EFPIA response to the consultation on the Pharmaceutical Strategy Roadmap

The EU Pharmaceutical Strategy has the potential to support Europe’s medical research eco-system, enhance the region’s resilience to global health threats, address our on-going health challenges as well as be a key driver for the EU’s economic recovery.  EFPIA welcomes the Commission’s recognition of the importance of the sector in the Roadmap and is committed to working with the EU and Member States to ensure that patients in Europe have access to the medicines they need and, learning the lessons from the COVID-19 crisis, creating the policy environment in which the industry in Europe can be a world leader in medical innovation.
Unfortunately, the Roadmap does not contain the necessary drivers of innovation to realize its own ambition of supporting the industry in Europe to be a world leader in innovation. In our response to the EU Industrial Strategy we have outlined the steps needed to recover the ground lost to other regions of the world in medical innovation, including alignment to the EU’s industrial and trade strategies.
Europe needs a research and manufacturing infrastructure that delivers the next generation of vaccines and treatments. That means developing clinical trial networks, biobanks and data banks, building a European health data space, delivering public-private collaboration mechanisms to accelerate bringing health solutions to patients and encouraging innovative manufacturing.
To place the EU at the forefront of pharmaceutical innovation, Europe needs a world-class IP framework to attract investment into the development of future treatments for the benefit of patients, including for patients with rare and paediatric diseases. Developing incentives to further address unmet medical needs and seize advances in science is critical to tackling issues like AMR and pandemic preparedness. SPC harmonisation and strong IP systems can increase certainty and predictability for innovators and investors alike.
Europe needs a regulatory framework that is stable but adaptable, fast, effective and globally competitive. We need; development support and regulatory approval times on par with other regions, EU regulators delivering world class scientific expertise in collaboration with global partners, simplification of the EU regulatory network, and connected regulatory oversight of drug-device/diagnostic combinations. To be able to deliver on its related 2025 regulatory science strategy, the EMA needs further strengthening.
We share the concern over inequalities of access to new treatments and vaccines across Europe. Faster, more equitable access for citizens is a shared goal.  The root causes of these issues are multi-factorial; including late start of market access assessment, duplicative evidence requirements, national pricing and reimbursement policies and companies’ behaviors responding to these and other factors. They can only be addressed by stakeholders working together. By creating a High-Level Forum on Better Access to Health Innovation we can identify multi-stakeholder solutions for introducing new technologies that can broaden access, reduce delays and mitigate the impact of shortages. This collaborative dialogue must be evidence-based, requiring an EU-led analysis of the root causes and drivers of access, supply and shortage issues.
EFPIA has proposed potential solutions utilizing novel pricing and payment models, which could be more broadly implemented across European healthcare systems. By concluding the HTA Regulation negotiations we can address the misalignment on evidence between industry, regulators and HTA bodies; one of the most prominent and complex delays to access. What is clear, is that access issues will not be addressed by tampering with the regulatory and incentives framework, integral to Europe’s ambition to be a world leader in medical innovation.
EFPIA and its members stand ready to work with all stakeholders to create medical innovation and facilitate sustainable access for all.

The root cause of unavailability and delay to innovative medicines: Reducing the time before patients have access to innovative medicines