With a new pharmaceutical legislation in the making, Europe finds itself at a crossroads.
This is a critical time for the innovation-driven pharmaceutical industry in Europe. Europe’s R&D investments have significantly fallen behind other regions in the world, most notably the United States and China. In today’s era of breakthrough innovation, the question is not if medical progress will happen, but rather where it will happen, given that the global competition for cutting-edge science and new investments is fierce.
Since 2014, only 56% of new drug innovations have been approved in the EU, compared to 73% in the US. This means that a quarter of the new medicines approved in the US are not approved in the EU and are thus not available to European patients.
With a new European Parliament now elected and an EU legislative framework for medicines currently undergoing its biggest revision in decades, we are at a crossroads. In one direction a continuing - or indeed worsening - of this trend and in the other, a future-proof EU legislation which values, incentivizes, and rewards #innovation, benefiting #patients and ensuring the long-term #competitiveness of the European pharmaceutical industry.
The revision of the EU legislative framework for medicines is an effort, which we, as the pharmaceutical industry, fully support. Initiated to increase patient access to medicines and foster an environment conducive to R&D in Europe, the legislative proposal - reducing Regulatory Data Protection from eight to six years for example - unfortunately fell short of addressing the needs for a thriving innovation-based pharmaceutical industry in and for Europe. The amendments that we have seen more recently by the (former) European Parliament are an improvement, but more is needed and there is much we can learn from others.
Several governments around the world have made the life sciences a strategic priority, which results in venture capital funding for biotech, in fast clearances to start clinical development, quicker approvals and a market that is willing to pay for innovation. In Europe, by contrast, rather than considering innovation in the life sciences an investment we often viewit solely as a cost.
With a new 5-year term for the European Parliament and the Commission ahead of us, the new cohort of decision makers have the opportunity (and responsibility) to (re)set the direction and shape the future of research, development, and manufacturing for decades to come. And with the right legislation and ecosystem in place, we believe that the potential of medical innovation is limitless.
Together with Lars Fruergaard Jørgensen and David Loew, I remain committed to working with the new European Parliament, the EU Member States, and other stakeholders involved to change the trajectory of Europe for the better and strive for a more competitive, healthier, and stronger Europe.
Scientist in rAAV Gene Therapy Toxicity
2moGreat milestone achieved