Rational rollout of new medicines for diseases of poverty

Key Points

• Tuberculosis and malaria kill more than two million people each year, primarily in low- and middle-income countries. Many of these deaths could be prevented if companies have incentives to produce medications for diseases of poverty more quickly and make them available more cheaply.
• Once effective new medicines for diseases of poverty are produced, government policies largely determine how or whether they are provided to the people most in need. Governments with high disease burdens must optimize their policies to ensure safe and timely access to new medicines.
• The world health community must get behind action to combat infectious disease drug resistance. Increasing pharmacovigilance (especially removing inferior medicines from the supply chain) and establishing fully funded sustainable treatment plans will help achieve this aim.

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Increasing access to medicines for diseases that primarily affect the poor, such as malaria and tuberculosis (TB), involves a complex interplay of private- and public-sector efforts—some of which are often ignored in public debates over how to best improve access. Producing new medicines is a necessary first step, and companies can be given incentives to do so through a variety of mechanisms. But production is only part of the story. Government policies largely determine how or whether effective new medicines are provided to the people most in need, and government requirements for local clinical trials, filing dossiers, and registering new drugs can create high costs and sometimes barriers to access. Governments with high disease burdens must optimize their policies to ensure safe and timely access to new medicines. Western nations could encourage such action at the 2015 World Health Assembly; this is the humanitarian thing to do, but Western self-interest should also drive such an effort. Escalating drug resistance does not respect national boundaries, and extremely drug-resistant variations of some diseases of poverty ultimately threaten the poor and the wealthy alike.

Treating the hundreds of millions around the world with infectious diseases is challenging even when effective medicines are cheaply available. For tuberculosis and malaria, two leading infectious killers, ensuring access to medicines involves a complex interplay of private-sector development and government implementation. Together, the high sums of investment required to develop new medicines, the range of stakeholders involved, the stringent ethical framework under which medical research must be conducted, the lack of market incentives to combat diseases of poverty, and other factors limit or slow each vital step in the process, from research to development and manufacturing to the delivery of new products. When new products finally reach the market, inadequate public health infrastructure feeds the emergence of medicine resistance as people receive incomplete or substandard treatments.

These problems are manifest in current efforts to treat TB and malaria, which together kill more than two million people each year, mainly in low- and middle-income countries. Each death is a personal tragedy that could have been avoided with proper treatment. The fact that large numbers of preventable deaths occur each year fuels a great deal of frustration in the public health community, some of which is directed at the pharmaceutical companies that produce new medicines. Ironically, anger is not directed at companies that do not make these medicines.

Certainly, medicines for diseases of poverty might be developed and manufactured more quickly, and made available more cheaply, but the activities of drug companies alone do not determine the pace at which new medicines are brought to market within developing countries, let alone whether patients actually receive them. When working to accelerate access to key medicines for diseases of poverty, it is crucial to look not only at pharmaceutical production and pricing policies, but also at government policies and actions that determine access within low- and middle-income countries.

Research and Development

There is little profit in developing medicines for TB and malaria, so either research and development costs are absorbed by for-profit companies or donor governments or drugs are priced so that costs can be recouped from the few segments of the market that can pay. Historically, while much truly original, or “blue-skies,” research is publicly funded, early-stage product development is almost never covered by government donors. This means that while research may be encouraged by the public sector, actual product development is not. Private companies have few incentives to create products that are safe and effective.

Nevertheless, over the past 20 years, pharmaceutical companies have developed medicines for diseases of poverty with little hope of profit. For example, Novartis signed a memorandum of understanding with the World Health Organization (WHO) to state that it would recover only costs—and not profit—from the sale of its breakthrough antimalarial artemisinin-based combination therapy (ACT), Coartem (Spar and Delacey 2008). Similarly, Sanofi (2013) developed a different ACT without expectation of significant gains.

Both of these medicines have since been copied by myriad generic firms, most of which have razor-thin margins to remain profitable if they make the product properly. Understanding the costs that are absorbed by for-profit pharmaceutical firms in the process of developing new malaria products, the Medicines for Malaria Venture (a private-public partnership) defrays some of the private sector’s R&D costs and helps coordinate research and is on track to deliver new combination medicines over the next decade (Zaracostas 2015).

While a few major pharmaceutical companies have research underway into TB medicines, others have closed TB research programs in what one advocacy group has described as “running for the exits” (Treatment Action Group 2014). Since rifampicin was introduced in 1967, only two new TB medicines have been introduced—bedaquiline (trade name Sirturo), produced by Janssen Pharmaceuticals, and delamanid (trade name Deltyba), produced by Otsuka Pharmaceutical. Both are approved for use exclusively to treat patients with multidrug-resistant strains of TB. The not-for-profit TB Alliance currently manages the world’s largest portfolio of TB drug candidates, with six different TB treatment regimens currently in various phases of testing (from two regimens in Phase 1 to one regimen in Phase 4) via five active clinical trials (TB Alliance 2015).

However, the development of new medicines is simply an intermediate step in getting improved treatments to patients. In some cases, even after new treatments have been discovered, the financing needed to move those medicines through the marketplace has not materialized.

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