Two billion of the world’s population living in low and middle income countries still do not have access to modern medicine. This is because “big pharma invariably lives in the first world” and “first tier countries still offer the lion’s share of their revenue stream,” CEO and founder of Masters Speciality Pharma Zulf Masters explains.

Leveraging his own experience selling drugs in Latin America, Masters Speciality Pharma facilitates the supply of high-quality medicines to patients in need in the developing world.

Although it is clear that broadening access to medicine in poorer countries is not purely the responsibility of pharma companies, tangible progress cannot be achieved without them.

Compared to governments and supranational bodies, the pharma industry contains the only stakeholders who can develop and bring urgently needed new medicines to market on a large scale. This is because of their research and development (R&D) expertise and capability. It is simply not feasible for poorer countries to be able to develop and manufacture innovative products themselves on the necessary scale.

The Amsterdam-based Access to Medicine Foundation was founded in 2008 to build a consensus on the expectations on pharma companies regarding broadening access to medicine, as the not-for-profit’s research programme manager Danny Edwards explains. “Companies should be developing the right products for global health and then ensuring their availability and affordability” in poorer countries.”

A decade after the creation of its index, the foundation performed a review of progress regarding access to medicine, concluding: “Compared with ten years ago, pharmaceutical companies are taking seriously the problems people face in low- and middle-income countries when accessing healthcare,” in the words of Access to Medicine Foundation executive director Jayasree K Iyer.

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However, she cautioned: “The situation is still fragile – a retreat by one company, or a drop in healthcare investments, will jeopardise the progress made so far.”

Pharma and access to medicine: a decade of progress

Based on analysing the 20 largest research-focused pharma companies’ performance in 106 low and middle income countries, the report found that pharma companies are changing how they do business to allow them to reach people in low income countries.

There are now 17 companies setting goals and targets related to access to medicine, compared to eight in 2008, as well as seven more companies disconnecting bonuses from sales incentives to a total of nine.

Moreover, R&D pipelines have grown significantly in certain disease areas. Edwards highlights neglected tropical diseases as an example of a success story. “This is an area where we would have seen very little research 15 years ago, because there is no commercial incentive for pharma companies to engage,” he says. But over the past decades the number of projects has grown from 38 to 90; other examples are malaria, HIV/ADIS and tuberculosis – all of which are high-burden and priority diseases.

Edwards singles out Sanofi and Johnson and Johnson (J&J) for their work in R&D for neglected areas. Sanofi recently secured approval for fexinidazole for sleeping sickness, while J&J is developing a paediatric version of drug-resistant tuberculosis focused bedaquiline.

The review also identified that the three primary methods for furthering access – equitable pricing, voluntary licensing and drug donations – were being employed more frequently and with a heightened focus on access.

Gilead is a prime example of success in voluntary licensing. “They are particularly effective at engaging with generic manufacturers to boost scale, reach and coverage of their products,” says Edwards. They agree licensing terms for patented products so that they can be supplied more cost-effectively by other manufacturers. Edwards focuses on Gilead’s work on HIV, but Masters focuses on the company’s impressive record in Hepatitis C.

In terms of pricing, Edwards provides the example of Novartis Access where they offer a basket of 15 on and off-patent medicines targeting key non-communicable diseases; 14 of these are on the WHO’s list of essential medicines. The medicines are priced at $1 per treatment a month, and the approach is currently being rolled out across sub-Saharan African, Southeast Asia, Central America and Central and Eastern Europe.

Main drivers behind pharma’s increased access commitments

The most progress is seen where multiple stakeholders are working in synergy, which Edwards notes is a particularly interesting finding of the review. He states that governments can contribute to the effort by setting research priorities and supporting the funding of research to create a “de-risking mechanism [which] tends to bring companies to the table”.

The Sanofi case study Edwards provides is a good example of multi-stakeholder efforts leading to success as the company worked the drugs for neglected diseases initiative on fexinidazole.

The need for a multiple actor approach is the central premise of Masters Speciality Pharma. Company CEO Zulf Masters explains the company provides a regulatory compliant and trustworthy partner; since it knows the corridors of power, it can facilitate relationships between companies and national governments and supranational bodies.

Other drivers noted by Edwards include “a marked shift in interest in [corporate social responsibility] from the investment community. It is not enough for companies to be interested only in commercial outcomes, they also need to be interested in social outcomes, such as sustainability and access to medicine. Companies are, of course, guided by the investment community”.

Further to this, “companies today find it really challenging to recruit talent unless they can tell a very compelling story about their engagement with these types of social outcomes”.

However, Masters thinks most companies are only paying lip service to corporate social responsibility, and instead pharma companies have moved towards a heightened focus on access to medicine because they have realised the enormous alternative revenue stream developing countries can bring. This is primarily due to the “sheer volume of people who are going to consume the products” so it will make up for a significant price reduction. The Access to Medicine Foundation records that 83% of the global population – around 6 billion people – live in low and middle income countries.

Remember this progress is fragile

Unfortunately, Edwards emphasised that “one of the interesting findings is that we do progress, but it is limited and concentrated.” Not only is the progress concentrated on certain disease areas, it also clustered in certain regions and five companies are carrying out almost two thirds of the work; GSK, Johnson and Johnson, the German-based Merck group, Novartis and Sanofi.

This creates fragility because if “one of those companies decides to change direction, this would cause a huge dent in R&D, which is so badly needed for global health”.

This concentrated situation means “only a fraction of the people in need are benefitting from solutions for improving access – even though effective treatments and vaccines now exist,” Iyer wrote in a LinkedIn article.

However, this is not the only concern about the results of the not-for-profit’s ten-year review. Edwards notes that “on the whole registration performance is poor; [this] is the first key step to access. You can develop and new product and register with the Food and Drug Administration in the US or the European Medicines Agency, but if you’re not registering it in low and middle income countries… there is [essentially] no access”.

This situation can largely be explained by continuing barriers to access – particularly in areas like Sub-Saharan Africa – which country governments and supranational bodies need to focus on rectifying if they want to encourage companies to do business there.

An example of a barrier to access is import taxes on drugs; Masters notes that this is the norm in some countries in Latin America – for example, Brazil and Colombia This creates a more complex access situation than in the first world. Where there is no VAT on medicines. Corruption and political instability are other problems, and these issues have actually caused “pharma to wholesale deregister products from certain geographies”.

Priorities for the next decade

Iyer noted: “Going forward, the big challenge for all of us working on access is to match the scale of action to the scale of the problem.”

“We see the success stories…the challenge [now is] to take the lessons we’ve learned [from] where it’s worked and scale that across other disease and into other countries,” Edwards explains.

Although Edwards notes more work needs to be done to ensure better access to poorer countries, such as Sub-Saharan Africa, resolving the access problem is much complicated than this; it is also necessary to focus on the poorer people in the richer middle income countries.

“When we talk about the two billion [without access to medicines], it’s very easy to assume we mean Sub-Saharan Africa, but, a significant proportion, are in the wealthier middle income countries, such as Brazil, China, India, Pakistan, Nigeria and South Africa,” Edwards adds.

“I think in our next round of analysis…we’ll be taking a closer look at what access means to the poorest people in those middle income countries.”

Masters concludes pharma needs to continue to re-focus itself towards patients and the need to provide the same, high quality drugs in the developing world as in the first world.