Marcel Lechanteur is President Lilly France, Benelux and EU Affairs. As the EU emerges from the pandemic, the next steps of the European Commission’s Pharmaceutical Strategy will define the EU’s future as a global leader in pharmaceuticals – or not. Marcel shares his views on how the medicines ecosystem in Europe can be reshaped for the benefit of patients.

The next three years are set to be a crucial yet uncertain time for the innovative biopharmaceutical sector. Having collaborated to develop COVID treatments and vaccines, the world is slowly emerging from the worst of the pandemic with the most exciting scientific advancement our industry has ever seen. However, in Europe this advancement is accompanied by the uncertainty of the European Commission’s Pharmaceutical Strategy for Europe. The EU is at a fork in the road. Does it choose to embrace and drive scientific advancement and innovation, underpinned by intellectual property rights and incentives, or does it opt for retrenchment and cost-containment in the face of a COVID driven debt crisis?

Europe can be a world leader in pharmaceuticals once again. There is a regulatory road to innovation through European Medicines Agency (EMA) reform, making the marketing authorisation process faster and more flexible and internationally aligned, as the EMA has demonstrated in the COVID crisis. Most recently, 68% of products were approved in the US by an expedited pathway vs. only 7% for the EMA[1]. The reform represents a golden opportunity for the Commission to drive faster patient access to innovation by c.200 days at the regulatory stage. Another is for Member States to address the root causes of delay in their own pricing and reimbursement systems.

The most recent EFPIA Patients Waiting to Access Innovative Therapies (W.A.I.T.) Indicator Survey shows the average time to access treatments in Europe is as long as 504 days, ranging from an average of 120 days in Germany to over 883 days in Romania. It is unacceptable that certain patients wait seven times longer than those in other countries for access to the same medicine. To this end, it was good to see the recent announcement during a meeting of the CSIS, France’s strategic council on health industries, that France will pilot the German system for innovative medicines with a French rating 1 to 4.  A free pricing system with reference to countries’ ability to pay, and a subsequent value assessment, could be a major step in transforming national patient access. Such changes, underpinned by a dynamic EU life
sciences strategy, would place the EU on the world stage as an innovation leader.  

The Commission has already started their legislative follow up to the Pharmaceutical Strategy. Officials are currently analysing the responses submitted to the roadmap – including our submission – and have recently launched a public consultation based on the findings. New legislation could then be proposed before the end of 2022.

The outcome of the elections in Germany and France give the citizens of these global economic powerhouses their say over the future direction of the EU. My hope is that advancement triumphs over retrenchment. Why? Because the work at EU level presents huge opportunities for patients, innovation and the European Union as a whole. With the prospect of new legislation, it’s a good time to reiterate our thoughts on how the EU can become a global leader in biopharmaceuticals. Here are our four priorities to set the future framework
for healthcare:

1. Future-proofed system

The EU needs flexible, well-resourced policies to ensure its regulatory system is efficient, effective and globally competitive. The current framework is fragmented, cumbersome and complex in comparison to those that exist elsewhere. Proactive policies and updated infrastructure are required for regulation to modernise, so cutting-edge approaches like innovative clinical trial designs, real world data evidence and cloud-based submissions can be enabled. The pandemic has shown how innovative the biopharmaceutical industry can be when given the tools and opportunity. It’s time for the EU to show this adaptability
as standard.

2. Competitive timelines

Simply put, it takes too long for medicines to be approved in the EU. In 2019, it took 423 days for the EMA to approve a new medicine, compared to just 243 days in the USA[2]. The pandemic has shown how quickly medicines can be approved when there is an appetite to do so. While Covid-19 is an extraordinary situation, things like shortening procedures across the board (such as moving from 67 days to seven days for final decision) can streamline the process and ensure Europeans have timely access to new medicines they need. Similarly, the impact of PRIME – the EMA’s scheme to enhance support for the development of medicines – would be greater if it were accessible to any product, indication or company from an early stage of development.

3. Resilient supply chains

80% of EU27 pharmaceutical imports come from Europe, as do over 70% of active pharmaceutical ingredients[3]. While being self-sufficient is positive, open trade is at the heart of the European project, and the EU’s commitment to it can help to keep global supply
chains of medicines and their raw materials flexible. A geographically diverse supply chain will protect against shortages and allow consistent access to the resources that are needed. If a natural disaster or another health crisis strikes, this will allow the innovative industry to adjust accordingly and avoid disruptions to production.

4. IP incentives

IP incentives play a crucial role in encouraging research into new medicines and investment in R&D in Europe. The various incentives work together across differentiated opportunities for new, innovative medicines that can help to address the unmet medical needs (UMNs) of patients in all areas, including those for rare diseases and children. Unfortunately, there are
still many UMNs to be tackled, and IP incentives are critical to ensuring this happens. Predictable incentives are key at the point of investment, and any additional incentives for UMNs should take this into account. 

Next steps

As the development of new pharmaceutical legislation at EU level progresses, we stand ready to help progress the debate and provide industry insight and knowledge. Read our solutions for improving the EU medicines ecosystem, making life better for patients, and facilitating the EU’s leadership in life sciences in more detail here.

[1] 2020 CIRS, R&D Briefing 77