Aids Fonds

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1016 GB Amsterdam
Date June 2014
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grants@aidsfonds.nl


Aids Fonds call for
proposals on
eliminating
intellectual
property barriers
that prevent access
to treatment for
people living with
HIV


June 2014
Aids Fonds
Keizersgracht 390
1016 GB Amsterdam
Date June 2014
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Setting Milestones

Setting milestones is the strategic plan of Aids Fonds for the period 2014 - 2017
1
.
This strategic plan is focussed on realising our vision: the end of AIDS in a world
where all people affected by HIV and STIs access prevention, treatment, care and
support. To reach this vision we have developed four long-term goals. This call for
proposals directly contributes to two of these goals, a strong Civil Society and
fewer barriers to access treatment, care and support. It will strengthen national
civil society organizations with a track record of treatment advocacy to address
intellectual property barriers and keep their governments accountable for access
to essential medicines.

HIV and Hepatitis C
HIV and Hepatitis C (HCV) share transmission routes. Although HCV can be
transmitted sexually, the main route of transmission is through blood-blood
contact. This may happen through insufficient precautions during medical
procedures, unsafe tattoo practices (e.g. in prisons), sharing of shaving equipment
or nail clippers and sharing of injecting material when using drugs. The latter
explains the high rates of HCV among people who use drugs (PUD). Studies
following a single needlestick exposure show that HCV is approximately 10 times
more transmissible than HIV. Currently around 4-5 million PLHIV are co-infected
with HCV. HIV adversely affects the course of HCV infection.
Worldwide 60% of the people who inject drugs (PWID) have HCV, but this
percentage can be as high as 90 in parts of the Russian Federation or Thailand.
In countries with high rates of injecting drug use, HCV and HCV/HIV co-infection
are often significant problems.
Although sexual transmission of HCV occurs, this transmission route for HCV is
not efficient. Only recently reports have emerged, mainly from higher income
countries, about a higher prevalence of HCV among MSM living with HIV, as
compared to MSM that do not live with this virus. The exact mechanism of this
sexual transmission has yet to be clarified.

HIV and TB
The risk of developing tuberculosis (TB) is estimated to be between 12-20 times
greater in people living with HIV than among those without HIV infection. In 2012,
there were 8.6 million new cases of TB, of which 1.1 million were among people
living with HIV. Untreated latent TB infection can quickly progress to TB disease in
people living with HIV since the immune system is already weakened. And without
treatment, TB disease can progress from sickness to death. TB disease is an
AIDS-defining condition for people living with HIV.

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www.aidsfonds.nl/settingmilestones
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Patents, pricing, and access to
medicines
Over the past decade, there has been a significant increase in
access to life-saving medicines for diseases like HIV and TB in low-
and certain middle- income countries, mainly due to increased
generic competition.

Patents can have a dramatic impact on access to medicines when they are used
to prevent competition. A drug company that holds patents on a medicine has the
right to prevent others from manufacturing it and therefore can charge a higher
price than would have been possible without this monopoly. HIV/AIDS medicines
provide a perfect illustration of how patents allow manufacturers to keep the price
of medicines high, and how competition brings those prices down. In 2000 a
years treatment course cost more than US$ 10,000 per person. At this time,
antiretrovirals (ARVs) were only available from the drug companies that held the
patents. With the onset of competition among multiple producers prices dropped
enormously. The most commonly used triple-drug HIV treatment in the
developing world now costs less than $100 per year. This 99% price reduction
was possible because the medicines were not under patent in several countries
with pharmaceutical production capacity such as Brazil, India and Thailand
allowing local producers in these countries to legally manufacture generic versions
of the medicines patented in developed countries, thereby driving prices down.
These affordable generics could also be exported to other developing countries
where the medicine was not under patent.

Important factors for price reductions of medicines:
Competition, often enhanced by the entry of generic manufacturers
Lack of pharmaceutical product patents in countries that enable production of
generics
The use of flexibilities afforded under Trade-Related Aspects of Intellectual
Property Rights (TRIPS)

Unfortunately, the situation has been changed in the past years and the progress
achieved is under threat. Key countries where generics are produced now grant
medicine patents, in order to comply with their international obligations as
members of the World Trade Organization. Newer drugs are already patented in
these countries, including new ARVs, meaning that production of affordable
generic medicines is now restricted. For HIV, this means that countries with
successful treatment programmes like Brazil or Thailand face a severe financial
risk when patients need to shift to newer, more expensive second line drugs.
For all newer medicines, including those to treat Hepatitis C and TB, now that
more and more countries apply tighter patent regimes, competition resulting in
affordable generics will be more difficult to achieve.

All pharmaceutical companies base their price-schemes on the GDP to improve
access in lower income countries. However, GDP doesn't say anything on disease
burden or the type of patients and their ability to pay for medicines. There are now
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over 100 middle income countries, accounting for about five of the worlds seven
billion people. Over 75% of all people living in poverty are based in middle income
countries. These countries are losing support from major donors which means that
treatment costs will need to be taken up by national governments, and intellectual
property barriers will become especially relevant. At the same time, middle income
countries are seen by pharmaceutical companies as promising markets because
there is an increasing wealthy elite that can pay high prices for patented
medicines out of pocket.
This situation is leading to a world in which low- and high-income countries have
access to health commodities - but the poor in middle income countries are being
left behind.

New drugs Hepatitis C
For Hepatitis C medicines, the actual situation is similar to the situation for HIV
medicines 15 years ago. Several new, patented oral direct-acting antivirals (DAAs)
are entering the market in the coming year. In clinical trials DAA combinations
lead to cure rates of up to 100%, regardless of HCV treatment history, cirrhosis, or
host genotype. DAAs therefore have the potential to eradicate hepatitis C virus,
but only if they are affordable for the vast majority who need them. According to a
recent study, large-scale manufacture of DAAs is feasible, with target prices of
$100-$200 per 12 weeks treatment course, if the drugs can be produced
generically.
In contrast, sofosbuvir, the first DAA on the market, is priced at $84,000 per
course in the US.

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Date June 2014
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Call for proposals
Goal
To increase access to medicines for HIV, TB and Hepatitis C for PLHIV, by
strengthening national civil society organizations to address intellectual property
barriers.

Objectives
To strengthen civil society organizations that work on the elimination of
intellectual property barriers leading to price reductions of medicines.
To advocate for the elimination of intellectual property obstacles to generic
competition (e.g., the issuing of compulsory licenses, repelling harmful
provisions in free trade agreements, the implementation of flexibilities in
patent laws or the opposition to new patents, and securing political
commitment to address IP barriers to medicines access)
To advocate for securing government funding and commitment to treat HIV,
TB and HCV.
To educate relevant stakeholders, like community groups, government or
medical professionals on issues around medicine patents, intellectual property
and medicine pricing for them to take a role in the advocacy activities.

Monitoring and Evaluation
Monitoring the results of advocacy is not always easy, but applicants should
indicate how they will define and measure the impact of their activities. The format
for the activity plan and budget includes indicators for outcome and output
(appendix).
If proposals are rewarded with a grant, the proposal will become the basis for
further monitoring, Annual financial statements and information on progress are
required. Aids Fonds explicitly values information with regard to the outcome of
the activities, which means that applicants commit to reporting about this after the
grant period has ended (since this is often the moment wherein outcome can be
observed). Projects that receive support as part of a specific call will be evaluated
in coherence with the other projects that receive a grant under the same call.

Eligibility criteria for proposals
1. Applications have to be submitted before the deadline of 15 September
2014.
2. Programmes should take place in one or more (lower or upper) middle-
income countries
2

3. Programmes should focus on the elimination of intellectual property
obstacles to price reductions and increased access to HIV, TB and/or
Hepatitis C medicines. Proposals on TB and Hepatitis medicines must
show how this work contributes to the health op PLHIV (for instance by
focusing on target populations or areas with high HIV prevalence or
medicines which are specifically important for PLHIV).
4. Applicants should articulate a clear 3-year strategy working towards one
or more of the following long-term outcomes: the issuing of compulsory
licenses, repelling harmful provisions in free trade agreements, the
implementation of flexibilities in patent laws or the opposition to new
patents.

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http://www.oecd.org/dac/stats/49483614.pdf
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5. Applications have to describe concrete activities based on a thorough
context analysis. The different steps towards the proposed outcomes
should be clearly explained, specifying targeted medicines.
6. Applicants should use the specific online application form which will be
available from August 1 2014 on. You can find an example of the
application form on the website of Aids Fonds. For specific questions
please contact grants@aidsfonds.nl.
7. The application should be in English.
8. Applicants should use the specific format provided in appendix I to
describe objectives, outcomes, indicators, activities and the budget. The
framework has to be uploaded in Microsoft Excel together with the
application.

Eligibility criteria for applicants
1. Funding will only be applied to registered organisations and not to
individuals.
2. Applicants must be non-profit and non-governmental organisations, based
in a (lower or upper) middle-income country
3
. Technical support from
international organisations specialised in this type of work can be included
in the proposal.
3. Applicants should have a strong track record in advocacy to address
intellectual property barriers on a national level
4. Organisations should provide their latest annual narrative and financial
report together with the application
5. Organisations must have strong management and the capacity to
formulate a proposal, to carry out the proposed activities and to effectively
manage award funds.

Budget
For each programme a maximum budget of 120.000 is available for the duration
of three years (maximum of 40.000 per year). The total available budget is
960.000.




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http://www.oecd.org/dac/stats/49483614.pdf
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Procedures
Publication
NGOs from the selected countries are asked to submit a proposal through this
call. NGOs are reached via global networks and partners of Aids Fonds. The call
is published on the Aids Fonds website and will be actively distributed at the
International Aids Conference in Melbourne.

Language
All communication will be in English.

Quality review
Proposals that are submitted before the deadline of 15 September, 2014, will be
checked on the above mentioned eligibility criteria for proposals and applicants.
Proposals that fulfil these criteria will be reviewed by experts in the field. The
submitting organizations receive the anonymous reviews and are given the
opportunity to write a rebuttal. Based on the reviews and the rebuttals, an external
commission will give its advice to the Board of Aids Fonds. The Board will make a
final decision.

Evaluation criteria
The reviewers will assess all eligible proposals on the following evaluation criteria:

Overall quality of the proposal
Quality of the context analysis
Track record in advocacy to address intellectual property barriers on a
national level
Coherence and feasibility of the proposed 3-year strategy and long term
outcomes
Impact of the proposed activities on barriers that prevent people living with
HIV to access treatment, care and support.
Relevance of the programme and potential impact on other countries and/or
stakeholders
Complementarity to existing activities on intellectual property barriers by the
applicant or other organisations.
Budget in comparison to the proposed activities
Sustainability: links with other stakeholders and other sources of funding
Innovativeness of the proposed activities, such as in generating new
evidence for advocacy, new communications messaging, new
collaborations, or approaches to recruiting, mentoring and supporting new
advocates.
Capacity to monitor outcomes of the proposed activities

Apart from these criteria, Aids Fonds aims for a diverse portfolio which means
that programmes of comparable quality may be assessed differently in order
to cover different subjects, different target groups and different regions within
one call.
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Timeline

15 September 2014 09:00 am CET - Deadline for submitting proposals
15 October 2014 Proposals reviewed by experts, anonymous reviews sent
to submitting organization
1 November 2014 09:00 am CET - Deadline for rebuttal by submitting
organization
25 November 2014 Advice of the external advisory committee based on
reviews and rebuttals
1 December 2014 Decision by the board of Aids Fonds, acknowledgements
immediately afterwards



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1016 GB Amsterdam
Date June 2014
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Appendix activity framework
and budget

http://www.aidsfonds.nl/funding/possibilities