Vaccines Europe's response to the EU roadmap on the “Evaluation and revision of the general pharmaceutical legislation”

Vaccines Europe (VE) believes that this evaluation is an opportunity to implement learnings from COVID-19 to ensure a future-proof and resilient healthcare system. The pandemic shows the importance of: EU crisis preparedness, a flexible regulatory environment, maintaining and enhancing innovative research and development, and an industrial capability and capacity in the EU. 

VE concurs with the response submitted by EFPIA to this consultation and herewith focuses on vaccine specific aspects: 1) accelerated vaccine development and authorization, 2) accelerated and equal access to vaccines and 3) sustainability of supply. 

  1. Accelerated vaccine development and authorization 

Regulatory pathways should be re-designed to allow for swift regulatory approval of new vaccines for use in emergencies or addressing other unmet medical needs and should sustain flexibilities that demonstrated benefits in terms of accelerating access to new vaccines. To this effect, the following should be leveraged to shape appropriate and fit for the future regulatory pathways: the concept of mock-up dossier as successfully used for pandemic flu vaccines, the use of master files and innovative study designs to facilitate the review and approval of new technological platforms, or the regulatory flexibilities applied in the development of COVID-19 vaccines.  

  1. Accelerated and equal access to vaccines 

In Europe, despite the far-reaching health and economic benefits that immunization provides, less than 0.5% of healthcare expenditure is on average allocated to vaccination and the proportion is even decreasing in some Member States (MSs). Due to budget constraints and the complexity of regulatory and market access processes, it often takes many years (estimated median times range from 2 to 6.4 years) from authorisation of a vaccine to its adoption in a National Immunisation Program (NIP).  

Low immunisation budgets do not support vaccination program implementation and monitoring, nor inclusion of new vaccines in NIPs. This also induces price-only procurement practices that do not consider innovation, broader benefits of vaccines, nor the sustainability and timeliness of supply. In the long run, suboptimal investments in vaccination stifles future R&D investment, downsizes manufacturing capacity and supply chains’ stability, and results in insufficient vaccination protection impacting public health and economics. 

Vaccination programmes with life-course approach should be prioritised by MSs and be supported with sufficient funding, expansion of vaccination pathways, education and awareness, and digital systems to ensure high coverage and protection. 

Exploring novel incentive options should consider the specificity of market access for vaccines. 

  1. Sustainability of supply 

Considering the global nature of vaccine supply chains, an adequate process to ensure timely import and export of vaccines and its components in and out the EU is of paramount. 

Despite manufacturers’ efforts, shortages of vaccines have been reported as an increasing concern in the EU. The revision of the pharmaceutical legislation is one of the initiatives undertaken by the EU to address the problem. 

VE conducted an analysis of the root causes of vaccine shortages in the EU. While a number of these causes are intrinsic to vaccine manufacturing, most are related to external factors. Vaccine shortages is multifactorial, making it essential that all root causes are appropriately addressed. 

Finding solutions require a concerted effort and dialogue with all stakeholders to which VE is keen to contribute by bringing expert industry perspectives and engage in developing recommendations. 

To summarise, simplification/optimisation of regulatory and market access processes, inclusive and sustained comprehensive immunization plans, dialogue between governments and industry, and adapted procurement practices will enable better manufacturing planning and improve vaccine supply and access in the EU.