Every new treatment, every transformational shift in the outlook for patients starts with the spark of an idea, writes Nathalie Moll.
Nathalie Moll is the director general of the European Federation of Pharmaceutical Industries and Associations (EFPIA).
Turning that idea into a new medicine or treatment takes passion, dedication and commitment. It takes resource, time, energy and expertise. The journey is often littered with uncertainty, setbacks, blind alleys and false horizons.
The process is as long as it is complex and risky. And throughout that journey, to survive, that spark of an idea needs incentives and funding, from the basic research through the phases of clinical development, from multi-centre clinical trials to navigating the regulatory process, paying the researchers and scientists developing your evidence base.
It takes around 12-15 years before that invention can reach the market and you can even think of recouping some of these costs, before getting to day zero.
Before day zero, the spark is only kept alive through investment. And investment only happens if that idea is protected from being freely used by businesses that have taken none of the risk, none of the financial and intellectual investment and spent none of the time that it takes to go from that spark to a groundbreaking new treatment or even a cure.
As a scientist and through my involvement in life science policy I have been around medical innovation all my working life. I know what it takes for companies both large and small to run those risks, to make those choices and to attract investment in the face of fierce competition from life science ecosystems across the world.
In such a risky undertaking, investors look for stability and certainty. Despite Europe’s unparalleled history of medical innovation, recent developments risk making our future less certain.
Intellectual property is the foundation on which all medical innovation is built, it protects the spark. There is no doubt that the Commission’s proposal to introduce an SPC manufacturing waiver sends a damaging signal to global life science investors that Europe is weakening its IP framework.
This, at a time of uncertainty caused by Brexit and shifting political paradigms across the continent. In stark contrast, global competitors are building their life science sectors offerings and developing their IP systems.
For those of us passionate about research and development in Europe, our fear is that sending the message that Europe is weakening IP at a time of uncertainty with increased competition from the US and China has the potential to represent a perfect storm of disinvestment in R&D in Europe.
The impact of a waiver goes beyond a global signal to very tangible impacts on the research-based industry in Europe. Impacts that were not sufficiently assessed as part of the development of the proposal.
The research-based industry currently invests around 35 billion euros every year in R&D in Europe, employing over 700,000 people who collectively contribute around €79 billion to the European balance of payments.
Studies project that implementation of the waiver could result in the loss of between 4,500 and 7,000 jobs employed directly by the research-based industry and the loss of a further 20,000 to 30,000 jobs from companies working with research-based companies.
It would result in a loss of between €1 and €1.85 billion in export sales and see a fall in R&D investment of between €215 and €360 million.
From the adoption of the ENVI committee’s compromise amendments earlier this week to speculation in the media on the likely direction of the Council on the SPC Waiver, there is no doubt that investors will be looking to see if and how Europe values the knowledge-based economy.
If the proposal goes ahead, then there will be intense scrutiny of its implementation to assess if there is any further erosion of IP rights in Europe. Investors will want to see:
- Legal certainty and clarity on the scope of the proposal
- No additional infringement of IP rights by allowing stockpiling of generic or biosimilar medicines still under an SPC patent extension
- A robust system of notification of the innovator company regarding who is doing what, where, and for which export markets
- and critically no application of the waiver to existing property rights or we risk moving the goal posts for life science investors that have committed to Europe in under the existing framework of IP incentives.
The waiver should not apply to any existing SPCs.
I am ambitious and optimistic about Europe’s future as an engine room of medical innovation and that starts with maintaining and developing our world-class IP framework.
Actually, we need to identify new mechanisms that can incentivise investors and innovators to address areas of unmet medical need such as antimicrobial resistance (AMR).
We need to look to one of Europe’s key strengths; scientific collaboration and ensure that we have the right flexible legal frameworks in place to support these collaborations to aim high, think big, break down sectoral barriers and make breakthroughs for patients.
And we need a strategic dialogue across stakeholders on how to maximise the potential of life sciences in Europe to meet the needs of patients, our healthcare systems, our academic and research community and the European economy.