There were 16 interviews performed (Table 1), with a total of 18 participants having active experience and/or knowledge on COVID-19 regulatory and/or market access practices.

Table 1 Participant characteristics. EU: European union, MA: market access, NA: not applicable, RA: regulatory affairs

Based on the interviews, the EMA ETF, rapid scientific advice, rolling review, CMA, and joint procurement were identified by participants as key regulatory / market access measures during the pandemic. Figure 1 provides an overview of most mentioned benefits and limitations of these regulatory / market access measures. The benefits brought forward by participants can be grouped into three main categories: (i) reduced timelines, (ii) enhanced collaboration, and (iii) procedural flexibilities. On the other hand, there are some important unintended consequences, associated with these practices. These can be grouped into two categories: (i) efficiency loss and (ii) reduced transparency. Detailed explanations of benefits and limitations of each item follow below.

Fig. 1

Overview of key benefits and limitations of pandemic regulatory and market access measures during the COVID-19 crisis according to interviewed stakeholders. CMA: Conditional Marketing Authorisation, EU: European Union, EMA: European Medicines Agency, ETF: Emergency Task Force, MA: Marketing Authorisation, RWE: Real World Evidence, SAWP: Scientific Advice Working Party

Regulatory Scientific SupportReported Strengths and Limitations of Pandemic Practices

Scientific advice was criticized by industry participants and policymakers/advisors as typically lengthy, rigid, and inefficient. However, during the COVID-19 pandemic, regular timelines for scientific advice were shortened, resulting in rapid scientific advice. These reduced timelines were achieved through efforts by the EMA and national regulatory authorities. Industry participants noted more efficient engagement in the scientific advice procedure, facilitated by proactive and iterative interactions between developers and assessors. Some scientific advice was reported to be issued outside the official procedure.

Industry participants reported greater acceptance of real-world evidence in regulatory and market access decision-making during the pandemic, alleviating pressure on lengthy clinical trials. Clinical trial flexibilities, such as remote participation, multiple laboratories for data assessment, and platform trials, were believed by industry participants to increase efficiency. Both stakeholder groups reported that greater flexibility in regulatory submission formats expedited processes, eliminating delays from changing or amending submission formats. These changes improved information transfer and expedited the process overall.

Duplication of efforts was reported as a significant source of inefficiency, with scientific advice provided at both European (i.e. EMA) and national levels. One policymaker/advisor explained that some companies preferred to first get scientific advice at the national level in member states with specialised expertise before seeking advice from the EMA. The ETF was crucial in providing scientific advice and coordinating regulatory activities, but duplication of efforts between the ETF and the Scientific Advice Working Party (SAWP) caused confusion in the delineation of responsibilities. Industry representatives mentioned that applicants were often unaware of internal deliberations and which expert groups were involved in assessment processes. Participants believed that early assignment of responsibilities could have reduced this duplication. One assessor reported inconsistencies in the structure and, in some cases, the content of scientific advice provided by EMA across different products, noting that advice was not always systematically aligned, partly due to limited time for cross-checking during the pandemic.

Optimisation Avenues

Rapid scientific advice was deemed by industry representatives to be a useful tool for early dialogue and hope this tool could be used to accelerate the development of products that address “unmet medical needs” or for “life-saving” products. Policymaker/advisors, however, think the procedure is too resource-intensive to be applied in routine practice. Nevertheless, they believe that a more pragmatic application procedure could lead to flexibilities that facilitate and accelerate submissions. Overall, policymakers/advisors agree that rapid scientific advice has low application potential, due to the time intensity.

“I think if there are products which really are life-saving for patients, it would certainly be valuable to shorten the timeline. Because otherwise, your normal scientific advice timeline is between 40 to 70 days.” (IND6).

“Scientific advice is usually quite fast, so you can have your scientific advice in 30 days if necessary. Further acceleration is probably not really meaningful, especially when you consider the time that applicants usually take to prepare for scientific advice.” (PMA6).

While industry representatives unanimously supported rapid scientific advice for future health emergencies, policymakers/advisors had varied responses. Increased support and capacity at national regulatory authorities were recommended to make this process feasible. The ETF was widely considered successful for EMA scientific advice during health emergencies. To avoid duplication with the SAWP, participants recommended clearly outlining the ETF’s responsibilities. One participant suggested the ETF should identify promising new products early in a pandemic and proactively circulate new information to national authorities, the EC, and the EMA to support institutional preparedness and continuity in decision-making across the network. Both stakeholder groups agreed on the high potential usefulness of the ETF going forward.

EMA Rolling ReviewReported Strengths and Limitations of Pandemic Practices

The rolling review process allowed developers to receive ongoing feedback on their submissions, addressing potential delays early. Participants reported reduced regulatory timelines due to parallel processing of steps. Industry participants noted close collaboration with the EMA, with continuous, iterative advice on COVID-19 vaccine and therapeutic development. The EMA’s OPEN initiative also involved other non-EU regulatory authorities, enhancing transparency and sharing expertise.

“EMA provided continuous, iterative advice on the development of the COVID vaccines and therapeutics. In particular, we had a constant dialogue with the regulators when we were developing the vaccine. Sort of like largely sitting alongside us as we’re seeing, analysing, and making decisions based upon the data from the trial.” (IND1).

However, many participants cautioned that the rapid review timelines placed pressure on regulatory authorities, forcing them to halt other activities to focus on COVID-19-related dossiers. This was believed by both industry participants and policymakers/advisors to be challenging given their limited resources and the dual roles many committee members played as both EU assessors and national positions. Participants felt they were resource-intensive for both assessors and applicants and sometimes inefficient. Regulators reported that the rolling review increased personnel commitments and total time spent on reviewing submission dossiers and questioned whether resources were deployed most efficiently, despite faster outcomes.

“The disadvantages are that you might prematurely submit something and then regulators spend a lot of their time looking at it and then that’s a waste of time because it turns out that the product is not working or the safety profile isn’t good enough. So you can waste your assessor’s time and assessors time is very precious.” (IND8).

Moreover, several participants noted that some member states conducted additional national regulatory evaluations, leading to duplicated efforts and unequal access to treatments across Europe. One industry participant raised concern that the close and continuous involvement of regulators in data review during the pandemic risked conflict of interest by blurring the line between evaluation and co-development, potentially affecting perceived objectivity. Additionally, industry participants highlighted that EMA processes were still slower compared to the FDA in the United States, suggesting potential for further acceleration.

All participants agreed that procedural flexibilities, such as reliance on digital support (e.g. digital informed consent, electronic product information, remote meetings), approval of decentralised trials, and early results-based approvals, facilitated and expedited clinical evidence generation during the pandemic. However, several participants reported that the EU Clinical Trials Regulation (CTR) 536/2014 was not yet fully implemented during the early phase of the pandemic. This lack of full implementation was perceived by participants to have contributed to a fragmented clinical trial landscape, with numerous small, underpowered trials insufficient for drawing meaningful conclusions. While the CTR and the Clinical Trials Information System (CTIS) do not prevent the conduct of small trials, participants believe that the absence of a harmonized, centralized process made it challenging for regulators to prioritize and coordinate resources. This proliferation of small trials was believed to create an overload for clinical trial assessors and limited the generation of robust, generalizable evidence. Participants advocated for larger, multi-country trials for robust data and reliable outcomes. The rolling review process allowed regular evidence submission, several policymakers/ advisors noted that the submitted data was often immature, leading to inefficiencies in both data generation and assessment.

Optimisation Avenues

Overall, both stakeholder groups agreed that the rolling review should be implemented in a future health emergency but there was no consensus on its application in routine practice. Most policymakers/advisors found it too resource-intensive, favouring the PRIME scheme and accelerated assessment for routine use. Industry representatives did not rule out its case-specific application, citing insufficient tools for accelerating authorisation. Both groups agreed that more resources for regulators and clear requirements are essential for applying the rolling review in both routine practice and health emergencies. In routine practice, some suggested limiting its use to products addressing unmet medical needs, innovations, or public health interests. The simplified reporting format from the rolling review was seen as valuable for enhancing routine submission processes.

“There are lessons learned that can be taken to see whether it is possible to work for the assessment of a medicine in a more iterative way. Not the rolling review, but in a more iterative way that you’re providing information when you think that you have a sufficient package of information.” (IND2).

Both policymakers/advisors and industry representatives expressed support for an EU clinical trial approval system, with one protocol for a multinational study, promoting harmonisation across the EU and resource efficiency (endorsed under Regulation (EU) No 536/2014). Industry representatives additionally underlined that there is a need for more aligned evidence requirements for submission between the different member states but also between stakeholders (e.g. HTA bodies, payers, regulators). Moreover, the effective use of real-world evidence generation during the pandemic led both policymaker/advisors and industry representatives to believe an increased use of real-world evidence in routine practise would be favourable, however participants also recommended greater alignment on how to evaluate it in their assessment processes. A vaccine monitoring platform and continuous dialogue through the European Centre for Disease Prevention and Control (ECDC) and reliance on a joint advisory board comprising stakeholders from various organizations were recommended to ensure this harmonization.

Conditional Marketing Authorisation (CMA)Reported Strengths and Limitations of Pandemic Practices

CMA is a tool that was already available prior to the pandemic in routine practice for medicines addressing an unmet medical need, allowing authorisation earlier in the development cycle based on an immature dataset, under the condition that additional data will be submitted and reassessed annually by the CHMP [16]. While many considered the tool essential to ensure rapid access during a public health emergency, some participants noted that its expanded use led to a considerable accumulation of workload for both industry and regulators. This additional burden, while not a structural inefficiency of CMA itself, was seen as a consequence of its broader application under crisis conditions. Furthermore, several participants believed that limited communication and transparency around the process and its evolving requirements may have contributed to public hesitancy and misunderstanding.

Optimisation Avenues

Regarding the CMA, both groups agreed that it is a needed and established tool in routine practice. While CMA is already an effective tool, participants did point out actions that could optimise the use, based on pandemic learnings. Both policymakers/advisors and industry representatives highlighted the need for stricter eligibility requirements, i.e. that CMA should only be applied in the case of unmet medical need, and further, when CMA is used, it should be communicated better to the public to generate more trust and limit hesitancy. CMA is essential for routine and emergency practices but poses challenges due to the post-approval burden of assessors of additional evidence. There were differing views on creating a separate emergency pathway, with some suggesting an alternative emergency use authorization. Overall, industry representatives recommended maintaining or creating a new emergency pathway, while policymakers noted CMA’s value despite the increased workload it generates.

Joint ProcurementReported Strengths and Limitations of Pandemic Practices

A frequently mentioned measure during the COVID-19 pandemic was joint procurement. Participants reported that this centralized process accelerated market access and explain that this enabled new products to enter the entire European market simultaneously at a uniform price, improving equity in access to innovative medicines and avoiding parallel trading.

Most participants believed that joint procurement increased efficiency by centralizing negotiations to one European negotiation party instead of each member state negotiating separately. However, there were also limitations mentioned. Some participants reported criticism from member states regarding the negotiated prices, which were perceived too low. One policymaker/advisor explained that “The European Commission is always in the dilemma that they have to take care of the public health of the community, of the population, but also they want to have a competitive pharma industry. While health ministers on the national level almost only have the perspective of purchasing goods for the public, and they don’t look whether the pharma companies are making enough money and whether they are competitive. So this double perspective of the European Commission is definitely difficult.” (PMA8). Furthermore, various participants highlighted that some member states still negotiated their own prices with companies to secure better deals, leading to inefficient use of resources.

Optimisation Avenues

Some industry representatives expressed their desire to move towards a European system with one price for all member states (with joint clinical assessment as the first step). Further, one policymaker/advisor believed that joint procurement is a good tool to drive innovation in areas where there is a clear need. Overall there was no clear consensus within industry, nor policymakers/advisors, regarding the broader applicability outside of emergency context.

“I think it would be beneficial for Europe to take this into their own hands and say for new drugs we start as of today and you put benchmarks. Then we have the prices of all the products in all the countries in Europe. In most of the countries the prices are publicly available. It’s possible to put benchmarks and say okay, you have a new drug, is it as good as something that exists? Okay, then you have to stay within the threshold of 90 to 105% for example.” (IND5).

“National politicians want to do their own thing, they want to make their own decisions. They don’t want the European Commission to interfere with their national decisions whether to purchase something or not. So I do know that the European Commission wanted to purchase some drugs as well, like [name medicinal product], but the member states were very much against it that the European Commission does this a second time.” (PMA8).

Some policymakers/advisors recommended that this action should be used in future health emergencies, but some raised concerns. A first proposed consideration related to the differences in healthcare systems across members states, and recommendation to differentiate prices in different countries depending on gross domestic product. Secondly, several policymakers/advisors pointed out to make sure that when member states sign-in on the joint procurement they would refrain from individually negotiating other contracts with companies for a better price. While most industry participants were cautious about applying joint procurement broadly in routine settings, some representatives highlighted potential benefits under specific conditions. These included avoiding parallel trade, supporting equitable access across Europe, reducing redundant data requests from member states, and streamlining joint clinical assessments. However, there was also consensus that pricing and reimbursement decisions should remain at the national level. These perspectives suggest that selective, well-defined applications of joint procurement mechanisms could be positively received by industry under the right circumstances.

Stakeholder Perceptions on Future Optimisation Avenues

Considering the benefits and limitations of these pandemic actions, stakeholders provided recommendations on how these actions could be best implemented going forward for future health emergencies as well as in routine practice. Table 2 provides an overview of the participants’ perceptions of their application potential.

Table 2 Overview of participants’ perceptions toward the application of the measures during future health emergencies and routine practices. CT: clinical trial, EMA: European Medicines Agency