Request for Proposals - Design, maintenance, and visualisation of a database of pharmaceutical regulatory intelligence

Request for proposals – Design, maintenance, and visualisation of a database of pharmaceutical regulatory intelligence in low to middle and upper-middle-income countries (LMICs & UMICs)

1. Background of the Medicines Patent Pool (MPP)

The Medicines Patent Pool (MPP) is a United Nations-backed public health organisation working to increase access to, and facilitate the development of, life-saving medicines for low- and middle-income countries. Through its innovative business model, MPP partners with civil society, governments, international organisations, industry, patient groups, and other stakeholders, to priorities and license needed medicines and pool intellectual property to encourage generic manufacture and the development of new formulations.

To date, MPP has signed agreements with 21 patent holders for 13 HIV antiretrovirals, 1 HIV technology platform, 3 hepatitis C direct-acting antivirals, a tuberculosis treatment, a cancer treatment, 4 long-acting technologies, 3 oral antiviral treatments for COVID-19 and 16 COVID-19 technologies.

MPP was founded by Unitaid, which continues to be MPP’s main founder. MPP’s work on access to essential medicines is also funded by the Swiss Agency for Development and Cooperation (SDC). MPP’s activities in COVID-19 are undertaken with the financial support of the Japanese Government, the French Ministry for Europe and Foreign Affairs, the German Agency for International Cooperation, and SDC.

The request is being led by the Head of Alliance Management.

https://medicinespatentpool.org/

2. Background of the project

With the support of external consultants, MPP has developed a database containing information on current pharmaceutical regulatory requirements in 130+ countries across 4 pharmaceutical product categories (generics, biosimilars, In vitro companion diagnostics and vaccines), along with intellectual property (IP) intelligence. The information in its current format is available in both excel files and in offline tableau reader format. The information is in terms of questions and answers (around 150 questions) clubbed into different topics and subtopics. The database is composed of a large volume of text, sourced from .pdf formatted documents, of which a large portion are recognised by Optical Character Recognition (OCR). A smaller part of the source documents contains images or diagrams. Both the excel file and the tableau database are in English language.

3. Database requirement

MPP is looking for a database design solution, to store, format, develop as well as update a front end accessible over the internet, behind a user/password log in interface, to render the information described above.

MPP is open to the use of commercially available solutions that encompass long-term support and maintenance, which are existing by established technology providers. Solutions which use open-source tools are preferred. Proposals that use commercially available solution(s) or tools to develop the final product(s) will be detailed as pass-through costs. MPP will only consider proposals in which tools and solutions can be hosted on its own infrastructure. MPP is looking for proposals that offer a five-year support with the eventual goal of integrating all updating and management in house.

The website architecture requirements are as follows:

  1. Regulatory Database should be accessible to the public by filling basic information like name, company name, email id, purpose of visit etc.
  2. Websites should be able to handle large amounts of data.
  3. Provision of database edits and modification at backend by MPP team; backend can convert excel or tableau data to representable format easily by MPP team.
  4. Display of information country wise for 5 workstreams (4 product categories + IP)
  5. Classification of questions and answers in terms of topics and subtopics.
  6. Search option by keyword
  7. Filtering option in terms of key questions (Y/N); regulatory countries; regions, product categories etc.
  8. Multiple layers of data under the same question
  9. External /Reference links to be accessible.
  10. Provision of comparing different countries on key questions
  11. Data visualisation over map/ other methods
  12. Provision of downloading information/ reference documents by user, including information extracted for selected questions or as requested by user in suitable format e.g. PDF
  13. Provision of receiving feedback/queries from the user
  14. Provision to provide the statistics to the MPP team with respect to the number of users visited; document download history.
  15. The preferred solutions are ones that are lightweight and responsive.
  16. SEO keyword analysis
  17. Flexible to accommodate any additional requirements which may come in future based on discussions or any feedback received from the user.
  18. Provide website training to MPP team responsible for handling website at backend.
  19. Bug fixing and checking responsive layout support.
  20. Compliant with applicable European and Indian laws.
  21. The proposed solution should meet all requirements on data protection, data security and privacy.
  22. Website language will be in English.

A sample of the database architecture can be accessed HERE. The architecture is for guiding proposal submissions which could be further modified based on the ongoing work on the database.

4. Proposal Submission Instructions

  • The proposal should contain the following:
    1. Name, address, email, phone, and website information of applicant.
    2. Organisation profile.
    3. Proposed solution, with general overview of website build process end-to-end.
    4. Information of team member(s) on the project, their roles and responsibilities in organisation, similar experience, years of experience.
    5. List any previous work related to pharmaceutical data, experience in similar regulatory work is desirable.
    6. References and contact details from two previous clients of the applicant. Note: MPP will be reaching out to the client to verify previous work completed.
    7. Breakdown of fixed and variable costs (this includes cost of Hosting, visualisation support, five-year technical support).
    8. Timelines for the project.
    9. Any additional resources required for support (ex: sub-contractors).
  • The proposal would be discussed in a 30 min call, a demonstration of the solution might be required with provided sample data.

5. Timeline & deadlines

  • RFP Release Date: 20 March 2024
  • Response Deadline: 5 April 2024
  • Vendor Selection: 20 April 2024
  • Project Kickoff: 1 May 2024
  • Pilot Demonstration: 1 June 2024
  • Desired Launch Goal Date: End June 2024

If you would like to submit your proposal, please email it to adas@medicinespatentpool.org including “Regulatory Database RFP” as a reference in the subject line by 5 April 2024.

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