The review of the general pharmaceutical legislation: an opportunity that should not be missed?

DISCLAIMER: All opinions in this column reflect the views of the author(s), not of EURACTIV Media network.

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By Bernard J. Grimm, Healthcare Biotechnology Director, EuropaBio

This year, the end of December will not only mark the Holiday rush, preparation of family gatherings and last attempts to buy presents – at least for the healthcare policy specialists. Instead of rushing to the Christmas markets, most of them will be busy finalising their contributions to one of the most important EU healthcare reforms in decades – the revision of the general pharmaceutical legislation.

The last comprehensive review of the pharmaceutical legislation was tabled almost 20 years ago. Since then, the world has changed: the pandemic has put health in the centre of the political agenda and has emphasised the tight link between health and well-being of citizens and the economy.

The recent Covid-19 crisis has also accelerated adoption of new technologies. Science and innovation including biological advances, computing bioinformatics and AI are transforming the world.

In this new world of global challenges and accelerated science, the ambition of the revision of the pharmaceutical legislation in the EU should be to look into how a strong research base can be more efficiently translated into breakthrough innovation to better address the health needs of Europeans and to regain EU’s global leadership as a home for R&D and cutting-edge industry.

How can we make the best of such an opportunity?

A long term healthcare investment vision is needed

Today Europe spends 6.9 b euro on public research compared to 28.4b in the United States. The United States generates about three times as many patents for new medicines as Europe, and China about nine times as many. Life sciences and biotechnology Venture capital is four times larger in the US than in Europe.

There are nearly five times fewer life sciences staff in Europe than in the U.S. At the same time, European biotechnology companies were responsible for less than one-sixth of the new drugs approved by the US Food and Drug Administration in recent years.

Europe‘s share of new drugs could grow if its small biotechnology companies were able to attract more investments in comparison to other regions of the world. To do so, investment in research and development for innovative medicines and treatments is essential.

The EU, member states, public and private stakeholders should work together to make new treatments available to patients faster. For this, the EU needs to mobilise and attract retail and pension funds investments, create critical capabilities and infrastructures, foster the transition from laboratories to enterprises and scale up from high-risk start-ups.

A stronger health innovation ecosystem to be built

Healthcare is experiencing a major paradigm shift, from traditional one-size-fits-all medical care to personalized medicine tailored to the genomic, molecular, and lifestyle characteristics of individual patients.

Harnessing data offers biopharmaceutical companies a deeper understanding of disease pathways and helps develop safer treatments faster. As a result, cellular therapies, gene therapies and genome editing are a reality today.

The fundamentals of a future health ecosystem are available in the EU and need to be further developed. They start from clear societal focus and priorities to ensure innovation is directed to patients and national health systems needs.

We need to tailor additional incentives to stimulate innovation in unmet medical need areas, look at innovation processes on data access and novel trial designs, create collaborative R&D models and assess healthcare outcomes on value rather than volumes.

Accelerated patient access to innovations

But it takes too much time for these health advancements to reach the patients and the speed varies from country to country throughout the EU. Let’s take an example of treatments tackling rare diseases which affect more than 30 million Europeans today. It takes between 10 and 15 years to develop a new treatment and even more years in ensuring patients’ access to them.

If we want to unlock the full power of new advances in health innovations and accelerate the speed of transformation a sound, flexible and coherent regulatory system based on better coordination between member states and streamlined processes would make a difference.

It is by accelerating the convergence of multi-disciplinary sciences and leveraging synergies of advanced technologies, data science and knowledge of biology that we will better promote health, predict and prevent diseases and diagnose earlier and make the best use of innovative treatments such as advanced therapies.

To conclude…

In a period of such rapid change and innovation, investing in the strong EU life sciences and biotechnology sector from basic research to effective product development should be fully prioritized if we aim for the EU pharmaceutical industry to regain its leadership at the global stage. To address the many patients’ unmet needs innovation must be stimulated at its source first.

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