibility and invest in their own health systems (health impact assessment, prevention, primary care systems etc.) to ensure strong credibility with other stakeholders. This leadership is critical to foster the engagement of private sector in a sustainable manner and maintain their commitment in local actions. Pharmaceutical companies will be stimulated to support further the achievements of

2 WHO, “The World Medicines Situation”, Chapter 7, 2004.

http://apps.who.int/medicinedocs/fr/d/Js6160e/9.html#Js6160e.9 33

A. Attaran. How do patents and economic policies affect access to essential medicines in developing countries ?, Health Affairs. Volume 23, Number 3, 2004. 4 This assessment may change slightly in light of the recent publication of the updated WHO Essential

Medicines List after review of the WHO Expert Committee on the Selection and Use of Essential Medicines on April 20, 2015.

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NCD targets if governments present consistent approaches in all fields, with adequate accountability frameworks for all stakeholders.

Hampered capacity for local manufacturing, especially in low- and middle-income countries. Local production capacity can be justified when it is sustainable to more efficiently serve the needs of patients. According to the RAND study, “while fear of supply insecurity, increased demand driven by donor funding or exemption from some international patent rules, and the hope for lower prices have been listed as arguments for local manufacturing in developing countries, both quality and affordability are not easily ensured by local manufacturing”. Eight critical imperatives were listed in the 2011 IFPMA study on the experience of the research-based pharmaceutical industry regarding collaborative approaches for technology transfer5, as follows: 1) a viable and accessible local market; 2) political stability, good economic governance; 3) clear development priorities; 4) effective regulation; 5) availability of skilled workers; 6) adequate capital markets; 7) strong IP rights and effective enforcement; 8) quality of the relationship between industry and government, and the extent to which they are able to work together effectively for long periods of time.

Failure to address inequity in access to medicines and other technologies for NCDs. The pathway to UHC represents a significant opportunity to ensure that disparities in access, uptake, coverage and impact of health services are minimized across populations if cost-effective, quality-assured NCD services are prioritized. A key element of UHC is ensuring a core package of health services is available to the populations that need it.

Question 3

• How best can governments utilize multistakeholder collaboration, including the private sector, to increase country capacity to improve access to medicines and other health technologies for NCDs within health systems?

For governments, failure to provide care for NCDs can decrease confidence in a national government’s ability to provide care for its citizens while good policy making is cheap and effective, with well-evidenced packages halving the cost of high-risk care (e.g. WHO “Best Buys”). Greater sustainability in solutions can come from coordination between stakeholders, including the private sector, thereby ensuring both its commitment to achieve the sustainable goals and its involvement in implementing sustainable solutions for NCDs that benefit societies. The need to continue investing in R&D to develop improved treatments and to address tomorrow’s challenges must not been overlooked.

It is essential to yield stakeholders’ long-term ability to remain viable partners to allow change to occur. By building reciprocal trust drawing upon areas of convergence that align, when possible, objectives between governments and commercial companies, shared value approaches can help define clear policy objectives and expectations about the role of the private sector in the NCD response for win-win outcomes. Risks of engagement, in particular conflicts of interest, need to be identified and managed appropriately. When interests are well-understood, no issues are encountered in bilateral relations on the field.

What additional information do donors and countries need in order to understand the business case for funding medicines and other health technologies for NCDs?

Development efforts have too often been hampered by a lack of the most basic data about the social and economic circumstances of individuals. In some countries for instance, poor people are

5IFPMA, “Technology Transfer: a Collaborative Approach to Improve Global Health The Research-Based

Pharmaceutical Industry Experience”, 2011. http://www.ifpma.org/fileadmin/content/Publication/IFPMA_Technology_Transfer_Booklet_2011.pdf

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sometimes never registered at birth or death as stressed by WHO Director General6. NCDs impede economic, social, and political development in countries that need such development the most because of loss of productivity in the working-age population and cost of care provision while investment in health play a decisive role in fostering economic growth and sustainable development.

There is a need to collect reliable data (e.g. epidemiology, burden of disease etc.) in countries, some lacking the capacities to develop registries. It is also essential to capture the impacts of NCDs on societies (e.g. disability life adjusted life years (DALY), cost-burden, productivity loss) and the efficiency of solutions implemented to address those issues (e.g. cost-effectiveness of treatments, patient adherence). This should enable stakeholders to measure progress and to leverage new opportunities of actions beyond the strict scope of healthcare systems (e.g. social, environmental cost of diseases, health outcomes), the need for a multisectoral approach being based on this premise.

Question 4

• Do Member States perceive a need for the development of a bottleneck assessment tool on NCDs? What assessment tools are countries and partners already using that could be adapted for assessing bottlenecks for NCDs?

The framework developed by the RAND7 provides a comprehensive “Value-Chain” approach to assess the different bottlenecks preventing access to essential NCD medicines and basic technologies (Figure S.1).

Question 5

• What are the most pressing needs for Member States as regard the availability of standard guidelines for management of the major NCDs and rational use of medicines for the alleviation of pain during palliative care? How can Member States strengthen implementation of existing WHO guidelines for management of NCDs at the first level of health care?

Given the variety of NCD patients’ interactions with healthcare professionals, they need to be categorized in different ways throughout the care disease journey. The adoption of adapted guidelines tailored to different categories of healthcare professionals, supported by a system of referral, is critical to facilitate collaborations among various health workers. It also depends on their knowledge and confidence in preventing and treating these NCD conditions. Noting the lack of standardized practices among physicians, Sanofi is partnering with the Mexican government to

6 Sarah Morris, (2013) 220 million children who don’t exist: A birth certificate is a passport to a better life – so

why can’t we all have one? London: Independent Newspaper, 28 July 2013. 7 S. Mattke and al., “Improving Access to Medicines for Non-Communicable Diseases in the Developing World”,

sponsored by the International Federation of Pharmaceutical Manufacturers and Associations (IFPMA), RAND Corporation, 2011.

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develop official continuous medical training programmes on NCDs through an online platform called PAEC (Programa de Actualización Enfermedades Crónicas). The academic programme, with chapters on topics such as diabetes, hypertension, obesity, insulinization diabetic foot or economic impact, has been adapted to the needs of seven States in Mexico. Since its launch, more than 25,000 physicians have registered to this programme. PAEC is currently expanded to almost all Mexican States.

In many instances, health workers shortage also limits the capacity of national governments to design and implement appropriate intervention programmes and enforce guidelines. Current rates of training in low-resource settings are insufficient to make up for the low densities of diabetologists for instance. Critical opportunities are offered by IT technologies to train healthcare professionals in remote areas through adapted tools, tailored to local settings. The launch of the e-Diabetes online educational programme in 2009, in close partnership with Sanofi, the Université Numérique Francophone Mondiale (UNFM), the RAFT Network, and Senghor University (Egypt), has proved efficient to support the training of health professionals in Africa with low speed Internet in order to improve early diagnosis of diabetes and reduce risks of associated complications and premature death. More than 1,000 healthcare professionals in 22 English and French speaking countries in Africa now take part in monthly educational teleconferences to interact and exchange experiences with local and international diabetes experts. Building on the success of e-diabetes, Sanofi, with its partners, has developed on the same platform a programme called e-pediatrie answering to the care needs of vulnerable populations (e.g. neonates and children)..

• What are the outstanding needs to improve patient acceptability of and adherence to medicines and other technologies for NCDs?

Closing the treatment adherence gap is essential to improve quality of life for patients while supporting treatment compliance as medical non adherence is increasingly associated with negative health outcomes and higher cost of care. This can be compounded in populations with NCDs because of the extended duration of multiple drug therapies. Fostering capacity building, including through customized patient support programmes, and the development of locally-adapted and integrated tools for patient empowerment, is critical to effectively transition towards a cost-efficient patient-centered model of care. The quality of the healthcare and supply chains and the long-term affordability of care are also key to ensure patient adherence to treatment. Patient’s trust in the quality of treatments is also dependent on the robustness of the local regulatory and law enforcement systems.

One of the key learnings of Sanofi was also in the area of communication and the need for adapted tools. Through its KIDs (India, Brazil) and Diabetes At School projects (Turkey), Sanofi has understood the relevance of schools as a key channel to highlight the benefits of healthy nutrition and exercise, and train students, teachers and parents about diabetes. Working in close relationships with teachers has proved particularly efficient to encourage a safe and supportive school environment for children to manage their diabetes and avoid discrimination.

Question 6

• What constraints do Member States face in accessing accurate and transparent information about procurement prices and quality of essential medicines and other health technologies for NCDs? How useful do stakeholders consider an initiative on knowledge sharing to be?

As a means of regulating prices, transparency may be of assistance to governments, but cannot be a substitute for having robust and principled negotiations based on achieving value for the healthcare

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system and the patients it serves. In some cases, a government’s negotiating position may be stronger if it is not fully-transparent about the terms it has agreed.

Pharmaceutical companies depend on the revenues from current sales of medicines to be successful sustainable businesses and to fund investments in R&D for future medicines and vaccines to meet unmet needs. Medicines prices should reflect the value of the medicines to the patients who receive them. The final price paid for a medicine is made up of many components, including the price charged by the pharmaceutical company that covers R&D, manufacturing, quality procedures and services provided by the company (education, patient support programmes, training etc.), but some other elements also include distribution, wholesale and dispensing margins, plus tariffs and taxes. Prices may fluctuate on a short term basis whereas the most important consideration is the sustainability of the pharmaceutical budget over the longer-term. The proportion of the final price that is borne “out of pocket” by the patient has also been highlighted by WHO as a key influence on the uptake of medicines quite separate from the price itself. This underlines the importance of social protection as a means of managing the costs of treatment.

Question 7

• Are there any gaps in current tools available to Member States that need to be addressed to adequately capture the quantification of needs for essential medicines and basic health technologies for NCDs? How best can Member States build and sustain capacity for effective national surveillance and data collection to forecast needs for medicines and other health technologies for NCDs?

Although potent NCD medicines exist, their availability in developing countries can be hampered by numerous obstacles. Better epidemiology measurement, health and economic outcomes monitoring, and everything that comes under the heading 'big data' offer the potential to better understand the health needs and the impact of active interventions on the health and well-being of patient. Transparent methods and systems for evaluating the therapeutic value of new medicines (e.g. structured health technology assessments activities) can improve evidence-informed decision-making and help in better forecasting healthcare system needs. Ultimately, it allows the reorientation of health systems interventions where they are most needed. To address some of the gaps, Sanofi has developed epidemiology studies in different countries (e.g. NATION to measure the prevalence of diabetes in Russia) and has also launched in 2005 the world largest study for diabetic people to better understand diabetes management practices in 27 countries through the International Diabetes Management Practices Survey (IDMPS).

Without secure supply chains and delivery services, as well as pharmacovigilance systems, access to quality products can be compromised. Good needs forecasting is a prerequisite for building an efficient supply system, and more broadly for enabling an effective response to the health needs of the population and optimizing the use of resources. It is therefore critical for governments to be able to ensure the efficiency and integrity of their supply chain systems to ensure both that a product can be available at the point of delivery, arrives undiminished in quality and quantity, and that the supply chain is not infiltrated by counterfeit medicines. In collaboration with DNDi, Sanofi has for instance developed an innovative malaria field surveillance programme for ASAQ Winthrop® to collect quality, safety and efficacy information. With more than 20,000 episodes of malaria treated, this programme, supported by Medicines for Malaria Venture, is the most ambitious proactive pharmacovigilance initiative ever launched in Africa.

Question 8

How best can Member States ensure the availability of safe, effective and quality-assured medicines and other health technologies for NCDs?

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Governments need to have a clear understanding of the real obstacles to access in their countries to engage constructively with relevant stakeholders (e.g. epidemiology, data, supply chains, human resources, funding, infrastructures, practices, cultural factors, etc.). For instance, a partnership was developed between Sanofi and the Ministry of Morocco to address failures in the management of drug inventory described by the national Court of Auditors (e.g. poor estimation of drug needs, absence of a hospital information system, unsuitable storage of local products, gaps in the inventory management, which all led to financial losses amounting to several million euros per year). The partnership aimed first to provide interactive trainings to national inspectors by experts from Sanofi and external training institutions, on good distribution practices, associated risks and audit of distribution centers. It also supported the deployment of a ‘Distribution Logistics’ module to help reduce malfunctions.

Unequal living conditions together with inappropriate policies also constitute a major barrier for people to enjoy the best possible health. Accelerating progress towards universal health coverage (UHC) is essential to ensuring the health and wellbeing of all people. With an ensured access to health services, the most vulnerable populations can continue to play their role in supporting their families whilst being protected from poverty, with no excessive out-of-pocket payments discouraging the impoverished from seeking or continuing care. As part of this global effort, Sanofi launched in 2012 an initiative called "Kawish" (meaning "Endeavor") in Pakistan in collaboration with the Diabetes Association of Pakistan (DAP), then extended at community level in 2013 through a long-term, sustainable partnership with an NGO, RLCC (Rana Liaquat Craftsmens Colony). Targeting an under-priviledged community in Karachi, the "Kawish Community Service" initiative includes an outreach programme (through RLCC health visitors) supported by Sanofi awareness training and material, blood glucose testing activities to ensure quick diagnosis, access to a `Kawish-certified’ doctor at subsidized charges and to quality therapies for diabetes management at a preferential price aligned to the economic conditions of the community (i.e. discount of up to 40% to RLCC on the purchase of anti-diabetes medicines (orals and human insulin)). The Kawish Clinic has a system in place whereby the patient is offered a flexible discount based on affordability levels, and allowing the poorest to get maximum discount or in rare cases, get the medicines for free. About 1,300 patients have been enrolled so far at the Kawish Community Service Clinic. More than 3,000 community people have been exposed to awareness campaigns, free sugar testing camps, awareness leaflets and house visits by lady health workers.

How can Member States strengthen quality assurance capacity for insulin, asthma inhalers and other more complex NCD essential medicines and health technologies?

It is essential for governments to continue to support regulatory system strengthening, including strong pharmacovigilance systems and capacity building, to ensure that people around the world have timely access to quality medicines and vaccines that are both effective and safe. To this end, regulatory convergence and harmonization, in particular at regional level, are paramount. This, alongside speeding up local review and authorization, are critical measures to make the best use of limited resources while at the same time supporting essential regulatory oversight on quality, safety, and efficacy. It is also important to stress the essential role of WHO’s prequalification program (PQP) in facilitating procurement of medical products, including medicines, vaccines and active pharmaceutical ingredients (APIs), with assured quality, safety, and efficacy.

Guarantying the compliance of our products with our quality criteria and ethical and regulatory norms, at any stage of their life cycle, from the drug substances to the distribution network, is a founding element of our industrial policy with respect to the production of insulin. The main challenge is to always reach sufficient volumes to obtain optimum finished products prices to adequately cover our suppliers and 500 to 600 subcontractors worldwide.

Question 9

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What are the best ways to increase awareness of the importance of essential medicines and basic health technologies to prevent and control NCDs?

Greater public consciousness concerning health and NCDs drives populations to act differently in daily lifestyle choices. It also leads to tangible action from governments to prevent and manage chronic diseases, which creates value for individuals and healthcare systems. Healthier behaviours, earlier diagnosis and more targeted care thus result in improved outcomes and redirection of limited health resources. It will be critical to develop platforms of discussion with countries to better understand the social impact and cost of inaction, in particular in terms of productivity loss. This would reinforce the case for investment in NCDs and secure long-term engagement of all stakeholders in a sustainable manner,

One of most effective ways to increase awareness on essential medicines for NCDs is through the harnessing of mobile technologies that enable learning and positive action in our increasingly connected world. Sanofi is a proud partner of the Be He@lthy Be Mobile initiative in partnership with ITU, WHO and other private sector partners in targeted countries. The initial phase of the initiative for diabetes launched in Senegal started with the mRamadan campaign and was followed by a wider campaign, for which targeted SMS messages validated by a dedicated team of Senegalese experts, WHO and academics, were sent to a broader audience (i.e. general population, people living with diabetes, high-risk populations, healthcare professionals). Sanofi has provided its existing diabetes education material developed in Senegal and other African countries, helped with the review of proposed SMS messages, assisted in the development of communication tools and evaluation criteria.

What other measures can be taken to enhance advocacy efforts to improve access to essential medicines and basic health technologies for NCDs in countries?

In order to enhance advocacy efforts for improved access to essential medicines and basic health technologies for NCDs, focus can be placed on the following areas:

- Moving to an integrated approach of healthcare and adapting reimbursement systems accordingly. Care delivery systems need to better emphasise coordination between detection, early diagnosis, treatment, care and disease management across the therapeutic spectrum. But strengthening policies will have only limited impact if not coupled with practical solutions to also address the financial sustainability issue.

- Patient-centred. Instead of assigning a passive role to patients, not believing in their ability to change, and not supporting them to do so, healthcare systems should rely on patient responsibility and involvement. We need to see a shift in awareness to engage patients as equal partners in their own health.

- Tailored to local needs. While it looks tempting to apply universal targets at governmental level everywhere, it risks becoming utopian and inadequate for certain countries as health systems are highly context-specific. There is a need to operationalize approaches, adapted to local needs and resources.

- Beyond stigma and cultural barriers. NCDs impact on people’s health and development across the lifecycle, causing morbidity and mortality, and compromising their socio-cultural status in communities. NCDs require culturally sensitive support that demystify conditions and break down the barriers of stigma that prevent people from seeking help while their disease is still treatable.

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Question 10

What key knowledge gaps are present for NCDs and how can these gaps be bridged using research?

There is a need to better understand the impact of multi-drug therapies. A particular focus also needs to be placed on research into the viability of fixed-dose combination products (e.g. polypills) for NCD treatment. Much debated, the development and manufacturing of polypills are not straightforward, because a limited range of population-adequate formulations has to be defined and produced at consistent quality.

In the consultation text, references to the decreasing R&D of new hypertension drugs are made but many different types of cheap versions of efficient medicines treating different conditions are already on the market. However, numerous obstacles remain in access for patients, beyond the strict price issue. Adherence to treatment is for instance a much more complicated issue for which a better understanding of the factors that drive behaviour change is needed.

As a research-based pharmaceutical company, Sanofi is committed to the discovery, development, and provision of health solutions and will continue to work with key partners to leverage its expertise to ensure greater access for patients globally. An Emerging Markets Innovation and Search Unit (EMISU) has for instance been created internally to identify and flesh out new solutions' ideas grounded on unmet emerging markets-specific medical needs.

While the discovery of new solutions plays an essential role in improving health, medicines and vaccines alone do not address the diverse issues that impact public health, especially in developing and emerging markets. In addition to new R&D solutions, it is worth looking at other barriers that prevent availability of quality medicines, disease screening and diagnosis, adherence to treatment, implementation adapted guidelines, adequate training of healthcare professionals, etc. to ensure access to prevention, treatment and care for patients.

Sanofi is willing to contribute to WHO efforts in finding concrete solutions to improve access to NCD drugs and basic technologies.

Geneva, September 1st 2015

Contact: martin.bernhardt@sanofi.com