At this year’s AMPLEXOR “Be The Expert 2017” event, Pharm Exec spoke to Andrew Marr about the implications of the EU’s new IDMP (Identification of Medicinal Products) regulations for the pharmaceutical industry.
PharmExec: Can you outline what the new IDMP regulations mean for pharma?
So, there will be a significant change to the process and it means an up-regulation in the amount of data that is needed. What that means is that the additional data will have to be found; it isn't necessarily sitting in corporate systems ready to be used. It is probably somewhere within an organization, but whether it is ready to be used, whether it is of good quality, whether it can be relied upon, whether it can be easily transferred and manipulated are other questions. I think some of the challenges will be around the identification of the key sources of truth, the authoritative data sources, and to establish management of the processes by which the data is going to be obtained and maintained via a number of different parts of the organization. It is a complex thing to pull together for anybody who has got more than tens of products approved.
What would you say is going to be the biggest challenge for companies?
One of the challenges is knowing exactly when EMA is going to require this data. It is probably going to be starting in the middle of June 2019 and will be required by the end of 2019. Although this seems a relatively long time, when you look at getting your project defined, making your funding available, integrating systems if necessary, and looking at different processes, in reality two years is not a great deal of time. Some of the challenges companies have at the moment are around obtaining and maintaining management attention. IDMP is more than generating just a little bit of extra data that a particular regulator wants, it is a fundamental change to the nature of the data that is provided.
What are the current levels of company readiness for these changes?
It certainly varies across company sizes. Most of large pharma has projects that are underway and in a few they have effectively implemented solutions ready for provision for this type of data. In mid-sized pharma, there are those who have initiated projects and know what they want to do, but there is a good proportion that has not yet got started. As you get to smaller pharma, I think that very few have even thought about IDMP. For them, it might not be a particular issue when you have got a small number of products, but as you expand, the complexity of who manages the data, the historic aspects of mergers and acquisitions, and the lack of conformity of data are really going to present a challenge.
Some of the big organizations that have got historical issues are perhaps the ones that , are a little bit further ahead because they recognize they can solve some of their own internal problems with the implementation of aspects of IDMP. I think it is down to a philosophy of “Are you doing this purely for compliance purposes, or are you trying to improve the way that you manage your own data?” And a lot of companies have seen that IDMP is a stimulus to do something a little bit wider, or in some cases fairly radical. From that they can meet the compliance needs.
Others will only have had time to do the minimum amount, and that will just amount to putting a sticking plaster over the problem. The companies who are doing it now and looking at the broader picture are definitely going to be in a better position as the data-need expands with time.
We have spoken mostly about Europe. How might this affect countries outside?
One of the things that a number of countries have been waiting for is the publication of the final ISO guidances, and those are just about finished; they have entered the publication process. So they can now say “Here are the ISO standards that have been revised and here are the equivalent implementation guides” as a basis for looking at things internally. I think countries like the US will begin to assess what changes they need regarding stricter product labeling to adhere the new requirements. And also possibly to look at new uses - new business cases.
There are agencies like Health Canada and Swissmedic, who are looking at how they manage their internal data and what IDMP can do for them. They are in the analysis phase at the moment, but I am sure that in the not too distant future they will be indicating the direction that they will want to go and what effect that will have upon industry. There are other projects in Japan and in Korea, in which they are doing research or proof-of-concept looking at how data is needed across a number of business processes. But those are things for the future.
EMA is facilitating some things through the International Pharmaceutical Regulators Forum, which is an adjunct to the International Conference on Harmonization (ICH), where a lot of regulators are present and there they just set up an IDMP implementation group. I'm not entirely sure of the remit of that group, but it is clear that a number of regulators are beginning to talk about IDMP. But it is true that the immediate focus is on Europe.
One of the hot topics during the breaks between sessions here at the conference has been Brexit. How might Brexit affect IDMP?
I think that the major impact is going to be upon EMA having to leave London and the disruption to their activities. It will need to re-establishing itself. There is, perhaps, a desire to keep things relatively small in the first instance, so it can be done before the move and then for expansion to be tackled after EMA has arrived wherever it arrives. If we try and do too much at the beginning, that may mean we have got a project which requires too much effort and time and if that then coincides with the move it would be problematic.
The other thing is what happens to the UK agency. We know that the current UK agency is looking at how it migrates its own data to an IDMP environment. However, if it is outside the EU then will it implement in the same or in a slightly different way to the remaining 27 member states (plus EMA).
The Qualified Persons for Pharmacovigilance (QPPVs) and the pharmacovigilance safety master files (PSMFs) that are based in the UK will no longer be acceptable after Brexit, so there will need to be new QPPVs or existing QPPVs relocated somewhere else, and the PSMF location moved and the regulators informed. The changes to the Variations process will allow these changes to be reported via Article 57 only. The UK leaving the EU will put pressure on the EU regulators as they absorb the work undertaken in the Mutual Recognition and Decentralised Procedures. I believe that there are something like 5000 mutual recognition procedures that are managed by the UK and the work has got to be absorbed by all the other regulators, probably without any increase in staff. Some of the IDMP targets for this first iteration are surely going to be around efficiency and what can be achieved through submission of data instead of Type 1A variations. So, some of the downsides of Brexit are tempered by opportunities — people are looking for efficiency gains.