Vaccines Europe - 04 Oct 2023
Vaccines Europe has published its official response to the European Commission’s proposal for the revision of General Pharmaceutical Legislation (GPL) published 26 April 2023.
Overall, Vaccines Europe supports the European Commission’s aim to ensure all Europeans have timely and equitable access to medicines, enhance security of supply and availability of medicines, and offer an attractive innovation and competitiveness friendly environment for the research, development and production of medicines in Europe.
The EU has been a leader in vaccine research, development, and manufacturing. In 2018, 3/4 of vaccines produced globally by Vaccines Europe members were manufactured in Europe. The COVID-19 pandemic further demonstrated the EU’s strong footprint in the vaccine ecosystem when by January 2022, the EU had contributed to nearly 40% of the world’s COVID-19 vaccine exports.
There are currently 100 vaccine candidates in Vaccines Europe members’ pipeline aimed at tackling the challenges of today and tomorrow.
However, new research shows that Europe’s position as a leader in vaccine innovation is at risk. Limited funding, incentives and support for diverse vaccine types and platforms are just some of the barriers to early-stage vaccine research. Further, complex clinical trial requirements and lengthy timelines have contributed to a 35% relative decline in the share of global vaccine clinical trials conducted in the region since 2000.
To reach its full potential, vaccination must be accessed by all. Concerning data shows that in 1/3 of EU Member States, it takes over six years to access innovative vaccines.
The revision of the GPL presents an opportunity to ensure that innovative vaccine development continues in Europe. The COVID-19 pandemic was a painful reminder of the value of vaccination and the need to sustainably incentivise innovation in the vaccine sector. As such, the unique characteristics of vaccines and vaccination must be considered in the legislative provisions to reward prevention and contribute meaningfully to public health in the EU.
Vaccines Europe believes that the following amendments would allow for greater consideration of vaccines and the value of prevention:
- Fair and achievable incentives that are linked to innovation by strengthening the baseline of RDP. This is especially relevant in the challenging market access landscape of EU Member States. Linking vaccine “release and supply” in 27 Member States to incentives for R&D would not address the root cause of the significant delays and inequality in population access.
- The definition of unmet medical need should be more inclusive and embrace the perspective of target populations, recognising the value of preventing diseases in the first place and of community protection. Implement electronic product information (ePI) for vaccines first and facilitate the use of EU common pack to enable modern infrastructure.
- Harmonised regulatory pathways with predictable reporting timelines and transparency across the supply chain. Flexible product naming should be maintained for vaccines to account for specific complexities where an International Non-proprietary Name (INN) cannot be assigned or where seasonality or emergency preparedness means that INN assignment could impede immediate access.
- An expanded Master Files concept to include platform technology master files enabling the use of prior knowledge and fostering innovation.
- Revisions to the reporting timeline requirements for clinical studies involving the use of vaccines in the paediatric population to allow time for all key procedures.
- Standardised definitions and reporting of shortages as well as a harmonised prevention and mitigation system to efficiently address vaccine shortages and support resilient supply chains.
This is a once-in-a-generation opportunity to equip the EU with the necessary tools to address health challenges of today and tomorrow and enable the next generation of innovative vaccine technologies.
Vaccine innovation is happening at a level not seen before. With a promising pipeline aimed at tackling current and future health challenges, the EU pharmaceutical legislation must be an enabler rather than a roadblock to this innovation. Vaccines have their own complexities that cannot be undertaken in a one size fits all proposal. Therefore, a holistic approach from prevention to care is needed to ensure that this promising industry – representing a valuable asset for the EU, healthcare systems, the economy and society as a whole – is not forgotten. Sibilia Quilici, Executive Director, Vaccines Europe