1. Home
  2. blogs
  3. Driving the healthcare regulatory system into the future

Driving the healthcare regulatory system into the future

Published on: Nov 17th, 2020

 

This is a summary report on the panel discussion at the TOPRA Symposium 2020. The panel discussed how the EMA and national regulatory agencies will ensure innovation and patients remain at the heart of the pharmaceutical strategy for the next decade. The panelists acknowledged to maintain a competitive position, EU pharma needs to embrace digital transformation by ensuring the scientific community has access to, and the capacity to analyze EU healthcare data. Guido Rasi, Executive Director, EMA, presented the “EMA Regulatory Science to 2025” which focuses on five goals, including the necessity to address emerging health threats, the leveraging of research and innovation in EMA processes, and driving collaborative evidence generation.

Panelists

CHAIR Greet Musch, General Director DG PRE-authorisation, Federal Agency for Medicines and Health Products (FAMHP), Belgium.

SPEAKERS Olga Solomon, Head of Unit B5 (Medicines: policy, authorisation & monitoring), DG Santé, European Commission; Guido Rasi, Executive Director, EMA; Thomas Senderovitz, Director General, Danish Medicines Agency (DKMA) – Denmark, and Chair, HMA Management Group; Xavier de Cuyper, Chief Executive Officer, Federal Agency for Medicines and Health Products (FAMHP), Belgium; and Sini Eskola, Director, Regulatory, Drug development and Manufacturing, European Federation of Pharmaceutical Industries (EFPIA), Belgium.

Key points

The European Commission, together with the EMA and national regulatory agencies (through the HMA), is actively preparing the pharmaceutical strategy for the coming decade to ensure innovation is widely embedded and that patients continue to remain the centre of attention.

EU pharma needs to maintain its competitive position and, among other challenges, needs to catch the wave of digital transformation. This means making sure the scientific community has access to all EU healthcare data and that they have the capacity to analyse it.

Industry and regulators need to target the unmet medical needs of patients, while ensuring affordability and availability of medicinal products.

After having welcomed the panellists, delegates and TOPRA organisers to the inaugural session of this virtual symposium, Greet Musch acknowledged that we are at a very specific moment in time. Indeed, the EC is working on the pharmaceutical strategy for Europe, the EMA is developing its 2025 Regulatory Strategy, as is the HMA. Now is therefore the perfect opportunity to check whether the future European pharmaceutical system being discussed will be sufficiently robust to face the pandemic and address all expectations for the next decade.

Olga Solomon outlined the reasons why a pharmaceutical strategy was under development for Europe and the broad consultation process, which ultimately will lead to the EU Commission deliverable. She
reminded the audience that one of the targets was to secure a competitive position for Europe in the global market, while fostering innovation and safeguarding a limited dependency on the supply of APIs and finished products from non-EU countries. In this context, availability and affordability are important considerations for patient market access.

Innovation is a key driver for the pharma industry and should also directly benefit patients. Ms. Solomon acknowledged that we are still learning from the COVID-19 crisis, but this should help us in building a strategy aimed at supporting sustainable innovation, emerging science (including digitalisation), while reducing medicines shortages and securing strategic autonomy.

The role of innovation is also key in the EC strategy to ensure the efficient development of new products. Artificial intelligence and modelling have an important role here, as they have in regulatory processes, eg, in the use of more and more RWD/RWE to support clinical development and regulatory approval, as well as improving the monitoring of medicines.

Thanks to feedback on the roadmap from the broad group of stakeholders, and the productive workshop that followed, the EC has identified convergent topics of interest, specifically the need for continued support of EU-based R&D, including incentives and rewards, while integrating environmental constraints.
Innovation also means giving support to both novel medicines and repurposed drugs, provided that the drug development targets unmet medical/patients’ needs. However, it was felt that this concept should be further clarified,  according to the stakeholders.

Ms. Solomon confirmed that a communication on pharmaceutical strategy will be made by the EC that will propose an action plan covering legislative and non-legislative measures over the short and long term, targeting an adoption by the Council by the end of 2020 and an implementation phase of 2021–2023.

Guido Rasi then presented the EMA Regulatory Science to 2025. This initiative focuses on five goals, including the necessity to address emerging health threats, the leveraging of research and innovation in EMA processes, and driving collaborative evidence generation.

The EMA will integrate the EC pharma strategy with key topics developed in another strategic roadmap prepared by the regulatory network of NCAs in the member states (European Medicines Regulatory Network, EMRN).

Professor Rasi pointed out the resource challenges the EMA was facing, resulting in the need to prioritize actions and maintain a high level of coordination between the different stakeholders/enablers. Considering future workload, it will be difficult to have sufficient staff, while ensuring a high level of expertise in various fields. To address this challenge, Professor Rasi spoke in favour of the creation of a European medical research centre, which should avoid the fragmentation of clinical data and the dispersion of resources in Europe.

Thomas Senderovitz started his presentation by reminding the audience how the EMRN was organised: a constellation of approximately 45 NCAs collaborating in conjunction with the EMA and the EC with the support of the HMA. Despite the complexity of this network, it works well. The European regulators strive to maintain Europe as a competitive marketplace by promoting dynamic regulation and policy to be able to face the challenges of data analysis and digital transformation while ensuring data security and maintaining ethical principles.

Xavier de Cuyper then provided the view of a “mid-size medicinal agency” using the way the Belgian agency actively collaborates with the EMA and the other agencies, notably, for example, via the EMA Emergency Task Force, the EU Steering Group on Shortages and the COVID Vaccines Steering Board. He said it is key to “dream the future” to be able to imagine how to cope with the coming challenges, eg, digital transformation. This means strengthening cooperation between the various European organisations and institutions and building bridges between regulatory frameworks. To this end Mr. de Cuyper concluded that, in line with the EC President, the creation of a European biomedical research agency modelled on BARDA, the US Biomedical Advanced Research and Development Authority, would be important.

The final presentation was given by Sini Eskola, who outlined how EFPIA is monitoring the works of the regulators, and the best way to support drug developers to foster innovation. EFPIA welcomed the EC pharmaceutical strategy and the roadmap published in June 2020. It acknowledged the issues raised in the roadmap and confirmed the pharmaceutical industry is willing to address the problems, even if in practice the measures need to be further clarified. EFPIA proposes concrete measurable outcomes which translate into the “regulatory road to innovation”, developed to address the identified challenges. Among the different measures, EFPIA believes that the EU regulatory framework should evolve to address the new challenges and the “unmet medical need”.

A short panel discussion followed. One delegate asked whether the EU has the capacity to maintain its global position and regulatory excellence. Ms. Solomon acknowledged that Europe was facing challenges considering the complexity of the EU legislative framework, as compared notably to the US. However, making sure the regulatory framework fosters innovation and creates a favourable regulatory and investment environment is the main driver of the EC pharma strategy.

Diverse team of professionals smiling, representing expert support at VCLS.

Questions? Get the answer by our expert team

No two product developments are the same, talk to our experts about your development challenges and we will provide your actional recommendations.