36 Sri Lanka offers triple tax incentives in the form of a deduction of 3LKR from the corporate tax of
private companies, for every 1LKR invested in RD, in collaboration with the government research institutes.
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In India, OSDD initiative as mentioned in 4.3 is an example .
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Global An economic analysis of various RD incentives for neglected diseases was done in 2012 by Dimitri.
107
She considered three types of incentives- those based on pull factors, the push programs, as well as the hybrid initiatives which consider both pull and push incentives. Supporters and critics of
these various incentive schemes have argued in favor of their relative merits and limitations, although the view that no mechanism is a perfect fit for all situations appears to be widely held.
For this reason, the debate on the advantages and disadvantages of different approaches has been important for policy decisions, but is dispersed in a variety of sources. With this in mind, the aim of
the paper was to contribute to the understanding of the economic determinants behind RD investments for neglected diseases by comparing the relative strength of different incentive
schemes within a simple economic model, based on the assumption of profit maximizing firms. The analysis suggests that co-funded push programs are generally more efficient than pure pull
programs. However, by setting appropriate intermediate goals hybrid incentive schemes could further improve efficiency.
In 2013, Agitha presented alternative incentive models delinking research and development costs from the price of pharmaceutical products. An open access, collaborative research model with
prize fund incentive delinking costs of RD from product price was suggested. In addition, the need to shift issues related to pharmaceutical RD from the trade fora to the human rights forum
was also recommended.
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6 Improving delivery and access
6.1 Encouraging increased investment in the health-delivery infrastructure and financing of health products
Regional Among the specific actions under this sub-element is the prioritization of health care in national
agendas. The 6
th
National Health Assembly of Thailand which was held in June 2014 tackled 8 agenda items which include the national strategy on community health system, a crucial area in
health delivery infrastructure. It also included the multidisciplinary collaboration on health care for humans, animals and the environment One Health which is highly relevant in the recent surge of
zoonotic diseases like the avian flu.
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In the case of India, the Prime Mi iste s -point agenda to take the nation forward released
recently included health reforms focusing on capability building for human resources.it involves deployment of male community health workers, setting-up of knowledge institutes in districts
which at the same time will function in coordination with upgraded district hospitals, and a 3-year
37 B.Sc. course in community health.
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The country has also been encouraging health care investment and financing of health products by implementing speciality care models, CSR and
medical tourism.
51
A boost to the health delivery infrastructure of Sri Lanka was the setting up of the National Control Laboratory NCL and Drug Testing Laboratory DTL under the Directorate General of Drug
Administration. The laboratory equipments were procured by WHO with financial support from the Health, Population and Nutrition Sector Development Program HPNSDP.
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Global There are several organizations which invest in health development. They include a diverse
selection of national and multinational development agencies, international financial institutions, and science and technology agencies. Among the agencies investing most i in developing health
delivery infrastructure during the period 2007
– 2011 are the US NIH, Bill and Melinda Gates Foundation, European Commission, USAID, Wellcome Trust and Institut Pasteur. Government
Development agencies like USAid and JICA channel aid funding to developing countries driven by aim to reduce poverty, affordable access and spread of awareness..
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The Bill and Meli da Gates Fou datio s Glo al Health Di isio ai s to ha ess ad a es i s ie e
and technology to save lives in developing countries. It works with partners to deliver proven tools including vaccines, drugs and diagnostics, as well as discover path-breaking new solutions that are
reliable and affordable. Equally important is innovation on how health interventions are brought to those who need them most. The Foundation invests heavily in vaccines against infectious diseases
and supports the development of integrated health solutions for family planning, nutrition and maternal and child health.
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6.2 Establishing and strengthening mechanisms to improve ethical review and regulate the quality, safety and efficacy of health products and medical devices
Regional Different SEAR Member States have different regulatory bodies and mechanisms for ethical review
and regulation of the quality, safety and efficacy of health products. A description of such mechanism was presented by 7 of the countries in the region during the regional Meeting on the
assessment of GSPA-PHI progress held in Bangkok in December 2014. These are summarized in Annex 5.
Global In order to assess national drug regulatory systems, WHO has developed an assessment tool to
strengthen national medicines regulatory and control capacity through an assessment of the drug regulatory system. Application of the tool enables countries to do the following: 1 review of the
existing legal framework, regulations and control activities with regard to medicinal products, in order to assess the national regulatory capacity, 2 identify of gaps and the development of
st ategies to add ess these gaps, ide tif of spe ifi a eas a d a ti ities fo WHO s te h i al
38 input. If used from time to time on the same national medicines regulatory authorities, it can
monitor the results brought by a project. The methodology enables the assessor to apply this tool to multiple health products like medical devices, cosmetics, etc.
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In the Americas, regulation is implemented by the Pan American Network for Drug Regulatory Harmonization PANDRH. PANDRH was officially established in November 1999. Its members
include drug regulatory authorities of all PAHO member states, representatives of the regional pharmaceutical industry associations ALIFAR, FIFARMA, academia, consumer groups, professional
associations and representatives from the five sub-regional trade integration groups within the Americas such as the
ANDEAN COMMUNITY, CARICOM ,
SICA ,
MERCOSUR and
NAFTA . Its mission
is to promote drug regulatory harmonisation for all aspects of quality, safety, and efficacy of pharmaceutical products as a contribution to the quality of life and health care of the citizens of
the Member Countries of the Americas. PANDRHs scope of harmonisationcooperative activities includes technical guidelines, regulatory processes and the strengthening of national regulatory
agencies through harmonisation of processes and standards to improve drug quality and quality assurance. Specific drug sectors covered include prescription, over the counter, generics, similars,
biologicsvaccines and herbal medicines.
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6.3 Promoting competition to improve availability and affordability of health products
Regional In 2013, India implemented the Drug Price Control Order DPCO 2013 which altered price
regulation dynamics and substantially increased the number of medicines covered under price cap umbrella. DPCO 2013 allowed the National Pharmaceutical Price Policy to regulate the prices of
348 drugs covered in the 2011 Essential Drugs List. This number of drugs under price control is so much higher compared to the 74 drugs previous covered.
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Department of Pharmaceuticals India notified the New First Schedule of DPCO, 2013 based on National list of Essential Medicines 2015
on March 10, 2016. NPPA has started the exercise of fixing the ceiling prices of the medicines in the NLEM-2015 and in a short span fixed and notified the ceiling price of 330 formulations as on June
10, 2016. The NLEM 2015 contains a total of 799 formulations under 30 therapeutic groups. NPPA is working to fix the price of these drugs as soon as possible. As on date, 969 scheduled
formulations are under direct price control
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. In Indonesia, generic pharmaceutical pricing is regulated by the government. Pharmaceuticals
included in the Essential Drugs List -- 92 of which are generic and 2.5 of which are innovator -- cannot be sold for more than a 50 margin. Other generics are also subject to pricing restrictions.
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During the country presentations in the regional meeting on GSPA-PHI assessment held in Bangkok on December 2014, Sri Lanka indicated that in order to improve local pharmaceutical production,
the state offers a buy-back guarantee as well as tax incentives for investment in production.
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39
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.
116
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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