In the first half of 2023, while Sweden holds the presidency of the Council of the EU, the European Commission will publish its proposal for a new General Pharmaceutical Legislation. Once this is published, the Swedish Presidency will have the important task of kicking off a legislative process together with the European Parliament. This will take time but the process will be vital to ensure the legislation meets the needs of patients across the region now and in the future. 

With this proposed legislation, the Commission aims, among other things, to ensure that all European patients have equal access to established and new innovative treatments when they need them, no matter where they live. 

At Roche, we believe any final legislation must also ensure that the EU remains a globally competitive destination for life sciences investment. Health and economic prosperity are interdependent in advancing the health of patients and society, and this begins with creating a dynamic environment within the EU for healthcare innovation. 

We also welcome the potential the proposals could have for patients. If implemented effectively, they could increase speed, promote efficiency and ensure agility of the European Medicines Agency (EMA) for the novel medicines and integrated solutions of the future. They could also help improve equity in the provision of treatments to European patients while strengthening the innovation environment for the life science industry in Europe. 

We call on the Commission to set a high bar and ambition level and to work together across the healthcare sector to ensure this legislation has a positive impact for patients in Europe. To support this, Roche has six bold actions for improving and future-proofing EMA’s regulatory system. 

1. Modernise and streamline the regulatory assessments

426 days. This was the median processing time when the EU granted a marketing authorisation of New Active Substances (NAS) in 2011-2020. The EU has by far the longest processing time compared to the USA (244 days), Canada (306), Japan (313) and Australia (315). As a result, European patients have to wait disproportionately long periods for new treatments, while innovation is losing momentum. All parties to the European healthcare system can likely agree that the EU must deliver high quality assessments much faster! 

Roche recommends that the EU modernise its procedures to ensure faster and streamlined assessment and authorisation of new drugs, specifically by increasing the use of digital tools, iterative advice and dynamic assessment. 

2. Assigning EMA as an orchestrator authority on integrated solutions

Integrated solutions will in the future play an increasingly important role in improving the patient journey and achieving better outcomes in our healthcare systems. Integrated solutions (e.g. a combination of diagnostics, technologies, tools and/or data) can optimise communication and decision making across the various stages of the journey (from symptoms, to diagnosis, therapy, monitoring and rehabilitation). 

To harness the potential of integrated solutions and to keep pace with the rapid advancement of science and technology, it is crucial EMA plays a leading role in orchestrating modern, streamlined regulatory approaches and procedures with all relevant authorities, bodies and stakeholders necessary in order to deliver these innovations to patients more quickly. 

3. Establish a “regulatory sandbox” for future novel and regulatory solutions

To address the intense challenges currently facing healthcare systems, healthcare innovation needs a framework that allows regulatory experimentation for products and solutions that we cannot yet describe, as they will be the future’s discoveries. 

A “sandbox environment” will solve for and accommodate the reality that science and technology typically advances ahead of any needed regulation, and will avoid the risk of regulating innovative new approaches prematurely or inappropriately. A regulatory sandbox will ensure dynamic and future-proof regulation of new solutions and support the interaction between regulation, new technology and new business models. 

4. Transforming EMA’s Committee Structure to focus and leverage scientific expertise

In the coming years, new immunotherapies, gene therapies and other advanced therapies will revolutionise the prevention and treatment of life-threatening diseases and chronic conditions. For this, we need to strengthen the use of best expertise in the system through transformation of the EMA’s Committee Structure to build systematic expertise and capability, drawing on the region’s strongest scientific minds, and underpinned by the inherent trust built over the past 27 years across Member States. 

5. Securing sufficient EMA funding and optimal resource allocation

Today’s EU pharmaceutical regulatory system was established in 1995. Due to revolutionary, highly dynamic developments in science and technology, the system has become complex and difficult to navigate. It is now behind other comparable systems in speed and agility. There is an urgent need for bold and ambitious action at EU and Member State levels. A fully modernised EU regulatory system will better attract R&D investment into the EU while promoting access to innovative medicines for European patients. 

Sufficient funding and excellent resource management are key requirements for EMA and the multi-stakeholder network to fulfil their strategic and operational missions. We are working together - collectively across stakeholders - to benefit patients, health systems and society. We do not accept that patients must wait on a slower approval time in the EU due to a lack of resources, or waste of available resources, arising from complex, outdated, and resource intensive processes and structure. 

6. Formalising the informal collaboration and work sharing of global pandemic times

During the global pandemic, a need arose for rapid and flexible sharing of knowledge and results. In a short time, new and unique standards of scientific work sharing and collaboration across national borders were established. Building on this positive experience, EMA can pave the way to a truly global scientific work sharing and collaboration (e.g. reliance mechanisms or parallel reviews) between the EU and third countries applying similar standards. This will reduce redundant scientific activities and optimise approval timelines, accelerate time to access and outcomes within and across health systems. 

We call on the European Council to take leadership in facilitating the proposal for a revision of EMA’s regulatory framework. At the same time, we appeal to the EU to consider the solutions proposed in Roche’s Six Bold Actions in the EU’s continuing discussions and final decision on a revision to increase the speed, efficiency and agility of EMA. 

Patients in Europe deserve this and together we can deliver.