Prize for TB low-cost point of care rapid diagnostic test

Pierre Chirac

Médecins Sans Frontières, Paris, FranceCampaign for Access to Essential Medicines

Present TB diagnostic methods leave half of all patients undiagnosed !

• sputum smear microscopy:

sensitivity < 50%, especially not suitable for:

– children– HIV positive patients– extra-pulmonary TB

Better diagnostic tools exist

• Improved sputum collection and microscopy methods

• Liquid and solid culture

• Colorimetric redox indicators

• IGRA’s• Molecular techniques

• Still lacking sensitivity and specificity

• Expensive

• Not suitable for the most peripheral settings: requires highly trained staff and/or highly equipped lab-infrastructure

What do we need?

• More needs-driven research for new TB diagnostic tools, taking especially into account the situation at peripheral level

Rapid, low cost, point of Care– Differentiate between active and latent TB

especially in high HIV prevalence areas– High sensitivity especially for smear

negatives and EP TB – Cheap– Easy to handle – Fast (results within hours)– Not sputum based / Usable for children– Suitable for follow up– Detecting Rifampicin resistance– ….

How to facilitate the development of POC:

MSF + experts meeting on TB prize, Geneva - April 2008

• « Developing simple, point-of-care tests soon requires innovative strategies, both financial and scientific »

• « The most fruitful way forward is to work with a combination of different antigens that would optimise the sensitivity and specificity of any test »

• « That would require actors who work now separately to join together to share the current status of their individual research, sum up these results and perform further tests together »

• « Protecting knowledge through patent monopoly stands in the way of this kind of innovative collaboration »

• Industry interested if prize is big enough

POC TB test : best candidate for a prize…

• The low-cost POC TB test is a perfect candidate for testing innovative R&D mechanisms and funding

• This would perfectly be in line with the « Global strategy and plan of action on public health, innovation and intellectual property » the WHA adopted in May 2008 at the end of the IGWG process:– « Explore and (…) promote a range of incentive schemes for

research and development including addressing (…) the de-linkage of the costs of research and development and the price of health products, for example through the award of prizes (…) »

A promising proposal

• Prize Fund for Development of Low-Cost Rapid Diagnostic Test for Tuberculosis, sponsored by Bolivia and Barbados.

• Presented during the IGWG process and expected to be considered soon by WHO

Grand Prix

Grand Prix of 100 million dollars for a TB test (every 7 years)

• feasible to manufacture for 1 $• feasible at POC in developing countries• results in 3 hours• sensitivity = X %• specificity = Y %

= needs first= innovation + Access

Sub-prizes

Awards (1 to 10 millions) for

• Small technical challenges• Best contributions (every 2 years)• Incentives to collaboration and access to knowledge

= cash flow on short term= rewards incremental advance= rewards collaboration and open access

Monopoly free

“Intellectual Property Rights For Grand Prix”

A licensing pool would be created for acquiringneeded rights for the relevant patents and know-how for the diagnostic test—the TB licensingagency (TBLA). In order to claim the Grand Prix, thewinner would have to grant licenses to all patentand know-how needed for competitive supply of thetest, worldwide.”

= no monopoly= competition for production

Public funding

Government would contribute to the prize

• Participating high-income countries would be expected to contribute 90 percent of the funds

• Developing countries would be expected to contribute 10 percent

• = public responsibility• = equity

Administration

• The prize would be placed in the WHO, but administered by a committee including several institutions and representatives of the interests of TB patients

Outstanding questions

• Medical and operational specification• IP - rights• Price• Partners• How much money to be allocated?• Money coming from?• When ? • Who ?

Invitation Any proposal on specifications,

please come back to us :

Pierre.chirac@paris.msf.org

www.accessmed-msf.org

Thank you