Investments in this area will support research, development, commercialisation and adoption of new drugs, diagnostics and vaccines, as well as measures to improve regulation, procurement, storage and distribution in relation to all relevant products.
Product Development Partnerships Fund
A centrepiece of the Health Security Initiative is the $75 million Product Development Partnerships (PDPs) Fund. The Centre for Health Security opened a call for proposals from eligible PDPs on 9 October 2017. The Fund will support the development of diagnostics and therapeutics for TB and malaria and/or vector control tools for malaria and other high-burden, mosquito-borne diseases. It will fund up to four PDPs at $10 - $15 million per proposal. Australia's initial commitment will cover a three-year period, with the possibility of a further two years' funding based on performance.
For more information about the PDP Fund please visit the Business Opportunities page on the DFAT website.
The Australian aid program has a track record of supporting innovative medical research through PDPs. PDPs are non-profit organisations that use a public-private-partnership model to engage the pharmaceutical industry and academic research institutions in research and development (R & D) for diseases prevalent in low and middle income countries, where there is a lack of commercial incentive to do so independently.
Australian has provided $40 million over the period 2013 to 2018, principally to three PDPs:
- Medicines for Malaria Venture (MMV) for the development of antimalarial drugs and to facilitate access to and uptake of new treatments
- Foundation for Innovative New Diagnostics (FIND) for the development of better diagnostic tools and tests for malaria and TB, and
- TB Alliance for the development of new TB drugs and regimen, including for drug-resistant TB.
These PDPs are building a strong track record. Achievements to date include:
- The release of a new paediatric antimalarial drug that treats both vivax and falciparum strains of the malaria parasite. This was added to the WHO's list of prequalified antimalarial drugs in March 2016.
- The introduction of the first ever highly sensitive rapid diagnostic test for malaria in pregnant women.
- The release of the first ever child-friendly treatment product for children suffering from TB. As of July 2016, more than 155,000 courses of the new treatment have been ordered by 18 countries.
- The introduction of highly sensitive diagnostic test for TB and drug resistant-TB (rifampicin), enabling earlier diagnosis for children and people with HIV.
An evaluation of DFAT's funding to PDPs found that they are a strong investment strategy for supporting research in global health.
Partnership with the Therapeutic Goods Administration
Countries with lower-capacity national medicines regulatory authorities can face long delays in accessing the latest and priority products and have an increased risk of drug-resistance. Increasing the availability of quality treatments and diagnostics is a prerequisite to achieving the global malaria and tuberculosis (TB) targets, particularly for drug-resistant variants.
As one of the Health Security Initiative's early investments, DFAT has partnered with the Australian Department of Health's Therapeutic Goods Administration (TGA) to strengthen the performance of key counterpart regulatory authorities in the region.
The TGA will establish people-to-people and institutional- links with counterpart authorities to support regulatory capacity development. TGA's support will be delivered initially under the Regional Regulatory Partnership (RRP) for malaria elimination, which includes regulatory authorities from the Asia-Pacific. Co-convened by the Asia Pacific Leaders Malaria Alliance (APLMA) and the WHO, the RRP aims to improve the efficiency and quality of the regulatory review for new antimalarial treatments and diagnostic tests.
The TGA will support regulatory authorities to address the capacity gaps related to product registration and market authorisation. As one of two world-class "Stringent Regulators" in the region, the TGA is an integral partner to increase the availability of quality new and priority products to combat health security threats.
DFAT and the TGA are currently working to design a wider partnership that will expand beyond malaria, and also maximise the benefits of DFAT's current and future investments in Product Development Partnerships.