Why Europe must future-proof its pharma legislation
Despite a rich history in the discovery of new treatments and vaccines, Europe is going backwards when it comes to medical innovation. As a region, we have been falling behind global competitors in R&D and manufacturing, with lower investment, fewer clinical trials and longer approval times for new medicines for the last 25 years.
That is the stark reality European policy makers face. If we fail to grasp the opportunity afforded by the revision of the EU pharmaceutical legislation, Europe will become a consumer of someone else’s innovation. It means losing high value jobs, investment in European research and manufacturing infrastructure, as well as slower access to new vaccines and treatments for patients across Europe.
Globally, R&D investments are growing, and they are moving out of the European Union.
Of the total R&D investments made in the US, Europe, China and Japan, only 31% of this occurs in Europe. This has declined steadily from 41% in 2001. China, meanwhile, has grown its share from 1% to 8%. In 2002, the US spent $2 billion more than Europe on R&D; today that difference has grown to $25 billion.
The data on clinical trials make for equally grim reading. Europe accounted for a 19.3% share of global clinical trials activity in 2020, a decrease of 6.3%, compared with a 25.6% average over the last ten-years.
However, there is some good news in all of this. The current revision of EU pharmaceutical legislation is a golden opportunity to reverse the trends of the last 25 years. It is our once-in-a-generation chance to reinvent the regulatory framework to ensure we have a modern approach that matches our ambition to be a hub of medical innovation.
It is the opportunity to ensure that Europe stays innovative and competitive by maintaining a robust and predictable intellectual property framework. It is critical that we do not erode Europe’s IP framework, or make elements of it conditional on things that are out with industry’s control. We cannot afford to put a straitjacket on science and R&D in diverse disease areas by creating central definition of Unmet Medical Need in the legislation. New incentives for AMR R&D such as the TEE can make a positive difference to one of the world’s most pressing health emergencies.
Time for the regulatory landscape to evolve
To be clear, the European regulatory system did what it was designed to do. Since its foundation in 1995, the European Medicines Agency (EMA) has recommended the approval of more than 1,500 new medicines that address the needs of patients.
However, time and technology march on. The pace of scientific progress has accelerated in recent years, delivering new classes of medicines and devices, new diagnostic and digital tools – and combinations of the above that were unthinkable when the current rules were written. There have been other changes too: the EU now has 27 Member States – adding complexity to the process.
These factors contribute to a worrying trend that sees Europe lagging behind other leading regulators in terms of agility and speed. For example, on average it takes the EMA 426 days to approve a new active substance, compared to 244 days in the USA, 306 in Canada, 313 in Japan or 315 in Australia. Compared to other regions of the world, in 2021 the EMA had a very low percentage of new active substances approved via expedited reviews: EMA 9%, Canada 26%, Japan 45%, FDA 71%.
What can and must be done?
EFPIA’s Regulatory Road to Innovation sets out 12 concrete proposals to help make Europe a hub of medical innovation. These include:
- harmonising processes that are now too fragmented between EU and national level
- expanding the EMA role where science is evolving (e.g. drug-device combinations)
- addressing any resource gaps related to both current and future workload.
For European citizens, our health systems and our economy, we must act decisively to reverse Europe’s decline in this vital field. The alarm bells are ringing and we must all play our part to reinvent our regulatory environment as part of a wider push to ensure an innovation-friendly ecosystem in Europe.