New data demonstrates the value of regulatory data protection (RDP), and its impact on European competitiveness and patient access to medicines

For innovative health and life science companies, European competitiveness being at the forefront of the agenda in Brussels and beyond could help reverse the loss of cutting-edge science and investment to other parts of the world. 

The COMPET Council Conclusions, adopted on 24 May, highlighted that a future-proof industrial policy for Europe, including a strong intellectual property framework, should be an integral part of the Commission’s agenda in the next mandate. It could be the catalyst to prevent further decline, reverse these trends and build a healthier, more competitive, resilient and strategically autonomous Europe.  

It sends a positive signal that the region wants to keep pace with the medical advances taking place in the US and China.  

Yet despite this welcome focus, and a raft of evidence that demonstrates that investment in European R&D, clinical trials and advanced manufacturing are all going the wrong way, we still have multiple legislative proposals that are set to reduce the competitiveness of the industry that contributes more to the EU trade surplus than any other. This includes weakening European intellectual property (IP) rights. 

Today, we are publishing new data that demonstrates the importance of one aspect of IP –regulatory data protection (RDP) – to Europe, and how it is a key driver of patient access to new medicines and of innovation more widely. 

Currently, Europe has only one area of IP which is appreciably stronger than the US for small molecules: RDP.  

Despite the competitiveness rhetoric, European policymakers are in the process of deciding not whether it’s a good idea to reduce RDP at all, but how much to reduce it by. 

The European Commission proposes 2 years, taking the RDP baseline from 8 to 6 years – seen as a nail in the coffin for European global investment by many – while the European Parliament proposals reduce this to six months. Better, of course, but a backwards step, nonetheless. 

RDP is the last line of IP protection, affecting about a third of all medicines – those with long and complex development - but it is an important factor for companies when planning where to carry out research and development for all medicines.  

New data from Copenhagen Economics explores, in depth, the role of RDP. 

It clearly shows that reducing the duration of RDP in Europe will exacerbate the EU’s inferior competitive position compared with the US, but also that the rationale for doing so is seriously flawed. 

A criticism levelled at RDP is that – according to research by the European Commission - each additional year would cost the EU 1.23 billlion annually, spread across 27 Member States. 

However, in context, across 27 Member States this figure represents just 0.07% of overall EU healthcare spending and represents 0.51% of annual pharmaceutical spending. 

And consider the disease burden that these medicines seek to alleviate; the figure represents 0.44% of the annual cost of cardiovascular disease to the EU and 0.74% of the cost of cancer in the EU. 

The data reaffirms previous studies – using different and multiple methodologies - that under the European Commission’s proposals the EU would stand to lose around two billion Euros in global R&D investment across the 27 Member States every year.  

Major life science hubs, like Germany, France and Belgium, would see the highest costs, however, they are also set to lose the most in investment, with benefits larger than the costs for almost all countries. 

This loss of investment runs completely contrary to the calls from Heads of State and Government, who want to see Europe gain its competitive edge, and it is counterintuitive from an economic perspective. 

Importantly, the research highlights the positive link between RDP and improved availability of medicines and innovation, the combined ambition of the pharmaceutical legislation. 

A study of 53 countries – with and without RDP – shows that patients in countries with RDP have three times higher availability of innovative medicines than those without, and significantly almost half of the difference in availability (45%) can be attributed to RDP. 

A single study shows how in Japan – with an advanced life science ecosystem, comparable with Europe – a six-year RDP baseline was implemented, increasing to eight years in 2007. In subsequent years the number of clinical trials in the country more than doubled. 

Where clinical trials take place matters. They bring quicker access to new therapeutics for patients who may not have access to an existing treatment. Increasing clinical trials creates a more attractive ecosystem for research, attract funds, talent and skills and brings additional revenue to hospitals. 

We would urge EU policy makers to look at these figures and consider the impact before taking decisions that will have a negative effect on the future of our sector and on patients. 

The pharmaceutical industry in Europe has already seen a 25% fall in its share of global R&D investment over the past two decades, clinical trial numbers are down. China now carries out three times more trials for advanced therapies than Europe.  

Previous EFPIA research has already shown that cutting RDP by two years in Europe could pull the plug on clinical research, with as many as 50 out of 225 new medicines that could have been researched in Europe no longer viable.  

We need to stop and reverse these trends.  

Through the revision of the EU Pharmaceutical Legislation, we can ensure that this strategically important industry is not weakened further.  

The global pipeline of new medicines is exciting; personalized treatments, cell and gene therapies, cancer immunotherapies, regenerative medicines, and mRNA vaccines among it.  

If Europe genuinely wants to play a leading role in where these new treatments and technologies are researched and developed - and ensure that Europeans can benefit from them swiftly - it’s time to join the dots. We need to look at all the evidence available and develop coherent strategies for Europe, whether in the context of a new EU industrial deal or in the revision of existing EU legislation. 


Nathalie Moll

Nathalie Moll joined the European Federation of Pharmaceutical Industries and Associations (EFPIA) as Director...
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