Why is LLS not covered by the MLM?

Nov 22, 2021

For the next two weeks, the Marketing Authorization Holders in EEA have a chance to impact a service that they pay for (obligatorily). EMA is conducting a survey on medical literature monitoring (MLM).

EMA told us earlier this year that nobody in the industry wanted changes based on the previous survey. However, based on communication with our contacts in the industry, it is hard to understand why local literature screening and other safety relevant information for PSURs is not covered by this service.

It will be interesting to see whether this survey leads to any meaningful change in EMA’s position on the need for local literature screening and how it is covered. We remain sceptical but perhaps with sufficient demand from the industry stakeholders, the regulator might yet innovate.

Background

Earlier this year, we performed an analysis of the amount of ICSRs from the local non-indexed journals in EudraVigilance. The portion of reports from the local journals was small but not non-existent. For more detailed description, see our two blog posts about the results:

During our initial research into the topic, we asked EMA whether there will be any changes to the legal requirement for performing local literature monitoring. We received a response from the agency, but we were not happy with this initial answer, so we followed up with our comments on their reply. And once again, EMA answered. The second answer read:

“Prior to revising the service, the Agency consulted with the pharmaceutical industry, writing to all MAHs affected by the MLM Service. None of them expressed a desire for the Agency to expand to cover local literature and thus the service specifications were published in their current form. We will, however, consider your important contribution for our next revision.”

Unpublished Document Request

No information about this survey is available online. We sent a request to receive the survey results by contacting EMA with their “request unpublished document” form. The document request to the EMA was sent on 19th of July 2021. We had not received a response by 19th of October 2021, so we sent a new question through the agency contact form, again requesting the results of the survey to all marketing authorization holders (MAH) affected by medical literature monitoring (MLM).

EMA swiftly responded that at the moment they cannot give us an estimate when they will start processing our request and an Access to Documents coordinator would contact us when our procedure starts. As of 19th of November, we have still not received the information we requested.

Asking the Industry Stakeholders

During October and November 2021, we directly asked a few of our colleagues who are running PV systems for MAH’s with products on the MLM list and they were unaware of such a questionnaire. Nobody came through about the survey even after we asked these questions on LinkedIn.

EMA is Working on it

EMA held the 16th industry stakeholder platform – operation of European Union (EU) pharmacovigilance on 17th November 2021. The aim of these meetings is to “foster dialogue between industry and EU regulators.” One of the topics included was EMA medical literature monitoring service update.

New Survey

On November 17th 2021, EMA contacted the QPPVs of the MAHs affected by MLM with the following message:

“Since you are the QPPV of an MAH of products affected by the EMA’s Medical Literature Monitoring (MLM) service, we are providing you with an opportunity to express your views, opinions and perceptions of the MLM Service.

Your input is extremely valuable and will help the EMA’s MLM Service to optimise the value it adds to industry. […]

If you are not directly involved in medical literature monitoring, please forward this message to a colleague who is, since this involves a number of detailed technical questions and we will best be able to enhance our service if we receive feedback from people who directly interact with it.

[…]

Please complete this survey by 30 November 2021. We will collate the responses and include the conclusions within our plans for future service enhancements.”

The survey is divided into two parts:

”Part I: Questions regarding demographics are used to group the surveys for comparison purposes only. In all cases, the groupings will be large enough to ensure anonymity. Comparisons help determine the perceptions of different parts of the stakeholder community.

Part II: These questions refer specifically to aspects of the MLM service. Please respond to each statement carefully and honestly. If you do not know the answer to a question, or have not used this aspect of the service referred to in the question, use the box marked “Not Applicable”.”

The survey includes 21 questions. The second part about the survey is mainly about the contents of the daily Excel trackers uploaded by the MLM contractor working for EMA and about the quality and timeliness of data they are entering to the trackers and ICSRs they submit to EudraVigilance. The survey does not contain any questions about the scope or the way the MLM service is being provided. However, there are two fields that give you the chance to truly affect this service that all the MAHs in EEA are paying for.

Take Action

By filling in the details to Questions 20 and 21 you can ask to be contacted by EMA and express your dissatisfaction and give additional feedback. We certainly did. Not only because the survey does not seem to be aimed to do what it is supposed to be doing (“express your views, opinions and perceptions of the MLM Service”) but also because the survey is done hastily but definitely not in a transparent way.

P.S.

The title of the survey is “EMA Medical Literature Monitoring Customer Satisfaction Survey (MAH – Q1 2021)”. Did EMA just forget to change the title?

See also our other recent blog posts:

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