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An analysis of what to expect from the upcoming review of the EU pharmaceutical legislation

Nov 24, 2021

Ursula von der Leyen

CONTEXT

Health policy experts are currently racing against time to finalise their contributions to one of the most important EU health care reforms in decades, the revision of the general pharmaceutical legislation. This input is particularly welcome given that the last one was twenty years ago and that the world has changed dramatically since then, especially after the Covid-19 pandemic which put the issue of health on the political agenda.

The revision will aim to:

  • Ensure access to affordable medicines
  • Foster innovation, including in areas of unmet medical need
  • Improve security of supply
  • Adapt to new scientific and technological developments
  • Reduce red tape

ANALISIS

Bernard Grimm, Director of Health and Biotechnology at EuropaBio says:

“In this new world of global challenges and accelerating science, the ambition of the review of pharmaceutical legislation in the EU should be to examine how a strong research base can be more effectively translated into disruptive innovation to better meet the health needs of Europeans and to regain the EU’s global leadership as a hotbed of R&D and high-tech industry.”

Three pillars would therefore seem to be necessary for Europe to become a global player in the health sector:

1. A long-term healthcare investment vision is needed

Today, the European pharmaceutical industry is struggling to make its mark in the world. For example, the US generates about three times as many patents for new medicines as Europe, and China about nine times as many. Also, there are almost five times fewer people working in the life sciences sector in Europe than in the US.

For example, small biotech companies need to be able to attract more investment, which necessarily includes investment in research and development of innovative medicines and treatments. Cooperation between the EU, Member States and public and private stakeholders will be key to bringing new treatments to patients more quickly. According to Grimm, “the EU needs to mobilise and attract investment from individuals and pension funds, create critical capacity and infrastructure, foster the transition from laboratories to companies and scale up from high-risk start-ups”.

2. A stronger health innovation ecosystem to be built

The EU has all the resources to create an effective health ecosystem for its population. The challenge now is to set clear societal priorities and directions to ensure that innovation is directed towards the needs of patients and national health systems. There is a need to promote innovation in areas where medical needs are not yet met and to create new R&D models to boost innovation.

3. Accelerated patient access to innovations

This last pillar can only be effectively achieved through the convergence of multidisciplinary sciences and the exploitation of the synergies of advanced technologies, data science and biological knowledge. This new way of working would promote health, predict, and prevent disease and diagnose earlier and make better use of innovative treatments such as advanced therapies.

Therefore, investing in health and biotechnology could be a new turning point for Europe to take its place on the world stage as a world leader, while providing its population with better access to healthcare.