Czech EU Presidency should recognise the importance of IP for the EU
The Czech Republic’s Presidency of the Council of the EU comes at a particularly testing time in world affairs. Prague is faced with the invasion of Ukraine and its effects on food security and energy prices. The agenda is heavy and, given Czechia’s location and history, expectations are high. Looking at our wider role in the world, the Czech Presidency priorities include deepening free trade with reliable trade partners, especially given the negative impact of export controls and supply chain constraints during the COVID-19 pandemic. The EU-US Trade and Technology Council is a great example of where more can be achieved. The priorities also make clear that strengthening strategic resilience is not about self-sufficiency but should instead focus on attracting innovation, diversifying suppliers, and reducing dependencies.
Behind the critical issues of armed conflict, an energy crisis and trade the Czech Presidency is also preparing the ground for one of the biggest overhauls of EU legislation: the review of pharmaceutical rules. The Commission is currently working on legislative proposals to be unveiled next year. The decisions it makes will affect the availability of innovative medicines for Europe’s citizens and the competitiveness of the European biopharmaceutical industry for decades to come.
This is a once in a generation opportunity to bring health and industrial policy together to enhance the health of patients and the EU’s industrial strength. It is strategically and economically important because today only 22% of global new treatments originate in Europe, while 47% come from the US. This represents a complete reversal of the situation just 25 years ago. It now requires investment in research and development and a fast and flexible regulatory process, underpinned by strong and predictable intellectual property (IP). These are essential pre-requisites to attracting and then retaining investment in cutting-edge science and manufacturing processes.
One of the priorities we would like to see from the Czech Republic during the remainder of their Presidency is the recognition thatwithout strong and predictable IP, innovation will continue to migrate to other parts of the world, particularly Asia and the US.
While IP policy is set at EU level, pricing, reimbursement, and market access are national competencies. The root causes of access delay are at a national level. For example, if we take cancer, the latest European Federation of Pharmaceutical Industries and Associations (EFPIA) Waiting to Access Innovative Therapies (W.A.I.T.) data shows that in Czechia, the average patient wait for access to new medicines after EMA marketing authorisation is 573 days. The EMA fast tracks some cancer medicines based on phase 2 clinical data, when there is a clear unmet medical need. Yet at a national level here in the Czech Republic a decision on standard reimbursement is not taken until phase 3 data is available, creating a significant delay. Situations like this can only be addressed nationally.
The publication of the Czech National Oncology Plan in June is a welcome example of how EU policy can be implemented nationally. Closely aligned with the EU’s Europe’s Beating Cancer Plan and given political momentum by the Next Generation EU recovery plan and the Czech Presidency, it prioritises cancer screening and tackling health inequalities with measurable targets. We need to learn from cancer treatment strategies and come together nationally and at a European level to expand on lessons learned. We also need to develop European and national plans for non-communicable diseases including cardiovascular disease, diabetes, obesity and Alzheimer’s disease. The current Czech National Diabetes Plan will expire this year and its renewal is critical to Lilly with its century of heritage in diabetes treatments, but more importantly to the Czech patients we serve.
With the right industrial strategy for the life sciences, and the European Commission and the member states aligned, Europe can still be a world leader in the exciting next generation of scientific discovery and personalised medicines. The current review of EU pharmaceutical rules is an opportunity for the European Commission to ensure that the European Medicines Agency (EMA) has the resources and processes to be faster and more flexible, thereby helping to speed innovation to patients across Europe. For this innovation to take place in the EU there needs to be strong and predictable intellectual property rights and faster and more equitably patient access at the national level.
The pharmaceutical industry has presented its own proposals to address national access issues, including applying for national pricing and reimbursement as soon as practical, and within two years of a central marketing authorisation, where national conditional allow. A portal is in place to track this and identify root causes of national delays. We stand ready to work with others to speed innovation to patients equitably across the EU. As Jakub Dvořáček, Czech Deputy Minister for Health, has recognised “ There is little time, but the industry proposals are viable and feasible so they can fulfil what Europe needs.” [1]
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