Strategic multilateral partnerships for distributing anti-malarial drugs in Nigeria

¶ … Strategic Multilateral Partnerships Help Address the Limitations of Access to Essential Medicines in Emerging Markets?

The Case of Anti-Malarial Drugs in Nigeria.

Business Case Background

The Company Challenge

Opportunities

Business Case Analysis

Wider Sustainability Context

Conceptual framework

Stakeholders and Community interest

Challenges for the Organization

Critical Analysis of Data Collected

Business Case Background

The organization known as Cure Pharmaceutical belongs to the pharmaceutical industry's drug delivery technology sector. A specific technology, designed by the firm, enables patients to effectively take medications without requiring water in the process. This patented Oral Thin Film technology (OTF) is small, light, and occupies much less space after packaging. Cure Pharmaceutical's innovative technology allows both easy transport and more convenient dosage forms of essential medications.

A 'for-profit' organization, Cure Pharmaceutical's source of income comes from developmental and humanitarian outcomes. The emerging markets and developing world are key targets. The firm's interests lie in initiating opportunities for business that profit both Cure Pharmaceuticals and the local communities. Its unique drug delivery methods and culturally suitable packaging makes offered medications more affordable, appealing, convenient, and safe.

1.1. The Company Challenge

The challenge incorporates development of a sustainable model for distribution through partnerships, which enables the corporation to access developing countries more swiftly and effectively. Cure's business model is to distribute essential medications such as its Oral Thin Film (OTF) pediatric malaria treatment to emerging markets in sub-Sahara Africa. Some barriers include distribution, government regulations, country regulatory compliance, educational gap (because it is connected with healthcare), fractured supply chain and distribution channels, and social unrest (Kremer, 2002).

As the Chief Executive Officer I have been tasked with analyzing the current distribution climate as well as presenting a plan of action to our board of directors. Cure has entered into the emerging market with its oral rehydration therapy technology in Ghana. This distribution was through a third party license distribution model and was rife with difficulties. It is Cure's experience that these basic license distribution models do not effectively navigate the barrier to entry in third world countries. The main research question posed in this paper is as follows: How can Cure Pharmaceutical navigate the barriers to entry into Nigera? This includes efficacious distribution of essential medications to emerging markets, through sustainable collaborative partnership between Cure, government bodies, and community enterprises (multilateral partnership) within Nigeria?

1.2. Opportunities

Millions of individuals in developing countries cannot access essential medicines necessary for sustaining well-being and life (Kremer, 2002). Cure Pharmaceuticals views these issues as mutable health issues having achievable solutions. Such solutions will deliver social and health benefits to individuals from developing countries, while creating a profitable international business for the firm. Emphasis lies on developing non-pharmaceutical and pharmaceutical drug delivery opportunities suited to every environmental condition, in addition to developing a business prototype that fosters sustainability by way of self-respect and entrepreneurship.

2. Business Case Analysis

2.1. Wider Sustainability Context

Many individuals from developing countries do not have access to, or receive pharmaceutical assistance that could be beneficial to their well-being. The failure of anti-retroviral therapy (for HIV / AIDS) to be more widely distributed in developing nations has drawn extensive publicity. However, this is not the only case. Even far cheaper medications that can readily be delivered aren't reaching the numerous individuals who require them. Over a fourth of children all over the world, and more than half of the children in a few nations, fail to receive vaccines. This comes under the World Health Organization's (WHO) Expanded Program on Immunization. Apparently, though these vaccines cost only a few pennies per dose and do not require diagnosis and/or expensive medical intervention, the failure of vaccinations annually results in three million deaths (World Bank, 2001a). Cure has experienced precisely this issue of deliverability with the launch of their cost effective Oral Rehydration Therapy OTF technology in Ghana through a license distribution model. The distribution of the technology was stymied both by the lack of an ongoing relationship with the government of Ghana, and by the limited financial resources dedicated to this project by the (local) distributor. Cure's challenge is to develop a multilateral partnership that encompasses both government and community enterprises in Nigeria to better navigate these obstacles.

2.1.1 Resource Availability

Often, developing countries just follow developed countries' approval decisions instead of carrying out their own calculations on risk-benefit. While this approach may, in some instances, be appropriate, it might also prove to be an obstacle to adopting essential vaccines and drugs. Rotavirus, for example, kills 0.75 million children per annum in undeveloped nations; in contrast, within the United States (U.S.), rotavirus is a relatively minor health nuisance resulting in childhood diarrhea (up to 3 million cases annually). Whereas the rotavirus can be fatal without treatment, in the U.S. there are hardly any losses of life (CVI, 1999; Murphy et al., 2001a).

Many pharmaceutical companies in third world countries do not have either the financial or research capabilities to develop their own drugs. Drawing from Cure's experience in the country of Ghana, these countries have few clinical resources to develop and clinically validate new drugs. The Ghana regulatory agencies relied wholly on the regulatory approval process of the United States Food and Drug administration. The absence of a specific national regulatory process in some countries becomes a major entry barrier for pharmaceutical companies, particularly where the goal is to distribute novel essential medicines in these emerging markets. It is extremely difficult to develop a protocol in the U.S.A. For a disease state that is not prevalent in that region. Because of these underlying issues with our license distribution model in Ghana, the rehydration therapy has taken three years to gain regulatory approval. Companies who have initiated multilateral partnerships, such as the Novartis Arogya Parivar scheme and the Accelerating Access Initiative (founded by Roche), are successful examples of pharmaceutical firms pooling all the available resources to ensure quality, regulatory access, minimizing the costs involved, and establishing distribution routes (Weyzig, 2004).

2.1.3 Environmental Impact

A considerably different 'disease environment' is faced by developing countries as compared with developed countries, as a result of their geography, cultural aspects, and relative economic state of poverty. Comparison of the burdens of various diseases can be carried out across nations by employing the Disability Adjusted Life Years (DALYs) concept (Murray and Lopez, 1996). This concept considers not just deaths due to disease; it also considers the years of disability brought about from the disease. The focus of Cure in the development of a pediatric malaria treatment for Nigeria can benefit from partnering with an organization of origin that truly comprehends the impact that these diseases have both culturally and environmentally.

For example, Novartis, through its multilateral partnership, called the Arogya Parivar scheme, was successful in implementing its approach through its partnering with health educators and clinics within the rural areas of India (Ionescu-Somers, 2015). In comparison, Cure's license distribution model in Ghana was wholly reliant on feedback from the distributor. The distributor lacked the core competency and scope to educate the community about the overall impact of the disease. As well, many individuals have differential views on the severity of various endemic diseases within their own community. Collaborative outreach within any partnership and public health awareness is needed to narrow the gap.

2.2 Conceptual Framework

The primary objectives of national pharmaceutical guidelines and public sector drugs supply systems incorporate providing access to essential supplies and medicines, promoting rational consumption of medication, and ensuring efficacy, quality, and safety of medicines. This aligns with Cure Pharmaceuticals overall objectives and mission statement. To better comprehend how a multilateral partnership model comprised of Cure, government, and community enterprise can help to successfully distribute pediatric malaria medication in Nigeria, we must delve into a comparative analysis of Cure's past model in Ghana vs. that of a successful multilateral partnership model attaining successful participation in the medicine management cycle (Pharmaceutical Supply Strategies, 2012). The Novartis Arogya Parivar Scheme was chosen as a case analysis because of its overall sustainability and known success in the dissemination of essential medicines in India and other emerging markets.

Arogya Parivar, an Indian social enterprise, addresses problems in the health sector among the poor people in rural areas of India. This model came into being as a joint venture of Novartis' Consumer Health, the government of India, and another pharmaceutical company, Sandoz, in the year 2006. The pilot projects were carried out modestly in two Indian states- Maharashtra and Uttar Pradesh. Today it has affected the lives and health of over twenty five million people spread across seven Indian States (Chamania, 2010). Health educators are recruited locally and given training so that they can assist to increase awareness concerning illnesses and preventive health. Health supervisors help make sure that there is countrywide availability of medicines. Through the expansion of access to health care, the enterprise is working to ensure that Indians in the remotest of places can have access to health care (Center for Health Market Innovations, 2007). The concepts driving the Arogya Parivar program are widening the healthcare scope, sustainability, accessibility, and education.

Education

Health education through the Arogya Parivar model is conducted right from the grassroots levels. The focus of the program is the building of local healthcare capacities and patient education. This is aimed at ensuring that the success attained is long-term. Educators are mainly women drawn from the local community; these educators focus on preventive health as well as diseases. Other people assisting are health supervisors, whose role is mainly ensuring that the medicine is widely distributed. Trust develops between the members of the community and the educators. In a meeting addressed by the volunteers, anywhere between 200-2000 locals may attend it, making it a mass outreach program (Chamania, 2010). With Cures' past license distribution model, education on the product and the disease was exclusively reliant on the distributor. Unfortunately, the distributor also disseminated a plethora of medical products that were not related to Cure. As well, due to the high volume of products the distributor was responsible for selling, there was very little emphasis placed on educating the community. Indeed, community education was clearly outside the scope of the distributor's core competency.

Accessibility

The Arogya Parivar partners recognized at the outset that the view of most locals is that medicine is costly. The organizations worked to change this mindset. Partnerships were made with local medical professionals, and medicine was made available to the local population at prices they could easily afford. This initiative made use of generic medicines, in collaboration with local manufacturers. At times, medicines given to the villagers would not even carry the Novartis brand. As well, other participants in this endeavor included various health camps and NGOs. In contrast, the past distribution model used by Cure had a retail price for medications set by the distributor; this pricing was not only inconsistent in adjacent geographic areas, but also Cure's product was cost prohibitive for the intended patients.

Sustainability

Arogya Parivar has proven that its model is sustainable, while Cure's license distribution model was ineffective in penetrating the market and sales are virtually stagnant. Meanwhile the Arogya Parivar model break-even was achieved, much earlier than the projected sixty month period, at thirty months. From the year 2007, the sales of the enterprise have grown twenty-five-fold. Because of the success of the Arogya Parivar model in India, it has been implemented by Novartis in Vietnam and Kenya. Spurred by the local initiative success, Novartis has also launched a similar social marketing drive in Kenya and Nigeria (Center for Health Market Innovations, 2007).

Scope

The Arogya Parivar program can be found in at least ten Indian States. The program offers close to eighty over-the-counter (OTC), pharmaceutical, and generic products (including vaccines) for treatment and/or prevention of several conditions like colds, pain, diabetes, and tuberculosis. For products to be added to the portfolio, they have to be customized to specific local needs, have affordable costs, and be distributed through a reliable, sustainable delivery and retail outlet channel with the active help of healthcare personnel (Center for Health Market Innovations, 2007).

Pharmaceutical supply approaches can be defined with regards to private and public roles in wholesale distribution, retail distribution, and financing as Figure 1 summarizes (Pharmaceutical Supply Strategies, 2012). A multilateral partnership like the Arogya Parivar model encompasses this approach, which is utilized for greater outreach into the market through government hospitals, clinics, private healthcare clinics, NGO's and a combination of educational outreach programs (Ionescu-Somers, 2015). The Cure license distribution model was not able to take advantage of each vertical due at least in part to the myopic approach employed by the distributor.

Figure 1: Supply Chain Management Framework (Pharmaceutical Supply Strategies, 2012)

2.3 Stakeholders and Community Interests

Engaging with stakeholders is crucial to identifying their concerns, needs, and expectations. By integrating stakeholder feedback into company strategy and daily business, through an approach like the Arogya Parivar Scheme, members can address common issues, in addition to developing long-standing solutions. Constructive, open dialogue is believed to be crucial in improving the ability to build sustainable growth and value (Stakeholder Engagement, 2014). In Cures license distribution model in Ghana, effective communication and open dialogue was hampered by the lack of cultural understanding, including points of differentiation in the geographic region. The reliance on the distributor to facilitate an accurate and open dialogue in communicating with stakeholders failed due to their lack of vested interest in the project. In contrast, the Arogya Parivar Scheme placed emphasis on transparency within the partnership, and subsequently utilized their partner's commitment to the success of the project as a catalyst.

Understanding the interest of stakeholders as well as what drives and motivates them is necessary to ensure that prioritization and dissemination is effective. Understanding what motivates them will enable the consortium to be able to engage effectively with them. While there are certain differences between categories of stakeholders, many of their barriers and interests do overlap. This is not surprising as stakeholders do exists in an interactive ecosystem; therefore priorities and directives may reflect independent areas of interest and influence as recognized by the Arogya Parivar model. An engagement that seeks to be effective should strive to address the interests of each stakeholder, while also striving to rise above the barriers experienced (Wyatt, 2013).

3. Challenges for the Organization

The extent to which infrastructure problems interfere with growth could be underestimated, as Novartis Arogya Parivar realized in its initiative in India. The creation of awareness from the beginning is not easy. There had to be considerations concerning suitable media to be used for outreach. This was a stumbling block for Cure's license deal in Ghana as well. There was no clear plan for creating awareness of medical products availability. One of the first attempts at creating buzz for the Arogya Parviar model was using branded audio/visual vans (A/V). Poor roads raise the cost of transport and this has to be factored in (Wee, 2014). Institutionally, social issues have to be addressed to allow for the coordination of activities that overlap. There is reported mismanagement by the civil society, including private actors as well as the public actors. One particular problem is that drugs are being distributed illegally so that some can gain financially from the programs (Ngoasong, 2010).

Some other issues that can pose challenges include a lack of goodwill from the political elite. Without the goodwill, it is difficult for healthcare workers to bring forth the needed resources to help fight malaria and provide the human resources to ease the workload. The Arogya Parivar model incorporated a multitude of verticals within their partnerships that allowed for the sharing of resources among the partners. The alliance with the government was also crucial in creating political goodwill within the Arogya Parivar model. This type of resource sharing was not available in Cure's license distribution partnership in Ghana. Cure relied on the distributor to utilize its resources and contacts within the government.

3.1 Barriers and Opportunities

3.1.1 Barriers and Risks

With respect to Cure's past distribution partnership in Ghana, Cure rapidly recognized that the Governments, irrespective of their economic development levels, are bound by a common series of constraints, which include:

Inefficient service delivery that may be caused by a shortage of individual motivations for performing well, bureaucratic inflexibility on the part of business partners, political supporters, concerned parties or local community members, which may result in inequitable or inefficient public resource usage (Pharmaceutical Supply Strategies, 2012). This was a pertinent lesson in the company's collaboration in Nigeria. The proper multilateral partnership as demonstrated by the Arogya Parivar model that involves the government may be able help the officials create a more seamless process as it relates to regulatory and distribution.