Two groups this week are urging the World Health Assembly to address access to diagnosis, treatment and new drugs for a tropical disease that is the leading parasitic killer in the Americas and spreading. At a side event on the first day of the assembly, civil society actors also expressed concern about the shrinking input of civil society in the annual WHO members’ meeting.

Médecins Sans Frontières (MSF, or Doctors without Borders) and the Drugs for Neglected Diseases initiative (DNDi) in a joint briefing yesterday on Chagas disease, commented positively on Resolution EB124.R7 [pdf], on “Chagas Disease: Control and Elimination,” which they said is expected to come up as soon as tomorrow and to be adopted by the WHA. But they said key elements are missing from the resolution.

Chagas disease is an infectious disease caused by the Trypanosoma cruzi parasite. The disease is endemic in several Latin American countries. It causes 14,000 deaths per year, and an estimated 10 to 15 million people suffer from the disease, according to MSF.

In 2009, MSF and DNDi joined forces to launch a campaign to raise awareness about Chagas disease, said Gemma Ortiz Genovese, MSF neglected diseases senior advocacy and liaison officer. The resolution on Chagas is a great opportunity, she said, but the resolution does not contain references to diagnosis and treatment of the disease, and the advocates are urging member states to integrate those key points in the declaration before adopting it.

A vast majority of people who have been diagnosed with Chagas do not have access to treatment, said Francisco Roman, vice-president of MSF Spain. The two current available drugs have an important toxicity, side effects, and partial efficiency, so new drugs are needed, he said. Financing research and development (R&D) is a key solution and governments have to find alternative means of financing.

For a long time limited to Latin America, Chagas disease has now spread to Europe, Japan, Australia and North America, mainly through congenital transmission from mother to child, or through blood transfusions, according to Nathalie Strub-Wourgaft, clinical development director for DNDi. In endemic regions, Chagas disease is transmitted through blood feeding bugs. Many Chagas infected people do not present noticeable symptoms, some will go on living with the parasite without health related issues, however, 30 percent of patients in the chronic phase will develop serious heart or digestive problems, some of which leading to death.

The most-needed development is for a treatment in paediatric dose, Stub-Wourgaft said, as treatments are more effective on a young population. It is also crucial that patients are treated before they are 50 years old. Diagnosis is thus of the utmost importance.

The barriers to access to treatment are not related to intellectual property protection, as there are no patents on the two current treatments, which have been on the market for a number of years, but to supply procurement and the under-notification of countries of the number of cases of Chagas disease.

Financing R&D is a challenge as current donors, such as the Organization for Economic Cooperation and Development (OECD) governments and the Bill and Melinda Gates Foundation have squeezed budgets due to the economic crisis and might shift their priorities to climate change, energy, and food security, said Pascale Boulet, IP and policy advisor for DNDi.

Milestone prizes could be an interesting option, she said, as it would pay for substantial reward for specific steps in the discovery process or clinical drug candidates that meet specific criteria. That could increase interest in the sector and maybe draw new actors, such as biotechnology companies. Funds could be sought from usual donors, she said.

Other mechanisms such as the UNITAID airline ticket tax, voluntary solidarity contribution or a currency transaction tax could be explored too, she said.

De-linkage of R&D Essential

Separating R&D from the price of the products is an important principle, said Michelle Childs, director of policy advocacy for MSF.

The WHO has a central role, she said, by defining priorities. It is important that endemic countries are R&D partners, funders and in the decision-making process. De-linking is a key concept that enables reconciliation of innovation and access, she said, asking that the WHO help member states to frame, develop and support R&D policies based on the de-linkage principle.

Civil Society Input in Assembly Reined In

At the opening of the briefing, Tido von Schoen-Angerer, director of the MSF Campaign for Access to Essential Medicines, said that they had been advised by the WHO that no room would be available for NGOs during the Assembly due to time and space issues. Later on, the WHO decided to allow one room per day to NGOs. “We are quite concerned,” said von Schoen-Angerer, as this limits civil society participation and contribution to the World Health Assembly (WHA). This is a significant change compared to previous years, he said, and an “awkward” situation where other international organisations such as the World Bank, the World Trade Organization, the World Intellectual Property Organization, sometimes have provided more space to civil society than is the case for the WHA.

A representative of Health Action International said “it is important to know that [WHO Director General] Margaret Chan repeated again today her commitment to engagement of civil society, but the evidence is kind of suggesting otherwise,” and James Love from Knowledge Ecology International said that at several institutions, there had been efforts to reduce input of civil society.