Context

The issue of intellectual property (IP) and its implications for access to health products has recently gained greater prominence due to the COVID-19 pandemic; the pandemic exposed intellectual property protections and other exclusive rights as an obstacle to equitable access to health products.

The use of TRIPS flexibilities and other solutions that foster competition can increase affordability, which enables access to more people and results in savings. It can also increase supply security by expanding the manufacturing base. Thus, it will contribute to enhancing equity between countries, as it benefits low-income countries and – particularly – middle-income countries that are normally not included in voluntary solutions. Without intervention, the inequities in access to health products will only worsen. As a result, populations that are already vulnerable and marginalized will face an elevated, and increasing, risk of disease, poverty, reduced quality of life, and even death.

Patents and other intellectual property rights incentivise innovation, but also limit competition that can stabilize supply and reduce prices. Unitaid has a longstanding commitment to IP-related work that aims to contribute to overcoming access challenges related to patents and other intellectual property rights when they hinder equitable access to health products. This is reflected in Unitaid’s investment in collaborative and voluntary solutions (such as the creation and funding of the Medicines Patent Pool, which negotiates voluntary licenses), which remain the foundation of Unitaid’s work on intellectual property and access to medicines. However, voluntary licenses and collaborative solutions do not extend to all LMICs or to all relevant patented health products and technologies. When intellectual property rights hamper access to health products in countries that are not included in voluntary licenses, or when there are no voluntary licenses for particular patented products and technologies, other solutions are needed, such as the use of TRIPS flexibilities. TRIPS flexibilities therefore complement the use of voluntary licenses.

Supporting the use of TRIPS flexibilities has been an integral part of Unitaid’s contribution to realizing more equitable access to medicines since 2018. Work supported by Unitaid has successfully removed unwarranted intellectual property barriers on HIV, TB and hepatitis C medicines, contributing to the availability of better formulations and lower prices. This type of work is even more necessary now, as the need to reallocate significant funds to addressing the COVID-19 pandemic has increased pressure on both national and donor budgets. Thus, it is anticipated that the price of health products will increasingly be a factor in determining access. Overcoming IP barriers, where they occur, to ensure affordability of optimized treatments for HIV, TB, hepatitis C and other diseases, will therefore remain crucial to help avoid (further) setbacks in the fight against these diseases.

Through this Call for Proposals, Unitaid aims to continue the support for capacity building on and use of TRIPS flexibilities and to expand these efforts to technical support, advocacy and awareness raising, and policy interventions. Unitaid also seeks to address a broader range of intellectual property barriers, such as trade secrets and regulatory exclusivity, that are particularly relevant for biological products.

Call scope

Under this call, Unitaid is soliciting proposals to prevent, remove or overcome IP-related barriers that hamper access to health products, in order to increase equitable access to affordable and appropriately formulated medicines, biologics, vaccines and diagnostics for people in LMICs. Proposals may address one or more of the areas [2] of work listed below.

• Area 1: Direct interventions to prevent, remove or overcome IP-related barriers that hamper access to specific health products. Direct interventions should focus on products to prevent, diagnose or treat HIV, TB, hepatitis C, and/or other diseases and conditions aligned with the programmatic priorities in Unitaid’s Strategy 2023-2027. The scope includes biologic products. Direct interventions are for example:
  • Preparing and filing (pre-grant) patent oppositions,
  • Using other TRIPS flexibilities,
  • Removing barriers related to trade secrets, data exclusivity and/or regulatory exclusivity,
  • These interventions may be supported by demand generation work and/or resource mobilization for this type of work.
• Area 2: Interventions that support the use of TRIPS flexibilities and other approaches to prevent, remove or overcome IP-related barriers, with the aim to enhance access to health products, such as:
  • Raising awareness and building capacity on the importance and use of TRIPS flexibilities and other approaches to overcome intellectual property barriers, where they exist,
  • Advocacy for the use of TRIPS flexibilities and/or other intellectual property-related solutions that facilitate access to health products,
  • Working with patent offices in order to improve the quality of patent examination,
  • Creating/implementing a mechanism, at global or regional level, to provide technical support on IP issues and/or to the use of TRIPS flexibilities in countries,
  • Providing training and/or training-of-trainers on intellectual property rights and access to medicine for civil society and/or government stakeholders.
• Area 3: Interventions that address policies, regulations and/or system-issues related to intellectual property and access to health products, and that aim to enhance access to health products, such as:
  • Advocating for and pioneering measures to safeguard access to innovations that result from publicly funded R&D, or to incentivize upstream innovations in ways that support widespread access,
  • Creating an intellectual property, regulatory and policy environment in which local manufacturing can thrive,
  • Providing input in global, regional, and national treaties, agreements and regulations related to intellectual property rights, in order to safeguard or enhance access to health products without deterring innovation,
  • Exploring the introduction and/or use of competition law as an alternative to, or to complement, the use of TRIPS flexibilities,
  • Enhancing policy coherence between national authorities responsible for health, trade, and intellectual property rights,
  • Safeguarding policy space by raising awareness about the implications of “TRIPS-plus” provisions in trade agreements.
• Area 4: Advocacy and engagement with governments, industry and other stakeholders in LMICs and/or high-income countries in favour of policies and solutions that facilitate access to and uptake of products for the prevention, diagnosis or treatment of people in LMICs, now and in the future. 

Civil society-led work on intellectual property and access to health products is important and can be a key factor contributing to the success of interventions. Proposals should therefore clearly indicate the role of and collaboration with communities and civil society.

Unitaid sees value in proposals from South-based implementors with experience in working on IP and access to health products in countries. We encourage coordination and collaboration across implementors and are interested in proposals that would have global impact or impact in several regions.    

Proposals should be carefully targeted, reflecting focused interventions to address key challenges with regard to intellectual property rights and access to health products. Proposals are expected to target one or more of the areas of work listed above. Proposals may, but do not have to, cover all four areas. Proposals should clearly indicate the level of effort and budget for each area. 

Proposals should demonstrate value for money and measurable impact. Proposals should also include analysis of pathways to impact, scalability and sustainability of key interventions.

Areas out of scope for this Call include proposals: a) product development; b) establishment of mechanisms such as prize funds aimed at incentivizing innovation and R&D; c) capacity building and reforms not related to intellectual property and access to health products. Also out of scope are proposals or activities that are not in line or not compatible with the TRIPS Agreement or other multilateral treaties on intellectual property rights.

Impact we are seeking

Through this Call for Proposals, Unitaid aims to improve access to health products of public health importance in low- and middle-income countries, and in particular:

• To increase their affordability in LMICs,
• To facilitate the supply of better adapted and appropriate health products in LMICs,
• To increase their adoption and use in LMICs,
• To contribute to diversifying the supply-base of health products in LMICs.

The objectives outlined above will lead to:  (1) better health outcomes due to additional people being treated, or due to people receiving better treatments (2) financial savings/efficiencies due to the availability and use of more affordable products, and (3) improved and more equitable access by making products available and/or affordable in LMICs. The ultimate goal is to enable widespread access to affordable health products through scale-up by governments and partners, in order to contribute to the global health response to diseases that predominantly affect people in LMICs.

Process for proposal submission

When developing a proposal, please note the following resources:

• Answers to frequently asked questions relevant to proposal development (this document is regularly updated), please click here [PDF: 406 KB, updated on 10 January 2023];
• Unitaid’s preliminary rationale for working in this area, please click here [PDF: 200 KB];

Applicants should be clear about the underlying assumptions made in their proposed approach and should highlight any major risks or other factors that may affect the delivery of results. Finally, proposals are expected to outline a lean, concrete and clear pathway to results and impact.

After assessment of the proposals and endorsement by the Unitaid Board all applicants will be officially notified as to whether they will be invited to develop a full grant agreement for Unitaid funding.

References

[1] Products for prevention, diagnosis, or treatment.

[2] Proposals do not need to address all the examples (bullets) listed under a particular area, and may include work not listed (i.e. the bullets are examples, but are not intended to be mandatory or limiting).

Important dates

Submission and format of proposals

Proposals, including all annexes, should be submitted electronically to proposalsUnitaid@who.int. A full proposal consists of the following documents:

• Proposal form with scanned version of signed Front page template, [DOC: 180 KB]
• Annex 1: Log frame and GANTT chart template, [XLS: 278 KB]
• Annex 2: Budget details template, [XLS: 24 KB]
• Annex 3: Organizational details and CVs of key team members [no template]
• Annex 4: Country engagement support Letters [no template]
• Annex 5: Declaration of relevant interest template, [DOC: 21 KB]
• Annex 6: Applicable ethics, anti-discrimination and environmental policies template, [DOC: 21 KB]
• Annex 7: Declaration regarding tobacco entities template, [DOC: 24 KB]
• Annex 8: Anti-Terrorism Declaration template, [DOC: 30 KB]
• Annex 9: Audited financial statements for the past 3 years [no template]

If you have any questions about the application processes throughout any stage of the application review process, please send your queries to the Grant Application Manager:  proposalsUnitaid@who.int

You will find further guidance in the Unitaid proposal process document [PDF: 530 KB]. Additional guidance can be found in the following documents:

• Guidance on Impact Assessment [PDF: 160 KB]
• Financial Guidelines for Unitaid Grantees [PDF: 1,2 MB]
• Unitaid Results Framework [PDF: 1.3 MB]
• Unitaid Scalability Framework [PDF: 466 KB]

Webinar on this Call for Proposals: