Term of Reference for Research on Voluntary Mechanism and Access to Medicines At International Treatment Preparedness Coalition

Background

The International Treatment Preparedness Coalition (ITPC) is a global coalition of PLHIV and community activists working to achieve universal access to optimal HIV, HCV and TB treatment of those in need. Formed in 2003 by a group of 125 HIV activists from 65 countries at a meeting in Cape Town, ITPC actively advocates for treatment access in eight regions across the globe. ITPC believes that the fight for treatment remains one of the most significant global social justice issues.

The project Use of TRIPS Flexibilities to Increase Affordability of Treatment for HIV, Tuberculosis and Hepatitis C Virus in Middle-income Countries aims to address a critical gap in the global HIV response: access in some LMICs and in UMICs to newer, optimized antiretrovirals (ARVs) for preventing and treating HIV. Access to newer medicines that can cure tuberculosis (TB) and hepatitis C virus (HCV), two common, dangerous coinfections, among people living with HIV, is also necessary. Optimized ARVs are essential to reaching global HIV treatment targets, enacting the WHO ‘treat all’ recommendation and addressing the growing threat of resistance to non-nucleoside reverse transcriptase inhibitors (NNRTIs), which are widely used in first-line treatment.

Another solution proposed to address the aforementioned issues is voluntary licensing, which is an old practice in the pharmaceutical field. In 2000, as a response to access issues in South Africa and the pressure created by HIV treatment activists combined with government threats to use TRIPS flexibilities, new voluntary licenses emerged. In 2010, the Medicines Patent Pool (MPP) was formed as a platform to promote non-exclusive voluntary licensing with a public-health approach that would enable people in low and middle-income countries to access affordable medicines.

The MPP licenses are meant to be transparent with increased geographical coverage and the inclusion of public health provisions, a departure from previous agreements. While voluntary licenses have increased access to some medicines in countries included in geographical territory of a particular license, middle-income countries have often been excluded from the licenses despite having a high burden of disease.

Eleven years after the emergence of voluntary licenses as a solution to overcome IP barriers to access to medicines, 22 voluntary licenses have been concluded with 14 patent holders across three disease areas (HIV, Viral Hepatitis and TB). ITPC would like to conduct an in-depth assessment of the nature and impact of these agreements on access to medicines, how these agreements have shaped the debate around the use of TRIPS flexibilities and to what extent the pharmaceutical industry have used the mechanism for increased market control.

Service Provider Scope of Work

ITPC wishes to engage a researcher, who will conduct research on voluntary licenses and access to medicines.

Consultant upon request from ITPC shall:

· Conduct literature review on VLs (10 days)

o History of emergence of VLs as mechanism to overcome IP barriers in LMICs.

o Analysis of evolution of VLs over time

· Analyze the impact of VLs on (10 days)

o Access to medicines of the 22 voluntary licenses signed to-date

o Debates on IP and access to medicines and use of flexibilities

o The behavior of the pharmaceutical industry

o India as the largest medicines supplier of medicines for developing countries.

· Provide recommendations to increase access to medicines (3 days)

· Draft comprehensive report and article (5 days)

Duration of Service Provision:

• Start date: 3 August 2021
• End date: 30 November 2021

Qualification/Eligibility Requirements to Provider:

· Graduate degree in social sciences or law, Doctorate preferred

· Minimum 7-10 years relevant experience working on intellectual property and access to medicines issues, with a deep understanding of intellectual property, patent law, free-trade agreements, the pharmaceutical industry and international organizations related to trade and health

· Experience drafting reports, developing research methodologies, remotely coordinating research teams

· Experience and/or academic training in HIV/AIDS, epidemiology, public health, health policy

· Experience collaborating with community-based organizations

· Fluency in English

Method of Selection

Quality and Cost-Based Selection method shall be used to determine the winner. The following selection criteria with relative weight of criteria showed in percentages shall be used for selection for the bidders’ proposals that meet all obligatory qualification/eligibility requirements above and that essentially meet the above scope and deliverables:

1. Qualifications and experience of the consultant in working on the subjects detailed above (relative weight 20%) – shall be assessed based on CV or description of experience;
2. Quality of previous work and reports developed by the consultant (relative weight 25%) – shall be assessed based on example(s) of previous research done by the candidate consultant;
3. Experience or training in HIV/AIDS, epidemiology, public health, health policy (relative weight 15%) – shall be assessed based on CV or description of experience;
4. Previous experience of collaboration with CSOs conducting research at national and international level (20%) – shall be assessed based on CV or description of experience;
5. Daily rate demanded by the consultant to achieve the work required (relative weight 20%) – shall be assessed based on provided quotation.

Compensation shall be performed in partial payments for number of days spent based on quoted daily rate (not to exceed 28 days) with satisfactory to ITPC quality of services. Consultant shall be paid within 30 days upon delivery of the monthly invoice.**

Instructions to Tenderers

Tender proposal validity should be no less than 60 days counting from the closing date of receiving proposals indicated below.

Tenderers shall have the right to seek written clarifications on any aspect of the tender documents and receive responses from ITPC in good time before the deadline for submission of tenders, not less than 2 days prior to the deadline.

The starting date of this tender is 29 June 2021. Closing date for receiving proposals is 27 July 2021 23:59 SAST.

Questions should be sent by potential bidders before 25 July 2021 to the same email address as indicated above.Expected date to inform the successful candidate is 3 August 2021, although this deadline can be extended by ITPC, if needed.

Tender proposals shall be evaluated by ITPC and the outcome of the selection procedure shall be notified to tenderers by email.