World IP Day – Protecting the future of innovation
26.04.22
It all starts with an idea. Every medical innovation that cures a patient or improves their quality of their life is the result of a spark of imagination. Ideas are like seeds: they have great potential for growth, but need the right environment to do so. They need to be nurtured, supported, protected.
Europe has a strong intellectual property (IP) framework designed to suit our societal needs. The ecosystem in which scientific ideas can thrive is complex and delicately balanced in healthcare. It includes patents, supplementary protection certificates (SPCs), regulatory data protection (RDP), as well as tailored rewards for research and development into areas such as rare diseases and diseases that affect children. Each of these nurtures, supports and protects different aspects of innovation.
This sophisticated ecosystem has delivered for patients and for Europe. It has brought new answers to diseases, increased protection through new vaccines as well as helped keep and attract research while supporting a growing number of jobs.
However, today, as we mark World IP Day, there is a sense that our IP environment is under threat in Europe. The cumulative effect of recent changes such as the adoption of an SPC manufacturing waiver, proposals for a COVID-19 vaccine IP waiver, as well as discussions to reduce regulatory data protection, orphan incentives and paediatric rewards, are concerning investors and industry alike and if realised, will severely impact Europe’s attractiveness as a destination for life science investment.
At the same time, medical research has become more complex over time. It now takes around 12-15 years to develop a new drug, at an estimated cost of almost €2 billion. As well as being costly and time-consuming, medicines development is littered with uncertainty.
Addressing patients’ unmet needs
Despite these challenges, there is no denying that strong, predictable and stable IP incentives have played a key role in addressing unmet patient need. Consider HIV, where death rates have fallen by over 80%, transforming HIV/AIDS into a manageable long-term disease. Or think of blood cancer, where CAR-T cell therapy are helping the body to fight back against tumour cells. Even high-risk areas such as Alzheimer’s Disease, where more than 99% of clinical trials fail, continue to attract investment.
IP has helped respond to the pandemic and make Europe more resilient against future outbreaks. Two years ago, on the first World IP Day in the COVID-19 era, I described IP as the driver of the medical innovation needed to find a way out of the pandemic. Cast your mind back to April 2020 when there were no vaccines and no new therapies.
Today, 11.5 billion doses of COVID-19 vaccines have been administered worldwide and an estimated 18 billion total doses will have been produced by the summer. Years of investment in research, supported by IP incentives, allowed the development of mRNA technologies and other vital tools that meant the world was ready to react in a moment of global crisis.
Getting the balance right
Despite the continued evidence that IP protection is delivering for patients, healthcare systems and society, it can be tempting to take medical innovation for granted. Some of the proposals under consideration by the European Commission for the revision of the EU pharmaceutical legislation suggest destabilising or weakening intellectual property rights as a way of addressing issues of access and affordability of medicines.
In our view, reducing certain incentives and attaching conditionality to others would risk accelerating the erosion of Europe’s research base. If pioneering research continues to leave for other regions of the world, so will the opportunity to deliver the best care to patients across Europe, to build resilience and drive growth.
Let’s work together to ensure Europe has the right industrial and pharmaceutical strategy, combined with the stable mix of incentives required to nurture, support and grow the ideas of tomorrow so that they may grow into the solutions patients need.
