02 June 2023
As part of a wide-ranging conversation with PharmaBoardroom published earlier this month, European Medicines Agency (EMA) Executive Director Emer Cooke laid out four of the Agency’s core focus areas for the coming year, including the lessons to be taken from the pandemic response, why antimicrobial resistance must not be neglected, how the EMA hopes to boost Europe’s clinical trials footprint, and why new initiatives for the collection and dissemination of real-world evidence are already having a significant impact.
“We must admit that the pandemic presented a unique set of circumstances. However, it did foreground the importance of a collective approach, bringing together different stakeholders to engage in open dialogue in what was effectively a non-competitive space. From a regulatory perspective, we see opportunities to continue some of these discussions in the ICMRA setting. We also now have a new legal mandate that allows us to do a lot more work on preparedness and anticipating possible future pandemics.
“Elsewhere, COVID restrictions prevented on-site inspections, leading to the introduction of virtual distant inspections as well as hybrid inspections whereby some national regulators could be on the ground while others participated remotely. Guidance for all of this now exists. There are, of course, pros and cons for all of these measures; they are quite resource intensive, meaning that these measures should be reserved for exceptional circumstances. In addition, it is important that industry submits mature dossiers. Rapid authorisations are facilitated by a combination of large datasets, quality dossiers, and agile regulators.”
“EMA has been doing a huge amount of work around AMR for a long time, and in a concerted manner since at least 2010. However, the regulatory aspects will only be one part of the solution. If a promising product emerges, as happened during COVID, EMA will bring regulators together and make sure that it is reviewed.
“In the context of the pandemic, EMA piloted the ‘OPEN’ initiative to increase international collaboration on the evaluation of vaccines and therapeutics, which saw regulators from outside the EU participate as members in our scientific meetings. This led, for example, to the AstraZeneca vaccine that we authorised achieving WHO pre-qualification and then authorisation in 160 countries within two weeks; a process could take between two to eight years in normal circumstances. OPEN has now been launched as a full programme, with a focus on AMR-related products and medicines that target an unmet medical need via our ‘PRIME’ pathway. The idea is to move towards more collaborative reviews and common inspections.
“Should the right AMR-related product be presented to EMA, there are a number of opportunities that we are ready to push the button on. Up until that moment, our role is to be prepared and support the developers. A lot of work is going on. The OPEN procedure allows for the involvement of regulators from other jurisdictions, we provide guidance to developers, we interact with international regulators, and our work within the ICMRA is helping us raise awareness of the threat of AMR among both patients and healthcare professionals globally. On the veterinary side, we monitor the sales and prescriptions of antimicrobials in animals. While we have seen a 47 percent decrease in the use of antimicrobials in animals in recent years, and an 80 percent decrease in the use of polymyxins, there is still a lot of work to be done. For example, last winter saw shortages of certain antimicrobials in Europe due to a supply-demand mismatch, but most of the unanticipated respiratory infections were actually viral rather than bacterial, meaning that antibiotics were not the solution. There is still a lot of inappropriate use of antibiotics and the need for better diagnosis.”
“EMA does not have a specific mandate to authorise clinical trials, but I like to see the agency as something of a ‘fairy godmother’ that does a huge amount to improve the environment for clinical trials. To this end, along with the European Commission and the heads of national medicines agencies which approve trials within their countries’ borders, we launched the Accelerating Clinical Trials in the EU (ACT EU) initiative last year. This initiative aims to relaunch the EU further as a competitive centre for innovative clinical research.
“ACT EU was borne out of the realisation that there is huge complexity in the system and has been designed around ten priority areas. Some major wins have already been secured, including guidance on complex clinical trials as well as decentralised clinical trials, which COVID helped promote the acceptability and importance of. Moving forward, we are focusing on the implementation of the Clinical Trial Regulation, as EMA holds responsibility for the management of the Clinical Trials Information System (CTIS), a game-changing initiative which allows for a single submission and supports the flow of information between clinical trial sponsors, EU Member States, European Economic Area (EEA) countries, and the European Commission.
“We feel a strong responsibility to create an enabling environment as part of this collective effort. The wider EU area represents 500 million people; a huge population that companies should not be running away from. What we are working towards will not happen overnight, but the foundations are in place for a sea change in how clinical trials are regulated across Europe.”
“EMA’s Data Analysis and Real World Interrogation Network (DARWIN EU) – a coordination centre to provide timely and reliable evidence on the use, safety and effectiveness of medicines from real world healthcare databases across the EU – recently celebrated its first anniversary. DARWIN EU brings together a federated network of data providers but also has regulators, patients, health technology assessment (HTA) bodies, and payers on its advisory board to help determine its work programme. While DARWIN EU only completed four studies in 2022, we are planning between ten to 15 in 2023, and around 150 per year from 2025. We have a huge opportunity to ensure that we are asking the right questions of our healthcare systems to optimise patient treatment.
“Companies need to be more engaged in collaboration with HTA bodies; currently, only 50 percent are considering the HTA perspective at the early development stage, for example, which is not enough. There needs to be a move beyond pure regulatory questions to a consideration of what HTA bodies and payers might need. EMA has already engaged in 62 parallel joint scientific consultations with the European Network for Health Technology Assessment (EUnetHTA) consortium, in the recent years.”Print
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