You are a generic manufacturer and would like to develop, manufacture and supply MPP’s licensed products.

Process

We invite qualified product developers to apply for licences to manufacture and sell licensed treatments in low- and middle-income countries. We do this through an Expression of Interest (EOI) process. By granting multiple sublicences, we aim to encourage adequate sources of supply, and competitive pricing models.

If you wish to apply, you should complete an online Expression of Interest (EOI) form, which serves as your proposal to use our licensed intellectual property to create or improve access to relevant medicines in countries enabled by the licence.

You will need to provide details of your capacity, capabilities and track-record for manufacturing quality-assured medicines, your R&D, regulatory compliance and financials. You should also provide specific plans for the products you wish to license. These should cover development, manufacturing, regulatory plan, distribution and predicted investments. Among other criteria, we will consider your organisation’s state of readiness with needed formulations, including fixed-dose combinations and paediatric formulations.

Our EOI form has two sections. One is about your organisation and the second concerns your state of readiness and plans for the products and licence in question. You do not need to complete the first section more than once; you can update it as needed. The second section is specific to each licence, so you should complete it for each separate application.

Method for granting sublicences

The EOI assessment is rigorous and objective and follows a two-stage process. A panel assesses each EOI and the final decision makers do not know the applicant’s identity. Each question carries a weighting and a maximum score. Responses are graded using a standardised tool and top-scoring applicants are selected. The number of licences we grant is based on WHO-MPP forecasts for the product in question. Criteria such as viability of development plans (especially in case of projects requiring specific capital expenditure or investments), quality and past performance (especially in case of serious breaches of voluntary licence agreements) may result in us rejecting an application.

For accurate assessment, we encourage applicants to provide as much detail as possible to ensure the EOI represents their actual capacities, capabilities and plans. Incomplete EOIs risk rejection.

In line with our mandate to promote local manufacturing in developing countries, we also encourage applications from qualified manufacturers for servicing demand in a limited region or selected countries.

EOIs usually open immediately after we announce that we have obtained a patent licence from a patent holder, and there is normally a three to four weeks period to apply online. If you have any queries regarding the process or specific questions on the EOI form, please email eoi@medicinespatentpool.org.

We will not disclose or use any commercial and technical information we receive in EOIs for any purpose other than assessment. We will always ask you for permission to use your details for any other purpose.

Companies not approved will be offered an explanation on why they were not selected. Companies may appeal to the MPP Board within 14 calendar days if they wish to challenge the decision made in the EoI process. The grounds for appeal are (a) the EoI process was not followed by MPP or (b) critical new information that would have led to a significantly different outcome in the EoI assessment has become available that was not available when the EoI was submitted.