The Commission plans to launch an EU Pharmaceutical Strategy to ensure Europe’s supply of safe and affordable medicines can meet patients’ needs and to secure Europe’s pharmaceutical industry as an innovator and world leader.

The Commission notes “the unprecedented coronavirus pandemic clearly demonstrates the need to modernise the way the EU ensures access to medicines for its population”.

Our submission on the proposal this week calls on the Commission to put innovation in humane and human-relevant safety and efficacy at the heart of the strategy.

We think the pharmaceutical sector will continue to struggle to respond to long term health issues such as our aging population and new pandemics like coronavirus unless it invests in better ways to predict the safety and effectiveness of new medicines.

Using animal research to find solutions to some of our ageing populations most important health problems such as cancer, dementia and cardiovascular disease has proved notoriously poor. Due to species differences including their shorter life spans, animals such as rats, dogs and even monkeys do not suffer from human diseases such as Alzheimer’s and Parkinson’s which must be induced artificially.

Despite decades of research in these areas using animals, we have no cure and have made little progress on effective treatments. We call on the Commission to:

• Put Innovation in safety and efficacy and specifically the replacement of animal testing in this strategy.
• Ensure the principles of ‘Promotion of Alternative Methods’ and ‘Animal testing as a Last resort’ (found in the EU REACH chemicals legislation) are embedded in the strategy, including considerations about funding, coordination of research and regulatory reform.
• Ensure Horizon Europe prioritises non-animal methods so that the EU can regain its leadership in this area, currently being overtaken by efforts in the US.
• Review the Medicines Directive 2001/83/EC, so that technological advances related to replacement of animal testing can be safely and efficiently accommodated.
• Give the European Medicines Agency similar powers to the European Chemicals Agency in ensuring ‘Promotion of Alternative Methods’ and ‘Animal Testing as a Last Resort’, including formalising a dedicated working group.
• Build regulatory change and increased investment in non-animal methods into the EU’s plans to restore resilience and competitiveness post-coronavirus.