June 10, 2010 Dr Tido von Schoen-Angerer, Director

1. June 10, 2010 Dr Tido von Schoen-Angerer, Director European Parliament Working Group on Innovation, Access to Medicines and Poverty-Related Diseases

2. International medical humanitarian organisation, founded in 1971.Emergency medical care in response to armed conflicts, disasters, social exclusion, epidemics Field operations in about 70 countries. In 2008: 8.8 million outpatient consultations 1.7 million malaria cases 150,000 people on anti-retroviral treatment 29,000 TB patients 1999 Launch of Campaign for Access to Essential Medicines Medical staff frustrated at not being able to diagnose and treat patients because medicines and diagnostic tools unavailable & unaffordable Orientation: innovation & access

3. Unavailable: The case of TB • Lack of health needs driven innovation. • In rural clinics we are still using a diagnostic that was invented more than 100 years ago. • Out-dated test, detects less than half of all cases and performs even worse in children and people co-infected with HIV • Problem not limited to TB: drugs and diagnostic tools are developed on the basis of their future market potential rather than on patients’ needs.

4. Unaffordable: the case of CMV retinitis • Where drugs and diagnostics do are developed they are too often priced out of reach • CMV retinitis is an infection of the eye that occurs in people with weakened immune system such as advanced AIDS. Early detection is crucial because vision loss is irreversible once it has begun. • Treatment: Valganciclovir. • Price: up to US$ 8,500 for four month treatment course. • May 2010: patent in India rejected

5. Council conclusions on the EU role in Global Health in relation to R & D • promotion of ‘effective and fair financing of research that benefits the health of all.’ • ensuring that innovations and interventions produce products and services that are accessible and affordable. • working towards a global framework for R & D that addresses the priority health needs of developing countries and prioritises pertinent research actions to tackle global health challenges. • as well as increasing research capacities in public health and health systems in partner countries and strengthening cooperation between the EU and partner countries.

6. De-linkage of R&D cost from price of product • In the current model R&D cost is recouped through high price of the product – consequence is that products not affordable and new products only developed when there is a profitable market • De-linkage of the costs of R&D from the price of the bio-medical products – a key concept of the WHO Global Strategy and Plan of Action on Public Health, Innovation and Intellectual Property (GSPA). Member States are identified as a key actor. • De-linkage: push or pull financing of R&D – without adding R&D cost to product cost

7. How to Operationalise De-linkage? • Push funding – for example through PDP if resulting innovation is open for competition • Pull funding – for example innovation prizes. Prizes can direct R&D towards specified health priorities and ensure the resulting innovation is accessible and affordable • Innovation and Access: • DNDi and sanofi developed malaria ASAQ fixed dose combination. Resulting innovation is patent free • rBCGΔureC:Hly (VPM1002) – TB vaccine candidate, where public access to government funded research has not been insisted upon and therefore no access provision included. • Access must be considered from the start. EU research funding must include provisions to secure access to the knowledge and tools generated as a global public good

8. Ensuring access: use of TRIPS Flexibilities • Point 16 of the Council conclusion: ‘to support third countries, in particular LDCs, in the effective implementation of flexibilities for the protection of public health provided for in TRIPs agreements, in order to promote access to medicines for all, and to ensure that EU bilateral trade agreements are fully supportive of this objective.’

9. Recommendations • Support R&D initiatives that de-link the cost of R&D from the cost of the resulting innovation. • Pilot a Prize fund competition for the development of a point-of-care TB test. • Support Product Development Partnerships (PDPs) through long-term, sufficient, sustained and predictable financial support through the ECs Research Framework Programmes and other initiatives • Support countries to make full use of the flexibilities in TRIPS to protect public health. This includes the use of compulsory licenses and appropriate patentability criteria. It must also make sure that no TRIPS plus provisions are included in the free trade agreement it is currently negotiating with India.