We are in the midst of a transition period with regard to the ESMP, the platform launched by the EMA (the European Medicines Agency) that should help to have more detailed and standardized information on medicines shortages in Member states (MS).
The basic version of the European Shortages Monitoring Platform was launched on 28th November, and the second phase will be triggered on 2nd February, with the full version whose use will become mandatory for industry.
“This is the last main milestone of the implementation of Regulation 2022/123, which is EMA’s extended mandate for crisis preparedness and also crisis management for medicine and medical devices”, reminds Monica Dias to TrendSanità. Dias is the Head of Supply and Availability of medicines and medical devices in EMA.
The purpose of the European Regulation is to facilitate information exchange for better prevention, identification and management of shortages, as well as improved communication between EMA, national competent authorities and industry stakeholders to ensure medicine availability for patients during public health emergencies and major events.
Mitigating the impact of shortages
The platform will centralise and automate data collection on medicine shortages, giving regulatory authorities access to real-time, comprehensive information to improve the prevention, monitoring, and management of medicine shortages across the EU and the European Economic Area (EEA).
EMSP will provide real-time information to improve the management of shortages at European level
Regulatory authorities within the European Union but also globally are working together to prevent shortages and if not possible to limit the impact of the shortages when they occur. “We really want to prevent shortages from happening in the first place, if we want to minimise the impact of shortages on patients, so we have to work with pharmaceutical companies – tells Dias -. So we have to get information and data from industry. When they have a shortage at the actual or potential shortage, we need to understand what are the contingencies, how they are going to resolve that shortage so they have to tell us what is the root cause and what are the measures that they can put in place to address”.
The issue could be a manufacturing issue, could be a distribution issue, and there are several root causes of shortages. “What we do is to see whether we can support that particular company to prevent the shortage or mitigating impact. And, in some instances, we might have to actually look at alternative medicines or suppliers that need to be used to compensate for the shortfall for that particular shortage”.
EMSP, a centralized hub
The platform was developed during Covid: “The ESMP is part of the extended mandate of EMA. We already had experience in data collection, but not through this platform, which was developed during the pandemic: we collected data from pharmaceutical companies for products that were part of the critical drug list”.
So far there has been a lack of a central repository, standardized across all Member States
The accumulated experience, in synergy with the new platform, will allow for a better response to future threats: “We now have an analytical tool that will help us process those data that were analyzed manually in the past,” Dias notes.
The difficulties experienced so far were also due to the lack of a central repository for shortages, standardized across all MS. “In addition, shortages of nationally authorized drugs, especially when they do not extend to other member states, are handled at the national level – says Dias -. EMA deals with shortages of centrally authorized products and critical shortages that are brought to the European level by MS, but most shortages are handled at the national level. Over the years we have obviously increased our involvement and put in place a number of measures for harmonization. I believe that having the EMSP as a centralized hub for information on shortages will help information exchange and better prevention and identification of deficiencies. All this will also improve communication between EMA and stakeholders and communication to the public”.
Changes on the horizon
Under discussion is the Pharmaceutical Legislation Reform, which it is speculated could be approved by the end of 2026. Among the aspects most criticized by the industry is that of market exclusivity, which would be extended for those medicines that reach the largest number of member states immediately. “In this case we are talking about an issue of accessibility and not availability – Dias clarifies -. Having said that, precisely because this is a text that is still under discussion, it is not clear how EMA, as a scientific body, can be involved to assist the Commission in resolving disputes between companies and member states related to the pricing and reimbursement submission process”.
Of course, the Agency will monitor the impact of this proposal on drugs availability: “We hope that whatever measure is put in place will have positive spillovers, because we know that the fact that medicines are not released at the same time in all member states leads to health inequalities.”
As regards the Critical Medicines Act, a document that the new Health Commissioner Olivér Várhelyi committed to publishing within 100 days, Dias says: “We see it as complementary to the proposed pharmaceutical legislation. The work has already started so we already have a list of critical medicines. So, we feel that the Critical Medicines Act could bring some important industrial policy tools to address vulnerabilities in the supply chain of critical medicines in the long term so we see this more of it as a long-term measure. And we of course are committed to support the Commission and the legislators as this evolves”.
