Vaccines Europe response to the publication of the proposal for the revised General Pharmaceutical Legislation

Reflecting on the European Commission’s proposal to revise the General Pharmaceutical Legislation published today, 26 April, Vaccines Europe would like to firstly emphasise on the value of vaccination for a healthy and resilient society and how it should be reflected in the legislative package. 

Vaccination is one of the greatest healthcare interventions of our times. Not only does it save millions of lives every year, but it also reduces healthcare costs and contributes to healthcare systems resilience. During the COVID-19 pandemic, vaccination helped save 20 million lives in its first year alone1.  

As we’ve seen over the last few years, vaccines are at the frontline of responses to major health crises such as pandemics, war, earthquakes and others. But vaccination is more than a tool to fight outbreaks of infectious diseases. The uncertain times ahead for the global population’s health and economy call for embracing vaccination as a key prevention measure to address current and upcoming health challenges. The ageing population, antimicrobial resistance (AMR), geopolitical instability and climate change are just a few of the challenges where vaccination can truly make a difference.  

In light of this, Vaccines Europe welcomes the inclusion of a ‘vaccine’ definition in the proposal, which recognises the innovation happening in the field of prevention of infectious diseases to leave no-one behind. Futureproofing the regulatory framework through leveraging several lessons learned from the COVID-19 pandemic such as the establishment of the temporary marketing authorisation, the phased review or the electronic product information, are steps in the right direction. 

In common with the medicines sector, of particular concern are the proposals in the new General Pharmaceutical Legislation that link regulatory data protection (RDP) to access, comparative clinical trials and the narrow definition of unmet medical needs. They have the potential to seriously undermine any renewed interest in vaccines research and development since they completely miss the product and market specificities of vaccines. 

Sibilia Quilici, Executive Director of Vaccines Europe, said: “Vaccines are regulated within the same legislative framework as all medicinal products; therefore, it is important that, in its pharmaceutical strategy for Europe, the EU takes a more holistic approach to health: from prevention to care.” 

The revision of the General Pharmaceutical Legislation is a once-in-a-generation opportunity to equip Europe with the necessary tools to address health challenges of today and tomorrow. Vaccination should be recognised as one of those key tools and vaccine innovation should be incentivised. Vaccines Europe is committed to working with all stakeholders in an open dialogue towards fulfilling its mission to protect people against infectious diseases at all stages of life.  

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