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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

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Setting Milestones

‘Setting milestones’ is the strategic plan of Aids Fonds for the period 2014 - 20171.

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.

1 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

year’s 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 world’s 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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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.

2 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 country3. 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.

3 http://www.oecd.org/dac/stats/49483614.pdf

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Procedures

Publication

NGO’s from the selected countries are asked to submit a proposal through this

call. NGO’s 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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Appendix – activity framework and budget

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