1. IP is the foundation on which all medical innovation is built. Without IP, there would be no new medical breakthroughs. That is because it generally takes 12-15 years and costs more than €2 billion to develop a new drug. IP protection offers a vital incentive to invest in medical innovation. Thanks to IP, we have seen improved survival rates in blood cancers, the development of COVID-19 vaccines, and continued investment in high-risk areas such as Alzheimer’s disease. 
   
   

2. There are many forms of IP protection, and all play an important role. Patents, supplementary protection certificates (SPCs), Regulatory Data Protection (RDP), and incentives for developing medicines for children and for rare diseases, combine to form an effective innovation ecosystem. As you can see in the graph below, the incentives mostly run in parallel, each protecting their own piece of the puzzle.
   
   
   

3. The IP framework allows for the sharing of information. Patents simultaneously protect and disclose an invention. That is because patents facilitate technology transfer through licensing and other arrangements, and they prevent competitors and potential licensees from ‘free riding’ on other innovators’ investments. The patent system thus makes important discoveries public, so that they can be used by anyone once the patent expires. The RDP system in the EU allows manufacturers of generic and biosimilar medicines to reference the innovators’ safety and efficacy data in follow-on marketing authorisation applications, saving them from having to fund their own costly clinical studies. Rather than being an obstacle to sharing knowledge, IP has a role in enabling successful collaborations.

4. IP is critical to the EU’s competitive advantage, fostering investment by high-tech industries and creating wealth and jobs​. IP-intensive industries constitute 44.8% of EU GDP and generate 38.9% of total EU employment​. Pharma invests €39 bn per year in R&D in Europe. The pharmaceutical sector is the most R&D intensive industry in the world, spending a greter percentage (15%) of its revenue on R&D than anyother sectior.
   
   
5. A strong IP framework is correlated with increased clinical trial activity. This, in turn, brings both clinical and economic benefits.

6. In the pharmaceutical sector, around half of the 20-year patent term is spent on clinical trials – before they can be made available to patients. Recognising this disadvantage, the EU introduced SPCs, which extends market exclusivity for up to five years. Between 1996 and 2016, the time taken to develop new medicines has increased meaning that the effective protection period has declined from an average of 15 to 13 years. The SPC system has never been more relevant.

7. IP helps prepare the world to respond to health emergencies. The substantial investment in R&D by multiple actors over many years into novel technologies (such as mRNA) would not have occurred without the robust IP system in the EU and some other countries. Patents provided the incentives for high-risk investments and the legal framework essential for the hundreds of collaborations required to produce novel vaccines and therapies.

8. Waiving IP rights will not help increase global vaccination rates. Overwhelming evidence shows that there is more than enough global vaccine production capacity to vaccinate the world in 2022, and the WHO has publicly stated that supply is not an issue. That is partly thanks to the 357 voluntary licensing agreements that allowed for the rapid scale up of production. Vaccine production is not a bottleneck – the issue is vaccine deployment, equitable distribution, and uptake. The European Patent Office says an IP waiver would lead to a 37% drop in R&D for COVID-19 related pharmaceutical and biotech products. Waiving IP rights for this pandemic will only seriously weaken intellectual property and have negative, unintended consequences for future pandemics.

9. IP supports vaccine confidence by reducing the risk of counterfeit vaccines. Public trust in vaccine safety is vital to uptake. By protecting IP, authorities can prevent counterfeit vaccines entering the supply chain around the world.

10. The IP framework and incentive system we built in the EU is one to be proud of. The stability of the current system has supported the pharmaceutical industry to invest in research and development, and to deliver new despite lengthy, costly, and risky development processes. 

For me, the take-away message is clear. To continue to attract investments into Europe and deliver the next generation of innovation, the IP and incentives ecosystem must remain world-class, robust, and predictable. Personally, I cannot wait to see what will be possible in the future.