Roadmap to the Pharmaceutical Strategy for Europe

Roadmap to the Pharmaceutical Strategy for Europe

Pfizer's response to the public consultation 

Pfizer has invested in Europe since 1952. We employ over 18.000 people here and operate 12 R&D and manufacturing sites across 8 Member States, including for APIs and vaccines. We conducted over 900 clinical trials in the EU and are involved in 323 R&D partnerships with EU universities and biotechs (2018). Over 60% of our medicines globally are handled here, with exports reaching patients in over 170 countries. Moreover, 85% of APIs for our patented medicines comes from Europe.

With this in mind, we aim to contribute to a Pharmaceutical Strategy which advances pro-patient and pro-innovation policies and provides an environment for the pharmaceuticals sector to flourish. 

Innovative partnerships for better access: Root causes of obstacles to the availability of innovative medicines are multi-factorial. They cannot be addressed by tampering with the regulatory and IP incentives framework, integral to Europe’s ambition to be a world leader in medical innovation. We support the EU Health Coalition’s call for a High-Level Forum on Better Access to Health Innovation to discuss, inter alia, common principles to align medicines’ prices to the level of economic development of the country concerned. In addition, to increase access to paradigm-shifting treatments such as gene therapies while addressing affordability concerns, the EU should enable and encourage the implementation of novel payment models such as spread payments, currently limited by EU accounting rules.

A world-class R&D incentives ecosystem: A key objective of the Pharma Strategy is to “support the European pharmaceutical industry to remain an innovator and world leader”, linking to the EU Industrial Strategy. To achieve this goal, the EU must ensure a world-class incentives ecosystem to attract investment into the development of future treatments for the benefit of patients, including those with rare and paediatric diseases. We believe this can be best achieved via targeted, non-legislative initiatives. To increase R&D in much-needed new antimicrobials to fight AMR, instead, we call for a specific EU Regulation establishing a market-based ‘pull’ incentive, notably transferable exclusivity, with stewardship conditions.

A science-based, competitive and effective regulatory framework: The Roadmap lacks concrete tools to support and encourage clinical development in Europe. This would include more competitive approval times and reduced administrative burden. By implementing the EMA’s 2025 strategy and the Network Strategy, regulatory improvements can be achieved efficiently without the need for legislative change. We also call for a more flexible and simplified post-approval process to monitor the safety and benefit-risk of medicines. To advance the Green Agenda, we support an extended environmental risk assessment to address latent discovered issues, as outlined in the industry’s Eco-Pharmaco-Stewardship approach. This would enable manufacturers to address environmental risks without undermining access to medicines.

Flexible and resilient supply chains: During the COVID-19 pandemic, Pfizer was able to meet the increased demand (150-300% higher than average) thanks to our stable and sophisticated global network and healthy pre-COVID inventory safety stocks. We remain committed to working with the EU and Member States on initiatives that support innovative, sustainable manufacturing and supply chain resilience to secure supply for patients. A fragmented, localised approach will not achieve this shared goal. Other measures include enabling rapid and efficient scale-up for supply of quality medicines and vaccines; reducing tariffs and other trade barriers; fighting counterfeit medicines; advancing harmonized regulations; strengthening regulatory oversight in third countries; and sharing data on availability and demand, especially in public health emergencies.