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Global In 2009, the governments of Italy, the UK, Canada, Russia, and Norway as well as the Bill and
Melinda Gates Foundation launched an advanced market commitment AMC administered by the GAVI Alliance to drive development and production of a pneumococcal vaccine specifically tailored
to the needs of developing countries.
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The result of this innovative financing scheme suggest that AMC has been successful because:
It has created competition – 4 suppliers have registered to sell their vaccines through the AMC at a fixed price
It has reduced prices – suppliers have committed to selling their vaccines through the AMC at a price that is lower than 10 compared to the next lowest price on the market, and 90
less compared to the industrial market It has facilitated widespread demand – 30 developing countries have expressed interest in
purchasing the pneumoccocal vaccine through the AMC; and It has spurred scale-up of production capacity – the volume of the pneumococcal vaccine
launch has been much higher than for any global health product historically, indicating that suppliers have scaled-up production capacity significantly
In the same year, GSK promised to cap the price of drugs in the poorest 50 nations to no more than 25 of the cost of drugs in wealthy nations. Included drugs are malaria, tuberculosis, and hepatitis.
Drugs for HIV were also included, to the extent that they were not already offered at this rate. GSK also promised to invest 20 of profits made in least developed countries to build health care
infrastructure in such countries.
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Building on this perspective, GSK in March 2016 announced it is evolving its graduated approach to fili g a d e fo i g pate ts so that IP p ote tio efle ts a ou t s e o o i atu it . Fo Least
Developed Countries LDCs and Low Income Countries LICs, GSK will not file patents for its medicines, so as to give clarity and confidence to generic companies seeking to manufacture and
supply generic versions of GSK medicines in those countries. For Lower Middle Income Countries LMICs generally, GSK will file for patents but will seek to offer and agree licenses to allow supplies
of generic versions of its medicines for 10 years. GSK intends to seek a small royalty on sales in those countries. This offer will apply even for those countries that move out of LMIC status due to
increased economic growth during this period. For High Income Countries, Upper Middle Income Countries and G20 countries, GSK will continue to seek full patent protection. Any GSK medicines
o the WHO s list of esse tial edi i es ill e i luded i these ha ges
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.
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7 Promoting sustainable financing mechanisms
7.1 Endeavoring to secure adequate and sustainable financing for research and development
Regional The International Finance Corporation IFC of the World Bank in the past 5 years has granted
several loans to pharmaceutical companies in developing countries in the past 5 years, in order to increase their production and RD capacities.. Among the recent projects granted loans by IFC, 4
are from SEAR, all of which are based in India.
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These are: Bharat Biotech located in Hyderabad, India. The company is involved in the development
and production of vaccines, contract development and manufacturing for developed country pharmaceuticalbiotechnical companies, and development of its own line of
molecules. Dabur Pharma, which is involved in marketing oncology formulations and APIs. Dishman Pharmaceuticals and Chemicals Limited, an Indian contract research and
manufacturing company. In 2009, it began an investment program with IFC which includes construction of new facilities, establishment of a Greenfield manufacturing facility in China,
and investments in overseas subsidiaries and joint ventures.
Ocimum Biosolutions which provides contract resource outsourcing services. It is a
comprehensive Integrated Life Science Informatics solutions provider with service offerings that span Sample and Data Management, Genomics Data Analysis Services such as Gene
Expression, Genotyping, and Next Gen Sequencing, Bioinformatics and Genomics Databases and Bio-IT consulting services. Majority of the top 25 pharmaceutical companies,
leading research institutes and emerging biotech companies worldwide have chosen it as their preferred vendor and outsourcing partner and utilize our expertise
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. During the December 2014 regional meeting on GSPA-PHI assessment in Bangkok, Bangladesh
reported that in the area of RD funding, the country invests less than 1 of total health budget with top pharma ivesting only 0.3-0.5 of their revenues. Mid-level modern pharmaceutical
companies allocate less than 0.1 - 0.2 of the turnover in their product development annually.
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In Sri Lanka, funding for health RD come from various sources, both national and international. Government funding comes from the National Research council; the National Science Foundation;
the University Grants Commission; and the National Health Research Council. For 2015, the total research grants coming from all sectors is approximately 5 million USD.
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I the sa e eeti g, I dia epo ted that the ou t s Te h olog De elop e t Boa d u de the Department of Science and Technology has provided a total funding assistance of 158.13
millionsince its inception in 1996. For the health and medical sectors in particular, it has provided the following assistance:
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No. of agreements : 62 Total cost : 128.08 million
41 TDB sanction: 40.44 million
Major projects funded: Vaccines: Shanvac-B; Revac-B; LARV; FMD Vaccine
Drugs: INF alfa; Indikinase; Cefixine, Betacarotene; Human growth Factor, anti-infectives Devices: Bone grafts; Membrane oxygenators; microarray chips; telemedicine solutions
Facilities for: Vaccine manufacturing; API manufacturing; Organ transplant; CRO Testing;
Tissue based product development for clinical use
Global The technical consultation meetings on innovative models for new antibiotic development held in
Geneva in 2014
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and the earlier workshop held in Uppsala Sweden in 2010
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as described in section 4.3, are examples of expert working groups trying to examine current financing and
coordination for health research and development. While product development partnerships PDPs have revitalized the search for drugs, vaccines and
other health technologies for the developing world, it is anticipated that they will need more funding in the coming years for expensive late-stage clinical trials as well as for expanded discovery
research to replenish their product pipelines. In relation to these needs, current financing for the PDPs can be considered as too short-term, insecure and inflexible. In mid-2008, the 3 leading
vaccine PDPs
– Aeras Global TB Vaccine Foundation, the International AIDS Vaccine Initiative and Malaria Vaccine Initiative set-up a technical working group to explore innovative ways to finance
the 3 PDPs. This group decided to analyze in greater depth the idea of augmenting grants to the PDPs with government-backed bond financing. They proposed the establishment of the PDP
Financing Facility PDPFP whose objective is to make available, through government guaranteed loans, some of the economic and social value that their work will create in the future. Proceeds
from the sale of bonds in private capital markets would be used to support RD and then repaid when vaccines developed by the 3 PDPs came to market. The funds to repay bonds would derive
from a combination of royalties on sales in high and middle-income countries and donor-funded premiums linked to sales of vaccines in low-income countries.
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Another organization involved in funding health research and development is CIHR. In the early 2000s, CIHR announced that global health research was one of its five major pillars and the Global
Health Research Initiative was established. It had limited funding early on, with CIHR, allocating C29.8 million to study Neglected Tropical Diseases from 1999 to 2009. However, since 2008, there
has been stronger focus in this area, and more resources were allocated in collaboration with Grand Challenges Canada. Agreements to allocate about 150 million were signed which leveraged
more than double the amount of co-funding.
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